Insmed (INSM) projects 2026 revenue to more than double on BRINSUPRI

Rhea-AI Filing Summary

Insmed Incorporated reported strong growth for the fourth quarter and full year 2025 while remaining deeply loss-making and setting ambitious 2026 revenue goals. Total revenue reached $606.4 million in 2025, up from $363.7 million, driven by the U.S. launch of BRINSUPRI and continued ARIKAYCE expansion.

BRINSUPRI generated $144.6 million in Q4 and $172.7 million for 2025, while ARIKAYCE delivered $119.2 million in Q4 and $433.8 million for the year, representing 19% annual growth. Despite this, Insmed posted a 2025 net loss of $1.28 billion, as operating expenses rose to $1.85 billion. The company ended 2025 with approximately $1.4 billion in cash, cash equivalents, and marketable securities and guides for at least $1 billion in 2026 BRINSUPRI revenue and $450–$470 million from ARIKAYCE. Insmed also highlighted Orphan Drug Designation for TPIP in pulmonary arterial hypertension and ongoing late-stage studies. Separately, director David W.J. McGirr will not stand for re-election at the 2026 annual meeting but will continue serving until then.

Positive

• 2025 revenue inflection: Total revenue rose to $606.4 million from $363.7 million, driven by the BRINSUPRI launch and 19% annual growth from ARIKAYCE.
• Strong 2026 outlook: Management guides for at least $1 billion in 2026 BRINSUPRI revenue and $450–$470 million from ARIKAYCE, implying company-wide revenue of at least $1.45 billion.
• Robust liquidity: The company ended 2025 with approximately $1.4 billion in cash, cash equivalents, and marketable securities, providing substantial funding capacity for commercialization and pipeline programs.
• Pipeline momentum: Treprostinil palmitil inhalation powder received FDA Orphan Drug Designation for pulmonary arterial hypertension, and key Phase 3 and Phase 2b topline data readouts remain on track.

Negative

• Large continuing losses: Insmed recorded a 2025 net loss of $1.28 billion, with operating expenses of $1.85 billion significantly exceeding $606.4 million in revenue.
• High spending intensity: Research and development plus selling, general and administrative costs totaled more than $1.59 billion in 2025, indicating a heavy ongoing investment burden relative to current sales.

Insights

Biopharma equity analyst

Rapid revenue growth and bullish 2026 guidance offset by very large losses.

Insmed is transitioning into a commercial-stage company with 2025 revenue of $606.4 million, up 67% year over year. Growth was fueled by the U.S. launch of BRINSUPRI and 19% annual growth from ARIKAYCE, with Q4 revenue at $263.8 million.

Management’s 2026 guidance targets at least $1 billion in BRINSUPRI revenue and $450–$470 million from ARIKAYCE, implying company-wide revenue of at least $1.45 billion. The balance sheet showed roughly $1.4 billion in cash, cash equivalents, and marketable securities as of December 31, 2025, supporting ongoing investment.

However, the company reported a 2025 net loss of $1.28 billion and total operating expenses of $1.85 billion, reflecting heavy R&D and SG&A spending. Future results will depend on sustaining BRINSUPRI uptake, continued ARIKAYCE growth, and execution of late-stage programs such as TPIP, where treprostinil palmitil recently received Orphan Drug Designation in pulmonary arterial hypertension.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 17, 2026

INSMED INCORPORATED

(Exact name of registrant as specified in its charter)

Virginia	000-30739	54-1972729
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

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

Registrant’s telephone number, including area code: (908) 977-9900

Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	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 is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2).

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. ☐

ITEM 2.02 Results of Operations and Financial Condition.

On February 19, 2026, Insmed Incorporated (the “Company”) issued a press release regarding its financial results for the three months and fiscal year ended December 31, 2025. A copy of this press release is furnished herewith as Exhibit 99.1 pursuant to this Item 2.02. The slide presentation to be used during the conference call referenced in the press release is attached hereto as Exhibit 99.2 and incorporated herein by reference.

The information contained herein, including the exhibits attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

ITEM 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On February 17, 2026, David W.J. McGirr notified the board of directors (the “Board”) of the Company that he will not stand for re-election to the Board upon the expiration of his current term as a Class II director, which will occur at the Company’s 2026 Annual Meeting of Shareholders (the “Annual Meeting”). Mr. McGirr will continue to serve as a member of the Board and chair of the Audit Committee of the Board until the Annual Meeting. Mr. McGirr’s decision to not stand for re-election to the Board was not a result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices.

ITEM 9.01 Financial Statements and Exhibits.

(d)  Exhibits

Exhibit No.		Description
99.1		Press release issued by Insmed Incorporated on February 19, 2026.
99.2		Insmed Incorporated February 19, 2026 Presentation.
104		Cover Page Interactive Date File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: February 19, 2026	INSMED INCORPORATED
	By:	/s/ Michael A. Smith
	Name:	Michael A. Smith
	Title:	Chief Legal Officer and Corporate Secretary

Exhibit 99.1

Insmed Reports Fourth-Quarter and Full-Year 2025 Financial Results and Provides Business Update

—Company Expects Full-Year 2026 BRINSUPRI^® (brensocatib) Revenues to Be at Least $1 Billion; Reiterates Full-Year 2026 ARIKAYCE^® (amikacin liposome inhalation suspension) Revenue Guidance of $450 Million to $470 Million—

—Total Company Revenues of $606.4 Million for Full-Year 2025—

—BRINSUPRI Total Revenues of $144.6 Million for Fourth-Quarter and $172.7 Million for Full-Year 2025—

—ARIKAYCE Total Revenues of $119.2 Million for Fourth-Quarter and $433.8 Million for Full-Year 2025, Representing 19% Annual Growth and Exceeding the Upper End of Full-Year 2025 Guidance—

—Topline Data Readouts from Phase 3 ENCORE and Phase 2b CEDAR Studies Remain on Track—

—FDA grants Orphan Drug Designation to Treprostinil Palmitil for Treatment of PAH—

—Company Ends 2025 with Approximately $1.4 Billion of Cash, Cash Equivalents, and Marketable Securities—

BRIDGEWATER, N.J., February 19, 2026 /PRNewswire/ — Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

“As we close out 2025 and begin an exciting new year at Insmed, I am energized by the significant opportunities ahead to serve patients with serious diseases,” said Will Lewis, Chair and Chief Executive Officer of Insmed. “Our U.S. commercial launch of BRINSUPRI continues to exceed our expectations, and we are proud to provide this medicine to patients who previously had no approved treatment for their disease. Throughout 2026, we will continue to bring BRINSUPRI to patients with bronchiectasis, expand our Phase 3 clinical programs for TPIP, and advance our early-stage pipeline, fueling the research engine that we hope will power the next wave of potentially life-transforming therapies for patients.”

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Progress and Anticipated Milestones by Therapeutic Area:

Respiratory

 
BRINSUPRI

• Insmed anticipates full-year 2026 BRINSUPRI revenues of at least $1 billion.

• In November 2025, the European Commission approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.

• Insmed anticipates regulatory decisions for brensocatib for the treatment of NCFB in the United Kingdom (UK) and Japan in 2026.

• Insmed continues to evaluate the potential effect of evolving U.S. policies which will then impact the timing for future potential international commercial launches.

ARIKAYCE

• Insmed continues to anticipate full-year 2026 ARIKAYCE revenues in the range of $450 million to $470 million.

• ARIKAYCE global revenue grew 19% in 2025 compared to 2024, reflecting year-over-year growth across all geographic regions and exceeding the upper end of 2025 guidance of $420 to $430 million.

• In March or April of 2026, the Company anticipates the topline readout of the Phase 3 ENCORE trial in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who have not started antibiotics.

• Pending positive topline data from the ENCORE trial, Insmed plans to submit a supplementary new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the second half of 2026. Similarly, Insmed plans to review the data with the Pharmaceuticals and Medical Devices Agency (PMDA) in the second half of 2026 to support potential label expansion in Japan.

TPIP

• In January 2026, the Office of Orphan Products Development of the FDA granted orphan drug designation (ODD) to treprostinil palmitil for the treatment of patients with pulmonary arterial hypertension (PAH). Insmed plans to initiate a Phase 3 study of TPIP (treprostinil palmitil inhalation powder) in patients with PAH in the first half of 2026.

• Insmed is actively enrolling patients in the PALM-ILD trial, a Phase 3 study of TPIP in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

• In January 2026, Insmed presented four abstracts from across its TPIP program at the Pulmonary Vascular Research Institute (PVRI) 2026 congress in Dublin.

• The Company expects to report data from the open-label extension (OLE) of its Phase 2b study of TPIP in PAH in the second half of 2026.

• The Company anticipates initiating additional Phase 3 studies of TPIP in patients with progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF) in the second half of 2026.

INS1148

• In December 2025, Insmed acquired INS1148, a Phase 2-ready monoclonal antibody targeting a specific isoform of Stem Cell Factor, called Stem Cell Factor 248 (SCF248).

2

• The Company plans to advance Phase 2 development programs for INS1148 initially in interstitial lung disease (ILD) and moderate to severe asthma.

Immunology & Inflammation

Brensocatib

• In October 2025, Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS). Insmed anticipates reporting topline data from CEDAR in the second quarter of 2026.

INS1033

• Insmed’s second dipeptidyl peptidase 1 (DPP1) inhibitor, INS1033, is currently advancing toward the clinic in rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), with an initial IND filing expected in 2026.

Neuro & Other Rare

INS1201

• Insmed continues to enroll the Phase 1 ASCEND clinical study of INS1201, an intrathecally delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).

INS1202

• In January 2026, the Company dosed the first patient in the Phase 1 ARMOR study of INS1202, an intrathecally delivered gene therapy for patients with amyotrophic lateral sclerosis (ALS).

INS1203

• Insmed’s third gene therapy candidate, INS1203, targeting Stargardt disease, is currently advancing toward the clinic, with an IND filing expected in 2026.

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Fourth-Quarter and Full-Year 2025 Financial Results

The following table summarizes fourth-quarter and full-year 2025 and 2024 revenues and revenue growth for BRINSUPRI and ARIKAYCE across all commercial regions:

		Three Months Ended												Twelve Months Ended
		December 31,												December 31,
(in millions)		2025				2024				Growth				2025				2024				Growth
ARIKAYCE
U.S.		$	73.4			$	67.8				8	%		$	280.3			$	254.8				10	%
International			45.9				36.7				25	%			153.5				108.9				41	%
Total		$	119.2			$	104.4				14	%		$	433.8			$	363.7				19	%
BRINSUPRI
U.S.		$	144.6			$	-				N/A			$	172.7			$	-				N/A
International			-				-				N/A				-				-				N/A
Total		$	144.6			$	-				N/A			$	172.7			$	-				N/A
Total Revenues
U.S.		$	218.0			$	67.8				222	%		$	453.0			$	254.8				78	%
International			45.9				36.7				25	%			153.5				108.9				41	%
Total		$	263.8			$	104.4				153	%		$	606.4			$	363.7				67	%

• Cost of product revenues (excluding amortization of intangibles) was $44.2 million for the fourth quarter of 2025, compared to $26.2 million for the fourth quarter of 2024. For full-year 2025, cost of product revenues (excluding amortization of intangibles) was $122.9 million compared to $85.7 million for full-year 2024. The increase in cost of product revenues in the fourth quarter of 2025 and full-year 2025 primarily reflects the increase in total product revenues for ARIKAYCE and BRINSUPRI, following BRINSUPRI’s U.S. commercial launch in August 2025. Cost of product revenues as a percentage of revenues decreased in the fourth quarter of 2025 and full-year 2025 due to sales of BRINSUPRI, which has a lower manufacturing cost than ARIKAYCE.

• Research and development (R&D) expenses were $254.9 million for the fourth quarter of 2025, compared to $179.7 million for the fourth quarter of 2024. For full-year 2025, R&D expenses were $771.1 million compared to $598.4 million for full-year 2024. The increase in R&D expenses for fourth quarter of 2025 and full-year 2025 was primarily related to increases in compensation and benefit-related expenses, as well as stock-based compensation, increases in manufacturing expense, and the acquisition of INS1148.

• Selling, general and administrative (SG&A) expenses for the fourth quarter of 2025 were $212.5 million, compared to $142.5 million for the fourth quarter of 2024. For full-year 2025, SG&A expenses were $701.2 million, compared to $461.1 million for full-year 2024. The increase in SG&A expenses for the fourth quarter of 2025 and full-year 2025 was primarily related to increases in compensation and benefit-related expenses, as well as stock-based compensation, and an increase in professional fees and other external expenses, both driven by commercial and commercial readiness activities for BRINSUPRI.

• For the fourth quarter of 2025, Insmed reported a net loss of $328.5 million, or $1.54 per share, compared to a net loss of $235.5 million, or $1.32 per share, for the fourth quarter of 2024. For full-year 2025, Insmed reported a net loss of $1,276.8 million, or $6.42 per share, compared to a net loss of $913.8 million, or $5.57 per share, for full-year 2024.

Balance Sheet, Financial Guidance, and Planned Investments

• As of December 31, 2025, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.4 billion.

• The Company anticipates full-year 2026 BRINSUPRI revenues of at least $1 billion.

• Insmed continues to anticipate full-year 2026 ARIKAYCE revenues in the range of $450 million to $470 million.

4

• The Company anticipates submitting an average of one to two INDs per year from its pre-clinical research programs.

• Insmed continues to anticipate that the totality of its pre-clinical research programs will comprise less than 20% of overall expenditures.

• The Company plans to continue to invest in the following key activities in 2026:

(i) commercialization and expansion of BRINSUPRI and ARIKAYCE;

(ii) preparation of regulatory submissions for full approval for ARIKAYCE in the U.S. and label expansion to include all patients with a MAC lung infection in the U.S. and Japan, pending positive topline results from the Phase 3 ENCORE trial;

(iii) advancement of the clinical development programs for TPIP, including the Phase 3 studies in patients with PH-ILD, PAH, PPF, and IPF;

(iv) advancement of clinical development programs for INS1148 in ILD and moderate to severe asthma;

(v) advancement of the clinical trial programs for INS1201 in DMD and INS1202 in ALS, as well as IND-enabling activities for INS1203 in Stargardt disease;

(vi) advancement of IND-enabling activities for INS1033 in RA and IBD; and

(vii) continued development of its pre-clinical research programs.

Conference Call

Insmed will host a conference call beginning today, February 19, 2026, at 8:00 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (U.S. and international) and referencing access code 7862189. The call will also be webcast live on the Company's website at www.insmed.com.

A replay of the conference call will be accessible approximately 1 hour after its completion through February 26, 2026, by dialing (800) 770-2030 (U.S. and international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at www.insmed.com.

5

INSMED INCORPORATED

Consolidated Statements of Net Loss

(in thousands, except per share data)

(unaudited)

		Three Months Ended December 31,								Twelve Months Ended December 31,
		2025				2024				2025				2024
License fees		$	-			$	-			$	-			$	-
Product revenues, net		$	263,843			$	104,442			$	606,423			$	363,707
Operating expenses:
Cost of product revenues (excluding amortization of intangible assets)			44,220				26,151				122,938				85,742
Research and development			254,911				179,727				771,093				598,367
Selling, general and administrative			212,483				142,515				701,167				461,116
Amortization of intangible assets			1,937				1,263				6,001				5,052
Change in fair value of deferred and contingent consideration liabilities			70,040				(14,800	)			251,993				91,682
Total operating expenses			583,591				334,856				1,853,192				1,241,959
Operating loss			(319,748	)			(230,414	)			(1,246,769	)			(878,252	)
Investment income			15,236				17,257				60,656				53,307
Interest expense			(20,599	)			(21,550	)			(83,795	)			(84,913	)
Change in fair value of interest rate swap			-				870				-				(236	)
Loss on extinguishment of debt			-				-								-
Other (expense) income, net			(1,823	)			(445	)			(1,841	)			29
Loss before income taxes			(326,934	)			(234,282	)			(1,271,749	)			(910,065	)
Provision for income taxes			1,551				1,266				5,026				3,707
Net loss		$	(328,485	)		$	(235,548	)		$	(1,276,775	)		$	(913,772	)
Basic and diluted net loss per share		$	(1.54	)		$	(1.32	)		$	(6.42	)		$	(5.57	)
Weighted average basic and diluted common shares outstanding			213,637				179,021				199,014				164,043

6

INSMED INCORPORATED

Consolidated Balance Sheets

(in thousands, except par value and share data)

		As of
		December 31, 2025				December 31, 2024
Assets
Current assets:
Cash and cash equivalents		$	510,445			$	555,030
Marketable securities			919,602				878,796
Accounts receivable			140,857				52,012
Inventory			132,068				98,578
Prepaid expenses and other current assets			91,236				37,245
Total current assets			1,794,208				1,621,661
Fixed assets, net			102,942				80,052
Finance lease right-of-use assets			15,561				18,273
Operating lease right-of-use assets			20,708				17,257
Intangibles, net			97,651				58,652
Goodwill			136,110				136,110
Other assets			97,378				93,226
Total assets		$	2,264,558			$	2,025,231
Liabilities and shareholders' equity
Current liabilities:
Accounts payable and accrued liabilities		$	456,060			$	285,209
Finance lease liabilities			3,345				2,961
Operating lease liabilities			9,469				9,358
Total current liabilities			468,874				297,528
Debt, long-term			540,964				1,103,382
Royalty financing agreement			162,865				161,067
Contingent consideration			314,340				144,200
Finance lease liabilities, long-term			20,719				24,064
Operating lease liabilities, long-term			12,174				9,112
Other long-term liabilities			5,646				499
Total liabilities			1,525,582				1,739,852
Shareholders' equity:
Common stock, $0.01 par value; 500,000,000 authorized shares, 214,255,853 and 179,382,635 issued and outstanding shares at December 31, 2025 and December 31, 2024, respectively			2,143				1,794
Additional paid-in capital			6,372,064				4,645,791
Accumulated deficit			(5,636,692	)			(4,359,917	)
Accumulated other comprehensive gain (loss)			1,461				(2,289	)
Total shareholders' equity			738,976				285,379
Total liabilities and shareholders' equity		$	2,264,558			$	2,025,231

7

About ARIKAYCE

ARIKAYCE^® is approved in the United States 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). Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed’s proprietary PULMOVANCE™ liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while limiting systemic exposure. ARIKAYCE is administered once daily using the Lamira^® Nebulizer System manufactured by PARI Pharma GmbH (PARI).

About PARI Pharma and the Lamira^® Nebulizer System

ARIKAYCE is delivered by a novel inhalation device, the Lamira^® Nebulizer System, developed by PARI. Lamira^® is a quiet, portable nebulizer that enables efficient aerosolization of ARIKAYCE via a vibrating, perforated membrane. Based on PARI's 100-year history working with aerosols, PARI is dedicated to advancing inhalation therapies by developing innovative delivery platforms to improve patient care.

About BRINSUPRI

BRINSUPRI^® (brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). BRINSUPRI (brensocatib 10 mg and 25 mg tablets) is indicated in the United States for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age or older. In the European Union, BRINSUPRI (brensocatib 25 mg tablets) is approved for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months.

Brensocatib is designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB. Brensocatib is also being evaluated for its potential role in hidradenitis suppurativa, another neutrophil-mediated disease.

About TPIP

Treprostinil palmitil inhalation powder (TPIP) is an investigational dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated as once-daily therapy for the treatment of patients with pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), and other rare and serious pulmonary disorders. TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction.

8

About INS1148

INS1148 is an investigational monoclonal antibody that Insmed is developing as a potential first-in-class therapy to address respiratory and immunological and inflammatory diseases with high unmet need. Through its novel mechanism of action, INS1148 preferentially targets a specific isoform of Stem Cell Factor, called Stem Cell Factor 248 (SCF248). Binding to SCF248 induces clearance of this SCF isoform and interrupts only the inflammatory cascade downstream of c-Kit signaling, while leaving its homeostatic and tissue healing pathways intact. INS1148 is an investigational drug product that has not been approved for any indication in any jurisdiction.

About INS1201

INS1201 is an investigational micro-dystrophin adeno-associated virus (AAV9) gene therapy that Insmed is developing as a potential treatment for patients with Duchenne muscular dystrophy (DMD). Administered intrathecally, this approach has the potential to target both skeletal and cardiac muscles as a one-time fixed (non-weight-based) dose. INS1201 is an investigational drug product that has not been approved for any indication in any jurisdiction.

About INS1202

INS1202 is an investigational adeno-associated virus (AAV9) short hairpin RNA (shRNA) construct targeting the human superoxide dismutase type 1 (SOD1) gene. Insmed is developing INS1202 as a potential treatment for patients with amyotrophic lateral sclerosis (ALS) who carry SOD1 mutations and those who do not have SOD1 mutations. INS1202 is administered intrathecally as a one-time fixed (non-weight-based) dose. INS1202 is an investigational drug product that has not been approved for any indication in any jurisdiction.

IMPORTANT SAFETY INFORMATION AND BOXED WARNING FOR ARIKAYCE IN THE U.S.

WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS

 

ARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases.

Hypersensitivity Pneumonitis has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and received treatment with corticosteroids. If hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate.

Hemoptysis has been reported with the use of ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%). If hemoptysis occurs, manage patients as medically appropriate.

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Bronchospasm has been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (28.7%) compared to patients treated with a background regimen alone (10.7%). If bronchospasm occurs during the use of ARIKAYCE, treat patients as medically appropriate.

Exacerbations of underlying pulmonary disease has been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (14.8%) compared to patients treated with background regimen alone (9.8%). If exacerbations of underlying pulmonary disease occur during the use of ARIKAYCE, treat patients as medically appropriate.

Anaphylaxis and Hypersensitivity Reactions: Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives, itching, flushing, swollen lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of anaphylaxis (tachycardia, low blood pressure, syncope, incontinence, dizziness). Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction occurs, discontinue ARIKAYCE and institute appropriate supportive measures.

Ototoxicity has been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen (17%) compared to patients treated with background regimen alone (9.8%). This was primarily driven by tinnitus (7.6% in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and dizziness (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background regimen alone arm). Closely monitor patients with known or suspected auditory or vestibular dysfunction during treatment with ARIKAYCE. If ototoxicity occurs, manage patients as medically appropriate, including potentially discontinuing ARIKAYCE.

Nephrotoxicity was observed during the clinical trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE.

Neuromuscular Blockade: Patients with neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions.

Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to the fetus.

Contraindications: ARIKAYCE is contraindicated in patients with known hypersensitivity to any aminoglycoside.

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Most Common Adverse Reactions: The most common adverse reactions in Trial 1 at an incidence ≥5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm (29% vs 11%), hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs 10%), diarrhea (13% vs 5%), nausea (12% vs 4%), pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%).

Drug Interactions: Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol.

Overdosage: Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment.

U.S. INDICATION

LIMITED POPULATION: ARIKAYCE^® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.

This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Limitation of Use:

ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.

Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088. You can also call the Company at 1-844-4-INSMED.

Please see Full Prescribing Information.

BRINSUPRI^® (brensocatib) U.S. INDICATION AND IMPORTANT SAFETY INFORMATION

Indication in the U.S.

BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older.

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Important Safety Information in the U.S.

WARNINGS AND PRECAUTIONS

Dermatologic Adverse Reactions

Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings.

Gingival and Periodontal Adverse Reactions

Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene.

Live Attenuated Vaccines

It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI.

ADVERSE REACTIONS

The most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions.

Less Common Adverse Reactions

Liver Function Test Elevations

In ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9%; the incidence of AST >3X ULN was 0.2%, 0.3%, and 0.5%; and the incidence of alkaline phosphatase >1.5X ULN was 2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively.

Skin Cancers

In ASPEN, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in placebo-treated patients.

Alopecia

In ASPEN, the incidence of alopecia among patients treated with BRINSUPRI 10 mg and 25 mg was 1.5% and 1.6% respectively, compared to 0.4% in placebo-treated patients.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are no clinical data on the use of BRINSUPRI in pregnant women.

Lactation: There is no information regarding the presence of BRINSUPRI and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition.

Pediatric use: The safety and effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Common adverse reactions in pediatric patients aged 12 years and older enrolled in ASPEN were consistent with those in adults. The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age.

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Please see full US Prescribing Information.

