Eton Pharmaceuticals Stock Price, News & Analysis

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 The live webcast is accessible on Eton's investor website, with an archived version available for 30 days post-event.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.

Eton Pharmaceuticals, Inc. (Nasdaq: ETON) and XGen Pharmaceuticals DJB, Inc. announced the commercial launch of Rezipres® (ephedrine hydrochloride) injection, approved for treating hypotension during anesthesia. The ready-to-use formulation aims to replace unapproved compounded options, enhancing safety for hospitals. The ephedrine injection market saw a 24% growth in 2021, reaching $86 million. Rezipres is supplied in a 5mL ampule and can be ordered through major wholesalers. Eton retains ownership of the FDA New Drug Application.

Eton Pharmaceuticals, Inc (Nasdaq: ETON) announced its fourth quarter 2021 financial results will be reported on March 16, 2022. Management will host a conference call and live audio webcast for investors at 7:00 p.m. ET due to ongoing litigation regarding their cysteine product. Investors can submit questions via email prior to or during the call. Eton currently holds six FDA-approved products and has four others submitted for approval, emphasizing their focus on rare diseases.

Eton Pharmaceuticals has launched Carglumic Acid tablets, the first FDA-approved generic version of Carbaglu®. Available exclusively through Anovo specialty pharmacy, this product treats acute and chronic hyperammonemia due to NAGS deficiency. Carglumic Acid is stable at room temperature, unlike Carbaglu®, and includes a patient support program offering $0 co-pays for eligible patients. The FDA has granted this product Competitive Generic Therapy designation, allowing for 180 days of exclusivity. Eton aims to improve patient access and reduce healthcare costs by providing a more affordable alternative.

Eton Pharmaceuticals, Inc (Nasdaq: ETON) reported its Q3 2021 financial results, achieving $0.8 million in revenue compared to no revenue in Q3 2020. The company made significant strides, gaining FDA approvals for EPRONTIA and carglumic acid, expected to launch in Q4 2021. Eton also partnered with Tolmar Pharmaceuticals to expand the commercial footprint of ALKINDI SPRINKLE®. Despite a net loss of $6.1 million, down from $6.5 million year-over-year, Eton anticipates these developments will bolster revenue and aim for profitability in 2022.

Eton Pharmaceuticals has entered a multi-year agreement with Tolmar Pharmaceuticals to co-promote ALKINDI SPRINKLE®, an FDA-approved treatment for adrenal insufficiency in children. Tolmar's sales force, consisting of 62 representatives, will leverage their existing relationships in pediatric endocrinology to enhance the product's adoption. The collaboration aims to improve face-to-face interactions with physicians, significantly increasing outreach and accelerating market penetration. The promotional efforts are set to begin in December 2021, coinciding with a digital marketing campaign aimed at raising awareness among patients and caregivers.