Eton Pharmaceuticals(ETON)
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Eton Pharma Near Term Catalysts Vanish
Seeking Alpha· 2025-07-15 13:33
Group 1 - The individual known as the Michigan Value Investor (MVI) has a PhD in theoretical physics and transitioned to investing after a brief career in the field [1] - MVI has experience working as an analyst at a billion-dollar fund before establishing a small fund in 2009, focusing on a select group of stocks [1] - MVI emphasizes strong relationships with management in the companies of interest, allowing for a pool of investable ideas without the need for extensive research [1] Group 2 - MVI's investment philosophy is influenced by Warren Buffett and Charlie Munger, diverging from traditional value investing principles associated with Ben Graham [2]
Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-600 (Desmopressin Oral Solution)
Globenewswire· 2025-07-08 10:50
Core Insights - Eton Pharmaceuticals has received FDA acceptance for its New Drug Application (NDA) for ET-600, with a target action date set for February 25, 2026 [1] - ET-600 is a patented formulation of desmopressin oral solution, protected until 2044, aimed at treating central diabetes insipidus in pediatric patients [1][3] - The company is preparing for a potential product launch in the first quarter of 2026, addressing a significant unmet need in pediatric endocrinology [2] Company Overview - Eton Pharmaceuticals focuses on developing and commercializing treatments for rare diseases, currently offering eight commercial products [4] - The company has five additional product candidates in late-stage development, including ET-600, Amglidia®, ET-700, ET-800, and ZENEO® hydrocortisone autoinjector [4] - ET-600 is expected to be the only oral liquid option available for pediatric patients requiring precise dosing, as current alternatives involve cutting tablets or using unapproved suspensions [2][3]
Eton Pharmaceuticals (ETON) Earnings Call Presentation
2025-07-03 06:58
Financial Performance and Growth Strategy - Eton achieved 16 straight quarters of sequential revenue growth, driven by Alkindi Sprinkle and Carglumic Acid [14] - The company projects a clear path to over $100 million in near-term revenue with the additions of Increlex, Galzin, and ET-400 [23] - Eton expects to exit 2025 with an approximate $80 million revenue run rate [81] - The company anticipates a favorable product mix shift, expecting approximately 70% adjusted gross margin in 2025 and over 75% by 2028 [83] Product Portfolio and Pipeline - Eton has built one of the broadest ultra-rare disease portfolios in the industry, including 13 products and programs [10, 11] - The company acquired two high-value commercial products, Increlex and Galzin, and added three pipeline assets, Amglidia, ET-700, and ET-800 [19, 20] - A return of Increlex to 185 active US patients would produce estimated US revenue of approximately $50 million [28] - The company estimates that harmonizing the US definition of SPIGFD to match the EU would expand the US patient population by approximately 5x to around 1,000 patients [29] - Eton remains highly confident that sales of Alkindi Sprinkle and ET-400 will exceed $50 million annually [43] Upcoming Launches and Milestones - ET-400 has a PDUFA date of May 28, 2025, with a commercial launch planned within 1 week of PDUFA [43] - NDA submission for ET-600 is expected in April 2025 [63] - Potential NDA filing for ET-700 is estimated in 2027, with a clear path to over $100 million of peak sales after approval [54, 56]
Eton Pharmaceuticals Announces Addition to Russell 2000® and Russell 3000® Indexes
Globenewswire· 2025-06-27 10:50
Core Insights - Eton Pharmaceuticals has been added to the Russell 3000 and Russell 2000 Indexes, effective after the U.S. market closes on June 27, 2025, marking a significant milestone for the company [1][2]. Company Overview - Eton Pharmaceuticals is focused on developing and commercializing treatments for rare diseases, currently offering eight commercial products and five additional candidates in late-stage development [4]. Market Impact - The inclusion in the Russell indexes is expected to enhance Eton's visibility among investors and reflects the shareholder value generated over the past year [2][3]. Product Portfolio - Eton's commercial rare disease products include KHINDIVI, INCRELEX, ALKINDI SPRINKLE, GALZIN, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous, and Nitisinone, with late-stage candidates including ET-600, Amglidia, ET-700, ET-800, and ZENEO hydrocortisone autoinjector [4].
Eton Pharmaceuticals: Rapid Revenue Growth And Pipeline Catalysts Point To More Upside
Seeking Alpha· 2025-06-06 21:26
Core Insights - The article discusses the author's academic and professional background in Machine Learning, Economics, and Finance, highlighting affiliations with prestigious institutions and experience in financial advisory, particularly in banking and mergers & acquisitions [1]. Group 1 - The author holds a PhD in Machine Learning with a focus on Economics and Finance [1]. - The author has academic affiliations with IESE Business School, ESADE Business School, and the Barcelona Supercomputing Center [1]. - The professional experience includes working at Deloitte Financial Advisory, specializing in banking and mergers & acquisitions [1]. Group 2 - The author's interests include machine learning and generative AI applications in finance and economics [1]. - The author is proficient in programming languages such as Python, R, and SQL [1].
