Eton Pharmaceuticals(ETON)
Search documents
Eton Pharmaceuticals(ETON) - 2025 Q1 - Quarterly Results
2025-05-13 20:16
Exhibit 99.1 "We are now less than one month away from a potential launch of ET-400. We have been actively engaged with the FDA as part of the ongoing review, and we remain prepared to launch quickly upon potential approval on its Prescription Drug User Fee Act (PDUFA) date of May 28th. With three expected product launches this year and several late-stage candidates progressing in development, 2025 is shaping up to be another monumental year for Eton as we further solidify our place as a leading ultra-rare ...
Eton Pharmaceuticals Reports First Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-05-13 20:01
Core Insights - Eton Pharmaceuticals reported exceptional first-quarter results for 2025, achieving record financial performance and launching two recently acquired products, INCRELEX and GALZIN, while advancing its development pipeline [2][4][11]. Financial Performance - Eton's first-quarter 2025 net revenues reached $17.3 million, a 117% increase from $8.0 million in the same period last year, with product sales of $14.0 million reflecting a 76% growth [11][12]. - The company reported a gross profit of $9.9 million, up 97% from $5.0 million year-over-year, driven by increased product sales [13]. - Adjusted EBITDA for the first quarter was $3.7 million, compared to $0.5 million in the prior year [18]. Product Developments - The relaunch of INCRELEX, a treatment for Severe Primary IGF-1 Deficiency, has seen a significant increase in new patients since its acquisition and relaunch [5][12]. - Eton is preparing for the anticipated launch of ET-400, targeting a $200 million market opportunity for oral hydrocortisone, with a PDUFA date set for May 28, 2025 [6][12]. - The company also relaunched GALZIN for Wilson disease and announced the development of ET-700, an extended-release form of zinc acetate [7][12]. Licensing and Partnerships - Eton out-licensed the commercial rights to INCRELEX outside the U.S. to Esteve Pharmaceuticals for up to ten years, receiving a $4.3 million upfront licensing fee [8][9]. - The licensing revenue recognized during the first quarter included $1.8 million from this out-licensing agreement [11]. Cash Position and Expenses - As of March 31, 2025, Eton had cash and cash equivalents of $17.4 million, with an operating cash flow of $2.1 million generated during the quarter [21]. - Research and Development (R&D) expenses increased to $1.2 million from $0.7 million year-over-year, primarily due to the development of ET-700 and ET-800 [15]. General and Administrative (G&A) expenses rose to $9.2 million, reflecting increased advertising and promotional costs [17].
Eton Pharmaceuticals to Report First Quarter 2025 Financial Results on Tuesday, May 13, 2025
Globenewswire· 2025-05-01 20:30
Core Viewpoint - Eton Pharmaceuticals, Inc. will report its first quarter 2025 financial results on May 13, 2025, and will host a conference call to discuss these results [1]. Company Overview - Eton Pharmaceuticals is focused on developing and commercializing treatments for rare diseases, currently offering seven commercial products: INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone [3]. - The company has six additional product candidates in late-stage development: ET-400, ET-600, Amglidia®, ET-700, ET-800, and ZENEO® hydrocortisone autoinjector [3]. Investor Relations - Investors can submit questions via email to investorrelations@etonpharma.com during the conference call [1]. - The live webcast of the conference call will be accessible on Eton's website, with an archived version available for 30 days post-event [2].
Eton Pharmaceuticals, Inc. (ETON) Earnings Expected to Grow: What to Know Ahead of Q1 Release
ZACKS· 2025-05-01 15:07
Eton Pharmaceuticals, Inc. (ETON) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, ...
Eton Pharmaceuticals Announces Submission of NDA for ET-600 (Desmopressin Oral Solution)
Globenewswire· 2025-04-28 10:50
Core Points - Eton Pharmaceuticals has submitted a New Drug Application (NDA) for ET-600, an oral solution of desmopressin for treating central diabetes insipidus, with a 10-month FDA review expected and a potential launch in Q1 2026 [1][2] - If approved, ET-600 will be the only FDA-approved oral liquid formulation of desmopressin, addressing the needs of approximately 3,000 pediatric patients in the U.S. [2] - Eton holds a patent for ET-600 that expires in 2044, with additional patent applications under review [2] - The company has seven commercial rare disease products and six additional product candidates in late-stage development [3]
Eton Pharmaceuticals Out-Licenses International Rights to Increlex®
Globenewswire· 2025-04-01 11:00
Core Insights - Eton Pharmaceuticals has out-licensed the commercial rights to Increlex® to Esteve Pharmaceuticals for markets outside the U.S. [1][2] - Esteve is expected to leverage its global infrastructure to successfully commercialize Increlex, allowing Eton to focus on growth opportunities within the U.S. [2][3] - The licensing agreement is for up to ten years, with an option for Esteve to acquire international rights in the future [3] Company Overview - Eton Pharmaceuticals specializes in developing and commercializing treatments for rare diseases, currently offering seven commercial products and six additional candidates in late-stage development [4]
CROSSJECT updates on its collaboration with ETON PHARMACEUTICALS, Inc. and the ZENEO® adrenal insufficiency program
GlobeNewswire News Room· 2025-03-25 06:30
Core Insights - CROSSJECT has announced positive updates regarding its collaboration with ETON PHARMACEUTICALS for the ZENEO® adrenal insufficiency program, particularly focusing on the development of ZENEO® Hydrocortisone for the US and Canadian markets [3][4][5] Company Developments - CROSSJECT has developed a proprietary ready-to-use liquid formulation of hydrocortisone, which simplifies the administration process compared to existing products like PFIZER's Solu-Cortef® that require over ten steps for preparation [4] - ETON will commercialize the CROSSJECT Formulation, referred to as ET-800, and CROSSJECT will receive a high single-digit royalty on ETON's net sales [4][9] - ETON anticipates capturing a significant share of the hospital market for hydrocortisone injectables, estimated at $100 million, with future evaluations suggesting the market opportunity could exceed $200 million in the US alone [4][5][9] Future Outlook - ETON has confirmed its commitment to the ZENEO® Hydrocortisone project, with development and manufacturing milestones expected to commence from early 2026 [5][9] - CROSSJECT is also focused on accelerating the development of its products for adrenal insufficiency in the US and plans to leverage its experience to introduce innovative solutions in Europe and globally [6]
Eton Pharmaceuticals(ETON) - 2024 Q4 - Earnings Call Transcript
2025-03-18 23:42
Financial Data and Key Metrics Changes - The fourth quarter of 2024 saw record revenue of $11.6 million, representing a year-over-year increase of 59% [35] - Gross profit increased by 78% year-over-year, despite negative impacts from stepped-up inventory values and increased IP amortization [36] - Operating income for the quarter was a positive $600,000, with SG&A expenses rising to $6.7 million due to one-time transaction costs and investments in commercial infrastructure [38] Business Line Data and Key Metrics Changes - The company has achieved sixteen consecutive quarters of product revenue growth since launching Alcindi Sprinkle, with expectations for continued growth from newly acquired products Acrolex and Galzum [17][31] - The IncraLex acquisition contributed less than $200,000 to Q4 revenue, while Galzum closed on December 31 and did not materially impact Q4 results [36] Market Data and Key Metrics Changes - The company targets ultra-rare diseases, with all conditions currently addressed by its products having fewer than 10,000 patients in the U.S., and many with even fewer than 1,000 [11] - The potential patient population for IncraLex could expand significantly if the FDA adopts a broader definition of severe primary IGF-1 deficiency, potentially increasing the U.S. patient population from 200 to approximately 1,000 [72] Company Strategy and Development Direction - The company aims to build a leading ultra-rare disease company through a three-pillar growth strategy: organic growth of existing products, development of internal pipeline programs, and external acquisitions [16] - Recent acquisitions of Acrolex and Galzum are expected to have significant immediate impacts on revenue in 2025, alongside the development of late-stage pipeline assets [14][31] - The company is focused on enhancing patient access and affordability through its Eton Cares program, which includes zero-dollar copays and free drug programs for uninsured patients [10][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching $100 million in revenue in the near term, driven by the integration of new products and a robust pipeline [31] - The company anticipates significant growth opportunities in the adrenal insufficiency franchise and Wilson disease treatment, with plans for new product launches and market education initiatives [79][115] Other Important Information - The company has established strong relationships with pediatric endocrinology and metabolic genetics communities, enhancing its competitive edge in launching new therapies [24] - The company has a broad ultra-rare disease portfolio, with thirteen approved or late-stage products, seven of which are currently commercial [29] Q&A Session Summary Question: What are the growth prospects for IncraLex? - Management highlighted the potential to increase the patient population significantly if the FDA harmonizes the U.S. and European labels, which could expand the market opportunity to over $250 million annually [77] Question: How does the company plan to address the challenges faced by Wilson disease patients? - The company plans to improve access and affordability through its Eton Cares program and aims to increase awareness and education about the benefits of its FDA-approved product over OTC alternatives [126][120] Question: What is the expected impact of ET400 on the adrenal insufficiency market? - Management expects ET400 to capture a significant portion of the market, addressing the needs of patients who prefer liquid formulations and potentially reducing discontinuation rates [88][104]
Eton Pharmaceuticals, Inc. (ETON) Reports Q4 Loss, Tops Revenue Estimates
ZACKS· 2025-03-18 13:00
Group 1: Financial Performance - Eton Pharmaceuticals reported a quarterly loss of $0.02 per share, consistent with the Zacks Consensus Estimate, compared to a loss of $0.09 per share a year ago [1] - The company posted revenues of $11.65 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 9.05%, and up from $7.31 million year-over-year [2] - The current consensus EPS estimate for the upcoming quarter is $0.04 on revenues of $14.31 million, and for the current fiscal year, it is $0.50 on revenues of $84.16 million [7] Group 2: Market Performance and Outlook - Eton Pharmaceuticals shares have increased by approximately 14.8% since the beginning of the year, while the S&P 500 has declined by 3.5% [3] - The company has a favorable estimate revisions trend, resulting in a Zacks Rank 2 (Buy), indicating expected outperformance in the near future [6] - The Medical - Biomedical and Genetics industry is currently in the top 28% of Zacks industries, suggesting a positive outlook for stocks within this sector [8]
Eton Pharmaceuticals(ETON) - 2024 Q4 - Annual Results
2025-03-18 11:15
Financial Performance - Eton reported record net sales of $11.6 million in Q4 2024, a 59% increase compared to $7.3 million in Q4 2023, marking the 16th consecutive quarter of sequential product sales growth [4]. - Eton's gross profit for Q4 2024 was $6.5 million, up from $3.6 million in Q4 2023, primarily due to increased product sales [13]. - The company reported a net loss of $598 thousand for the three months ended December 31, 2024, an improvement compared to a net loss of $2,256 thousand for the same period in 2023 [28]. - The company generated net cash from operating activities of $(765) thousand for the three months ended December 31, 2024, compared to $387 thousand in the same period of 2023 [28]. - Cash flows from investing activities totaled $(38,132) thousand for the three months ended December 31, 2024, compared to $(775) thousand in the same period of 2023 [28]. Expenses - Research and Development (R&D) expenses for Q4 2024 were $(0.9) million, a decrease from $1.0 million in the prior year, influenced by a refund of the NDA filing fee for ET-400 [14]. - General and Administrative (G&A) expenses rose to $6.7 million in Q4 2024 from $4.6 million in the prior year, driven by personnel additions and increased marketing investments [15]. Acquisitions and New Products - The company successfully closed the acquisition of Increlex and Galzin, contributing less than $0.2 million in revenue for the quarter, with Increlex already adding new patients at a pace ahead of expectations [2][12]. - Eton is preparing for the potential launch of ET-400, with launch inventory manufactured and ready for a possible approval on its PDUFA goal date of May 28, 2025 [6]. - The company announced positive pivotal study results for ET-600 and plans to submit an NDA in April 2025, which could lead to approval in Q1 2026 [8]. - Eton has two new internal development programs, ET-700 and ET-800, which will be detailed in the upcoming Investor Day conference call [10]. Financial Position - As of December 31, 2024, Eton had cash and cash equivalents of $14.9 million, providing a solid financial position for future growth initiatives [17]. - Total assets increased significantly to $76,123 million in 2024 from $31,740 million in 2023, representing a growth of 139% [26]. - Current assets rose to $41,021 million in 2024, up from $26,839 million in 2023, marking a 53% increase [26]. - Total liabilities surged to $51,695 million in 2024, compared to $16,263 million in 2023, indicating a 218% increase [26]. - Stockholders' equity increased to $24,428 million in 2024 from $15,477 million in 2023, reflecting a growth of 58% [26]. - The company raised $25,309 thousand from the issuance of long-term debt during the year [28]. - The acquisition of a business cost the company $30,000 thousand, impacting cash flows from investing activities significantly [28]. Future Outlook - The company expects sequential growth in quarterly product revenue to continue through 2025 and beyond, driven by the relaunch of Increlex and Galzin [4].