Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced its third-quarter 2024 financial results, showcasing a 23% increase in revenue compared to the same period in 2023. The company is also making strides in its clinical development programs, with key milestones expected in the near term.
Total net product sales for Q3 2024 reached $47.7 million, driven by contributions from Fanapt (iloperidone), HETLIOZ (tasimelteon), and PONVORY (ponesimod). Fanapt sales increased by 12% to $23.9 million, while HETLIOZ sales saw a modest increase of 2% to $17.9 million. PONVORY, acquired from Actelion Pharmaceuticals Ltd. (Janssen), generated $5.9 million in sales during the quarter.
Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board, stated, "We are very pleased with the lead indicators of the initial market response to our commercial launch of Fanapt in bipolar I disorder... In parallel, we have launched Ponvory for multiple sclerosis and we are looking forward to increased prescriber and patient awareness in the near future."
Psychiatry Portfolio Expansion
Vanda is actively expanding its psychiatry franchise. The commercial launch of Fanapt for the acute treatment of bipolar I disorder in adults has shown promising early results, with new patient starts increasing by over 90% in Q3 2024 compared to Q3 2023. The company expects to initiate a Phase III program for a long-acting injectable (LAI) formulation of Fanapt in Q4 2024.
A New Drug Application (NDA) for milsaperidone, the active metabolite of Fanapt, is expected to be submitted to the FDA in early 2025 for the treatment of schizophrenia and acute bipolar I disorder. Additionally, Vanda plans to initiate a Phase III program for milsaperidone in major depressive disorder (MDD) by the end of 2024.
PONVORY and Immunological Indications
The commercial launch of PONVORY for the treatment of relapsing forms of multiple sclerosis was initiated in Q3 2024. Vanda is also exploring the potential of PONVORY in other immunological indications, with Investigational New Drug (IND) applications for psoriasis and ulcerative colitis expected to be completed in Q4 2024.
Tradipitant for Motion Sickness
Vanda expects to submit an NDA for tradipitant for the treatment of motion sickness to the FDA in Q4 2024. The NDA will include data from three placebo-controlled clinical studies demonstrating the efficacy of tradipitant in preventing vomiting associated with motion sickness. The company also plans to initiate a clinical trial to study tradipitant in the prevention of vomiting induced by GLP-1 analogs like semaglutide in Q4 2024.
Other Pipeline Developments
Vanda is also advancing several early-stage programs, including:
- VSJ-110, a CFTR activator, for the treatment of dry eye disorder.
- VPO-227, a CFTR inhibitor for the treatment of cholera, with a Phase I study planned in Bangladesh.
- VCA-894A for the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S).
- VTR-297 for the treatment of onychomycosis, with Phase I study results expected by the end of 2024.
- VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, for the treatment of acute performance anxiety in social situations.
Financial Update
Vanda is updating its 2024 financial guidance and expects to achieve total revenues between $190 to $210 million and year-end 2024 cash between $370 to $390 million.
