Hypersplenism

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 . 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: . 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 [email protected] (Financial Tables Follow) SOURCE Emmaus Life Sciences, Inc. 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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 . 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: . 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 [email protected] (Financial Tables Follow) SOURCE Emmaus Life Sciences, Inc. 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TORRANCE, Calif., July 12, 2024 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCPK: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today announced receiving the coveted "No Action Indicated" classification following a routine inspection by the United States Food and Drug Administration (FDA) of Emmaus' Postmarketing Adverse Drug Experience (PADE) compliance program. The PADE program aims to shield patients from poor quality, unsafe, and ineffective dugs through proactive compliance strategies and risk-based enforcement actions. A major objective of the PADE program is to ensure that accurate, reliable, and timely safety data are submitted to the FDA in compliance with postmarking laws and regulations. The two and a half-day inspection by two FDA Consumer Safety Officers found no objectional condition or practice in the six years that Endari has been marketed and thereby received a "No Action Indicated" (NAI) inspection classification. "Based on the 2019 FDA inspection results survey, this places Emmaus within the top 16% of all companies investigated in 2019," stated Charles Stark, Pharm.D., Chief Scientific Officer of Emmaus Life Sciences, Inc. "This exemplifies Emmaus' mission to provide the highest quality Endari® (L-glutamine oral powder) and monitor its safety for our patients living with Sickle Cell Disease. These outcomes were possible due to the consistent and dedicated compliance to FDA regulations around surveillance, receipt, evaluation, and timely reporting of safety data by the Safety and Regulatory colleagues at Emmaus (Rafael Razon, M.D. and Rajani Singh). In addition, Emmaus is grateful to APCER Life Sciences, our long-standing Pharmacovigilance business partner, for their continued support," added Dr. Stark. More about the PADE program Additional information on the PADE compliance program (inspection classifications, and inspection observations made during the Fiscal Year 2017 through 2019 from the Postmarketing Drug Safety Compliance Inspections -- April 29, 2020) can be found at: About Emmaus Life Sciences Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease. The company currently markets U.S. Food and Drug Administration approved Endari® (L-glutamine oral powder) indicated to reduce the acute complications of sickle cell disease in adults and children 5 years and older. The company is also engaged in the discovery and development of innovative treatments and therapies for certain rare and orphan diseases as well as those affecting larger populations, such as diverticulosis. For more information, please visit . About Endari® (prescription grade L-glutamine oral powder) Endari®, Emmaus' prescription grade L-glutamine oral powder, was approved by the FDA in July 2017 for treating sickle cell disease in adult and pediatric patients five years of age and older. Sales of Endari® began in the United States in 2018. 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: . 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. Throughout the Middle East North Africa region, Emmaus estimates that there are approximately 225,000 sickle cell disease patients that could potentially be treated with Endari®. Company Contact: Emmaus Life Sciences, Inc. Willis Lee Chief Operating Officer (310) 214-0065, Ext. 1130 [email protected] SOURCE Emmaus Life Sciences, Inc.