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Eton Pharmaceuticals to Present at Piper Sandler 37th Annual Healthcare Conference on December 4th
Globenewswire· 2025-11-24 21:30
Core Insights - Eton Pharmaceuticals is set to participate in the Piper Sandler 37th Annual Healthcare Conference on December 4, 2025, at 9:30 AM ET in New York City [1] Company Overview - Eton Pharmaceuticals focuses on developing and commercializing treatments for rare diseases, currently offering eight commercial products [2] - The company's commercial rare disease products include KHINDIVI™, INCRELEX, ALKINDI SPRINKLE, GALZIN, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous, and Nitisinone [2] - Eton has five additional product candidates in late-stage development: ET-600, Amglidia, ET-700, ET-800, and ZENEO hydrocortisone autoinjector [2]
Eton Pharmaceuticals to Participate at 16th Annual Craig-Hallum Alpha Select Conference on November 18th
Globenewswire· 2025-11-12 21:30
Core Insights - Eton Pharmaceuticals is participating in the 16th Annual Craig-Hallum Alpha Select Conference on November 18, 2025, in New York, where its executive leadership will host 1x1 meetings [1] Company Overview - Eton Pharmaceuticals focuses on developing and commercializing treatments for rare diseases, currently offering eight commercial products for rare diseases [3] - The company's commercial products include KHINDIVI™, INCRELEX, ALKINDI SPRINKLE, GALZIN, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous, and Nitisinone [3] - Eton has five additional product candidates in late-stage development: ET-600, Amglidia, ET-700, ET-800, and ZENEO hydrocortisone autoinjector [3]
Eton Pharmaceuticals Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-11-06 21:05
Core Insights - Eton Pharmaceuticals reported a strong third quarter in 2025, with product sales increasing by 129% year-over-year, reaching $22.5 million, marking the 19th consecutive quarter of sequential growth [2][5][14]. Financial Performance - The company achieved a net revenue of $22.5 million for Q3 2025, compared to $10.3 million in the same period last year, reflecting an increase of 118% [14]. - Gross profit for the quarter was $7.9 million, up from $6.3 million in the prior year, representing a 25% increase [17]. - Adjusted EBITDA for Q3 2025 was $2.9 million, compared to $2.0 million in the prior year [22]. - The net loss for the quarter was $1.9 million, or $0.07 per diluted share, compared to a net income of $0.6 million, or $0.02 per diluted share, in the prior year [22][23]. Product Performance - The relaunch of INCRELEX significantly contributed to revenue, being the largest revenue contributor in Q3 2025, with strong adoption and awareness efforts [6][9]. - ALKINDI SPRINKLE and Carglumic Acid also showed strong year-over-year growth, supported by a dedicated sales force [11]. - The company is preparing for the launch of ET-600, with its New Drug Application accepted by the FDA and a PDUFA date set for February 25, 2026 [3][13]. Strategic Initiatives - Eton is focusing on expanding the KHINDIVI label and has received positive feedback from the FDA regarding a revised formulation aimed at younger patients [12]. - The company is pursuing harmonization of SPIGFD definitions between the U.S. and EU to increase patient access [6][8]. - Eton's cash position as of September 30, 2025, was $37.1 million, with $12.0 million generated from operations during the quarter [24]. Market Position - Eton Pharmaceuticals is positioned as an innovative company in the rare disease treatment market, with a portfolio of eight commercial products and five additional candidates in late-stage development [28].
Eton Pharmaceuticals to Participate at 2025 Wells Fargo Healthcare Conference
Globenewswire· 2025-08-20 10:50
Group 1 - Eton Pharmaceuticals, Inc is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases [3] - The company currently has eight commercial rare disease products, including KHINDIVI™, INCRELEX, and Nitisinone [3] - Eton has five additional product candidates in late-stage development, such as ET-600 and ZENEO hydrocortisone autoinjector [3] Group 2 - Eton's executive leadership team will host 1x1 meetings at the 2025 Wells Fargo Healthcare Conference from September 3-5, 2025 in Boston, MA [1] - Interested parties can schedule a meeting by contacting their Wells Fargo institutional sales representative [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]
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].