AI Earnings Predictions for Vanda Pharmaceuticals Inc. (VNDA)

EX-99.1

2 vnda8-k10282026exhibit991.htm

EX-99.1

Document

Exhibit 99.1

Vanda Pharmaceuticals Reports Third Quarter 2026 Financial Results

•Q3 2026 Total Revenues increased 24% to $69.8 million compared to Q3 2025 and 38% compared to Q2 2026

•Q3 2026 Total Operating Expenses decreased by 18% to $93.3 million compared to Q2 2026

•Announced positive results from the Phase III study of NEREUS™ for prevention of GLP-1-induced vomiting

•NEREUS™ for prevention of vomiting induced by motion became commercially available in Q2 2026

•BYSANTITM commercial launch expected in Q4 2026

•QuimilzaTM BLA for GPP under review by the FDA; PDUFA target action date of December 12, 2026

WASHINGTON – October 28, 2026 – Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the third quarter ended September 30, 2026.

“We are pleased with the strong revenue growth in the third quarter, increasing 24% year-over-year, driven by continued Fanapt momentum and the early contribution from our NEREUS commercial launch, while operating expenses decreased 18% compared to the second quarter as key Phase III and launch-preparation activities conclude,” said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board. “Looking ahead, with the commercial launch of BYSANTI expected in the fourth quarter, the Quimilza BLA under FDA review with a December PDUFA date, and positive Phase III results supporting potential expansions for NEREUS in GLP-1-induced vomiting and HETLIOZ in Delayed Sleep-Wake Phase Disorder, we are focused on further moderating costs and driving revenue growth from our current portfolio and planned launches to support sustainable long-term value.”

Financial Highlights

Operating Expenses

•During 2025 and 2026, Vanda has advanced multiple Phase III programs, continued its commercial activities for Fanapt® (iloperidone), HETLIOZ® (tasimelteon) and PONVORY® (ponesimod) and prepared for the commercial launches, including manufacturing commercial supplies, of NEREUSTM (tradipitant), BYSANTITM (milsaperidone), and QuimilzaTM (imsidolimab). These activities resulted in significantly increased operating expenses in 2025 and 2026. As certain of these activities began concluding in Q3 2026, operating expenses have decreased and Vanda expects operating expenses to decrease further in future quarters, as the remainder of these activities conclude.

Third Quarter of 2026

•Total net product sales were $69.8 million in Q3 2026, a 24% increase compared to $56.3 million in Q3 2025 and a 38% increase compared to $50.5 million in Q2 2026. Total net product sales includes approximately $7.0 million of HETLIOZ® revenue for orders shipped on June 29, 2026 that arrived on July 1, 2026.

•Total operating expenses were $93.3 million in Q3 2026, a 7% increase compared to $87.5 million in Q3 2025 and an 18% decrease compared to $114.3 million in Q2 2026.

•Fanapt® net product sales were $38.8 million in Q3 2026, a 24% increase compared to $31.2 million in Q3 2025 and an 8% increase compared to $36.0 million in Q2 2026.

•HETLIOZ® net product sales were $21.7 million in Q3 2026, a 21% increase compared to $18.0 million in Q3 2025 and a 289% increase compared to $5.6 million in Q2 2026, and includes orders totaling approximately $7.0 million in revenue that were shipped on June 29, 2026 and arrived on July 1, 2026. These orders were recognized as revenue in Q3 2026.

•PONVORY® net product sales were $7.7 million in Q3 2026, a 10% increase compared to $7.0 million in Q3 2025 and a 2% decrease compared to $7.9 million in Q2 2026.

•NEREUSTM net product sales were $1.6 million in Q3 2026, a 60% increase compared to $1.0 million in Q2 2026. Vanda launched NEREUSTM commercially in the U.S. in Q2 2026, with the direct-to-consumer offering via the web portal nereus.us, and began sales force promotion in Q3 2026.

•Loss before income taxes was $22.4 million in Q3 2026 compared with $28.4 million in Q3 2025.

•Cash, cash equivalents and marketable securities (Cash) totaled $140.5 million as of September 30, 2026, representing a decrease to Cash of $29.5 million in Q3 2026.

First Nine Months of 2026

•Total net product sales were $172.1 million in the first nine months of 2026, an 8% increase compared to $158.9 million in the first nine months of 2025.

•Total operating expenses were $309.6 million in the first nine months of 2026, a 15% increase compared to $269.7 million in the first nine months of 2025.

•Fanapt® net product sales were $104.3 million in the first nine months of 2026, a 24% increase compared to $84.1 million in the first nine months of 2025.

•HETLIOZ® net product sales were $43.2 million in the first nine months of 2026, a 21% decrease compared to $55.0 million in the first nine months of 2025.

•PONVORY® net product sales were $21.9 million in the first nine months of 2026, an 11% increase compared to $19.8 million in the first nine months of 2025.

•NEREUSTM n

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EX-99.1

2 vnda8-k562026exhibit991.htm

EX-99.1

Document

Exhibit 99.1

Vanda Pharmaceuticals Reports First Quarter 2026 Financial Results

•Fanapt® net product sales rose 26% to $29.6 million; total prescriptions increased 32% and new-to-brand prescriptions surged 76%

•NEREUSTM (tradipitant) launched via nereus.us, an innovative direct-to-consumer platform – the first new prescription medicine in more than 40 years for the prevention of vomiting induced by motion, with convenient online ordering and rapid direct home delivery

•Full-year 2026 revenue guidance raised to $240-$290 million, including $10-30 million from newly launched NEREUSTM

•BYSANTITM (milsaperidone) received FDA approval for bipolar I disorder and schizophrenia on February 20, 2026

•Imsidolimab BLA for Generalized Pustular Psoriasis accepted for FDA review; PDUFA target action date of December 12, 2026

WASHINGTON – May 6, 2026 – Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2026.

“Vanda delivered strong commercial execution in the first quarter, highlighted by 26% growth in Fanapt sales, the groundbreaking U.S. launch of NEREUS with its pioneering direct-to-consumer platform at nereus.us, and the FDA approval of BYSANTI,” said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board. “We believe that these achievements, combined with meaningful pipeline progress and our raised 2026 revenue guidance, position the company for continued growth and value creation.”

Financial Highlights

•Total net product sales reached $51.7 million in Q1 2026, a 3% increase compared to $50.0 million in Q1 2025.

•Fanapt® net product sales were $29.6 million, up 26% year-over-year.

•HETLIOZ® net product sales were $15.9 million, down 24% year-over-year.

•PONVORY® net product sales were $6.2 million, up 10% year-over-year.

•Loss before income taxes was $48.4 million compared with $37.4 million in Q1 2025, reflecting continued investment in new product launches and pipeline advancement.

•Cash, cash equivalents and marketable securities (Cash) totaled $202.3 million as of March 31, 2026, representing a decrease to Cash of $61.5 million in Q1 2026, which included a one-time payment of a $10.0 million milestone to Eli Lilly due upon approval of NEREUS™ (tradipitant).

Key Commercial Highlights

•Fanapt® saw continued strong momentum with total prescriptions (TRx)1 up 32% and new-to-brand prescriptions (NBRx)1 up 76% versus Q1 2025. In April 2026, weekly TRx for Fanapt® reached an 11-year high of over 2,600 prescriptions for the week ending April 24, 2026.

•NEREUSTM is now commercially available nationwide through nereus.us, Vanda’s innovative direct-to-consumer platform. This pioneering patient-centric model enables convenient ordering online with rapid direct delivery, eliminating traditional pharmacy barriers and providing a seamless, modern access experience. As the first new prescription therapy approved for the prevention of vomiting induced by motion in adults in more than 40 years, NEREUSTM represents a breakthrough in both science and patient access.

Key Regulatory & Clinical Development Highlights

•BYSANTITM (milsaperidone) received U.S. Food and Drug Administration (FDA) approval for the treatment of bipolar I disorder and schizophrenia. BYSANTITM is protected by data exclusivity through February 20, 2031 and multiple patents, the latest of which expires on May 31, 2044.

•Vanda’s ongoing late-stage clinical studies are progressing rapidly and are expected to generate topline results in 2026 or early 2027, including:

◦The Phase III study of BYSANTITM as a once-daily adjunctive treatment for major depressive disorder (MDD), with results expected in Q1 2027.

◦The Thetis Phase III study of NEREUS™ for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies, with results expected in 2026.

◦The Phase III study of VQW-765 in the treatment of adults with social anxiety disorder, with results expected by the end of 2026.

•The FDA accepted the Biologics License Application (BLA) for imsidolimab in Generalized Pustular Psoriasis (GPP) with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026. The results of the pivotal clinical study were published in the April 28, 2026 issue of the New England Journal of Medicine (NEJM) Evidence2.

Corporate Highlight

•On April 22, 2026, Vanda appointed Charles Duncan, Ph.D. to its Board of Directors. The Board now consists of seven directors, six of whom are independent.

GAAP Financial Results

Net loss was $48.6 million (diluted loss per share of $0.82) in Q1 2026 compared with a net loss of $29.5 million (diluted loss per share of $0.50) in Q1 2025.

2026 Financial Guidance

Vanda is raising its full-year 2026 total revenue guidance to reflect the contribution of the newly launched NEREUS™ while maintaining prior ranges for Fanapt® and other