JERSEY CITY, N.J. - Organon (NYSE: OGN), a global healthcare company focused on women's health, announced today that the FDA has extended the review period for the supplemental New Drug Application (sNDA) of their VTAMA® (tapinarof) cream, 1%, intended for treating atopic dermatitis in adults and children over two years old. The new target action date is set for March 12, 2025, a three-month extension from the original date of December 12, 2024.
The FDA's request for final datasets and a clinical study report from the long-term extension study for VTAMA prompted the extension. The agency clarified that the additional data requested is considered a major amendment to the sNDA, which typically warrants an extension of the review timeframe.
Despite the delay, Organon's Head of Research & Development, Dr. Juan Camilo Arjona Ferreira, expressed confidence in the data submitted to the FDA, emphasizing the company's commitment to providing all necessary information for the review process.
Organon anticipates that VTAMA will generate approximately $125 million in revenue for the full year 2025, with an expected 75 basis point impact on the Adjusted EBITDA margin for the same period. This financial forecast updates the company's previous statements from its third-quarter earnings call on October 31, 2024. A more detailed financial outlook for 2025 will be provided in February 2025 when the company reports its full-year results for 2024.
Atopic dermatitis, often known as eczema, is a prevalent inflammatory skin condition, affecting over 26 million people in the U.S. and up to 10% of adults globally. The disease is characterized by itchy, red, swollen, and cracked skin, mainly impacting children, which can lead to sleep disturbances and social challenges.
VTAMA cream is a non-steroidal topical treatment, previously evaluated in clinical trials for plaque psoriasis and currently under FDA review for atopic dermatitis. Common adverse reactions include folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
This news is based on a press release statement from Organon. The company, headquartered in Jersey City, New Jersey, employs around 10,000 people worldwide and aims to innovate in women's health and biosimilars to drive future growth.
In other recent news, Organon has reported a third-quarter revenue of $1.6 billion, marking a 5% growth at constant currency. This increase was driven by a 6% rise in the women's health franchise and a 17% surge in biosimilars. Despite challenges such as loss of exclusivity and pricing pressures, the company has raised its full-year revenue guidance and projects growth from its recent acquisition of Dermavant. The adjusted EBITDA for the period reached $459 million, with a 29% margin, and free cash flow nearing $700 million year-to-date. Organon also revised its adjusted EBITDA margin guidance for 2024 to 30%-31% due to increased expenses and a less favorable product mix. The company expects revenue growth in 2025, including $150 million from the Dermavant acquisition. These are some of the recent developments in Organon's business operations.
InvestingPro Insights
Organon's recent FDA review extension for VTAMA® cream aligns with several key financial metrics and insights from InvestingPro. Despite the delay, the company's financial position remains strong, with a market capitalization of $4.36 billion and a revenue of $6.41 billion over the last twelve months as of Q3 2024.
An InvestingPro Tip highlights that Organon "pays a significant dividend to shareholders," which is supported by the current dividend yield of 6.62%. This attractive yield could provide a cushion for investors during the extended review period for VTAMA.
Another relevant InvestingPro Tip notes that the company has been "profitable over the last twelve months." This is reflected in Organon's impressive P/E ratio of 3.34, suggesting that the stock may be undervalued relative to its earnings. The low PEG ratio of 0.03 further supports this notion, indicating potential for growth at a reasonable price.
It's worth noting that Organon's revenue growth of 4.21% over the last twelve months demonstrates the company's ability to expand its business, even as it navigates regulatory processes for new products like VTAMA.
For investors seeking more comprehensive analysis, InvestingPro offers 6 additional tips for Organon, providing a deeper understanding of the company's financial health and market position.
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