Journey Medical Corporation (Nasdaq: DERM) has announced the FDA approval of Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the treatment of inflammatory lesions of rosacea in adults. The company expects to launch the product in late Q1 or early Q2 of 2025.
Emrosi Approval and Launch
The FDA's approval of Emrosi marks a significant milestone for Journey Medical. Claude Maraoui, Journey Medical’s Co-Founder, President and Chief Executive Officer, stated that this approval is a transformational milestone, with Emrosi potentially becoming the best-in-class oral medication for rosacea. The company is currently focused on completing manufacturing activities and deploying its sales force to ensure patient access to this new therapeutic option.
Clinical Data Highlights
Recent clinical data presented at the 44th Fall Clinical Dermatology Conference compared the pharmacokinetics of Emrosi to oral Doxycycline 40 mg capsules. The data indicated that Emrosi, with its extended-release formulation, provides a higher dermal concentration than doxycycline from Day 1 onward at a similar dose. This is expected to translate into a clinically meaningful impact for treating patients with rosacea, as demonstrated in Emrosi’s Phase 3 clinical trials.
Financial Performance
Journey Medical reported total revenues of $14.6 million for the third quarter ended September 30, 2024. While total net product revenues saw a slight decrease of 4% compared to the same period in 2023, Qbrexza net product sales increased by 29% due to focused marketing efforts. The company's gross product margin increased from 57.9% to 63.9%, driven by decreased cost of goods sold and product royalties. The net loss for the quarter was $2.4 million, compared to a net income of $16.8 million for the same period in 2023, which included a one-time $19.0 million upfront payment from a license agreement.
About Rosacea
Rosacea is a chronic inflammatory skin condition that affects millions of adults. Symptoms include facial redness, visible blood vessels, and inflammatory lesions such as papules and pustules. Effective treatments are essential to manage the condition and improve patients' quality of life. Emrosi offers a new treatment option with the potential for improved outcomes due to its enhanced dermal concentration of minocycline.
