Form 8-K
8-K — INSMED Inc
Accession: 0001140361-26-019430
Filed: 2026-05-07
Period: 2026-05-07
CIK: 0001104506
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — ef20072589_8k.htm (Primary)
EX-99.1 — EXHIBIT 99.1 (ef20072589_ex99-1.htm)
EX-99.2 — EXHIBIT 99.2 (ef20072589_ex99-2.htm)
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8-K
8-K (Primary)
Filename: ef20072589_8k.htm · Sequence: 1
false000110450600011045062026-05-072026-05-07
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): May 7, 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 May 7, 2026, Insmed Incorporated (the “Company”) issued a press release regarding its financial results for the quarter ended March 31, 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 May 7, 2026.
99.2
Insmed Incorporated May 7, 2026 Presentation.
104
Cover Page Interactive Date File (embedded within the Inline XBRL document).
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
Dated: May 7, 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: ef20072589_ex99-1.htm · Sequence: 2
Exhibit 99.1
Insmed Reports First-Quarter 2026 Financial Results and Provides Business Update
— Total Company Revenues of $306.0 Million for the First Quarter of 2026—
—BRINSUPRI® (brensocatib) Revenues
of $207.9 Million for the First Quarter of 2026, Reflecting 44% Growth Over the Fourth Quarter of 2025—
— ARIKAYCE® (amikacin liposome inhalation suspension) Revenues of $98.1 Million for the First Quarter of 2026, Reflecting 6% Growth Over
the First Quarter of 2025—
—Company Reiterates 2026 BRINSUPRI Revenue Guidance of at Least $1 Billion and 2026 ARIKAYCE Revenue Guidance of $450 Million to $470 Million—
— Phase 3b ENCORE Study of ARIKAYCE in Patients with MAC Lung Disease Met Primary and All Multiplicity-Controlled Secondary Culture Conversion Endpoints—
—Phase 3 PALM-PAH Study of TPIP in Patients with PAH Initiated in April 2026—
BRIDGEWATER, N.J., May 7, 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 first quarter ended March 31, 2026, and provided a business update.
“In the first quarter of 2026, momentum across Insmed’s commercial portfolio and pipeline continued to build,” said Will Lewis, Chair and Chief Executive Officer of Insmed.
“The trajectory of the BRINSUPRI launch continues to exceed our expectations, and we are especially encouraged by the positive topline results from the ENCORE Phase 3b study, which could enable us to extend our reach to even more patients. We remain
focused on improving bronchiectasis diagnosis, expanding the ARIKAYCE label, advancing our Phase 3 programs for TPIP, and progressing our early-stage pipeline, with the ambition of delivering meaningful innovation and improving the lives of patients
with serious diseases.”
Progress and Anticipated Milestones by Therapeutic Area:
Respiratory
BRINSUPRI
•
BRINSUPRI global revenue grew 44% in the first quarter of 2026 compared to the fourth quarter of 2025, driven by strong growth in the U.S. market.
•
In February 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization in the United Kingdom (U.K.) for BRINSUPRI (brensocatib 25 mg tablets) for the
treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more flare-ups or worsening of symptoms in the past 12 months.
•
Insmed anticipates a regulatory decision for brensocatib for the treatment of NCFB in Japan in 2026.
•
Insmed continues to evaluate the potential effect of evolving U.S. policies which will then impact the timing for future potential international commercial launches.
1
ARIKAYCE
•
ARIKAYCE global revenue grew 6% in the first quarter of 2026 compared to the first quarter of 2025, driven by strong growth in international markets.
•
In March 2026, Insmed reported positive topline results from the Phase 3b ENCORE study of ARIKAYCE in patients with Mycobacterium
avium complex (MAC) lung disease, which met its primary and all multiplicity-controlled secondary culture conversion endpoints.
•
Insmed plans to submit a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the second half of 2026.
Similarly, Insmed plans to review the data with the Pharmaceuticals and Medical Devices Agency (PMDA) in the second half of 2026 to support potential label expansion in Japan.
TPIP
•
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).
•
In January 2026, the Office of Orphan Products Development of the FDA granted orphan drug designation to treprostinil palmitil for the treatment of patients with pulmonary arterial hypertension
(PAH).
•
In April 2026, Insmed initiated the Phase 3 PALM-PAH study of TPIP in patients with PAH.
•
Insmed expects to report data from the open-label extension (OLE) of its Phase 2b study of TPIP in PAH in the third quarter of 2026.
•
Insmed anticipates initiating a Phase 3 study of TPIP in patients with progressive pulmonary fibrosis (PPF) by the end of 2026 and a Phase 3 study in patients with idiopathic pulmonary fibrosis (IPF)
in the first half of 2027.
INS1148
•
Insmed plans 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 SCF248 may be
beneficial.
Immunology & Inflammation
INS1033
•
Insmed’s second dipeptidyl peptidase 1 (DPP1) inhibitor, INS1033, is currently advancing toward the clinic in rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), with an initial
investigational new drug (IND) filing expected in the second half 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).
2
INS1203
•
Insmed’s third gene therapy candidate, INS1203, targeting Stargardt disease, is currently advancing toward the clinic, with an IND filing expected in 2026.
Corporate Updates
•
Insmed plans to present six abstracts from across its Respiratory Therapeutic Area (BRINSUPRI, ARIKAYCE, TPIP) at the American Thoracic Society (ATS) 2026 International Conference, taking place May
15-20, 2026.
3
First-Quarter 2026 Financial Results
The following table summarizes first-quarter 2026 and 2025 revenues and revenue growth for BRINSUPRI and ARIKAYCE across all commercial regions:
Three Months Ended March 31,
(in millions)
2026
2025
Growth
ARIKAYCE
U.S.
$
62.9
$
64.3
-2
%
International
35.2
28.5
23
%
Total
$
98.1
$
92.8
6
%
BRINSUPRI
U.S.
$
207.2
$
-
N/A
International
0.7
-
N/A
Total
$
207.9
$
-
N/A
Total Revenues
U.S.
$
270.1
$
64.3
320
%
International
35.9
28.5
26
%
Total
$
306.0
$
92.8
230
%
•
Cost of product revenues (excluding amortization of intangibles) was $47.4 million for the first quarter of 2026, compared to $21.3 million for the first quarter of 2025. The increase in cost of
product revenues in the first quarter of 2026 primarily reflects the increase in total product revenues for ARIKAYCE and BRINSUPRI, following BRINSUPRI’s U.S. commercial launch in August 2025. Cost of product revenues as a percentage of
revenues decreased in the first quarter of 2026 due to sales of BRINSUPRI, which has lower manufacturing costs than ARIKAYCE.
•
Research and development (R&D) expenses were $209.5 million for the first quarter of 2026, compared to $152.6 million for the first quarter of 2025. The increase in R&D expenses for the first
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, increases in manufacturing costs, and an increase in clinical development
and research costs.
•
Selling, general and administrative (SG&A) expenses for the first quarter of 2026 were $247.3 million, compared to $147.5 million for the first quarter of 2025. The increase in SG&A expenses
for the first quarter of 2026 was primarily related to increases in professional fees and other external expenses, and an increase in compensation and benefit-related expenses and stock-based compensation costs, both driven by commercial
activities for BRINSUPRI.
•
For the first quarter of 2026, Insmed reported a net loss of $163.6 million, or $0.76 per share, compared to a net loss of $256.6 million, or $1.42 per share, for the first quarter of 2025.
Balance Sheet, Financial Guidance, and Planned Investments
•
As of March 31, 2026, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.2 billion.
•
The Company continues to anticipate full-year 2026 BRINSUPRI revenues 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 continues to anticipate submitting an average of one to two INDs per year from its pre-clinical research programs.
4
•
Insmed continues to anticipate that the totality of its pre-clinical research programs will comprise less than 20% of overall expenditures.
