insm-20250331

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number 000-30739

INSMED INCORPORATED

(Exact name of registrant as specified in its charter)


Virginia						54-1972729
(State or other jurisdiction of incorporation or organization)						(I.R.S. employer identification no.)

700 US Highway 202/206,
Bridgewater, New Jersey						08807
(Address of principal executive offices)						(Zip Code)

(908) 977-9900

(Registrant’s telephone number including area code)

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section12(b) of the Act:


Title of each class	Trading symbols	Name of each exchange on which registered
Common stock, par value $0.01 per share	INSM	Nasdaq Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer x						Accelerated filer o

Non-accelerated filer o						Smaller reporting company ☐
Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No x

As of May 2, 2025, there were 182,138,923 shares of the registrant’s common stock outstanding.

INSMED INCORPORATED

FORM 10-Q

FOR THE QUARTER ENDED MARCH 31, 2025

INDEX


PART I. FINANCIAL INFORMATION

ITEM 1	Consolidated Financial Statements

	Consolidated Balance Sheet s as of March 31, 2025 (unaudited) and December 31, 2024	3

	Consolidated Statements of Comprehensive Loss (unaudited) for the three months ended March 31, 2025 and 2024	4

	Consolidated Statements of Shareholders' Equit y (unaudited) for the three months ended March 31, 2025 and 2024	5

	Consolidated Statements of Cash Flows (unaudited) for the three months ended March 31, 2025 and 2024	6

	Notes to Consolidated Financial Statements (unaudited)	7

ITEM 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	27
ITEM 3	Quantitative and Qualitative Disclosures about Market Risk	41
ITEM 4	Controls and Procedures	41

PART II. OTHER INFORMATION

ITEM 1	Legal Proceedings	41
ITEM 1A	Risk Factors	41
ITEM 2	Unregistered Sales of Equity Securities and Use of Proceeds	42
ITEM 5	Other Information	42
ITEM 6	Exhibits	43

SIGNATURE		44

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.

PART I. FINANCIAL INFORMATION

ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS

INSMED INCORPORATED

Consolidated Balance Sheets

(in thousands, except par value and share data)


	As of		As of
	March 31, 2025		December 31, 2024
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	403,247	$	555,030
Marketable securities	796,204		878,796
Accounts receivable	47,746		52,012
Inventory	100,713		98,578
Prepaid expenses and other current assets	54,782		37,245
Total current assets	1,402,692		1,621,661

Fixed assets, net	88,358		80,052
Finance lease right-of-use assets	17,595		18,273
Operating lease right-of-use assets	10,832		17,257
Intangibles, net	57,389		58,652
Goodwill	136,110		136,110
Other assets	89,759		93,226
Total assets	$	1,802,735	$	2,025,231

Liabilities and shareholders’ equity
Current liabilities:
Accounts payable and accrued liabilities	$	232,674	$	285,209


Finance lease liabilities	3,054		2,961
Operating lease liabilities	3,505		9,358

Total current liabilities	239,233		297,528

Debt, long-term	1,105,068		1,103,382
Royalty financing agreement	162,508		161,067
Contingent consideration	159,900		144,200
Finance lease liabilities, long-term	23,266		24,064
Operating lease liabilities, long-term	8,480		9,112
Other long-term liabilities	5,121		499
Total liabilities	1,703,576		1,739,852

Shareholders’ equity:
Common stock, $0.01 par value; 500,000,000 authorized shares, 181,900,074 and 179,382,635 issued and outstanding shares at March 31, 2025 and December 31, 2024, respectively	1,819		1,794
Additional paid-in capital	4,714,742		4,645,791
Accumulated deficit	(4,616,500)		(4,359,917)
Accumulated other comprehensive loss	(902)		(2,289)
Total shareholders’ equity	99,159		285,379
Total liabilities and shareholders’ equity	$	1,802,735	$	2,025,231

See accompanying notes to the unaudited consolidated financial statements

INSMED INCORPORATED

Consolidated Statements of Comprehensive Loss (unaudited)

(in thousands, except per share data)


