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 18, 2025
 
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 20, 2025, Insmed Incorporated issued a press release regarding its financial results for the three months and fiscal year ended December 31, 2024. 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 18, 2025, Alfred Altomari 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 I director, which occurs at the Company’s 2025 Annual Meeting of Shareholders (the “Annual Meeting”). Mr. Altomari will continue to serve as a member of the Board and of the Audit Committee and Compensation Committee of the Board until the Annual Meeting. Mr. Altomari’s decision not to 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
 
Press release issued by Insmed Incorporated on February 20, 2025.
 
Insmed Incorporated February 20, 2025 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 20, 2025
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 2024 Financial Results and
Provides Business Update

—ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of $104.4 Million for Fourth-Quarter and $363.7 Million for Full-Year 2024, Reflecting 19% Annual Growth and Exceeding the Upper End of Full-Year 2024 Guidance Range—

—Company Reiterates 2025 Global ARIKAYCE Revenue Guidance of $405 Million to $425 Million, Reflecting Double-Digit Growth Compared to 2024—

—NDA for Brensocatib in Patients with Bronchiectasis Accepted by FDA and Granted Priority Review with a PDUFA Target Action Date of August 12, 2025—
 
—Phase 2b Study of TPIP in Patients with PAH, Phase 2b BiRCh Study of Brensocatib in Patients with CRSsNP, and Phase 3 ENCORE Study of ARIKAYCE Remain on Track for Topline Data in Mid-2025, End of 2025, and First Quarter of 2026, Respectively—

—Company Ends 2024 with Approximately $1.4 Billion of Cash, Cash Equivalents, and Marketable Securities—

BRIDGEWATER, N.J., February 20, 2025 /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, 2024 and provided a business update.

“As we report on the most important year in Insmed’s history, we feel we are in a rare position in our industry, with extraordinary opportunities ahead. Our success across all areas of the business in 2024—most notably the delivery of positive data from the landmark Phase 3 ASPEN study of brensocatib in bronchiectasis—has positioned us to potentially reach many more patients suffering from serious diseases, and resulted in significant value creation,” said Will Lewis, Chair and Chief Executive Officer of Insmed. “In 2025, we look forward to delivering the highly anticipated U.S. launch of brensocatib, pending FDA approval, and we are delighted to be one step closer to achieving that goal with the FDA’s acceptance of our NDA with Priority Review. Simultaneously, we expect to continue to advance our robust mid- to late-stage pipeline while generating double-digit worldwide revenue growth for ARIKAYCE. We believe that Insmed's strong balance sheet and unique company culture will enable us to deliver on behalf of patients in need.”

Recent Progress and Anticipated Milestones by Program:

ARIKAYCE


 •
ARIKAYCE global revenue grew 19% in 2024 compared to 2023, reflecting continued strong growth in the U.S., Japan, and Europe.

•
In the fourth quarter of 2024, the Company completed enrollment in the Phase 3 ENCORE study for patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who had not started antibiotics. Total enrollment in the study was 425 patients.

•
The Company continues to anticipate a topline readout for ENCORE in the first quarter of 2026, with the submission of a supplementary new drug application (sNDA) to the FDA for ARIKAYCE in all patients with MAC lung disease in the U.S. expected later in 2026.

Brensocatib


 •
In February 2025, the FDA accepted the Company’s New Drug Application (NDA) for brensocatib for patients with bronchiectasis and granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of August 12, 2025. Insmed continues to expect brensocatib will launch in the U.S. in the third quarter, if approved.

•
Regulatory submissions for brensocatib in the EU, UK, and Japan are planned for 2025, with commercial launches anticipated in 2026, pending approval in each territory.

•
The Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) remains on track to report topline results by the end of 2025.

•
The Company has initiated dosing of patients in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS).

TPIP


 •
Insmed presented additional lung imaging data from the Phase 2a study of treprostinil palmitil inhalation powder (TPIP) in pulmonary hypertension associated with interstitial lung disease (PH-ILD) at the Pulmonary Vascular Research Institute’s 2025 Annual World Congress on February 1, 2025.

o
Treatment with TPIP resulted in a significant increase in the fraction of blood volume in small arteries and a directional improvement in small-to-large artery volume ratio versus placebo, suggesting small vessel vasodilation and improved pulmonary arteriole recruitment.

o
In addition, a numerical decrease in high-attenuation abnormality score was observed in patients treated with TPIP.

•
The Company plans to initiate a Phase 3 study of TPIP in patients with PH-ILD in the second half of 2025.

•
Enrollment in the Phase 2b study of TPIP in pulmonary arterial hypertension (PAH) completed in December 2024, with 102 patients randomized. Insmed continues to anticipate topline data from the study in the middle of 2025, ahead of the anticipated U.S. launch of brensocatib.

Gene Therapy


 •
The Company received clearance from the FDA for its investigational new drug (IND) application for INS1201, an intrathecally-delivered gene therapy for patients with Duchenne muscular dystrophy (DMD), in December 2024.

•
Insmed plans to initiate a clinical study of INS1201 in the first half of 2025.

•
The Company’s next two gene therapy candidates, which target amyotrophic lateral sclerosis (ALS) and Stargardt disease, are currently advancing toward the clinic.

Pre-Clinical Programs


 •
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.

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

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

Fourth-Quarter and Full-Year 2024 Financial Results


 •
The following table summarizes fourth-quarter and full-year 2024 and 2023 revenues and revenue growth for ARIKAYCE across all commercial regions:

   
Three Months Ended
December 31,
          
Twelve Months Ended
December 31,
        
(in millions)
  
2024
    
2023
    
Growth
    
2024
    
2023
    
Growth
  
U.S.
  
$
67.8
    
$
58.3
      
16.4
%
  
$
254.8
    
$
224.2
      
13.7
%
Japan
    
30.7
      
21.0
      
46.6
%
    
87.7
      
65.7
      
33.4
%
Europe & Rest of World
    
5.9
      
4.5
      
32.5
%
    
21.2
      
15.3
      
38.8
%
Total Revenues
  
$
104.4
    
$
83.7
      
24.8
%
  
$
363.7
    
$
305.2
      
19.2
%


•
Cost of product revenues (excluding amortization of intangibles) was $26.2 million for the fourth quarter of 2024, compared to $18.4 million for the fourth quarter of 2023. For the full-year 2024, cost of product revenues (excluding amortization of intangibles) was $85.7 million compared to $65.6 million for the full-year 2023. The increase in cost of product revenues in the fourth-quarter and full-year primarily reflects growth in ARIKAYCE sales.

•
Research and development (R&D) expenses were $179.7 million for the fourth quarter of 2024, compared to $137.0 million for the fourth quarter of 2023. For the full-year 2024, R&D expenses were $598.4 million compared to $571.0 million for the full-year 2023. The increase in R&D expenses for the fourth-quarter and full-year was primarily related to increases in compensation and benefit-related expenses, as well as stock-based compensation, due to an increase in headcount.

•
Selling, general and administrative (SG&A) expenses for the fourth quarter of 2024 were $142.5 million, compared to $89.5 million for the fourth quarter of 2023. For the full-year 2024, SG&A expenses were $461.1 million, compared to $344.5 million for the full-year 2023. The increase in SG&A expenses for the fourth-quarter and full-year was primarily related to increases in compensation and benefit-related expenses, as well as stock-based compensation, due to an increase in headcount in preparation for the anticipated launch of brensocatib in the U.S., pending regulatory approval.
 

 •
For the fourth-quarter 2024, Insmed reported a net loss of $235.5 million, or $1.32 per share, compared to a net loss of $186.1 million, or $1.28 per share, for the fourth-quarter 2023. For the full-year 2024, Insmed reported a net loss of $913.8 million, or $5.57 per share, compared to a net loss of $749.6 million, or $5.34 per share, for the full-year 2023.

Balance Sheet, Financial Guidance, and Planned Investments


 •
As of December 31, 2024, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.4 billion.

•
Insmed continues to anticipate full-year 2025 global ARIKAYCE revenues in the range of $405 million to $425 million, representing between 11% and 17% year-over-year growth compared to 2024.

•
The Company plans to continue to invest in the following key activities in 2025:

(i)
commercialization and expansion of ARIKAYCE globally;

(ii)
commercial launch of brensocatib in the U.S., if approved, with advancement of regulatory submissions in the EU, UK, and Japan;

(iii)
advancement of clinical trial programs for brensocatib, including the ongoing Phase 2b BiRCh study in patients with CRSsNP and the Phase 2b CEDAR study in patients with HS;

(iv)
advancement of the clinical trial program for ARIKAYCE, which is intended to satisfy the post-marketing requirement for full approval of its current indication and potentially support label expansion to include all patients with a MAC lung infection;

(v)
advancement of the clinical development programs for TPIP, including the Phase 2b study in patients with PAH and the initiation of a Phase 3 study in patients with PH-ILD;

(vi)
advancement of the clinical trial program for INS1201 in DMD; and

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

Insmed will host a conference call beginning today, February 20, 2025, 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 27, 2025, 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.

INSMED INCORPORATED
Consolidated Statements of Net Loss
(in thousands, except per share data)
(unaudited)

   
Three Months Ended
December 31,
    
Twelve Months Ended
December 31,
  
   
2024
    
2023
    
2024
    
2023
  
                   
Product revenues, net
  
$
104,442
    
$
83,693
    
$
363,707
    
$
305,208
  
                                 
Operating expenses:
                                
Cost of product revenues (excluding amortization of intangible assets)
    
26,151
      
18,443
      
85,742
      
65,573
  
Research and development
    
179,727
      
137,029
      
598,367
      
571,011
  
Selling, general and administrative
    
142,515
      
89,530
      
461,116
      
344,501
  
Amortization of intangible assets
    
1,263
      
1,263
      
5,052
      
5,052
  
Change in fair value of deferred and contingent consideration liabilities
    
(14,800
)
    
15,700
      
91,682
      
28,697
  
Total operating expenses
    
334,856
      
261,965
      
1,241,959
      
1,014,834
  
                                 
Operating loss
    
(230,414
)
    
(178,272
)
    
(878,252
)
    
(709,626
)
                                 
Investment income
    
17,257
      
9,853
      
53,307
      
42,132
  
Interest expense
    
(21,550
)
    
(20,784
)
    
(84,913
)
    
(81,694
)
Change in fair value of interest rate swap
    
870
      
1,970
      
(236
)
    
320
  
Other (expense) income, net
    
(445
)
    
2,170
      
29
      
1,856
  
Loss before income taxes
    
(234,282
)
    
(185,063
)
    
(910,065
)
    
(747,012
)
                                 
Provision for income taxes
    
1,266
      
998
      
3,707
      
2,555
  
                                 
Net loss
  
$
(235,548
)
  
$
(186,061
)
  
$
(913,772
)
  
$
(749,567
)
                                 
Basic and diluted net loss per share
  
$
(1.32
)
  
$
(1.28
)
  
$
(5.57
)
  
$
(5.34
)
                                 
Weighted average basic and diluted common shares outstanding
    
179,021
      
144,806
      
164,043
      
140,433
  

INSMED INCORPORATED
Consolidated Balance Sheets
(in thousands, except par value and share data)

   
As of
    
As of
  
   
December 31, 2024
    
December 31, 2023
  
             
Assets
            
Current assets:
            
Cash and cash equivalents
  
$
555,030
    
$
482,374
  
Marketable securities
    
878,796
      
298,073
  
Accounts receivable
    
52,012
      
41,189
  
Inventory
    
98,578
      
83,248
  
Prepaid expenses and other current assets
    
37,245
      
24,179
  
Total current assets
    
1,621,661
      
929,063
  
                 
Fixed assets, net
    
80,052
      
65,384
  
Finance lease right-of-use assets
    
18,273
      
20,985
  
Operating lease right-of-use assets
    
17,257
      
18,017
  
Intangibles, net
    
58,652
      
63,704
  
Goodwill
    
136,110
      
136,110
  
Other assets
    
93,226
      
96,574
  
Total assets
  
$
2,025,231
    
$
1,329,837
  
                 
Liabilities and shareholders' equity
                
Current liabilities:
                
Accounts payable and accrued liabilities
  
$
285,209
    
$
214,987
  
Finance lease liabilities
    
2,961
      
2,610
  
Operating lease liabilities
    
9,358
      
8,032
  
Total current liabilities
    
297,528
      
225,629
  
                 
Debt, long-term
    
1,103,382
      
1,155,313
  
Royalty financing agreement
    
161,067
      
155,034
  
Contingent consideration
    
144,200
      
84,600
  
Finance lease liabilities, long-term
    
24,064
      
27,026
  
Operating lease liabilities, long-term
    
9,112
      
11,013
  
Other long-term liabilities
    
499
      
3,145
  
Total liabilities
    
1,739,852
      
1,661,760
  
                 
Shareholders' equity:
                
Common stock, $0.01 par value; 500,000,000 authorized shares, 179,382,635 and 147,977,960 issued and outstanding shares at December 31, 2024 and December 31, 2023, respectively
    
1,794
      
1,480
  
Additional paid-in capital
    
4,645,791
      
3,113,487
  
Accumulated deficit
    
(4,359,917
)
    
(3,446,145
)
Accumulated other comprehensive loss
    
(2,289
)
    
(745
)
Total shareholders' equity (deficit)
    
285,379
      
(331,923
)
Total liabilities and shareholders' equity (deficit)
  
$
2,025,231
    
$
1,329,837
  

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 Brensocatib

Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis, chronic rhinosinusitis without nasal polyps, hidradenitis suppurativa, and other neutrophil-mediated diseases. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs. Brensocatib is an investigational drug product that has not been approved for any indication in any jurisdiction.

