Highlights

“We experienced a 25% decline in net revenues in 2025 as compared to 2024 due to ongoing competition from generic L-Glutamine in the U.S., partially offset by an increase of sales in the Middle East North Africa, or MENA, region,” commented Willis Lee, Chairman and Chief Executive Officer of Emmaus. “We nonetheless realized income from operations of $0.2 million compared to loss from operations of $1.9 million in the prior year due to a 34% reduction in operating expenses. We believe the international markets offer greater growth potential and have undertaken a change in strategy for our U.S. operations going forward by entering into a license and exclusive distribution arrangement with NeoImmuneTech, Inc. which we expect to be fully implemented in the second quarter of this year,” he added.

Financial and Operating Results

Net Revenues. Net revenues for the year ended December 31, 2025 were $12.5 million, compared to $16.7 million in the same period in 2024. The decrease was due to a decrease in U.S. sales which management attributes primarily to competition from the generic version of L-Glutamine introduced in the market in mid-2024 partially offset by an increase of sales in the MENA region.

Operating Expenses. Total operating expenses for the year ended were $11.4 million compared to $17.3 million in the comparable period in 2024. The decrease was due to a headcount reduction and other cost cutting measures.

Income (Loss) From Operations. Income from operations for the year ended December 31, 2025 was $0.2 million compared to loss from operations of $1.9 million in the same period in 2024. This was due to lower operating expenses, which more than offset the decrease in net revenues.

Other Expense. The company realized other expense of $7.5 million for the year ended December 31, 2025 compared to $4.5 million in the same period in 2024. The increase was primarily due to increases of $1.4 million in loss on debt extinguishment and $1.4 million in interest expense, and a decrease of $1.0 million in gain on restructured debt, partially offset by an increase of $0.9 million in gain on lease modification.

Net Loss. For the year ended December 31, 2025, the company realized net loss of $7.2 million, or $0.11 per share based on approximately 64.0 million weighted-average basic common shares, compared to net loss of $6.5 million, or $0.10 per share based on approximately 63.2 million weighted-average basic common shares in 2024. The increase in net loss was attributable primarily to the increase in other expenses.

Liquidity and Capital Resources. At December 31, 2025, the company had cash and cash equivalents of $2.1 million, compared to $1.4 million at December 31, 2024.

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.com/PI.

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

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.

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. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including doubt about the company’s ability to continue as a going concern, uncertainties regarding the implementation of the change in strategy for our U.S., operations and commercialization efforts in the MENA region, and other factors disclosed in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260330024056/en/

Company Contact:
Emmaus Life Sciences, Inc.
Investor Relations
(310) 214-0065
IR@emmauslifesciences.com

Source: Emmaus Life Sciences, Inc.

TORRANCE, Calif.--(BUSINESS WIRE)-- Emmaus Life Sciences, Inc. (OTCQB: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today announced that it has entered into a License and Exclusive Distribution Agreement with NeoImmuneTech, Inc. (KOSDAQ:950220), or NIT, pursuant to which Emmaus has granted NIT an exclusive license to all rights to market, sell and distribute Endari® (prescription grade L-glutamine oral powder) and any generic equivalents in sickle cell disease in the U.S., its territories, and Canada in exchange for a upfront payment and a royalty on NIT’s product sales.

The effective date is subject to NIT’s obtaining the necessary regulatory approvals and licensing to sell and distribute the products and other specified conditions.

“Emmaus has continuously reassessed its commercialization strategy to maximize global value of Endari®. While the U.S. market represents a mature and stable revenue base, we believe other regions such as the Middle East, Brazil, and Europe offer greater growth potential,” commented Willis Lee, Chairman and Chief Executive Officer of Emmaus.

Tae Woo Kim, Acting Chief Executive Officer of NeoImmuneTech, said, “The completion of this definitive agreement is highly meaningful, as it establishes a foundation for direct commercialization of an FDA-approved therapy. The U.S. distribution, reimbursement, and marketing infrastructure built through Endari® will also create significant synergies for the future commercialization of our proprietary pipeline, including NT-I7.”

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 NeoImmuneTech, Inc.

NeoImmuneTech, Inc. (NIT) is a clinical-stage biopharmaceutical company specializing in T cell-based immunotherapy, with a mission to expand the potential of immuno-oncology and enhance immune responses to infectious diseases. Backed by a seasoned leadership team, NIT is advancing NT-I7 across multiple programs as a monotherapy and in combination with other immunotherapeutics. To learn more, please visit www.neoimmunetech.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.com/PI.

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

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.

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. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the possibility that the effective date of the License and Exclusive Distribution Agreement will not occur and doubt about Emmaus’s ability to continue as a going concern and other factors disclosed in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on April 14, 2025 and Quarterly Report on Form 10-Q filed on November 14, 2025, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251230947552/en/

Emmaus Contact:
Emmaus Life Sciences, Inc.
Investor Relations
(310) 214-0065
IR@emmauslifesciences.com

NeoImmuneTech Contact:
IR@neoimmunetech.com

Source: Emmaus Life Sciences, Inc.

TORRANCE, Calif., Nov. 14, 2025 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQB: 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, 2025.

Highlights

"We experienced a 38% decline in net revenues for the three months ended September 30, 2025 as compared to the same period in 2024 due to ongoing competition from generic L-Glutamine in the U.S. and lower sales in the Middle East North Africa, or MENA, region," commented Willis Lee, Chairman and Chief Executive Officer of Emmaus. "We realized income from operations of $0.7 million compared to $0.8 million in the prior year, partially offset by a 43% reduction in operating expenses," he added.

Financial and Operating Results

Net Revenues. Net revenues for the three months ended September 30, 2025 were $3.4 million, compared to $5.5 million in the same period in 2024. The decrease was due to a decrease in U.S. sales which management attributes to competition from the generic version of L-Glutamine introduced in the market in mid-2024 and a decrease of sales in the MENA region, which management attributes to the timing of sales in the region.

Operating Expenses. Total operating expenses for the three months were $2.4 million compared to $4.3 million in the comparable period in 2024. The decrease was due primarily to decreases in selling expenses and general and administrative expenses attributable to a reduction in force and other cost cutting measures in the second half of 2024.

Income (Loss) From Operations. Income from operations for the three months was $0.7 million compared to $0.8 million in the same period in 2024.  This was due to the decrease in net revenues, partially offset by lower operating expenses.

Other Income ( Expense ) . The company realized other expense of $2.2 million for the three months compared to other income of $1.0 million in the same period in 2024. The increase in other expense was due to a decrease of $2.3 million in change in fair value of conversion feature derivative liabilities and increases in $0.6 million in interest expense and $0.3 million in loss on debt extinguishment.

Net Loss. For the three months, the company realized net loss of $2.1 million, or $0.03 per share based on approximately 63.9 million weighted-average basic common shares, compared to net income of $1.8 million, or $0.03 per share based on approximately 63.9 million weighted-average basic common shares in the comparable period in 2024. The increase in net loss was attributable primarily to the increase in other expense. 

Liquidity and Capital Resources. At September 30, 2025, the company had cash and cash equivalents of $0.3 million, compared to $1.4 million at December 31, 2024. 

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.com/PI.

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

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.

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. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including doubt about the company's ability to continue as a going concern  and other factors disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on April 14, 2025 and Quarterly Report on Form 10-Q filed on November 14, 2025, 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.
Investor Relations
(310) 214-0065
IR@emmauslifesciences.com 

(Financial Tables Follow)

View original content to download multimedia:https://www.prnewswire.com/news-releases/emmaus-life-sciences-reports-quarterly-financial-results-302616058.html

SOURCE Emmaus Life Sciences, Inc.

TORRANCE, Calif., Aug. 14, 2025 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQB: 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 six months ended June 30, 2025.

Highlights

"We experienced a 48% decline in net revenue for the three months ended June 30, 2025 as compared to the same period in 2024 due to ongoing competition from generic L-Glutamine, partially offset by a 33% reduction in operating expenses," commented Willis Lee, Chairman and Chief Executive Officer of Emmaus. "We realized loss from operations of $0.4 million compared to income from operations of $0.6 million in the prior year," he added.

Financial and Operating Results

Net Revenues. Net revenues for the three months ended June 30, 2025 were $2.8 million, compared to $5.4 million in the same period in 2024. The decrease was due to a decrease in U.S. sales which management attributes to competition from the generic version of L-Glutamine introduced in the market in mid-2024.

Operating Expenses. Total operating expenses for the three months were $3.0 million compared to $4.6 million in the comparable period in 2024. The decrease was due primarily to decreases in selling expenses and general and administrative expenses attributable to a reduction in force in Q4 2024.

Income (Loss) From Operations. Total loss from operations for the three months was $0.4 million compared to income from operation of $0.6 million in the same period in 2024.  This was due to the decrease in net revenues.

Other Expense. The company realized other expense of $1.4 million for the three months compared to $2.7 million in the same period in 2024. The decrease was due primarily to a decrease of $1.4 million in change in fair value of conversion feature derivative liabilities and an increase in decreases in $0.9 million nonrecurring gain recognized on lease modification of the Torrance headquarter office lease partially offset by $0.7 million increase in interest expenses.

Net Loss. For the three months, the company realized net loss of $1.1 million, or $0.02 per share based on approximately 63.9 million weighted-average basic common shares, compared to net loss of $2.2 million, or $0.03 per share based on approximately 63.4 million weighted-average basic common shares in the comparable period in 2024. The decreased net loss was attributable to the decrease in other expense. 

Liquidity and Capital Resources. At June 30, 2025, the company had cash and cash equivalents of $0.9 million, compared to $1.4 million at December 31, 2024. 

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.com/PI.

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

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.

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 recent trend in net revenues . These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including doubt about the company's ability to continue as a going concern  and other factors disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on April 14, 2025 and Quarterly Report on Form 10-Q filed on August 14, 2025, 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.
Investor Relations
(310) 214-0065
IR@emmauslifesciences.com 

(Financial Tables Follow)

View original content to download multimedia:https://www.prnewswire.com/news-releases/emmaus-life-sciences-reports-quarterly-financial-results-302530517.html

SOURCE Emmaus Life Sciences, Inc.

Changes Based on Additional Pharmacokinetics Data

TORRANCE, Calif., June 26, 2025 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQB: EMMA), a leader in sickle cell disease treatment, announced today that it has received Food and Drug Administration (FDA) approval for changes to the labelling of Endari® to reflect additional prescribing information derived from post-marketing pharmacokinetic study data submitted by Emmaus. The additional information provides a more comprehensive characterization of Endari, including confirmation of dosing by body weight, no unwanted accumulation through twice daily dosing, and the ability to administer Endari with or without food. Endari® is approved in the U.S. and elsewhere to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.

About Emmaus Life Sciences

Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company focused on the discovery, development, marketing, and sale of innovative treatments and therapies, including those for rare and orphan diseases.  For more information, please visit www.emmausmedical.com.

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

Indication - Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients aged five years 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.com/PI.

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

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.

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 safety of Endari. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the risks and other factors previously disclosed in the company's reports filed with the Securities and Exchange Commission, 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.
Investor Relations
IR@emmauslifesciences.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/emmaus-life-sciences-receives-fda-approval-for-endari-label-enhancements-302491840.html

SOURCE Emmaus Life Sciences, Inc.

TORRANCE, Calif., May 15, 2025 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQB: 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 months ended March 31, 2025.

Highlights

"We are pleased to report that our Q1 2025 net revenues were comparable to the same period last year," commented Willis Lee, Chairman and Chief Executive Officer of Emmaus. "We also improved the loss from operations to less than $1 million in the first quarter," he added.

Financial and Operating Results

Net Revenues. Net revenues for the three months ended March 31, 2025 were $2.4 million, compared to $2.5 million in the same period in 2024.  The slight decrease was due to a decrease in U.S. sales which management attributes to competition from the generic version of L-Glutamine introduced in the market in mid-2024.

Operating Expenses. Total operating expenses for the three months were $3.2 million compared to $5.0 million in the comparable period in 2024. The decrease was due primarily to decreases in selling expenses and general and administrative expenses attributable to a reduction in force in Q4 2024.

Loss From Operations. We realized markedly improved loss from operations for the three months of $1.0 million compared to $2.7 million in the same period in 2024.  The improvement was due primarily to the reduction in operating expenses.

Other Expense. The company realized other expense of $1.3 million for the three months compared to $1.6 million in the same period in 2023. The decrease was due primarily to an improvement in change in fair value of conversion feature derivative liabilities, note payable, largely offset by the nonrecurrence of a gain on restructured debt realized in the same period in 2024.

Net Loss. For the three months, the company realized net loss of $2.3 million, or $0.04 per share based on approximately 63.9 million weighted-average basic common shares, compared to $4.3 million, or $0.07 per share based on approximately 61.8 million weighted-average basic common shares in the comparable period in 2024. The reduced net loss was primarily attributable to the decrease in loss from operations and, to a lesser extent, the decrease in other expense. 

