# EDGAR Filing Document

**Accession Number:** 0001104506
**File Stem:** 0001140361-26-000778
**Filing Date:** 2026-1
**Character Count:** 68992
**Document Hash:** 285acb5b468483c1e1bae342e9a1dedb
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001140361-26-000778.hdr.sgml**: 20260109

**ACCESSION NUMBER**: 0001140361-26-000778

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 39

**CONFORMED PERIOD OF REPORT**: 20260109

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260109

**DATE AS OF CHANGE**: 20260109

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** INSMED Inc
- **CENTRAL INDEX KEY:** 0001104506
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 541972729
- **STATE OF INCORPORATION:** VA
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 000-30739
- **FILM NUMBER:** 26521333

**BUSINESS ADDRESS:**
- **STREET 1:** 700 US HIGHWAY 202/206
- **CITY:** BRIDGEWATER
- **STATE:** NJ
- **ZIP:** 08807
- **BUSINESS PHONE:** 908-977-9900

**MAIL ADDRESS:**
- **STREET 1:** 700 US HIGHWAY 202/206
- **CITY:** BRIDGEWATER
- **STATE:** NJ
- **ZIP:** 08807

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** INSMED INC
- **DATE OF NAME CHANGE:** 20000128

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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): January 9, 2026

## INSMED INCORPORATED
*(Exact name of registrant as specified in its charter)*

---

| | | |
|:---|:---|:---|
| **Virginia**<br>| **000-30739**<br>| **54-1972729**<br>|
| *(State or other jurisdiction of incorporation)* | *(Commission File Number)* | *(IRS Employer Identification No.)* |

---

---

| | |
|:---|:---|
| **700 US Highway 202/206**<br>**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**<br> **registered** |
| Common Stock, par value $0.01 per share<br>| INSM<br>| Nasdaq Global Select Market<br>|

---

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. ☐

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| | |
|:---|:---|
| **ITEM 7.01 —** | **Regulation FD Disclosure.** |

---

As previously announced, management of Insmed Incorporated (the "Company") will present at the 44<sup>th</sup> Annual J.P. Morgan Healthcare Conference on January 12, 2026, at 3:00 p.m. Pacific Time (6:00 p.m. Eastern Time). A live webcast of the presentation will be accessible through the investor relations section of the Company's website. On January 9, 2026, in connection with the presentation, the Company issued a press release, a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference. The slide presentation to be used during the presentation is attached hereto as Exhibit 99.2 and incorporated herein by reference.

The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act"), as amended, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

---

| | |
|:---|:---|
| **ITEM 9.01 –** | **Financial Statements and Exhibits.** |

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&nbsp;&nbsp;&nbsp;&nbsp;(d) Exhibits

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| [99.1](ef20062540_ex99-1.htm) | Press release issued by Insmed Incorporated on January 9, 2026. |
| [99.2](ef20062540_ex99-2.htm) | Insmed Incorporated J.P. Morgan Healthcare Conference Presentation. |
| 104 | Cover Page Interactive Date File (embedded within the Inline XBRL document). |

---

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#### 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.

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| | | |
|:---|:---|:---|
| Dated: January 9, 2026 | INSMED INCORPORATED | INSMED INCORPORATED |
|  | By: | /s/ Michael A. Smith |
|  | Name: | Michael A. Smith |
|  | Title: | Chief Legal Officer and Corporate Secretary |

---

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## Exhibit 99.1

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**Exhibit 99.1**<br>

![](image00001.jpg)

#### Insmed Provides Business Update at 44th Annual J.P. Morgan Healthcare Conference

*— BRINSUPRI*<sup>®</sup> *(brensocatib) Unaudited Total Revenues of Approximately $144.6 Million for First Full Quarter of Launch; Approximately $172.7 Million for Full-Year 2025—*

*—ARIKAYCE<sup>®</sup> (amikacin liposome inhalation suspension) Exceeds the Upper End of Guidance Range for Full-Year 2025 with Unaudited Global Revenues of Approximately $433.8 Million—*

*—Full-Year 2026 Global ARIKAYCE Revenues Expected to be Between $450 Million and $470 Million—*

*—Topline Data from Phase 3 ENCORE Study of ARIKAYCE in Patients with Newly Diagnosed or Recurrent MAC Lung Disease Now Anticipated in March or April of 2026—*

*— Topline Data from Phase 2b CEDAR Study of Brensocatib in Patients with HS Now Anticipated in the Second Quarter of 2026—*

*— Phase 3 PALM-ILD Study of TPIP in PH-ILD Initiated in the Fourth Quarter of 2025; Additional Phase 3 Studies Planned for PAH, PPF, and IPF in 2026—*

BRIDGEWATER, N.J., January 9, 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 provided an update on the Company's commercial and clinical programs and its outlook for 2026. These updates will be discussed as part of the Company's presentation at the 44<sup>th</sup> Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 12, 2026, at 3:00 p.m. PT (6:00 p.m. ET).

"2025 was a landmark year for the patients we serve, our company, and our people, during which we demonstrated what's possible when breakthrough science meets steadfast execution. Our strong BRINSUPRI launch and encouraging TPIP readout in PAH reinforced both the clinical potential of our growing portfolio and the remarkable discipline of our teams," said Will Lewis, Chair and Chief Executive Officer of Insmed. "As monumental as this past year was, the road ahead is poised to be even more exciting. With numerous upcoming clinical and commercial catalysts across our designated therapeutic areas *—* Respiratory, Immunology & Inflammation, and Neuro & Other Rare *—* we believe that the next 18 months could accelerate our trajectory even further and bring us closer to helping more patients living with serious diseases."

#### Preliminary Full-Year 2025 Global Net Product Revenues (Unaudited)

The following table summarizes Insmed's preliminary unaudited financial revenues expected for full-year 2025 and revenue growth across all commercial regions:

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---

| |
|:---|
| **INSMED INCORPORATED** |
| **Revenue by Region** |
| **(in millions)** |

---

---

| | | | |
|:---|:---|:---|:---|
| ***Preliminary Full-Year 2025 (Unaudited) and 2024 Net Product Revenues by Region*** | ***Preliminary Full-Year 2025 (Unaudited) and 2024 Net Product Revenues by Region*** | ***Preliminary Full-Year 2025 (Unaudited) and 2024 Net Product Revenues by Region*** | ***Preliminary Full-Year 2025 (Unaudited) and 2024 Net Product Revenues by Region*** |
| &nbsp;&nbsp;&nbsp; *(in millions)* | **2025** | **2024** | **Growth** |
| **ARIKAYCE** |  |  |  |
| &nbsp;&nbsp;&nbsp; U.S. | $280.3 | $254.8 | 10% |
| &nbsp;&nbsp;&nbsp; International | 153.5 | 108.9 | 41% |
| &nbsp;&nbsp;&nbsp; Total | $433.8 | $363.7 | 19% |
| **BRINSUPRI** |  |  |  |
| &nbsp;&nbsp;&nbsp; U.S. | $172.7 | $- | N/A |
| &nbsp;&nbsp;&nbsp; International | - | - | N/A |
| &nbsp;&nbsp;&nbsp; Total | $172.7 | $- | N/A |
| **Total Revenues** |  |  |  |
| &nbsp;&nbsp;&nbsp; U.S. | $453.0 | $254.8 | 78% |
| &nbsp;&nbsp;&nbsp; International | 153.5 | 108.9 | 41% |
| &nbsp;&nbsp;&nbsp; Total | $606.4 | $363.7 | 67% |

---

These preliminary unaudited results are subject to adjustment. Insmed will report its final and complete fourth-quarter and full-year 2025 financial results in February 2026. The actual results could be materially different from these preliminary unaudited financial results.

As of year-end 2025, approximately 4,000 medical professionals had prescribed BRINSUPRI, with approximately 9,000 new patients starting therapy during the fourth quarter of 2025 alone.

#### Progress and Anticipated Milestones by Therapeutic Area:

#### Respiratory

<br> BRINSUPRI

• 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 plans to launch BRINSUPRI in the European Union (EU) in the first half of 2026.

<br> • Insmed anticipates commercial launches in the United Kingdom and Japan in 2026, pending approval in each territory.

<br> ARIKAYCE

• Insmed anticipates 2026 global ARIKAYCE revenues to be between $450 million and $470 million.

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

<br> • Pending successful results 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 U.S. in the second half of 2026.

<br> TPIP

<br> • Insmed initiated PALM-ILD, a Phase 3 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), in the fourth quarter of 2025.

<br> • Insmed plans to initiate a Phase 3 study of TPIP in patients with pulmonary arterial hypertension (PAH) in early 2026.

<br> • 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.

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

<br> INS1148

• In December 2025, Insmed acquired INS1148, a Phase 2-ready monoclonal antibody targeting a specific isoform of Stem Cell Factor 248 (SCF248). The Company plans to advance Phase 2 development programs for INS1148 initially in interstitial lung disease and moderate-to-severe asthma.

#### Immunology and Inflammation

<br> Brensocatib

<br> • 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

<br> • 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 IND filing expected in 2026.

#### <br>

#### Neuro & Other Rare

INS1201

<br> • Insmed is currently enrolling cohorts 2 and 3 in the Phase 1 ASCEND clinical study of INS1201, an intrathecally-delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).

INS1202

<br> • In December 2025, the Company opened the first clinical site for the Phase 1 ARMOR study of INS1202, an intrathecally-delivered gene therapy for patients with Amyotrophic Lateral Sclerosis (ALS).

INS1203

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

#### Pre-Clinical Programs

<br> • Insmed's research efforts include more than 30 identified pre-clinical programs in development, all of which have the potential to become first-in-class or best-in-class therapies for the indications being pursued.

<br> • 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.

#### Presentation at the 44<sup>th</sup> Annual J.P. Morgan Healthcare Conference

Will Lewis, Chair and Chief Executive Officer of Insmed, will present at the 44<sup>th</sup> Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026, at 3:00 p.m. PT (6:00 p.m. ET). A live audio webcast of the presentation will be available on the Investor Relations section of the Company's website at <u>www.insmed.com.</u> A replay will also be archived for a period of 30 days following the conclusion of the live event.

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**About ARIKAYCE** 

ARIKAYCE<sup>®</sup> 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**<sup>®</sup> **Nebulizer System**

ARIKAYCE is delivered by a novel inhalation device, the Lamira<sup>®</sup> Nebulizer System, developed by PARI. Lamira<sup>®</sup> 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<sup>®</sup> (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.

#### 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 has the potential to preferentially target a specific isoform of Stem Cell Factor 248 (SCF248), which prevents only the inflammatory cascade downstream of c-Kit signaling, while leaving its critical homeostatic and tissue healing pathways intact. INS1148 is an investigational drug product that has not been approved for any indication in any jurisdiction.

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#### About INS1201

INS1201 is an investigational micro-dystrophin adeno-associated virus gene replacement 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 at lower doses. INS1201 is an investigational drug product that has not been approved for any indication in any jurisdiction.

#### About INS1202

INS1202 is an investigational micro-dystrophin adeno-associated virus gene replacement therapy that Insmed is developing as a potential treatment for patients with Amyotrophic lateral sclerosis (ALS). Administered intrathecally, this approach has the potential to target both skeletal and cardiac muscles at lower doses. 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.** <br>

&nbsp;&nbsp;&nbsp; **WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS**<br>**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.** <br>

**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.

**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.

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**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.

**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.

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**U.S. INDICATION** 

LIMITED POPULATION: ARIKAYCE<sup>®</sup> 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 <u>**www.fda.gov/medwatch**</u>, or call 1-800-FDA-1088. You can also call the Company at 1-844-4-INSMED.

**<br> Please see** <u>**Full Prescribing Information**</u>**.** 

#### BRINSUPRI<sup>®</sup> (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.

#### Important Safety Information in the U.S.

**WARNINGS AND PRECAUTIONS**<br> **Dermatologic Adverse Reactions**<br> 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**<br> 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.

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**Live Attenuated Vaccines**<br> 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**<br> 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*<br> 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*<br> 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*<br> 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**<br> **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.

#### 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.

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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 <u>**www.insmed.com**</u> to learn more or follow us on <u>**LinkedIn**</u>, <u>**Instagram**</u>, <u>**YouTube**</u>, and <u>**X**</u>.

#### 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.

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 the U.S., Europe or Japan, including separate regulatory approval for Lamira<sup>®</sup> in each market and for each usage, or for brensocatib in NCFB in the U.K. or Japan; 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; the 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 government healthcare legislation or other government action materially increases our costs and damages our financial condition; 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; the 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, 2024 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.

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#### Contact:

Investors:

Bryan Dunn

Vice President, Investor Relations

(646) 812-4030

<u>investor.relations@insmed.com</u>

Media:

Claire Mulhearn

Vice President, Corporate Communications

(862) 842-6819

<u>media@insmed.com</u>

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## Exhibit 99.2

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**Exhibit 99.2**<br>

![](ef20062540_ex99-2slide1.jpg)

January 12, 2026 J.P. Morgan Healthcare Conference Presentation

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![](ef20062540_ex99-2slide2.jpg)

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 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 the U.S., Europe or Japan, including separate regulatory approval for Lamira® in each market and for each usage, or for brensocatib in NCFB in the U.K. or Japan; 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; the 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 government healthcare legislation or other government action materially increases our costs and damages our financial condition; 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; the 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 brensocatib in HS, TPIP, 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, brensocatib in HS, TPIP, 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

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![](ef20062540_ex99-2slide3.jpg)

Patient Minute

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![](ef20062540_ex99-2slide4.jpg)

Three Therapeutic Areas, One Goal: Develop First- and Best-in-Class\* Therapies TPIP: Treprostinil Palmitil Inhalation Powder \| PAH: pulmonary arterial hypertension \| PH-ILD: pulmonary hypertension due to interstitial lung disease \| PPF: Progressive pulmonary fibrosis \| IPF: Idiopathic pulmonary fibrosis \| COPD: Chronic obstructive pulmonary disease \| SCF248: stem cell factor 248 \| SCF248 mAb: stem cell factor 248 monoclonal antibody \| ILD: interstitial lung disease \| HS: hidradenitis suppurativa \| DPP1: dipeptidyl peptidase 1 inhibitor \| Next-Gen: next generation \| RA: Rheumatoid arthritis \| IBD: Inflammatory bowel disease \| IgG: Immunoglobulin G \| GTx: Gene Therapy \| DMD: Duchenne muscular dystrophy \| ALS: amyotrophic lateral sclerosis \| ASO: Antisense Oligonucleotide \| AT: Ataxia Telangiectasia \| AOA1: Ataxia with Oculomotor Apraxia Type 1 \| MoA: Mechanism of Action \| \* "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. Respiratory Immunology & Inflammation Neuro & Other Rare Research & Business Development BRINSUPRI® ARIKAYCE® TPIP: PAH & PH-ILD TPIP: PPF & IPF DPP1: Other INS1148 (SCF248 mAb): ILD & Asthma INS1202 (GTx): ALS INS1203 (GTx): Stargardt Synthetic Rescue (ASO): AT Other Rare Diseases INS1201 (GTx): DMD Synthetic Rescue (ASO): AOA1 Brensocatib: HS INS1033 (DPP1): RA & IBD Novel MoA Next-Gen Uricase: Gout IgG Protease INS1148 (SCF248 mAb): Other

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![](ef20062540_ex99-2slide5.jpg)

Next 18+ Months Poised to Deliver Multiple Commercial and Clinical Catalysts \* Pending regulatory approval in the United Kingdom (UK) and Japan \| \*\* Pending regulatory approval \| Initiation indicates that trial sites are open and ready to screen participants for enrollment \| TPIP: Treprostinil Palmitil Inhalation Powder \| PAH: pulmonary arterial hypertension \| PPF: Progressive pulmonary fibrosis \| IPF: Idiopathic pulmonary fibrosis \| I&I: Immunology & Inflammation \| RA: Rheumatoid arthritis \| I&I: Immunology & Inflammation \| IBD: Inflammatory bowel disease \| ILD: interstitial lung disease \| DMD: Duchenne muscular dystrophy \| ALS: Amyotrophic lateral sclerosis \| OLE: open label extension …Prior 18+ Months Next 18+ Months… TODAY Commercial Catalysts Clinical Catalysts U.S. Launch EU & UK Launch\* Label Expansion\*\* Ph3 ENCORE Readout Ph3 PALM-ILD Initiation Ph3 PALM-PPF Initiation Ph3 PALM-IPF Initiation Ph2 PAH OLE Updates Ph2 ILD Initiation Ph2 Asthma Initiation Respiratory Japan Launch\* Ph2 PH-ILD Readout Ph3 ASPEN Readout Ph2 PAH Readout Ph3 PALM-ILD Initiated DMD IND Filed ALS IND Filed INS1148 Acquired Immunology & Inflammation Ph2 CEDAR Readout IBD IND Filing RA IND Filing Neuro & Other Rare Stargardt IND Filing Ph1 ASCEND Updates (DMD) Ph1 ARMOR Updates (ALS) Ph1 Stargardt Updates Business Development

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![](ef20062540_ex99-2slide6.jpg)

Potential Value Drivers BRINSUPRI launch execution ARIKAYCE: ENCORE readout & label expansion\* CEDAR readout TPIP: Phase 2 PAH OLE data update INS1148: Phase 2 ILD & Asthma trial initiations Multiple Phase 3 trial initiations ~1-2 INDs filed per year Continued R&D and BD activity Potential Future Value Creation Driven by Commercial & Clinical Execution 2 April 2024: Represents the approximate average market cap of the 6 weeks preceding the ASPEN readout \| May 31, 2024: Ph3 ASPEN data on brensocatib in non-cystic fibrosis bronchiectasis (NCFB) were released \| June 10, 2025: Ph2 data on treprostinil palmitil inhalation powder (TPIP) in pulmonary arterial hypertension (PAH) were released \| August 12, 2025: BRINSUPRI received FDA approval for the treatment of diagnosed NCFB patients 12 years and older 1 Market capitalization/cap: number of shares outstanding multiplied by share close price. Approximate incremental market cap considers the average market cap increase for the period of weeks after which an event significantly impacted the stock price \| 2 December 31, 2025 \| \* Pending regulatory approval \| Ph: Phase \| OLE: open label extension \| ILD: interstitial lung disease \| IND: investigational new drug application \| R&D: Research & Development \| BD: Business Development Market Cap1 APR-24 MAY-24 JUN-25 AUG-25 DEC:252 ASPEN Ph2 PAH ~$37B ~$4B U.S. BRINSUPRI APPROVAL Key Events2

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![](ef20062540_ex99-2slide7.jpg)

Respiratory T H E R A P E U T I C A R E A

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![](ef20062540_ex99-2slide8.jpg)

BRINSUPRI Demonstrates Continued Strength in First Full-Quarter of Revenue Preliminary Unaudited U.S. Net Revenues1 ~$144.6M Q4 2025 FY 2025 ~$172.7M New Patient Starts Cumulative Prescribers2 ~4,000 up from ~1,700 prescribers as of 9/30/2025 as of 12/31/2025 Q3:25 ~2,550 (Partial Quarter) ~9,000 Q4:25 (Full Quarter) 1 Three months and year ended December 31, 2025. These preliminary unaudited results are subject to adjustment. The Company will report its final and complete fourth-quarter and full-year 2025 financial results in February 2026. The actual results could be materially different from these preliminary unaudited financial results \| 2 Defined as physicians that have written at least one script since launch. Additional physicians responsible for prescriptions placed directly by hospital pharmacies are not included in this metric \| FY: Full-Year \| Q: Quarter \| M: Million

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![](ef20062540_ex99-2slide9.jpg)

BRINSUPRI Results Are Promising but Do Not Reflect Final Contracting and Access Dynamics NCFB: non-cystic fibrosis bronchiectasis \| 1 Includes approvals by both Medicare and commercial payors \| Q: Quarter Access continues to be broad as only approved therapy for NCFB Vast majority of prescriptions have been approved for coverage1 Continue to engage with payors to establish frictionless access requirements Expect out-of-pocket reset dynamics in Q1:26 Expect rebating to increase and access criteria to be more strictly enforced as payor contracts are finalized in 2026 Inventory stocking accounted for ~9% of Q4 revenues Encouraging Signs Reasons for Caution

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![](ef20062540_ex99-2slide10.jpg)

