Vanda Pharmaceuticals Files 2024 10-K

TL;DR

Vanda Pharma dropped its 2024 10-K. Full year results are in.

AI Summary

Vanda Pharmaceuticals Inc. filed its 2024 10-K on February 14, 2025, reporting on its fiscal year ending December 31, 2024. The company, incorporated in Delaware, is based in Washington D.C. and operates in the pharmaceutical preparations sector. Key financial data and business operations for the fiscal year 2024 are detailed in this comprehensive filing.

Why It Matters

This filing provides investors and analysts with a detailed overview of Vanda Pharmaceuticals' financial performance, strategic initiatives, and risk factors for the fiscal year 2024, crucial for understanding the company's current standing and future outlook.

Risk Assessment

Risk Level: medium — As a pharmaceutical company, Vanda is subject to inherent risks including regulatory approvals, market competition, and patent expirations, which are detailed in the 10-K.

Key Numbers

• 2024 — Fiscal Year End (The period covered by the 10-K filing.)
• 2025-02-14 — Filing Date (The date the 10-K was submitted to the SEC.)

Key Players & Entities

• Vanda Pharmaceuticals Inc. (company) — Filer of the 10-K
• 2024-12-31 (date) — Fiscal year end
• 2025-02-14 (date) — Filing date
• 2024 (date) — Reporting period
• 2023 (date) — Prior reporting period
• 2022 (date) — Prior reporting period

FAQ

Key Financial Figures

• $0.001 — ich registered Common Stock, par value $0.001 per share VNDA The Nasdaq Global Market
• $94.3 — ated with bipolar I disorder (tablets) $94.3 United States Israel (schizophrenia o
• $76.7 — psules and HETLIOZ LQ oral suspension) $76.7 United States Europe (Non-24 in blind
• $27.8 — forms of multiple sclerosis (tablets) $27.8 United States Canada Fanapt for sch

Filing Documents

• vnda-20241231.htm (10-K) — 2294KB
• vnda12312024ex191.htm (EX-19.1) — 73KB
• vnda12312024ex231.htm (EX-23.1) — 2KB
• vnda12312024ex311.htm (EX-31.1) — 10KB
• vnda12312024ex312.htm (EX-31.2) — 10KB
• vnda12312024ex321.htm (EX-32.1) — 7KB
• vnda-20241231_g1.gif (GRAPHIC) — 4KB
• vnda-20241231_g2.gif (GRAPHIC) — 5KB
• vnda-20241231_g3.jpg (GRAPHIC) — 31KB
• vnda-20241231_g4.gif (GRAPHIC) — 8KB
• vnda-20241231_g5.jpg (GRAPHIC) — 110KB
• vnda-20241231_g6.jpg (GRAPHIC) — 174KB
• 0001628280-25-005761.txt ( ) — 11432KB
• vnda-20241231.xsd (EX-101.SCH) — 71KB
• vnda-20241231_cal.xml (EX-101.CAL) — 117KB
• vnda-20241231_def.xml (EX-101.DEF) — 275KB
• vnda-20241231_lab.xml (EX-101.LAB) — 815KB
• vnda-20241231_pre.xml (EX-101.PRE) — 589KB
• vnda-20241231_htm.xml (XML) — 1548KB

Risk Factors

Item 1A Risk Factors 35

Unresolved Staff Comments

Item 1B Unresolved Staff Comments 68 Item 1C Cybersecurity 68

Properties

Item 2 Properties 70

Legal Proceedings

Item 3 Legal Proceedings 70

Mine Safety Disclosures

Item 4 Mine Safety Disclosures 70 Part II

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 5 Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 70

Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 7 Management's Discussion and Analysis of Financial Condition and Results of Operations 72

Qualitative and Quantitative Disclosures about Market Risk

Item 7A Qualitative and Quantitative Disclosures about Market Risk 82

Financial Statements and Supplementary Data

Item 8 Financial Statements and Supplementary Data 82

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 82

Controls and Procedures

Item 9A Controls and Procedures 82

Other Information

Item 9B Other Information 83

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 83 Part III

Directors, Executive Officers and Corporate Governance

Item 10 Directors, Executive Officers and Corporate Governance 83

Executive Compensation

Item 11 Executive Compensation 83

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Item 12 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 83

Certain Relationships and Related Transactions, and Director Independence

Item 13 Certain Relationships and Related Transactions, and Director Independence 84

Principal Accountant Fees and Services

Item 14 Principal Accountant Fees and Services 84 Part IV

Exhibits and Financial Statement Schedules

Item 15 Exhibits and Financial Statement Schedules 84

Form 10-K Summary

Item 16 Form 10-K Summary 84

Signatures

Signatures 85 Exhibit Index 122 Table of Contents PART I CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This annual report on Form 10-K (Annual Report) contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended (Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act). Words such as, but not limited to, "believe," "expect," "anticipate," "estimate," "intend," "plan," "project," "target," "goal," "likely," "will," "would," and "could," or the negative of these terms and similar expressions or words, identify 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, the results of Vanda Pharmaceuticals Inc. (we, our, the Company or Vanda) may differ materially from those expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements in this Annual Report may include, but are not limited to, statements about: our ability to commercialize Fanapt (iloperidone) oral tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder; our ability to continue to generate United States (U.S.) sales of Fanapt oral tablets for the treatment of schizophrenia; our ability to obtain approval from the FDA for Bysanti TM (milsaperidone) for bipolar I disorder, schizophrenia and major depressive disorder (MDD); our ability to continue to commercialize HETLIOZ (tasimelteon) capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in the U.S., in light of existing and potential generic competition, and Europe and HETLIOZ capsules and oral suspension (HETLIOZ LQ ) for the tre

BUSINESS

ITEM 1. BUSINESS Overview Vanda Pharmaceuticals Inc. (we, our, the Company or Vanda) is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. We strive to advance novel approaches to bring important new medicines to market through responsible innovation. We are committed to the use of technologies that support sound science, including genetics and genomics, in drug discovery, clinical trials and the commercial positioning of our products. Our commercial portfolio is currently comprised of three products: Fanapt for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of schizophrenia, HETLIOZ for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) and for the treatment of nighttime sleep disturbances in Smith-Magenis syndrome (SMS) and PONVORY for the treatment of relapsing forms of multiple sclerosis (RMS) including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. HETLIOZ is the first product approved by the United States Food and Drug Administration (FDA) for patients with Non-24 and for patients with SMS. In addition, we have a number of drugs and/or additional indications for current products in development, including: Fanapt (iloperidone) long acting injectable (LAI) formulation for the treatment of schizophrenia; Bysanti TM (milsaperidone), the active metabolite of Fanapt (iloperidone), for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia and major depressive disorder (MDD); HETLIOZ (tasimelteon) for the treatment of jet lag disorder, insomnia, pediatric insomnia, delayed sleep phase disorder (DSPD) and pediatric Non-24; PONVORY (ponesimod) for the treatment of psoriasis and ulcerative colitis; Tradipitant (VLY-686), a small molecule neurokinin-1

View Full Filing

View this 10-K filing on SEC EDGAR