Full Press Release Details
Insmed Reports Fourth-Quarter and Full-Year 2025 Financial Results and Provides Business Update
-Company Expects Full-Year 2026 BRINSUPRI (brensocatib) Revenues to Be at Least $1 Billion; Reiterates Full-Year 2026 ARIKAYCE (amikacin liposome inhalation suspension) Revenue Guidance of $450 Million to $470 Million-
-Total Company Revenues of $606.4 Million for Full-Year 2025-
-BRINSUPRI Total Revenues of $144.6 Million for Fourth-Quarter and $172.7
Million for Full-Year 2025-
-ARIKAYCE Total Revenues of $119.2 Million for Fourth-Quarter and $433.8 Million for Full-Year 2025, Representing 19% Annual Growth and Exceeding
the Upper End of Full-Year 2025 Guidance-
-Topline Data Readouts from Phase 3 ENCORE and Phase 2b CEDAR Studies Remain on Track-
-FDA grants Orphan Drug Designation to Treprostinil Palmitil for Treatment of PAH-
-Company Ends 2025 with Approximately $1.4 Billion of Cash, Cash Equivalents, and Marketable Securities-
BRIDGEWATER, N.J., February 19, 2026 /PRNewswire/ - Insmed Incorporated (Nasdaq: INSM), a people-first global
biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided
"As we close out 2025 and begin an exciting new year at Insmed, I am energized by the significant opportunities ahead to serve patients with serious diseases," said Will
Lewis, Chair and Chief Executive Officer of Insmed. "Our U.S. commercial launch of BRINSUPRI continues to exceed our expectations, and we are proud to provide this medicine to patients who previously had no approved treatment for their disease.
Throughout 2026, we will continue to bring BRINSUPRI to patients with bronchiectasis, expand our Phase 3 clinical programs for TPIP, and advance our early-stage pipeline, fueling the research engine that we hope will power the next wave of
potentially life-transforming therapies for patients."
Progress and Anticipated Milestones by Therapeutic Area:
Immunology & Inflammation
Fourth-Quarter and Full-Year 2025 Financial Results
The following table summarizes fourth-quarter and full-year 2025 and 2024 revenues and revenue growth for BRINSUPRI and ARIKAYCE across all commercial regions:
| Three Months Ended | Twelve Months Ended | |||||||||||||||||||||||
| December 31, | December 31, | |||||||||||||||||||||||
| (in millions) | 2025 | 2024 | Growth | 2025 | 2024 | Growth | ||||||||||||||||||
| ARIKAYCE | ||||||||||||||||||||||||
| U.S. | $ | 73.4 | $ | 67.8 | 8 | % | $ | 280.3 | $ | 254.8 | 10 | % | ||||||||||||
| International | 45.9 | 36.7 | 25 | % | 153.5 | 108.9 | 41 | % | ||||||||||||||||
| Total | $ | 119.2 | $ | 104.4 | 14 | % | $ | 433.8 | $ | 363.7 | 19 | % | ||||||||||||
| BRINSUPRI | ||||||||||||||||||||||||
| U.S. | $ | 144.6 | $ | - | N/A | $ | 172.7 | $ | - | N/A | ||||||||||||||
| International | - | - | N/A | - | - | N/A | ||||||||||||||||||
| Total | $ | 144.6 | $ | - | N/A | $ | 172.7 | $ | - | N/A | ||||||||||||||
| Total Revenues | ||||||||||||||||||||||||
| U.S. | $ | 218.0 | $ | 67.8 | 222 | % | $ | 453.0 | $ | 254.8 | 78 | % | ||||||||||||
| International | 45.9 | 36.7 | 25 | % | 153.5 | 108.9 | 41 | % | ||||||||||||||||
| Total | $ | 263.8 | $ | 104.4 | 153 | % | $ | 606.4 | $ | 363.7 | 67 | % |
Balance Sheet, Financial Guidance, and Planned Investments
Insmed will host a conference call beginning today, February 19, 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 February 26, 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.