Liquidity and Capital Resources. At March 31, 2025, the company had cash and cash equivalents of $1.3 million, compared to $1.4 million at December 31, 2024. 

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.com/PI.

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

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.

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 recent trend in net revenues. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the company's need to restructure or refinance its indebtedness included in current liabilities and raise additional funds from related-party loans, third-party loans or other financing to meet its current liabilities and fund its business and operations and doubt about the company's ability to continue as a going concern  and other factors disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on April 14, 2025, 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.                                       
Investor Relations                                         
(310) 214-0065                                               
IR@emmauslifesciences.com

(Financial Tables Follow)

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SOURCE Emmaus Life Sciences, Inc.

TORRANCE, Calif., April 14, 2025 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQB: 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 year ended December 31, 2024.

Recent Highlights

"We experienced a decline of nearly 44% in net revenues in 2024 as compared to 2023 due to a lack of available inventory that began early in 2024 and extended into the third quarter.  Although sales rebounded once the shortage was resolved, they could not make up for the lost sales earlier in the year," remarked Willis Lee, Chairman of the Board and Chief Executive Officer of Emmaus. "The decline in net revenues was partially offset by a nearly 30% reduction in net operating expenses, resulting in a loss from operations of approximately $1.9 million as compared to income from operations of approximately $3.5 million in 2023.  The second half of 2024 yielded slightly positive income from operations.  Net loss per share increased somewhat to $0.10 from $0.07 in 2023," he added.

"We believe we have sufficient inventory on hand for the balance of 2025, and currently expect net revenues for the year to reach or exceed 2024 levels absent unexpected developments," noted Mr. Lee.

Financial and Operating Results

Net Revenues. Net revenues for the year were $16.7 million compared to $29.6 million in 2023.  The decreased net revenues were attributable to the inventory shortages that existed throughout much of 2024. No similar widespread shortages were experienced in 2023.

Operating Expenses. Total operating expenses for the year were $17.3 million compared with $24.7 million in 2023. The decrease was due to decreases of $4.2 million in general and administrative expenses and $2.6 million in selling expenses attributable to reduced headcount and a decrease of $0.5 million in research and development expenses due to the suspension of substantially all research and development activities in late 2023.

Income From Operations. Loss from operations for the year was $1.9 million compared to income from operations of $3.5 million in 2023.  The decrease resulted from decreased net revenues, partially offset by the decrease in total operating expenses compared to 2023.

Other Expense. The company incurred other expense of $4.5 million for the year compared to $7.3 million in 2023. The decrease was due primarily to an increase of $1.0 million in gain on restructured debt and decreases of $1.9 million in interest expenses, $1.7 million in net loss on equity method investment and $1.6 million in foreign exchange loss, partially offset by a $2.5 million change in fair value of conversion feature derivative liability and $1.1 million in change in fair value of warrant derivative liabilities.

Net Loss. For the year, the company realized net loss of $6.5 million, or $0.10 per share based on approximately 63.2 million weighted average basic and diluted common shares, compared a net loss of $3.7 million, or $0.07 per share based on approximately 53.1 million weighted average basic and diluted common shares in 2023. The increase in net loss was attributable to the loss from operations, partially offset by the decrease in other expense.

Liquidity and Capital Resources. At December 31, 2024, the company had cash and cash equivalents of $1.4 million, compared with $2.5 million at December 31, 2023. 

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.com/PI.

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

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.

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 outlook for sales in 2025. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the company's need to restructure or refinance its existing indebtedness and raise additional funds from related-party loans, third-party loans or other financing to meet its current liabilities and fund its business and operations and doubt about the company's ability to continue as a going concern  and other factors disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2024, 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.
Investor Relations
(310) 214-0065
IR@emmauslifesciences.com 

(Financial Tables Follow)

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SOURCE Emmaus Life Sciences, Inc.

Initial One-Year Exclusivity Period Will Be Extended to Three Years if Endari is Approved for Marketing

TORRANCE, Calif., Jan. 29, 2025 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQB: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, announced today that its Endari® (L-glutamine oral powder) has been afforded market exclusivity in the Kingdom of Saudi Arabia, or KSA, by the National Uniform Procurement Agency, or NUPCO (NUPCO Tender No. 014/24 COMPLIMENTARY PHARMA TENDER January 09, 2025).  NUPCO, KSA's unified purchasing system, extends to all KSA government institutions, including hospitals under the Ministry of Health, Military Hospitals, the National Guard, the Security Forces, and King Faisal Specialty Hospitals and Research Centers.

