TORRANCE, Calif., April 3, 2023 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQX: EMMA), a leader in sickle cell disease treatment, announced today preliminary results for the 3 months ended March 31, 2023.
"We look forward to reporting our complete interim financial results on our Forms 10-Q for the first quarter as soon as possible. In the meantime, we are pleased to provide information regarding our interim volume of shipments," said Dr. Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer.
In the three months ended March 31, 2023, Emmaus shipped 8,248 boxes of Endari® to its U.S. and Middle East distributors, specialty pharmacies and other customers compared to 6,930 boxes in the three months ended December 31, 2022, a 19% increase. The shipment volume trend has been as follows:
- Q1 2022: 3,340
- Q2 2022: 5,586
- Q3 2022: 4,810
- Q4 2022: 6,930
- Q1 2023: 8,248
Emmaus expects to report its full interim financial results in its Quarterly Reports on Form 10-Q for Q1 2023 to be filed with the Securities and Exchange Commission next month. In accordance with U.S. GAAP, reported net revenue will be determined by adjusting gross sales for shipments in transit, fees, discounts, rebates, and other variable considerations, and any adjustments to prior period estimates.
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, Bahrain, Oman, Qatar, and the United Arab Emirates and is available on a named patient or early access basis in France, The Netherlands and the Kingdom of Saudi Arabia. In the Kingdom of Saudi Arabia, Emmaus' application for marketing authorization is awaiting final action by the Saudi Food & Drug Administration. 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 & Drug Administration 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.
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.
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.
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 interim shipment volume and trending sales. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including factors disclosed in the company's amended and restated Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2023 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.
Emmaus Life Sciences, Inc.
Chief Operating Officer
(310) 214-0065, Ext. 1130