VNDA
Vanda Pharmaceuticals Inc.6.65
+0.02+0.3%
Dec 16, 4:00:01 PM EST
Earnings Call Transcripts
This Quarter (Q4 '25)
No earnings call transcript available yet
Last Quarter (Q3 '25)
FY Q3 '25
Q&A bullish on FDA, PONVORY demand
Q&A reinforced Fanapt's momentum with sequential prescription gains, but spotlighted PONVORY's underlying demand rising two quarters running after sales force ramp-up. Management stayed bullish on tradipitant approval by December 30 amid FDA collaborative progress, no efficacy snags flagged for Bysanti. Guidance tightened to $210M-$230M revenues due to HETLIOZ inventory volatility. Tradipitant's GLP-1 vomiting study wrapped, results due Q4. PONVORY demand ticks up. Investors eye FDA PDUs and launch prep.
Key Stats
Market Cap
392.99MP/E (TTM)
-Basic EPS (TTM)
-1.44Dividend Yield
0%Recent Filings
8-K
FDA approves NEREUS™ for motion sickness
Vanda Pharmaceuticals scored FDA approval for NEREUS™ (tradipitant) on December 30, 2025, to prevent motion-induced vomiting—the first new treatment in over 40 years. Pivotal trials showed vomiting rates plunging to 18.3–19.5% versus 44.3% on placebo in Motion Syros, with similar wins in Motion Serifos. Launch slated for coming months. Execution risks loom large.
8-K
FDA lifts tradipitant hold
Vanda Pharmaceuticals scored a win as the FDA lifted the partial clinical hold on tradipitant's motion sickness protocol VP-VLY-686-3403 on December 4, 2025, after agreeing it's an acute therapy, not chronic. This unlocks extended clinical studies. FDA's NDA review for motion-induced vomiting stays on track for December 30 PDUFA. Risks linger on approval timing.
8-K
Tradipitant FDA updates
Vanda Pharmaceuticals extended the FDA's expedited re-review of tradipitant's partial clinical hold on long-term motion sickness studies to December 5, 2025, due to FDA personnel changes. Separately, NDA labeling discussions began, keeping the PDUFA date at December 30, 2025. Timelines hold firm. FDA outcomes remain uncertain.
10-Q
Q3 FY2025 results
Vanda's Q3 revenue climbed 18% y/y to $56.3M, driven by Fanapt® up 31% y/y to $31.2M while HETLIOZ held flat at $18.0M amid generic pressure and PONVORY rose 20% y/y to $7.0M. Operating loss widened to $31.3M from $11.0M on 60% higher SG&A to $60.3M for Fanapt bipolar and PONVORY MS launches, plus R&D up 34% to $22.6M including imsidolimab license. Net loss hit $22.6M or $(0.38) diluted EPS, confirmed vs 59.1M shares. Cash plus marketable securities stood at $293.8M after $80M operating outflow. Fanapt fuels growth. Generic competition shadows HETLIOZ.
8-K
Vanda Q3 sales up 18%
Vanda Pharmaceuticals posted Q3 2025 net product sales of $56.3 million, up 18% from last year, driven by Fanapt's 31% surge to $31.2 million while HETLIOZ held steady at $18.0 million. Pipeline advances include FDA reviews for tradipitant (PDUFA December 30, 2025) and Bysanti (February 21, 2026), plus a new FDA collaboration resolving HETLIOZ and tradipitant disputes. Net loss widened to $22.6 million amid R&D and SG&A hikes. Approvals remain uncertain.
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