Vanda Pharmaceuticals Q3 2024 Financial Results

Vanda Pharmaceuticals Inc. has reported its financial and operational performance for the third quarter ending September 30, 2024. The company announced that revenues for Q3 2024 reached $47.7 million, reflecting a 23% increase from the same period in the previous year. This increase is attributed to the successful commercial launch of Fanapt® for bipolar I disorder and the introduction of PONVORY® for multiple sclerosis.

The launch of Fanapt® in bipolar I disorder has shown promising results, with new patient starts increasing by over 90% in Q3 2024 compared to Q3 2023. Vanda's CEO, Mihael H. Polymeropoulos, expressed optimism about the market response and highlighted the company's robust commercial strategy. He also mentioned the initiation of a long-acting injectable program for Fanapt®, expected to start in Q4 2024.

Additionally, Vanda plans to submit a New Drug Application (NDA) for milsaperidone, intended for the treatment of schizophrenia and bipolar I disorder, in early 2025. The company also anticipates beginning a major depressive disorder program for milsaperidone by the end of 2024.

PONVORY® has also been a significant highlight, with its commercial launch for multiple sclerosis in Q3 2024. Vanda expects to submit Investigational New Drug (IND) applications for PONVORY® targeting psoriasis and ulcerative colitis by Q4 2024. Despite these advancements, PONVORY®'s net product sales declined by 32% in Q3 2024 compared to the second quarter of 2024, largely due to the acquisition from Actelion Pharmaceuticals Ltd., a Johnson & Johnson Company, finalized in December 2023.

For the first nine months of 2024, Vanda's total net product sales amounted to $145.6 million, a slight decrease from the $147.4 million recorded in the same period in 2023. Fanapt® sales for this period reached $67.6 million, slightly down from $68.3 million the previous year. HETLIOZ® sales also saw a notable decrease, attributed to increased generic competition in the U.S.

On the research front, Vanda is progressing with its HETLIOZ LQ® program for pediatric insomnia and is pursuing FDA approval for jet lag disorder and insomnia treatments. The company has been involved in litigation to protect its HETLIOZ® patents and expects a jury trial in early 2026. Additionally, the European Medicines Agency is expected to take action on Vanda's Marketing Authorization Application for HETLIOZ® in early 2025.

In the area of tradipitant, Vanda is preparing to submit an NDA for motion sickness treatment to the FDA in Q4 2024, following the positive results from clinical trials. Moreover, a clinical trial to explore tradipitant's efficacy in preventing vomiting induced by a GLP-1 analog is set to begin in Q4 2024.

Vanda's early-stage programs include studies on VSJ-110 for dry eye disorder, VPO-227 for cholera, VCA-894A for Charcot-Marie-Tooth disease, and VTR-297 for onychomycosis. The company is also developing VQW-765 for treating acute performance anxiety in social situations.

Financially, Vanda reported a net loss of $5.3 million for Q3 2024, contrasting with a net income of $0.1 million for Q3 2023. For the first nine months of 2024, the net loss was $14.0 million, compared to a net income of $4.9 million in the same period the previous year. As of September 30, 2024, Vanda held $376.3 million in cash, cash equivalents, and marketable securities, not accounting for an $8.1 million payment from Janssen received in Q4 2024.

In summary, Vanda Pharmaceuticals Inc. has demonstrated significant progress in its commercial launches and research initiatives while navigating financial challenges. The company remains focused on expanding its portfolio and diversifying its revenue streams through strategic product development and market introductions.