Vanda Pharmaceuticals Reports $198.8M Revenue in Fiscal Year 2024, Net Loss of $18.9M

Vanda Pharmaceuticals Inc. reported total revenues of $198.8 million for the fiscal year 2024, a 3% increase compared to $192.6 million in 2023. Net product sales for Fanapt increased by 4% to $94.3 million, driven by price increases and volume growth, including the launch of Fanapt for bipolar I disorder in the third quarter of 2024. However, HETLIOZ net product sales decreased by 23% to $76.7 million due to decreased volume, partially offset by price increases, and the impact of elevated inventory levels at specialty pharmacies. PONVORY net product sales, acquired in December 2023, contributed $27.8 million to the total.

Cost of goods sold decreased by 24% to $11.3 million in 2024, primarily due to lower royalty costs following the expiration of certain royalty agreements. Research and development expenses decreased slightly by 3% to $74.4 million, while selling, general, and administrative expenses increased by 30% to $146.4 million, largely due to increased commercialization efforts for Fanapt and PONVORY. Intangible asset amortization increased to $7.3 million, reflecting the amortization of the PONVORY acquisition. The company reported a net loss of $18.9 million for 2024 compared to a net income of $2.5 million in 2023.

Significant developments during the year included the FDA approval of Fanapt for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the acquisition of the U.S. and Canadian rights to PONVORY. The company also initiated Phase III programs for Fanapt's long-acting injectable formulation and Bysanti for major depressive disorder. Furthermore, Vanda submitted a Marketing Authorization Application to the EMA for Fanapt and is pursuing clinical development of HETLIOZ for pediatric insomnia and delayed sleep phase disorder. An NDA for tradipitant for motion sickness was submitted to the FDA.

The company's financial performance was impacted by several factors, including the launch of generic versions of HETLIOZ, resulting in decreased sales and increased inventory levels at specialty pharmacies. The company is involved in ongoing patent litigation related to HETLIOZ and is pursuing additional legal actions to protect its intellectual property. The company also noted uncertainty regarding the impact of the Inflation Reduction Act of 2022 on future pricing and reimbursement.

Vanda Pharmaceuticals ended 2024 with $374.6 million in cash, cash equivalents, and marketable securities. The company anticipates that its current resources will be sufficient for at least the next 12 months, but future funding needs may require additional capital raising through debt, equity, or collaborative arrangements. The company's outlook remains contingent upon the successful commercialization of its products, the outcome of ongoing clinical trials and legal proceedings, and the evolving regulatory landscape.