Consolidated Statements of Net Loss
(in thousands, except per share data)
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| License fees | $ | - | $ | - | $ | - | $ | - | ||||||||
| Product revenues, net | $ | 263,843 | $ | 104,442 | $ | 606,423 | $ | 363,707 | ||||||||
| Operating expenses: | ||||||||||||||||
| Cost of product revenues (excluding amortization of intangible assets) | 44,220 | 26,151 | 122,938 | 85,742 | ||||||||||||
| Research and development | 254,911 | 179,727 | 771,093 | 598,367 | ||||||||||||
| Selling, general and administrative | 212,483 | 142,515 | 701,167 | 461,116 | ||||||||||||
| Amortization of intangible assets | 1,937 | 1,263 | 6,001 | 5,052 | ||||||||||||
| Change in fair value of deferred and contingent consideration liabilities | 70,040 | (14,800 | ) | 251,993 | 91,682 | |||||||||||
| Total operating expenses | 583,591 | 334,856 | 1,853,192 | 1,241,959 | ||||||||||||
| Operating loss | (319,748 | ) | (230,414 | ) | (1,246,769 | ) | (878,252 | ) | ||||||||
| Investment income | 15,236 | 17,257 | 60,656 | 53,307 | ||||||||||||
| Interest expense | (20,599 | ) | (21,550 | ) | (83,795 | ) | (84,913 | ) | ||||||||
| Change in fair value of interest rate swap | - | 870 | - | (236 | ) | |||||||||||
| Loss on extinguishment of debt | - | - | - | |||||||||||||
| Other (expense) income, net | (1,823 | ) | (445 | ) | (1,841 | ) | 29 | |||||||||
| Loss before income taxes | (326,934 | ) | (234,282 | ) | (1,271,749 | ) | (910,065 | ) | ||||||||
| Provision for income taxes | 1,551 | 1,266 | 5,026 | 3,707 | ||||||||||||
| Net loss | $ | (328,485 | ) | $ | (235,548 | ) | $ | (1,276,775 | ) | $ | (913,772 | ) | ||||
| Basic and diluted net loss per share | $ | (1.54 | ) | $ | (1.32 | ) | $ | (6.42 | ) | $ | (5.57 | ) | ||||
| Weighted average basic and diluted common shares outstanding | 213,637 | 179,021 | 199,014 | 164,043 |
Consolidated Balance Sheets
(in thousands, except par value and share data)
| As of | ||||||||
| December 31, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 510,445 | $ | 555,030 | ||||
| Marketable securities | 919,602 | 878,796 | ||||||
| Accounts receivable | 140,857 | 52,012 | ||||||
| Inventory | 132,068 | 98,578 | ||||||
| Prepaid expenses and other current assets | 91,236 | 37,245 | ||||||
| Total current assets | 1,794,208 | 1,621,661 | ||||||
| Fixed assets, net | 102,942 | 80,052 | ||||||
| Finance lease right-of-use assets | 15,561 | 18,273 | ||||||
| Operating lease right-of-use assets | 20,708 | 17,257 | ||||||
| Intangibles, net | 97,651 | 58,652 | ||||||
| Goodwill | 136,110 | 136,110 | ||||||
| Other assets | 97,378 | 93,226 | ||||||
| Total assets | $ | 2,264,558 | $ | 2,025,231 | ||||
| Liabilities and shareholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 456,060 | $ | 285,209 | ||||
| Finance lease liabilities | 3,345 | 2,961 | ||||||
| Operating lease liabilities | 9,469 | 9,358 | ||||||
| Total current liabilities | 468,874 | 297,528 | ||||||
| Debt, long-term | 540,964 | 1,103,382 | ||||||
| Royalty financing agreement | 162,865 | 161,067 | ||||||
| Contingent consideration | 314,340 | 144,200 | ||||||
| Finance lease liabilities, long-term | 20,719 | 24,064 | ||||||
| Operating lease liabilities, long-term | 12,174 | 9,112 | ||||||
| Other long-term liabilities | 5,646 | 499 | ||||||
| Total liabilities | 1,525,582 | 1,739,852 | ||||||
| Shareholders' equity: | ||||||||
| Common stock, $0.01 par value; 500,000,000 authorized shares, 214,255,853 and 179,382,635 issued and outstanding shares at December 31, 2025 and December 31, 2024, respectively | 2,143 | 1,794 | ||||||
| Additional paid-in capital | 6,372,064 | 4,645,791 | ||||||
| Accumulated deficit | (5,636,692 | ) | (4,359,917 | ) | ||||
| Accumulated other comprehensive gain (loss) | 1,461 | (2,289 | ) | |||||
| Total shareholders' equity | 738,976 | 285,379 | ||||||
| Total liabilities and shareholders' equity | $ | 2,264,558 | $ | 2,025,231 |
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
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.
Brensocatib is designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB.
Brensocatib is also being evaluated for its potential role in hidradenitis suppurativa, another neutrophil-mediated disease.
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.
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
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.
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.
Hypersensitivity Pneumonitis has been reported
with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with
ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and received treatment with corticosteroids. If
hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate.
Hemoptysis has been reported with the use of
ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%). If hemoptysis occurs, manage
patients as medically appropriate.
Bronchospasm has been reported with the use of
ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated
with ARIKAYCE plus background regimen (28.7%) compared to patients treated with a background regimen alone (10.7%). If bronchospasm occurs during the use of ARIKAYCE, treat patients as medically appropriate.
Exacerbations of underlying pulmonary disease
has been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of
bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (14.8%) compared to patients treated with background regimen alone (9.8%). If exacerbations of underlying pulmonary disease occur
during the use of ARIKAYCE, treat patients as medically appropriate.
Anaphylaxis and Hypersensitivity Reactions:
Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives,
itching, flushing, swollen lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of
anaphylaxis (tachycardia, low blood pressure, syncope, incontinence, dizziness). Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction
occurs, discontinue ARIKAYCE and institute appropriate supportive measures.
Ototoxicity has been reported with the use of
ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen (17%) compared to patients treated
with background regimen alone (9.8%). This was primarily driven by tinnitus (7.6% in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and dizziness (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background
regimen alone arm). Closely monitor patients with known or suspected auditory or vestibular dysfunction during treatment with ARIKAYCE. If ototoxicity occurs, manage patients as medically appropriate, including potentially discontinuing
Nephrotoxicity was observed during the clinical
trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal
dysfunction may be needed when prescribing ARIKAYCE.
Neuromuscular Blockade: Patients with
neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle weakness by
blocking the release of acetylcholine at neuromuscular junctions.
Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness in
pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to the fetus.
Contraindications: ARIKAYCE is contraindicated
in patients with known hypersensitivity to any aminoglycoside.
Most Common Adverse Reactions: The most common
adverse reactions in Trial 1 at an incidence 5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm (29% vs 11%),
hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs 10%), diarrhea (13% vs 5%), nausea
(12% vs 4%), pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%).
Drug Interactions: Avoid concomitant use of
ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with
ethacrynic acid, furosemide, urea, or intravenous mannitol.
Overdosage: Adverse reactions specifically
associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin