Vanda Pharmaceuticals — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total net product sales for Q3 2026 reached $69.8 million, a 24% increase year-over-year from $56.3 million in Q3 2025 and a 38% increase from $50.5 million in Q2 2026.
• Total operating expenses for Q3 2026 were $93.3 million, a 7% increase from $87.5 million in Q3 2025 but an 18% decrease from $114.3 million in Q2 2026.
• Net loss for Q3 2026 was $22.6 million ($0.37 diluted loss per share), compared to a net loss of $22.6 million ($0.38 diluted loss per share) in Q3 2025 and $62.5 million ($1.04 diluted loss per share) in Q2 2026.
• Loss before income taxes for Q3 2026 was $22.4 million, compared to $28.4 million in Q3 2025.
• Cash, cash equivalents, and marketable securities totaled $140.5 million as of September 30, 2026, representing a decrease of $29.5 million during Q3 2026 and a decrease of $123.4 million compared to December 31, 2025.
• For the first nine months of 2026, total net product sales were $172.1 million, an 8% increase from $158.9 million in the same period in 2025.
• For the first nine months of 2026, total operating expenses were $309.6 million, a 15% increase from $269.7 million in the same period in 2025.
• Net loss for the first nine months of 2026 was $133.6 million ($2.23 diluted loss per share), compared to $79.3 million ($1.35 diluted loss per share) in the first nine months of 2025.

Guidance and Future Outlook:

• Vanda updated its 2026 financial guidance, expecting total revenue for the full year 2026 to be greater than $240 million.
• Management expects operating expenses to decrease further in future quarters as key Phase III and launch-preparation activities conclude.
• The commercial launch of BYSANTITM is expected in Q4 2026.
• The BLA for QuimilzaTM for Generalized Pustular Psoriasis (GPP) is under FDA review with a PDUFA target action date of December 12, 2026.
• Vanda plans to submit a supplemental New Drug Application (sNDA) for NEREUS™ for the prevention of vomiting associated with GLP-1 receptor agonist therapy following positive Phase III results.
• Vanda intends to submit an sNDA for HETLIOZ® for Delayed Sleep-Wake Phase Disorder (DSWPD) following positive Phase III results.
• The Phase III study for BYSANTITM as an adjunctive treatment for major depressive disorder (MDD) is ongoing with results expected in the first half of 2027.

Business Segments and Product Lines:

• Fanapt® net product sales were $38.8 million in Q3 2026, a 24% increase from Q3 2025 and an 8% increase from Q2 2026.
• HETLIOZ® net product sales were $21.7 million in Q3 2026, a 21% increase from Q3 2025 and a 289% increase from Q2 2026; this includes approximately $7.0 million in revenue from orders shipped June 29, 2026, and arrived July 1, 2026.
• PONVORY® net product sales were $7.7 million in Q3 2026, a 10% increase from Q3 2025 and a 2% decrease from Q2 2026.
• NEREUS™ net product sales were $1.6 million in Q3 2026, a 60% increase from Q2 2026, following its commercial launch in the U.S. in Q2 2026.
• Fanapt® saw total prescriptions (TRx) up 25% and new-to-brand prescriptions (NBRx) up 18% versus Q3 2025.
• BYSANTITM received FDA approval in Q1 2026 for bipolar I disorder and schizophrenia and is protected by data exclusivity through February 20, 2031.
• NEREUS™ began sales force promotion in Q3 2026, showing strong growth in total prescriptions and unique prescribers compared to Q2 2026.

Market and Competitive Landscape:

• HETLIOZ® would be the first FDA-approved medicine for Delayed Sleep-Wake Phase Disorder (DSWPD) if the upcoming sNDA is approved.
• Vanda continues to pursue legal challenges regarding FDA refusals to approve HETLIOZ® for insomnia and NEREUS™ for gastroparesis, with briefing underway for the NEREUS case and awaiting a decision for the HETLIOZ insomnia case.
• An FDA formal hearing regarding HETLIOZ® for jet lag disorder is scheduled to culminate in a five-day hearing before the Administrative Law Judge from December 14, 2026, to December 18, 2026.

Risks and Challenges:

• Forward-looking statements regarding the timing of commercial launches, FDA review completion, regulatory paths, and expense reduction are subject to risks and uncertainties.
• Specific risks include the FDA's ability to complete the Quimilza™ BLA review by December 12, 2026, and the outcomes of administrative hearings and court cases regarding HETLIOZ® and NEREUS™.
• The company faces risks related to successfully executing the commercial launch of BYSANTITM in Q4 2026 and the ability to continue reducing operating expenses.

Management Commentary and Tone:

• Mihael H. Polymeropoulos, M.D., President, CEO, and Chairman, expressed pleasure with the strong revenue growth and decreased operating expenses, attributing the latter to the conclusion of key Phase III and launch-preparation activities.
• Management stated a focus on moderating costs and driving revenue growth from the current portfolio and planned launches to support sustainable long-term value.

Other Key Points:

• Vanda announced positive results from the Phase III study (VP-VLY-686-3601) of NEREUS™ for the prevention of vomiting associated with GLP-1 receptor agonist therapy.
• Positive topline results were announced in September 2026 from the pivotal Phase III study of HETLIOZ® in adults with Delayed Sleep-Wake Phase Disorder.
• The results of the pivotal clinical study for Quimilza™ were published in the April 28, 2026 issue of the New England Journal of Medicine (NEJM) Evidence.
• The Phase III study for BYSANTITM in MDD has enrolled 55% of its 500-patient target across 54 sites in the U.S. and Europe.
• A conference call was scheduled for October 28, 2026, at 4:30 PM ET to discuss the results, with a replay available until November 4, 2026.