About TPIP

Treprostinil palmitil inhalation powder (TPIP) is a 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 for the treatment of patients with PAH, 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 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. 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.

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.

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.

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 1800FDA1088. You can also call the Company at 1-844-4-INSMED.

Please see Full 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 a therapy approved in the United States, Europe, and Japan to treat a chronic, debilitating lung disease. The Company's pre-clinical research 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 four consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more.

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, our only approved product, in the U.S., Europe or Japan (amikacin liposome inhalation suspension, Liposomal 590 mg Nebuliser Dispersion, and amikacin sulfate inhalation drug product, respectively), or to maintain US, European or Japanese approval for ARIKAYCE; 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 brensocatib, TPIP or our other product candidates in the U.S., Europe or Japan or for ARIKAYCE outside the US, Europe or Japan, including separate regulatory approval for Lamira® in each market and for each usage; failure to successfully commercialize brensocatib, TPIP or our other product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for brensocatib, TPIP or our other product candidates, if approved; uncertainties or changes in the degree of market acceptance of ARIKAYCE or, if approved, brensocatib, TPIP or our other 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 ARIKAYCE or, if approved, brensocatib, TPIP or our other product candidates, or acceptable prices for ARIKAYCE or, if approved, brensocatib, TPIP or our other product candidates; inaccuracies in our estimates of the size of the potential markets for ARIKAYCE, brensocatib, TPIP or our other 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 the Company is dependent to manufacture sufficient quantities of ARIKAYCE, brensocatib, or TPIP for commercial or clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business; the risks and uncertainties associated with, and the perceived benefits of, our secured senior 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 ARIKAYCE or any of our product candidates that are approved in the future; failure to successfully conduct future clinical trials for ARIKAYCE, brensocatib, TPIP or our other 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 ARIKAYCE, brensocatib, TPIP or our other 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;  the 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 recent 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 reform 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 ARIKAYCE, brensocatib or our other 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; our limited experience operating internationally; 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.

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.

Contact:

Investors:

Bryan Dunn
Vice President, Investor Relations
(646) 812-4030
bryan.dunn@insmed.com

Michael V. Morabito, Ph.D.
Director, Investor Relations
(917) 936-8430
michael.morabito@insmed.com
 
Gianna De Palma
Manager, Investor Relations
(973) 886-2236
gianna.depalma@insmed.com

Media:

Mandy Fahey
Vice President, Corporate Communications
(732) 718-3621
amanda.fahey@insmed.com
 

Exhibit 99.2

 February 2025  Investor Presentation  
 
 Forward Looking Statements  This presentation 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 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, our only approved product, in the U.S., Europe or Japan (amikacin liposome inhalation suspension, Liposomal 590 mg Nebuliser Dispersion, and amikacin sulfate inhalation drug product, respectively), or to maintain US, European or Japanese approval for ARIKAYCE; 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 brensocatib, TPIP or our other product candidates in the US, Europe or Japan or for ARIKAYCE outside the US, Europe or Japan, including separate regulatory approval for Lamira® in each market and for each usage; failure to successfully commercialize brensocatib, TPIP or our other product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for brensocatib, TPIP or our other product candidates, if approved; uncertainties or changes in the degree of market acceptance of ARIKAYCE or, if approved, brensocatib,TPIP or our other 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 ARIKAYCE or, if approved, brensocatib, TPIP or our other product candidates, or acceptable prices for ARIKAYCE or, if approved, brensocatib, TPIP or our other product candidates; inaccuracies in our estimates of the size of the potential markets for ARIKAYCE, brensocatib, TPIP or our other 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 the Company is dependent to manufacture sufficient quantities of ARIKAYCE, brensocatib, or TPIP for commercial or clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business; the risks and uncertainties associated with, and the perceived benefits of, our secured senior 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 ARIKAYCE or any of our product candidates that are approved in the future; failure to successfully conduct future clinical trials for ARIKAYCE, brensocatib, TPIP and our other 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 ARIKAYCE, brensocatib, TPIP or our other 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; the 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 recent 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 reform 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 US, 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 ARIKAYCE, brensocatib or our other 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; our limited experience operating internationally; 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.    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 presentation. 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. 
 
 Additional Disclaimers  With respect to the blended and blinded data observed from the ongoing TPIP study in pulmonary arterial hypertension, the dose titration and efficacy analyses were based on data available as of April 1, 2024, and the safety analyses were based on data available as of January 25, 2024, respectively. These findings may not be representative of results after the study is completed and all data are collected and analyzed. As a result, later interim data readouts and final data from this study may be materially different than the observations described herein, including with respect to efficacy, safety and tolerability of TPIP.  Please be aware that brensocatib and TPIP 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. This presentation is not promotion or advertisement of ARIKAYCE, brensocatib, or TPIP.  Insmed and ARIKAYCE are registered trademarks of Insmed Incorporated. All other trademarks are property of their respective owner(s).  Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources, as well as our own internal estimates and research. While we believe the information in these third-party sources to be reliable as of the date of this presentation, we have not independently verified any such information or the underlying assumptions relied on in such third-party sources. In addition, while we believe our internal research is reliable, such research has not been verified by any independent source. 
 
 Portfolio of First-in-Class and Potentially Best-in-Class* Assets Across Each Stage of Development  Pre-clinical Phase 1 Phase 2 Phase 3 Approved   ARIKAYCE®  Refractory MAC  All MAC Lung Disease  Brensocatib  Bronchiectasis  CRSsNP  HS  TPIP  PH-ILD  PAH  Pre-Clinical Research  INS1202: ALS  INS1203: Stargardt Disease  Next-Gen DPP1 Inhibitor (Multiple indications)  Other Pre-Clinical Research (Multiple indications)  Gene Therapy  INS1201: DMD  * “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.  TPIP: Treprostinil Palmitil Inhalation Powder; MAC / MAC LD: mycobacterium avium complex lung disease; Bronchiectasis: non-cystic fibrosis bronchiectasis; PAH: pulmonary arterial hypertension; PH-ILD: pulmonary hypertension associated with interstitial lung disease; CRSsNP: chronic rhinosinusitis without nasal polyps; HS: hidradenitis suppurativa; DMD: Duchenne muscular dystrophy; ALS: amyotrophic lateral sclerosis 
 
 * If pipeline of assets are approved   Bronchiectasis: non-cystic fibrosis bronchiectasis; MAC / MAC LD: Mycobacterium avium complex lung disease; CRSsNP: chronic rhinosinusitis without nasal polyps; PH-ILD: pulmonary hypertension due to interstitial lung disease; PAH: pulmonary arterial hypertension; HS: hidradenitis suppurativa  ARIKAYCE  Refractory MAC  2018 - Today  30K patients  Total Addressable Patients Has Potential to Grow 80x Through 2030*  2025 - 2030  Brensocatib  Bronchiectasis  +1.25M   ARIKAYCE  MAC LD  +275K  Brensocatib  CRSsNP   +400K  TPIP  PH-ILD  +135K  TPIP  PAH  +90K  Brensocatib  HS   +600K  Additional 2.5M+ patients* 
 
 Potential Value Creation Will Be Shaped by Two Distinct Drivers  * Pending regulatory approval for bronchiectasis indication; U.S. FDA target action date set for August 12, 2025  ** Guidance growth versus 2024 ARIKAYCE revenue results  † Europe/EU5 comprised of France, Germany, Italy, Spain, and the United Kingdom  ‡ Priority Review designation received; NDA: New Drug Application  (P) Indicates trial phase of respective clinical program; TLR: Topline Results  Revenue Generation  Clinical Execution  Value Creation  Mid-25  TPIP PAH   TLR (P2)  3Q:25  U.S. Launch   of Brensocatib*  YE:25  BiRCh   CRSsNP   TLR (P2)  FY:25  Double-Digit  ARIKAYCE Growth**     2H:25  TPIP PH-ILD   (P3) Initiation  YE:24  Expanded   U.S. Salesforce  1Q:26  ENCORE  MAC LD   TLR (P3)  ’25/’26  DMD First Clinical Data  2026  Brensocatib EU5†  & Japan Launch*  PAH: pulmonary arterial hypertension; PH-ILD: pulmonary hypertension associated with interstitial lung disease; Bronchiectasis: non-cystic fibrosis bronchiectasis; CRSsNP: chronic rhinosinusitis without nasal polyps; MAC / MAC LD: Mycobacterium avium complex lung disease; DMD: Duchenne muscular dystrophy  2024  2025  2026  1Q:25  FDA Accepted Brensocatib NDA Filing‡ 
 
 ARIKAYCE  Refractory Mycobacterium avium complex lung disease  A rare and chronic disease that can cause irreversible lung damage and is the most common form of NTM respiratory pathogen  Mycobacterium avium complex lung disease   Image source: Hendrix C, McCrary M, Hou R, Abate G. Diagnosis and Management of Pulmonary NTM with a Focus on Mycobacterium avium Complex and Mycobacterium abscessus: Challenges and Prospects. Microorganisms. 2023; 11(1):47. https://doi.org/10.3390/microorganisms11010047  ®   (amikacin liposome inhalation suspension)  
 
 ARIKAYCE Expected to Deliver Double-Digit Revenue Growth in 20251  1 Guidance growth vs. 2024 ARIKAYCE revenue results  EU5 comprised of France, Germany, Italy, Spain, and the United Kingdom  Double-digit   growth entering 7th year post launch  +19%   2024 vs. 2023  +14%   +39%   +33%   FY 2024  $364M   Beat $340-$360M Guidance  $255M   $21M  $88M   $405 to $425M  Full-Year 2025  +11% to 17%1   2025 vs. 2024  FY 2025E  ARIKAYCE   Revenue Guidance  
 
 ARIKAYCE has the Potential to be the Best in MAC LD Treatment  MAC / MAC LD: Mycobacterium avium complex lung disease; TAM: Total Addressable Market  †EU5 comprised of France, Germany, Italy, Spain, and the United Kingdom  Note: Numbered footnote references related to patient prevalence can be found at the end of this presentation.  125-145K  US  TAM  EU5†  TAM  Japan  TAM  Refractory MAC1  95-115K  14K  MAC LD1  15-18K  12-17K  1.4K  If approved, we anticipate marketing ARIKAYCE in MAC LDat same price and dosage as currently available ARIKAYCE  Phase 3 ENCORE Readout   Expected 1Q:26 
 
 ARIKAYCE Phase 3 Program to Potentially Expand MAC Indication  Trial summary  Key Endpoints  Screening  Double-Blind Registration PMR Trial   ARIKAYCE + AZI* + ETH*  Placebo + AZI* + ETH*  Key Endpoints   Month 13   Culture Negativity Endpoint  Month 15  R  Months 1-6  ARIKAYCE +   AZI* + ETH*  Off Treatment  Months 1-12  Adults with new MAC lung infection  (n=250+)  Psychometric Validation Study  Month 7  Placebo +   AZI + ETH  Off Treatment  Adults with new MAC lung infection  (n=100)  ENCORE  ARISE  R   ENCORE  Primary Endpoint  Change from Baseline to Month 13 (one month off treatment) in respiratory symptom score  Key Secondary Endpoint  Proportion of subjects achieving durable culture conversion at Month 15 (3 months off treatment)   ARISE  Primary Objective  Demonstrate reliability, validity and responsiveness of the PRO/symptom scores  Secondary Objective  Demonstrate effect of ARIKAYCE on culture conversion, time to culture conversion  200-220 sites across ARISE and ENCORE  Topline results from Phase 3 ENCORE trial expected in Q1:26     Aligned on Primary Endpoint (PE) with FDA (8 questions from QoL-B)  ENCORE enrollment of 425 patients (>90% powering on PE)  Positive topline results from Phase 3 ARISE trial shared in September 2023  *Azithromycin (AZI), Ethambutol (ETH) 
 
 Brensocatib  Image sources: 1) Fraser CS, José RJ. Insights into Personalised Medicine in Bronchiectasis. Journal of Personalized Medicine. 2023; 13(1):133. https://doi.org/10.3390/jpm13010133. | 2) Rethinkbronchiectasis.com | 3) Yang Y, Zhang N, Crombruggen KV, Lan F, Hu G, Hong S, Bachert C. Differential Expression and Release of Activin A and Follistatin in Chronic Rhinosinusitis with and without Nasal Polyps. PLoS One. 2015 Jun 1;10(6):e0128564. doi: 10.1371/journal.pone.0128564. PMID: 26030615; PMCID: PMC4451080 | 4) Z.N. Ovadja, M.M. Schuit, C.M.A.M. van der Horst, O. Lapid, Inter‐ and intrarater reliability of Hurley staging for hidradenitis suppurativa, British Journal of Dermatology, Volume 181, Issue 2, 1 August 2019, Pages 344–349, https://doi.org/10.1111/bjd.17588   Non-Cystic Fibrosis Bronchiectasis  A chronic, progressive inflammatory disease that causes permanent lung damage  Chronic Rhinosinusitis without Nasal Polyps  Hidradenitis   Suppurativa  A burdensome disease that significantly impairs quality of life  A debilitating, chronic inflammatory disease with significant treatment challenges  1)  2)  3)  4)  (DPP1 inhibitor)  
 
 U.S. Bronchiectasis Market Primed for a Strong Brensocatib Launch*   * Pending regulatory approval for bronchiectasis indication  ** Since website launch in November 2023 through December 2024  † From February-October 2024; Commercial lives include Veterans Affairs, Tricare, and Dept. of Defense  ‡ Highly engaged defined as those patients who have downloaded support tools or registered for Customer Relationship Management (CRM)  1 Based on US Segmentation Study (currently in field)  2 Based on US Demand Study (fieldwork: June/July 2024)  3 Patient website metrics dashboard; as of December 2024  4 Payer KPI metrics; as of October 2024  Doctors  Intend to Prescribe  64%  Indicated high unmet   need in bronchiectasis1  90%  Likely to prescribe brensocatib for   patients with 2+ exacerbations2  Patients  Are Motivated to Act3  ~900K  Unique visits to disease state website**  ~41K  Highly engaged‡ visitors who have acted**  Payors  Recognize the Disease Burden4  >90%  Medicare lives†  >90%  Commercial lives †  Lives covered by engaged accounts: 
 
 Brensocatib in Bronchiectasis Opportunity Could Reach >1M Patients at Launch*  * Pending regulatory approval for bronchiectasis indication  † Includes misdiagnosed, miscoded, undiagnosedNote: COPD and asthma may be comorbid with bronchiectasis and not all patients with bronchiectasis have comorbid asthma or COPD Note: Numbered footnote references related to patient prevalence can be found at the end of this presentation  † EU5 comprised of France, Germany, Italy, Spain and the United KingdomBronchiectasis refers to non-cystic fibrosis bronchiectasis  TAM: Total Addressable Market  US  TAM  EU5†  TAM  Japan  TAM  Diagnosed with Bronchiectasis2  0.8M  2.4M  2.1M  Undiagnosed† Bronchiectasis3   Asthma or COPD4  150K  500K  600K  17M  32M  27M  Bronchiectasis  NDA for Brensocatib in Bronchiectasis Accepted by FDA and Granted Priority Review with a PDUFA Target Action Date of August 12, 2025 
 
 Brensocatib Phase 3 in Bronchiectasis:  Trial summary  Off treatment4 weeks  Treatment period  52 weeks  Baseline  day 1  randomization  End of trial  day 364  End of studyday 392 ± 3   6 weeks  Randomization:  1:1:1 for adults  2:2:1 for adolescents  Screening  Brensocatib 10 mg once daily  Brensocatib 25 mg once daily  Placeboonce daily  Adults stratified by:  Sputum Pseudomonas aeruginosa culture status at screening (positive or negative)  Number of exacerbations in the prior 12 months (2 or ≥3)  Geographic region (Europe, Japan, North America, or ROW)  Primary endpoint:  Annualized rate of adjudicated pulmonary exacerbationsa over 52 weeks  Secondary endpoints (hierarchical):  Time to first exacerbation  Proportion of patients who remained exacerbation-free  Change from baseline in post-bronchodilator FEV1 at week 52  Annualized rate of severe exacerbations  Change from baseline in QoL-B Respiratory Symptom Domain score at week 52  ASPEN  a Defined as the presence of ≥3 of the following symptoms for at least 48 hours, resulting in a physician’s decision to prescribe systemic antibiotics: (1) increased cough, (2) increased sputum production or change in sputum consistency, (3) increased sputum purulence, (4) increased breathlessness and/or decreased exercise tolerance, (5) fatigue and/or malaise, or (6) hemoptysis.   Bronchiectasis refers to non-cystic fibrosis bronchiectasis; FEV1=forced expiratory volume in 1 second; PO=orally; QoL-B=Quality of Life-Bronchiectasis questionnaire; ROW=rest of world.  
 
 Phase 3 ASPEN Study a Clear Win: Primary Endpoint Achieved Statistical Significance on Both Doses  PE=Pulmonary ExacerbationFEV1=Forced Expiratory Volume Over 1 Second  QoL-B=Quality of Life-Bronchiectasis Questionnaire* Statistically significant^ Nominally significant p-value   Brensocatib 10 mg   compared to placebo  Brensocatib 25 mg compared to placebo  Primary Endpoint  Reduction in annualized rate of PEs   21.1%  p = 0.0019*  19.4%  p = 0.0046*  Secondary Endpoints  Prolongation of time to first PE   18.7%  p = 0.0100*  17.5%  p = 0.0182*  Increase in odds of remaining exacerbation free over 52 weeks   41.2%  p = 0.0059*  40.0%  p = 0.0074*  Change from baseline in post-bronchodilator FEV1 at week 52   11 mL  p = 0.3841  38 mL  p = 0.0054*  Reduction in annualized rate of severe PEs   25.8%  p = 0.1277  26.0%  p = 0.1025  Change from baseline in the QoL-B Respiratory Score at week 52   2.0 points  p = 0.0594  3.8 points  p = 0.0004^ 
 
 Chronic Rhinosinusitis without Nasal Polyps Represents Another Potential Large Patient Opportunity  Included in   Phase 2b  BiRCh Trial;  >75% Enrolled  Annual New Surgical Patients (Incidence)5  0.5M  3.1M  2.6M  Steroid Non-responders (Prevalence)5  40K  200K  160K  6M  29M  24M  CRSsNP  CRSsNP (Prevalence)4  US  TAM  EU5†  TAM  Japan  TAM  US  TAM  EU5†  TAM  Japan  TAM  CRSsNP: chronic rhinosinusitis without nasal polyps | TAM: Total Addressable Market  † EU5 comprised of France, Germany, Italy, Spain and the United Kingdom  Note: Numbered footnote references related to patient prevalence can be found at the end of this presentation 
 
 Brensocatib Phase 2b in CRSsNP: BiRCh  Brensocatib 40 mg QD  Placebo QD   Screening  BASELINE  EOT (primary analysis)  Up to 5 weeks  Brensocatib 10 mg QD  4 weeks  Treatment period  24 weeks  EOS  R  Off-treatment follow-up  N=~270 total  Key eligibility criteria:  Male or female ≥18 years old and ≤75 years old  At least a 12-week history of CRSsNP and confirmed by endoscopy at Screening  Ongoing CRS symptoms: nasal congestion score of at least 2, sTSS score of at least 5 and sino-nasal outcome test 22 score of at least 20 at screening and baseline  Blood eosinophil count of ≤750 cells/μL at Screening  Previous sinonasal surgery for CRS and/or treatment with systemic steroids or antibiotics for CRS within a year of Screening Visit  Primary Endpoint  Change in daily sinus total symptom score (sTSS)  Secondary Endpoints  Change in percentage sinus opacification  Change in modified LMK CT (Lund-MacKay computed tomography) score  Proportion of participant requiring rescue  Change in Sino-nasal Outcome Test 22 score  Exploratory Endpoint  Neutrophil serine proteases (NSPs) in blood  CRSsNP: Chronic rhinosinusitis without nasal polyps; EOS: end of study; EOT: end of treatment; QD: once daily.   Trial summary   BiRCh 
 
 Potential Expansion into Hidradenitis Suppurativa Could Be a New Treatment Option for >600K Patients  Hurley Stage 2 & 36  Global Diagnosed Prevalence6  30K  275K  300K  HS  1.2M – 2.6M  US  TAM  EU5†  TAM  Japan  TAM  HS: hidradenitis suppurativa | TAM: Total Addressable Market  † EU5 comprised of France, Germany, Italy, Spain and the United Kingdom  Note: Numbered footnote references related to patient prevalence can be found at the end of this presentation 
 
 Primary Endpoint (Week 16)  Percent change in total abscess and inflammatory nodule (AN) count  Secondary Endpoints (Week 16)  Percentage achieving HiSCR50  Percentage achieving HiSCR75  Change from baseline in draining tunnel count  Percentage remaining free from HS flare  Change from baseline in International HS Severity Score System (IHS4) score  Percentage achieving IHS-55  Change from baseline on Dermatology Life Quality Index (DLQI) Global Score  Percentage achieving Numeric Rating Scale 30 (NRS30) with Baseline NRS >3  Brensocatib Phase 2b in HS: CEDAR  Trial summary  HS: Hidradenitis suppurativa; QD: once daily; Q2W: once every 2 weeks; Q4W: once every 4 weeks; HiSCR: Hidradenitis suppurativa clinical response  Up to   35 days  Period 1  Double-Blind Placebo-Controlled  (16 weeks)  Period 2  Double-Blind Active Treatment  (36 weeks)  Follow-up  Period  (4 weeks)  No Study   Treatment  SCREENING  1:1:1  N = 204  (68/arm)  Clinic Visits Q2W  Clinic Visits Q4W  Baseline  Day 1  Randomization  Period 1  End of Treatment  Week 16  (Primary Analysis)  Period 2  End of Treatment  Week 52  End of  Study  Week 56  Tissue Biopsy (Sub-study: N=~36)  *Optional, at selected sites  Brensocatib 10 mg QD  Brensocatib 10 mg QD (n=68)  Brensocatib 40 mg QD  Brensocatib 40 mg QD (n=68)  Placebo QD  Brensocatib 10 mg QD (n=34)  Brensocatib 40 mg QD (n=34)  Interim Futility Analysis  Independent Data Monitoring Committee examines ~100 randomized participants completing 16 weeks of treatment to obtain a preliminary perspective of benefit/risk ratio in this population  CEDAR 
 
 TPIP  Pulmonary Hypertension due to Interstitial Lung Disease  A rapidly progressing disease associated with poor survival and decreased quality of life  Pulmonary Arterial Hypertension  A devastating and debilitating disease that   pervades all aspects of a patient’s daily life  Image source: Valentini A, Franchi P, Cicchetti G, Messana G, Chiffi G, Strappa C, Calandriello L, del Ciello A, Farchione A, Preda L, et al. Pulmonary Hypertension in Chronic Lung Diseases: What Role Do Radiologists Play? Diagnostics. 2023; 13(9):1607. https://doi.org/10.3390/diagnostics13091607  (Treprostinil Palmitil Inhalation Powder) 
 
 TPIP has the Potential for Clear Differentiation in PH-ILD and PAH  * No head-to-head or convenience studies have been conducted or planned** Safety analysis based on topline safety and tolerability data from the Phase 2 PH-ILD study of TPIP disclosed on May 6, 2024  †Based on most recent publicly available data  TPIP  Inhaled   (dry powder)  Once daily  Yes**  Currently being evaluated in Phase 2  Phase 2 data support advancing to Phase 3  Remodulin®  IV or subcutaneous  Continuous  Yes  Yes  No data  Tyvaso®  & Yutrepia®  Inhaled (nebulized and/or dry powder)2  4-times  per day  No  Yes  Yes  Orenitram®  & Uptravi®  Oral  2- or 3-times  per day3  No  Yes  No data  Route of administration  Dosing frequency  Favorable tolerability for dose expansion†  Efficacy in PAH  (WHO Group 1)  Efficacy in   PH-ILD  (WHO Group 3)  Potential  Differentiators  1 Yutrepia® is tentatively approved for PAH & PH-ILD; Tyvaso ® is approved in PAH & PH-ILD; all other listed products are approved in PAH   2 Tyvaso: nebulized and dry-powder | Yutrepia: dry powder   3 Orenitram: 2-3 times per day | Uptravi: 2-times per day  Approved Treprostinil Therapies1  Convenience*  Safety &   Efficacy**  Favorable safety profile & higher dosing may lead to improved outcomes  TPIP=Treprostinil Palmitil Inhalation Powder 
 
 PH-ILD and PAH Represent Substantial Commercial Opportunities  TPIP: A Potential Best-in-Class* Prostanoid  ‡ Wholesale acquisition cost (WAC) as of March 12, 2024  TAM: Total Addressable Market; †EU5 comprised of France, Germany, Italy, Spain and the United Kingdom   Note: Numbered footnote references related to patient prevalence can be found at the end of this presentation.  * “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.Note: Diagnosed pulmonary hypertension (PH) consists of pulmonary arterial hypertension (PAH), pulmonary hypertension due to left heart diseases (PH-LHD), pulmonary hypertension due to interstitial lung disease (PH-ILD), chronic thromboembolic pulmonary hypertension (CTEPH), Idiopathic PH  ~$300K  U.S. Pricing Benchmark  Tyvaso DPI   List Price‡  US  TAM  EU5†  TAM  Japan  TAM  15K  35K  40K  PAH7  PH-ILD8  20K  50K  65K  Diagnosed PH  45K  190K  150K  TPIP  TPIP=Treprostinil Palmitil Inhalation Powder 
 
 TPIP Phase 2 in PH-ILD  4 weeks  TPIP 80-640 µg  inhalation capsules QD   Placebo  inhalation capsules QD   Screening  Treatment period  16 weeks  Baseline  EOT  (primary analysis)  EOS  4 weeks  Primary Endpoints  Secondary Endpoints  Follow-up  Pharmacokinetics  39 participants randomized   in the study   3:1 active : placebo  Safety and tolerability  Oxygenation  Exploratory Efficacy Endpoints  Improvement in 6-Minute Walk Distance (6MWD)  Improvement in biomarkers of cardiac stress (NT-proBNP)  Improvement in lung function and pulmonary vascular volume (FRI)  Improvements in Quality of Life (CAMPHOR questionnaire)  Clinical worsening*  Steady-state period  3-week titration period; last   dose increase at   week 5 visit  * Clinical worsening is defined as one of the following: (1) Hospitalization due to a cardiopulmonary indication, (2) Lung transplantation, (3) Death from any cause, or (4) Decrease in 6MWD of at least 15% from baseline (at 2 consecutive visits at least 24 hours apart), directly related to disease  TPIP=Treprostinil Palmitil Inhalation Powder | 6MWD=six-minute walk distance | PH-ILD=pulmonary hypertension due to interstitial lung disease | QD=once daily  Trial summary  PH-ILD Trial 
 
 PH-ILD Phase 2 Study Met Primary Objective of Safety and Tolerability, With Lower Rates of Treatment Discontinuation and SAEs vs. Placebo  “N” = total participants randomized in specified group | “n” = number of participants within the group1 Based on investigator’s evaluation | 2 All events of cough were mild, and none led to treatment discontinuation. | 3 Includes any death that occurred on or after the first dose date. All deaths in the trial were related to disease progression or comorbid causes and none were attributed to TPIP. TEAE=Treatment emergent adverse event | SAE=Serious adverse event | TPIP=Treprostinil Palmitil Inhalation Powder | PH-ILD=pulmonary hypertension due to interstitial lung disease  TPIP (N=29)  Placebo (N=10)  Dose Titration  % Patients Titrated to Maximum 640 µg Dose of TPIP or Placebo (n)  % Patients Titrated to at least 480 µg Dose of TPIP or Placebo (n)  79.3% (23)  89.6% (26)  100.0% (10)  100.0% (10)  % Patients with Any TEAE (n)  Adverse Events (%)  93.1% (27)  90.0% (9)  % Patients with Study Drug Related1 TEAE (n)  % Patients with Study Drug Related Cough2 (n)  Adverse Events (%)  55.2% (16)  37.9% (11)  40.0% (4)  0.0% (0)  % Patients with TEAE Leading to Treatment Discontinuation (n)  Serious Adverse Events (%)  13.8% (4)  30.0% (3)  % Patients with Any SAE (n)  Serious Adverse Events (%)  20.7% (6)  40.0% (4)  % Patients with Study Drug Related1 SAE (n)  0.0% (0)  0.0% (0)  % Patient Deaths3 (n)  Deaths2  6.9% (2)  20.0% (2)  Trial was randomized 3:1 TPIP vs. placebo 
 
 PH-ILD Phase 2 Exploratory Efficacy Endpoints Support Advancement into Phase 3  “N” = total participants randomized in specified group; “n” = number of events, or participants within the group1 Calculation based on Hodges-Lehmann Estimate Location Shift | 2 Calculation based on geometric mean | 3 Calculation based on Fisher's Exact Test | 4 Two placebo patients each experienced two events, but this analysis counted only one event per subject | TPIP=Treprostinil Palmitil Inhalation Powder | PH-ILD=pulmonary hypertension due to interstitial lung disease  Trial was randomized 3:1 TPIP vs. placebo  TPIP (N=29)  Placebo (N=10)  Week 16  n  Week 16  n  6-Minute Walk Distance (6MWD)  Treatment effect (TPIP vs. placebo) at Week 161 (m)            Confidence interval            P-value  30  [-49.0, 171.0]  0.3484  29  N/A  10  NT-proBNP concentrations (pg/mL)2  (Baseline concentrations)  Geometric mean ratio to Baseline (Geometric SD)   Adverse Events (%)  197.50  (242.90)  0.81 (3.36)  24  382.59  (338.43)  1.13 (1.50)  7  % Patients with Clinical Worsening Event (n)     P-value (TPIP vs. placebo)3  Serious Adverse Events (%)  10.3% (3)  0.0164  29  50.0% (5)4  10  % Patients hospitalized due to cardiopulmonary indication (n)  0.0% (0)  29  30.0% (3)  10  % Patients with decrease in 6MWD ≥ 15% from Baseline (n)  3.4% (1)  29  20.0% (2)  10  % Patients who died from any cause (n)  6.9% (2)  29  20.0% (2)  10 
 
 TPIP Phase 2b in PAH  4 weeks  TPIP 80-640 µg  inhalation capsules QD   Placebo  inhalation capsules QD   Screening  Treatment period  16 weeks  Baseline  EOT  (primary analysis)  EOS  4 weeks  Follow-up  Approximately 100 participants randomized in the study   2:1 active : placebo  Steady-state period  3-week titration period; last dose increase at week 5 visit  Primary Endpoint  Change from baseline in pulmonary vascular resistance (PVR) at week 16  Secondary Exploratory Efficacy Endpoints  Change from baseline in exercise capacity (6MWD)  Change from baseline in WHO Functional class  Change from baseline in Quality of Life (CAMPHOR questionnaire)  Change from baseline in biomarkers of cardiac stress (NT-proBNP)  Trial summary  PAH Trial  TPIP=Treprostinil Palmitil Inhalation Powder | PAH=pulmonary arterial hypertension | 6MWD=six-minute walk distance | QD=once daily 
 
 Blended Blinded Phase 2 Data in PAH Indicates Potential of TPIP to Become Best-in-Class* Prostanoid  1 Dose titration analysis based on data available as of April 1, 2024. Dose titration data in PAH reflect first sets of patients in each trial who reached the Week 5 visit, which is the last possible point at which the dose can be increased in the trial.2 Efficacy analysis based on data available as of April 1, 2024. PVR data in PAH based on a review of 40 patients who had completed 16 weeks of treatment.3 6-Minute Walk Distance analysis based on data available as of April 1, 2024.  Blended/Blinded Data from Treatment and Placebo Arms (2:1 Randomization)  Dose Titration1  Patients Titrated to Maximum   Dose of 640 µg or Placebo (%)  34 (79%)  of first 43 patients who reached Week 5 visit  Most countries have approved protocol changes to increase the maximum dose of TPIP from 640 µg to up to 1,280 µg, once daily, for the open-label extension of its PAH study  Pulmonary Vascular   Resistance (PVR)2  Mean Reduction in PVR   from Baseline  19.9%  Based on first 40 patients who completed Week 16 of treatment, including active and placebo arms  6-Minute Walk Distance3  Mean Improvement in Distance  43 Meters  Based on first 40 patients who completed Week 16 of treatment, including active and placebo arms  Phase 2 PAH Trial Fully Enrolled with 102 Patients. Readout Expected in Mid-2025  * “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.DMC=Data Monitoring Committee 
 
 Gene Therapy &   Pre-Clinical Research  Gene Therapy  Duchenne Muscular Dystrophy (DMD)1  A rare genetic disorder that causes progressive muscle degeneration, primarily affecting young boys  Pre-Clinical Pipeline:  INS1202: ALS (Gene Therapy)  INS1203: Stargardt Disease (Gene Therapy)  Next Gen DPP1 (Multiple Indications)  Other Pre-Clinical Research (Multiple Indications)  1 INS1201 is Insmed’s lead gene therapy, an intrathecally-delivered treatment for patients with Duchenne muscular dystrophy (DMD); Plans to initiate a clinical trial in patients with DMD in the first half of 2025.   DMD: Duchenne muscular dystrophy; ALS: amyotrophic lateral sclerosis 
 
 Research Engine Has Produced First Product Candidate  Gene Therapy IND for Duchenne Muscular Dystrophy Cleared in December 20241  Our Approach  Low Upfront Costs  to acquire   the technologies  Low Ongoing Expense  <20% of   expenditures  Expect ~1-2 IND filings per year  Gene Therapy   Deimmunized Protein Engineering Using AI  Synthetic Rescue  RNA End-Joining  Our Platforms  1 INS1201 is Insmed’s lead gene therapy, an intrathecally-delivered treatment for patients with Duchenne muscular dystrophy (DMD); Plans to initiate a clinical trial in patients with DMD in the first half of 2025.  
 
 * 30-day safety observation period between each participant in each cohort  IDMC=Independent Data Monitoring Committee   Key Trial Information  Single dose via intrathecal administration  30-day safety monitoring period between each patient in each cohort  Patients must be ambulatory at time of screening  Primary Endpoint  Safety and Tolerability  Secondary Endpoints  Muscle dystrophin levels  Dose Finding  Exploratory Endpoints  Multiple age-appropriate functional and developmental outcomes  ASCEND  ASCEND Phase 1 in Duchenne Muscular Dystrophy (DMD)  Trial summary  Cohort 2: 3 - <5yrs  INS1201 IT  Dose Strength B  (3 patients)*  Cohort 1: 3 - <5yrs  INS1201 IT  Dose Strength A  (3 patients)*  Cohort 3: 2yrs  INS1201 IT  Dose Strength A  (3 patients)*  Cohort 4: 2yrs  INS1201 IT  Dose Strength B  (3 patients)*  The IDMC will meet after the completion of the 30-day safety period for the last participant in cohorts 1 and 3 for a safety review before initiating the next cohort(s)   SCREENING  INS1201 is Insmed’s lead gene therapy, an intrathecally-delivered treatment for patients with Duchenne muscular dystrophy (DMD); Plans to initiate a clinical trial in patients with DMD in the first half of 2025.  
 
 Our Culture is Our Greatest Strength  In a recent survey*  >90% of   Employees  who responded said they felt:  * The 2024 annual Insmed Pulse Survey included 89.4% participation across the organization  Proud to work at Insmed  Inspired by what we do  Confident in Insmed’s future  Driven to do their best work  No. 1 on Science’s Top BioPharma Employers List  Certified as a U.S. Great Place to Work  Four years in a row  Four years in a row 
 
 Appendix 
 
 Strong, Long-Dated Patent Exclusivity  a Based on U.S. Patent Application No.18/024,040 and ex-U.S. counterpart applications issuing as patents. Additionally, given the complexity of drug product (liposomal inhalation with specific nebulizer), required bioequivalence testing could be difficult and lead to few generic entrants.  b Based on potential patent term extension (PTE) in the U.S. and US Application No. 16/975,292, which has been allowed, issuing in the U.S. c Based on SPC and Japan PTE being capped at 5 yearsd Based on US Application No. 18/513,377 and ex-US counterparts issuing as a patent  Brensocatib  ARIKAYCE  TPIP  Current   Exclusivity  Potential   Exclusivity  Current   Exclusivity  Potential   Exclusivity  Current   Exclusivity  Potential   Exclusivity   2034 2041d   2034 2041d   2034 2041d   2040 2040+b   2039 2040+c   2035 2040c   2035 2041a   2035 2041a   2035 2041a  US  EU  Japan 
 
 Manufacturing  Brensocatib  ARIKAYCE  TPIP  API  Drug Product  Spain  Canada   API  Drug Product  Taiwan   US   API  Drug Product  Italy  UK   To come online  Canada 
 
 ARISE: QoL-B Respiratory Score Changes* Show Clear Separation When PGI-S Category Improved vs. No Change or Decline  QoL-B: Quality of Life-Bronchiectasis Respiratory Domain questionnaire | PGI-S: Patient Global Impression of Severity | MAC: Mycobacterium avium complex   * Includes patient data from both the treatment and control arm of the ARISE study  Estimated Meaningful Score Difference Region is +12.2 to +16.7 points  ARIKAYCE  Estimated Meaningful Score Difference for QoL-B Resp. in MAC patients is +14.8 points 
 
 QoL-B Respiratory Domain  ALIS+AZI+ETH  N=48  ELC+AZI+ETH  N=51  Difference  # of Participants Evaluated for Change from Baseline to Month 7  43  48  # of Missing Change from Baseline to Month 7 Value  5  3  Change in PRO Score from Baseline to Month 7 (LS-Mean)  12.24  7.76  4.48   (95% Confidence Interval)   (7.96, 16.53)  (3.76, 11.77)  (-0.97, 9.93)   p-value  0.1073  ARISE: Comparison Between Treatment Arms Shows Clear Favorable Trend for ARIKAYCE Arm  ALIS: amikacin liposome inhalation suspension | AZI: azithromycin | ELC: empty liposome control | ETH: ethambutol | LS: least-squares | QoL-B: Quality of Life-Bronchiectasis Respiratory Domain questionnaire |   PRO: patient-reported outcome  ITT analysis with multiple imputation for missing data  ANCOVA model includes change from baseline as response variable and treatment, baseline Resp Score, and history of MAC lung infection as independent variables.  ARIKAYCE 
 
 ARISE: QoL-B Respiratory Score Changes from Baseline to Month 7   Show Clear Separation for ARIKAYCE Group  CDF: cumulative distribution function | ALIS: amikacin liposome inhalation suspension | AZI: azithromycin; ELC: empty liposome control | ETH: ethambutol |   QoL-B: Quality of Life-Bronchiectasis Respiratory Domain questionnaire | MAC: Mycobacterium avium complex  ARIKAYCE  Estimated Meaningful Score Difference for QoL-B Resp. in MAC patients is +14.8 points  Estimated Meaningful Score Difference Region is +12.2 to +16.7 points  43.8% of patients in ARIKAYCE arm achieved >14.8-point improvement   33.3% of patients in control arm achieved >14.8-point improvement 
 
 ARISE: Significantly* Higher, More Persistent Culture Conversion in ARIKAYCE Arm  ALIS: amikacin liposome inhalation suspension | AZI: azithromycin | ELC: empty liposome control | ETH: ethambutol  * “Nominally statistically significant” because no hierarchical testing or adjustment for multiplicity was conducted in ARISE.  Difference at Month 7 Nominally Statistically Significant*  (p-value = 0.0010)  Proportions estimated by Standardized Logistic Regression with treatment group and History of MAC Lung Infection as factors in the model with multiple imputation for missing data.  ARIKAYCE 
 
 ARISE: For Those Who Achieved Culture Conversion, Patients in ARIKAYCE Arm Converted Faster  ALIS: amikacin liposome inhalation suspension | AZI: azithromycin | ELC: empty liposome control | ETH: ethambutol  ~74% of converters on ARIKAYCE achieved clinical conversion at the first possible time point (Month 2) vs. ~47% for the control arm  ARIKAYCE 
 
 ALIS+AZI+ETH (N=48)  Culture Converted   by Month 6  Not Culture Converted   by Month 6  Difference  Change in QoL-B Resp. Score   (Baseline to Month 7)  +15.74  +3.53  +12.21    (95% Confidence Interval)   (+11.45, +20.03)  (-5.34, +12.41)  (+2.33, +22.08)    p-value   0.0167  Culture Converted   by Month 7  Not Culture Converted   by Month 7  Difference  Change in QoL-B Resp. Score   (Baseline to Month 7)  +14.89  +4.50  +10.39    (95% Confidence Interval)   (+10.47, +19.31)  (-4.40, +13.40)  (+0.42, +20.37)    p-value   0.0416  ARISE: Correlation Shown Between Culture Conversion and QoL-B Respiratory Score Changes in ARIKAYCE Arm  ALIS: amikacin liposome inhalation suspension | AZI: azithromycin | ETH: ethambutol | LS: least-squares; QoL-B: Quality of Life-Bronchiectasis Respiratory Domain questionnaire  ANCOVA model includes change from baseline as the response variable and baseline Resp Score, and culture conversion status as independent variables using observed data.  ARIKAYCE 
 
 ALIS+AZI+ETH  N=48  ELC+AZI+ETH  N=51  Total  N=99  Study completion (%)  44 (91.7)  48 (94.1)  92 (92.9)  Treatment completion with all 3 drugs (%)  35 (72.9)  47 (92.2)  82 (82.8)   Early ALIS/ELC discontinuation (%)  11 (22.9)  4 (7.8)  15 (15.2)  Any TEAE (%)  44 (91.7)  41 (80.4)  85 (85.9)   Dysphonia (%)  20 (41.7)  2 (3.9)  22 (22.2)   Cough (%)  13 (27.1)  4 (7.8)  17 (17.2)   Diarrhea (%)  13 (27.1)  13 (25.5)  26 (26.3)   COVID-19 (%)   6 (12.5)  5 (9.8)  11 (11.1)  # Participants with Serious TEAE (%)  7 (14.6)  3 (5.9)  10 (10.1)  ARISE: No New or Unexpected Safety Signals in ARISE  ALIS: amikacin liposome inhalation suspension | AZI: azithromycin | ELC: empty liposome control | ETH: ethambutol | TEAE: treatment-emergent adverse event; EAR: exposure adjusted incidence rate  All serious TEAEs unrelated to ARIKAYCE   ARIKAYCE 
 
 ASPEN: Annualized Rate of Adjudicated Pulmonary Exacerbations Over 52 Weeks  a Exacerbations were adjudicated events in the ITT analysis set analyzed using a negative binomial model b P value is statistically significant when adjusted for multiplicity control  c See Appendix for subgroup analysis | ITT=intention-to-treat  Annualized rate of exacerbationsa  21.1% Risk reduction  19.4% Risk reduction  Brensocatib 10 mgn=583  Brensocatib 25 mgn=575  Rate ratio vs. placebo  (95% CI)   0.789  (0.680–0.916)  0.806  (0.694–0.936)  P value  0.0019b  0.0046b  Primary endpoint  Risk Reduction Consistent Across Nearly All Pre-specified Subgroupsc  Brensocatib 
 
 ASPEN: Change From Baseline in Post-Bronchodilator FEV1 at Week 52  a % Predicted FEV1 analyzed using a linear repeated measures model in the ITT analysis set. b P value is statistically significant when adjusted for multiplicity controlc See Appendix for subgroup analysis  BD=bronchodilator | FEV1=forced expiratory volume in 1 second | ITT=intention-to-treat | LS=least squares  Secondary endpoint  Brensocatib 25 mg showed a 38 mL less FEV1 decline vs. placebo  (with similar results observed across  all prespecified subgroupsc)  Brensocatib 10 mg  Brensocatib 25 mg  Placebo  LS mean change from baseline to week 52 in post-BD FEV1 (mL)  −50  −24  −62  LS mean difference vs placebo in post-BD FEV1 (mL)  11  38  –  P value vs placebo  0.3841  0.0054b  –  LS mean (SE) change from baseline   in post-BD FEV1, mLa  1  16  28  40  52  Week  0  −20  −40  −60  579  545  529  513  475  571  529  523  494  487  563  522  513  494  468  Brensocatib 10 mg   Brensocatib 25 mg  Placebo  Placebo  Brensocatib 25 mg  Brensocatib 10 mg  Number of patients with observation  Brensocatib 
 
 ASPEN: Change From Baseline in QoL-B Respiratory Symptom Domain Score at Week 52  a Adult patients only. b P value vs placebo calculated using a linear repeated measures model in the ITT analysis set. c Nominally significant P value.LS=least squares | QoL-B RSS=Quality of Life-Bronchiectasis Questionnaire Respiratory Symptom Domain score.  Secondary endpoint  Brensocatib 25 mg showed a nominally significant improvement in QoL-B RSS of 3.8 points vs placebo  Brensocatib 10 mg  Brensocatib 25 mg  Placebo  LS mean change from baseline to week 52 in QoL-B RSS  6.841  8.575  4.809  LS mean difference vs placebo in QoL-B RSS  2.031  3.766  –  P value vs placebob  0.0594  0.0004c  –  1  4  8  12  16  20  24  28  32  36  40  44  48  52  0  2  4  6  8  LS mean (SE) change from baseline in QoL-B RSS  488  473  463  456  453  450  446  443  418  418  435  423  416  381  497  476  464  459  454  456  442  446  434  438  432  426  423  394  487  457  459  452  448  437  421  434  428  411  408  405  399  366  Placebo  Brensocatib 25 mg  Brensocatib 10 mg  Number of patients with observationa  Brensocatib 10 mg   Brensocatib 25 mg  Placebo  Week  Brensocatib 
 
 ASPEN: TEAEs and Treatment Discontinuations Were Comparable in Brensocatib and Placebo Arms  TEAE=treatment-emergent adverse event * As reported by study investigators  Brensocatib 10 mgn=582  Brensocatib 25 mgn=574  Placebon=563  Any TEAE, n (%)  452 (77.7)  440 (76.7)  448 (79.6)  Severe TEAE, n (%)   74 (12.7)  67 (11.7)  90 (16.0)  Serious TEAE, n (%)   101 (17.4)  97 (16.9)  108 (19.2)  TEAE leading to death, n (%)  3 (0.5)  4 (0.7)  7 (1.2)  TEAE leading to treatment discontinuation, n (%)   25 (4.3)  22 (3.8)  23 (4.1)  TEAEs of special interest*, n (%)  42 (7.2)  56 (9.8)  53 (9.4)  Hyperkeratosis, n (%)  8 (1.4)  17 (3.0)  4 (0.7)  Periodontal/gingival event, n (%)  8 (1.4)  12 (2.1)  15 (2.7)  Severe infection, n (%)  4 (0.7)  7 (1.2)  4 (0.7)  Pneumonia, n (%)  23 (4.0)  27 (4.7)  33 (5.9)  Rates of TEAEs of Special Interest* Were Comparable Between Treatment Arms and Placebo  Brensocatib 
 
 ASPEN: Change From Baseline in Post-Bronchodilator FVC at Week 52  Brensocatib  aFVC analyzed using a linear repeated measures model in the ITT analysis set. bNominally significant P value.BD=bronchodilator; FVC=forced vital capacity; ITT=intention-to-treat; LS=least squares.  Exploratory endpoint  Brensocatib 10 mg  Brensocatib 25 mg  Placebo  LS mean change from baseline to week 52 in post-BD FVC (mL)  -51  -12  -87  LS mean difference vs placebo in post-BD FVC (mL)  36  75  –  P value vs placebo  0.0331b  <0.0001b  –  Placebo  Brensocatib 25 mg  Brensocatib 10 mg  Number of patients with observation  545  529  513  475  529  523  494  487  522  513  494  468  579  571  563  1  16  28  40  52  20  0  −40  −80  Brensocatib 10 mg   Brensocatib 25 mg  Placebo  −100  −20  −60  LS mean (SE) change from baseline   in post-BD FVC, mLa  Week 
 
 ASPEN: Change From Baseline in Average Daily BEST Score  Brensocatib  a Average daily change in the BEST score analyzed with an analysis of covariance model in adult patients in the ITT analysis set. | b Nominally significant P value.BEST, Bronchiectasis Exacerbation and Symptoms Tool.  Exploratory endpoint  Brensocatib 10 mg  Brensocatib 25 mg  Placebo  LS mean change from baseline in 52-week average daily BEST score  −0.594  −0.999  −0.426  LS mean difference vs placebo in BEST score  −0.168  −0.572  –  P value vs placebo  0.1696  <0.0001b  –  Mean change from baseline in BEST scorea  Week  Number of patients with observationa  Placebo  Brensocatib 25 mg  Brensocatib 10 mg  558  553  555  547  544  534  528  520  515  506  504  505  497  488  557  552  542  540  534  529  517  520  522  513  507  505  499  494  549  549  541  534  527  520  517  508  505  499  493  490  485  477  1  4  8  12  16  20  24  28  32  36  40  44  48  52  −1.5  −1.0  −0.5  0.0  Brensocatib 10 mg   Brensocatib 25 mg   Placebo 
 
 Subgroup  Brensocatib 10 mg  (N=583)  n (%)  Brensocatib 25 mg  (N=575)  n (%)  Placebo (N=563)  n (%)  Brensocatib 10 mg  Rate ratio  (95% CI)  Brensocatib 10 mg  Rate ratio  (95% CI)  Brensocatib 25 mg  Rate ratio  (95% CI)  Brensocatib 25 mg  Rate ratio  (95% CI)  Overall  583 (100.0)  575 (100.0)  563 (100.0)  0.79 (0.68-0.92)  0.81 (0.69-0.94)  Age  12 to <18 years  17 (2.9)  16 (2.8)  8 (1.4)  0.41 (0.11-1.58)  0.73 (0.20-2.68)  18 to <65 years  289 (49.6)  257 (44.7)  295 (52.4)  0.81 (0.66-0.99)  0.70 (0.57-0.86)  ≥65 years  277 (47.5)  302 (52.5)  260 (46.2)  0.79 (0.63-0.99)  0.93 (0.74-1.15)  <75 years  500 (85.8)  491 (85.4)  470 (83.5)  0.81 (0.69-0.95)  0.79 (0.68-0.93)  ≥75 years  83 (14.2)  84 (14.6)  93 (16.5)  0.61 (0.40-0.94)  0.89 (0.59-1.34)  ≥18 years  566 (97.1)  559 (97.2)  555 (98.6)  0.80 (0.69-0.93)  0.80 (0.69-0.93)  Sex  Female  385 (66.0)  360 (62.6)  362 (64.3)  0.81 (0.68-0.96)  0.83 (0.70-1.00)  Male  198 (34.0)  215 (37.4)  201 (35.7)  0.75 (0.57-0.99)  0.75 (0.57-0.98)  Race  American Indian or Alaska Native  8 (1.4)  6 (1.0)  9 (1.6)  NE  NE  Asian  63 (10.8)  64 (11.1)  64 (11.4)  0.40 (0.23-0.67)  0.41 (0.24-0.70)  Black or African American  2 (0.3)  5 (0.9)  3 (0.5)  NE  NE  Native Hawaiian or Other Pacific Islander  1 (0.2)  0 (0.0)  1 (0.2)  NE  NE  White  431 (73.9)  430 (74.8)  405 (71.9)  0.79 (0.67-0.94)  0.79 (0.67-0.93)  Othera  15 (2.6)  13 (2.3)  11 (2.0)  NE  NE  Ethnicity  Hispanic or Latino  177 (30.4)  164 (28.5)  170 (30.2)  0.94 (0.70-1.26)  0.92 (0.69-1.24)  Not Hispanic or Latino  391 (67.1)  397 (69.0)  373 (66.3)  0.73 (0.61-0.87)  0.77 (0.64-0.92)  Number of PEs in prior 12 months  2  411 (70.5)  412 (71.7)  396 (70.3)  0.73 (0.60-0.89)  0.78 (0.65-0.95)  ≥3  172 (29.5)  163 (28.3)  167 (29.7)  0.89 (0.72-1.11)  0.85 (0.67-1.07)  PE=pulmonary exacerbationaOther races were Asian/Maori, Australian Aboriginal, Brown Race, Latin, Latino, Maori, Mestizo, Mexican, mixed, mixed race, New Zealand Maori, other mixed, and Puerto Rican.  Metersky ML, et al. CHEST Annual Meeting, Boston, MA, USA, October 6-9, 2024. Poster 3186.  0.1  1  Brensocatib 10 mg better  Placebo better  10  0.1  1  Brensocatib 25 mg better  Placebo better  10  ASPEN: Annualized Rate of Adjudicated Pulmonary Exacerbations Over 52 Weeks Among Prespecified Subgroups (1 of 3)  Brensocatib 
 
 Subgroup  Brensocatib 10 mg  (N=583)  n (%)  Brensocatib 25 mg  (N=575)  n (%)  Placebo (N=563)  n (%)  Brensocatib 10 mg  Rate ratio  (95% CI)  Brensocatib 10 mg  Rate ratio  (95% CI)  Brensocatib 25 mg  Rate ratio  (95% CI)  Brensocatib 25 mg  Rate ratio  (95% CI)  Chronic use of antibiotics  Yes  146 (25.0)  154 (26.8)  133 (23.6)  0.76 (0.59-0.97)  0.74 (0.57-0.96)  No  437 (75.0)  421 (73.2)  430 (76.4)  0.80 (0.66-0.96)  0.82 (0.68-0.98)  Maintenance use of macrolides  Yes  110 (18.9)  114 (19.8)  105 (18.7)  0.79 (0.58-1.06)  0.79 (0.58-1.08)  No  473 (81.1)  461 (80.2)  458 (81.3)  0.78 (0.66-0.93)  0.80 (0.67-0.95)  P. aeruginosa colonization status  Positive  203 (34.8)  205 (35.7)  199 (35.3)  0.75 (0.59-0.95)  0.88 (0.70-1.10)  Negative  380 (65.2)  370 (64.3)  364 (64.7)  0.81 (0.67-0.98)  0.77 (0.64-0.94)  BSI score  ≤4  136 (23.3)  150 (26.1)  148 (26.3)  0.77 (0.55-1.07)  0.69 (0.50-0.95)  5-8  275 (47.2)  239 (41.6)  220 (39.1)  0.71 (0.56-0.89)  0.77 (0.60-0.97)  ≥9  168 (28.8)  182 (31.7)  195 (34.6)  0.92 (0.72-1.17)  0.92 (0.73-1.17)  <Median  286 (49.1)  278 (48.3)  275 (48.8)  0.77 (0.61-0.97)  0.74 (0.59-0.92)  ≥Median  293 (50.3)  293 (51.0)  288 (51.2)  0.80 (0.66-0.97)  0.86 (0.70-1.04)  BE-CT score  <Median  274 (47.0)  273 (47.5)  255 (45.3)  0.78 (0.62-0.98)  0.91 (0.73-1.14)  ≥Median  309 (53.0)  302 (52.5)  308 (54.7)  0.81 (0.67-0.98)  0.74 (0.61-0.91)  Post-BD FEV1 (% predicted)  <50%  101 (17.3)  102 (17.7)  98 (17.4)  1.01 (0.70-1.46)  1.23 (0.86-1.75)  ≥50%  478 (82.0)  469 (81.6)  465 (82.6)  0.74 (0.62-0.87)  0.72 (0.61-0.85)  BD=bronchodilator; BE-CT=bronchiectasis computed tomography; BSI=Bronchiectasis Severity Index;   FEV1=forced expiratory volume in 1 second  Metersky ML, et al. CHEST Annual Meeting, Boston, MA, USA, October 6-9, 2024. Poster 3186.  0.1  1  Brensocatib 10 mg better  Placebo better  10  0.1  1  Brensocatib 25 mg better  Placebo better  10  ASPEN: Annualized Rate of Adjudicated Pulmonary Exacerbations Over 52 Weeks Among Prespecified Subgroups (2 of 3)  Brensocatib 
 
 COPD=chronic obstructive pulmonary disease; PE=pulmonary exacerbationbIncludes the United States and Canada. cIncludes Austria, Belgium, Bulgaria, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Serbia, Slovakia, Spain, Turkey, and United Kingdom. dIncludes Argentina, Australia, Brazil, Chile, Colombia, Korea (the Republic of), Malaysia, Mexico, New Zealand, Peru, Taiwan, and Thailand. eIncludes Argentina, Brazil, Chile, Colombia, Mexico, and Peru. fIncludes Bulgaria, Greece, Hungary, Latvia, Poland, Serbia, Slovakia, and Turkey. gIncludes Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Portugal, Spain, United Kingdom, and United States. hIncludes Israel, Japan, Korea (the Republic of), Malaysia, Taiwan, and Thailand. iIncludes Australia and New Zealand.   Metersky ML, et al. CHEST Annual Meeting, Boston, MA, USA, October 6-9, 2024. Poster 3186.  Subgroup  Brensocatib 10 mg  (N=583)  n (%)  Brensocatib 25 mg  (N=575)  n (%)  Placebo (N=563)  n (%)  Brensocatib 10 mg  Rate ratio  (95% CI)  Brensocatib 10 mg  Rate ratio  (95% CI)  Brensocatib 25 mg  Rate ratio  (95% CI)  Brensocatib 25 mg  Rate ratio  (95% CI)  Stratification region  North Americab  84 (14.4)  83 (14.4)  81 (14.4)  0.66 (0.45-0.97)  0.83 (0.59-1.18)  Europec  231 (39.6)  221 (38.4)  221 (39.3)  0.90 (0.72-1.14)  0.86 (0.70-1.08)  Japan  30 (5.1)  28 (4.9)  29 (5.2)  0.37 (0.16-0.87)  0.32 (0.14-0.75)  Rest of Worldd  238 (40.8)  243 (42.3)  232 (41.2)  0.79 (0.63-0.99)  0.83 (0.65-1.06)  Geographic region  South Americae  174 (29.8)  157 (27.3)  157 (27.9)  0.91 (0.68-1.23)  0.92 (0.67-1.26)  Eastern Europef  75 (12.9)  68 (11.8)  72 (12.8)  0.54 (0.29-0.99)  0.62 (0.35-1.08)  Western countriesg  216 (37.0)  205 (35.7)  201 (35.7)  0.86 (0.70-1.07)  0.86 (0.69-1.06)  Asian countriesh  81 (13.9)  91 (15.8)  88 (15.6)  0.62 (0.41-0.94)  0.62 (0.41-0.94)  Oceaniai  37 (6.3)  54 (9.4)  45 (8.0)  0.79 (0.54-1.17)  0.77 (0.51-1.18)  Blood eosinophil count  ≥300/mm3  115 (19.7)  111 (19.3)  106 (18.8)  0.72 (0.52-0.99)  0.86 (0.62-1.20)  <300/mm3  465 (79.8)  461 (80.2)  452 (80.3)  0.81 (0.68-0.95)  0.79 (0.67-0.94)  Smoking status  Former smoker  164 (28.1)  163 (28.3)  183 (32.5)  0.83 (0.64-1.07)  0.75 (0.58-0.97)  Never smoked  419 (71.9)  412 (71.7)  380 (67.5)  0.78 (0.65-0.93)  0.84 (0.70-1.01)  Use of inhaled steroids  Yes  324 (55.6)  324 (56.3)  352 (62.5)  0.83 (0.69-0.99)  0.76 (0.63-0.92)  No  259 (44.4)  251 (43.7)  211 (37.5)  0.78 (0.60-1.01)  0.93 (0.73-1.20)  History of asthma  Yes  101 (17.3)  109 (19.0)  111 (19.7)  0.96 (0.71-1.30)  0.99 (0.72-1.34)  No  482 (82.7)  466 (81.0)  452 (80.3)  0.75 (0.63-0.89)  0.76 (0.64-0.90)  History of COPD  Yes  77 (13.2)  83 (14.4)  102 (18.1)  0.70 (0.44-1.13)  0.81 (0.56-1.18)  No  506 (86.8)  492 (85.6)  461 (81.9)  0.80 (0.68-0.93)  0.80 (0.68-0.95)  Hospitalized in prior 24 months for PE  Yes  146 (25.0)  133 (23.1)  142 (25.2)  0.89 (0.68-1.16)  0.81 (0.61-1.07)  No  437 (75.0)  442 (76.9)  421 (74.8)  0.76 (0.63-0.90)  0.81 (0.68-0.96)  0.1  1  Brensocatib 10 mg better  Placebo better  10  0.1  1  Brensocatib 25 mg better  Placebo better  10  ASPEN: Annualized Rate of Adjudicated Pulmonary Exacerbations Over 52 Weeks Among Prespecified Subgroups (3 of 3)  Brensocatib 
 
 Subgroup  Brensocatib 10 mg  (N=583)  n (%)  Brensocatib 25 mg  (N=575)  n (%)  Placebo (N=563)  n (%)  Brensocatib 10 mg  LS mean difference  (95% CI)  Brensocatib 10 mgLS mean difference  (95% CI)  Brensocatib 25 mg  LS mean difference  (95% CI)  Brensocatib 25 mg  LS mean difference  (95% CI)  Overall  583 (100.0)  575 (100.0)  563 (100.0)  11 (–14 to 37)  38 (11 to 65)  Age  12 to <18 years  17 (2.9)  14 (2.4)  8 (1.4)  287 (–134 to 707)  324 (–96 to 745)  18 to <65 years  281 (48.2)  243 (42.3)  280 (49.7)  –4 (–43 to 35)  31 (–11 to 74)  ≥65 years  266 (45.6)  294 (51.1)  251 (44.6)  21 (–12 to 55)  42 (9 to 75)  <75 years  482 (82.7)  470 (81.7)  448 (79.6)  10 (–19 to 39)  40 (10 to 70)  ≥75 years  82 (14.1)  81 (14.1)  91 (16.2)  23 (–35 to 80)  29 (–26 to 83)  ≥18 years  547 (93.8)  537 (93.4)  531 (94.3)  8 (–18 to 34)  36 (10 to 63)  Sex  Female  371 (63.6)  342 (59.5)  347 (61.6)  –3 (–32 to 26)  32 (2 to 62)  Male  193 (33.1)  209 (36.3)  192 (34.1)  42 (–9 to 94)  50 (–1 to 102)  Race  American Indian or Alaska Native  8 (1.4)  6 (1.0)  8 (1.4)  256 (–233 to 746)  256 (34 to 478)  Asian  63 (10.8)  63 (11.0)  58 (10.3)  18 (–27 to 63)  69 (24 to 114)  Black or African American  1 (0.2)  5 (0.9)  2 (0.4)  NE  NE  Native Hawaiian or Other Pacific Islander  1 (0.2)  0 (0.0)  1 (0.2)  NE  NE  White  416 (71.4)  409 (71.1)  392 (69.6)  11 (–19 to 40)  27 (–4 to 58)  Othera  14 (2.4)  13 (2.3)  10 (1.8)  30 (–118 to 178)  152 (–96 to 399)  Ethnicity  Hispanic or Latino  171 (29.3)  156 (27.1)  164 (29.1)  19 (–36 to 75)  29 (–26 to 84)  Not Hispanic or Latino  378 (64.8)  382 (66.4)  355 (63.1)  6 (–23 to 35)  40 (9 to 70)  Number of PEs in prior 12 months  2  395 (67.8)  392 (68.2)  375 (66.6)  11 (–21 to 44)  38 (7 to 70)  ≥3  169 (29.0)  159 (27.7)  164 (29.1)  12 (–30 to 55)  35 (–16 to 87)  FEV1=forced expiratory volume in 1 second; LS=least squares; PE=pulmonary exacerbationa Other races were Asian/Maori, Australian Aboriginal, Brown Race, Latin, Latino, Maori, Mestizo, Mexican, mixed, mixed race, New Zealand Maori, other mixed, and Puerto Rican.   Aksamit TR, et al. CHEST Annual Meeting, Boston, MA, USA, October 6-9, 2024. Poster 3185.  Placebo better  Brensocatib 10 mg better  -300  -200  -100  0  100  200  300  400  500  600  700  800  Placebo better  Brensocatib 25 mg better  -300  -200  -100  0  100  200  300  400  500  600  700  800  ASPEN: Change From Baseline in Post-Bronchodilator FEV1 at Week 52 Among Prespecified Subgroups (1 of 3)  Brensocatib 
 
 Subgroup  Brensocatib 10 mg  (N=583)  n (%)  Brensocatib 25 mg  (N=575)  n (%)  Placebo (N=563)  n (%)  Brensocatib 10 mg  LS mean difference  (95% CI)  Brensocatib 10 mgLS mean difference  (95% CI)  Brensocatib 25 mg  LS mean difference  (95% CI)  Brensocatib 25 mg  LS mean difference  (95% CI)  Chronic use of antibiotics  Yes  141 (24.2)  147 (25.6)  128 (22.7)  –22 (–75 to 30)  40 (–9 to 89)  No  423 (72.6)  404 (70.3)  411 (73.0)  22 (–8 to 52)  37 (5 to 68)  Maintenance use of macrolides  Yes  106 (18.2)  110 (19.1)  104 (18.5)  –15 (–70 to 39)  44 (–16 to 104)  No  458 (78.6)  441 (76.7)  435 (77.3)  17 (–12 to 47)  35 (2 to 73)  P. aeruginosa colonization status  Positive  199 (34.1)  194 (33.7)  190 (33.7)  4 (–32 to 39)  40 (2 to 78)  Negative  365 (62.6)  357 (62.1)  349 (62.0)  16 (–19 to 51)  37 (2 to 73)  BSI score  ≤4  131 (22.5)  144 (25.0)  144 (25.6)  –7 (–68 to 54)  23 (–33 to 80)  5-8  270 (46.3)  231 (40.2)  208 (36.9)  23 (–15 to 61)  22 (–17 to 60)  ≥9  163 (28.0)  176 (30.6)  187 (33.2)  17 (–22 to 56)  74 (28 to 121)  <Median  277 (47.5)  268 (46.6)  261 (46.4)  0 (–40 to 40)  18 (–21 to 58)  ≥Median  287 (49.2)  283 (49.2)  278 (49.4)  26 (–8 to 59)  58 (22 to 94)  BE-CT score  <Median  266 (45.6)  261 (45.4)  249 (44.2)  8 (–33 to 50)  30 (–13 to 72)  ≥Median  298 (51.1)  290 (50.4)  290 (51.5)  17 (–15 to 49)  48 (15 to 81)  Post-BD FEV1 (% predicted)  <50%  98 (16.8)  96 (16.7)  92 (16.3)  –10 (–60 to 40)  32 (–23 to 87)  ≥50%  466 (79.9)  455 (79.1)  447 (79.4)  16 (–13 to 46)  39 (9 to 69)  BD=bronchodilator; BE-CT=bronchiectasis computed tomography; BSI=Bronchiectasis Severity Index; FEV1=forced expiratory volume in 1 second; LS=least squares  Aksamit TR, et al. CHEST Annual Meeting, Boston, MA, USA, October 6-9, 2024. Poster 3185.  Placebo better  Brensocatib 10 mg better  -300  -200  -100  0  100  200  300  400  500  600  700  800  Placebo better  Brensocatib 25 mg better  -300  -200  -100  0  100  200  300  400  500  600  700  800  ASPEN: Change From Baseline in Post-Bronchodilator FEV1 at Week 52 Among Prespecified Subgroups (2 of 3)  Brensocatib 
 
 COPD=chronic obstructive pulmonary disease; FEV1=forced expiratory volume in 1 second; LS=least squares; PE=pulmonary exacerbationbIncludes the United States and Canada. cIncludes Austria, Belgium, Bulgaria, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Serbia, Slovakia, Spain, Turkey, and United Kingdom. dIncludes Argentina, Australia, Brazil, Chile, Colombia, Korea (the Republic of), Malaysia, Mexico, New Zealand, Peru, Taiwan, and Thailand. eIncludes Argentina, Brazil, Chile, Colombia, Mexico, and Peru. fIncludes Bulgaria, Greece, Hungary, Latvia, Poland, Serbia, Slovakia, and Turkey. gIncludes Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Portugal, Spain, United Kingdom, and United States. hIncludes Israel, Japan, Korea (the Republic of), Malaysia, Taiwan, and Thailand. iIncludes Australia and New Zealand.   Aksamit TR, et al. CHEST Annual Meeting, Boston, MA, USA, October 6-9, 2024. Poster 3185.  Subgroup  Brensocatib 10 mg  (N=583)  n (%)  Brensocatib 25 mg  (N=575)  n (%)  Placebo (N=563)  n (%)  Brensocatib 10 mg  LS mean difference  (95% CI)  Brensocatib 10 mgLS mean difference  (95% CI)  Brensocatib 25 mg  LS mean difference  (95% CI)  Brensocatib 25 mg  LS mean difference  (95% CI)  Stratification region  North Americab  79 (13.6)  81 (14.1)  75 (13.3)  20 (–44 to 85)  77 (–5 to 159)  Europec  223 (38.3)  211 (36.7)  214 (38.0)  5 (–36 to 46)  35 (–8 to 78)  Japan  30 (5.1)  28 (4.9)  29 (5.2)  47 (–20 to 115)  97 (32 to 162)  Rest of Worldd  232 (39.8)  231 (40.2)  221 (39.3)  11 (–32 to 54)  20 (–20 to 60)  Geographic region  South Americae  169 (29.0)  149 (25.9)  151 (26.8)  10 (–46 to 67)  13 (–41 to 66)  Eastern Europef  74 (12.7)  65 (11.3)  67 (11.9)  48 (–23 to 120)  41 (–50 to 131)  Western countriesg  206 (35.3)  196 (34.1)  193 (34.3)  1 (–42 to 44)  56 (8 to 104)  Asian countriesh  79 (13.6)  90 (15.7)  84 (14.9)  –1 (–44 to 42)  39 (–4 to 82)  Oceaniai  36 (6.2)  51 (8.9)  44 (7.8)  28 (–51 to 108)  32 (–44 to 109)  Blood eosinophil count  ≥300/mm3  110 (18.9)  110 (19.1)  101 (17.9)  0 (–57 to 57)  43 (–24 to 110)  <300/mm3  452 (77.5)  438 (76.2)  434 (77.1)  16 (–13 to 46)  37 (7 to 66)  Smoking status  Former smoker  159 (27.3)  159 (27.7)  177 (31.4)  11 (–33 to 55)  51 (8 to 93)  Never smoked  405 (69.5)  392 (68.2)  362 (64.3)  12 (–20 to 44)  33 (–1 to 66)  Use of inhaled steroids  Yes  314 (53.9)  312 (54.3)  337 (59.9)  13 (–21 to 47)  41 (6 to 76)  No  250 (42.9)  239 (41.6)  202 (35.9)  10 (–29 to 49)  37 (–4 to 78)  History of asthma  Yes  96 (16.5)  105 (18.3)  106 (18.8)  –23 (–89 to 42)  24 (–41 to 90)  No  468 (80.3)  446 (77.6)  433 (76.9)  20 (–8 to 48)  42 (12 to 71)  History of COPD  Yes  77 (13.2)  80 (13.9)  96 (17.1)  10 (–45 to 65)  39 (–12 to 90)  No  487 (83.5)  471 (81.9)  443 (78.7)  10 (–19 to 39)  37 (7 to 67)  Hospitalized in prior 24 months for PE  Yes  141 (24.2)  130 (22.6)  134 (23.8)  58 (4 to 113)  110 (53 to 166)  No  423 (72.6)  421 (73.2)  405 (71.9)  –3 (–32 to 26)  15 (–15 to 44)  Placebo better  Brensocatib 10 mg better  -300  -200  -100  0  100  200  300  400  500  600  700  800  Placebo better  Brensocatib 25 mg better  -300  -200  -100  0  100  200  300  400  500  600  700  800  ASPEN: Change From Baseline in Post-Bronchodilator FEV1 at Week 52 Among Prespecified Subgroups (3 of 3)  Brensocatib 
 
 TPIP showed substantially lower Cmaxand longer half-life  Supports the potential for improved tolerability, efficacy and convenience  Safety profile was generally well tolerated, AEs were mild and consistent with inhaled prostanoid  Tolerability was improved with an up-titration approach  Findings suggest TPIP may be safely dosed at nominal doses far in excess of Tyvaso  PK supports development of TPIP with once daily dosing  TPIP showed substantially lower Cmax and longer half-life than that of Tyvaso  Future studies would use an up-titration dosing schedule to the maximum individual tolerated dose exceeding 600 µg once daily  TPIP  TPIP Phase 1 Study: Key Takeaways  TPIP=treprostinil palmitil inhalation powder; AES=adverse events; Cmax=highest concentration of a drug in blood, fluid, or target organ after dosing; PK=pharmacokinetics 
 
 TPIP  TPIP: Change From Baseline in Small and Large Blood Vessels  aEffect size was calculated as a percentage of the treatment effect divided by the placebo arm baseline mean.   SD=standard deviation; TPIP=treprostinil palmitil inhalation powder; BV5A=volume of pulmonary arteries smaller than 5 mm2 in cross-sectional area; BV10A=volume of pulmonary arteries larger than 10 mm2 in cross-sectional area  There was a consistent increase of blood volume in small arteries observed with TPIP vs. placebo  Baseline, mean (SD)  Change from baseline, %  Effect size,a %  P value  TPIP(n=9)  Placebo(n=5)  TPIP(n=9)  Placebo(n=5)  BV5A (mL)  volume of pulmonary arteries <5 mm2  19.5 (7.3)  33.6 (21.1)  +14.0  –7.5  +13.0  0.24  BV5A PR (%)  volume of small arteries (<5 mm2) as a fraction of total pulmonary vessel volume  24.1 (5.0)  27.6 (8.2)  +8.4  –5.5  +13.7  0.02  BV5A PRA (%)  volume of small arteries (<5 mm2) as a fraction of total pulmonary artery volume  44.4 (8.1)  47.1 (13.2)  +8.0  –3.8  +13.6  0.05  BV10A (mL)  volume of pulmonary arteries >10 mm2  11.9 (6.5)  15.8 (6.4)  –7.1  +16.3  –25.7  0.14  BV10A PR (%)  volume of large arteries (>10 mm2) as a fraction of total pulmonary vessel volume  14.0 (4.3)  14.6 (5.2)  –10.8  +16.4  –23.2  0.08  BV10A PRA (%)  volume of large arteries (>10 mm2) as a fraction of total pulmonary artery volume  25.7 (7.0)  25.0 (8.5)  –12.0  +18.7  –24.8  0.07  BV5A:BV10A RATIO  2.0 (1.1)  2.6 (2.5)  +31.4  –10.5  +49.4  0.17  Lung imaging results from the Phase 2 PH-ILD study 
 
 TPIP  TPIP: Change From Baseline in High Attenuation Abnormality Scorea   bThe HAA score is expressed as a percentage of total lung volume.  cEffect size was calculated as a percentage of the treatment effect divided by the placebo arm baseline mean.  HAA=high-attenuation abnormality; SD=standard deviation; TPIP=treprostinil palmitil inhalation powder  A numerical decrease from baseline in the HAA score observed with   TPIP and slight increase with placebo  aA deep-learning algorithm was trained to distinguish between patches of voxels from scans of subjects with IPF and healthy subjects using automatically extracted high-attenuation textural features, excluding segmented blood vessels and airway walls, and to output a probability that a given patch is "fibrotic.” The algorithm is applied to overlapping patches, calculating the attenuation probability for a given voxel as an average probability of all the patches which cover that voxel. The HAA score is that volume of high-attenuation voxels with a greater than 50% chance of being "fibrotic.“  Change from baseline, mean (SD)  Effect size,c %  P value  TPIP (n=9)  Placebo (n=5)  HAA score,b %  –0.7 (2.7)  0.3 (1.8)  –10.5  0.54  Lung imaging results from the Phase 2 PH-ILD study 
 
 Color indicates vessel size. Small vessels with cross-sectional area (CSA) <5 mm2 are colored in red (●), vessels with CSA 5-10 mm2 – in yellow (●), and CSA >10 mm2 – in blue (●). Parameters indicated as BV5 and BV10 represent the total volume of vessels with CSA <5 mm2 and >10 mm2, respectively. Note the increase of small vessels colored in red (●) in patients treated with TPIP at week 16, compared with placebo.   TPIP  TPIP: FRI in Representative Patients Treated with TPIP (A) vs. Placebo (B)  TPIP treatment resulted in a significant increase in the fraction of blood volume in small arteries and a directional improvement in small-to-large artery volume ratio versus placebo  Results suggestive of small vessel vasodilation and improved pulmonary arteriole recruitment  A numerical decrease in HAA score was observed with TPIP  Limitations included the small sample size, which may limit the generalizability of the results and may increase the risk of random variation  Further evaluation of FRI in a larger trial may provide additional insights and support the strength and potential increased generalizability of these findings  FRI=functional respiratory imaging; CSA=cross-sectional area; BV5A=volume of pulmonary arteries smaller than 5 mm2 in cross-sectional area; BV10A=volume of pulmonary arteries larger than 10 mm2 in cross-sectional area; TPIP=treprostinil palmitil inhalation powder; HAA=high-attenuation abnormality  TPIP  Change from baseline, mL (%)  BV5A:BV10A RATIO  +0.45 (+29.7%)  Placebo  Change from baseline, mL (%)  BV5A:BV10A RATIO  -0.11 (-8%)  TPIP (A)  Placebo (B)  Lung imaging results from the Phase 2 PH-ILD study 
 
 Epidemiological Footnotes (1 of 3)  1. Internal analysis of published NTM epidemiology, including internal market research and US patient level claims data analysis:   Jennifer Adjemian, Kenneth N Olivier, Amy E Seitz, Steven M Holland, D Rebecca Prevots: Prevalence of nontuberculous mycobacterial lung disease in U.S. Medicare beneficiaries Am J Respir Crit Care Med. 2012 Apr 15; 185(8):881-6 DOI: 10.1164/rccm.201111-2016OC  Jennifer Adjemian, D Rebecca Prevots, Jack Gallagher, Kylee Heap, Renu Gupta, David Griffith: Lack of adherence to evidence-based treatment guidelines for nontuberculous mycobacterial lung disease Ann Am Thorac Soc. 2014 Jan; 11(1): 9–16 DOI: 10.1513/AnnalsATS.201304-085OC  Sara E. Strollo , Jennifer Adjemian, Michael K. Adjemian, and D. Rebecca Prevots: The Burden of Pulmonary Nontuberculous Mycobacterial Disease in the United States Ann Am Thorac Soc Vol 12, No 10, pp 1458–1464, Oct 2015 DOI: 10.1513/AnnalsATS.201503-173OC  https://www.kff.org/medicare/state-indicator/total-medicare-beneficiaries/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D  Felix C. Ringshausen, Dirk Wagner, Andrés de Roux, Roland Diel, David Hohmann, Lennart Hickstein, Tobias Welte, Jessica Rademacher: Prevalence of Nontuberculous Mycobacterial Pulmonary Disease, Germany, 2009–2014 Emerging Infectious Diseases • www.cdc.gov/eid • Vol. 22, No. 6, June 2016 DOI: http://dx.doi.org/10.3201/eid2206.151642  Jonathan E Moore, Michelle E Kruijshaar, L Peter Ormerod, Francis Drobniewski , Ibrahim Abubakar: Increasing reports of non-tuberculous mycobacteria in England, Wales and Northern Ireland, 1995-2006 BMC Public Health 2010, 10:612 http://www.biomedcentral.com/1471-2458/10/612  Hoefsloot, Van Ingen et al, The geographic diversity of nontuberculous mycobacteria isolated from pulmonary samples, AN NTM-NET collaborative study; 2013, European Respiratory Journal 2013 42: 1604-1613; DOI: 10.1183/09031936.00149212   Kozo Morimoto , Kazuro Iwai , Kazuhiro Uchimura , Masao Okumura , Takashi Yoshiyama , Kozo Yoshimori, Hideo Ogata , Atsuyuki Kurashima , Akihiko Gemma, and Shoji Kudoh: A Steady Increase in Nontuberculous Mycobacteriosis Mortality and Estimated Prevalence in Japan Ann Am Thorac Soc Vol 11, No 1, pp 1–8, Jan 2014, DOI: 10.1513/AnnalsATS.201303-067OC   2. Internal analysis of published BE epidemiology, including internal market research and US patient level claims data analysis:  Weycker, et al. Prevalence and incidence of NCFBE among US adults in 2013. Chronic Respiratory Disease. 2017   BE Patient Level Claims Data Analysis. Source: swoop/ipm.ai  Trinity Epidemiology Assessment; 2020 (for Japan epi)  Ringausen et al 2019 Growth (Germany)  Aliberti 2016; quality standards for the management of bronchiectasis in Italy  Snell et al. United Kingdom; 2019  Internal Insmed NCFBE market sizing EU5 report   3. Internal analysis and estimations based on internal market research and US patient level claims data analysis:  Insmed Analysis 2022: Potential Undiagnosed or Misdiagnosed (with COPD, Asthma) BE patients in US estimated based on Medical Experts driven insights, applied to Patient Level Claims Data -using advanced analytics / statistical methods Potential Undiagnosed or Co-morbid (with COPD) BE patients in US derived based on internal Insmed meta-analysis of 16 epi studies that look at BE prevalence in COPD patients; Ex-US estimates are based on extrapolation of US focused claims and epi data analysis   4 
 
 Epidemiological Footnotes (2 of 3)  4. Internal analysis and estimations based on published epidemiology studies:  National Health Interview Survey (NHIS) Data (2021)  Alshabanat A, Zafari Z, Albanyan O, Dairi M, FitzGerald JM (2015) Asthma and COPD Overlap Syndrome (ACOS): A Systematic Review and Meta Analysis. PLoS ONE 10(9): e0136065. doi:10.1371/ journal.pone.0136065  OECD/European Union (2016), “Asthma and COPD prevalence”, in Health at a Glance: Europe 2016: State of Health in the EU Cycle, OECD Publishing, Paris.   Hosseini, M., Almasi-Hashiani, A., Sepidarkish, M. et al. Global prevalence of asthma-COPD overlap (ACO) in the general population: a systematic review and meta-analysis. Respir Res 20, 229 (2019). https://doi.org/10.1186/s12931-019-1198-4  Blanco I, Diego I, Bueno P, et al. Geographic distribution of COPD prevalence in the world displayed by Geographic Information System maps. Eur Respir J 2019; 54: 1900610 [https://doi.org/ 10.1183/13993003.00610-2019].   R. de Marco et al. Eur Respir J 2012; 39:883-892. DOI: 10.1183/09031936.000611.  Iwanaga T, Tohda Y. [Epidemiology of asthma in Japan]. Nihon Rinsho. 2016 Oct;74(10):1603-1608. Japanese. PMID: 30551268  Massoth L, Anderson C, McKinney KA. Asthma and Chronic Rhinosinusitis: Diagnosis and Medical Management. Med Sci (Basel). 2019 Mar 27;7(4):53. doi: 10.3390/medsci7040053. PMID: 30934800; PMCID: PMC6524348.  Hashimoto S, Yoshida Y, Makita N, Sorimachi R, Sugaya S, Arita Y, Hayashi N, Tashiro N, Ichinose M. Real-World Evidence on the Diagnostic and Clinical Characteristics of Asthma in Japanese Patients with COPD: The ACO Japan Cohort Study. Int J Chron Obstruct Pulmon Dis. 2023;18:37-46   Awad MT, Sankari A. Asthma and COPD Overlap. [Updated 2023 Jun 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK592422/  https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm  https://www.cdc.gov/copd/php/case-reporting/national-trends-in-copd.html  Minakata Y, Ichinose M. [Epidemiology of COPD in Japan]. Nihon Rinsho. 2011 Oct;69(10):1721-6. Japanese. PMID: 22073563   5. Internal assessment of published epidemiology and US patient level claims data analysis:  Cho et. al, Chronic Rhinosinusitis without Nasal Polyps J Allergy Clin Immunol Pract. 2016 ; 4(4): 575–582. doi:10.1016/j.jaip.2016.04.015  Benjamin et. al, Clinical Characteristics of Patients with Chronic Rhinosinusitis without Nasal Polyps in an Academic Setting, J ALLERGY CLIN IMMUNOL PRACT VOLUME 7, NUMBER 3, MARCH 2019  Komodo Health: CRS patient level claims data analysis 2022 - US only, Extrapolated to Europe5 and Japan  Palmer JN, Messina JC, Biletch R, Grosel K, Mahmoud RA. A cross-sectional, population-based survey of U.S. adults with symptoms of chronic rhinosinusitis. Allergy Asthma Proc. 2019 Jan 14;40(1):48-56. doi: 10.2500/aap.2019.40.4182. PMID: 30582496   6. Internal assessment of market research, published epidemiology and US patient level claims data analysis:   Hidradenitis Suppurativa (HS) - Market Insights, Epidemiology, and Market Forecast Report (2019-2032). Source: DelveInsight  Komodo Health: HS patient level claims data analysis 2024: Potential HS Patients (1+ HS Dx in claims history 2016-23) - US only, Extrapolated to Europe5 and Japan 
 
 Epidemiological Footnotes (3 of 3)  7. Internal assessment of published epidemiology and US patient level claims data analysis, including:  Kirson, N. Y., Birnbaum, H. G., Ivanova, J. I., Waldman, T., Joish, V., & Williamson, T. (2011). Prevalence of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension in the United States. Current Medical Research and Opinion, 27(9), 1763–1768. https://doi.org/10.1185/03007995.2011.604310  2019 National Audit of Pulmonary Hypertension Great Britain; Humbert M et al, “Pulmonary arterial hypertension in France: results from a national registry”, Feb 2006  Ling Y, Johnson MK, Kiely DG, Condliffe R, Elliot CA, Gibbs JS, Howard LS, Pepke-Zaba J, Sheares KK, Corris PA, Fisher AJ, Lordan JL, Gaine S, Coghlan JG, Wort SJ, Gatzoulis MA, Peacock AJ. Changing demographics, epidemiology, and survival of incident pulmonary arterial hypertension: results from the pulmonary hypertension registry of the United Kingdom and Ireland. Am J Respir Crit Care Med. 2012 Oct 15;186(8):790-6. doi: 10.1164/rccm.201203-0383OC. Epub 2012 Jul 12. PMID: 22798320.  Escribano-Subias P, Blanco I, López-Meseguer M, Lopez-Guarch CJ, Roman A, Morales P, Castillo-Palma MJ, Segovia J, Gómez-Sanchez MA, Barberà JA; REHAP investigators. Survival in pulmonary hypertension in Spain: insights from the Spanish registry. Eur Respir J. 2012 Sep;40(3):596-603. doi: 10.1183/09031936.00101211. Epub 2012 Feb 23. PMID: 22362843.  Hoeper MM, Huscher D, Pittrow D. Incidence and prevalence of pulmonary arterial hypertension in Germany. Int J Cardiol. 2016 Jan 15;203:612-3. doi: 10.1016/j.ijcard.2015.11.001. Epub 2015 Nov 9. PMID: 26580339.  Humbert M, Sitbon O, Chaouat A, Bertocchi M, Habib G, Gressin V, Yaici A, Weitzenblum E, Cordier JF, Chabot F, Dromer C, Pison C, Reynaud-Gaubert M, Haloun A, Laurent M, Hachulla E, Simonneau G. Pulmonary arterial hypertension in France: results from a national registry. Am J Respir Crit Care Med. 2006 May 1;173(9):1023-30. doi: 10.1164/rccm.200510-1668OC. Epub 2006 Feb 2. PMID: 16456139.  Secondary research: Japan’s Intractable Disease Database 2021  Diagnosed prevalence for PH-LHD, CTEPH and PH-Idiopathic sourced from “Patient-Based Forecast Model Pulmonary Hypertension”, Datamonitor, September 2023.   8. Internal assessment of published epidemiology, including:  Andersen, C. U., Mellemkjær, S., Hilberg, O., Nielsen-Kudsk, J. E., Simonsen, U., & Bendstrup, E. (2012). Pulmonary hypertension in interstitial lung disease: prevalence, prognosis and 6 min walk test. Respiratory medicine, 106(6), 875-882.  Ryu, Jay H., et al. "Pulmonary hypertension in patients with interstitial lung diseases." Mayo Clinic Proceedings. Vol. 82. No. 3. Elsevier, 2007  Duchemann et al., “Prevalence and incidence of interstitial lung diseases in a multi-ethnic county of Greater Paris.” European Respiratory Journal, 2017  Diagnosed prevalence for PH-LHD, CTEPH and PH-Idiopathic sourced from “Patient-Based Forecast Model Pulmonary Hypertension”, Datamonitor, September 2023.  
 
 


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