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Eton Pharmaceuticals Reports First Quarter 2024 Financial Results

Eton Pharmaceuticals Reports First Quarter 2024 Financial Results

伊頓製藥公佈2024年第一季度財務業績
Eton Pharmaceutical ·  05/09 12:00

• 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 年第一季度收入爲 800 萬美元,比 2023 年第一季度和 13 季度增長 50%第四 產品銷售連續增長一個季度
• 收購 PKU GOLIKE,推出尼替西農,並提交了候選產品 ET-400 的新藥申請(NDA)
• 管理層將於美國東部時間今天下午 4:30 舉行電話會議

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.

伊利諾伊州鹿園,2024年5月9日(GLOBE NEWSWIRE)——專注於開發和商業化罕見疾病療法的創新制藥公司伊頓製藥公司(“伊頓” 或 “公司”)(納斯達克股票代碼:ETON)今天公佈了截至2024年3月31日的季度財務業績。

"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,我們的開局非常富有成效。除了報告創紀錄的產品銷售額和我們的 13%第四 在產品銷售連續增長的季度中,我們收購了PKU GOLIKE,這爲我們的代謝投資組合增加了引人注目的新商業增長資產。我們還推出了尼替西農,併爲我們備受期待的 ET-400 候選產品提交了保密協議。” 伊頓製藥首席執行官肖恩·布林傑爾森說。

"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.

“對於伊頓來說,這是一個激動人心的時刻,因爲我們將繼續實現我們的願景。布林傑爾森總結道,預計現有產品將實現強勁增長,再加上PKU GOLIKE和Nitisinone的加入,我們有望在2024年實現非常強勁的2024年,因爲我們正在爲2025年初可能推出的 ET-400 做準備。

First quarter and Recent Business Highlights

第一季度和近期業務亮點

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 產品銷售和特許權使用費收入連續一個季度連續增長。伊頓公佈,2024年第一季度產品銷售額爲800萬美元,比上年增長50%,這主要是由ALKINDI SPRINKL和Carglumic Acid的持續勢頭推動的。該公司預計,產品銷售將持續在2024年及以後的季度環比增長。

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.

獲得了PKU GOLIKE的美國版權,這是一種用於苯丙酮尿症(PKU)患者的醫療配方。據估計,美國有8,000名PKU患者依賴PKU GOLIKE等醫療配方。該病由代謝遺傳學家及其支持人員管理,他們與伊頓公學積極參與其他代謝產品的醫療保健專業人員相同。據估計,PKU醫療配方的美國市場每年約爲1億美元。憑藉GOLIKE誘人的產品優勢和伊頓的商業基礎設施,該公司的目標是在未來幾年內佔據至少10%的市場份額,即每年1000萬美元。
向美國食品藥品監督管理局 (FDA) 提交了針對 ET-400 的保密協議。4月,伊頓提交了其專有的氫化可的鬆口服溶液專利配方 ET-400 的保密協議。預期的10個月審查將允許在2025年第一季度獲得批准。該公司仍然對候選產品表現出濃厚的興趣,並認爲 ET-400 和 ALKINDI SPRINKLE 相結合,可以實現每年超過5000萬美元的峯值銷售額。

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 的持續增長。在第一季度,該公司啓動了ALKINDI SPRINKLE採樣計劃,該計劃允許醫生持有產品並立即開始對患者進行治療。該公司估計,Carglumic Acid現在已經覆蓋了50%以上的患者群體,並且還在繼續增加新的患者。甜菜鹼和尼替西農的推出進一步加強了伊頓公學與代謝界的關係,並有助於增加與卡葡糖酸處方者的互動頻率。

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.

推出罕見病產品尼替西農。該產品於2024年2月推出,提供全面的患者和提供者支持服務。據估計,尼替西農市場每年爲5000萬美元,分爲多個參與者。伊頓預計將佔據現有市場的份額,而尼替西農的推出將爲該公司提供更多交叉銷售卡葡糖酸和PKU GOLIKE的機會。

First Quarter Financial Results

第一季度財務業績

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.

淨收入:2024年第一季度的淨收入爲800萬美元,而去年同期爲530萬美元,增長了50%。增長主要是由ALKINDI SPRINKLE和Carglumic Acid的增長推動的。

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年第一季度的毛利爲500萬美元,而去年同期爲330萬美元,增長還主要是由ALKINDI SPRINKL和Carglumic Acid的增長推動的。

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.

研發(R&D)費用:由於與候選產品 ET-400 和公司研發管道中的其他產品相關的開發成本增加,2024年第一季度的研發費用爲70萬美元,而去年同期爲50萬美元。儘管該公司預計第二季度研發費用將增加,ET-400 申請費爲200萬美元,但不包括一次性申請費,預計2024年的研發支出約爲400萬美元。

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)費用:2024年第一季度的併購支出爲520萬美元,而去年同期爲530萬美元,下降是由於員工相關費用和物流成本略有減少。

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.

淨收益:2024年第一季度的淨虧損爲80萬美元,合每股基本虧損和攤薄後每股虧損0.03美元,而去年同期淨虧損270萬美元,攤薄每股虧損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.

現金狀況:截至2024年3月31日,該公司的現金及現金等價物爲1,670萬美元,並預計持續的銷售增長將在2024年剩餘時間內帶來正的運營現金流。

Conference Call and Webcast Information

電話會議和網絡直播信息

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

正如先前宣佈的那樣,伊頓製藥將舉辦2024年第一季度的電話會議,具體如下:

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
時間 美國東部時間下午 4:30(美國東部時間下午 3:30)
註冊*(僅限音頻) 點擊這裏

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.

除了在電話會議上回答參與者的現場提問外,管理層還將回答投資者通過電子郵件發送的問題。投資者可以通過電子郵件將問題發送至: 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.

可以在伊頓公學網站的 “投資者” 部分觀看網絡直播,網址爲 https://ir.etonpharma.com/。存檔的網絡直播將在活動結束大約兩小時後在伊頓公學的網站上提供,之後將持續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.

* 電話會議參與者應註冊以獲取其撥入和密碼的詳細信息。請務必使用有效的電子郵件地址註冊。

About Eton Pharmaceuticals

關於伊頓製藥

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.

伊頓是一家創新制藥公司,專注於開發和商業化罕見疾病的治療方法。該公司目前有五種商用罕見病產品:ALKINDI SPRINKLE、PKU GOLIKE、Carglumic Acid、無水甜菜鹼和尼替西農。該公司還有另外三種候選產品處於後期開發階段:ET-400、ET-600 和ZENEO氫化可的松自動注射器。欲了解更多信息,請訪問我們的網站 www.etonpharma.com

Forward-Looking Statements

前瞻性陳述

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.

本新聞稿中有關非歷史事實事項的陳述是1995年《私人證券訴訟改革法》所指的 “前瞻性陳述”,包括與伊頓公學開展某些活動和實現某些目的和目標的預期能力相關的陳述。這些聲明包括但不限於有關伊頓商業戰略、伊頓開發和商業化其候選產品的計劃、伊頓候選產品的安全性和有效性、伊頓在監管申報和批准方面的計劃和預期時機以及伊頓候選產品的市場規模和增長潛力的聲明。由於此類陳述受風險和不確定性的影響,因此實際結果可能與此類前瞻性陳述所表達或暗示的結果存在重大差異。諸如 “相信”、“預期”、“計劃”、“期望”、“打算”、“將”、“目標”、“潛力” 等詞語以及類似的表述旨在識別前瞻性陳述。這些前瞻性陳述基於伊頓當前的預期,涉及可能永遠無法實現或可能被證明不正確的假設。由於各種風險和不確定性,包括但不限於發現、開發和商業化可用作人類療法的安全有效藥物的過程以及圍繞此類藥物開展業務的努力,實際結果和事件發生時間可能與此類前瞻性陳述中的預期存在重大差異。伊頓向美國證券交易委員會提交的文件中進一步詳細描述了這些風險以及其他與伊頓公學發展計劃和財務狀況有關的風險。本新聞稿中包含的所有前瞻性陳述僅代表其發佈之日。伊頓沒有義務更新此類聲明以反映在聲明發表之日後發生的事件或存在的情況。

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

投資者關係:
麗莎·威爾遜,現場通信公司
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
伊頓製藥有限公司
運營聲明
(以千計,每股金額除外)
(未經審計)
在結束的三個月裏
3月31日 3月31日
2024 2023
收入:
許可收入 $ $
產品銷售和特許權使用費 7,966 5,304
淨收入總額 7,966 5,304
銷售成本:
許可收入
產品銷售和特許權使用費 2,959 1,958
總銷售成本 2,959 1,958
毛利 5,007 3,346
運營費用:
研究和開發 651 535
一般和行政 5,156 5,345
運營費用總額 5,807 5,880
運營損失 (800) (2,534)
其他收入(支出):
其他收入
利息支出,淨額 (11) (126)
其他收入總額(支出) (11) (126)
所得稅支出前的虧損 (811) (2,660)
所得稅支出
淨虧損 $ (811) $ (2,660)
每股淨虧損,基本 $ (0.03) $ (0.10)
已發行普通股的加權平均數,基本 25,763 25,525
每股淨虧損,攤薄 $ (0.03) $ (0.10)
攤薄後已發行普通股的加權平均數 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
伊頓製藥有限公司
資產負債表
(以千計,股票和每股金額除外)
2024年3月31日 2023年12月31日
(未經審計)
資產
流動資產:
現金和現金等價物 $ 16,655 $ 21,388
應收賬款,淨額 4,240 3,411
庫存 2,318 911
預付費用和其他流動資產 1,050 1,129
流動資產總額 24,263 26,839
財產和設備,淨額 57 58
無形資產,淨額 6,388 4,739
經營租賃使用權資產,淨額 74 92
其他長期資產,淨額 12 12
總資產 $ 30,794 $ 31,740
負債和股東權益
流動負債:
應付賬款 $ 2,263 $ 1,848
扣除折扣後的債務的當期部分 5,020 5,380
應計負債 8,017 9,013
流動負債總額 15,300 16,241
經營租賃負債,扣除流動部分 22
負債總額 15,300 16,263
承付款和或有開支(注11)
股東權益
普通股,面值0.001美元;授權5000萬股;截至2024年3月31日和2023年12月31日分別已發行和流通25,690,562股和25,688,062股和25,688,062股 26 26
額外的實收資本 120,349 119,521
累計赤字 (104,881) (104,070)
股東權益總額 15,494 15,477
負債和股東權益總額 $ 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 $ $
伊頓製藥有限公司
現金流量表
(以千計)
(未經審計)
三個月已結束 三個月已結束
2024年3月31日 2023年3月31日
來自經營活動的現金流
淨虧損 $ (811) $ (2,660)
爲使淨虧損與經營活動中使用的淨現金相一致而進行的調整:
基於股票的薪酬 821 872
折舊和攤銷 252 213
債務折扣攤銷 25 29
運營資產和負債的變化:
應收賬款 (829) (1,022)
庫存 (1,407) 120
預付費用和其他資產 79 191
應付賬款 414 (530)
應計負債 (1,017) 1,239
用於經營活動的淨現金 (2,473) (1,548)
來自投資活動的現金流
購買產品許可權 (1,868)
購買財產和設備 (14)
用於投資活動的淨現金 (1,882)
來自融資活動的現金流
償還長期債務 (385)
股票期權行使的收益 7 132
支付與股票期權行使淨股結算相關的預扣稅 (181)
用於融資活動的淨現金 (378) (49)
現金和現金等價物的變化 (4,733) (1,597)
期初的現金和現金等價物 21,388 16,305
期末的現金和現金等價物 $ 16,655 $ 14,708
現金流信息的補充披露
支付利息的現金 $ 190 $ 216
爲所得稅支付的現金 $ $

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Source: Eton Pharmaceuticals

來源:伊頓製藥

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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