Emmaus Life Sciences Reports Improved Quarterly Financial Results
Emmaus Life Sciences Reports Improved Quarterly Financial Results
Torrance CA, November 19, 2024 - 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.
加利福尼亞州託蘭斯,2024年11月19日——處於商業階段的生物製藥公司、鐮狀細胞病治療領域的領導者Emmaus Life Sciences, Inc.(場外交易代碼:EMMA)今天公佈了截至2024年9月30日的三個月和九個月的財務狀況和經營業績。
Highlights
亮點
"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.
董事長兼首席執行官威利斯·李評論說:「我們很高興地報告,我們得以在8月份恢復庫存生產和履行延期訂單,這使淨收入和運營收入分別增加了50萬美元,增長了9%,增長了80萬美元,增長了3000%以上,淨收入爲180萬美元,與2023年第三季度相比增長了2626%。」 以馬烏斯的。「我們預計淨收入和運營收入將在第四季度穩定下來。由於我們在今年早些時候遭受庫存短缺,截至9月30日的九個月的淨收入與2023年相比下降了41%,與上一年的運營收入相比,我們實現了運營虧損。出於同樣的原因,我們預計全年經營業績將大大低於2023年。他補充說,7月份推出的競爭性仿製L-谷氨醯胺口服粉可能對我們在美國的Endari銷售產生了不利影響,我們將繼續評估對Endari未來銷售和淨收入的可能影響,以及促進Endari銷售的措施。」
Financial and Operating Results
財務和經營業績
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.
淨收入。截至9月30日的三個月,淨收入爲550萬美元,而2023年同期爲500萬美元。這一增長是由於中東北非地區的銷售增長,但部分被管理層歸因於來自仿製藥的競爭的美國銷售下降所抵消。
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.
運營費用。這三個月的總運營支出爲430萬美元,而2023年同期爲480萬美元。下降的主要原因是臨床研究組織開支減少。九個月的總運營支出爲1,380萬美元,而2023年同期爲1,920萬美元。減少的主要原因是工資支出減少了230萬美元,包括基於股份的薪酬。
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.
運營收入(虧損)。我們在三個月中實現的運營收入爲80萬美元,而2023年同期的運營收入爲02萬美元。增長是由於淨收入增加了50萬美元,運營費用減少了50萬美元。在截至2024年9月30日的九個月中,我們的運營虧損爲130萬美元,而去年同期的運營收入爲220萬美元。減少的原因是淨收入減少了920萬美元,部分被運營費用減少的540萬美元所抵消。
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.
其他收入(支出)。該公司三個月的其他收入爲100萬美元,而2023年同期爲08萬美元。增長的主要原因是外匯損失減少70萬美元,利息支出減少60萬美元,債務清償損失60萬美元,部分被轉換功能衍生品負債公允價值變動減少40萬美元所抵消。截至2024年9月30日的九個月中,其他支出從2023年同期的710萬美元降至330萬美元,這主要是由於重組債務收益增加了100萬美元,外匯損失減少了320萬美元,利息支出減少了100萬美元,但被轉換特徵衍生負債公允價值變動從2023年的210萬美元增加到2024年的10萬美元增加的220萬美元所部分抵消。
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.
淨收益(虧損)。在這三個月中,該公司實現了180萬美元的淨收益,按約6390萬股加權平均基本普通股計算,合每股收益0.03美元,而根據2023年同期約5360萬股加權平均基本普通股,淨收益爲0.7萬美元,合每股收益0.00美元。淨收入的增加主要歸因於運營收入和其他收入的增加。在截至2024年9月30日的九個月中,根據約6300萬股加權平均基本普通股,該公司報告淨虧損470萬美元,合每股虧損0.07美元。相比之下,根據截至2023年9月30日的九個月中約5240萬股加權平均基本普通股,淨虧損490萬美元,合每股虧損0.09美元。減少的主要原因是運營費用減少了540萬美元,其他支出減少了370萬美元,部分被920萬美元的淨收入減少所抵消。
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.
流動性和資本資源。截至2024年9月30日,該公司的現金及現金等價物爲130萬美元,而截至2023年12月31日爲250萬美元。
About Emmaus Life Sciences
關於 Emmaus 生命科學
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 .
Emmaus Life Sciences, Inc. 是一家處於商業階段的生物製藥公司,也是鐮狀細胞病治療領域的領導者。Endari(L-谷氨醯胺口服粉)被證明可以減少成人和5歲及以上兒童的鐮狀細胞病急性併發症,已獲准在美國、以色列、科威特、卡塔爾、阿拉伯聯合酋長國、巴林和阿曼上市,法國、荷蘭和沙特阿拉伯王國以指定患者或搶先獲得的方式發售,Emmaus的上市許可申請正在等待沙特食品和藥物管理局的最終行動藥物管理局。欲了解更多信息,請訪問。
About Endari (prescription grade L-glutamine oral powder)
關於 Endari(處方級 L-谷氨醯胺口服粉)
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.
Emmaus處方級L-谷氨醯胺口服粉Endari於2017年7月獲得美國食品藥品監督管理局(FDA)的批准,用於治療五歲及以上成人和兒童患者的鐮狀細胞病。
Indication
指示
Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
Endari有望減少五歲及以上成人和兒童患者的鐮狀細胞病急性併發症。
Important Safety Information
重要安全信息
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.
臨床研究中最常見的不良反應(發病率>10%)是便秘、噁心、頭痛、腹痛、咳嗽、四肢疼痛、背痛和胸痛。
Adverse reactions leading to treatment discontinuation included one case each of hypersplenism, abdominal pain, dyspepsia, burning sensation, and hot flash.
導致停止治療的不良反應包括脾功能亢進、腹痛、消化不良、燒灼感和潮熱各一例。
The safety and efficacy of Endari in pediatric patients with sickle cell disease younger than five years of age has not been established.
Endari對五歲以下小兒鐮狀細胞病患者的安全性和有效性尚未確定。
For more information, please see full Prescribing Information of Endari at: .
欲獲得更多信息, 請在以下網址查看Endari的完整處方信息:.
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
關於鐮狀細胞病
美國大約有10萬人患有鐮狀細胞病(SCD),全球還有數百萬人患有鐮狀細胞病(SCD)。鐮刀基因存在於每個族裔群體中,而不僅僅是非洲裔群體;在美國,估計每365名非裔美國人中就有1名和16,300名西班牙裔美國人中就有1人出生時患有SCD.1 導致SCD的基因突變導致個人的紅細胞變形成 「C」 或鐮刀形狀,從而降低他們向全身輸送氧氣的能力。這些鐮狀的紅細胞會迅速分解,變得非常粘稠,併產生聚集在一起的傾向,這會導致它們卡住並在血管內造成損傷。結果是流向遠端器官的血液減少,從而導致喪失行爲能力的疼痛、組織和器官損傷以及過早死亡等身體症狀。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.
1來源:鐮狀細胞病數據和統計數據——美國疾病控制與預防中心國家出生缺陷和發育障礙中心,2020年12月。
2來源:解決鐮狀細胞病委員會——戰略計劃和行動藍圖——美國國家科學院出版社,2020年。
Forward-looking Statements
前瞻性陳述
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.
本新聞稿包含根據經修訂的1995年《私人證券訴訟改革法》的安全港條款做出的前瞻性陳述,包括有關2024年全年預期淨收入以及推出競爭性仿製藥可能對恩達利銷售和淨收入產生的影響的陳述。這些前瞻性陳述受許多假設、風險和不確定性的影響,這些假設、風險和不確定性會隨着時間的推移而發生變化,包括公司需要重組或再融資,從關聯方貸款、第三方貸款或其他融資中籌集額外資金以償還其流動負債併爲其業務和運營提供資金,以及對公司繼續經營能力的懷疑以及公司截至2023年12月31日的10-k表年度報告中披露的其他因素以及表格 10 的季度報告-截至2024年9月30日的季度與實際業績可能存在重大差異。此類前瞻性陳述僅代表其發表之日,除非法律要求,否則,Emmaus沒有義務對其進行更新。
Company Contact:
公司聯繫人:
Emmaus Life Sciences, Inc.
Emmaus 生命科學有限公司
Investor Relations
投資者關係
(310) 214-0065
(310) 214-0065
IR@emmauslifesciences.com
IR@emmauslifesciences.com
(Financial Tables Follow)
(財務表如下)
Emmaus Life Sciences, Inc. |
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Condensed Consolidated Statement of Operations and Comprehensive Income Loss |
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(In thousands, except share and per share amounts)
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Emmaus 生命科學有限公司 |
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簡明合併運營報表和綜合收益虧損 |
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(以千計,股票和每股金額除外)
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Emmaus Life Sciences, Inc.
Emmaus 生命科學有限公司
Condensed Consolidated Balance Sheets
簡明合併資產負債表
(In thousands)
(以千計)
As of |
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September 30, 2024 (Unaudited) |
December 31, 2023 |
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Assets |
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Current Assets: |
|||
Cash and cash equivalents |
$1,255 |
$2,547 |
|
Accounts receivable, net |
4,938 |
4,010 |
|
Due from factoring of accounts receivable |
54 |
1,514 |
|
Inventories, net |
1,610 |
1,711 |
|
Prepaid expenses and other current assets |
1,347 |
1,727 |
|
Total Current Assets |
9,204 |
11,509 |
|
Property and equipment, net |
49 |
59 |
|
Right of use assets |
1,719 |
2,337 |
|
Investment in convertible bond |
16,059 |
20,978 |
|
Other Assets |
312 |
296 |
|
Total Assets |
$27,343 |
$35,179 |
|
Liabilities and Stockholders' Deficit |
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Current Liabilities: |
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Accounts payable and accrued expenses |
$18,707 |
$16,951 |
|
Conversion feature derivative, notes payable |
523 |
451 |
|
Notes payable, current portion |
7,915 |
8,215 |
|
Convertible notes payable, net of discount |
16,205 |
16,383 |
|
Other current liabilities |
20,781 |
19,507 |
|
Total Current Liabilities |
64,131 |
61,507 |
|
Other long-term liabilities |
16,993 |
21,428 |
|
Total Liabilities |
81,124 |
82,935 |
|
Stockholders' Deficit |
(53,781) |
(47,756) |
|
Total Liabilities & Stockholders' Deficit |
$27,343 |
$35,179 |
截至 |
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2024 年 9 月 30 日(未經審計) |
2023 年 12 月 31 日 |
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資產 |
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流動資產: |
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現金和現金等價物 |
1,255 美元 |
2,547 美元 |
|
應收賬款,淨額 |
4,938 |
4,010 |
|
應收賬款保理應付款 |
54 |
1,514 |
|
庫存,淨額 |
1,610 |
1,711 |
|
預付費用和其他流動資產 |
1,347 |
1,727 |
|
流動資產總額 |
9,204 |
11,509 |
|
財產和設備,淨額 |
49 |
59 |
|
使用權資產 |
1,719 |
2,337 |
|
投資可轉換債券 |
16,059 |
20,978 |
|
其他資產 |
312 |
296 |
|
總資產 |
27,343 美元 |
35,179 美元 |
|
負債和股東赤字 |
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流動負債: |
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應付賬款和應計費用 |
18,707 美元 |
16,951 美元 |
|
轉換功能導數,應付票據 |
523 |
451 |
|
應付票據,當期部分 |
7,915 |
8,215 |
|
扣除折扣後的可轉換應付票據 |
16,205 |
16,383 |
|
其他流動負債 |
20,781 |
19,507 |
|
流動負債總額 |
64,131 |
61,507 |
|
其他長期負債 |
16,993 |
21,428 |
|
負債總額 |
81,124 |
82,935 |
|
股東赤字 |
(53,781) |
(47,756) |
|
負債總額和股東赤字 |
27,343 美元 |
35,179 美元 |