Vanda Pharmaceuticals (VNDA, Financial) has expressed frustration over the U.S. Food and Drug Administration's (FDA) delay in addressing the company's request for a hearing on the approval of tradipitant, a treatment intended for gastroparesis. The company claims that the FDA has postponed the hearing, citing internal issues and recent administrative changes, including the appointment of Dr. Martin Makary as Commissioner and staff reductions.
According to Vanda's President, CEO, and Chairman, Dr. Mihael Polymeropoulos, the company has long advocated for greater transparency and logic within FDA processes, emphasizing that innovation thrives under democratic principles rather than bureaucratic constraints. He urged the FDA and the Department of Justice to consider constructive feedback and facilitate a more transparent and rational decision-making framework.
As the pharmaceutical company seeks a path forward, Vanda hopes for a receptive approach from regulatory bodies to address these delays and improve the drug approval process for innovative treatments like tradipitant.
Wall Street Analysts Forecast
Based on the one-year price targets offered by 4 analysts, the average target price for Vanda Pharmaceuticals Inc (VNDA, Financial) is $10.80 with a high estimate of $20.00 and a low estimate of $5.00. The average target implies an upside of 149.48% from the current price of $4.33. More detailed estimate data can be found on the Vanda Pharmaceuticals Inc (VNDA) Forecast page.
Based on the consensus recommendation from 3 brokerage firms, Vanda Pharmaceuticals Inc's (VNDA, Financial) average brokerage recommendation is currently 2.3, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
Based on GuruFocus estimates, the estimated GF Value for Vanda Pharmaceuticals Inc (VNDA, Financial) in one year is $6.65, suggesting a upside of 53.58% from the current price of $4.33. GF Value is GuruFocus' estimate of the fair value that the stock should be traded at. It is calculated based on the historical multiples the stock has traded at previously, as well as past business growth and the future estimates of the business' performance. More detailed data can be found on the Vanda Pharmaceuticals Inc (VNDA) Summary page.
Key Business Developments
Release Date: February 13, 2025
- Total Revenue (Full Year 2024): $198.8 million, a 3% increase from $192.6 million in 2023.
- Fanapt Net Product Sales (Full Year 2024): $94.3 million, a 4% increase from $90.9 million in 2023.
- HETLIOZ Net Product Sales (Full Year 2024): $76.7 million, a 23% decrease from $100.2 million in 2023.
- PONVORY Net Product Sales (Full Year 2024): $27.8 million.
- Net Loss (Full Year 2024): $18.9 million compared to net income of $2.5 million in 2023.
- Operating Expenses (Full Year 2024): $239.4 million, up from $206.6 million in 2023.
- Cash, Cash Equivalents, and Marketable Securities (End of 2024): $374.6 million.
- Total Revenue (Q4 2024): $53.2 million, a 17% increase from $45.3 million in Q4 2023.
- Fanapt Net Product Sales (Q4 2024): $26.6 million, an 18% increase from $22.6 million in Q4 2023.
- HETLIOZ Net Product Sales (Q4 2024): $20 million, a 5% decrease from $21.1 million in Q4 2023.
- PONVORY Net Product Sales (Q4 2024): $6.5 million.
- Net Loss (Q4 2024): $4.9 million compared to a net loss of $2.4 million in Q4 2023.
- Operating Expenses (Q4 2024): $63.5 million, up from $52.4 million in Q4 2023.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Vanda Pharmaceuticals Inc (VNDA, Financial) reported strong revenue growth for Fanapt, with new patient starts increasing by over 160% in the fourth quarter of 2024 compared to the same period in 2023.
- The company initiated a Phase III program for the long-acting injectable formulation of Fanapt, which could drive future growth in their psychiatry portfolio.
- Vanda Pharmaceuticals Inc (VNDA) launched PONVORY for the treatment of multiple sclerosis, contributing to revenue diversification.
- The company entered into an exclusive global license agreement with AnaptysBio for imsidolimab, an IL-36 receptor antagonist, which could expand their anti-inflammatory portfolio.
- Vanda Pharmaceuticals Inc (VNDA) is targeting total annual revenue in excess of $1 billion by 2030, with significant contributions expected from their psychiatry portfolio.
Negative Points
- HETLIOZ net product sales decreased by 23% in 2024 compared to 2023 due to continued generic competition in the US.
- Vanda Pharmaceuticals Inc (VNDA) recorded a net loss of $18.9 million for the full year 2024, compared to a net income of $2.5 million in 2023.
- Operating expenses increased by $32.8 million in 2024, primarily driven by higher SG&A expenses related to commercial launches and legal activities.
- The company is facing challenges with an IRB objecting to a placebo-controlled design for a schizophrenia maintenance study, potentially delaying the Fanapt long-acting injectable program.
- Vanda Pharmaceuticals Inc (VNDA) did not provide 2025 cash guidance due to uncertainties in determining the right size for direct-to-consumer advertising investments.
