Insmed (NASDAQ: INSM) posts $306M Q1 sales, reiterates 2026 outlook
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Insmed reported strong first-quarter 2026 growth, with total revenues of $306.0 million, up from $92.8 million a year earlier, driven by the U.S. launch of BRINSUPRI and continued ARIKAYCE demand. BRINSUPRI generated $207.9 million, while ARIKAYCE contributed $98.1 million and remained in growth eight years post-launch.
The company still posted a net loss of $163.6 million, though this narrowed from $256.6 million in 2025 as operating leverage improved. Management reiterated 2026 revenue guidance of at least $1 billion for BRINSUPRI and $450–$470 million for ARIKAYCE, and highlighted a goal of reaching cash-flow positivity in 2027 supported by roughly $1.2 billion in cash and marketable securities.
Positive
- Total revenue surged to $306.0 million in Q1 2026, up 230% from $92.8 million a year earlier, driven primarily by the BRINSUPRI launch and continued ARIKAYCE growth.
- BRINSUPRI generated $207.9 million in its first reported full quarter, and management reiterated ambitious 2026 BRINSUPRI revenue guidance of at least $1 billion.
- ARIKAYCE delivered $98.1 million in Q1 2026 revenue, growing 5.7% year over year in its eighth year post-launch, underscoring durable demand in refractory MAC lung disease.
- Net loss narrowed to $163.6 million from $256.6 million year over year, reflecting improving operating leverage despite substantial R&D and SG&A investment.
- Insmed ended March 31, 2026 with roughly $1.2 billion in cash, cash equivalents, and marketable securities, supporting ongoing commercial expansion and late-stage clinical programs.
- Positive Phase 3b ENCORE results for ARIKAYCE and initiation of the Phase 3 PALM-PAH trial for TPIP add meaningful late-stage clinical catalysts and potential future label and indication expansions.
Negative
- The company remains loss-making, with a Q1 2026 net loss of $163.6 million and total operating expenses of $459.3 million continuing to exceed rapidly growing revenues.
- R&D and SG&A expenses rose sharply year over year to $209.5 million and $247.3 million respectively, reflecting heavy spending needs that could delay the timing of sustained profitability if growth slows.
Insights
Q1 shows a transformative BRINSUPRI launch, strong ARIKAYCE durability, and a clearer path toward profitability.
Insmed delivered Q1 2026 revenue of $306.0M, up 230% year over year, with BRINSUPRI contributing $207.9M and ARIKAYCE $98.1M. This indicates rapid uptake in non-cystic fibrosis bronchiectasis and resilient demand in refractory MAC lung disease.
Despite higher R&D and SG&A to support launches and late-stage trials, the net loss narrowed to $163.6M from $256.6M, helped by BRINSUPRI’s margin profile and a favorable change in contingent consideration. The balance sheet shows about $1.2B in cash and marketable securities as of March 31, 2026, alongside existing debt and royalty financing.
Management reiterated 2026 revenue guidance of at least $1B for BRINSUPRI and $450–$470M for ARIKAYCE and articulated an ambition to reach cash-flow positivity in 2027. Positive Phase 3b ENCORE results for ARIKAYCE and initiation of the Phase 3 PALM-PAH study for TPIP add late-stage pipeline depth, though execution and regulatory outcomes remain key variables.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Total revenue: $306.0M
BRINSUPRI revenue: $207.9M
ARIKAYCE revenue: $98.1M
+5 more
8 metrics
Total revenue
$306.0M
Three months ended March 31, 2026; vs. $92.8M in 2025
BRINSUPRI revenue
$207.9M
Three months ended March 31, 2026; first reported quarter
ARIKAYCE revenue
$98.1M
Three months ended March 31, 2026; 5.7% growth year over year
Net loss
$163.6M
Three months ended March 31, 2026; improved from $256.6M in 2025
Basic and diluted EPS
$(0.76)
Net loss per share for Q1 2026; vs. $(1.42) in Q1 2025
Cash and cash equivalents
$582.2M
As of March 31, 2026; balance sheet figure
Marketable securities
$641.3M
As of March 31, 2026; adds to liquidity
2026 BRINSUPRI guidance
≥$1.0B
Full-year 2026 revenue guidance reiterated by management
Key Terms
non-cystic fibrosis bronchiectasis, Mycobacterium avium complex lung disease, pulmonary arterial hypertension, royalty financing agreement, +2 more
6 terms
non-cystic fibrosis bronchiectasis medical
"BRINSUPRI (brensocatib) is indicated in the United States for the treatment of non-cystic fibrosis bronchiectasis (NCFB)"
A chronic lung condition in which the airways become permanently widened and scarred, making them less able to clear mucus and more prone to repeated infections; think of damaged plumbing that traps debris and breeds clogs. It matters to investors because a persistent patient population with ongoing infections and hospital visits creates steady demand for drugs, diagnostics, inhaled therapies, and medical services, which can affect revenues and R&D priorities in healthcare and biotech.
Mycobacterium avium complex lung disease medical
"ARIKAYCE is indicated in adults... for the treatment of Mycobacterium avium complex (MAC) lung disease"
pulmonary arterial hypertension medical
"Phase 3 PALM-PAH Study of TPIP in Patients with PAH initiated in April 2026"
Pulmonary arterial hypertension is a progressive medical condition in which the arteries that carry blood from the heart to the lungs become narrowed or stiff, causing high pressure in the lung circulation and extra strain on the heart — like a pump working against clogged pipes. For investors, it matters because the condition defines the need, market size, clinical trial design, regulatory hurdles and potential revenue or risk for companies developing drugs, devices or diagnostics to treat or manage it.
royalty financing agreement financial
"our royalty financing agreement with OrbiMed Royalty & Credit Opportunities IV, LP"
An agreement where a company receives upfront capital in exchange for paying a fixed percentage of future sales or product royalties until a set amount is repaid. Think of it as selling a slice of future revenue instead of issuing shares or taking a traditional loan; it preserves ownership while creating a predictable payment stream tied to business performance. Investors care because it affects future cash flow, growth funding needs, and the return profile without diluting equity.
contingent consideration liabilities financial
"Change in fair value of deferred and contingent consideration liabilities"
accelerated approval regulatory
"This indication is approved under accelerated approval based on achieving sputum culture conversion"
Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.
Earnings Snapshot
Revenue: $306.0M · Guidance included
Q1 2026
Revenue
$306.0M
+230% YoY
Net loss
$163.6M
improved from $256.6M YoY
EPS (basic and diluted)
$(0.76)
improved from $(1.42) YoY
BRINSUPRI revenue
$207.9M
N/A prior-year comparison
ARIKAYCE revenue
$98.1M
+5.7% YoY
Guidance
Management reiterated 2026 revenue guidance of at least $1B for BRINSUPRI and $450M–$470M for ARIKAYCE and expressed an ambition to reach cash-flow positivity in 2027.
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
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Zip Code)
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(Address of principal executive offices)
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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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or
Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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Results of Operations and Financial Condition.
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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.
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Financial Statements and Exhibits.
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(d) Exhibits
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Exhibit
No.
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Description
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99.1
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Press release issued by Insmed Incorporated on May 7, 2026.
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99.2
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Insmed Incorporated May 7, 2026 Presentation.
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104
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Cover Page Interactive Date File (embedded within the Inline XBRL document).
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
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Dated: May 7, 2026
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INSMED INCORPORATED
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By:
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/s/ Michael A. Smith
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Name:
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Michael A. Smith
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Title:
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Chief Legal Officer and Secretary
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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
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BRINSUPRI
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| • |
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.
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| • |
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.
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| • |
Insmed anticipates a regulatory decision for brensocatib for the treatment of NCFB in Japan in 2026.
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| • |
Insmed continues to evaluate the potential effect of evolving U.S. policies which will then impact the timing for future potential international commercial launches.
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1
ARIKAYCE
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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.
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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.
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| • |
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.
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TPIP
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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).
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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).
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In April 2026, Insmed initiated the Phase 3 PALM-PAH study of TPIP in patients with PAH.
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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.
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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.
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INS1148
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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.
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Immunology & Inflammation
INS1033
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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.
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Neuro & Other Rare
INS1201
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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).
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INS1202
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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).
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2
INS1203
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Insmed’s third gene therapy candidate, INS1203, targeting Stargardt disease, is currently advancing toward the clinic, with an IND filing expected in 2026.
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Corporate Updates
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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.
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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:
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Three Months Ended March 31,
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(in millions)
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2026
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2025
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Growth
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ARIKAYCE
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U.S.
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$
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62.9
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$
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64.3
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-2
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%
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International
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35.2
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28.5
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23
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%
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Total
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$
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98.1
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$
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92.8
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6
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%
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BRINSUPRI
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U.S.
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$
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207.2
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$
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-
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N/A
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International
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0.7
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-
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N/A
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Total
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$
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207.9
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$
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-
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N/A
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Total Revenues
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U.S.
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$
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270.1
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$
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64.3
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320
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%
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International
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35.9
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28.5
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26
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%
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Total
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$
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306.0
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$
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92.8
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230
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%
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| • |
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.
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| • |
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.
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| • |
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.
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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.
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Balance Sheet, Financial Guidance, and Planned Investments
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As of March 31, 2026, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.2 billion.
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The Company continues to anticipate full-year 2026 BRINSUPRI revenues of at least $1 billion.
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The Company continues to anticipate full-year 2026 ARIKAYCE revenues in the range of $450 million to $470 million.
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The Company continues to anticipate submitting an average of one to two INDs per year from its pre-clinical research programs.
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4
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Insmed continues to anticipate that the totality of its pre-clinical research programs will comprise less than 20% of overall expenditures.
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The Company plans to continue to invest in the following key activities in 2026:
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commercialization and expansion of BRINSUPRI and ARIKAYCE;
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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;
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advancement of the clinical development programs for TPIP, including the Phase 3 studies in patients with PH-ILD, PAH, PPF, and IPF;
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advancement of multiple development programs for INS1148;
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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;
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advancement of IND-enabling activities for INS1033 in RA and IBD; and
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continued development of its pre-clinical research programs.
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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)
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||||||||
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Three Months Ended March 31,
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|||||||
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2026
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2025
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Product revenues, net
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$
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305,964
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$
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92,823
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Operating expenses:
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||||||||
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Cost of product revenues (excluding amortization of intangible assets)
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47,420
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21,278
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||||||
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Research and development
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209,485
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152,577
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Selling, general and administrative
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247,259
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147,545
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||||||
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Amortization of intangible assets
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2,081
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1,263
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Change in fair value of deferred and contingent consideration liabilities
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(46,961
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)
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18,300
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|||||
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Total operating expenses
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459,284
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340,963
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||||||
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||||||||
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Operating loss
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(153,320
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)
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(248,140
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)
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||||
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||||||||
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Investment income
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12,040
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13,906
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||||||
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Interest expense
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(20,082
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)
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(21,569
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)
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||||
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Other (expense) income, net
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(736
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)
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132
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|||||
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Loss before income taxes
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(162,098
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)
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(255,671
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)
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||||
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||||||||
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Provision for income taxes
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1,465
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912
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||||||
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Net loss
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$
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(163,563
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)
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$
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(256,583
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)
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||
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||||||||
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Basic and diluted net loss per share
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$
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(0.76
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)
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$
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(1.42
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)
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||
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||||||||
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Weighted average basic and diluted common shares outstanding
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215,468
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180,860
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6
INSMED INCORPORATED
Consolidated Balance Sheets
(in thousands, except par value and share data)
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As of
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March 31, 2026
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December 31, 2025
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(unaudited)
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Assets
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||||||||
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Current assets:
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Cash and cash equivalents
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$
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582,188
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$
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510,445
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Marketable securities
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641,326
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919,602
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Accounts receivable
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178,555
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140,857
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Inventory
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132,909
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132,068
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Prepaid expenses and other current assets
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78,195
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91,236
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Total current assets
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1,613,173
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1,794,208
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||||||
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Fixed assets, net
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102,846
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102,942
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Finance lease right-of-use assets
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14,883
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15,561
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Operating lease right-of-use assets
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14,004
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20,708
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Intangibles, net
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95,570
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97,651
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Goodwill
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136,110
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136,110
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Other assets
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99,277
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97,378
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||||||
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Total assets
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$
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2,075,863
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$
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2,264,558
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||||
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Liabilities and shareholders’ equity
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||||||||
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Current liabilities:
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||||||||
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Accounts payable and accrued liabilities
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$
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352,555
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$
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456,060
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||||
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Finance lease liabilities
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3,446
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3,345
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||||||
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Operating lease liabilities
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5,007
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9,469
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||||||
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Total current liabilities
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361,008
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468,874
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||||||
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Debt, long-term
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542,215
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540,964
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||||||
|
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
Exhibit 99.2
FAQ
How much revenue did Insmed (INSM) report for Q1 2026?
Insmed reported total Q1 2026 revenue of $306.0 million, up from $92.8 million a year earlier. Growth was driven mainly by the BRINSUPRI launch, contributing $207.9 million, and ARIKAYCE, which delivered $98.1 million in product revenues across U.S. and international markets.
What were Insmed’s BRINSUPRI and ARIKAYCE sales in Q1 2026?
In Q1 2026, BRINSUPRI generated $207.9 million in revenue, with $207.2 million from the U.S. and $0.7 million internationally. ARIKAYCE recorded $98.1 million, including $62.9 million in the U.S. and $35.2 million internationally, reflecting ongoing adoption in refractory MAC lung disease.
Did Insmed (INSM) make a profit in the first quarter of 2026?
No. Insmed reported a net loss of $163.6 million for Q1 2026, compared with a net loss of $256.6 million in Q1 2025. The loss narrowed as revenues grew faster than expenses, but total operating costs of $459.3 million still exceeded the company’s product revenues.
What 2026 revenue guidance did Insmed provide for BRINSUPRI and ARIKAYCE?
Insmed reiterated 2026 guidance for BRINSUPRI revenue of at least $1 billion and ARIKAYCE revenue of $450 million to $470 million. These targets reflect management’s confidence in BRINSUPRI’s U.S. launch trajectory and ARIKAYCE’s continued growth and potential label expansion opportunities.
How strong is Insmed’s cash position after Q1 2026?
As of March 31, 2026, Insmed held $582.2 million in cash and cash equivalents and $641.3 million in marketable securities. This totals roughly $1.2 billion, providing significant financial flexibility to fund commercial activities and late-stage clinical development programs across its portfolio.
What key clinical milestones did Insmed highlight in this update?
Insmed highlighted positive Phase 3b ENCORE results for ARIKAYCE in MAC lung disease and the initiation of the Phase 3 PALM-PAH study of TPIP in pulmonary arterial hypertension. The company also noted ongoing enrollment in the Phase 3 PALM-ILD study and progress across its broader pipeline.
When does Insmed expect to reach cash-flow positivity?
Insmed stated it believes it can achieve cash-flow positivity in 2027 without raising additional capital, assuming no material expansion of its expense base beyond current plans. This outlook is supported by strong BRINSUPRI and ARIKAYCE revenue guidance and a sizable cash and marketable securities position.