Eton Pharmaceuticals Q1 2024 Financial Results

Eton Pharmaceuticals, an innovative company focused on developing and commercializing treatments for rare diseases, announced its financial results for the first quarter of 2024. The company reported a notable revenue increase and sustained growth in product sales, marking its 13th consecutive quarter of sequential product sales growth.

For Q1 2024, Eton Pharmaceuticals achieved revenue of $8.0 million, a 50% increase compared to Q1 2023. This growth was primarily driven by its key products, ALKINDI SPRINKLE® and Carglumic Acid. The company expects this upward trend to continue throughout 2024 and beyond.

One of the significant highlights of the quarter was the acquisition of PKU GOLIKE®, a medical formula for patients with phenylketonuria (PKU). An estimated 8,000 PKU patients in the U.S. rely on medical formulas like PKU GOLIKE. The U.S. market for PKU medical formulas is estimated at approximately $100 million annually. Eton aims to capture at least 10% of this market share in the coming years, leveraging GOLIKE’s benefits and its own commercial infrastructure.

In addition, Eton launched Nitisinone, a product for treating rare diseases, in February 2024. The Nitisinone market is valued at around $50 million annually. Eton expects to gain a share of this market and strengthen its cross-selling opportunities with products like Carglumic Acid and PKU GOLIKE.

Another significant development was Eton’s submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ET-400, a proprietary formulation of hydrocortisone oral solution. If approved, this could lead to a product launch in early 2025. The company believes that ET-400, combined with ALKINDI SPRINKLE, has the potential to achieve peak sales of over $50 million annually.

Eton’s ALKINDI SPRINKLE and Carglumic Acid products continued to show strong performance. The ALKINDI SPRINKLE sampling program was launched in Q1, allowing physicians to start patient treatments immediately. Carglumic Acid has captured over 50% of the patient population, with continued new patient additions bolstering its position in the market. The launches of Betaine and Nitisinone further solidified Eton’s interactions with the metabolic community, enhancing customer relationships.

Financially, Eton reported a net revenue of $8.0 million for Q1 2024, up from $5.3 million in the same period the previous year. Gross profit increased to $5.0 million from $3.3 million. Research and Development (R&D) expenses rose to $0.7 million due to increased development costs for ET-400 and other pipeline products. Despite an anticipated increase in R&D expenses in the second quarter due to a $2.0 million ET-400 filing fee, the projected R&D spending for 2024 remains approximately $4.0 million, excluding the one-time filing fee.

General and Administrative (G&A) expenses for Q1 2024 were $5.2 million, slightly down from $5.3 million in the prior year, reflecting reduced employee-related and logistics costs. The net loss for the quarter was $0.8 million, or $0.03 per share, compared to a net loss of $2.7 million, or $0.10 per share, in Q1 2023.

As of March 31, 2024, Eton had $16.7 million in cash and cash equivalents. The company expects continued sales growth to result in positive operating cash flow for the remainder of 2024.

Eton Pharmaceuticals remains focused on its vision of developing and commercializing treatments for rare diseases. With strong growth prospects from its existing products and new additions like PKU GOLIKE and Nitisinone, the company is well-positioned for a robust 2024 and anticipates the potential launch of ET-400 in early 2025.