Form 8-K
8-K — INSMED Inc
Accession: 0001140361-26-031502
Filed: 2026-08-06
Period: 2026-08-06
CIK: 0001104506
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — ef20079469_8k.htm (Primary)
EX-99.1 — EXHIBIT 99.1 (ef20079469_ex99-1.htm)
EX-99.2 — EXHIBIT 99.2 (ef20079469_ex99-2.htm)
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8-K
8-K (Primary)
Filename: ef20079469_8k.htm · Sequence: 1
false000110450600011045062026-08-062026-08-06
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): August 6, 2026
INSMED INCORPORATED
(Exact name of registrant as specified in its charter)
Virginia
000-30739
54-1972729
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)
700 US Highway 202/206
Bridgewater, New Jersey
08807
(Zip Code)
(Address of principal executive offices)
Registrant’s telephone number, including area code: (908) 977-9900
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.01 per share
INSM
Nasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or
Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
ITEM 2.02
Results of Operations and Financial Condition.
On August 6, 2026, Insmed Incorporated (the “Company”) issued a press release regarding its financial results for the second quarter ended June 30, 2026.
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 9.01
Financial Statements and Exhibits.
(d) Exhibits
Exhibit
No.
Description
99.1
Press release issued by Insmed Incorporated on August 6, 2026.
99.2
Insmed Incorporated August 6, 2026 Presentation.
104
Cover Page Interactive Data 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: August 6, 2026
INSMED INCORPORATED
By:
/s/ Michael A. Smith
Name:
Michael A. Smith
Title:
Chief Legal Officer and Secretary
EX-99.1 — EXHIBIT 99.1
EX-99.1
Filename: ef20079469_ex99-1.htm · Sequence: 2
Exhibit 99.1
Insmed Reports Second-Quarter 2026 Financial Results and Provides Business Update
—Total Company Revenues of $425.5 Million for the Second Quarter of 2026—
—BRINSUPRI® (brensocatib) Revenues
of $309.2 Million for the Second Quarter of 2026, Reflecting 49% Growth Over the First Quarter of 2026—
—ARIKAYCE® (amikacin liposome inhalation suspension) Revenues of $116.3 Million for the Second Quarter of 2026, Reflecting 8% Growth Over
the Second Quarter of 2025—
—Company Raises 2026 BRINSUPRI Revenue Guidance to $1.25 Billion to $1.40 Billion—
—Company Reiterates 2026 ARIKAYCE Revenue Guidance of $450 Million to $470 Million—
—Company Raises Peak Revenue Estimate for its Three Lead Programs to More than $14 Billion Total—
—Peak Revenue Estimate Consists of More than $7 Billion for BRINSUPRI, More than $6 Billion for TPIP, and More than $1 Billion for ARIKAYCE—
BRIDGEWATER, N.J., August 6, 2026 — 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 second quarter ended June 30, 2026, and provided a business update.
“Our team delivered tremendous results in the second quarter of the year, reflecting our operational excellence and positioning for the future,” said Will Lewis, Chair and
Chief Executive Officer of Insmed. “The U.S. BRINSUPRI launch continues to be met with significant enthusiasm and demand from patients and physicians. Additionally, we were pleased to report positive data from our ongoing open-label extension study
of TPIP in PAH, reinforcing TPIP’s potential to become the prostanoid of choice. Looking ahead, our focus is on building upon the early success of the BRINSUPRI launch, preparing to execute on the potential ARIKAYCE label expansion in the U.S. and
Japan, progressing our Phase 3 TPIP programs across four large indications, and advancing our multiple early-stage pipeline candidates. As a result of our team’s significant efforts, we are raising our peak revenue estimates for both BRINSUPRI and
TPIP. We now expect that our three lead programs will generate more than $14 billion in combined peak sales. This ambitious yet achievable objective reflects our team's proven ability to execute and the opportunity to improve the lives of hundreds of
thousands of patients worldwide.”
1
Progress and Anticipated Milestones by Therapeutic Area:
Respiratory
BRINSUPRI
•
BRINSUPRI global revenue grew 49% in the second quarter of 2026 compared to the first quarter of 2026, driven by strong growth in the U.S. market.
•
Insmed continues to anticipate a regulatory decision for brensocatib for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in Japan in the second half of 2026.
•
In June 2026, the European Multi-centre Bronchiectasis Audit and Research Collaboration (EMBARC) announced a collaboration with Insmed to conduct a landmark three-year open-label interventional study
evaluating the disease modification potential of 25 mg brensocatib in bronchiectasis.
•
Insmed continues to evaluate the potential effect of evolving U.S. policies which will then impact the timing for future potential international commercial launches.
ARIKAYCE
•
ARIKAYCE global revenue grew 8% in the second quarter of 2026 compared to the second quarter of 2025, primarily driven by strong growth in international markets.
•
In July 2026, Insmed submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in newly diagnosed patients with MAC lung disease. Similarly,
Insmed plans to review the Phase 3b ENCORE data with the Pharmaceuticals and Medical Devices Agency (PMDA) in the second half of 2026 to support potential label expansion in Japan.
TPIP
•
Insmed continues to enroll patients in the PALM-ILD trial, a Phase 3 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung
disease (PH-ILD).
•
Insmed is actively enrolling patients in the PALM-PAH trial, a Phase 3 study of TPIP in patients with pulmonary arterial hypertension (PAH).
•
In July 2026, Insmed reported positive 12-month data from the ongoing open-label extension (OLE) study of TPIP in patients with PAH.
•
Insmed continues to anticipate initiating a Phase 3 study of TPIP in patients with progressive pulmonary fibrosis (PPF) in the second half of 2026 and a Phase 3 study in patients with idiopathic
pulmonary fibrosis (IPF) in the first half of 2027.
INS1148
•
Insmed continues to advance a Phase 2 development program for INS1148, initially targeting PPF and IPF, and is exploring other diseases where inhibition of the inflammatory functions of Stem Cell
Factor 248 (SCF248) may be beneficial.
2
Immunology & Inflammation
INS1033
•
In July 2026, the Investigational New Drug (IND) filing for INS1033, Insmed’s second dipeptidyl peptidase 1 (DPP1) inhibitor, was cleared by the FDA for patients with rheumatoid arthritis (RA).