"We are honored and pleased that NUPCO has selected Endari as the exclusive L-glutamine prescription therapy to treat sickle cell disease in the large addressable market of affected patients in KSA's healthcare system," commented Willis Lee, Chairman and Chief Executive Officer of Emmaus.

"While the exclusivity period will be for an initial period of one, we are informed that it will be extended for an additional two years if our pending marketing registration for Endari is approved in the KSA," added Charles W. Stark, Pharm. D., Executive Vice President and Chief Scientific Officer.

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.com/PI.

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

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.

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 possibility of marketing approval for Endari in the KSA. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the company's need to restructure or refinance its existing indebtedness and raise additional funds from related-party loans, third-party loans or other financing to meet its current liabilities and fund its business and operations and doubt about the company's ability to continue as a going concern  and other factors disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2023 and Quarterly Reports on Form 10-Q for the quarter ended September 30, 2024, 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.
Investor Relations
(310) 214-0065
IR@emmauslifesciences.com

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SOURCE Emmaus Life Sciences, Inc.

TORRANCE, Calif., Nov. 19, 2024 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQB: 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, 2024.

Highlights

"We are pleased to report that we were able to resume inventory production and fulfill back orders in August which led to increases of $0.5 million, or 9%, and $0.8 million, or over 3000%, in net revenues and income from operations, respectively, as compared to the same period a year earlier and net income of $1.8 million, an increase of 2,626% as compared to Q3 2023," commented Willis Lee, Chairman and Chief Executive Officer of Emmaus. "We expect net revenues and income from operations to stabilize in Q4.  Due to the inventory shortages we suffered earlier this year, net revenues for the nine months ended September 30 decreased 41% as compared to 2023 and we realized a loss from operations as compared to income from operations in the prior year. We expect results of operations for the full year to be materially lower than in 2023 for the same reason. Our Endari U.S. sales in Q3 may have been adversely affected by the launch in July of a competing generic L-Glutamine Oral Powder, and we are continuing to assess the possible effect on future Endari sales and net revenues and steps to bolster Endari sales," he added.

Financial and Operating Results

Net Revenues. Net revenues for the three months ended September 30 were $5.5 million, compared to $5.0 million in the same period in 2023.  The increase was due to an increase in sales in the Middle East North Africa region, partially offset by a decrease in U.S. sales which management attributes to competition from a generic product.

Operating Expenses. Total operating expenses for the three months were $4.3 million compared to $4.8 million in the comparable period in 2023. The decrease was due primarily to a decrease in clinical research organization expenses. Total operating expenses for the nine months were $13.8 million compared to $19.2 million in the comparable period in 2023. The decrease was due primarily to a $2.3 million decrease in payroll expenses including share-based compensation.

Income (Loss) From Operations. We realized income from operations for the three months of $0.8 million compared to income from operations of $0.02 million in the same period in 2023.  The increase was due to the $0.5 million increase in net revenues and $0.5 million decrease in operating expenses. We recorded a $1.3 million loss from operations for the nine months ended September 30, 2024 compared to $2.2 million of income from operations for the same period last year. The decrease resulted from the $9.2 million decrease in net revenues, partially offset by the $5.4 million decrease in operating expenses.

Other Income (Expense). The company realized other income of $1.0 million for the three months compared to $0.08 million in the same period in 2023. The increase was due primarily to decreases of $0.7 million in foreign exchange loss, $0.6 million in interest expense and $0.6 million in loss on debt extinguishment, partially offset by a decrease of $0.4 million in change in fair value of conversion feature derivative liabilities. Other expense for the nine months ended September 30, 2024 decreased to $3.3 million from $7.1 million in the same period in 2023 due primarily to an increase of $1.0 million in gain on restructured debt and decreases of $3.2 million in foreign exchange loss and $1.0 million in interest expenses, partially offset by an increase of $2.2 million  in change in fair value of conversion feature derivative liabilities from a $2.1 million decrease in 2023 to a $0.1 million increase in 2024.

