Slides
Page 2
Various statements in this presentation, including, but not limited to, the guidance provided under “2025 Financial Guidance” and statements regarding Vanda’s commercial products, plans, priorities and opportunities, as well as statements about Vanda’s strategic focus and its products in development and the related clinical development and regulatory timelines and commercial and therapeutic potential for such products, are “forward-looking statements” under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. If the risks, changes in circumstances or uncertainties materialize or the assumptions prove incorrect, Vanda’s results may differ materially from those expressed or implied by such forward-looking statements. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effect on, Vanda. Important factors that could cause actual results to differ materially from those reflected in Vanda’s forward-looking statements include, among others: Vanda’s ability to commercialize NEREUS for the prevention of vomiting induced by motion; Vanda’s ability to generate U.S. sales of Fanapt® for the acute treatment of bipolar I disorder in adults; Vanda’s ability to continue to generate U.S. sales of Fanapt ® for the treatment of schizophrenia; Vanda’s ability to continue to commercialize HETLIOZ® for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in the U.S. and Europe, in light of existing and potential generic competition, and for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in the U.S.; Vanda’s ability to increase market awareness of Non-24 and SMS and market acceptance of HETLIOZ ®; Vanda’s ability to overcome the increased reimbursement challenges it faces as a result of declining third-party payor coverage; Vanda’s ability to generate U.S. sales of PONVORY® for the treatment of relapsing forms of multiple sclerosis; Vanda’s ability to resolve or otherwise address the deficiencies identified by the FDA in the complete response letters relating to HETLIOZ ® for the treatment of insomnia and tradipitant for the treatment of gastroparesis and to obtain regulatory approval of HETLIOZ ® and tradipitant for such indications; the FDA’s ability to complete its reviews of, and reach decisions with respect to, the New Drug Applications for Bysanti for the treatments of acute bipolar I disorder and schizophrenia; the FDA’s next action following its refusal to approve the supplemental New Drug Application for HETLIOZ ® for the treatment of jet lag disorder on January 7, 2026; Vanda’ s ability to complete the clinical development of and obtain regulatory approval of the Fanapt ® long acting injectable (LAI), Bysanti in the treatment of major depressive disorder, HETLIOZ ® in the treatment of delayed sleep phase disorder and pediatric Non-24, HETLIOZ LQ ® in the treatment of pediatric insomnia, tradipitant in the treatment of vomiting induced by a GLP-1 analog, PONVORY ® in the treatment of psoriasis and ulcerative colitis, imsidolimab in the treatment of generalized pustular psoriasis, VSJ-110 for the treatment of dry eye, VPO-227 for the treatment of secretory diarrhea disorders, including cholera, VTR-297 in the treatment of hematologic malignancies and onychomycosis, and VQW-765 for the treatment of social/performance anxiety; Vanda’s ability to progress VCA-894A in Charcot-Marie-Tooth Disease; Vanda's ability to leverage the ASO platform to develop precision medicine therapeutics; Vanda’s ability to realize the benefits of its strategic focus; Vanda’s ability to satisfy the conditions necessary to extend patent exclusivity for the Fanapt ® LAI into the 2040s; Vanda’s dependence on third-party manufacturers to manufacture Fanapt ®, HETLIOZ®, PONVORY ® and NEREUS in sufficient quantities and quality; Vanda’s ability to prepare, file, prosecute, defend and enforce any patent claims and other intellectual property rights; Vanda’s ability to maintain rights to develop and commercialize Vanda’s products under its license agreements; Vanda’s ability to obtain and maintain regulatory approval of Vanda’s products, and the labeling for any approved products; Vanda’s level of success in commercializing Fanapt ® and HETLIOZ ® in new markets; Vanda’s expectations regarding the timing and success of preclinical studies and clinical trials; the safety and efficacy of Vanda’s products; regulatory developments in the U.S., Europe and other jurisdictions; limitations on Vanda’s ability to utilize some or all of its prior net operating losses and