Welcome to our dedicated page for Eton Pharmaceutcials news (Ticker: ETON), a resource for investors and traders seeking the latest updates and insights on Eton Pharmaceutcials stock.
Eton Pharmaceuticals, Inc. (NASDAQ: ETON) is a Deer Park, Illinois-based specialty pharmaceutical company dedicated to developing and commercializing innovative pharmaceutical products, particularly those aimed at treating rare diseases. The company's mission is to advance healthcare by introducing affordable and accessible medicines to patients in need.
Eton utilizes the U.S. Food and Drug Administration’s (FDA) 505(b)(2) regulatory pathway to develop its products. Currently, Eton has four commercial rare disease products: ALKINDI SPRINKLE® for pediatric adrenocortical insufficiency, Carglumic Acid for hyperammonemia, Betaine Anhydrous for homocystinuria, and Nitisinone for hereditary tyrosinemia type 1 (HT-1). The recent addition of Nitisinone further advances Eton's goal of having ten commercial rare disease products by the end of 2025.
Beyond these, Eton has several promising candidates in late-stage development. These include ET-400, a liquid formulation of hydrocortisone for adrenocortical insufficiency, the ZENEO® hydrocortisone autoinjector for adrenal crisis, and ET-600 for diabetes insipidus. Eton's ET-400 product recently received a new U.S. patent with an expiration date in 2043, and it is expected to significantly complement the existing ALKINDI SPRINKLE product.
Financial Performance and Recent Achievements
- The company has reported eleven consecutive quarters of growth in product sales and royalty revenue, achieving cash flow break-even ahead of schedule.
- Third quarter 2023 net revenue reached $7.0 million, marking a 118% increase from the prior year period.
- Gross profit for the same quarter more than doubled year-over-year, underscoring the company's strong commercial execution.
Eton's strategic acquisitions further bolster its portfolio. The recent acquisition of U.S. rights to PKU GOLIKE® from Relief Therapeutics positions the company to address the needs of patients with phenylketonuria (PKU), a rare metabolic disorder. Eton also aims to leverage its strong relationships within the metabolic community to drive adoption and market penetration for both existing and new products.
Patient Support and Community Initiatives
Eton is committed to supporting patients and their families through initiatives like the Eton Cares program, which provides comprehensive support services including prescription fulfillment, insurance benefits investigation, educational support, and financial assistance for qualified patients. The program aims to make treatments like Nitisinone more accessible to those who need them the most.
Looking Ahead
With a robust pipeline, strategic acquisitions, and a strong financial footing, Eton Pharmaceuticals is well-positioned for continued growth and success. The company's focus on rare diseases and commitment to patient care make it a valuable player in the pharmaceutical industry.
For more detailed information, please visit the company's website at www.etonpharma.com.
Eton Pharmaceuticals reported Q2 2022 revenue of $7.4 million, a 139% increase from the previous year. The company completed the divestiture of its hospital products division, focusing solely on rare diseases. Key growth drivers included ALKINDI SPRINKLE®, which saw 293% year-over-year growth, and Carglumic Acid, with a 100% sequential increase in sales. The FDA approved Zonisade™, with a $5 million milestone payment expected upon launch. Net loss for the quarter was $1.6 million.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) will report its second quarter 2022 financial results on August 11, 2022. A conference call and audio webcast will be held at 4:30 p.m. ET, featuring a Q&A session for investors. Eton specializes in developing treatments for rare diseases, currently marketing ALKINDI SPRINKLE® and Carglumic Acid tablets, and has additional products under development. The company also receives royalties from seven other products. Interested investors can access the live webcast on Eton's website.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) announced FDA approval for ZONISADE™ (zonisamide oral suspension) on July 18, 2022. This marks the eighth product approval for Eton's development team. ZONISADE™ will be commercialized by Azurity Pharmaceuticals, resulting in a $5 million milestone payment to Eton, along with royalties on net sales and potential commercial milestones totaling up to $15 million. The funds from this launch will help expand Eton's rare disease portfolio.
Dr. Reddy’s Laboratories has acquired a portfolio of branded and generic injectable products from Eton Pharmaceuticals for approximately $5 million upfront, with potential contingent payments of $45 million. The acquisition includes the NDAs for Biorphen® and Rezipres® injections and aims to enhance Dr. Reddy’s institutional business in the U.S. market, where the total addressable market for these products is estimated at $174 million for the year ending April 2022. This move supports Dr. Reddy’s commitment to expanding affordable medications.
Eton Pharmaceuticals has sold its rights to Biorphen®, Rezipres®, and Cysteine Hydrochloride products to Dr. Reddy's Laboratories for potential payments of up to $50 million. This strategic move allows Eton to concentrate on its core business of rare disease treatments. Eton's royalty portfolio is set to earn up to $70 million from milestone payments and royalties on additional products. The company retains its focus on four rare disease candidates, enhancing its position in the pharmaceutical market aimed at underserved conditions.
Eton Pharmaceuticals (ETON) reported a strong financial performance for Q1 2022, achieving $2.2 million in product sales and royalties, a 100% increase from Q4 2021. The company attained final FDA approval for cysteine injection and submitted a Prior Approval Supplement for its Biorphen vial product, expecting an action date in August 2022. Eton's commercial products, such as ALKINDI SPRINKLE and carglumic acid, are performing well, with strong growth and market share projections. However, Eton reported a net loss of $5.3 million for the quarter.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) will report its first quarter 2022 financial results on May 12, 2022. A conference call and live audio webcast will occur at 4:30 p.m. ET, allowing management to discuss results and take live questions from participants. Investors can also submit questions via email. The live webcast is accessible on Eton's investor website, with an archived version available for 30 days post-event. Eton specializes in treatments for rare diseases and currently holds royalties from seven FDA-approved products, with three more awaiting FDA review.
Eton Pharmaceuticals (Nasdaq: ETON) announced the appointment of James Gruber as Chief Financial Officer, effective immediately, following the retirement of Wilson Troutman. Mr. Troutman will assist in the transition until the end of May. Gruber brings over 20 years of financial experience, including a significant tenure at Horizon Therapeutics where he managed financial operations during substantial growth. Eton, focused on rare disease treatments, currently owns or earns royalties from seven FDA-approved products and has three additional submissions pending.
Eton Pharmaceuticals (Nasdaq: ETON) has received FDA approval for its cysteine hydrochloride ANDA, a bioequivalent generic to Exela Pharma's Elcys™, securing 180 days of exclusivity. Cysteine is essential for newborns, used as an additive in amino acid solutions. Following Exela's price hike from $22 to $82 per vial, Eton aims to offer a cost-effective alternative. The FDA approval comes amid ongoing litigation regarding the validity of Exela’s patents, with a decision expected in Q3 2022. The cysteine market exceeds $50 million annually, positioning Eton for substantial revenue opportunities.
Eton Pharmaceuticals reported a fourth quarter 2021 revenue of $6.1 million, including a $5 million milestone payment from the launch of EPRONTIA. The company achieved a net income of $1 million and EPS of $0.04, compared to a net loss of $7.7 million in the same quarter last year. The launch of carglumic acid is exceeding expectations, and the partnership with Tolmar for ALKINDI SPRINKLE is driving new prescriptions. Eton has six FDA-approved products in the launch phase, with four more awaiting approval.
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