Vanda Pharmaceuticals Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Vanda Pharmaceuticals Inc. has submitted its 2023 10-K filing, detailing financial performance and business operations for the fiscal year ending December 31, 2023.</b>

AI Summary

Vanda Pharmaceuticals Inc. (VNDA) filed a Annual Report (10-K) with the SEC on February 8, 2024. Vanda Pharmaceuticals Inc. filed its 2023 Form 10-K on February 8, 2024. The filing covers the fiscal year ending December 31, 2023. Key financial data for 2023, 2022, and 2021 are included. Specific product segments like Hetlioz, Fanapt, and PONVORY are detailed. The company is incorporated in Delaware and headquartered in Washington, D.C.

Why It Matters

For investors and stakeholders tracking Vanda Pharmaceuticals Inc., this filing contains several important signals. This 10-K provides a comprehensive overview of Vanda's financial health and strategic direction for investors and analysts. The detailed segment reporting allows for an in-depth understanding of the performance drivers for key products like Hetlioz and Fanapt.

Risk Assessment

Risk Level: — Vanda Pharmaceuticals Inc. shows moderate risk based on this filing. The company's financial performance is subject to the success of its key products and market competition, as indicated by the segment reporting and general industry risks.

Analyst Insight

Review the detailed financial statements and segment performance to assess the growth trajectory and competitive positioning of Vanda's product portfolio.

Revenue Breakdown

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-02-08 — Filing Date (Date of submission)
• 2834 — SIC Code (Pharmaceutical Preparations)

Key Players & Entities

• Vanda Pharmaceuticals Inc. (company) — Filer name
• 2023-12-31 (date) — Fiscal year end
• 2024-02-08 (date) — Filing date
• 2200 Pennsylvania Ave NW (address) — Business address
• Washington (location) — Business address city
• DE (location) — State of incorporation

FAQ

Industry Context

Vanda Pharmaceuticals operates within the pharmaceutical industry, focusing on the development and commercialization of treatments for central nervous system disorders.

Regulatory Implications

As a pharmaceutical company, Vanda is subject to regulatory oversight from bodies like the FDA regarding drug development, approval, and marketing.

What Investors Should Do

1. Analyze the revenue trends for Hetlioz, Fanapt, and PONVORY across the reported fiscal years.
2. Review any disclosed risk factors related to market competition or regulatory changes.
3. Examine the company's financial position, including assets, liabilities, and equity, as detailed in the balance sheet.

Key Dates

• 2023-12-31: Fiscal Year End — Covers the full fiscal year's financial performance.
• 2024-02-08: Filing Date — Official submission date of the 10-K.

Year-Over-Year Comparison

This is the initial 10-K filing provided for analysis, so no prior filing data is available for comparison.

Key Financial Figures

• $0.001 — ich registered Common Stock, par value $0.001 per share VNDA The Nasdaq Global Market
• $100.2 — psules and HETLIOZ LQ oral suspension) $100.2 United States Europe (Non-24 in blind
• $90.9 — atients only) Schizophrenia (tablets) $90.9 United States Israel Relapsing forms
• $1.6 — forms of multiple sclerosis (tablets) $1.6 United States Canada HETLIOZ for No

Filing Documents

• vnda-20231231.htm (10-K) — 2139KB
• vnda12312023ex1047.htm (EX-10.47) — 422KB
• vnda12312023ex231.htm (EX-23.1) — 2KB
• vnda12312023ex311.htm (EX-31.1) — 10KB
• vnda12312023ex312.htm (EX-31.2) — 10KB
• vnda12312023ex321.htm (EX-32.1) — 7KB
• vnda12312023ex97.htm (EX-97) — 26KB
• vnda-20231231_g1.gif (GRAPHIC) — 5KB
• vnda-20231231_g2.jpg (GRAPHIC) — 31KB
• vnda-20231231_g3.gif (GRAPHIC) — 4KB
• vnda-20231231_g4.gif (GRAPHIC) — 8KB
• vnda-20231231_g5.jpg (GRAPHIC) — 76KB
• vnda-20231231_g6.jpg (GRAPHIC) — 177KB
• 0001628280-24-003785.txt (&nbsp;) — 10487KB
• vnda-20231231.xsd (EX-101.SCH) — 66KB
• vnda-20231231_cal.xml (EX-101.CAL) — 97KB
• vnda-20231231_def.xml (EX-101.DEF) — 242KB
• vnda-20231231_lab.xml (EX-101.LAB) — 810KB
• vnda-20231231_pre.xml (EX-101.PRE) — 532KB
• vnda-20231231_htm.xml (XML) — 1255KB

Risk Factors

Item 1A Risk Factors 33

Unresolved Staff Comments

Item 1B Unresolved Staff Comments 65 Item 1C C ybersec urity 65

Properties

Item 2 Properties 66

Legal Proceedings

Item 3 Legal Proceedings 67

Mine Safety Disclosures

Item 4 Mine Safety Disclosures 67 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 67

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 69

Qualitative and Quantitative Disclosures about Market Risk

Item 7A Qualitative and Quantitative Disclosures about Market Risk 78

Financial Statements and Supplementary Data

Item 8 Financial Statements and Supplementary Data 79

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 79

Controls and Procedures

Item 9A Controls and Procedures 79

Other Information

Item 9B Other Information 79

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 79 Part III

Directors, Executive Officers and Corporate Governance

Item 10 Directors, Executive Officers and Corporate Governance 80

Executive Compensation

Item 11 Executive Compensation 80

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 80

Certain Relationships and Related Transactions, and Director Independence

Item 13 Certain Relationships and Related Transactions, and Director Independence 80

Principal Accountant Fees and Services

Item 14 Principal Accountant Fees and Services 80 Part IV

Exhibits and Financial Statement Schedules

Item 15 Exhibits and Financial Statement Schedules 80

Form 10-K Summary

Item 16 Form 10-K Summary 80

Signatures

Signatures 81 Exhibit Index 112 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 continue to commercialize HETLIOZ (tasimelteon) capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in the United States (U.S.), in light of existing and potential generic competition, and Europe and HETLIOZ capsules and oral suspension (HETLIOZ LQ ) for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in the U.S.; our ability to increase market awareness of Non-24 and SMS and market acceptance of HETLIOZ ; our ability to overcome the continued reimbursement and patient access challenges we face as a result of third-party payor coverage; our ability to continue to generate U.S. sales of Fanapt (iloperidone) oral tablets for the trea

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, 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), Fanapt for the treatment of schizophrenia and PONVORY , which we acquired the U.S. and Canadian rights to on December 7, 2023, for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, in adults. HETLIOZ is the first product approved by the FDA for patients with Non-24 and for patients with SMS. In addition, we have a number of drugs in development, including: HETLIOZ (tasimelteon) for the treatment of jet lag disorder, insomnia, delayed sleep phase disorder (DSPD) and pediatric Non-24; Fanapt (iloperidone) for the treatment of bipolar I disorder and a long acting injectable (LAI) formulation for the treatment of schizophrenia; PONVORY (ponesimod) for the treatment of inflammatory/autoimmune disorders, including but not limited to ulcerative colitis, psoriasis, Crohn's disease, atopic dermatitis, eosinophilic esophagitis and alopecia areata; Tradipitant (VLY-686), a small molecule neurokinin-1 (NK-1) receptor antagonist, for the treatment of gastroparesis, motion sickness and atopic dermatitis; VHX-896, the active metabolite of iloperidone; Portfolio of C

View Full Filing

View this 10-K filing on SEC EDGAR