Vanda Pharmaceuticals Q1 2024 Financial Results

Vanda Pharmaceuticals Inc. released its financial and operational performance for the first quarter ending on March 31, 2024. Vanda recorded revenues of $47.5 million in Q1 2024, marking a 5% growth from the preceding quarter. However, this figure is a 24% drop from the $62.5 million reported in Q1 2023. The company showed a net loss of $4.1 million for Q1 2024, compared to a net income of $3.3 million in Q1 2023 and a net loss of $2.4 million in Q4 2023. The company ended the quarter with $394.1 million in cash and equivalents, a $5.9 million increase from the end of 2023.

Fanapt® sales amounted to $20.6 million in Q1 2024, down 10% from Q1 2023 and 9% from Q4 2023. HETLIOZ® sales were $20.1 million, showing a 49% year-on-year decline due to generic competition in the U.S. PONVORY®, acquired from Janssen in December 2023, saw its first quarter sales at $6.8 million.

Operationally, Vanda achieved several milestones. The FDA approved Fanapt® for the acute treatment of bipolar I disorder in April 2024. The commercial launch is scheduled for Q3 2024. The company plans to submit a New Drug Application (NDA) for milsaperidone for schizophrenia and bipolar disorder by early 2025. The commercial launch of PONVORY® for multiple sclerosis is also expected in Q3 2024.

The review of Tradipitant’s NDA for the treatment of gastroparesis is ongoing, with a PDUFA date set for September 18, 2024. The results from a second Phase III study of Tradipitant in treating motion sickness are expected in Q2 2024, with the NDA submission anticipated in Q4 2024.

Vanda's CEO, Mihael H. Polymeropoulos, expressed pride in the company's Q1 achievements and highlighted the upcoming launches and submissions as key growth drivers. The company aims to expand its addressable patient populations significantly through these initiatives.

In the psychiatry portfolio, Vanda plans to test Fanapt® and milsaperidone in treating depressive symptoms. A Phase III study for Fanapt® LAI (long-acting injectable) is set to begin by the end of 2024.

For HETLIOZ®, Vanda is planning to initiate a pediatric insomnia program. The company also received a complete response letter from the FDA regarding HETLIOZ® for insomnia and is evaluating its next steps. The litigation regarding HETLIOZ® patents against Teva Pharmaceuticals and Apotex is ongoing.

In terms of PONVORY®, Vanda is preparing for its commercial launch and aims to expand its use to treat psoriasis and ulcerative colitis, with Phase III studies expected to start by the end of 2024.

Early-stage programs include a Phase II study of VSJ-110 for dry eye, a Phase I study for VCA-894A in Charcot-Marie-Tooth disease, and a Phase I study of VTR-297 for onychomycosis. VQW-765 is being developed for acute performance anxiety.

Due to uncertainties in the U.S. market for HETLIOZ® and the upcoming product launches, Vanda has not provided financial guidance for 2024.

In conclusion, Vanda Pharmaceuticals is advancing its clinical programs and preparing for multiple product launches, which are expected to drive significant growth and value creation in the coming years.