VNDA

Commercial Portfolio Updates

• FNAPT (Phenapt) continued strong growth post-bipolar I disorder approval: total prescriptions up 62% and new-to-brand prescriptions up 300% compared to Q2 2024. It is one of the fastest growing atypical antipsychotics in the market as of Q2 2026, with a 300-representative sales force and 30% more face-to-face prescriber calls YoY in Q2 2026
• Bisanti received FDA approval for bipolar I disorder and schizophrenia in Q1 2026, and is on track for a H2 2026 launch, protected by data exclusivity through 2031 and patents expiring as late as 2044
• Nereus launched an early direct-to-consumer commercial offering via its web portal in May 2026; sales force-led personal promotion is scheduled to begin later in 2026
• Hetlios remains the U.S. market share leader despite over three years of generic competition

Pipeline and Regulatory Updates

• Four late-stage trials are on track to release top-line data by end of 2026 or early 2027: Nereus for GLP-1-induced vomiting (2026), VQW-765 for social anxiety disorder (2026), Hetlios for delayed sleep phase disorder (2026), Bisanti for major depressive disorder (H1 2027)
• The BLA for Quimilza (for generalized pustular psoriasis) is under FDA review with a December 12, 2026 PDUFA date. Quimilza has received orphan drug designation in Japan and the EU, and VCA894A for CMT2S received FDA Rare Pediatric Disease designation
• The formal administrative hearing for Hetlios for jet lag disorder is on schedule, with a five-day hearing before an administrative law judge scheduled for December 2026

Financial Position

• As of June 30, 2026, cash, cash equivalents, and marketable securities totaled $170 million
• Operating expenses are expected to moderate starting in late 2026, with a more significant decrease in 2026 after launch preparation and late-stage trial activities conclude
• Management expects current cash plus anticipated product revenue will fund operations through at least the end of 2027

• Management reaffirms full-year 2026 total revenue guidance of $240 million to $290 million across all commercial products. The midpoint of $265 million represents 23% YoY revenue growth
• Combined full-year 2026 net product sales guidance for FNAPT and Basanti is $150 million to $170 million, with a midpoint implying 36% combined YoY growth compared to 2025 FNAPT revenue
• Full-year 2026 other net product sales (Hetlios and Ponvori) guidance is $80 million to $90 million
• Full-year 2026 Nereus net product sales guidance is $10 million to $30 million
• Vanda maintains its position of not providing 2026 cash burn guidance, but confirms 2026 cash burn will likely be higher than 2025 cash burn
• Operating expense guidance projects expense reductions starting at the end of 2026, with much larger decreases throughout 2027 as late-stage trials and launch preparation activities conclude

For the full first half 2026 (H1 2026):

• FNAPT: Net product sales of $65.5 million, a 24% increase year-over-year (YoY), accounting for 64.1% of total H1 2026 revenue
• Hetlios: Net product sales of $21.5 million, a 42% decrease YoY, accounting for 21.0% of total H1 2026 revenue (does not include $7 million in shipments that arrived July 1, 2026)
• Ponvori: Net product sales of $14.1 million, an 11% increase YoY, accounting for 13.8% of total H1 2026 revenue
• Nereus: Net product sales of $1 million, accounting for 1.0% of total H1 2026 revenue (initial wholesaler stocking of $15.2 million, with $12.6 million of revenue constrained due to patient demand uncertainty)

For the second quarter 2026 (Q2 2026):

• FNAPT: Net product sales of $36 million, a 23% increase YoY and 22% increase quarter-over-quarter (QoQ), accounting for 71.3% of total Q2 2026 revenue. Total prescriptions grew 31% YoY and 11% QoQ, new-to-brand prescriptions grew 32% YoY and 10% QoQ
• Hetlios: Net product sales of $5.6 million, a 66% decrease YoY and 65% decrease QoQ, accounting for 11.1% of total Q2 2026 revenue (does not include $7 million in shipments that arrived July 1, 2026). The decrease stemmed from generic competition and customer inventory destocking
• Ponvori: Net product sales of $7.9 million, a 12% increase YoY and 27% increase QoQ, accounting for 15.6% of total Q2 2026 revenue
• Nereus: Net product sales of $1 million, accounting for 2.0% of total Q2 2026 revenue. The same $12.6 million revenue constraint from initial wholesaler stocking applies

• Nereus revenue recognition is constrained by uncertainty around initial patient demand and potential product returns from elevated wholesaler inventory levels
• Hetlios sales have declined sharply due to ongoing generic competition, and future sales may remain volatile or decline further as specialty pharmacies reduce excess inventory levels
• Outcome of the Hetlios jet lag disorder administrative hearing is uncertain, and no predictions of the final result are provided
• There is uncertainty around whether Phase 3 trial results will confirm positive Phase 2 findings for VQW-765, Nereus for GLP-1-induced vomiting, and other late-stage programs
• Higher than expected operating expenses and cash burn in 2025-2026 could impact funding availability beyond 2027 if product revenue falls short of expectations

Q: Nereus has had ~3 months of launch activity. Where are the biggest patient funnel drop-offs, and what metrics indicate whether 2026 Nereus sales will land at the low or high end of the guided $10-$30 million range? / A: Nereus is still very early in launch, with only direct-to-consumer activities active so far. Personal sales force promotion will begin in H2 2026. Key metrics investors should track are doctor engagement and receptivity, patient acquisition rates, refill rates, and pills per fill. Early data on these metrics remains limited, and the company will continue monitoring to update revenue projections. (192 characters)

Q: How many sales representatives will be used for Nereus personal promotion, what drives the upcoming operating expense moderation, and what caused Q2 2026 R&D expense increases? / A: Nereus will be detailed by existing sales teams: the ~300 reps supporting FNAPT/Basanti and ~50 reps supporting Ponvori, requiring no additional major headcount. Upcoming operating expense decreases will come from wrapping up late-stage Phase 3 trials and pre-approval commercial manufacturing for upcoming launches. Q2 2026 R&D increases came from this ramp-up of trial activity and pre-approval production, which is expensed to R&D per accounting rules. (327 characters)

Q: What gives Vanda confidence that VQW-765 will succeed in Phase 3, and could efficacy be stronger than in Phase 2? / A: The current Phase 3 study uses the same design, dose, and primary endpoint as the positive Phase 2 study, which already showed a significant anxiety reduction effect and established a clear dose-response curve. The Phase 3 sample size was calculated based on Phase 2 data to ensure the study is properly powered to confirm the earlier findings. (218 characters)

Q: What is Nereus' filing strategy for the GLP-1-induced vomiting indication, and has the FDA aligned on the Phase 3 design? / A: Positive Phase 2 data showed Nereus cut vomiting rates from ~60% (placebo) to ~30% for patients on full-dose GLP-1s. The current Phase 3 uses the same design to confirm these results. The company believes the existing approval plus new Phase 3 data will support a supplemental NDA filing, and continues ongoing discussions with the FDA on the trial's statistical analysis plan. (230 characters)