	Three Months Ended March 31,
		2025		2024

Product revenues, net		$	92,823	$	75,500

Operating expenses:
Cost of product revenues (excluding amortization of intangible assets)		21,278		17,457
Research and development		152,577		121,083
Selling, general and administrative		147,545		93,102
Amortization of intangible assets		1,263		1,263
Change in fair value of deferred and contingent consideration liabilities		18,300		(11,900)
Total operating expenses		340,963		221,005

Operating loss		(248,140)		(145,505)

Investment income		13,906		8,783
Interest expense		(21,569)		(21,042)
Change in fair value of interest rate swap		—		2,362

Other income (expense), net		132		(1,100)
Loss before income taxes		(255,671)		(156,502)

Provision for income taxes		912		589

Net loss		$	(256,583)	$	(157,091)

Basic and diluted net loss per share		$	(1.42)	$	(1.06)

Weighted average basic and diluted common shares outstanding		180,860		148,456

Net loss		$	(256,583)	$	(157,091)
Other comprehensive income (loss):
Foreign currency translation gains (losses)		1,828		(855)
Unrealized loss on marketable securities		(441)		(36)
Total comprehensive loss		$	(255,196)	$	(157,982)

See accompanying notes to the unaudited consolidated financial statements

INSMED INCORPORATED

Consolidated Statements of Shareholders' Equity (Deficit) (unaudited)

(in thousands)


	Common Stock			Additional Paid-in Capital		Accumulated Deficit		Accumulated Other Comprehensive Income (Loss)		Total
	Shares	Amount
Balance at December 31, 2023	147,978	$	1,480	$	3,113,487	$	(3,446,145)	$	(745)	$	(331,923)
Comprehensive loss:
Net loss						(157,091)				(157,091)
Other comprehensive loss								(891)		(891)
Exercise of stock options and ESPP share issuance	217	2		4,050						4,052
Net proceeds from issuance of common stock				(409)						(409)
Issuance of common stock for vesting of RSUs	366	4								4


Stock-based compensation expense				21,450						21,450
Balance at March 31, 2024	148,561	$	1,486	$	3,138,578	$	(3,603,236)	$	(1,636)	$	(464,808)

Balance at December 31, 2024	179,383	$	1,794	$	4,645,791	$	(4,359,917)	$	(2,289)	$	285,379
Comprehensive loss:
Net loss						(256,583)				(256,583)
Other comprehensive income								1,387		1,387
Exercise of stock options and ESPP share issuance	2,063	20		29,684						29,704

Issuance of common stock for vesting of RSUs	454	5								5

Issuance of common stock upon conversion of convertible notes				5						5

Stock-based compensation expense				39,262						39,262
Balance at March 31, 2025	181,900	$	1,819	$	4,714,742	$	(4,616,500)	$	(902)	$	99,159

See accompanying notes to the unaudited consolidated financial statements

INSMED INCORPORATED

Consolidated Statements of Cash Flows (unaudited)

(in thousands)


	Three Months Ended March 31,
	2025		2024
Operating activities
Net loss	$	(256,583)	$	(157,091)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	1,883		1,588
Amortization of intangible assets	1,263		1,263
Stock-based compensation expense	39,262		21,450

Amortization of debt issuance costs	1,822		1,851
Paid-in-kind interest capitalized	—		6,242
Royalty financing non-cash interest expense	5,023		4,822
Accretion of discount on marketable securities, net	(8,332)		(1,963)
Finance lease amortization expense	678		678
Non-cash operating lease expense	686		6,516
Change in fair value of deferred and contingent consideration liabilities	18,300		(11,900)
Change in fair value of interest rate swap	—		(2,362)


Changes in operating assets and liabilities:
Accounts receivable	5,361		2,955
Inventory	(1,021)		(598)
Prepaid expenses and other current assets	(16,941)		(19,330)
Other assets	10,168		333
Accounts payable and accrued liabilities	(61,490)		(32,345)
Other liabilities	(2,167)		(6,144)

Net cash used in operating activities	(262,088)		(184,035)
Investing activities
Purchase of fixed assets	(10,070)		(4,679)
Purchase of marketable securities	(630,518)		—

Maturities of marketable securities	721,000		300,000
Net cash provided by investing activities	80,412		295,321
Financing activities

SEC Form 10-Q filed by Insmed Incorporated