Insmed plans to initiate a Phase 1 trial in healthy volunteers in the third quarter of 2026.
Neuro & Other Rare
INS1201
•
Insmed continues to enroll patients in the Phase 1 ASCEND clinical study of INS1201, an intrathecally delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).
INS1202
•
Insmed continues to enroll patients in the Phase 1 ARMOR study of INS1202, an intrathecally delivered gene therapy for patients with amyotrophic lateral sclerosis (ALS).
Corporate Updates
•
In May 2026, Insmed presented six abstracts from across its Respiratory Therapeutic Area at the American Thoracic Society (ATS) 2026 International Conference.
•
In June 2026, Insmed appointed Samuele Butera as Senior Vice President, General Manager, Global Respiratory to lead its Respiratory Therapeutic Area.
Second-Quarter 2026 Financial Results
The following table summarizes second-quarter and year-to-date 2026 and 2025 revenues and revenue growth for BRINSUPRI and ARIKAYCE across all commercial regions:
Three Months Ended June 30,
Six Months Ended June 30,
(in millions)
2026
2025
Growth
2026
2025
Growth
ARIKAYCE
U.S.
$
70.2
$
68.7
2
%
$
133.1
$
133.0
<1
%
International
46.1
38.7
19
%
81.4
67.3
21
%
Total
$
116.3
$
107.4
8
%
$
214.4
$
200.2
7
%
BRINSUPRI
U.S.
$
308.6
$
-
N/A
$
515.7
$
-
N/A
International
0.6
-
N/A
1.3
-
N/A
Total
$
309.2
$
-
N/A
$
517.0
$
-
N/A
Total Revenues
U.S.
$
378.7
$
68.7
451
%
$
648.8
$
133.0
388
%
International
46.7
38.7
21
%
82.6
67.3
23
%
Total
$
425.5
$
107.4
296
%
$
731.5
$
200.2
265
%
3
•
Cost of product revenues (excluding amortization of intangibles) were $67.2 million for the second quarter of 2026, compared to $28.1 million for the second quarter of 2025. The increase in cost of
product revenues in the second quarter of 2026 primarily reflects the increase in total product revenues for ARIKAYCE and BRINSUPRI. Cost of product revenues as a percentage of revenues decreased in the second quarter of 2026 due to sales of
BRINSUPRI, which has lower manufacturing costs than ARIKAYCE.
•
Research and development (R&D) expenses were $210.0 million for the second quarter of 2026, compared to $177.2 million for the second quarter of 2025. The increase in R&D expenses for the
second quarter of 2026 was primarily related to increases in compensation and benefit-related expenses, as well as stock-based compensation due to an increase in headcount, and an increase in clinical development and research costs primarily
related to TPIP.
•
Selling, general and administrative (SG&A) expenses for the second quarter of 2026 were $247.5 million, compared to $154.8 million for the second quarter of 2025. The increase in SG&A
expenses for the second quarter of 2026 was primarily related to increases in professional fees and other external expenses, and an increase in compensation and benefit-related expenses due to an increase in headcount, both driven by
commercial activities for BRINSUPRI.
•
For the second quarter of 2026, Insmed reported a net loss of $13.2 million, or $0.06 per share, compared to a net loss of $321.7 million, or $1.70 per share, for the second quarter of 2025.
Balance Sheet, Financial Guidance, and Planned Investments
•
As of June 30, 2026, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.2 billion.
•
The Company raised its guidance for full-year 2026 BRINSUPRI revenues to a range of $1.25 billion to $1.40 billion from the previous guidance of at least $1 billion. The Company continues to
anticipate full-year 2026 ARIKAYCE revenues in the range of $450 million to $470 million.
•
The Company raised its peak revenue estimate for BRINSUPRI to more than $7 billion, raised its peak revenue estimate for TPIP to more than $6 billion, and reiterated its peak revenue estimate for
ARIKAYCE as more than $1 billion.
•
The Company continues to anticipate submitting an average of one to two INDs per year from its pre-clinical research programs.
•
Insmed continues to anticipate that the totality of its pre-clinical research programs will comprise less than 20% of overall expenditures.
•
The Company plans to continue to invest in the following key activities in 2026:
(i)
acceleration of BRINSUPRI commercial efforts in the U.S. and preparations for launch in Japan;
(ii)
strengthening of ARIKAYCE commercial efforts;
(iii)
preparation of regulatory submissions for full approval for ARIKAYCE in the U.S. and label expansion to include newly diagnosed patients with MAC lung disease in the U.S. and Japan;
(iv)
advancement of the clinical development programs for TPIP, including the Phase 3 studies in patients with PH-ILD, PAH, PPF, and IPF;
(v)
advancement of multiple development programs for INS1148;
(vi)
advancement of the clinical trial programs for INS1201 in DMD and INS1202 in ALS, as well as IND-enabling activities for additional programs;
(vii)
advancement of clinical trial programs for INS1033 in RA; and
(viii)
continued development of its pre-clinical research programs.
4
Conference Call
Insmed will host a conference call beginning today, August 6, 2026, at 8:00 AM Eastern Time. Shareholders and other interested parties may participate in the conference
call by dialing (888) 210-2654 (U.S. and international) and referencing access code 7862189. The call will also be webcast live on the Company's website at www.insmed.com.
A replay of the conference call will be accessible approximately 1 hour after its completion through August 13, 2026, by dialing (800) 770-2030 (U.S.) and (609) 800-9909
(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 June 30,
Six Months Ended June 30,
2026
2025
2026
2025
Product revenues, net
$
425,486
$
107,415
$
731,450
$
200,238
Operating expenses:
Cost of product revenues (excluding amortization of intangible assets)
67,212
28,075
114,632
49,353
Research and development
210,034
177,190
419,519
329,767
Selling, general and administrative
247,467
154,763
494,726
302,308
Amortization of intangible assets
2,081
1,263
4,162
2,526
Change in fair value of contingent consideration liabilities
(99,760
)
59,000
(146,721
)
77,300
Total operating expenses
427,034
420,291
886,318
761,254
Operating loss
(1,548
)
(312,876
)
(154,868
)
(561,016
)
Investment income
10,979
13,225
23,019
27,131
Interest expense
(20,273
)
(21,245
)
(40,355
)
(42,814
)
Other (expense) income, net
(531
)
453
(1,267
)
585
Loss before income taxes
(11,373
)
(320,443
)
(173,471
)
(576,114
)
Provision for income taxes
1,869
1,243
3,334
2,155
Net loss
$
(13,242
)
$
(321,686
)
$
(176,805
)
$
(578,269
)
Basic and diluted net loss per share
$
(0.06
)
$
(1.70
)
$
(0.82
)
$
(3.12
)
Weighted average basic and diluted common shares outstanding
217,352
189,302
216,415
185,104
5
INSMED INCORPORATED
Consolidated Balance Sheets
(in thousands, except par value and share data)
As of
June 30, 2026
December 31, 2025
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
544,765
$
510,445
Marketable securities
615,547
919,602
Accounts receivable
215,325
140,857
Inventory
142,384
132,068
Prepaid expenses and other current assets
115,898
91,236
Total current assets
1,633,919
1,794,208
Fixed assets, net
107,219
102,942
Finance lease right-of-use assets
14,205
15,561
Operating lease right-of-use assets
13,179
20,708
Intangibles, net
93,489
97,651
Goodwill
136,110
136,110
Other assets
104,444
97,378
Total assets
$
2,102,565
$
2,264,558
Liabilities and shareholders' equity
Current liabilities:
Accounts payable and accrued liabilities
$
428,929
$
456,060
Finance lease liabilities
3,549
3,345
Operating lease liabilities
6,266
9,469
Total current liabilities
438,744
468,874
Debt, long-term
543,513
540,964
Royalty financing agreement
159,843
162,865
Contingent consideration
170,550
314,340
Finance lease liabilities, long-term
18,890
20,719
Operating lease liabilities, long-term
7,663
12,174
Other long-term liabilities
5,868
5,646
Total liabilities
1,345,071
1,525,582
Shareholders' equity:
Common stock, $0.01 par value; 500,000,000 authorized shares, 218,281,059 and 214,255,853 issued and
outstanding shares at June 30, 2026 and December 31, 2025, respectively
2,183
2,143
Additional paid-in capital
6,572,181
6,372,064
Accumulated deficit
(5,813,497
)
(5,636,692
)
Accumulated other comprehensive (loss) gain
(3,373
)
1,461
Total shareholders' equity
757,494
738,976
Total liabilities and shareholders' equity
$
2,102,565
$
2,264,558
6
About ARIKAYCE
ARIKAYCE® is approved in the United States as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion,
and in Japan as ARIKAYCE inhalation 590 mg (amikacin sulfate inhalation drug product). Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of
amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed’s proprietary PULMOVANCE™ liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while
limiting systemic exposure. ARIKAYCE is administered once daily using the Lamira® Nebulizer System manufactured by PARI Pharma GmbH (PARI).
About PARI Pharma and the Lamira® Nebulizer System
ARIKAYCE is delivered by a novel inhalation device, the Lamira® Nebulizer System, developed by PARI. Lamira® is a quiet, portable nebulizer that
enables efficient aerosolization of ARIKAYCE via a vibrating, perforated membrane. Based on PARI's 100-year history working with aerosols, PARI is dedicated to advancing inhalation therapies by developing innovative delivery platforms to improve
patient care.
About BRINSUPRI
BRINSUPRI® (brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). BRINSUPRI (brensocatib 10 mg and 25 mg
tablets) is indicated in the United States for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age or older. In the European Union, BRINSUPRI (brensocatib 25 mg tablets) is approved for the
treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. In the U.K., BRINSUPRI (brensocatib 25 mg tablets) is approved for the treatment of NCFB in patients 12 years of age and older with two or
more flare ups or worsening of symptoms in the past 12 months. Brensocatib is designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB.
About TPIP
Treprostinil palmitil inhalation powder (TPIP) is an investigational dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil
linked by an ester bond to a 16-carbon chain. Designed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being developed as once-daily therapy for the treatment of patients with pulmonary arterial hypertension
(PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), progressive pulmonary fibrosis (PPF), and idiopathic pulmonary fibrosis (IPF). 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.
7
About INS1033
INS1033 is an investigational small molecule, oral, reversible dipeptidyl peptidase 1 (DPP1) inhibitor. Designed entirely in Insmed’s laboratories, INS1033 is being
developed as a potential once-daily therapy, initially for patients with rheumatoid arthritis (RA), with additional clinical programs expected to follow in ulcerative colitis (UC) and chronic obstructive pulmonary disease (COPD). 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. Excessive activation and secretion of NSPs can cause inflammatory response and tissue damage. By inhibiting DPP1 and its activation of NSPs, INS1033 may address the chronic neutrophilic-related inflammation
associated with diseases such as RA, UC, and COPD. INS1033 is an investigational drug product that has not been approved for any indication in any jurisdiction.
About INS1148
INS1148 is an investigational monoclonal antibody that Insmed is developing as a potential first-in-class therapy initially for patients with progressive pulmonary fibrosis
(PPF) and idiopathic pulmonary fibrosis (IPF), with other diseases being explored where inhibition of the inflammatory functions of Stem Cell Factor 248 (SCF248) may be beneficial. Through its novel mechanism of action, INS1148 preferentially targets
a specific isoform of Stem Cell Factor, called SCF248. Binding to SCF248 induces clearance of this SCF isoform and interrupts only the inflammatory cascade downstream of c-Kit signaling, while leaving its homeostatic and tissue healing pathways
intact. INS1148 is an investigational drug product that has not been approved for any indication in any jurisdiction.
About INS1201
INS1201 is an investigational micro-dystrophin adeno-associated virus (AAV9) gene therapy that Insmed is developing as a potential treatment for patients with Duchenne
muscular dystrophy (DMD). Administered intrathecally, this approach has the potential to target both skeletal and cardiac muscles as a one-time fixed (non-weight-based) dose. INS1201 is an investigational drug product that has not been approved for
any indication in any jurisdiction.
About INS1202
INS1202 is an investigational adeno-associated virus (AAV9) short hairpin RNA (shRNA) construct targeting the human superoxide dismutase type 1 (SOD1) gene. Insmed is
developing INS1202 as a potential treatment for patients with amyotrophic lateral sclerosis (ALS) who carry SOD1 mutations and those who do not have SOD1 mutations. INS1202 is administered intrathecally as a one-time fixed (non-weight-based) dose.
INS1202 is an investigational drug product that has not been approved for any indication in any jurisdiction.
IMPORTANT SAFETY INFORMATION AND BOXED WARNING FOR ARIKAYCE IN THE U.S.
WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS
ARIKAYCE has been associated with an increased risk of respiratory adverse
reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases.
8
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.
9
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.
10
Limitation of Use:
ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6
consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.
Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1‑800‑FDA‑1088. You can also call the Company at 1-844-4-INSMED.
Please see Full Prescribing Information.
BRINSUPRI® (brensocatib) U.S. INDICATION AND IMPORTANT SAFETY INFORMATION
Indication in the U.S.
BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older.
Important Safety Information in the U.S.
WARNINGS AND PRECAUTIONS
Dermatologic Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis. Monitor patients
for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings.
Gingival and Periodontal Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions. Refer patients to dental care services for regular
dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene.
Live Attenuated Vaccines
It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The
use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI.
ADVERSE REACTIONS
The most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and
hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions.
11
Less Common Adverse Reactions
Liver Function Test Elevations
In ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both
BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9%; the incidence of AST >3X ULN was 0.2%, 0.3%, and 0.5%; and the incidence of alkaline phosphatase >1.5X ULN was
2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively.
Skin Cancers
In ASPEN, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in
placebo-treated patients.
Alopecia
In ASPEN, the incidence of alopecia among patients treated with BRINSUPRI 10 mg and 25 mg was 1.5% and 1.6% respectively, compared to 0.4% in
placebo-treated patients.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no clinical
data on the use of BRINSUPRI in pregnant women.
Lactation: There is no information
regarding the presence of BRINSUPRI and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's
clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition.
Pediatric use: The safety and
effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Common adverse reactions in pediatric patients aged 12 years and older enrolled in ASPEN were consistent with those in adults.
The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age.
Please see full US Prescribing Information.
About Insmed
Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing
serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines — including two approved therapies to treat chronic, debilitating lung diseases — as well as cutting-edge drug discovery
focused on serving patient communities where the need is greatest. Insmed's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The Company's
research engine is advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates.
Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one
of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram,
YouTube, and X.
12
Forward-looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. “Forward-looking statements,” as that term is defined in the
Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,”
“believes,” “estimates,” “projects,” “predicts,” “intends,” “potential,” “continues,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.
The forward-looking statements in this press release are based upon the Company’s current expectations and beliefs, and involve known and unknown risks, uncertainties and
other factors, which may cause the Company’s actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in
any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to continue to successfully commercialize ARIKAYCE in the U.S., Europe or Japan or failure to successfully commercialize
BRINSUPRI in the U.S. or Europe, or to maintain U.S., European or Japanese approval for ARIKAYCE or U.S. or European approval for BRINSUPRI; our inability to obtain full approval of ARIKAYCE from the FDA or our failure to obtain regulatory approval
to expand ARIKAYCE’s indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the U.S., Europe or Japan, for ARIKAYCE outside of the U.S., Europe and Japan, including
separate regulatory approval for the Lamira® Nebulizer System in each market and for each usage, or for BRINSUPRI outside of the U.S. and Europe; failure to successfully commercialize our product candidates, if approved by applicable
regulatory authorities, or to maintain applicable regulatory approvals for such product candidates, if approved; uncertainties or changes in the degree of market acceptance of our marketed products or, if approved, our product candidates, by
physicians, patients, third-party payors and others in the healthcare community; our inability to obtain and maintain adequate reimbursement from government or third-party payors for our marketed products or, if approved, our product candidates, or
acceptable prices for our marketed products or, if approved, our product candidates; inaccuracies in our peak sales estimates for our marketed products and our product candidates; inaccuracies in our estimates of the size of the potential markets for
our marketed products and our product candidates or in data we have used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; failure of third parties on
which we are dependent to manufacture sufficient quantities of our marketed products and our product candidates for commercial or clinical needs, as applicable, to conduct our clinical trials, or to comply with our agreements or laws and regulations
that impact our business; risks and uncertainties associated with, and the perceived benefits of, our senior secured loan with certain funds managed by Pharmakon Advisors, LP and our royalty financing with OrbiMed Royalty & Credit Opportunities
IV, LP, including our ability to maintain compliance with the covenants in the agreements for the senior secured loan and royalty financing and the impact of the restrictions on our operations under these agreements; our inability to create or
maintain an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of our marketed products or any of our product candidates that are approved in the future; failure to
successfully conduct future clinical trials for our marketed products or our product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval
of our product candidates; development of unexpected safety or efficacy concerns related to our marketed products or our product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug
development, or that any protocol amendments submitted will be rejected; failure to successfully predict the time and cost of development, regulatory approval and commercialization for novel gene therapy products; risk that interim, topline or
preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed, or that blinded data will not be predictive
of unblinded data; risk that our competitors may obtain orphan drug exclusivity for a product that is essentially the same as a product we are developing for a particular indication; our inability to attract and retain key personnel or to effectively
manage our growth; our inability to successfully integrate our acquisitions and appropriately manage the amount of management’s time and attention devoted to integration activities; risks that our acquired technologies, products and product
candidates will not be commercially successful; inability to adapt to our highly competitive and changing environment; inability to access, upgrade or expand our technology systems or difficulties in updating our existing technology or developing or
implementing new technology; risk that we are unable to maintain our significant customers; risk that healthcare legislation or other government action materially adversely affects our business; business or economic disruptions due to catastrophes or
other events, including natural disasters or public health crises; risk that our current and potential future use of AI and machine learning may not be successful; deterioration in general economic conditions in the U.S., Europe, Japan and globally,
including the effect of prolonged periods of inflation, affecting us, our suppliers, third-party service providers and potential partners; risk that we could become involved in costly intellectual property disputes, be unable to adequately protect
our intellectual property rights or prevent disclosure of our trade secrets and other proprietary information, and incur costs associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on us by
agreements related to our marketed products or our product candidates, including our license agreements with PARI and AstraZeneca AB, and failure to comply with our obligations under such agreements; the cost and potential reputational damage
resulting from litigation to which we are or may become a party, including product liability claims; risk that our operations are subject to a material disruption in the event of a cybersecurity attack or issue; changes in laws and regulations
applicable to our business, including any pricing reform and laws that impact our ability to utilize certain third parties in the research, development or manufacture of our product candidates, and failure to comply with such laws and regulations;
our history of operating losses, and the possibility that we never achieve or maintain profitability; goodwill impairment charges affecting our results of operations and financial condition; inability to repay our existing indebtedness and
uncertainties with respect to our ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses
associated with those plans.
13
The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature,
forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's
business, please see the factors discussed in Item 1A, “Risk Factors,” in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and any subsequent Company filings with the Securities and Exchange Commission (SEC).
The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company
disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements
may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
14
Contact:
Investors:
Bryan Dunn
Vice President, Investor Relations
(646) 812-4030
investor.relations@insmed.com
Media:
Claire Mulhearn
Vice President, Corporate Communications
(862) 842-6819
media@insmed.com
15
EX-99.2 — EXHIBIT 99.2
EX-99.2
Filename: ef20079469_ex99-2.htm · Sequence: 3
Exhibit 99.2
August 6, 2026 Second-Quarter 2026 Earnings Presentation
Forward Looking Statements The forward-looking statements in this presentation
are based upon the Company’s current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company’s actual results, performance and achievements and the timing of certain events to
differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure
to continue to successfully commercialize ARIKAYCE® in the U.S., Europe or Japan or failure to successfully commercialize BRINSUPRI® in the U.S. or Europe, or to maintain U.S., European or Japanese approval for ARIKAYCE or U.S. or European
approval for BRINSUPRI; our inability to obtain full approval of ARIKAYCE from the FDA, or our failure to obtain regulatory approval to expand ARIKAYCE’s indication to a broader patient population; failure to obtain, or delays in obtaining,
regulatory approvals for our product candidates in the U.S., Europe or Japan, for ARIKAYCE outside of the U.S., Europe and Japan, including separate regulatory approval for the Lamira® Nebulizer System in each market and for each usage, or for
BRINSUPRI outside of the U.S. and Europe; failure to successfully commercialize our product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for such product candidates, if approved;
uncertainties or changes in the degree of market acceptance of our marketed products or, if approved, our product candidates, by physicians, patients, third-party payors and others in the healthcare community; our inability to obtain and
maintain adequate reimbursement from government or third-party payors for our marketed products or, if approved, our product candidates, or acceptable prices for our marketed products or, if approved, our product candidates; inaccuracies in our
peak sales estimates for our marketed products and our product candidates; inaccuracies in our estimates of the size of the potential markets for our marketed products and our product candidates or in data we have used to identify physicians,
expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; failure of third parties on which we are dependent to manufacture sufficient quantities of our marketed products and our
product candidates for commercial or clinical needs, as applicable, to conduct our clinical trials, or to comply with our agreements or laws and regulations that impact our business; risks and uncertainties associated with, and the perceived
benefits of, our senior secured loan with certain funds managed by Pharmakon Advisors, LP and our royalty financing with OrbiMed Royalty & Credit Opportunities IV, LP, including our ability to maintain compliance with the covenants in the
agreements for the senior secured loan and royalty financing and the impact of the restrictions on our operations under these agreements; our inability to create or maintain an effective direct sales and marketing infrastructure or to partner
with third parties that offer such an infrastructure for distribution of our marketed products or any of our product candidates that are approved in the future; failure to successfully conduct future clinical trials for our marketed products or
our product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates, among other things; development of
unexpected safety or efficacy concerns related to our marketed products or our product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol
amendments submitted will be rejected; failure to successfully predict the time and cost of development, regulatory approval and commercialization for novel gene therapy products; risk that interim, topline or preliminary data from our clinical
trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed, or that blinded data will not be predictive of unblinded data; risk that
our competitors may obtain orphan drug exclusivity for a product that is essentially the same as a product we are developing for a particular indication; our inability to attract and retain key personnel or to effectively manage our growth; our
inability to successfully integrate our acquisitions and appropriately manage the amount of management’s time and attention devoted to integration activities; risks that our acquired technologies, products and product candidates will not be
commercially successful; inability to adapt to our highly competitive and changing environment; inability to access, upgrade or expand our technology systems or difficulties in updating our existing technology or developing or implementing new
technology; risk that we are unable to maintain our significant customers; risk that healthcare legislation or other government action materially adversely affects our business; business or economic disruptions due to catastrophes or other
events, including natural disasters or public health crises; risk that our current and potential future use of AI and machine learning may not be successful; deterioration in general economic conditions in the U.S., Europe, Japan and globally,
including the effect of prolonged periods of inflation, affecting us, our suppliers, third-party service providers and potential partners; risk that we could become involved in costly intellectual property disputes, be unable to adequately
protect our intellectual property rights or prevent disclosure of our trade secrets and other proprietary information, and incur costs associated with litigation or other proceedings related to such matters; restrictions or other obligations
imposed on us by agreements related to our marketed products or our product candidates, including our license agreements with PARI and AstraZeneca AB, and failure to comply with our obligations under such agreements; the cost and potential
reputational damage resulting from litigation to which we are or may become a party, including product liability claims; risk that our operations are subject to a material disruption in the event of a cybersecurity attack or issue; changes in
laws and regulations applicable to our business, including any pricing reform and laws that impact our ability to utilize certain third parties in the research, development or manufacture of our product candidates, and failure to comply with
such laws and regulations; our history of operating losses, and the possibility that we never achieve or maintain profitability; goodwill impairment charges affecting our results of operations and financial condition; inability to repay our
existing indebtedness and uncertainties with respect to our ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities
and unexpected expenses associated with those plans. Additional Disclaimers: Please be aware that TPIP, INS1201, INS1202, and INS1033 are investigational products that have not been approved for sale or found safe or effective by the FDA or
any regulatory authority. In addition, ARIKAYCE has not been approved for the treatment of all patients with MAC lung disease and brensocatib has not been approved for the treatment of patients with non-cystic fibrosis bronchiectasis outside
the U.S. and Europe. This presentation is not promotion or advertisement of ARIKAYCE, BRINSUPRI, TPIP, INS1201, INS1202, or INS1033. Insmed, ARIKAYCE, BRINSUPRI, and inLighten are registered trademarks of Insmed Incorporated. All other
trademarks are property of their respective owner(s). TPIP: treprostinil palmitil inhalation powder | MAC / MACLD: Mycobacterium avium complex lung disease | U.S.: United States | FDA: Food & Drug Administration | AI: artificial
intelligence
Opening Remarks Commercial Updates TPIP Updates Financial
Results 5-6 8-12 15-16 19-23 Will Lewis Chair & CEO Sara Bonstein Chief Financial Officer TPIP: treprostinil palmitil inhalation powder
Opening Remarks Will Lewis | Chair & CEO
Q2 Performance Positions Insmed for Potential Future Commercial and Clinical
Success Q: quarter | sNDA: supplemental new drug application | FDA: Food and Drug Administration | MACLD: Mycobacterium avium complex lung disease | U.S.: United States | OLE: open-label extension | TPIP: treprostinil palmitil inhalation
powder | PAH: pulmonary arterial hypertension | PH-ILD: pulmonary hypertension due to interstitial lung disease | PPF: progressive pulmonary fibrosis | IPF: idiopathic pulmonary fibrosis | H: half | RA: rheumatoid arthritis | IND:
investigational new drug application | UC: ulcerative colitis | COPD: chronic obstructive pulmonary disease | next-gen: next generation | DPP1: dipeptidyl peptidase 1 inhibitor BRINSUPRI® ARIKAYCE® TPIP Strong revenue growth outpaces
industry benchmarks Efforts underway to improve diagnosis Investing in Japan launch readiness* Continued revenue growth in 8th year post-launch Filed sNDA with FDA for newly diagnosed MACLD patients Reported positive 12-month data from OLE
study in PAH Phase 3 PH-ILD and PAH studies actively enrolling patients Operational Excellence Pipeline Leadership Financials INS1033 IND cleared in RA; Expect UC & COPD indications to follow Developing next-gen DPP1s to target other
neutrophil-mediated inflammatory conditions Welcomed Samuele Butera to lead the Global Respiratory Therapeutic Area Remain on path to cash flow positivity in 2027 without raising additional capital Future Positioning Key
Accomplishments: Investing in label expansion launch readiness in U.S. and Japan Phase 3 PPF/IPF studies expected to initiate in 2H:26/1H:27
Peak Revenue Estimate Raised to $14B+ for Three Lead Assets Across Their
Respective Indications* B: billion | NCFB / Bronchiectasis: non-cystic fibrosis bronchiectasis | TPIP: treprostinil palmitil inhalation powder | PAH: pulmonary arterial hypertension | PH-ILD: pulmonary hypertension due to interstitial lung
disease | PPF: progressive pulmonary fibrosis | IPF: idiopathic pulmonary fibrosis | MAC / MACLD: Mycobacterium avium complex lung disease | COPD: chronic obstructive pulmonary disease | FDA: Food and Drug Administration | * Assumes approval in
listed indications by applicable regulatory authorities | † Updated estimate reflects expected growth of the currently addressable NCFB market, driven by earlier and more consistent diagnosis and exacerbation tracking due to increased awareness
among physicians and patients. This estimate does not include contributions from the potentially meaningful opportunity of NCFB patients from the comorbid COPD and asthma populations | Note: TPIP is an investigational product that has not been
approved for sale or found safe or effective by the FDA or any regulatory authority TPIP Prior Bronchiectasis PAH, PH-ILD, PPF, IPF All MACLD Bronchiectasis† All MACLD PAH & PH-ILD
Only $5B+ $7B+ $2B+ $6B+ $1B+ $1B+ $14B+ Updated (Investigational Product) Total Peak Revenue Estimate*
BRINSUPRI® Updates Will Lewis | Chair & CEO
Strong Second-Quarter Revenue Results Increase Confidence to Raise Full-Year 2026
Guidance M: million | B: billion | Q: quarter | † Unaudited revenues for three months ended June 30, 2026 $309.2M Q2 2026 RESULTS GUIDANCE Full-Year 2026 Revenues $1.25 $1.4B Global Net Revenues† to
All Monitored Launch Metrics Continue to Track Ahead of Our Expectations NEW
PATIENT DEMAND PRESCRIBER DEPTH PRESCRIBER BREADTH ~7,000 new patients began therapy in Q2 Expect ~7,000 new patients per quarter for the remainder of 2026 >6,300 cumulative prescribers* since launch Total prescribers increased by
~1,300 in Q2 ~30% of prescribers have written scripts for at least 5 patients** Key Metric Updates: Q: quarter | * Includes all physicians that have written at least one prescription since launch that we have visibility into (does not
include account level data). Additional physicians responsible for prescriptions placed directly by hospital pharmacies are not included in this metric | ** Based on physicians that we have visibility into (does not include account level data);
additional physicians responsible for prescriptions placed directly by hospital pharmacies are not included in this metric. Opportunity remains to deepen prescribing among doctors trialing BRINSUPRI
Strategic Collaborations and Future Studies Aim to Expand Long-Term
Evidence European Multi-centre Bronchiectasis Audit and Research Collaboration (EMBARC) 3-year open-label study Up to 3,000 patients Across six countries Assess long-term disease modification potential with sustained 25 mg brensocatib
treatment Evaluate whether earlier brensocatib initiation further slows disease progression Study Goals: v Ongoing plans to demonstrate long-term evidence through Phase 4 and real-world studies in the U.S. that reinforce BRINSUPRI's
leadership in NCFB EMBARC: European Multi-centre Bronchiectasis Audit and Research Collaboration (European bronchiectasis registry) | mg: milligram | U.S.: United States | NCFB: non-cystic fibrosis bronchiectasis
Multiple Initiatives Underway to Improve NCFB Diagnosis and Enhance Patient
Care American Thoracic Society Announces Landmark Initiative to Improve Diagnosis of Bronchiectasis Across the United States† APRIL 2026 MAY 2026 JUNE 2026 Insmed hosts inaugural Bronchiectasis and COPD Stakeholder Summit to advance
research priorities that improve the diagnosis of comorbid NCFB and NTM 2H:26+ Insmed and Ty Pennington Team Up to Drive Awareness and Proper Diagnosis of Bronchiectasis Insmed piloting initiatives to advance efforts that support earlier
& more accurate diagnosis of NCFB patients NCFB / Bronchiectasis: non-cystic fibrosis bronchiectasis | COPD: chronic obstructive pulmonary disease | NTM: Nontuberculous Mycobacterium | H: half | †This initiative is supported by an
independent research grant provided by Insmed
ARIKAYCE® Updates Will Lewis | Chair & CEO
Executing Commercially While Preparing for Label Expansion in the U.S. &
Japan* U.S.: United States | Int’l: international | M: million | sNDA: supplemental new drug application | FDA: Food and Drug Administration | PMDA: Pharmaceuticals and Medical Devices Agency | H: half | MACLD: Mycobacterium avium complex lung
disease | * if expanded label for ARIKAYCE is approved in the U.S. and Japan | † Unaudited revenues for three months ended June 30, 2026; Growth is vs. same prior year period Preparing for Potential Label Expansion Q2 2026
Revenue† U.S. $70.2M +2.2% Int’l $46.1M +19.1% Worldwide $116.3M +8.3% Filed sNDA with FDA in July in newly diagnosed MACLD patients Intend to submit data to PMDA in 2H:26 to support potential Japanese label expansion Demonstrated
clinical evidence and an experienced commercial team position ARIKAYCE for launch success* U.S. label expansion would extend ARIKAYCE treatment to all MACLD patients, if approved
TPIP Updates TPIP: treprostinil palmitil inhalation powder Will Lewis | Chair
& CEO
s Positive OLE Study Results in PAH Reinforce TPIP’s Potential to Become the
Prostanoid of Choice Phase 2b Study Results 6MWD Improvement2 (meters) PVR Reduction1 NT-proBNP Reduction3 ~35% * +35.5 ^ ~60% ^ 12-Month Data from Ongoing OLE Study‡ 6MWD Improvement4 (meters) WHO FC I or II
Achievement6 NT-proBNP Reduction5 +55 † ~60% † REVEAL Lite 2.0: Refined Low Risk Status Achievement7 ~80% ~65% Results Evaluated Against the Lead-in Study Baseline and Measured ~24 Hours After Dose for Applicable Measures (Not
Placebo-Adjusted) Placebo-Adjusted Efficacy Results Measured at Week 16 (~24 Hours After Dose) TPIP: treprostinil palmitil inhalation powder | PAH: pulmonary arterial hypertension | PVR: pulmonary vascular resistance | 6MWD: 6-minute walk
distance | NT-proBNP: N-terminal pro-B-type natriuretic peptide, a biomarker for cardiac stress (concentration levels) | WHO: World Health Organization | FC: functional class | OLE: open-label extension | The REVEAL Lite 2.0 risk calculator is
a simplified, non-invasive medical tool used to estimate the mortality and disease progression risk for adult patients with PAH | * Highly statistically significant | ^ Nominally statistically significant; not adjusted for multiplicity | †
Metric measured ~24 hours after prior dose was administered and evaluated against the Phase 2b lead-in study pre-randomization baseline value | ‡ Includes all OLE patients in both the “Continued TPIP” and “Placebo Crossed” treatment groups |
Note: Numbered footnotes referenced on this slide can be found in the appendix of this presentation
Expansive Registrational Program Across Four Indications Progressing on
Track TPIP: treprostinil palmitil inhalation powder | TRE: treprostinil | PAH: pulmonary arterial hypertension | PH-ILD: pulmonary hypertension due to interstitial lung disease | PPF: progressive pulmonary fibrosis | IPF: idiopathic pulmonary
fibrosis | µg: micrograms | Note: Initiation indicates that trial sites are open and ready to screen patients for enrollment PH-ILD IPF PPF PAH TPIP PALM-ILD study actively enrolling PALM-PAH study actively enrolling Phase 3 study
initiation expected 2H:26 Phase 3 study initiation expected 1H:27 TPIP's broad dosing range could provide physicians with the flexibility to optimize the balance between efficacy and tolerability The flexibility to quickly & safely dose
TPIP to higher levels than other inhaled TRE therapies could meaningfully differentiate it within the class All Phase 3 studies permit titration to patient maximum tolerated dose (up to 1,280 µg) The ability to continue to dose patients
higher on inhaled therapy could delay their need to switch to parenteral options
Let’s Recap BRINSUPRI’s launch momentum supports upward revision of Full-Year
2026 revenue guidance to between $1.25 and $1.4B ARIKAYCE continues to deliver steady growth while positioning for potential label expansion in the U.S. and Japan Positive OLE data in PAH and once-daily dosing profile reinforce TPIP’s
potential to become the prostanoid of choice across four indications B: billion | U.S.: United States | TPIP: treprostinil palmitil inhalation powder | OLE: open-label extension | PAH: pulmonary arterial hypertension
Financial Results Sara Bonstein | Chief Financial Officer
v v Strong Second-Quarter Revenue Performance Across Both Commercial
Products $309.2M in revenue +49% sequential growth Strength primarily driven by new & existing patient demand, along with favorable GTN $116.3M in revenue +8% growth vs. Q2 2025 GTN fell within annual guidance range of low- to
mid-20%s Total Revenues $425.5M M: million | Q: quarter | GTN: gross-to-net
Second-Quarter Performance Supports Updated Full-Year Guidance for BRINSUPRI
Revenue $1.25B to $1.4B† $450M to $470M‡ Gross-to-Net Mid-20%s to High-20%s Low-20%s to Mid-20%s B: billion | M: million | † BRINSUPRI guidance does not contemplate meaningful revenue contribution from a potential Japanese
approval in the second-half of 2026 | ‡ ARIKAYCE guidance does not contemplate contribution from a potential label expansion approval in the U.S. and Japan in 2026 G U I D A N C E G U I D A N C E Full-Year 2026 Previously “Greater than
$1B” Previously “Mid-20%s to Low-30%s” Unchanged Unchanged
Advancing Commercial and Clinical Programs Through Investment Three Months
Ended1 6/30/2026 6/30/2025 Total Revenues $425.5 $107.4 Cost of Product Revenues2 As a % of Revenues (67.2) 15.8% (28.1) 26.1% R&D (210.0) (177.2) SG&A (247.5) (154.8) Other† 97.7 (60.3) Total Operating Expenses
$(427.0) $(420.3) Operating Loss $(1.5) $(312.9) Costs2 as % of revenues decreased y/y, reflecting BRINSUPRI contribution R&D and SG&A increased y/y reflecting investments in growth: U.S. BRINSUPRI launch Clinical pipeline
development R&D: research and development | SG&A: selling, general and administrative expenses | y/y: year-over-year | U.S.: United States | 1 Unaudited | 2 Excludes amortization of intangible assets; also referred to as “costs” | †
Includes amortization of intangible assets and change in fair value of contingent consideration (in $ millions, except for percentages)
We Continue to Believe Cash Flow Positivity in 2027 Can Be Achieved Without
Additional Capital DTC: direct-to-consumer | BD: business development | H: half | B: billion | 1 Includes anticipated payments of $50 million to AstraZeneca related to regulatory & sales-based milestones | 2 Assuming no material expansion
in expense base from BD | † Unaudited cash, cash equivalents, and marketable securities position as of June 30, 2026 ~$1.2B June 30, 2026† In Cash, Cash Equivalents, and Marketable Securities Cash burn was meaningfully lower than in
recent quarters, driven by higher revenue generation and appropriate financial discipline Expect increased investment in clinical programs, DTC advertising, and Japan commercial infrastructure in 2H:261 Continue to expect to achieve cash flow
positivity in 2027 without raising additional capital2
Long-Term Financial Profile: Positioned for Attractive Future Revenue and Earnings
Growth Multiple commercial and pipeline value drivers expected to support sustained long-term revenue growth Strong revenue growth expected to translate into durable earnings growth and long-term shareholder value creation Synergistic
respiratory portfolio and shared infrastructure expected to enhance operating leverage potential 1 2 3
Q&A Session Will Lewis Chair & CEO Sara Bonstein Chief Financial
Officer Martina Flammer Chief Medical Officer
Appendix
Footnotes Insmed Phase 2b Study of TPIP in PAH; Placebo-Adjusted Reduction from
Baseline PVR at Week 16; Analysis performed using an ANCOVA model, adjusting for treatment group, baseline pulmonary vascular resistance (PVR), and randomization stratification factors. The model was applied to log-transformed PVR values, which
were then back-transformed to the original scale; statistically significant, p<0.001; Measurements were taken at ~24 hours post dose (“at trough”); Topline results presented June 2025. Insmed Phase 2b Study of TPIP in PAH; Placebo-Adjusted
Improvement from Baseline 6MWD at Week 16; Covariate-adjusted estimate of location shift. Analysis performed using a rank ANCOVA model, adjusting for treatment group, baseline 6-minute walk distance (6MWD), and randomization stratification
factors; Nominally statistically significant, not adjusted for multiplicity, p=0.003; Measurements were taken at ~24 hours post dose (“at trough”); Topline results presented June 2025. Insmed Phase 2b Study of TPIP in PAH; Placebo-Adjusted
Mean Ratio to baseline NT-proBNP of 0.40; Analysis performed using a repeated measures mixed model, adjusting for treatment group, baseline NT-proBNP, randomization stratification factors, visit and treatment-by-visit interaction. The model was
applied to log-transformed NT-proBNP values, which were then back-transformed to the original scale; nominally statistically significant, not adjusted for multiplicity, p<0.001; Measurements were taken at ~24 hours post dose (“at trough”);
Topline results presented June 2025. Insmed OLE Study of TPIP in PAH (12-Month Analysis); Patients in the TPIP Continued group showed a mean improvement from baseline 6MWD of 55.7 meters at Month 12. Patients in the Placebo Crossed group
showed a mean improvement from baseline 6MWD of 54.1 meters; Measurements were taken at ~24 hours post dose (“at trough”); The baseline values used in this OLE are from the Phase 2b study (pre-randomization values). The Phase 2a 24-hour PVR
study single patient data were not included in this change from baseline analysis as no baseline data were available; Last observation carried forward (LOCF) is used to impute the missing values at each visit; Results presented July
2026. Insmed OLE Study of TPIP in PAH (12-Month Analysis); Patients in the TPIP Continued group showed a mean improvement from baseline NT-proBNP concentration of 60% at Month 12. Patients in the Placebo Crossed group showed a mean reduction
from baseline NT-proBNP concentration of 60%; Measurements were taken at ~24 hours post dose (“at trough”); The baseline values used in this OLE are from the Phase 2b study (pre-randomization values). The Phase 2a 24-hour PVR study single
patient data were not included in this change from baseline analysis as no baseline data were available; Last observation carried forward (LOCF) is used to impute the missing values at each visit; Results presented July 2026. Insmed OLE Study
of TPIP in PAH (12-Month Analysis); ~80% of patients in the TPIP Continued group and the Placebo Crossed group achieved WHO Functional Class I or II at Month 12; Results presented July 2026. Insmed OLE Study of TPIP in PAH (12-Month Analysis);
~65% of patients in the TPIP Continued group and the Placebo Crossed group achieved Refined Low Risk status (REVEAL Lite 2.0 Score of ≤4) at Month 12; Percentage is based on responder analysis where the denominator is the full analysis set
within that treatment group; When calculating the mean REVEAL Lite 2.0 score, last observation carried forward (LOCF) methodology was used to impute the missing values at each visit. The Phase 2b lead-in study (pre-randomization values) was
used as the baseline. The Phase 2a 24-hour PVR study single patient did not have baseline REVEAL data but did have Day 1 OLE observed data. LOCF was used to impute data for Month 6 and Month 12 for this patient; Results presented July
2026. TPIP: treprostinil palmitil inhalation powder | PAH: pulmonary arterial hypertension | PVR: pulmonary vascular resistance | 6MWD: 6-minute walk distance | NT-proBNP: N-terminal pro-B-type natriuretic peptide | WHO: World Health
Organization | OLE: open-label extension | ANCOVA: analysis of covariance | LOCF: last observation carried forward | REVEAL Lite 2.0: A simplified, non-invasive risk calculator used to estimate mortality and disease progression risk in adult
patients with PAH | p / p-value: indicates statistical significance
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