•
The Company plans to continue to invest in the following key activities in 2026:
(i)
commercialization and expansion of BRINSUPRI and ARIKAYCE;
(ii)
preparation of regulatory submissions for full approval for ARIKAYCE in the U.S. and label expansion to include all patients with a MAC lung infection in the U.S. and Japan;
(iii)
advancement of the clinical development programs for TPIP, including the Phase 3 studies in patients with PH-ILD, PAH, PPF, and IPF;
(iv)
advancement of multiple development programs for INS1148;
(v)
advancement of the clinical trial programs for INS1201 in DMD and INS1202 in ALS, as well as IND-enabling activities for INS1203 in Stargardt disease;
(vi)
advancement of IND-enabling activities for INS1033 in RA and IBD; and
(vii)
continued development of its pre-clinical research programs.
Conference Call
Insmed will host a conference call beginning today, May 7, 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 May 14, 2026, by dialing (800) 770-2030 (U.S. and international) and
referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company’s website at www.insmed.com.
5
INSMED INCORPORATED
Consolidated Statements of Net Loss
(in thousands, except per share data)
(unaudited)
Three Months Ended March 31,
2026
2025
Product revenues, net
$
305,964
$
92,823
Operating expenses:
Cost of product revenues (excluding amortization of intangible assets)
47,420
21,278
Research and development
209,485
152,577
Selling, general and administrative
247,259
147,545
Amortization of intangible assets
2,081
1,263
Change in fair value of deferred and contingent consideration liabilities
(46,961
)
18,300
Total operating expenses
459,284
340,963
Operating loss
(153,320
)
(248,140
)
Investment income
12,040
13,906
Interest expense
(20,082
)
(21,569
)
Other (expense) income, net
(736
)
132
Loss before income taxes
(162,098
)
(255,671
)
Provision for income taxes
1,465
912
Net loss
$
(163,563
)
$
(256,583
)
Basic and diluted net loss per share
$
(0.76
)
$
(1.42
)
Weighted average basic and diluted common shares outstanding
215,468
180,860
6
INSMED INCORPORATED
Consolidated Balance Sheets
(in thousands, except par value and share data)
As of
March 31, 2026
December 31, 2025
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
582,188
$
510,445
Marketable securities
641,326
919,602
Accounts receivable
178,555
140,857
Inventory
132,909
132,068
Prepaid expenses and other current assets
78,195
91,236
Total current assets
1,613,173
1,794,208
Fixed assets, net
102,846
102,942
Finance lease right-of-use assets
14,883
15,561
Operating lease right-of-use assets
14,004
20,708
Intangibles, net
95,570
97,651
Goodwill
136,110
136,110
Other assets
99,277
97,378
Total assets
$
2,075,863
$
2,264,558
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable and accrued liabilities
$
352,555
$
456,060
Finance lease liabilities
3,446
3,345
Operating lease liabilities
5,007
9,469
Total current liabilities
361,008
468,874
Debt, long-term
542,215
540,964
Royalty financing agreement
162,137
162,865
Contingent consideration
270,310
314,340
Finance lease liabilities, long-term
19,820
20,719
Operating lease liabilities, long-term
9,837
12,174
Other long-term liabilities
5,684
5,646
Total liabilities
1,371,011
1,525,582
Shareholders’ equity:
Common stock, $0.01 par value; 500,000,000 authorized shares, 216,521,841
and 214,255,853 issued and outstanding shares at March 31, 2026 and December 31, 2025, respectively
2,165
2,143
Additional paid-in capital
6,502,938
6,372,064
Accumulated deficit
(5,800,255
)
(5,636,692
)
Accumulated other comprehensive gain
4
1,461
Total shareholders’ equity
704,852
738,976
Total liabilities and shareholders’ equity
$
2,075,863
$
2,264,558
7
About ARIKAYCE
ARIKAYCE® is approved in the United States as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion,
and in Japan as ARIKAYCE inhalation 590 mg (amikacin sulfate inhalation drug product). Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of
amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed’s proprietary PULMOVANCE™ liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while
limiting systemic exposure. ARIKAYCE is administered once daily using the Lamira® Nebulizer System manufactured by PARI Pharma GmbH (PARI).
About PARI Pharma and the Lamira® Nebulizer System
ARIKAYCE is delivered by a novel inhalation device, the Lamira® Nebulizer System, developed by PARI. Lamira® is a quiet, portable nebulizer that
enables efficient aerosolization of ARIKAYCE via a vibrating, perforated membrane. Based on PARI’s 100-year history working with aerosols, PARI is dedicated to advancing inhalation therapies by developing innovative delivery platforms to improve
patient care.
About BRINSUPRI
BRINSUPRI® (brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). BRINSUPRI (brensocatib 10 mg and 25 mg
tablets) is indicated in the United States for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age or older. In the European Union, BRINSUPRI (brensocatib 25 mg tablets) is approved for the
treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. 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. Developed entirely in Insmed’s laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated as once-daily therapy for the treatment of patients with pulmonary arterial hypertension
(PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), and other rare and serious pulmonary disorders. TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been
approved for any indication in any jurisdiction.
8
About INS1148
INS1148 is an investigational monoclonal antibody that Insmed is developing as a potential first-in-class therapy to address respiratory and immunological and inflammatory
diseases with high unmet need. Through its novel mechanism of action, INS1148 preferentially targets a specific isoform of Stem Cell Factor, called Stem Cell Factor 248 (SCF248). Binding to SCF248 induces clearance of this SCF isoform and interrupts
only the inflammatory cascade downstream of c-Kit signaling, while leaving its homeostatic and tissue healing pathways intact. INS1148 is an investigational drug product that has not been approved for any indication in any jurisdiction.
About INS1201
INS1201 is an investigational micro-dystrophin adeno-associated virus (AAV9) gene therapy that Insmed is developing as a potential treatment for patients with Duchenne
muscular dystrophy (DMD). Administered intrathecally, this approach has the potential to target both skeletal and cardiac muscles as a one-time fixed (non-weight-based) dose. INS1201 is an investigational drug product that has not been approved for
any indication in any jurisdiction.
About INS1202
INS1202 is an investigational adeno-associated virus (AAV9) short hairpin RNA (shRNA) construct targeting the human superoxide dismutase type 1 (SOD1) gene. Insmed is
developing INS1202 as a potential treatment for patients with amyotrophic lateral sclerosis (ALS) who carry SOD1 mutations and those who do not have SOD1 mutations. INS1202 is administered intrathecally as a one-time fixed (non-weight-based) dose.
INS1202 is an investigational drug product that has not been approved for any indication in any jurisdiction.
IMPORTANT SAFETY INFORMATION AND BOXED WARNING FOR ARIKAYCE IN THE U.S.
WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS
ARIKAYCE has been associated with an increased risk of respiratory adverse
reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases.
Hypersensitivity Pneumonitis has been reported
with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with
ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and received treatment with corticosteroids. If
hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate.
Hemoptysis has been reported with the use of
ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%). If hemoptysis occurs, manage
patients as medically appropriate.
9
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.
10
Most Common Adverse Reactions: The most common
adverse reactions in Trial 1 at an incidence ≥5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm (29% vs 11%), hemoptysis
(18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs 10%), diarrhea (13% vs 5%), nausea (12% vs 4%),
pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%).
Drug Interactions: Avoid concomitant use of ARIKAYCE
with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic
acid, furosemide, urea, or intravenous mannitol.
Overdosage: Adverse reactions specifically
associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from
the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment.
U.S. INDICATION
LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a
multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use
in a limited and specific population of patients.
This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month
6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Limitation of Use:
ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6
consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.
Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1‑800‑FDA‑1088. You can also call the Company at 1-844-4-INSMED.
Please see Full Prescribing Information.
BRINSUPRI® (brensocatib) U.S. INDICATION AND IMPORTANT SAFETY INFORMATION
Indication in the U.S.
BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older.
Important Safety Information in the U.S.
11
WARNINGS AND PRECAUTIONS
Dermatologic Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis. Monitor patients
for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings.
Gingival and Periodontal Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions. Refer patients to dental care services for regular
dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene.
Live Attenuated Vaccines
It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The
use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI.
ADVERSE REACTIONS
The most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and
hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions.
Less Common Adverse Reactions
Liver Function Test Elevations
In ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both
BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9%; the incidence of AST >3X ULN was 0.2%, 0.3%, and 0.5%; and the incidence of alkaline phosphatase >1.5X ULN was
2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively.
Skin Cancers
In ASPEN, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in
placebo-treated patients.
Alopecia
In ASPEN, the incidence of alopecia among patients treated with BRINSUPRI 10 mg and 25 mg was 1.5% and 1.6% respectively, compared to 0.4% in
placebo-treated patients.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no clinical
data on the use of BRINSUPRI in pregnant women.
Lactation: There is no information
regarding the presence of BRINSUPRI and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s
clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition.
Pediatric use: The safety and
effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Common adverse reactions in pediatric patients aged 12 years and older enrolled in ASPEN were consistent with those in adults.
The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age.
12
Please see full US Prescribing Information.
About Insmed
Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing
serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed’s most
advanced programs are in pulmonary and inflammatory conditions, including two approved therapies to treat chronic, debilitating lung diseases. The Company’s early-stage programs encompass a wide range of technologies and modalities, including gene
therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue.
Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one
of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram,
YouTube, and X.
Forward-looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. “Forward-looking statements,” as that term is defined in the
Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,”
“believes,” “estimates,” “projects,” “predicts,” “intends,” “potential,” “continues,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.
13
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 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.
14
The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company’s forward-looking statements because, by their nature,
forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company’s
business, please see the factors discussed in Item 1A, “Risk Factors,” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and any subsequent Company filings with the Securities and Exchange Commission (SEC).
The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company
disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements
may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Contact:
Investors:
Bryan Dunn
Vice President, Investor Relations
(646) 812-4030
investor.relations@insmed.com
Media:
Claire Mulhearn
Vice President, Corporate Communications
(862) 842-6819
media@insmed.com
15
EX-99.2 — EXHIBIT 99.2
EX-99.2
Filename: ef20072589_ex99-2.htm · Sequence: 3
Exhibit 99.2
May 7, 2026 First-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
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, and INS1202 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, or
INS1202. 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 | FDA: Food & Drug Administration | AI: artificial intelligence
Opening Remarks Commercial Updates TPIP Updates Financial
Results 5 7-17 19-21 24-26 Will Lewis Chair & CEO Sara Bonstein Chief Financial Officer TPIP: treprostinil palmitil inhalation powder
Opening Remarks Will Lewis | Chair & CEO
Q1 Performance Positions Insmed to Deliver on 2026 Priorities Recent
Accomplishments Commercial BRINSUPRI®: Strong sequential Q1 revenue growth ARIKAYCE®: Q1 revenue growth in 8th year post-launch Clinical Positive Ph3b ENCORE results Ph3 PALM-ILD continues to enroll patients Ph3 PALM-PAH initiated April
2026 2026 Priorities Maximize BRINSUPRI’s impact on currently diagnosed NCFB patients Unlock BRINSUPRI’s impact on NCFB patients with comorbid COPD or asthma Submit data to regulatory authorities supporting expanded ARIKAYCE label Q:
quarter | Ph: Phase | NCFB: non-cystic fibrosis bronchiectasis | COPD: chronic obstructive pulmonary disease | TPIP: treprostinil palmitil inhalation powder | IND: investigational new drug application | BD: business development Execute on Ph3
TPIP programs File ~1-2 INDs, further diversifying our early-stage pipeline Explore opportunities to supplement our pipeline with select BD
BRINSUPRI® Updates Will Lewis | Chair & CEO
Launch Performance Reinforces Confidence in Full-Year Revenue Guidance of At Least
$1 Billion 1 Unaudited revenues for three months ended March 31, 2026 | M: million | Q: quarter Sequential growth in first calendar Q1 exceeded strong comparable launches… Negligible inventory stocking observed; expected to be immaterial
in future …including those unimpacted by Medicare coverage gap dynamics True demand: No price increase in 2026 $207.9M +44% Q1 2026 vs. Q4 2025 Global Net Revenues1 Sequential Growth
Launch Dashboard: Key Indicators Reinforce Our Confidence in BRINSUPRI’s Launch
Trajectory Rx: prescription / prescribing | SP: specialty pharmacy | * Approximate approval rate derived from payor channels with available visibility as of March 31, 2026, including specialty pharmacy partner data and excluding ASD Healthcare
(Cencora) | ** Includes all physicians that have written at least one prescription since launch. Additional physicians responsible for prescriptions placed directly by hospital pharmacies are not included in this metric PATIENT DEMAND PAYOR
ACCESS PRESCRIBER DEEPENING & BROADENING COMPLIANCE RATES Healthy organic patient demand continues to build Favorable monthly new patient starts and dispenses trends ~90% payor approval rate for patients processed by SPs since
launch* inLighten® helps >80% of patients engage with treatment High treatment continuation and timely Rx refill rates >5,000 prescribers since launch** Positive patient feedback with potential to deepen Rx over time Education &
outreach initiatives underway <1 week required for approval for a majority of patients
Patient Demand: We Believe Organic Demand Has Increased Sequentially Since
Launch K: thousand | R&W: “ready & waiting” | Q: quarter | NPS: new patient starts | EMR: electronic medical record | est.: estimated | * We have relied on internal analyses and calculations to estimate R&W patient demand,
including by comparing new patient script volumes at large institutions in Q4:25 versus February–March 2026 (within the same institutions) to quantify incremental Q4 new patients following the resolution of Q3 EMR system update limitations.
These estimates necessarily require assumptions subject to significant judgment and may prove to be inaccurate. As a result, our estimates of the size of R&W patient demand could prove to be incorrect, perhaps materially | Note: each
patient box represents 150 patients Q3:25 (Partial Quarter) ~2.55K (~0.75K est. R&W patients*) Q4:25 ~9K (~3.5K est. R&W patients*) ~7.8K (~1.5K est. R&W patients*) Q1:26 NPS mostly driven by organic demand, with strong
run rate exiting the quarter Q1:26 “READY & WAITING” DEMAND Estimate of new patients motivated to proactively seek treatment upon approval ORGANIC DEMAND Estimate of new patients that learned about treatment from pulmonologist visits,
digital education, etc. post-approval Q4:25 Data suggest that most R&W patients from large institutions began therapy Q3:25 Large institution EMR updates lagged approval NEW PATIENT STARTS DEMAND DYNAMICS
Payor Access: Strong Launch Supported by Consistently High and Timely Payor
Approval Rates SP: specialty pharmacy | *Approximate approval rate derived from payor channels with available visibility as of March 31, 2026, including specialty pharmacy partner data and excluding ASD Healthcare (Cencora) v Favorable Payor
Access Dynamics ~90% approval rate for patients processed by SPs since launch* v Frictionless Patient Experience 1 < week required for approval for a majority of patients
Compliance: Positive Patient Experience Reflected in High Continuation and Timely
Refill Rates On average, patients seek to refill their 30-day Rx sooner than industry benchmark (~37 days) Motivated to Remain on Therapy We have observed BRINSUPRI patients to be: Less Likely to Discontinue Highly Compliant >80%
enrollment in patient support program since launch Positive patient experience Favorable safety profile Continuation rate tracking slightly ahead of well-tolerated daily oral medicines, like statins Rx: prescription
Expect Positive Patient Feedback to Deepen Prescriber Behavior While Prescriber
Base Continues to Broaden >20% of prescribers have written scripts for at least 5 patients*** Positive patient feedback discussed at return visits and upcoming medical conferences could motivate additional prescribing Cumulative
Prescribers* Represents >25% of all pulmonologists in the U.S.** >5,000 Q: quarter | U.S.: United States | * 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. | ** Estimate approximately 20,000 pulmonologists in the U.S., including those with
pulmonology as a secondary specialty | *** 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. X 5
Diagnosis-Focused Education Campaign Aims to Drive Proper NCFB Diagnosis
ATS Initiates Effort to Enable Earlier and More Accurate NCFB Diagnosis Across
Large U.S. Medical Systems ATS: American Thoracic Society | COPD: chronic obstructive pulmonary disease | EHR: electronic health records | CME: continuing medical education | U.S.: United States Note: This initiative is supported by an
independent research grant provided by Insmed Identify COPD or asthma patients that may also have bronchiectasis by leveraging EHR data Four Key Goals Assess disease burden and characterize potential evaluation gaps among frequent
exacerbators Pilot scalable solutions to improve diagnosis & clinical practice (e.g., EHR prompts, point-of-care tools, CME) Broadly disseminate findings through educational resources for health systems nationwide
Encouraging Launch Fundamentals Support Promising Revenue Trajectory Strong &
growing patient demand Favorable payor access High patient compliance and continuation rates Opportunity to further broaden & deepen physician prescribing Key launch observations:
ARIKAYCE® Updates Will Lewis | Chair & CEO
ARIKAYCE Demonstrates Revenue Growth in 8th Year of Launch MAC / MACLD:
Mycobacterium avium complex lung disease | U.S.: United States | Int’l: International | M: million | K: thousand | RSS: Respiratory Symptom Score | CC: culture conversion | TAM: total addressable market | 1 Growth is vs. same prior year period
| 2 Durable converters at Month 15 are participants who achieved and maintained negative MAC cultures by Months 11, 12, 13 and 15 after applying adjustment rules as specified in the statistical analysis plan (SAP) | * statistically significant,
controlled for multiplicity | ** If expanded label for ARIKAYCE is approved | † Total addressable Refractory MAC patients in the U.S., Europe (France, Germany, Italy, Spain, and United Kingdom), and Japan | ‡ Additional addressable MAC patients
in the U.S. and Japan if expanded ARIKAYCE label is approved | Note: References related to patient TAMs can be found in the Company's Investor Presentation. ENCORE Results Potential Label Expansion** Early treatment with ARIKAYCE +
multidrug therapy can significantly improve outcomes for MACLD patients Q1 2026 Revenues1 U.S. $62.9M (2.2%) Int’l $35.2M +23.4% Worldwide $98.1M +5.7% Greater Durable CC2 at Month 15* RSS Improvement at Month 13* ARIKAYCE
Well-Tolerated Expect to submit data to U.S. and Japan regulatory authorities in 2H:26 Current TAM 30K† (Refractory MAC) ~+200K‡ Additional Patients** (All MACLD)
TPIP Updates TPIP: Treprostinil Palmitil Inhalation Powder Will Lewis | Chair
& CEO
TPIP: Focused on Designing and Conducting an Expansive Registrational Program
Across Four Indications PAH TAM: ~90K IPF PPF PH-ILD TPIP 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 | K: thousand | H: half | TAM: total addressable market (including the U.S., Europe (France, Germany, Italy, Spain and UK), and Japan | Note: IPF and PPF estimates do not account for overlap with
PH-ILD; estimated that ~10% of IPF and PPF patients may overlap with PH-ILD | Note: References related to patient TAMs can be found in the Company's Investor Presentation TAM: ~135K TAM: ~255K TAM: ~220K
PAH: pulmonary arterial hypertension | OLE: open-label expansion | Q: quarter |
Ph: phase | 6MWD: six-minute walk distance | FC: World Health Organization functional class improvement | NT-proBNP: N-terminal pro b-type natriuretic peptide; a biomarker of cardiac stress | µg: micrograms | 1 placebo-adjusted metric measured
1-3 hours post-dose at Week 24 | 2 placebo-adjusted metric measured pre-dose at Week 22 | 3 91 patients enrolled in the OLE Ph3 PALM-PAH First trial site opened in April One trial required for regulatory approval, if successful KEY
DETAILS Primary: 6MWD at peak exposure1 Key Secondaries: FC improvement, 6MWD at trough2, NT-proBNP Background sotatercept capped at 20% of sample Ph2b PAH OLE ~25% of patients have exceeded max randomized trial dose (640µg)3 DEFINING
SUCCESS Sustained best-in-class 6MWD, NT-proBNP, FC improvement measures Favorable dosing effect with similar safety Study Initiated; Phase 3 PAHData from Phase 2b OLE Now Expected Q3:26 7 patients have titrated to 1,280µg
Phase 3 PH-ILD Study Progressing On Track Plans to Finalize PPF & IPF Studies
Underway PH-ILD: pulmonary hypertension due to interstitial lung disease | PPF: progressive pulmonary fibrosis | IPF: idiopathic pulmonary fibrosis | H: half | TPIP: treprostinil palmitil inhalation powder | TRE: treprostinil | Note:
Initiation indicates that trial sites are open and ready to screen participants for enrollment Ph3 PALM-ILD PH-ILD patients now randomized in 7 countries Recruiting in the U.S. despite existence of approved competitor treprostinil
product Ph3 PALM-PPF Expect study to initiate in 2H:26 Ph3 PALM-IPF Expect study to initiate in 1H:27 Potential Advantages of TPIP: A once-daily dry powder with… localization of inhaled therapy inert formula limiting airway
effects slow release properties enabling high, consistent TRE levels in lungs continuity of parenteral treatment
Let’s Recap BRINSUPRI launch remains on track and supports ambitious 2026 revenue
guidance of at least $1B ARIKAYCE continues to grow in its current indication and is poised for an inflection if an expanded label is approved First Phase 3 PAH trial site opened; PALM-ILD continues to enroll patients; Phase 2 PAH OLE data
expected Q3:26 B: billion | PAH: pulmonary arterial hypertension | OLE: open-label extension | Q: quarter
Financial Results Sara Bonstein | Chief Financial Officer
First-Quarter Performance Supports Existing Full-Year Guidance Expectations
Revenue At Least $1B $450M to $470M Gross-to-Net Mid-20%s to Low-30%s Low-20%s to Mid-20%s B: billions | M: millions G U I D A N C E G U I D A N C E Full-Year 2026
We Believe Cash Flow Positivity in 2027 Can Be Achieved Without Additional Capital
1 Cash burn excludes cash received from option exercises | † Unaudited cash, cash equivalents, and marketable securities position as of March 31, 2026 | BD: business development ~$1.2B March 31, 2026† In Cash, Cash Equivalents, and
Marketable Securities Underlying cash burn1 was in-line with past year levels Cash burn expected to decline as revenue ramps faster than spend over time Path to cash flow positivity in 2027, assuming no material expansion in expense base
from BD
Advancing Commercial and Clinical Programs Through Investment Three Months
Ended1 3/31/2026 3/31/2025 Total Revenues $306.0 $92.8 Cost of Product Revenues2 As a % of Revenues (47.4) 15.5% (21.3) 22.9% R&D (209.5) (152.6) SG&A (247.3) (147.5) Other† 44.9 (19.6) Total Operating Expenses
$(459.3) $(341.0) Operating Loss $(153.3) $(248.1) 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 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 | R&D: research and development |
SG&A: selling, general and administrative expenses | y/y: year-over-year | U.S.: United States (in $ millions, except for percentages)
Closing Remarks Strong execution across clinical and commercial
priorities Well-positioned to deliver for patients and drive long-term value creation Solid financial position supports continued investment in our commercial portfolio and clinical pipeline
Q&A Session Will Lewis Chair & CEO Sara Bonstein Chief Financial
Officer Martina Flammer Chief Medical Officer
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