INSMED Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>INSMED Inc. has filed its annual 10-K report for the fiscal year ended December 31, 2023.</b>

AI Summary

INSMED Inc (INSM) filed a Annual Report (10-K) with the SEC on February 22, 2024. INSMED Inc. filed its 2023 Form 10-K on February 22, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal executive offices are located at 700 US Highway 202/206, Bridgewater, NJ 08807. INSMED Inc. is classified under the Pharmaceutical Preparations industry (SIC 2834). The filing includes financial data for the fiscal years 2021, 2022, and 2023.

Why It Matters

For investors and stakeholders tracking INSMED Inc, this filing contains several important signals. This 10-K filing provides a comprehensive overview of INSMED Inc.'s financial performance, business operations, and risk factors for the fiscal year 2023, crucial for investors to assess the company's health and future prospects. The detailed financial statements and disclosures within the 10-K are essential for understanding INSMED Inc.'s financial position, including revenue, net income, and debt levels, which can influence investment decisions.

Risk Assessment

Risk Level: medium — INSMED Inc shows moderate risk based on this filing. The company operates in the pharmaceutical industry, which is subject to significant regulatory oversight, lengthy drug development cycles, and intense competition, posing inherent risks to its financial performance and market position.

Analyst Insight

Investors should review the detailed risk factors and financial statements in the 10-K to understand potential challenges and opportunities for INSMED Inc. in the pharmaceutical sector.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-02-22 — Filing Date (Date the 10-K was filed)
• 000-30739 — SEC File Number (SEC filing identifier)
• 541972729 — IRS Number (Company's IRS identification number)

Key Players & Entities

• INSMED Inc. (company) — Filer name and company name
• 2023-12-31 (date) — Fiscal year end
• 2024-02-22 (date) — Filing date
• 700 US Highway 202/206, Bridgewater, NJ 08807 (address) — Business address
• 2834 (industry_code) — Standard Industrial Classification (SIC)
• Michael A. Smith (person) — Executive name mentioned in XBRL data

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The pharmaceutical industry is subject to extensive government regulation, including the FDA, which can impact product approval, marketing, and pricing.
• Competition [high — market]: The company faces intense competition from other pharmaceutical and biotechnology companies, which could affect market share and profitability.
• Research and Development [high — operational]: Drug development is a lengthy, costly, and uncertain process; failure to successfully develop or commercialize new products could adversely affect the business.
• Financing Risks [medium — financial]: The company may require additional capital to fund its operations and development activities, and future financing may not be available on favorable terms.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-02-22: Filing Date — Date the 10-K was officially submitted to the SEC.

Key Financial Figures

• $0.01 — ich registered Common Stock, par value $0.01 per share INSM Nasdaq Global Select Mar

Filing Documents

• insm-20231231.htm (10-K) — 2284KB
• insm20231231ex211.htm (EX-21.1) — 9KB
• insm20231231ex231.htm (EX-23.1) — 3KB
• insm20231231ex311.htm (EX-31.1) — 8KB
• insm20231231ex312.htm (EX-31.2) — 8KB
• insm20231231ex321.htm (EX-32.1) — 5KB
• insm20231231ex322.htm (EX-32.2) — 5KB
• insm20231231ex97.htm (EX-97) — 23KB
• image_0.jpg (GRAPHIC) — 8KB
• insm-20231231_g1.jpg (GRAPHIC) — 85KB
• insm-20231231_g2.jpg (GRAPHIC) — 35KB
• 0001104506-24-000008.txt (&nbsp;) — 12553KB
• insm-20231231.xsd (EX-101.SCH) — 76KB
• insm-20231231_cal.xml (EX-101.CAL) — 129KB
• insm-20231231_def.xml (EX-101.DEF) — 470KB
• insm-20231231_lab.xml (EX-101.LAB) — 1082KB
• insm-20231231_pre.xml (EX-101.PRE) — 762KB
• insm-20231231_htm.xml (XML) — 1742KB

BUSINESS

BUSINESS 6 ITEM 1A

RISK FACTORS

RISK FACTORS 34 ITEM 1B UNRESOLVED STAFF COMMENTS 61 ITEM 1C CYBERSECURITY 61 ITEM 2

PROPERTIES

PROPERTIES 62 ITEM 3

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS 62 ITEM 4 MINE SAFETY DISCLOSURES 62 PART II 63 ITEM 5 MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 63 ITEM 6 [RESERVED] 65 ITEM 7

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 66 ITEM 7A

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 75 ITEM 8

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 75 ITEM 9 CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 75 ITEM 9A

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 75 ITEM 9B OTHER INFORMATION 76 ITEM 9C DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 76 PART III 77 ITEM 10 DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 77 ITEM 11

EXECUTIVE COMPENSATION

EXECUTIVE COMPENSATION 77 ITEM 12

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 77 ITEM 13 CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE 77 ITEM 14 PRINCIPAL ACCOUNTANT FEES AND SERVICES 77 PART IV 78 ITEM 15 EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 78 ITEM 16 FORM 10-K SUMMARY 82 REPORTS OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM 84 CONSOLIDATED FINANCIAL STATEMENTS 87 Unless the context otherwise indicates, references in this Annual Report on Form 10-K to "Insmed Incorporated" refer to Insmed Incorporated, a Virginia corporation, and the "Company," "Insmed," "we," "us" and "our" refer to Insmed Incorporated together with its consolidated subsidiaries. INSMED, PULMOVANCE, ARIKARES and ARIKAYCE are trademarks of Insmed Incorporated. This Annual Report on Form 10-K also contains trademarks of third parties. Each trademark of another company appearing in this Annual Report on Form 10-K is the property of its owner. 3 Table of Contents CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the Exchange Act) , are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) identify forward-looking statements. Forward-looking statements are based on our current expectations and beliefs, and involve known and unknown risks, uncertainties and

BUSINESS

ITEM 1. BUSINESS Business Overview We are a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. Our first commercial product, ARIKAYCE, is approved in the US as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590mg (amikacin sulfate inhalation drug product). ARIKAYCE received accelerated approval in the US in September 2018 for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options in a refractory setting. In October 2020, the European Commission (EC) approved ARIKAYCE for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by MAC in adults with limited treatment options who do not have cystic fibrosis (CF). In March 2021, Japan's Ministry of Health, Labour and Welfare (MHLW) approved ARIKAYCE for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. NTM lung disease caused by MAC (which we refer to as MAC lung disease) is a rare and often chronic infection that can cause irreversible lung damage and can be fatal. Our pipeline includes clinical-stage programs, brensocatib and TPIP, as well as other early-stage research programs. Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), which we are developing for the treatment of patients with bronchiectasis and other neutrophil-mediated diseases, including chronic rhinosinusitis without nasal polyps (CRSsNP). TPIP is an inhaled formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH). Our early-stage research prog