Earnings summaries and quarterly performance for Vanda Pharmaceuticals.
Executive leadership at Vanda Pharmaceuticals.
MP
Mihael Polymeropoulos
Detailed
President and Chief Executive Officer
CEO
GB
Gunther Birznieks
Senior Vice President, Business Development
JW
Joakim Wijkstrom
Senior Vice President, Chief Marketing Officer
KM
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
TW
Timothy Williams
Senior Vice President, General Counsel and Secretary
Board of directors at Vanda Pharmaceuticals.
Research analysts who have asked questions during Vanda Pharmaceuticals earnings calls.
RS
Raghuram Selvaraju
H.C. Wainwright & Co.
5 questions for VNDA
Also covers: ABEO, ACOG, AQST +20 more
Andrew Tsai
Jefferies
3 questions for VNDA
Also covers: ARQT, ATAI, ATHA +16 more
CD
Charles Duncan
Cantor Fitzgerald & Co.
3 questions for VNDA
Also covers: ACAD, ALKS, ATAI +12 more
ME
Madison El-Saadi
B. Riley
2 questions for VNDA
Also covers: ARWR, WVE
AS
Andrew Sy
Jefferies
1 question for VNDA
Linda Tsai
Jefferies
1 question for VNDA
Also covers: ADC, AKR, AMH +32 more
MB
Matthew Barcus
Jefferies
1 question for VNDA
Also covers: RLMD, VTGN
OB
Olivia Breyer
Cantor Fitzgerald
1 question for VNDA
Also covers: UTHR
RS
Rahim Suleman
H.C.W.
1 question for VNDA
S
Simon
Cantor Fitzgerald
1 question for VNDA
Recent press releases and 8-K filings for VNDA.
Vanda Pharmaceuticals Announces FDA Acceptance of Imsidolimab BLA Filing
VNDA
Product Launch
New Projects/Investments
- Vanda Pharmaceuticals announced on February 25, 2026, that the U.S. FDA has accepted the filing of its Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), with a target action date of December 12, 2026.
- Imsidolimab, a fully humanized IgG4 monoclonal antibody, demonstrated rapid disease clearance in pivotal studies (53% of patients achieving clear or almost clear skin at Week 4 vs. 13% on placebo) and could address a significant unmet medical need.
- Regulatory and patent exclusivity for imsidolimab is expected to extend into the late 2030s. If approved, it would be the third new drug product approved for Vanda in the past 12 months.
3 days ago
Vanda Pharmaceuticals Announces FDA Approval of BYSANTI™
VNDA
Product Launch
New Projects/Investments
- Vanda Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved BYSANTI™ (milsaperidone) tablets.
- BYSANTI™ is a first-line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults.
- Commercial availability of BYSANTI™ is anticipated in Q3 of 2026, with marketing exclusivity expected to be protected by regulatory data exclusivity and issued US patents until 2044.
- This marks Vanda's second new drug approval in less than 2 months, following the approval of NEREUS™ in December 2025.
7 days ago
Vanda Pharmaceuticals Reports Q4 and Full Year 2025 Results, Provides 2026 Guidance, and Updates on Pipeline
VNDA
Earnings
Guidance Update
Product Launch
- Vanda Pharmaceuticals reported full year 2025 total revenues of $216.1 million, a 9% increase year-over-year, and Q4 2025 total revenues of $57.2 million, an 8% increase compared to Q4 2024. Fanapt net product sales for full year 2025 grew 24% to $117.3 million, and for Q4 2025 increased 25% to $33.2 million.
- For 2026, the company expects total revenues from its current marketed products (Fanapt, HETLIOZ, and PONVORY) to be between $230 million and $260 million, with Fanapt net product sales projected at $150 million to $170 million.
- The FDA approved Nereus (tradipitant) in late 2025 for motion sickness, with commercial launch materials anticipated by late Q2 or early Q3 2026. Vanda also plans to initiate a Phase III program for Nereus in GLP-1 induced vomiting in H1 2026.
- The Bysanti (iloperidone) NDA for bipolar I disorder and schizophrenia is currently under FDA review with a PDUFA target action date of February 21, 2026, and the imsidolimab BLA for generalized pustular psoriasis was submitted in Q4 2025.