About Insmed

Insmed Incorporated 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 is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including two approved therapies to treat chronic, debilitating lung diseases. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.

Forward-looking Statements

This press release 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, 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) may identify forward-looking statements.

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The forward-looking statements in this press release are based upon the Company’s current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company’s actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to continue to successfully commercialize ARIKAYCE in the U.S., Europe or Japan or failure to successfully commercialize BRINSUPRI in the U.S. or Europe, or to maintain U.S., European or Japanese approval for ARIKAYCE or U.S. or E.U. approval for BRINSUPRI; our inability to obtain full approval of ARIKAYCE from the FDA, including the risk that we will not successfully or in a timely manner complete the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE, or our failure to obtain regulatory approval to expand ARIKAYCE’s indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the U.S., Europe or Japan, for ARIKAYCE outside of the U.S., Europe and Japan, including separate regulatory approval for the Lamira^® Nebulizer System in each market and for each usage, or for BRINSUPRI outside of the U.S. and the E.U.; failure to successfully commercialize our product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for such product candidates, if approved; uncertainties or changes in the degree of market acceptance of our marketed products or, if approved, our product candidates, by physicians, patients, third-party payors and others in the healthcare community; our inability to obtain and maintain adequate reimbursement from government or third-party payors for our marketed products or, if approved, our product candidates, or acceptable prices for our marketed products or, if approved, our product candidates; inaccuracies in our estimates of the size of the potential markets for our marketed products and our product candidates or in data we have used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; failure of third parties on which we are dependent to manufacture sufficient quantities of our marketed products and our product candidates for commercial or clinical needs, as applicable, to conduct our clinical trials, or to comply with our agreements or laws and regulations that impact our business; risks and uncertainties associated with, and the perceived benefits of, our senior secured loan with certain funds managed by Pharmakon Advisors, LP and our royalty financing with OrbiMed Royalty & Credit Opportunities IV, LP, including our ability to maintain compliance with the covenants in the agreements for the senior secured loan and royalty financing and the impact of the restrictions on our operations under these agreements; our inability to create or maintain an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of our marketed products or any of our product candidates that are approved in the future; failure to successfully conduct future clinical trials for our marketed products or our product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates or to permit the use of ARIKAYCE in the broader population of patients with MAC lung disease, among other things; development of unexpected safety or efficacy concerns related to our marketed products or our product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected; failure to successfully predict the time and cost of development, regulatory approval and commercialization for novel gene therapy products; risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed, or that blinded data will not be predictive of unblinded data; risk that our competitors may obtain orphan drug exclusivity for a product that is essentially the same as a product we are developing for a particular indication; our inability to attract and retain key personnel or to effectively manage our growth; our inability to successfully integrate our acquisitions and appropriately manage the amount of management’s time and attention devoted to integration activities; risks that our acquired technologies, products and product candidates will not be commercially successful; inability to adapt to our highly competitive and changing environment; inability to access, upgrade or expand our technology systems or difficulties in updating our existing technology or developing or implementing new technology; risk that we are unable to maintain our significant customers; risk that healthcare legislation or other government action materially adversely affects our business; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; risk that our current and potential future use of AI and machine learning may not be successful; deterioration in general economic conditions in the U.S., Europe, Japan and globally, including the effect of prolonged periods of inflation, affecting us, our suppliers, third-party service providers and potential partners; risk that we could become involved in costly intellectual property disputes, be unable to adequately protect our intellectual property rights or prevent disclosure of our trade secrets and other proprietary information, and incur costs associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on us by agreements related to our marketed products or our product candidates, including our license agreements with PARI and AstraZeneca AB, and failure to comply with our obligations under such agreements; the cost and potential reputational damage resulting from litigation to which we are or may become a party, including product liability claims; risk that our operations are subject to a material disruption in the event of a cybersecurity attack or issue; changes in laws and regulations applicable to our business, including any pricing reform and laws that impact our ability to utilize certain third parties in the research, development or manufacture of our product candidates, and failure to comply with such laws and regulations; our history of operating losses, and the possibility that we never achieve or maintain profitability; goodwill impairment charges affecting our results of operations and financial condition; inability to repay our existing indebtedness and uncertainties with respect to our ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans.

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The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, “Risk Factors,” in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and any subsequent Company filings with the Securities and Exchange Commission (SEC).

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Contact:

 

Investors:

Bryan Dunn

Vice President, Investor Relations

(646) 812-4030

investor.relations@insmed.com

Media:

Claire Mulhearn

Vice President, Corporate Communications

(862) 842-6819

media@insmed.com

 

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Exhibit 99.2

 February 19, 2026  Fourth-Quarter 2025 Earnings Presentation 

 Forward Looking Statements  The forward-looking statements in this presentation are based upon the Company’s current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company’s actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to continue to successfully commercialize ARIKAYCE® in the U.S., Europe or Japan or failure to successfully commercialize BRINSUPR®I in the U.S. or Europe, or to maintain U.S., European or Japanese approval for ARIKAYCE or U.S. or E.U. approval for BRINSUPRI; our inability to obtain full approval of ARIKAYCE from the FDA, including the risk that we will not successfully or in a timely manner complete the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE, or our failure to obtain regulatory approval to expand ARIKAYCE’s indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the U.S., Europe or Japan, for ARIKAYCE outside of the U.S., Europe and Japan, including separate regulatory approval for the Lamira® Nebulizer System in each market and for each usage, or for BRINSUPRI outside of the U.S. and the E.U.; failure to successfully commercialize our product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for such product candidates, if approved; uncertainties or changes in the degree of market acceptance of our marketed products or, if approved, our product candidates, by physicians, patients, third-party payors and others in the healthcare community; our inability to obtain and maintain adequate reimbursement from government or third-party payors for our marketed products or, if approved, our product candidates, or acceptable prices for our marketed products or, if approved, our product candidates; inaccuracies in our estimates of the size of the potential markets for our marketed products and our product candidates or in data we have used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; failure of third parties on which we are dependent to manufacture sufficient quantities of our marketed products and our product candidates for commercial or clinical needs, as applicable, to conduct our clinical trials, or to comply with our agreements or laws and regulations that impact our business; risks and uncertainties associated with, and the perceived benefits of, our senior secured loan with certain funds managed by Pharmakon Advisors, LP and our royalty financing with OrbiMed Royalty & Credit Opportunities IV, LP, including our ability to maintain compliance with the covenants in the agreements for the senior secured loan and royalty financing and the impact of the restrictions on our operations under these agreements; our inability to create or maintain an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of our marketed products or any of our product candidates that are approved in the future; failure to successfully conduct future clinical trials for our marketed products or our product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates or to permit the use of ARIKAYCE in the broader population of patients with MAC lung disease, among other things; development of unexpected safety or efficacy concerns related to our marketed products or our product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected; failure to successfully predict the time and cost of development, regulatory approval and commercialization for novel gene therapy products; risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed, or that blinded data will not be predictive of unblinded data; risk that our competitors may obtain orphan drug exclusivity for a product that is essentially the same as a product we are developing for a particular indication; our inability to attract and retain key personnel or to effectively manage our growth; our inability to successfully integrate our acquisitions and appropriately manage the amount of management’s time and attention devoted to integration activities; risks that our acquired technologies, products and product candidates will not be commercially successful; inability to adapt to our highly competitive and changing environment; inability to access, upgrade or expand our technology systems or difficulties in updating our existing technology or developing or implementing new technology; risk that we are unable to maintain our significant customers; risk that healthcare legislation or other government action materially adversely affects our business; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; risk that our current and potential future use of AI and machine learning may not be successful; deterioration in general economic conditions in the U.S., Europe, Japan and globally, including the effect of prolonged periods of inflation, affecting us, our suppliers, third-party service providers and potential partners; risk that we could become involved in costly intellectual property disputes, be unable to adequately protect our intellectual property rights or prevent disclosure of our trade secrets and other proprietary information, and incur costs associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on us by agreements related to our marketed products or our product candidates, including our license agreements with PARI and AstraZeneca AB, and failure to comply with our obligations under such agreements; the cost and potential reputational damage resulting from litigation to which we are or may become a party, including product liability claims; risk that our operations are subject to a material disruption in the event of a cybersecurity attack or issue; changes in laws and regulations applicable to our business, including any pricing reform and laws that impact our ability to utilize certain third parties in the research, development or manufacture of our product candidates, and failure to comply with such laws and regulations; our history of operating losses, and the possibility that we never achieve or maintain profitability; goodwill impairment charges affecting our results of operations and financial condition; inability to repay our existing indebtedness and uncertainties with respect to our ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans.  Additional Disclaimers: Please be aware that TPIP, brensocatib in HS, INS1201, INS1202, INS1148, and INS1033 are investigational products that have not been approved for sale or found safe or effective by the FDA or any regulatory authority. In addition, ARIKAYCE has not been approved for the treatment of all patients with MAC lung disease and brensocatib has not been approved for the treatment of patients with non-cystic fibrosis bronchiectasis outside the U.S. and the E.U. This presentation is not promotion or advertisement of ARIKAYCE, BRINSUPRI, TPIP, brensocatib in HS, INS1201, INS1202, INS1148, or INS1033. Insmed, ARIKAYCE and BRINSUPRI are registered trademarks of Insmed Incorporated. All other trademarks are property of their respective owner(s).   HS: Hidradenitis Suppurativa | TPIP: Treprostinil Palmitil Inhalation Powder | MAC / MAC LD: Mycobacterium avium complex lung disease | FDA: Food & Drug Administration  

 Opening Remarks  Commercial Updates  TPIP Updates  Financial Results  5-6  8-13  15-16  19-21  Will Lewis  Chair & CEO  Sara Bonstein  Chief Financial Officer 

 Opening Remarks  Will Lewis | Chair & CEO 

 2025 Set the Commercial and Clinical Foundation Upon Which 2026 is Expected to Accelerate  2025 Accomplishments  Commercial  Clinical  FDA Approval of BRINSUPRI®  U.S. BRINSUPRI Launch  Double-Digit Global ARIKAYCE® Growth  Positive Ph2 TPIP Data in PAH  GTx for DMD & ALS Entered Clinic  Acquired Ph2-Ready INS1148  2026 Priorities  Accelerate & Expand   U.S. BRINSUPRI Launch  Deliver Continued ARIKAYCE Growth  Invest in First- or Best-in-Class Therapies  Expand Pipeline via BD  FDA: Food and Drug Administration | U.S.: United States | Ph: Phase | GTx: Gene Therapies | DMD: Duchenne muscular dystrophy | ALS: amyotrophic lateral sclerosis | BD: business development 

 Anticipate Full-Year Total Company Revenues to More Than Double in 20261  At Least   $1 Billion  Full-Year 2026 Guidance  $450 to $470  Million  Full-Year 2026 Guidance  1 2026 revenue guidance for BRINSUPRI and ARIKAYCE as of February 2026 implies full-year company-wide revenues of at least $1.45B, which would represent an increase of ~139% versus full-year 2025 company-wide revenues of $606.4M | BD: business development  Confident that cash flow positivity can be achieved without raising capital   May raise capital to support BD or other value-creating initiatives 

 Commercial Updates  Will Lewis | Chair & CEO 

 Launch Trajectory Remains Encouraging Following Strong First Full Quarter Performance  U.S. Net Revenues1  ~$144.6M  Q4 20251  1 Unaudited revenues for three months ended December 31, 2025 | M: million  Revenue performance surpassed high bar set by comparable respiratory launches  Commercial team continues to execute at a very high level  BRINSUPRI on track to become one of the most successful specialty respiratory launches ever 

 DIAGNOSED NCFB PATIENTS   ON U.S. LABEL FOR BRINSUPRI (500K)  250K (2+ PE)  250K (<2 PE)  Initial U.S. TAM  $5B+ Peak Sales  Multiple Opportunities to Potentially Expand Initial U.S. TAM  1 Flume PA, et al. ERJ Open Res. 2023;9(4):00021-2023. | 2 COPD & asthma patients with comorbid NCFB not currently counted in the 500K diagnosed NCFB U.S. population | NCFB: non-cystic fibrosis bronchiectasis | PE: pulmonary exacerbations in prior 12-month period | COPD: chronic obstructive pulmonary disease | U.S.: United States | TAM: total addressable market | K: thousand | M: million | B: billion | Note: References related to patient TAMs can be found in the Company's Investor Presentation.   Outside Currently Diagnosed Population  Comorbid undiagnosed NCFB patients2 could contribute substantial upside if diagnosed  Efforts underway to quantify undiagnosed opportunity and encourage assessment of potential NCFB  Within Currently Diagnosed Population  2-year study suggests ~9% conversion rate from <2 PE to 2+ PE category in 2nd year1  Any conversion would represent upside to potential $5B+ peak sales  Expansion Drivers:  COPD OR ASTHMA PATIENTS (U.S.)  32M   POTENTIAL NCFB PATIENTS  IF DIAGNOSED 

 Positive Launch Feedback Positions BRINSUPRI for Broader Adoption Over Time  Physician Behavior  What We’re Seeing  Potential Impact  Potential for increased NCFB screening of exacerbating COPD & asthma patients  Expansion  Potential signals of increased diagnoses expected 2027+  Monitoring for signs of diagnosis expansion over time  Positive feedback from early patients could deepen Rx tendencies  Adoption  Positive feedback from early physicians & patients  Positive experiences could drive increased Rx  Broad physician base Rx to limited patients given new mechanism  Exploration  Nearly half of cumulative prescribers have only written one script1  Positive feedback expected to influence willingness to Rx more broadly  Today  Next Several Quarters  Future  1 ~4,000 cumulative prescribers as of December 31, 2025 | Rx: prescribe / prescribing | NCFB: non-cystic fibrosis bronchiectasis | Q: quarter | COPD: chronic obstructive pulmonary disease  

 Early Payor Contracting Success Supports Access for a Majority of BRINSUPRI Patients  Aligned with   pre-launch expectations  Among payors requiring additional documentation  Offered to payors accepting simple authorization criteria  Have access to reimbursement for BRINSUPRI1  >90%  Targeted Patient Lives  Modest Rebates  High   Approval  Rate  Broad Access  1 Either through documented payor policy or medical exception  

 BRINSUPRI Positioned to Maximize its Commercial Potential   v  Strong Commercial Conviction  Manageable market access dynamics  Expect at least $1B in revenues in 2026  Clear path to achieving peak sales goal of $5B+  v  Opportunity to   Expand TAM  Potential to unlock upside in COPD & asthma populations  Intend to resource the launch to maximize adjacent patient opportunities  1 Launch metrics as of December 31, 2025 | B: billion | COPD: chronic obstructive pulmonary disease | TAM: total addressable market 

 ARIKAYCE Demonstrates Continued Strength  1 Growth is vs. same prior year period | GTN: Gross-to-Net | U.S.: United States | Int’l: International | M: Million | * If expanded label for ARIKAYCE is approved | † Total addressable Refractory MAC patients in the U.S., Europe (France, Germany, Italy, Spain, and United Kingdom), and Japan | ‡ Additional addressable MAC patients in the U.S. and Japan if expanded ARIKAYCE label is approved | MAC / MAC LD: Mycobacterium avium complex lung disease | TAM: total addressable market |   Note: References related to patient TAMs can be found in the Company's Investor Presentation.   U.S.  $280.3M  +10.0%  GTN: ~20%  Int’l  $153.5M   +40.9%  FY 20251  ENCORE  Topline readout expected March/April   Potential Label Expansion*  Current TAM 30K† (Refractory MAC)  ~+200K‡ Additional Patients* (All MAC LD)  Worldwide  $433.8M  +19.3% 

 TPIP Updates  TPIP: Treprostinil Palmitil Inhalation Powder  Will Lewis | Chair & CEO 

 FDA Grants Treprostinil Palmitil Orphan Drug Designation  Potential   Clinical Superiority  Major Contribution   to Patient Care  Once-daily therapy with:  continuity of parenteral treatment  localization of inhaled therapy  TPIP Profile  Efficacy  Placebo-Adjusted Improvement in 6MWD † at Week 161  * Nominally statistically   significant in Phase 2  +35.5  meters  *  vs. same drugs already   approved for PAH  PAH: pulmonary arterial hypertension | FDA: Food and Drug Administration | TPIP: Treprostinil Palmitil Inhalation Powder | * Nominal p-value not adjusted for multiplicity | † Covariate-adjusted estimate of location shift. Analysis performed using a rank ANCOVA model, adjusting for treatment group, baseline 6-minute walk distance (6MWD), and randomization stratification factors | 1 Measured ~24 hours after dose  

 Change in baseline exercise capacity (6MWD) at peak exposure (1-3 hours post-dose)   Proportion of patients with baseline WHO FC improvement   Change in baseline 6MWD at trough exposure (pre-dose) at Week 22  Change in baseline cardiac stress (NT-proBNP concentration)  Change in baseline PAH-SYMPACT domain scores  Time to clinical worsening2  PALM-PAH (Week 24)  Change from baseline in Quality of Life (QoL)  Plasma concentrations of TP and treprostinil over time  Safety & tolerability3  Primary Endpoint   Secondary Endpoints  Exploratory Endpoints  1 Participants enrolled in the OLE study will remain on-treatment until Week 104, followed by a 4-week follow-up | 2 Clinical worsening is defined as one of the following: (1) death from any cause,(2) hospitalization for worsening of PAH (≥24 hours), (3) need for atrial septostomy, (4) worsening-related listing for lung and/or heart-lung transplant, (5) need to initiate parenteral therapy with an approved PAH therapy, or (6) deterioration of PAH (defined as a combination of the following changes from baseline: a decrease in 6MWD of ≥15%, confirmed by 2 tests ≥4 hours but not >2 weeks apart, and signs/symptoms of worsened right heart failure or worsened WHO/NYHA FC). All events will be adjudicated by an independent blinded committee. | 3 including AEs, laboratory assessments, vital signs, and 12-lead electrocardiogram | TPIP: Treprostinil Palmitil Inhalation Powder | TP: treprostinil palmitil | PAH: pulmonary arterial hypertension | 6MWD: 6-minute walk distance | OLE: open label extension | NT-proBNP: N-terminal pro b-type natriuretic peptide; a biomarker of cardiac | WHO: World Health Organization | NYHA: New York Heart Association | FC: functional class  4 weeks  TPIP 80-1,280 µg  inhalation capsules once daily   Placebo  inhalation capsules once daily   Screening  Treatment period  24 weeks  Baseline  End of Study  30 days  Follow-up  For participants that have not entered the OLE study1  Expect ~344 patients randomized  Steady-state   period  4-week initial titration to the individual max tolerated dose  active : placebo  1:1  End of Treatment  Primary Analysis  Dose increases allowed up to Week 16  Participants on background sotatercept capped at ~20% of sample size (stratification factor)  Phase 3 PAH Trial Designed to Further Evaluate the Efficacy & Tolerability of Once-Daily TPIP  Measured at Week 24 unless otherwise specified 

 Let’s Recap  BRINSUPRI launch on track and supports 2026 revenue guidance of at least $1B  Robust pipeline of first- or best-in-class* clinical programs poised to contribute catalysts over the next several years  Treprostinil palmitil received ODD in PAH; FDA has indicated a single Phase 3 TPIP trial would be sufficient to file, if successful  PAH: pulmonary arterial hypertension | FDA: Food and Drug Administration | ODD: Orphan Drug Designation | TPIP: Treprostinil Palmitil Inhalation Powder | B: billion  * “Best-in-disease/best-in-class" indicates a profile that could be considered more attractive than other treatment options for a particular disease. Head-to-head clinical trials are not anticipated.  

 Financial Results  Sara Bonstein | Chief Financial Officer 

 Modest Gross-to-Net Impact Positions Commercial Products For Success In 2026  Revenue  At Least   $1B  $450M to   $470M  Gross-to-Net  Mid-20%s to   Low-30%s  Low-20%s to   Mid-20%s  B: billions | M: millions  G U I D A N C E  G U I D A N C E  Full-Year 2026 

 Strong Capital Position to Support Upcoming Catalysts  1 Cash burn excludes cash received from option exercises as well as ~$70M in non-recurring items attributed to the acquisition of asset INS1148 and a milestone payment to AstraZeneca related to BRINSUPRI’s U.S. approval | 2 Cash burn does not reflect full benefit of BRINSUPRI sales given timing of quarter close | 3 Pending regulatory approvals and the success of current clinical programs | † Unaudited cash, cash equivalents, and marketable securities position as of December 31, 2025 | BD: business development | U.S.: United States  ~$1.4B  December 31, 2025†  In Cash, Cash Equivalents,   and Marketable Securities   Underlying cash burn1 was similar to prior quarter  Only a portion of BRINSUPRI revenues were received in cash as of quarter close2  Expect spending to increase alongside revenue as we resource launches and clinical programs3  Confident cash flow positivity can be achieved without additional capital   May raise capital to support BD or other value-creating initiatives 

 Advancing Commercial and Clinical Programs Through Investment  Three Months Ended1  12/31/2025  12/31/2024  Total Revenues  $263.8  $104.4  Cost of Product Revenues2   As a % of Revenues  (44.2)  16.8%  (26.2)  25.0%  R&D  (254.9)  (179.7)  SG&A  (212.5)  (142.5)  Other†  (72.0)  13.5  Total Operating Expenses  $(583.6)  $(334.9)  Operating Loss  $(319.7)  $(230.4)  Costs2 as % of sales decreased y/y, reflecting BRINSUPRI contribution  R&D and SG&A increased y/y reflecting investments in growth:  U.S. BRINSUPRI launch  Clinical pipeline development  1 Unaudited | 2 Excludes amortization of intangible assets; also referred to as “costs” | † Includes amortization of intangible assets and change in fair value of deferred and contingent consideration liabilities | R&D: research and development | SG&A: selling, general, and administrative expenses | y/y: year-over-year | U.S.: United States  (in $ millions, except for percentages) 

 Closing Remarks  Entering 2026 with a strong financial position, enabling the pursuit of our ambitious goals  Committed to utilizing our resources to pursue value-creating opportunities  Capacity to continue to invest in our commercial portfolio and clinical pipeline to enhance our impact on patients 

 Q&A Session  Will Lewis  Chair & CEO  Sara Bonstein  Chief Financial Officer  Martina Flammer  Chief Medical Officer 

FAQ

How did Insmed (INSM) perform financially in full-year 2025?

Insmed reported strong 2025 revenue growth to $606.4 million, up from $363.7 million. The increase was driven by the BRINSUPRI launch and higher ARIKAYCE sales, but the company still posted a net loss of $1.28 billion due to elevated operating expenses.

What were Insmed’s key product revenues for BRINSUPRI and ARIKAYCE in 2025?

In 2025, BRINSUPRI generated $172.7 million in revenue, including $144.6 million in the fourth quarter. ARIKAYCE delivered $433.8 million for the year and $119.2 million in Q4, representing 19% annual growth across all commercial regions.

What revenue guidance did Insmed (INSM) provide for 2026?

Insmed expects full-year 2026 BRINSUPRI revenue of at least $1 billion and ARIKAYCE revenue of $450–$470 million. Combined, this implies company-wide revenue of at least $1.45 billion, more than double the 2025 total of $606.4 million.

What is Insmed’s cash position and balance sheet strength at year-end 2025?

Insmed ended 2025 with approximately $1.4 billion in cash, cash equivalents, and marketable securities. The consolidated balance sheet showed total assets of $2.26 billion and shareholders’ equity of $739.0 million, supporting ongoing commercialization and clinical development plans.

Did Insmed announce any significant pipeline or regulatory milestones in this update?

Yes. Insmed highlighted that the FDA granted Orphan Drug Designation to treprostinil palmitil inhalation powder (TPIP) for pulmonary arterial hypertension. The company also noted that topline data readouts from the Phase 3 ENCORE and Phase 2b CEDAR studies remain on track.

What board or leadership changes did Insmed (INSM) disclose?

Insmed disclosed that David W.J. McGirr, a Class II director and Audit Committee chair, will not stand for re-election at the 2026 Annual Meeting of Shareholders. He will continue serving on the board and as Audit Committee chair until the meeting.

Is Insmed profitable, and how large are its operating expenses?

Insmed is not yet profitable. In 2025, it reported a net loss of $1.28 billion and total operating expenses of $1.85 billion, including substantial research and development and selling, general, and administrative spending to support its growing portfolio.

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