Eton Pharmaceuticals (ETON) Upgraded to Buy: Here's Why
ZACKS· 2025-06-02 17:05
Core Viewpoint - Eton Pharmaceuticals, Inc. (ETON) has received a Zacks Rank 2 (Buy) upgrade, indicating a positive trend in earnings estimates which is expected to positively influence its stock price [1][4]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for Eton Pharmaceuticals indicates an expected earnings per share (EPS) of $0.56 for the fiscal year ending December 2025, reflecting a significant year-over-year increase of 473.3% [9]. - Over the past three months, the Zacks Consensus Estimate for Eton has risen by 13.1%, showcasing a trend of increasing earnings estimates [9]. Zacks Rating System - The Zacks rating system is based on changes in a company's earnings picture, which is a critical factor in stock price movements [2][5]. - The system classifies stocks into five groups, with Zacks Rank 1 (Strong Buy) to Zacks Rank 5 (Strong Sell), and has a proven track record of generating an average annual return of +25% for Zacks Rank 1 stocks since 1988 [8][10]. - Eton Pharmaceuticals' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating strong potential for market-beating returns in the near term [11].
Eton Pharmaceuticals (ETON) Is a Great Choice for 'Trend' Investors, Here's Why
ZACKS· 2025-06-02 13:50
Core Viewpoint - The article emphasizes the importance of confirming the sustainability of a trend in short-term investing, highlighting that successful entry timing is crucial for profitability [1][2]. Group 1: Trend Analysis - The trend can reverse before exiting a trade, potentially leading to short-term capital losses for investors [2]. - A stock's recent price strength is a key indicator of its potential to maintain upward momentum, with Eton Pharmaceuticals, Inc. (ETON) being highlighted for its solid price increase of 29.5% over the past 12 weeks [4]. - ETON has also shown a price increase of 8.9% over the last four weeks, indicating that the upward trend is still intact [5]. Group 2: Fundamental Strength - ETON is currently trading at 85.9% of its 52-week high-low range, suggesting it may be on the verge of a breakout [5]. - The stock carries a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises [6]. - The Average Broker Recommendation for ETON is 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [7]. Group 3: Investment Strategy - The article suggests that investors should consider stocks that pass the "Recent Price Strength" screen, which identifies stocks with sufficient fundamental strength to maintain their uptrend [3][8]. - The Zacks Rank stock-rating system has a strong historical performance, with Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [7].
Eton Pharmaceuticals Announces U.S. FDA Approval for KHINDIVI™ (hydrocortisone) Oral Solution
Globenewswire· 2025-05-28 21:28
Core Insights - Eton Pharmaceuticals has received FDA approval for KHINDIVI, the first and only hydrocortisone oral solution, aimed at pediatric patients with adrenocortical insufficiency [1][3][9] - The commercial launch of KHINDIVI is expected in the week of June 2, with projected combined peak sales of KHINDIVI and ALKINDI SPRINKLE exceeding $50 million annually [1][6] Product Details - KHINDIVI is formulated as a 1mg/ml oral solution, designed for easy dosing without the need for refrigeration or mixing, making it suitable for patients with swallowing difficulties [2][4] - The product is indicated for replacement therapy in pediatric patients aged five years and older with adrenocortical insufficiency [9] Market Context - There are over 5,000 pediatric patients in the U.S. diagnosed with adrenal insufficiency, highlighting a significant market opportunity for KHINDIVI [6] - Eton's existing commercial team will promote KHINDIVI alongside ALKINDI SPRINKLE, providing additional treatment options for patients and caregivers [5][7] Strategic Partnerships - KHINDIVI will be available exclusively through Anovo, a specialty pharmacy, which will also manage the Eton Cares Program to assist patients with prescription fulfillment and financial support [7][8] Company Overview - Eton Pharmaceuticals focuses on developing treatments for rare diseases and currently has eight commercial products, including KHINDIVI and ALKINDI SPRINKLE [41]
Eton Pharmaceuticals Set To Dominate Orphan Drug Niche
Seeking Alpha· 2025-05-21 06:57
Group 1 - The individual known as the Michigan Value Investor (MVI) has a PhD in theoretical physics and transitioned from a brief career in that field to investing [1] - MVI has experience as an analyst at a billion-dollar fund before establishing a small fund in 2009, focusing on a select group of stocks [1] - MVI's long-standing familiarity with certain companies allows for a pool of investable ideas without the need for extensive research [1] Group 2 - MVI's investment philosophy is influenced by Warren Buffett and Charlie Munger, emphasizing value investing principles [2] - Unlike many value investors, MVI does not regard Ben Graham as a significant influence on their investment approach [2]
Eton Pharmaceuticals to Participate at Upcoming Investor Conferences
Globenewswire· 2025-05-14 20:30
Company Overview - Eton Pharmaceuticals, Inc is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases [3] - The company currently has seven commercial rare disease products: INCRELEX, ALKINDI SPRINKLE, GALZIN, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous, and Nitisinone [3] - Eton has six additional product candidates in late-stage development: ET-400, ET-600, Amglidia, ET-700, ET-800, and ZENEO hydrocortisone autoinjector [3] Upcoming Events - Eton's CEO, CFO, and Chief Business Officer will participate in two upcoming investor conferences [1] - The 25th Annual B. Riley Securities Investor Conference is scheduled for May 22, 2025, at 11:15 am ET in Marina Del Rey, California [5] - The 22nd Annual Craig-Hallum Institutional Investor Conference will take place on May 28, 2025, in Minneapolis, Minnesota [5]