insm-20260331

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, 2026

☐ 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 1, 2026, there were 216,752,451 shares of the registrant’s common stock outstanding.

INSMED INCORPORATED

FORM 10-Q

FOR THE QUARTER ENDED MARCH 31, 2026

INDEX


PART I. FINANCIAL INFORMATION

ITEM 1	Consolidated Financial Statements

	Consolidated Balance Sheet s as of March 31, 2026 (unaudited) and December 31, 2025	3

	Consolidated Statements of Comprehensive Loss (unaudited) for the three months e nded March 31, 2026 and 2025	4

	Consolidated Statements of Shareholders' Equity (unaudited) for the three months ended March 31, 2026 and 2025	5

	Consolidated Statements of Cash Flows (unaudited) for the three months ended March 31, 2026 and 2025	6

	Notes to Consolidated Financial Statements (unaudited)	7

ITEM 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	24
ITEM 3	Quantitative and Qualitative Disclosures about Market Risk	39
ITEM 4	Controls and Procedures	39

PART II. OTHER INFORMATION

ITEM 1	Legal Proceedings	40
ITEM 1A	Risk Factors	40
ITEM 2	Unregistered Sales of Equity Securities and Use of Proceeds	40
ITEM 5	Other Information	40
ITEM 6	Exhibits	41

SIGNATURE		42

Unless the context otherwise indicates, references in this Form 10-Q 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, ARIKAYCE, and BRINSUPRI 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, 2026		December 31, 2025
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	582,188	$	510,445
Marketable securities	641,326		919,602
Accounts receivable	178,555		140,857
Inventory	132,909		132,068
Prepaid expenses and other current assets	78,195		91,236
Total current assets	1,613,173		1,794,208

Fixed assets, net	102,846		102,942
Finance lease right-of-use assets	14,883		15,561
Operating lease right-of-use assets	14,004		20,708
Intangibles, net	95,570		97,651
Goodwill	136,110		136,110
Other assets	99,277		97,378
Total assets	$	2,075,863	$	2,264,558

Liabilities and shareholders’ equity
Current liabilities:
Accounts payable and accrued liabilities	$	352,555	$	456,060


Finance lease liabilities	3,446		3,345
Operating lease liabilities	5,007		9,469

Total current liabilities	361,008		468,874

Debt, long-term	542,215		540,964
Royalty financing agreement	162,137		162,865
Contingent consideration	270,310		314,340
Finance lease liabilities, long-term	19,820		20,719
Operating lease liabilities, long-term	9,837		12,174
Other long-term liabilities	5,684		5,646
Total liabilities	1,371,011		1,525,582

Shareholders’ equity:
Common stock, $0.01 par value; 500,000,000 authorized shares, 216,521,841 and 214,255,853 issued and outstanding shares at March 31, 2026 and December 31, 2025, respectively	2,165		2,143
Additional paid-in capital	6,502,938		6,372,064
Accumulated deficit	(5,800,255)		(5,636,692)
Accumulated other comprehensive gain	4		1,461
Total shareholders’ equity	704,852		738,976
Total liabilities and shareholders’ equity	$	2,075,863	$	2,264,558

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,
		2026		2025

Product revenues, net		$	305,964	$	92,823

Operating expenses:
Cost of product revenues (excluding amortization of intangible assets)		47,420		21,278
Research and development		209,485		152,577
Selling, general and administrative		247,259		147,545
Amortization of intangible assets		2,081		1,263
Change in fair value of contingent consideration		(46,961)		18,300
Total operating expenses		459,284		340,963

Operating loss		(153,320)		(248,140)

Investment income		12,040		13,906
Interest expense		(20,082)		(21,569)


Other (expense) income, net		(736)		132
Loss before income taxes		(162,098)		(255,671)

Provision for income taxes		1,465		912

Net loss		$	(163,563)	$	(256,583)

Basic and diluted net loss per share		$	(0.76)	$	(1.42)

Weighted average basic and diluted common shares outstanding		215,468		180,860

Net loss		$	(163,563)	$	(256,583)
Other comprehensive income (loss):
Foreign currency translation (losses) gains		(668)		1,828
Unrealized loss on marketable securities		(789)		(441)
Total comprehensive loss		$	(165,020)	$	(255,196)

See accompanying notes to the unaudited consolidated financial statements

INSMED INCORPORATED

Consolidated Statements of Shareholders' Equity (unaudited)

(in thousands)


	Common Stock			Additional Paid-in Capital		Accumulated Deficit		Accumulated Other Comprehensive Income (Loss)		Total
	Shares	Amount
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
Issuance of common stock for exercise of stock options, vesting of RSUs and PSUs, and ESPP	2,517	25		29,684						29,709
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

Balance at December 31, 2025	214,256	$	2,143	$	6,372,064	$	(5,636,692)	$	1,461	$	738,976
Comprehensive loss:
Net loss						(163,563)				(163,563)
Other comprehensive loss								(1,457)		(1,457)
Issuance of common stock for exercise of stock options, vesting of RSUs, and ESPP	1,902	19		30,255						30,274


Contingent payments for Business Acquisition	364	3		54,865						54,868

Stock-based compensation expense				45,754						45,754
Balance at March 31, 2026	216,522	$	2,165	$	6,502,938	$	(5,800,255)	$	4	$	704,852

See accompanying notes to the unaudited consolidated financial statements

INSMED INCORPORATED

Consolidated Statements of Cash Flows (unaudited)

(in thousands)


	Three Months Ended March 31,
	2026		2025
Operating activities
Net loss	$	(163,563)	$	(256,583)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	2,934		1,883
Amortization of intangible assets	2,081		1,263
Stock-based compensation expense	45,754		39,262

Amortization of debt issuance costs	1,382		1,822

Royalty financing non-cash interest expense	5,114		5,023
Accretion of discount on marketable securities, net	(6,513)		(8,332)
Finance lease amortization expense	678		678
Non-cash operating lease expense	567		686
Change in fair value of contingent consideration	(46,961)		18,300



Changes in operating assets and liabilities:
Accounts receivable	(38,190)		5,361
Inventory	(1,886)		(1,021)
Prepaid expenses and other current assets	12,594		(16,941)
Other assets	(2,357)		10,168
Accounts payable and accrued liabilities	(33,875)		(61,490)
Other liabilities	(497)		(2,167)

Net cash used in operating activities	(222,738)		(262,088)
Investing activities
Purchase of fixed assets	(3,480)		(10,070)
Payment of AZ milestone	(15,000)		—
Purchase of marketable securities	—		(630,518)
Maturities of marketable securities	284,000		721,000
Net cash provided by investing activities	265,520		80,412
Financing activities
Proceeds from exercise of stock options and ESPP	30,313		29,704





Payments of finance lease principal	(799)		(706)


Net cash provided by financing activities	29,514		28,998
Effect of exchange rates on cash and cash equivalents	(553)		895
Net increase (decrease) in cash and cash equivalents	71,743		(151,783)
Cash and cash equivalents at beginning of period	510,445		555,030
Cash and cash equivalents at end of period	$	582,188	$	403,247
Supplemental disclosures of cash flow information:
Cash paid for interest	$	13,122	$	13,122
Cash paid for income taxes	$	2,940	$	2,176

See accompanying notes to the unaudited consolidated financial statements

Table of Contents

INSMED INCORPORATED

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 commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. To complement the Company's internal research and development, the Company also actively evaluates in-licensing and acquisition opportunities for commercial products, product candidates, and technologies.

The Company's first two commercial products, ARIKAYCE® and BRINSUPRI®, are both part of the Respiratory therapeutic area. 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 Liposomal 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.

BRINSUPRI (brensocatib 25 mg and 10 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (referred to as bronchiectasis or NCFB) in patients 12 years of age and older, was approved in the US in August 2025. In November 2025, the EC approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. In February 2026, the United Kingdom's (UK) Medicines and Healthcare products Regulatory Agency (MHRA) approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of NCFB in patients 12 years of age and older with two or more flare-ups or worsening of symptoms in the past 12 months. Bronchiectasis is a serious, chronic lung disease in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage.

The Company's Respiratory therapeutic area also includes clinical-stage programs for treprostinil palmitil inhalation powder (TPIP) and INS1148. TPIP is an inhaled dry powder formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for pulmonary hypertension associated with interstitial lung disease (PH-ILD), pulmonary arterial hypertension (PAH), progressive pulmonary fibrosis (PPF), and idiopathic pulmonary fibrosis (IPF). INS1148 is a monoclonal antibody targeting a specific isoform of Stem Cell Factor, called Stem Cell Factor 248 (SCF248), which we plan to initially develop for PPF and IPF. The Company is also exploring additional opportunities utilizing its various technologies within the Respiratory therapeutic area.

The Company's Immunology & Inflammation therapeutic area is exploring opportunities utilizing its various technologies.

The Company's Neuro & Other Rare therapeutic area includes the clinical-stage programs INS1201, an intrathecally delivered gene therapy for patients with Duchenne muscular dystrophy (DMD), and INS1202, an intrathecally delivered gene therapy for patients with amyotrophic lateral sclerosis (ALS). The Company is also exploring additional opportunities utilizing its various technologies within the Neuro & Other Rare therapeutic area.

The Company's pre-clinical research programs encompass a wide range of technologies and modalities, including gene therapy, artificial intelligence (AI)-driven protein engineering, RNA end-joining, and synthetic rescue.

The Company was incorporated in the Commonwealth of Virginia on November 29, 1999 and its principal executive offices are located in Bridgewater, New Jersey. The Company has legal entities in the US, France, Germany, Ireland, Italy, the Netherlands, Switzerland, the UK, and Japan.

The accompanying unaudited interim consolidated financial statements have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by accounting principles generally accepted in the US (GAAP) for complete consolidated financial statements are not included herein. The unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements and

Table of Contents

INSMED INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

1. The Company and Basis of Presentation (Continued)

notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2025. Any references in these notes to applicable accounting guidance are meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) of the Financial Accounting Standards Board (FASB).

The results of operations of any interim period are not necessarily indicative of the results of operations for the full year. The unaudited interim consolidated financial information presented herein reflects all normal and recurring adjustments that are, in the opinion of management, necessary for a fair statement of the financial position, results of operations and cash flows for the periods presented. All intercompany transactions and balances have been eliminated in consolidation. Certain prior period line items within the consolidated statements of shareholders' equity have been combined to conform to the current period presentation.

The Company had $582.2 million of cash and cash equivalents and $641.3 million of marketable securities as of March 31, 2026 and reported a net loss of $163.6 million for the three months ended March 31, 2026. The Company has funded its operations through public offerings of equity securities, debt financings, revenue interest financings, and revenues generated from ARIKAYCE and BRINSUPRI. The Company expects to continue to incur consolidated operating losses, including losses in its US and certain international entities, while funding research and development (R&D) activities for ARIKAYCE, TPIP, INS1148, INS1201, INS1202, and its other pipeline programs, and commercialization and regulatory activities for BRINSUPRI and ARIKAYCE.

The Company expects its future cash requirements to be substantial. While the Company currently has sufficient funds to meet its financial needs for at least the next 12 months, the Company may raise additional capital in the future to fund its operations, its ongoing commercialization and clinical trial activities, and its future product candidates, and to develop, acquire, in-license, or co-promote other products or product candidates, including those that address serious diseases with significant unmet need. The source, timing, and availability of any future financing or other transaction will depend principally upon continued progress in the Company’s commercial, regulatory, and development activities. Any future financing will also be contingent upon market 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 subsidiaries, 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, 2025. 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, the revenue interest purchase agreement (the Royalty Financing Agreement), and accounting for R&D costs. Actual results could differ from those estimates.

Concentration of Credit Risk—Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and marketable securities. The Company places its cash equivalents and marketable securities with high credit-quality financial institutions and may invest its investments in US treasury securities, mutual funds, and government agency bonds. The Company has established guidelines relative to credit ratings and maturities that seek to maintain safety and liquidity.

The Company is exposed to risks associated with extending credit to customers related to the sale of products. The Company does not require collateral to secure amounts due from its customers. The Company uses an expected loss methodology to calculate allowances for trade receivables. The Company's measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable

Table of Contents

INSMED INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

2. Summary of Significant Accounting Policies (Continued)

forecasts that affect the collectability of the reported amount. The Company does not currently have a material allowance for uncollectible trade receivables.

The following table presents the customers representing 10% or more of the Company's gross product revenues for the three months ended March 31, 2026 and their respective percentages for the three months ended March 31, 2025.


	Three Months Ended March 31,
	2026	2025
Customer A	38%	29%
Customer B	22%	31%
Customer C	16%	9%
Customer D	14%	4%

The Company relies on third-party manufacturers and suppliers for manufacturing and supply of its products. The inability of the suppliers or manufacturers to fulfill supply requirements of the Company could materially impact future operating results. A change in the relationship with the suppliers or manufacturers, or an adverse change in their business, could materially impact future operating results.

Net Loss Per Share—Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares and other dilutive securities outstanding during the period. Potentially dilutive securities from stock options, restricted stock units (RSUs), performance stock units (PSUs) and formerly outstanding convertible debt securities would be anti-dilutive as the Company incurred a net loss. Potentially dilutive common shares resulting from the assumed exercise of outstanding stock options and from the assumed conversion of the Company's previously outstanding convertible notes are determined based on the treasury stock method.

The following table sets forth the reconciliation of the weighted average number of common shares used to compute basic and diluted net loss per share for the three months ended March 31, 2026 and 2025 (in thousands, except per share amounts):


	Three Months Ended March 31,
		2026	2025

Numerator: