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Emmaus Life Sciences Reports Improved Quarterly Financial Results

Emmaus Life Sciences Reports Improved Quarterly Financial Results

Emmaus生命科学公司公布了改进的季度财务结果
EMMAUS LIFE SCIENCES INC NEW ·  2024/11/19 13:00

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.

加州托兰斯,2024年11月19日 - Emmaus Life Sciences, Inc. (OTCQB: EMMA),一家处于商业阶段的生物制药公司和镰状细胞病治疗领域的领导者,今天报告了截至2024年9月30日的三个月和九个月的财务状况和运营业绩。

Highlights

亮点

"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.

"我们很高兴地报告,我们能够在8月恢复库存生产并履行之前的订单,从而导致净收入和营业收入分别增加50万美元,增长了9%,和80万美元,增长超过3000%,相比于一年前的同期;净收入为180万美元,比2023年第三季度增加了2626%," Emmaus的主席兼首席执行官威利斯·李评论说:"我们预计净收入和营业收入将在第四季度稳定。由于我们今年早些时候遭受的库存短缺,截至2024年9月30日的九个月的净收入与2023年相比下降了41%,我们实现了营业亏损,而不是与去年相比的营业收入。由于这个原因,我们预计全年的运营业务结果将明显低于2023年。我们在第三季度的Endari美国销售可能受到了于7月推出的一种竞争性通用L-谷氨酰胺口服粉的不利影响,我们将继续评估对未来Endari销售和净收入的可能影响以及增强Endari销售的步骤。"

Financial and Operating Results

财务和运营业绩

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.

净收入。截至9月30日的三个月净收入为550万美元,而2023年同期为500万美元。这一增长是由于中东和北非地区销售增加,部分抵消了美国销售下降,管理部门将其归因于来自一种通用产品的竞争。

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.

营业费用。三个月的总营业费用为430万美元,而2023年同期为480万美元。这种降低主要是由于临床研究组织费用的减少。九个月的总营业费用为1380万美元,而2023年同期为1920万美元。这种减少主要是由于薪资支出减少230万美元,包括股份报酬。

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.

业务收入(损失)。我们实现了三个月的业务收入为80万美元,相比2023年同期的2万美元的业务收入。增长主要是由于净收入增加50万美元和营业费用减少50万美元所致。截至2024年9月30日的九个月,我们的业务损失为130万美元,相比去年同期的220万美元的业务收入。这一减少是由于净收入减少920万美元,部分抵消了营业费用减少540万美元。

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(费用)。公司实现了三个月的其他收入为100万美元,相比2023年同期的8万美元的其他收入。增长主要是由于外汇亏损减少70万美元,利息费用减少60万美元和债务注销亏损减少60万美元,部分抵消了变现特征衍生性负债公允价值变动减少40万美元。截至2024年9月30日的九个月,其他费用从2023年同期的710万美元减少至330万美元,主要是由于重组债务收益增加100万美元,外汇亏损减少320万美元和利息费用减少100万美元,部分抵消了变现特征衍生性负债公允价值变动从2012年间的210万美元减少至2024年的10万美元增加220万美元。

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.

净利润(损失)。公司实现了三个月的净利润为180万美元,或每股0.03美元,基于约6390万加权平均基本普通股,相比2023年同期的7万美元,或每股0.00美元,基于约5360万加权平均基本普通股。净利润增加主要归因于业务收入和其他收入的增加。截至2024年9月30日的九个月,公司报告了470万美元的净亏损,每股0.07美元,基于约6300万加权平均基本普通股。对比2023年9月30日结束的九个月的净亏损为490万美元,每股0.09美元,基于约5240万加权平均基本普通股。这一减少主要是由营业费用减少540万美元和其他费用减少370万美元所致,部分抵消了净收入减少920万美元。

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.

截至2024年9月30日,公司的现金及现金等价物为130万美元,较2023年12月31日的250万美元少。

About Emmaus Life Sciences

关于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 .

Emmaus Life Sciences,Inc.是一家处于商品化阶段的生物制药公司,也是镰刀状细胞病治疗领域的领导者。Endari(L-谷氨酰胺口服粉末)已获批用于降低成年人和5岁以上儿童镰刀状细胞病的急性并发症,在美国、以色列、科威特、卡塔尔、阿拉伯联合酋长国、巴林和阿曼获得营销许可,并可在法国、荷兰和沙特阿拉伯王国根据指定患者或提前获得准入的基础上使用,其中Emmaus的营销授权申请正在等待沙特食品药品管理局的最终行动。更多信息,请访问 。

About Endari (prescription grade L-glutamine oral powder)

关于Endari (处方级L-谷氨酰胺口服粉剂)

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.

Endari,Emmaus的处方级L-谷氨酰胺口服粉末,于2017年7月获得美国食品药品监督管理局(FDA)批准,用于治疗成人和5岁及以上的小儿镰刀状细胞病患者。

Indication

适应症

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

Endari被指示用于减少成人和5岁及以上小儿镰刀状细胞病的急性并发症。

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.

在临床研究中,最常见的不良反应(发生率超过10%)包括便秘,恶心,头痛,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.

导致中止治疗的不良反应包括脾功能亢进、腹痛、消化不良、灼热感和潮热各一个案例。

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

Endari在五岁以下患镰状细胞病的小儿患者中的安全性和有效性尚未确立。

For more information, please see full Prescribing Information of Endari at: .

有关更多信息,请查看Endari的完整处方信息。

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

关于镰状细胞病
在美国有大约10万患有镰状细胞病(SCD)的人,在全球有数百万人。镰状基因不仅仅存在于非洲人种群中,而且在每个族裔群体中都能找到;在美国,据估计,每365名非裔美国人中就有1人患有SCD,每16,300名西班牙裔美国人中就有1人患有SCD。引起SCD的遗传突变导致个体的红细胞扭曲成“C”或镰刀形状,降低了它们在全身运输氧气的能力。这些扭曲的红细胞迅速分解,变得非常粘稠,并倾向于聚集在一起,导致堵塞并在血管内造成损害。结果是血流减少到远端器官,导致体内丧失的疼痛症状、组织和器官受损,以及早死。

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资料来源:《关于镰状细胞病的数据与统计-国家先天缺陷和发育迟缓中心,疾病控制与预防中心,2020年12月》。
2资料来源:《解决镰状细胞病委员会-行动的战略计划和蓝图-国家科学院出版社,2020年》。

Forward-looking Statements

前瞻性声明

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.

本新闻稿包含根据1995年私人证券诉讼改革法案的安全港条款所作出的前瞻性声明,包括关于2024财年全年预计净收入的声明,以及引入竞争性仿制药对Endari销售和净收入可能造成的影响。这些前瞻性声明受到许多假设、风险和不确定性的影响,这些因素会随着时间而变化,包括公司需要重组或再融资其现有债务,并从关联方贷款、第三方贷款或其他融资中筹集额外资金,以满足其当前负债,并为其业务和运营提供资金,以及对公司继续作为持续经营实体的能力的怀疑,以及公司在2023年12月31日结束的年度的10-K表格年报和2024年9月30日结束的季度的10-Q表格季度报告中披露的其他因素,实际结果可能会有重大差异。这些前瞻性声明仅在作出声明的日期有效,Emmaus不承担更新这些声明的义务,除非法律要求。

Company Contact:

公司联系方式:

Emmaus Life Sciences, Inc.

Emmaus Life Sciences, Inc.

Investor Relations

投资者关系

(310) 214-0065

(310) 214-0065

IR@emmauslifesciences.com

IR@emmauslifesciences.com

(Financial Tables Follow)

(财务表格如下)

Emmaus Life Sciences, Inc.

Condensed Consolidated Statement of Operations and Comprehensive Income Loss

(In thousands, except share and per share amounts)

Three Months Ended September 30

Nine Months Ended September 30

2024

2023

2024

2023

Revenues, Net

$5,478

$5,018

$13,361

$22,530

Cost of Goods Sold

394

214

892

1,151

Gross Profit

5,084

4,804

12,469

21,379

Operating Expenses

4,263

4,780

13,806

19,194

Income (Loss) from Operations

821

24

(1,337)

2,185

Total Other Income (Expense)

1,005

81

(3,345)

(7,074)

Net Income (Loss)

1,827

67

(4,705)

(4,942)

Comprehensive Income (Loss)

3,205

(1,322)

(6,561)

(3,826)

Net Income (Loss) Per Share

$0.03

$0.00

($0.07)

($0.09)

Weighted Average Common Shares Outstanding

63,865,571

53,637,554

63,025,296

52,414,903

Emmaus Life Sciences,Inc.(伊玛斯生命科学公司)

综合利润及综合收益损失简明合并利润表

(以千为单位,除每股及每价外)

截至2019年9月30日三个月的收入

截至九月三十日的九個月

2024

2023

2024

2023

销售收入净额

$5,478

$5,018

$13,361

$22,530

销售成本

394

214

892

1,151

毛利润

5,084

4,804

12,469

21,379

运营费用

4,263

4,780

13,806

19,194

来自运营的收入(亏损)

821

24

(1,337)

2,185

其他收入(费用),净额

1,005

81

(3,345)

(7,074)

净利润(损失)

合同履行资产的减值损失

67

(4,705)

(4,942)

综合收益(损失)

3,205

(1,322)

(6,561)

(3,826)

每股净(损失)收益

$0.03

$0.00

($ 0.07)

($0.09)

加权平均普通股数

63,865,571

53,637,554

63,025,296

52,414,903

Emmaus Life Sciences, Inc.

Emmaus Life Sciences,Inc.

Condensed Consolidated Balance Sheets

汇编的综合资产负债表

(In thousands)

(以千为单位)

As of

September 30, 2024 (Unaudited)

December 31, 2023

Assets

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

Current Liabilities:

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

2024年9月30日(未经审计)

2023年12月31日

资产

流动资产:

现金及现金等价物

$1,255

$2,547

应收账款,净额

4,938

4,010

应收账款保理

54

1,514

净存货

1,610

1,711

预付费用及其他流动资产

1,347

1,727

流动资产合计

9,204

11,509

物业和设备,净值

49

59

使用权资产

1,719

2,337

投资于可转债型基金

16,059

20,978

其他资产

312

296

总资产

$27,343

$35,179

负债和股东权益

流动负债:

应付账款和应计费用

$18,707

$16,951

转换特性衍生工具,应付票据

523

451

应付票据,短期部分

7,915

8,215

应付可转换票据,减计折扣后

16,205

16,383

其他流动负债

20,781

19,507

总流动负债

64,131

61,507

其他长期负债

16,993

21,428

总负债

81,124

82,935

股东赤字

(53,781)

(47,756)

负债和股东赤字总额

$27,343

$35,179

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