ARIKAYCE Demonstrates Continued Strength 1 Growth is vs. same prior year period; These preliminary unaudited results are subject to adjustment. The Company will report its final and complete fourth-quarter and full-year 2025 financial results in February 2026. The actual results could be materially different from these preliminary unaudited financial results \| GTN: Gross-to-Net \| U.S.: United States \| Int'l: International \| E: Expected \| M: Million Strength in U.S. demonstrates commercial ability to execute across multiple products U.S. ~$280.3M ~+10.0% GTN: ~20% Int'l ~$153.5M ~+40.9% Worldwide ~$433.8M ~+19.3% FY 20251 $450 to $470M Full-Year 2026 ARIKAYCE Revenue Guidance FY 2026E Represents continued growth in eighth year on the market

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![](ef20062540_ex99-2slide25.jpg)

\* If expanded label for ARIKAYCE is approved \| 1 ARISE was a Phase 3 designed to help support the validation of a PRO tool to be used in ENCORE, the ongoing Phase 3b registrational study evaluating the efficacy and safety of an ARIKAYCE-based regimen in patients with newly diagnosed or recurrent MAC lung disease who have not received antibiotics for their current infection \| 2 Compared to the active control group \| 3 80% of patients in the ARIKAYCE arm achieved and maintained a negative sputum culture at Month 7 compared to 47% of patients in the control arm \| † 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 \| Ref: Refractory \| U.S.: United States \| H: half \| PRO: patient reported outcome \| TAM: total addressable market \| Note: References related to patient TAMs can be found in the Company's Investor Presentation. ENCORE: Topline Data Readout Expected March/April 2026 MAC LD Potential Label Expansion\* Current TAM 30K† (Ref MAC) ~+200K‡ Additional Patients\* (All MAC LD) Primary Endpoint U.S.: Change from baseline respiratory symptom score at Month 13 Japan: Proportion of patients achieving durable culture conversion at Month 15 ARIKAYCE patients showed faster, greater, and more durable culture conversion2 Highlighted benefit of earlier treatment3 Validated PRO tool Takeaways From ARISE1 11

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![](ef20062540_ex99-2slide12.jpg)

PALM-ILD: Initiated Dec:25 Primary Endpoint: Change in baseline 6MWD Key Secondary: 6MWD at trough1, NT-proBNP, PK Phase 3 initiation expected early 2026 Primary Endpoint: Change in baseline 6MWD Expect Phase 2 OLE updates 2H:26 Expect Phase 3 studies to initiate in 2H:26 Meeting and aligning with FDA in 1H:26 Increasing TPIP manufacturing to adequately resource these studies PH-ILD PAH PPF IPF TPIP: Designing and Conducting an Expansive Registrational Program 1 Secondary endpoint; placebo-adjusted metric measured pre-dose at Week 22 \| Initiation indicates that trial sites are open and ready to screen participants for enrollment \| alpha (α): significance level representing the probability of concluding a treatment is effective when it is not \| TPIP: Treprostinil Palmitil Inhalation Powder \| PH-ILD: pulmonary hypertension due to interstitial lung disease \| PAH: pulmonary arterial hypertension \| 6MWD: six-minute walk distance \| NT-proBNP: N-terminal pro b-type natriuretic peptide; a biomarker of cardiac stress \| PK: pharmacokinetics \| Dec: December \| OLE: open-label extension \| H: half \| YE: year-end

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![](ef20062540_ex99-2slide13.jpg)

INS1148: Potential First-in-Class Therapy for Respiratory and I&I Diseases \* Humanized monoclonal antibody \| 1 SCF is the only known ligand for the c-Kit receptor with 2 known splice variants: SCF220 and SCF248. SCF220 is ubiquitously expressed and exerts its biological function as a transmembrane dimer that binds to c-Kit to signal homeostatic & tissue healing pathways. \| 2 Promoting inflammation, tissue remodeling, and fibrosis \| SCF: stem cell factor \| I&I: immunology & inflammatory \| Eos: eosinophils \| ILC2: Group 2 innate lymphoid cells that produce different cytokines to direct immune responses \| mAb: monoclonal antibody \| c-Kit: critical receptor tyrosine kinase protein on cell surfaces; binding site to SCF to trigger growth signals \| ILD: interstitial lung disease \| IL: interleukin; cell signaling cytokines INS1148\* is designed to selectively target SCF248, a specific isoform of SCF and a c-Kit receptor ligand1 INS1148 has the potential to… Inhibit upstream SCF248/c-Kit signaling associated with inflammatory diseases Preserve homeostatic & tissue healing pathways associated with SCF2201 Plan to initiate Phase 2 programs in ILD and moderate-to-severe asthma Inflammatory Mediators SCF248/c-Kit Signaling Pathway Upstream Inflammatory SCF248 Signaling Secreted Cytokines2 (IL-4, IL-9, IL-13, IL-25, TGFβ, etc.) Immune Cells with SCF248 c-Kit Receptors (Mast Cells, ILC2, Eosinophils, etc.) When INS1148 is not present When INS1148 is present SCF248 Signaling Inhibited SCF220 Signaling Preserved1 Return to Quiescent Tissue INS1148 (Y) Selectively Binds SCF248 () Y Y Y Y Fibroblasts (Nearby Quiescent Tissue) Myofibroblasts Expressing SCF248 ()

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![](ef20062540_ex99-2slide14.jpg)

Respiratory Therapeutic Area Portfolio & Pipeline \* Brensocatib remains under review by regulatory authorities in the UK and Japan (approved in the U.S. and EU) \| \*\* moderate-to-severe asthma \| Bronchiectasis: non-cystic fibrosis bronchiectasis \| Initiation indicates that trial sites are open and ready to screen participants for enrollment \| MAC: Mycobacterium avium complex lung disease \| TPIP: Treprostinil Palmitil Inhalation Powder \| PH-ILD: pulmonary hypertension due to interstitial lung disease \| PAH: pulmonary arterial hypertension \| PPF: progressive pulmonary fibrosis \| IPF: idiopathic pulmonary fibrosis \| ILD: interstitial lung disease \| DPP1: dipeptidyl peptidase 1 inhibitor \| Next-Gen: next-generation \| U.S.: United States \| UK: United Kingdom \| EU: European Union \| H: Half \| Ph: Phase Anticipated Catalysts \| ENCORE Ph3 readout \| PALM-PAH Ph3 trial initiation 1H:26 \| BRINSUPRI EU launch\* 2H:26 \| PALM-PPF Ph3 trial initiation 2H:26 \| PALM-IPF Ph3 trial initiation 2H:26 \| BRINSUPRI UK & Japan launch\* '26/'27 \| ILD & Asthma Ph2 trial initiations Mar/Apr 2026 BRINSUPRI® (brensocatib) Bronchiectasis\* Pre-Clinical Ph1 Ph2 Ph 3 Commercial DPP1 Inhibitors Other Indications TPIP PH-ILD PAH PPF IPF INS1148 ILD Asthma\*\* ARIKAYCE® Refractory MAC All MAC Lung Disease Early 2026

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![](ef20062540_ex99-2slide15.jpg)

Immunology & Inflammation T H E R A P E U T I C A R E A

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![](ef20062540_ex99-2slide16.jpg)

AN: inflammatory nodule \| H: half \| alpha (α): significance level representing the probability of concluding a treatment is effective when it is not Hidradenitis Suppurativa Primary: Percent reduction in abscess and inflammatory nodule (AN) count vs. baseline CEDAR Powering: alpha of 0.10 95% to show 40% reduction in AN count 214 patients exceeded enrollment goal CEDAR: Topline Data Readout Expected Q2:26 Defining Success Clear Win: ~20% reduction in AN count vs. baseline Key Trial Details Homerun: ~40% reduction in AN count vs. baseline

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![](ef20062540_ex99-2slide17.jpg)

Immunology & Inflammation Therapeutic Area Pipeline BRINSUPRI® (brensocatib) HS Pre-Clinical Ph1 Ph2 Ph 3 Commercial Other Next-Gen Uricase: Gout IgG Protease INS1148: Other Indications Novel MoA DPP1 Inhibitors INS1033: RA INS1033: IBD Anticipated Catalysts Q2:26 \| CEDAR Ph2 readout 2H:26 \| IND for RA filing 2H:26 \| IND for IBD filing HS: hidradenitis suppurativa \| RA: Rheumatoid arthritis \| IBD: Inflammatory bowel disease \| MoA: Mechanism of Action \| IgG: Immunoglobulin G \| Next-Gen: next generation \| IND: investigational new drug application \| Q: Quarter \| Ph: Phase

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![](ef20062540_ex99-2slide18.jpg)

Neuro & Other Rare T H E R A P E U T I C A R E A

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![](ef20062540_ex99-2slide19.jpg)

Gene Therapies: Phase 1 Trials Progressing On-Track Initiation indicates that trial sites are open and ready to screen participants for enrollment \| DMD: Duchenne muscular dystrophy \| IDMC: Independent Data Monitoring Committee \| ALS: amyotrophic lateral sclerosis \| IND: Investigational new drug application \| INS1202 is Insmed's second gene therapy candidate for the treatment of patients with ALS \| SOD1: Superoxide Dismutase 1; refers to the gene and protein for a major antioxidant enzyme that converts toxic superoxide radicals into oxygen and hydrogen peroxide \| H: half DMD IDMC recommended to advance dosing in study Advanced to next stage of ASCEND study: Cohort 2: boys aged 3 to <5 years at higher dose Cohort 3: boys aged 2 years at lower dose ALS ARMOR study initiated in Q4:25 Studying both SOD1 and sporadic ALS Strong pre-clinical data exist in both models Cohort 4 2 years old Higher Dose (3 patients) Cohort 2 3 - <5 years old Higher Dose (3 patients) Cohort 3 2 years old Lower Dose (3 patients) Cohort 1 3 - <5 years old Lower Dose (3 patients) Screening Cohort 3 High Dose Sporadic & SOD1 (5 patients each) Cohort 2 Medium Dose Sporadic & SOD1 (5 patients each) Cohort 1 Low Dose Sporadic ONLY (3 patients) Screening Intrathecally Delivered Gene Therapies with Non-Weight-Based Dosing

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![](ef20062540_ex99-2slide20.jpg)

Anticipated Catalysts 2026 \| IND for Stargardt filing '26/'27 \| ASCEND DMD updates '26/'27 \| ARMOR ALS updates 2027 \| Stargardt Ph1 trial updates Neuro & Other Rare Therapeutic Area Pipeline Gene Therapy INS1201: DMD INS1202: ALS\* INS1203: Stargardt Pre-Clinical Ph1 Ph2 Ph 3 Commercial Synthetic Rescue DMD: Duchenne muscular dystrophy \| ALS: amyotrophic lateral sclerosis \| ASO: Antisense Oligonucleotide \| AOA1: Ataxia with Oculomotor Apraxia Type 1 \| IND: investigational new drug application \| H: Half \| YE: Year-end \| Ph: Phase \| \* Studying both SOD1 and sporadic ALS ASO: Ataxia Telangiectasia ASO: AoA1

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Financial Strength Allows Us to Pursue Our Ambitious Goals 1 Unaudited revenue results and/or cash, cash equivalents, and marketable securities \| 2 year-over-year growth vs. unaudited 2025 revenue results \| 3 Revenue guidance for current label; does not include revenues from potential label expansion \| BD: business development \| U.S.: United States Capital Allocation Deploy capital to maximize opportunities for patients Prioritize BD opportunities with promising science $1.7B as of 9/30/20251 Cash Position 2025 $433.8M 2026 Guidance $450M to $470M $28.1M U.S. Only1 Q3:25 (Partial) $144.6M U.S. Only1 Q4:25 (Full) 1 Preliminary unaudited revenue results are subject to adjustment. The Company will report its final and complete fourth-quarter and full-year 2025 financial results in February 2026. The actual results could be materially different from these preliminary unaudited financial results \| U.S.: United States \| M: Million \| BD: Business development Worldwide1 Worldwide

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Our Culture is Our Greatest Strength In a recent survey\* >90% of employees who responded said they felt: Proud to work at Insmed Inspired by what we do Confident in Insmed's future Driven to do their best work \* The 2025 annual Insmed Pulse Survey included 92% participation across the organization Certified as a U.S. Great Place to Work No. 1 on Science's Top BioPharma Employers List Five Years in a Row

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2026: Building On Our Momentum Next 18+ Months: Potential future value creation driven by commercial execution and clinical progress Three Therapeutic Areas: New structure supports the evolution of our commercial portfolio & clinical pipeline BRINSUPRI: Strong start to U.S. launch; multiple international launches expected in 2026\* U.S.: United States \| \* Pending regulatory approval in the United Kingdom (UK) and Japan

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Thank You

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