Feb 11, 2026, 9:30 PM
Vanda Pharmaceuticals Reports Q4 and Full-Year 2025 Results and Provides 2026 Guidance
VNDA
Earnings
Guidance Update
Product Launch
- Vanda Pharmaceuticals Inc. reported full-year 2025 total revenues of $216.1 million, a 9% increase year-over-year, driven by Fanapt net product sales of $117.3 million, up 24%. The company recorded a net loss of $220.5 million for the full year 2025, primarily due to a one-time, non-cash income tax charge of $113.7 million related to a valuation allowance against deferred tax assets.
- For 2026, Vanda expects total revenues from its currently commercialized products (Fanapt, Hetlioz, and Ponvory) to be between $230 million and $260 million, with Fanapt net product sales projected between $150 million and $170 million. The company anticipates 2026 cash burn will be greater than 2025, with $263.8 million in cash, cash equivalents, and marketable securities as of December 31, 2025.
- Vanda achieved significant regulatory milestones, including FDA approval of Nereus in late 2025 for motion sickness, with commercial launch preparations underway. The Bysanti-iloperidone NDA for bipolar I disorder and schizophrenia is under FDA review with a PDUFA target action date of February 21, 2026, and the imsidolimab BLA was submitted in Q4 2025 for generalized pustular psoriasis.
- The company plans to initiate a Phase III program for Nereus in the first half of 2026 to pursue label expansion for preventing vomiting induced by GLP-1 analogs.
Feb 11, 2026, 9:30 PM
Vanda Pharmaceuticals Reports Q4 and Full-Year 2025 Results, Provides 2026 Revenue Guidance
VNDA
Earnings
Guidance Update
Revenue Acceleration/Inflection
- Vanda Pharmaceuticals reported full-year 2025 total revenues of $216.1 million, a 9% increase from 2024, and a net loss of $220.5 million, which included a $113.7 million non-cash income tax charge for a valuation allowance against deferred tax assets. For Q4 2025, total revenues were $57.2 million, an 8% increase year-over-year, with a net loss of $141.2 million.
- Fanapt net product sales grew 24% to $117.3 million for FY 2025 and 25% to $33.2 million for Q4 2025, primarily due to increased volume from bipolar commercial launches and a significant expansion of the sales force. HETLIOZ sales decreased due to generic competition, while Ponvory sales saw a slight decrease for FY 2025 but increased in Q4 2025.
- The company provided 2026 revenue guidance of $230 million to $260 million for Fanapt, HETLIOZ, and PONVORY, with Fanapt net product sales expected to be $150 million to $170 million, implying approximately 36% growth for Fanapt.
- Vanda anticipates 2026 cash burn to be greater than 2025, with a $10 million milestone payment to Eli Lilly for the Nereus approval impacting the Q1 2026 cash balance.
- The Nereus NDA was approved on December 30, 2025, and the company is preparing for its commercial launch. A Phase III study for VQW-765 in social anxiety disorder has been initiated, and the iloperidone LAI Phase III study continues to enroll patients for schizophrenia relapse prevention.
Feb 11, 2026, 9:30 PM
Vanda Pharmaceuticals Reports Q4 and Full Year 2025 Results, NEREUS Approval, and 2026 Guidance
VNDA
Earnings
Guidance Update
Product Launch
- Vanda Pharmaceuticals Inc. reported full year 2025 total revenues of $216.1 million, a 9% increase from 2024, with Fanapt® net product sales increasing by 24% to $117.3 million for the full year.
- The company recorded a net loss of $220.5 million for the full year 2025 and $141.2 million for the fourth quarter of 2025, primarily due to a one-time, non-cash income tax charge of $113.7 million from a valuation allowance against deferred tax assets.
- The FDA approved NEREUS™ (tradipitant) for the prevention of vomiting induced by motion, and the Bysanti™ (milsaperidone) New Drug Application (NDA) for bipolar I disorder and schizophrenia is under review with a PDUFA target action date of February 21, 2026.
- As of December 31, 2025, Vanda held $263.8 million in cash, cash equivalents, and marketable securities.
- For full year 2026, Vanda expects total revenues of $230 to $260 million from its currently commercialized products (Fanapt®, HETLIOZ®, and PONVORY®).
Feb 11, 2026, 9:05 PM
Vanda Pharmaceuticals Reports Q4 and Full Year 2025 Financial Results
VNDA
Earnings
Guidance Update
Product Launch
- Full year 2025 total revenues for Vanda Pharmaceuticals increased by 9% to $216.1 million, with Fanapt net product sales growing 24% to $117.3 million compared to full year 2024.
- The company reported a full year 2025 net loss of $220.5 million and diluted net loss per share of $3.74, which includes a $113.7 million one-time, non-cash income tax charge.
- As of December 31, 2025, Vanda's cash, cash equivalents, and marketable securities totaled $263.8 million.
- For full year 2026, Vanda expects total revenues between $230 million and $260 million, with Fanapt net product sales projected to be $150 million to $170 million.
- The FDA approved NEREUS™ (tradipitant) for motion-induced vomiting prevention, and the Bysanti™ (milsaperidone) NDA has a PDUFA target action date of February 21, 2026.
Feb 11, 2026, 9:01 PM
Vanda Pharmaceuticals Highlights Recent Approvals, Pipeline Progress, and Financial Guidance
VNDA
Product Launch
Guidance Update
New Projects/Investments
- Vanda Pharmaceuticals recently received FDA approval for Nereus for vomiting induced by motion on December 30th, with a commercial launch anticipated in the second half of 2026.
- The company has an upcoming PDUFA date of February 21st, 2026, for Bysanti in bipolar I disorder and schizophrenia, and expects Phase 3 results for Bysanti in Major Depressive Disorder (MDD) in 2026.
- A Biologics License Application (BLA) for Imsidolimab in generalized pustular psoriasis (GPP) was submitted in Q4 2025, with a potential PDUFA date in summer 2026 if priority review is granted.
- Vanda reported $56.3 million in revenue for Q3 2025, reaffirmed its full-year 2025 revenue guidance of $210 million-$230 million, and expects year-end 2025 cash of $260 million-$290 million. The company also aims to have six commercial products on the market by the end of 2026 and maintains a strong debt-free balance sheet.
Jan 15, 2026, 5:00 PM
Vanda Pharmaceuticals Provides Business Update and 2025 Financial Guidance
VNDA
Guidance Update
Product Launch
New Projects/Investments
- Vanda Pharmaceuticals reported Q3 2025 total revenue of $56.3 million and reaffirmed its 2025 total revenue guidance of $210 million-$230 million and year-end cash guidance of $260 million-$290 million.
- The company received FDA approval for Nereus for motion sickness on December 30, 2025, with a commercial launch planned for the second half of 2026. Nereus also has a Phase 3 program for GLP-1 induced vomiting starting in the first half of 2026.
- An upcoming PDUFA date for Bysanti (for bipolar I disorder and schizophrenia) is set for February 21, 2026, which is crucial for extending the psychiatry portfolio beyond Fanapt's expected loss of exclusivity in late 2027. Phase 3 results for Bysanti in Major Depressive Disorder (MDD) are also expected in 2026.
- The Biologics License Application (BLA) for Imsidolimab in Generalized Pustular Psoriasis (GPP) was submitted in Q4 2025, with a potential PDUFA date in summer 2026 if priority review is granted.
- Fanapt demonstrated strong commercial performance, with 35% growth in total prescriptions and 147% growth in new-to-brand prescriptions between Q3 2024 and Q3 2025.
Jan 15, 2026, 5:00 PM
Vanda Pharmaceuticals Highlights Q3 2025 Results, Upcoming Catalysts, and Pipeline Expansion
VNDA
Guidance Update
Product Launch
New Projects/Investments
- Vanda Pharmaceuticals reported Q3 2025 total revenue of $56.3 million, with full-year 2025 revenue guidance set at $210 million-$230 million and year-end 2025 cash guidance at $260 million-$290 million.
- The company has several near-term regulatory catalysts, including a PDUFA date for Bysanti on February 21st, 2026, for bipolar I disorder and schizophrenia, and a potential PDUFA date for imsidolimab in summer 2026 for generalized pustular psoriasis.
- NEREUS received FDA approval for motion sickness on December 30th, with a commercial launch anticipated in the second half of 2026, and a Phase III program for GLP-1 induced vomiting is expected to start in the first half of 2026.
- Vanda aims to expand its commercial portfolio to six products by the end of 2026, with Bysanti Phase III results for Major Depressive Disorder expected in 2026.
- Fanapt demonstrated significant commercial growth between Q3 2024 and Q3 2025, with 35% growth in total prescriptions and 147% growth in new-to-brand prescriptions.
Jan 15, 2026, 5:00 PM
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