orphan drug and research development credits; the size and growth of the potential markets for Vanda’s products and the ability to serve those markets; the accuracy of the third-party market and other data on which Vanda relies; Vanda’s expectations regarding trends with respect to its revenues, costs, expenses, liabilities and cash, cash equivalents and marketable securities; Vanda’s ability to identify or obtain rights to new products; Vanda’s ability to attract and retain key scientific or management personnel; the costs and effects of litigation; Vanda’s ability to obtain the capital necessary to fund its research and development or commercial activities; the costs and effects of litigation; potential losses incurred from product liability claims made against Vanda; the use of existing cash, cash equivalents and marketable securities and other factors that are described in the “Cautionary Note Regarding Forward-Looking Statements”, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Vanda’s most recent annual report on Form 10-K, as updated by Vanda’s subsequent quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, which are available on the SEC’s website at www.sec.gov. Vanda cautions investors not to rely too heavily on the forward-looking statements contained in this presentation. All written and oral forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. The information in this presentation is provided only as of the date of this presentation, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
Page 3
Innovation-Led Strategy, with decades-long track record of successfully developing and commercializing innovative therapies Robust Commercial Portfolio anchored by four FDA-approved brands: Fanapt®, HETLIOZ®, PONVORY® and newly approved NEREUS Strong Debt-Free Balance Sheet, providing substantial capital for R&D and commercial activities NASDAQ: VNDA Founded: 2003 Headquarters: Washington D.C. Late-Stage Growth Pipeline, with numerous high-potential programs targeting significant unmet needs in billion-dollar markets Imminent Regulatory Catalysts, with potential for significant commercial expansion in 2026 Vanda is a leading global biopharmaceutical company dedicated to innovating in the service of people’s pursuit of happiness
Page 4
Grow revenue across current products in existing indications Diversify revenue with potential for six products on market by end of 2026 Programs in regulatory review with upcoming PDUFA dates and programs currently at Phase III stage Multiple early-stage programs, including emerging ASO platform NEREUS potential as key adjunct in GLP-1 Agonist market Focus on large markets with unmet patient needs Increase access and affordability for patients Engaging directly with consumers Grow & Diversify Revenue Advance Pipeline Focus on Consumers
Page 5
Fanapt oral tablets approved in U.S. for acute treatment of bipolar I disorder in adults. Fanapt Long Acting Injectable (LAI): Phase III program ongoing. Bysanti (milsaperidone): NDA accepted for treatment of adults with acute bipolar I disorder and schizophrenia; PDUFA target action date February 2026. Clinical program in major depressive disorder (MDD) ongoing with results expected in 2026. HETLIOZ oral capsules approved in U.S. and Europe for treatment of Non-24. HETLIOZ oral capsules and HETLIOZ LQ liquid formulation approved in U.S. for treatment of Smith- Magenis Syndrome (SMS) in adults and children. HETLIOZ in the indications of insomnia and jet lag disorder at regulatory stage. Programs in pediatric insomnia, delayed sleep phase disorder and pediatric non-24 are ongoing. PONVORY approved in U.S. for treatment of relapsing forms of multiple sclerosis (MS). IND applications accepted by FDA for PONVORY in the treatments of psoriasis and ulcerative colitis: Phase III programs ongoing. NEREUS approved in the U.S. for the prevention of vomiting induced by motion. A Phase III program for NEREUS in preventing GLP- 1 induced nausea and vomiting is expected to initiate in first half of 2026. NEREUS in the indication of gastroparesis at regulatory stage.
Page 6
2025 2026
Page 7
Product Portfolio Indication Phase I/II Phase III Regulatory Market Psychiatry Bipolar I Disorder Schizophrenia Long Acting Injectable (LAI) Bipolar l Disorder Schizophrenia Major Depressive Disorder Sleep Disorder Non-24 SMS Jet Lag Disorder Insomnia Pediatric Insomnia Delayed Sleep Phase Disorder Pediatric Non-24Anti- inflammatory Multiple Sclerosis Ulcerative Colitis Psoriasis Generalized Pustular Psoriasis Gastrointestinal & Nausea Motion Sickness Vomiting induced by a GLP-1 Gastroparesis imsidolimab
Page 8
Product Indication Preclinical Phase I Phase II Phase III Regulatory Dry Eye Cholera Social Performance Anxiety Hematologic Malignancies Onychomycosis Parkinson’s Disease CMT2S BPO-27 (CFTR Inhibitor) VSJ-110 (CFTR Activator) VQW-765 VTR-297 ASO Programs
Page 9
2025 - 2027 Commercial Growth Drivers 2028+ Growth Drivers BIPOLAR SCHIZOPHRENIA MULTIPLE SCLEROSIS imsidolimab GPP BIPOLAR SCHIZOPHRENIA MOTION SICKNESS NON-24 / SMS MDD SCHIZOPHRENIA ULCERATIVE COLITIS GLP-1 ADJUNCT GASTROPARESIS PSORIASIS Fanapt® Long- acting Injectable
Page 11
An oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion. First new pharmacologic treatment in motion sickness in over four decades. Premium prescription medication for those who use currently available motion sickness medication but are not satisfied. Approx. 30% of adults1 (roughly 78 million people) in the U.S. experience symptoms during common travel modes such as cars, planes, or boats. Approx. 15% of that population (roughly 12 million people) experience severe symptoms requiring treatment. 1. Turner M, Griffin MJ. Motion sickness in public road transport: passenger behavior and susceptibility. Ergonomics. 1999: 42: 444-461
Page 12
A new unmet need…
Page 13
Endpoint Placebo (N=58) Tradipitant (N=58) P-value Proportion with Vomiting* 58.6% 29.3% 0.0016 Primary Endpoint 0% 10% 20% 30% 40% 50% 60% 70% Placebo (N=58) Tradipitant (N=58) Proportion with Vomiting (%) Key Secondary Endpoint Endpoint Placebo (N=58) Tradipitant (N=58) P-value Proportion with vomiting and worst nausea ≥3** 48.3% 22.4% 0.0039 0% 10% 20% 30% 40% 50% 60% 70% Placebo (N=58) Tradipitant (N=58) Proportion with Vomiting and Nausea ≥ 3 (%) * Primary endpoint **Key secondary endpoint, nausea of >= 3 denotes moderate or worse on a 0- 5 point scale of severity
Page 16
Schizophrenia Bipolar Disorder MDD 3M Patients1 11M patients2 21M patients3 Fanapt® Approved Bysanti PDUFA Feb 21, 2026 Bysanti MDD Phase 3 Fanapt® Approved Bysanti PDUFA Feb 21, 2026 1. Johns Hopkins Medicine. Mental health disorder statistics. https://www.hopkinsmedicine.org/health/wellness -and-prevention/mental-health-disorder-statistics. Accessed Jan 14, 2026. 2. National Institute of Mental Health. Bipolar disorder. https://www.nim h.nih.gov/health/statistics/bipolar-disorder. Accessed Jan 14, 2026. 3. National Institute of Mental Health. Major depression. https://www.nimh.nih.gov/health/statistics/majordepression.h tml. Accessed Jan 14, 2026.
Page 21
3. Sugiura, K. et al. The Majority of Generalized Pustular Psoriasis without Psoriasis Vulgaris Is Caused by Deficiency of Inter leukin-36 Receptor Antagonist. Journal of Investigative Dermatology 133, 2514– 2521 (2013). 4. Sachen, K. L., Arnold Greving, C. N. & Towne, J. E. Role of IL-36 cytokines in psoriasis and other inflammatory skin conditions. Cytokine 156, 155897 (2022). 5. National Psoriasis Foundation Generalized Pustular Psoriasis https://www.psoriasis.org/generalized-pustular-psoriasis/. Accessed Jan 14, 2026 1. Prinz, J. C. et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. Journal o f the European Academy of Dermatology and Venereology 37, 256– 273 (2022). 2. Marrakchi, S. et al. Interleukin-36–Receptor Antagonist Deficiency and Generalized Pustular Psoriasis. New England Journal of Medicine 365, 620–628 (2011).
Page 24
Source: IQVIA +35% YoY Total prescriptions (TRx) growth from Q3 2024 to Q3 2025 +57% YoY New prescriptions (NRx) growth from Q3 2024 to Q3 2025 +147% YoY New to brand prescriptions (NBRx) growth from Q3 2024 to Q3 2025
Page 33
Fanapt® net product sales were $31.2 million in Q3 2025 HETLIOZ® net product sales were $18.0 million Q3 2025 Q3 2025 Financial Highlights Q3 2025 Cash balance of $293.8M and weighted average shares outstanding of 58.9M $56.3 million PONVORY® net product sales were $7.0 million in Q3 2025 2025 Financial Guidance1 1.Guidance provided by Vanda on February 13, 2025, updated on October 29, 2025, and updated to include year-end 2025 Cash. Vanda undertakes no duty to update this guidance, and actual results may differ. Total Revenues $210M - $230M Year-end 2025 Cash $260M - $290M
Page 34
For more information on HETLIOZ®, please visit www.HETLIOZ.com For more information on Fanapt®, please visit www.FANAPT.com For more information on PONVORY®, please visit www.PONVORYUS.com For more information on NEREUS , please visit www.NEREUS.US.com