Insmed Inc. Files Q3 2024 10-Q Report

TL;DR

Insmed Q3 2024 10-Q filed. Check financials.

AI Summary

Insmed Inc. reported its third quarter 2024 results for the period ending September 30, 2024. The company's financial performance for this quarter is detailed in the 10-Q filing. Specific financial figures and operational highlights for the period are available within the document.

Why It Matters

This filing provides investors with the latest financial performance data for Insmed Inc., crucial for understanding the company's current health and future prospects.

Risk Assessment

Risk Level: medium — As a pharmaceutical company, Insmed faces inherent risks related to drug development, regulatory approvals, and market competition.

Key Numbers

• 2024-09-30 — Reporting Period End Date (Indicates the end of the fiscal quarter covered by the report.)
• 2024-10-31 — Filing Date (The date the report was officially submitted to the SEC.)

Key Players & Entities

• INSMED Inc (company) — Filer of the 10-Q report
• 20240930 (date) — End of the reporting period
• 20241031 (date) — Date of filing
• 000-30739 (dollar_amount) — SEC file number

FAQ

Key Financial Figures

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

Filing Documents

• insm-20240930.htm (10-Q) — 1416KB
• insm-20240930ex311.htm (EX-31.1) — 9KB
• insm-20240930ex312.htm (EX-31.2) — 9KB
• insm-20240930ex321.htm (EX-32.1) — 6KB
• insm-20240930ex322.htm (EX-32.2) — 6KB
• 0001104506-24-000033.txt ( ) — 8304KB
• insm-20240930.xsd (EX-101.SCH) — 54KB
• insm-20240930_cal.xml (EX-101.CAL) — 74KB
• insm-20240930_def.xml (EX-101.DEF) — 356KB
• insm-20240930_lab.xml (EX-101.LAB) — 694KB
• insm-20240930_pre.xml (EX-101.PRE) — 552KB
• insm-20240930_htm.xml (XML) — 1096KB

FINANCIAL INFORMATION

PART I. FINANCIAL INFORMATION ITEM 1 Consolidated Financial Statements Consolidated Balance Sheets as of September 30, 2024 (unaudited) and December 31, 202 3 3 Consolidated Statements of Comprehensive Loss (unaudited) for the three and nine months ended September 30, 2024 and 2023 4 Consolidated Statements of Shareholders' Equity (Deficit) (unaudited) for the three and nine months ended September 30, 2024 and 2023 5 Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 30, 2024 and 2023 7

Notes to Consolidated Financial Statements (unaudited)

Notes to Consolidated Financial Statements (unaudited) 8 ITEM 2

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

Management's Discussion and Analysis of Financial Condition and Results of Operations 31 ITEM 3

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 48 ITEM 4

Controls and Procedures

Controls and Procedures 48

OTHER INFORMATION

PART II. OTHER INFORMATION ITEM 1

Legal Proceedings

Legal Proceedings 48 ITEM 1A

Risk Factors

Risk Factors 48 ITEM 2 Unregistered Sales of Equity Securities and Use of Proceeds 49 ITEM 5 Other Information 50 ITEM 6 Exhibits 51 SIGNATURE 52 Unless the context otherwise indicates, references in this Form 10-Q to "Insmed Incorporated" refers 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, and ARIKAYCE are trademarks of Insmed Incorporated. This Form 10-Q also contains trademarks of third parties. Each trademark of another company appearing in this Form 10-Q is the property of its owner. 2

