share_log

Eton Pharmaceuticals Reports First Quarter 2024 Financial Results

Eton Pharmaceuticals Reports First Quarter 2024 Financial Results

伊顿制药公布2024年第一季度财务业绩
Eton Pharmaceutical ·  05/09 00:00

• Q1 2024 revenue of $8.0 million, representing 50% growth over Q1 2023 and the 13th straight quarter of sequential product sales growth
• Acquired PKU GOLIKE, launched Nitisinone, and submitted a new drug application (NDA) for product candidate ET-400
• Management to hold conference call today at 4:30pm ET

• 2024 年第一季度收入为 800 万美元,比 2023 年第一季度和 13 季度增长 50%第四 产品销售连续增长一个季度
• 收购 PKU GOLIKE,推出尼替西农,并提交了候选产品 ET-400 的新药申请(NDA)
• 管理层将于美国东部时间今天下午 4:30 举行电话会议

DEER PARK, Ill., May 09, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc ("Eton" or "the Company") (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the quarter ended March 31, 2024.

伊利诺伊州鹿园,2024年5月9日(GLOBE NEWSWIRE)——专注于开发和商业化罕见疾病疗法的创新制药公司伊顿制药公司(“伊顿” 或 “公司”)(纳斯达克股票代码:ETON)今天公布了截至2024年3月31日的季度财务业绩。

"We have had a very productive start to 2024. In addition to reporting record product sales and our 13th straight quarter of sequential product sales growth, we acquired PKU GOLIKE which adds a compelling new commercial growth asset to our metabolic portfolio. We also launched Nitisinone and submitted an NDA for our highly anticipated ET-400 product candidate," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

“到2024年,我们的开局非常富有成效。除了报告创纪录的产品销售额和我们的 13%第四 在产品销售连续增长的季度中,我们收购了PKU GOLIKE,这为我们的代谢投资组合增加了引人注目的新商业增长资产。我们还推出了尼替西农,并为我们备受期待的 ET-400 候选产品提交了保密协议。” 伊顿制药首席执行官肖恩·布林杰尔森说。

"It's an exciting time for Eton as we continue to execute on our vision. With strong growth expected from our existing products, plus the additions of PKU GOLIKE and Nitisinone, we are positioned for a very strong 2024 as we gear up for the potential launch of ET-400 in early 2025," concluded Brynjelsen.

“对于伊顿来说,这是一个激动人心的时刻,因为我们将继续实现我们的愿景。布林杰尔森总结道,预计现有产品将实现强劲增长,再加上PKU GOLIKE和Nitisinone的加入,我们有望在2024年实现非常强劲的2024年,因为我们正在为2025年初可能推出的 ET-400 做准备。

First quarter and Recent Business Highlights

第一季度和近期业务亮点

13th straight quarter of sequential growth in product sales and royalty revenue. Eton reported first quarter 2024 product sales of $8.0 million, representing 50% growth over the prior year, driven primarily by the ongoing momentum of ALKINDI SPRINKLE and Carglumic Acid. The Company expects sequential quarter-over-quarter growth of product sales to continue throughout 2024 and beyond.

13第四 产品销售和特许权使用费收入连续一个季度连续增长。伊顿公布,2024年第一季度产品销售额为800万美元,比上年增长50%,这主要是由ALKINDI SPRINKL和Carglumic Acid的持续势头推动的。该公司预计,产品销售将持续在2024年及以后的季度环比增长。

Acquired U.S. rights to PKU GOLIKE, a medical formula for patients with phenylketonuria (PKU). An estimated 8,000 PKU patients in the U.S. rely on medical formulas such as PKU GOLIKE. The condition is managed by metabolic geneticists and their support staff, the same healthcare professionals that Eton is actively engaged with on its other metabolic products. The U.S. market for PKU medical formulas is estimated to be approximately $100 million annually. With GOLIKE's attractive product benefits and Eton's commercial infrastructure, the Company's goal is to capture at least 10% market share, or $10 million annually, in the coming years.
Submitted NDA to the U.S. Food and Drug Administration (FDA) for ET-400. In April, Eton submitted an NDA for ET-400, its proprietary patented formulation of hydrocortisone oral solution. The anticipated 10-month review would allow for potential approval in the first quarter of 2025. The Company continues to see strong interest in the product candidate and believes that ET-400 and ALKINDI SPRINKLE can combine to achieve peak sales of over $50 million annually.

获得了PKU GOLIKE的美国版权,这是一种用于苯丙酮尿症(PKU)患者的医疗配方。据估计,美国有8,000名PKU患者依赖PKU GOLIKE等医疗配方。该病由代谢遗传学家及其支持人员管理,他们与伊顿公学积极参与其他代谢产品的医疗保健专业人员相同。据估计,PKU医疗配方的美国市场每年约为1亿美元。凭借GOLIKE诱人的产品优势和伊顿的商业基础设施,该公司的目标是在未来几年内占据至少10%的市场份额,即每年1000万美元。
向美国食品药品监督管理局 (FDA) 提交了针对 ET-400 的保密协议。4月,伊顿提交了其专有的氢化可的松口服溶液专利配方 ET-400 的保密协议。预期的10个月审查将允许在2025年第一季度获得批准。该公司仍然对候选产品表现出浓厚的兴趣,并认为 ET-400 和 ALKINDI SPRINKLE 相结合,可以实现每年超过5000万美元的峰值销售额。

Continued growth in ALKINDI SPRINKLE and Carglumic Acid. In the first quarter, the Company launched an ALKINDI SPRINKLE sampling program, which allows physicians to hold product and immediately start a patient on treatment. The Company estimates that Carglumic Acid has now captured over 50% of the patient population and continues to see new patient additions. The launches of Betaine and Nitisinone have further strengthened Eton's relationships with the metabolic community and have helped increase the frequency of interactions with Carglumic Acid prescribers.

ALKINDI SPRINKLE 和 Carglumic Acid 的持续增长。在第一季度,该公司启动了ALKINDI SPRINKLE采样计划,该计划允许医生持有产品并立即开始对患者进行治疗。该公司估计,Carglumic Acid现在已经覆盖了50%以上的患者群体,并且还在继续增加新的患者。甜菜碱和尼替西农的推出进一步加强了伊顿公学与代谢界的关系,并有助于增加与卡葡糖酸处方者的互动频率。

Launched rare disease product Nitisinone. The product was launched in February 2024 with full patient and provider support services. The Nitisinone market is estimated to be $50 million annually, split across multiple participants. Eton expects to capture a share of the existing market and the Nitisinone launch should provide the Company with additional opportunities to cross-sell Carglumic Acid and PKU GOLIKE.

推出罕见病产品尼替西农。该产品于2024年2月推出,提供全面的患者和提供者支持服务。据估计,尼替西农市场每年为5000万美元,分为多个参与者。伊顿预计将占据现有市场的份额,而尼替西农的推出将为该公司提供更多交叉销售卡葡糖酸和PKU GOLIKE的机会。

First Quarter Financial Results

第一季度财务业绩

Net Revenue: Net revenues for the first quarter of 2024 were $8.0 million compared with $5.3 million in the prior year period, an increase of 50%. The increase was driven primarily by growth in ALKINDI SPRINKLE and Carglumic Acid.

净收入:2024年第一季度的净收入为800万美元,而去年同期为530万美元,增长了50%。增长主要是由ALKINDI SPRINKLE和Carglumic Acid的增长推动的。

Gross Profit: Gross profit for the first quarter of 2024 was $5.0 million compared with $3.3 million in the prior year period, with the increase also driven primarily by growth in ALKINDI SPRINKLE and Carglumic Acid.

毛利:2024年第一季度的毛利为500万美元,而去年同期为330万美元,增长还主要是由ALKINDI SPRINKL和Carglumic Acid的增长推动的。

Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2024 were $0.7 million compared to $0.5 million in the prior year period due to increased development costs associated with product candidate ET-400 and other products in the Company's R&D pipeline. While the Company expects an increase in second quarter R&D expenses with a $2.0 million ET-400 filing fee, R&D spend for 2024 is forecasted to be approximately $4.0 million excluding the one-time filing fee.

研发(R&D)费用:由于与候选产品 ET-400 和公司研发管道中的其他产品相关的开发成本增加,2024年第一季度的研发费用为70万美元,而去年同期为50万美元。尽管该公司预计第二季度研发费用将增加,ET-400 申请费为200万美元,但不包括一次性申请费,预计2024年的研发支出约为400万美元。

General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2024 were $5.2 million compared to $5.3 million in the prior year period, with the decrease due to a slight reduction in employee related expenses and logistics costs.

一般和管理(G&A)费用:2024年第一季度的并购支出为520万美元,而去年同期为530万美元,下降是由于员工相关费用和物流成本略有减少。

Net Income: Net loss for the first quarter of 2024 was $0.8 million or $0.03 per basic and diluted share compared to a net loss of $2.7 million or $0.10 per diluted share in the prior year period.

净收益:2024年第一季度的净亏损为80万美元,合每股基本亏损和摊薄后每股亏损0.03美元,而去年同期净亏损270万美元,摊薄每股亏损0.10美元。

Cash Position: As of March 31, 2024, the Company had cash and cash equivalents of $16.7 million and expects continued sales growth to result in positive operating cash flow throughout the remainder of 2024.

现金状况:截至2024年3月31日,该公司的现金及现金等价物为1,670万美元,并预计持续的销售增长将在2024年剩余时间内带来正的运营现金流。

Conference Call and Webcast Information

电话会议和网络直播信息

As previously announced, Eton Pharmaceuticals will host a its first quarter 2024 conference call as follows:

正如先前宣布的那样,伊顿制药将举办2024年第一季度的电话会议,具体如下:

Date May 9, 2024
Time 4:30 p.m. ET (3:30 p.m. CT)
Register* (Audio Only) Click here
日期 2024年5月9日
时间 美国东部时间下午 4:30(美国东部时间下午 3:30)
注册*(仅限音频) 点击这里

In addition to taking live questions from participants on the conference call, management will be answering emailed questions from investors. Investors can email questions to: investorrelations@etonpharma.com.

除了在电话会议上回答参与者的现场提问外,管理层还将回答投资者通过电子邮件发送的问题。投资者可以通过电子邮件将问题发送至: investorrelations@etonpharma.com

The live webcast can be accessed on the Investors section of Eton's website at https://ir.etonpharma.com/. An archived webcast will be available on Eton's website approximately two hours after the completion of the event and for 30 days thereafter.

可以在伊顿公学网站的 “投资者” 部分观看网络直播,网址为 https://ir.etonpharma.com/。存档的网络直播将在活动结束大约两小时后在伊顿公学的网站上提供,之后将持续30天。

* Conference call participants should register to obtain their dial-in and passcode details. Please be sure to register using a valid email address.

* 电话会议参与者应注册以获取其拨入和密码的详细信息。请务必使用有效的电子邮件地址注册。

About Eton Pharmaceuticals

关于伊顿制药

Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has five commercial rare disease products: ALKINDI SPRINKLE, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.

伊顿是一家创新制药公司,专注于开发和商业化罕见疾病的治疗方法。该公司目前有五种商用罕见病产品:ALKINDI SPRINKLE、PKU GOLIKE、Carglumic Acid、无水甜菜碱和尼替西农。该公司还有另外三种候选产品处于后期开发阶段:ET-400、ET-600 和ZENEO氢化可的松自动注射器。欲了解更多信息,请访问我们的网站 www.etonpharma.com

Forward-Looking Statements

前瞻性陈述

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton's business strategy, Eton's plans to develop and commercialize its product candidates, the safety and efficacy of Eton's product candidates, Eton's plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton's product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton's development programs and financial position are described in additional detail in Eton's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

本新闻稿中有关非历史事实事项的陈述是1995年《私人证券诉讼改革法》所指的 “前瞻性陈述”,包括与伊顿公学开展某些活动和实现某些目的和目标的预期能力相关的陈述。这些声明包括但不限于有关伊顿商业战略、伊顿开发和商业化其候选产品的计划、伊顿候选产品的安全性和有效性、伊顿在监管申报和批准方面的计划和预期时机以及伊顿候选产品的市场规模和增长潜力的声明。由于此类陈述受风险和不确定性的影响,因此实际结果可能与此类前瞻性陈述所表达或暗示的结果存在重大差异。诸如 “相信”、“预期”、“计划”、“期望”、“打算”、“将”、“目标”、“潜力” 等词语以及类似的表述旨在识别前瞻性陈述。这些前瞻性陈述基于伊顿当前的预期,涉及可能永远无法实现或可能被证明不正确的假设。由于各种风险和不确定性,包括但不限于发现、开发和商业化可用作人类疗法的安全有效药物的过程以及围绕此类药物开展业务的努力,实际结果和事件发生时间可能与此类前瞻性陈述中的预期存在重大差异。伊顿向美国证券交易委员会提交的文件中进一步详细描述了这些风险以及其他与伊顿公学发展计划和财务状况有关的风险。本新闻稿中包含的所有前瞻性陈述仅代表其发布之日。伊顿没有义务更新此类声明以反映在声明发表之日后发生的事件或存在的情况。

Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

投资者关系:
丽莎·威尔逊,现场通信公司
T: 212-452-2793
E: lwilson@insitecony.com

Eton Pharmaceuticals, Inc.
Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
For the three months ended
March 31, March 31,
2024 2023
Revenues:
Licensing revenue $ $
Product sales and royalties 7,966 5,304
Total net revenues 7,966 5,304
Cost of sales:
Licensing revenue
Product sales and royalties 2,959 1,958
Total cost of sales 2,959 1,958
Gross profit 5,007 3,346
Operating expenses:
Research and development 651 535
General and administrative 5,156 5,345
Total operating expenses 5,807 5,880
Loss from operations (800) (2,534)
Other income (expense):
Other income
Interest expense, net (11) (126)
Total other income (expense) (11) (126)
Loss before income tax expense (811) (2,660)
Income tax expense
Net loss $ (811) $ (2,660)
Net loss per share, basic $ (0.03) $ (0.10)
Weighted average number of common shares outstanding, basic 25,763 25,525
Net loss per share, diluted $ (0.03) $ (0.10)
Weighted average number of common shares outstanding, diluted 25,763 25,525
伊顿制药有限公司
运营声明
(以千计,每股金额除外)
(未经审计)
在结束的三个月里
3月31日 3月31日
2024 2023
收入:
许可收入 $ $
产品销售和特许权使用费 7,966 5,304
净收入总额 7,966 5,304
销售成本:
许可收入
产品销售和特许权使用费 2,959 1,958
总销售成本 2,959 1,958
毛利 5,007 3,346
运营费用:
研究和开发 651 535
一般和行政 5,156 5,345
运营费用总额 5,807 5,880
运营损失 (800) (2,534)
其他收入(支出):
其他收入
利息支出,净额 (11) (126)
其他收入总额(支出) (11) (126)
所得税支出前的亏损 (811) (2,660)
所得税支出
净亏损 $ (811) $ (2,660)
每股净亏损,基本 $ (0.03) $ (0.10)
已发行普通股的加权平均数,基本 25,763 25,525
每股净亏损,摊薄 $ (0.03) $ (0.10)
摊薄后已发行普通股的加权平均数 25,763 25,525
Eton Pharmaceuticals, Inc.
Balance Sheets
(In thousands, except share and per share amounts)
March 31, 2024 December 31, 2023
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 16,655 $ 21,388
Accounts receivable, net 4,240 3,411
Inventories 2,318 911
Prepaid expenses and other current assets 1,050 1,129
Total current assets 24,263 26,839
Property and equipment, net 57 58
Intangible assets, net 6,388 4,739
Operating lease right-of-use assets, net 74 92
Other long-term assets, net 12 12
Total assets $ 30,794 $ 31,740
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 2,263 $ 1,848
Current portion of debt, net of discount 5,020 5,380
Accrued liabilities 8,017 9,013
Total current liabilities 15,300 16,241
Operating lease liabilities, net of current portion 22
Total liabilities 15,300 16,263
Commitments and contingencies (Note 11)
Stockholders' equity
Common stock, $0.001 par value; 50,000,000 shares authorized; 25,690,562 and 25,688,062 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively 26 26
Additional paid-in capital 120,349 119,521
Accumulated deficit (104,881) (104,070)
Total stockholders' equity 15,494 15,477
Total liabilities and stockholders' equity $ 30,794 $ 31,740
伊顿制药有限公司
资产负债表
(以千计,股票和每股金额除外)
2024年3月31日 2023年12月31日
(未经审计)
资产
流动资产:
现金和现金等价物 $ 16,655 $ 21,388
应收账款,净额 4,240 3,411
库存 2,318 911
预付费用和其他流动资产 1,050 1,129
流动资产总额 24,263 26,839
财产和设备,净额 57 58
无形资产,净额 6,388 4,739
经营租赁使用权资产,净额 74 92
其他长期资产,净额 12 12
总资产 $ 30,794 $ 31,740
负债和股东权益
流动负债:
应付账款 $ 2,263 $ 1,848
扣除折扣后的债务的当期部分 5,020 5,380
应计负债 8,017 9,013
流动负债总额 15,300 16,241
经营租赁负债,扣除流动部分 22
负债总额 15,300 16,263
承付款和或有开支(注11)
股东权益
普通股,面值0.001美元;授权5000万股;截至2024年3月31日和2023年12月31日分别已发行和流通25,690,562股和25,688,062股和25,688,062股 26 26
额外的实收资本 120,349 119,521
累计赤字 (104,881) (104,070)
股东权益总额 15,494 15,477
负债和股东权益总额 $ 30,794 $ 31,740
Eton Pharmaceuticals, Inc.
Statements of Cash Flows
(In thousands)
(Unaudited)
Three months ended Three months ended
March 31, 2024 March 31, 2023
Cash flows from operating activities
Net loss $ (811) $ (2,660)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation 821 872
Depreciation and amortization 252 213
Debt discount amortization 25 29
Changes in operating assets and liabilities:
Accounts receivable (829) (1,022)
Inventories (1,407) 120
Prepaid expenses and other assets 79 191
Accounts payable 414 (530)
Accrued liabilities (1,017) 1,239
Net cash used in operating activities (2,473) (1,548)
Cash flows from investing activities
Purchases of product license rights (1,868)
Purchases of property and equipment (14)
Net cash used in investing activities (1,882)
Cash flows from financing activities
Repayment of long-term debt (385)
Proceeds from stock option exercises 7 132
Payment of tax withholding related to net share settlement of stock option exercises (181)
Net cash used in financing activities (378) (49)
Change in cash and cash equivalents (4,733) (1,597)
Cash and cash equivalents at beginning of period 21,388 16,305
Cash and cash equivalents at end of period $ 16,655 $ 14,708
Supplemental disclosures of cash flow information
Cash paid for interest $ 190 $ 216
Cash paid for income taxes $ $
伊顿制药有限公司
现金流量表
(以千计)
(未经审计)
三个月已结束 三个月已结束
2024年3月31日 2023年3月31日
来自经营活动的现金流
净亏损 $ (811) $ (2,660)
为使净亏损与经营活动中使用的净现金相一致而进行的调整:
基于股票的薪酬 821 872
折旧和摊销 252 213
债务折扣摊销 25 29
运营资产和负债的变化:
应收账款 (829) (1,022)
库存 (1,407) 120
预付费用和其他资产 79 191
应付账款 414 (530)
应计负债 (1,017) 1,239
用于经营活动的净现金 (2,473) (1,548)
来自投资活动的现金流
购买产品许可权 (1,868)
购买财产和设备 (14)
用于投资活动的净现金 (1,882)
来自融资活动的现金流
偿还长期债务 (385)
股票期权行使的收益 7 132
支付与股票期权行使净股结算相关的预扣税 (181)
用于融资活动的净现金 (378) (49)
现金和现金等价物的变化 (4,733) (1,597)
期初的现金和现金等价物 21,388 16,305
期末的现金和现金等价物 $ 16,655 $ 14,708
现金流信息的补充披露
支付利息的现金 $ 190 $ 216
为所得税支付的现金 $ $

Primary Logo

Source: Eton Pharmaceuticals

来源:伊顿制药

声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
    抢沙发