Net Income (Loss). For the three months, the company realized net income of $1.8 million, or $0.03 per share based on approximately 63.9 million weighted average basic common shares, compared to net income of $0.07 million, or $0.00 per share based on approximately 53.6 million weighted average basic common shares in the comparable period in 2023. The increase in net income was primarily attributable to the increases in income from operations and other income. For the nine months ended September 30, 2024, the company reported a net loss of $4.7 million, or $0.07 per share, based on approximately 63.0 million weighted average basic common shares. This compares to a net loss of $4.9 million, or $0.09 per share, based on approximately 52.4 million weighted average basic common shares for the nine months ended September 30, 2023. The decrease was primarily due to the decreases of $5.4 million in operating expenses and $3.7 million in other expenses, partially offset by the decrease in net revenues of $9.2 million.

Liquidity and Capital Resources. At September 30, 2024, the company had cash and cash equivalents of $1.3 million, compared to $2.5 million at December 31, 2023. 

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.com/PI.

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

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.

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 expected net revenues for the full year 2024 and the possible effect on Endari sales and net revenues of the introduction of competing generic drugs. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the company's need to restructure or refinance its existing indebtedness and raise additional funds from related-party loans, third-party loans or other financing to meet its current liabilities and fund its business and operations and doubt about the company's ability to continue as a going concern  and other factors disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2023 and Quarterly Reports on Form 10-Q for the quarter ended September 30, 2024, 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.                                       
Investor Relations                                                                                                 
(310) 214-0065                                               
IR@emmauslifesciences.com

(Financial Tables Follow)                 

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SOURCE Emmaus Life Sciences, Inc.

TORRANCE, Calif., Sept. 10, 2024 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTC Markets: 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 year quarters ended March 31 and June 30, 2024.

Recent Highlights

"As previously reported, after increasing annual net revenues in 2023 by nearly 61% as compared to 2022 we suffered a 55% decline in net revenues for the six months ended June 30 due to a prolonged shortage of inventory beginning in February and a further interruption in Supply beginning in mid-June that extended into August," noted Willis Lee, Chairman and Chief Executive Officer of Emmaus. "While our packager has resumed the production of new inventory and we have begun fulfilling back orders, we do not currently expect net revenues for the full year to reach the level achieved in 2023," he added.

"We are working with alternative manufacturers to avoid similar shortages in the future," remarked George Sekulich, Chief Commercial Officer.  "We also are assessing the possible effect on Endari sales and net revenues of the recent launch of a generic L-Glutamine Oral Powder," he added.

Financial and Operating Results

Net Revenues. Net revenues for the six months ended June 30 were $7.9 million, compared to $17.5 million in the same period in 2023.  The decrease was primarily attributable to repeated delays in the production of finished goods inventory at our packager.

Operating Expenses. Total operating expenses for the six months were $9.5 million compared with $14.4 million in the comparable period in 2023. The decrease was due primarily to decreases of $3.4 million in general and administrative expenses, $1.3 million in selling expenses, and $0.2 million in research and development expenses.

Income (Loss) From Operations. Loss from operations for the six months was $2.2 million compared to income from operations of $2.2 million in the same period in 2023.  The decrease resulted from lower net revenues described above, partially offset by decreased operating expenses compared to 2023.

Other Expense. The company incurred other expense of $4.4 million for the six months compared to $7.2 million in the same period in 2023. The decrease was due primarily to an increase of $1.0 million in gain on debt restructuring, a decrease of $2.5 million in foreign exchange loss, and a $1.0 million decrease in net loss on equity method investment, partially offset by a $1.4 million decrease in change in fair value of embedded conversion option of convertible promissory notes.

Net Loss. For the six months, the company realized a net loss of $6.5 million, or $0.10 per share based on approximately 62.6 million weighted average basic common shares, compared to a net loss of $5.0 million, or $0.10 per share based on approximately 51.8 million weighted average basic and diluted common shares in the comparable period in 2023. The increase in net loss was primarily attributable to the decrease in income from operations, partially offset by the decrease in other expense.

Liquidity and Capital Resources. At June 30, 2024, the company had cash and cash equivalents of $1.5 million, compared with $2.5 million at December 31, 2023. 

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.com/PI.

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

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.

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 expected net revenues for the full year 2024 and the possible effect on Endari sales and net revenues of the introduction of competing generic drugs. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the company's need to restructure or refinance its existing indebtedness and raise additional funds from related-party loans, third-party loans or other financing to meet its current liabilities and fund its business and operations and doubt about the company's ability to continue as a going concern  and other factors disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2023 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2024 and June 30, 2024, 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.                                       
Investor Relations                                                      
(310) 214-0065                                               
IR@emmauslifesciences.com

(Financial Tables Follow)

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SOURCE Emmaus Life Sciences, Inc.