FINANCIAL INFORMATION

PART I. FINANCIAL INFORMATION

CONSOLIDATED FINANCIAL STATEMENTS

ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS INSMED INCORPORATED Consolidated Balance Sheets (in thousands, except par value and share data) As of As of September 30, 2024 December 31, 2023 (unaudited) Assets Current assets: Cash and cash equivalents $ 461,451 $ 482,374 Marketable securities 1,006,457 298,073 Accounts receivable 42,317 41,189 Inventory 98,470 83,248 Prepaid expenses and other current assets 41,150 24,179 Total current assets 1,649,845 929,063 Fixed assets, net 75,265 65,384 Finance lease right-of-use assets 18,951 20,985 Operating lease right-of-use assets 16,030 18,017 Intangibles, net 59,915 63,704 Goodwill 136,110 136,110 Other assets 96,856 96,574 Total assets $ 2,052,972 $ 1,329,837 Liabilities and shareholders' equity Current liabilities: Accounts payable and accrued liabilities $ 248,684 $ 214,987 Finance lease liabilities 2,871 2,610 Operating lease liabilities 7,633 8,032 Total current liabilities 259,188 225,629 Debt, long-term 954,831 1,155,313 Royalty financing agreement 160,049 155,034 Contingent consideration 157,600 84,600 Finance lease liabilities, long-term 24,841 27,026 Operating lease liabilities, long-term 9,692 11,013 Other long-term liabilities 3,356 3,145 Total liabilities 1,569,557 1,661,760 Shareholders' equity: Common stock, $ 0.01 par value; 500,000,000 authorized shares, 178,846,991 and 147,977,960 issued and outstanding shares at September 30, 2024 and December 31, 2023, respectively 1,788 1,480 Additional paid-in capital 4,605,449 3,113,487 Accumulated deficit ( 4,124,369 ) ( 3,446,145 ) Accumulated other comprehensive income (loss) 547 ( 745 ) Total shareholders' equity (deficit) 483,415 ( 331,923 ) Total liabilities and shareholders' equity (deficit) $ 2,052,972 $ 1,329,837 See accompanying notes to the unaudited consolidated financial statements 3 INSMED INCORPORATED Consolidated Statements of Comprehensive Loss (unaudited) (in thousands, except per share data) T

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. The Company and Basis of Presentation Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company's first commercial product, ARIKAYCE, is approved in the United States (US) as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590 mg (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 the Company refers to as MAC lung disease) is a rare and often chronic infection that can cause irreversible lung damage and can be fatal. The Company's pipeline includes clinical-stage programs, brensocatib and treprostinil palmitil inhalation powder (TPIP), as well as early-stage research programs. Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), which the Company is developing for the treatment of patients with bronchiectasis and other neutrophil-mediated diseases, including chronic rhinosinusitis without nasal polyps (CRSsNP) and hidradenitis suppurativa (HS). TPIP is an inhaled formulation of the treprostinil prod

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued) 1. The Company and Basis of Presentation (Continued) conditions. If the Company is unable to obtain sufficient additional funds when required, the Company may be forced to delay, restrict or eliminate all or a portion of its development programs or commercialization efforts. The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiarie s, Celtrix Pharmaceuticals, Inc., Insmed France SAS, Insmed Gene Therapy LLC, Insmed Germany GmbH, Insmed Godo Kaisha, Insmed Holdings Limited, Insmed Innovation UK Limited, Insmed Ireland Limited, Insmed Italy S.R.L., Insmed Limited, Insmed Netherlands B.V., Insmed Netherlands Holdings B.V., and Insmed Switzerland GmbH. 2. Summary of Significant Accounting Policies The Company's complete listing of significant accounting policies is set forth in Note 2 of the notes to the consolidated financial statements in the Company's Annual Report on Form 10-K for the year ended December 31, 2023 . Selected significant accounting policies are discussed in detail below. Use of Estimates —The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and on various other assumptions. The amounts of assets and liabilities reported in the Company's balance sheets and the amounts of revenues and expenses reported for each period presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for revenue allowances, stock-based compensation, income taxes, loss contingencies, acquisition related intangibles including in process research and development (IPR&D) and goodwill, fair value of contingent consideration, and accounting for research and development costs. Act

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued) 2. Summary of Significant Accounting Policies (Continued) assets are found to not be recoverable, the Company measures the amount of the impairment by comparing the carrying value of the assets to the fair value of the assets. Business Combinations and Asset Acquisitions —The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business. If determined to be a business combination, the Company accounts for the transaction under the acquisition method of accounting as indicated in ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, which requires the acquiring entity in a business combination to recognize the fair value of all assets acquired, liabilities assumed, and any non-controlling interest in the acquiree and establishes the acquisition date as the fair value measurement point. Accordingly, the Company recognizes assets acquired and liabilities assumed in business combinations, including contingent assets and liabilities, and non-controlling interest in the acquiree based on the fair value estimates as of the date of acquisition. In accordance with ASC 805, Business Combinations, the Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired