INSMED Inc
For the period ended Jun 30, 2026. Filed Aug 6, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 6, 2026
INSM$114.41+5.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001104506-26-000032
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001104506-26-000041
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 210 previous paragraphs and 151 current paragraphs.
90 unchanged; 32 reworded; 21 added; 80 removed; 8 previous and 8 current paragraphs rearranged.
Tables are not compared: 8 previous and 10 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (21)
Current report
Our Marketed Products
Current report
Our Product Candidates & Research
Current report
•Ensure successful US commercialization of BRINSUPRI;
Current report
•In July 2026, we reported positive 12-month data from the ongoing open-label extension study of TPIP in patients with PAH (the OLE Study). See below for additional detail regarding the OLE Study.
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Clinical Trial Developments
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The OLE Study
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The OLE Study is a non-placebo-controlled trial and was designed to evaluate the long-term safety, tolerability, and effectiveness of TPIP over 24 months in patients who completed the lead-in TPIP PAH studies.
Current report
In July 2026, we reported positive 12-month data from the ongoing OLE Study. Data for the primary endpoint of safety and tolerability showed that once-daily TPIP therapy was generally well tolerated with no newly identified safety signals at doses up to 1,280 µg through month 12. Of the 91 patients in the OLE Study, treatment-emergent adverse events (TEAEs) occurred in 89.0% of patients; serious TEAEs were observed in 18.7% of patients; and severe TEAEs were observed in 16.5% of patients in the study. TEAEs leading to study discontinuation were experienced by 7.7% of patients. There were four deaths, none of which were considered related to TPIP treatment. The most common TEAEs through month 12 occurring in 5.0% or more of all patients were headache (28.6%), cough (15.4%), nasopharyngitis (14.3%), diarrhea (11.0%), upper respiratory tract infection (9.9%), bronchitis (7.7%), dizziness (6.6%), epistaxis (6.6%), nausea (6.6%), anemia (5.5%), influenza (5.5%), and pneumonia (5.5%).
Current report
Data for secondary efficacy endpoints demonstrated sustained improvement with TPIP in six-minute walk distance (6MWD), N-terminal fragment pro-B-type natriuretic peptide (NT-proBNP) concentration, and World Health Organization (WHO) Functional Class, as well as a clinically meaningful improvement in REVEAL Lite 2.0 score at month 12. Patients in the Placebo Crossed group (n=31) showed similar outcomes to patients in the TPIP Continued group (n=60) across all efficacy measures at month 12.
Current report
At month 12, mean improvement from baseline for 6MWD was +55.7 meters for the TPIP Continued group and +54.1 meters for the Placebo Crossed group; NT-proBNP concentration was reduced by approximately 60% in both groups with geometric mean ratios to baseline of 0.40 and 0.41 in TPIP Continued and Placebo Crossed, respectively; WHO Functional Class I or II was achieved in 78.3% of TPIP Continued group and 80.6% of Placebo Crossed group patients, and more than 25% of patients across both groups achieved WHO Functional Class I; and mean REVEAL Lite 2.0 score improved 2.0-points from baseline for the TPIP Continued group and 1.4-points from baseline for the Placebo Crossed group. Approximately 65% of all patients achieved Refined Low Risk status.
Current report
R&D expenses were $210.0 million for the three months ended June 30, 2026 as compared to $177.2 million for the same period in 2025, an increase of$32.8 million, or 19%. This increase was primarily due to a $17.0 million increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, and a $14.6 million increase in clinical development and research costs primarily related to TPIP.
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RESULTS OF OPERATIONS
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Comparison of the Six Months Ended June 30, 2026 and 2025
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Cost of product revenues (excluding amortization of intangible assets) for the six months ended June 30, 2026 and 2025 were as follows (in thousands):
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R&D Expenses
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R&D expenses for the six months ended June 30, 2026 and 2025 were comprised of the following (in thousands):
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SG&A Expenses
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SG&A expenses for the six months ended June 30, 2026 and 2025 were comprised of the following (in thousands):
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SG&A expenses were $494.7 million for the six months ended June 30, 2026 as compared to $302.3 million for the same period in 2025, an increase of $192.4 million, or 64%. This increase was primarily due to a $150.9 million increase in professional fees and other external expenses and a $39.2 million increase in compensation and benefit-related expenses due to an increase in headcount, both driven by commercial activities for BRINSUPRI.
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Investment Income
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Investment income was $23.0 million for the six months ended June 30, 2026 as compared to $27.1 million for the same period in 2025, a decrease of $4.1 million, or 15%. This decrease was due to lower average cash and marketable securities balances and lower interest rates in 2026 relative to the same period in 2025.
Removed paragraphs (80)
Previous report
•In August 2025, BRINSUPRI (brensocatib 25 mg and 10 mg tablets), an oral, once-daily treatment for NCFB in adults and children 12 years and older, was approved in the US by the FDA. We launched BRINSUPRI in the US in the third quarter of 2025.
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•In February 2026, the MHRA granted marketing authorisation for BRINSUPRI (brensocatib 25 mg tablets) 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.
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•In March 2026, we reported positive topline results from the Phase 3b ENCORE study, which met its primary and all multiplicity-controlled secondary culture conversion endpoints.
Previous report
•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 PAH. In April 2026, we initiated the Phase 3 PALM-PAH study of TPIP in patients with PAH.
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•We expect to report data from the open-label extension (OLE) of our Phase 2b study of TPIP in PAH in the third quarter of 2026.
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•In December 2025, we acquired INS1148, a Phase 2-ready monoclonal antibody targeting SCF248.
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Immunology & Inflammation
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We are exploring opportunities utilizing our various technologies within the Immunology & Inflammation therapeutic area.
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We strive to develop and commercialize first- and best-in-class therapies that serve patient communities where the need is greatest. Our commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. Our Respiratory therapeutic area includes our commercial products ARIKAYCE and BRINSUPRI and the clinical-stage product candidates TPIP and INS1148. Our first product, ARIKAYCE, is approved in the US as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590mg (amikacin sulfate inhalation drug product). Our second commercial product, BRINSUPRI, was approved in the US, EU, and UK in August 2025, November 2025, and February 2026, respectively, for the treatment of NCFB. The regulatory submission for brensocatib in Japan has been accepted. TPIP is our product candidate that may offer a differentiated product profile for patients with PH-ILD, PAH, PPF, and IPF. INS1148 is a monoclonal antibody targeting SCF248, which we plan to initially develop for PPF and IPF. Our Immunology & Inflammation therapeutic area is exploring opportunities utilizing our various technologies. Our Neuro & Other Rare therapeutic area includes INS1201, our intrathecally delivered gene therapy product candidate for patients with DMD, and INS1202, our intrathecally delivered gene therapy product candidate for patients with ALS. We are also advancing pre-clinical research programs encompassing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue.
Previous report
•Ensure successful US commercial launch of BRINSUPRI;
Previous report
Respiratory
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BRINSUPRI
Previous report
BRINSUPRI (brensocatib 25 mg and 10 mg tablets), an oral, once-daily treatment for NCFB in adults and children 12 years and older, was approved in the US by the FDA in August 2025. In November 2025, BRINSUPRI (brensocatib 25 mg tablets), an oral, once-daily treatment for NCFB in adults and children 12 years and older with two or more exacerbations in the prior 12 months, was approved by the EC. In February 2026, the MHRA granted a marketing authorisation for BRINSUPRI to treat patients 12 years and older with NCFB who have experienced two or more flare-ups or worsening of symptoms in the past 12 months. A regulatory submission for brensocatib in Japan has been accepted.
Previous report
Brensocatib is a small molecule, reversible inhibitor of DPP1, which we licensed from AstraZeneca in October 2016. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs) in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. Neutrophils contain the NSPs (including neutrophil elastase, proteinase 3, and cathepsin G) that have been implicated in a variety of inflammatory diseases. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs.
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In June 2020, the FDA granted breakthrough therapy designation for brensocatib for the treatment of adult patients with NCFB for reducing exacerbations. In November 2020, brensocatib was granted access to the PRIME scheme from the EMA for patients with NCFB. In October 2021, the EMA’s Paediatric Committee approved the brensocatib Pediatric Investigational Plan (the PIP) for the treatment of patients with NCFB. As a result, the ASPEN trial included 41 adolescent patients between ages 12 to 17, which trial design satisfied the pediatric study requirements to support marketing applications in this patient population in the US, Europe and Japan. As a condition of BRINSUPRI’s approval in the US, we agreed with the FDA to conduct a pediatric post marketing study of BRINSUPRI in children between ages 6 and 11. We are also required to continue to progress the PIP notwithstanding BRINSUPRI’s approval in the EU.
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The ASPEN Study
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Based on positive results of our Phase 2b study of brensocatib in patients with NCFB (the WILLOW study), in December 2020 we commenced the ASPEN study, a global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib in adult patients with bronchiectasis. Patients with bronchiectasis due to CF were not enrolled in the study. The primary endpoint was the rate of adjudicated pulmonary exacerbations (PEs) over the 52-week treatment period. Secondary endpoints included the time to first adjudicated PE, the proportion of subjects free of adjudicated PE by 52 weeks, the absolute change from baseline in post-bronchodilator FEV1, the reduction in annualized rate of severe adjudicated PE, and the change from baseline in the Bronchiectasis QOL-B Respiratory Symptoms Domain Score.
Previous report
As part of the ASPEN study, more than 460 trial sites were engaged in nearly 40 countries. After excluding sites that did not enroll any patients and all sites in Ukraine, due to the ongoing conflict, the total number of active sites in ASPEN was 391 sites in 35 countries. Adult patients (ages 18 to 85 years) were randomized 1:1:1 and adolescent patients (ages 12 to <18 years) were randomized 2:2:1 for treatment with brensocatib 10 mg, brensocatib 25 mg, or placebo once daily for 52 weeks, followed by 4 weeks off treatment.
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ASPEN Safety Information and Efficacy Data
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We announced positive topline results from the ASPEN trial in May 2024. Results from the ASPEN trial were published in the New England Journal of Medicine in April 2025. The primary efficacy analysis included data from 1,680 adult patients and 41 adolescent patients. Brensocatib was well-tolerated in the study. In addition, the study met its primary endpoint, with both dosage strengths of brensocatib demonstrating statistically significant reductions in the annualized rate of adjudicated PEs versus placebo. The study also met several of its prespecified secondary endpoints with statistical significance.
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Topline efficacy results from the ASPEN study were as follows:
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ARIKAYCE for Patients with MAC Lung Disease
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ARIKAYCEis our first approved product. ARIKAYCE received accelerated approval in the US in September 2018 for the treatment of refractory MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. In October 2020, ARIKAYCE received approval in Europe for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have CF. In March 2021, ARIKAYCE received approval in Japan for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. MAC lung disease is a rare and often chronic infection that can cause irreversible lung damage and can be fatal. Amikacin solution for parenteral administration is an established drug that has activity against a variety of NTM; however, its use is limited by the need to administer it intravenously and by toxicity to hearing, balance, and kidney function. Unlike amikacin solution for intravenous administration, our proprietary Pulmovance™ technology uses charge-neutral liposomes to deliver amikacin directly to the lungs where liposomal amikacin is taken up by the lung macrophages where the MAC infection resides. This technology also prolongs the release of amikacin in the lungs, while minimizing systemic exposure, thereby offering the potential for decreased systemic toxicities. ARIKAYCE's ability to deliver high levels of amikacin directly to the lung and sites of MAC infection via the use of our Pulmovance technology distinguishes it from intravenous amikacin. ARIKAYCE is administered once-daily using Lamira, an inhalation device developed and manufactured by PARI. Lamira is a portable nebulizer that enables aerosolization of liquid medications via a vibrating, perforated membrane, and was designed specifically for ARIKAYCE delivery.
Previous report
The FDA has designated ARIKAYCE as an orphan drug and a Qualified Infectious Disease Product (QIDP) for NTM lung disease. Orphan designated drugs are eligible for seven years of exclusivity for the orphan indication. QIDP designation provides an additional five years of exclusivity for the designated indication. The FDA granted a total of 12 years of exclusivity in the indication for which ARIKAYCE was approved.
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ARIKAYCE also has been included in the international treatment guidelines for NTM lung disease. The evidence-based guidelines, issued by the American Thoracic Society (ATS), European Respiratory Society (ERS), European Society of Clinical Microbiology and Infectious Diseases (ESCMID), and Infectious Diseases Society of America (IDSA), strongly recommend the use of ARIKAYCE for MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options who have failed to convert to a negative sputum culture after at least six months of treatment.
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In October 2020, the FDA approved an sNDA for ARIKAYCE, adding important efficacy data regarding the durability and sustainability of culture conversion to the ARIKAYCE label. The data, which are from the Company's Phase 3 study of ARIKAYCE (the CONVERT study), demonstrate that the addition of ARIKAYCE to guideline-based therapy (GBT) was associated with sustained culture conversion through the end of treatment as well as durable culture conversion three months post-treatment compared with GBT alone.
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Accelerated Approval and Post-Marketing Confirmatory Clinical Trial
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In September 2018, the FDA granted accelerated approval for ARIKAYCE under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) for the treatment of refractory MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. LPAD, which was enacted as part of the 21st Century Cures Act, serves to advance the development of new antibacterial drugs to treat serious or life-threatening infections in limited populations of patients with unmet needs. As required for drugs approved under the LPAD pathway, labeling for ARIKAYCE includes certain statements to convey that the drug has been shown to be safe and effective only for use in a limited population.
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As a condition of accelerated approval, we must conduct a post-marketing confirmatory clinical trial. In December 2020, we commenced the post-marketing confirmatory clinical trial program for ARIKAYCE in patients with MAC lung disease consisting of the ARISE trial, an interventional study designed to validate cross-sectional and longitudinal characteristics of a patient-reported outcome (PRO) tool in MAC lung disease, and the ENCORE trial, designed to establish the clinical benefits and evaluate the safety of ARIKAYCE in patients with newly diagnosed or recurrent MAC lung infection who have not started antibiotics using the PRO tool validated in the ARISE trial. In September 2023, we announced positive topline results from the ARISE trial. The study met its primary objective of demonstrating that the QOL-B respiratory domain works effectively as a PRO tool in patients with MAC lung disease. Based on feedback and in alignment with the FDA, we determined that the primary endpoint for the ENCORE study would include eight questions from the QOL-B respiratory domain PRO.
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The ARISE Study
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The ARISE trial was a global, randomized, double-blind, placebo-controlled Phase 3b study in adult patients with newly diagnosed or recurrent MAC infections that aimed to generate evidence demonstrating the domain specification, reliability, validity, and responsiveness of PRO-based scores, including a respiratory symptom score. The ARISE study met its primary objective of demonstrating that the QOL-B respiratory domain works effectively as a PRO tool in patients with MAC lung disease.
Previous report
Patients in ARISE (N=99) were randomized 1:1 to treatment with ARIKAYCE plus macrolide-based background regimen (ARIKAYCE arm) or placebo plus macrolide-based background regimen (comparator arm) once daily for six months, followed by one month off treatment. ARIKAYCE-treated patients performed better than those in the comparator arm as measured by the QOL-B instrument, with 43.8% of patients achieving an improvement in QOL-B respiratory score above the estimated meaningful within-subject score difference of 14.8, compared with 33.3% of patients in the comparator arm. While the study was not powered to show a statistically significant difference between treatment arms, a strong trend toward significance was observed for improvement from baseline at Month 7 (12.24 vs. 7.76, p=0.1073). Patients in the ARIKAYCE arm also achieved nominally statistically significantly higher culture conversion rates at Month 7 versus patients in the comparator arm (78.8% vs. 47.1%, p=0.0010), and culture conversion was faster and more likely to persist through Month 7 for the ARIKAYCE arm, suggesting that ARIKAYCE-treated patients are more likely to remain negative.
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Consistent with our expectations, the FDA and the PMDA in Japan confirmed that they would not consider a label expansion for ARIKAYCE based on data from the ARISE study alone.
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ARISE Culture Conversion
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Consistent with prior clinical studies, a higher proportion of patients in the ARIKAYCE arm achieved culture conversion by Month 6 (defined as negative cultures at Months 5 and 6) compared to patients in the comparator arm (80.6% vs. 63.9%, p=0.0712). Among patients who achieved culture conversion by Month 6, more patients in the ARIKAYCE arm achieved the first of their two required monthly negative cultures for clinical conversion at Month 1 versus the comparator arm (74.3% vs. 46.7%). As reported above, at Month 7 (one month following the cessation of treatment), 78.8% of patients in the ARIKAYCE arm vs. 47.1% of patients in the comparator arm were culture-converted, suggesting that ARIKAYCE-treated patients are more likely to remain negative.
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Correlation Between ARISE Culture Conversion and QOL-B Performance
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Patients in the ARIKAYCE arm who achieved culture conversion at both Month 6 and Month 7 had nominally statistically significantly greater improvements in QOL-B respiratory domain scores at Month 7 compared to patients in the ARIKAYCE arm who did not achieve culture conversion (15.74 vs. 3.53, p=0.0167 at Month 6 and 14.89 vs. 4.50, p=0.0416 at Month 7).
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ARISE Safety and Tolerability
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The discontinuation rate of ARIKAYCE or the placebo used in the comparator arm was 22.9% in the ARIKAYCE arm and 7.8% in the comparator arm. Study completion rates were 91.7% in the ARIKAYCE arm and 94.1% in the comparator arm. No new safety events were observed in the ARIKAYCE arm, and the safety profile in general was as expected in both treatment arms. Treatment-emergent adverse events (TEAEs) were reported by 91.7% of patients in the ARIKAYCE arm and 80.4% of patients in the comparator arm. The most common TEAEs were dysphonia (41.7% for the ARIKAYCE arm vs. 3.9% for the comparator arm), cough (27.1% vs. 7.8%), diarrhea (27.1% vs. 25.5%), and COVID-19 (12.5% vs. 9.8%). Of the treatment-emergent serious adverse events observed in the trial, none were determined to be related to ARIKAYCE by investigators.
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The ENCORE Study
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Reworded paragraphs (32)
Previous wording
We are a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. Our commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. To complement our internal research and development, we also actively evaluate in-licensing and acquisition opportunities for commercial products, product candidates, and technologies.
Current wording
We are a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. Our commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. To complement our internal research and development, we also actively evaluate in-licensing and acquisition opportunities for commercial products, product candidates, and technologies. For a more complete discussion of our business, strategy, products and pipeline, see Part I, Item 1, “Business,” of our Annual Report on Form 10-K for the year ended December 31, 2025.
Previous wording
Our two commercial products, ARIKAYCE and BRINSUPRI, are both part of the Respiratory therapeutic area. ARIKAYCE is approved in the US as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590mg (amikacin sulfate inhalation drug product). ARIKAYCE received accelerated approval in the US in September 2018 for the treatment of MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options in a refractory setting. In October 2020, the EC approved ARIKAYCE Liposomal for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have CF. In March 2021, Japan's MHLW approved ARIKAYCE for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. NTM lung disease caused by MAC (which we refer to as MAC lung disease) is a rare and often chronic infection that can cause irreversible lung damage and can be fatal. We are not aware of any other approved inhaled therapies specifically indicated to treat MAC lung disease in North America, Europe, or Japan.
Current wording
Our two commercial products, ARIKAYCE and BRINSUPRI, are both part of our Respiratory therapeutic area. ARIKAYCE is approved in the US 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). ARIKAYCE received accelerated approval in the US in September 2018 for the treatment of MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options in a refractory setting. In October 2020, the EC approved ARIKAYCE Liposomal for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have CF. In March 2021, Japan's MHLW approved ARIKAYCE for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. NTM lung disease caused by MAC (which we refer to as MAC lung disease) is a rare and often chronic infection that can cause irreversible lung damage and can be fatal. We are not aware of any other approved inhaled therapies specifically indicated to treat MAC lung disease in North America, Europe, or Japan.
Previous wording
BRINSUPRI (brensocatib 25 mg and 10 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (referred to as bronchiectasis or NCFB) in patients 12 years of age and older, was approved in the US in August 2025. In November 2025, the EC approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. In February 2026, the MHRA granted a marketing authorisation for BRINSUPRI to treat patients 12 years and older with NCFB who have experienced two or more flare-ups or worsening of symptoms in the past 12 months. Bronchiectasis is a serious, chronic lung disease in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. We are not aware of any other approved therapies in the US, Europe, or Japan for the treatment of patients with bronchiectasis.
Current wording
BRINSUPRI (brensocatib 25 mg and 10 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (referred to as bronchiectasis or NCFB) in patients 12 years of age and older, was approved in the US in August 2025. In November 2025, the EC approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. In February 2026, the MHRA granted a marketing authorisation for BRINSUPRI (brensocatib 25 mg tablets) to treat patients 12 years and older with NCFB who have experienced two or more flare-ups or worsening of symptoms in the past 12 months. Bronchiectasis is a serious, chronic lung disease in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. We are not aware of any other approved therapies in the US, Europe, or Japan for the treatment of patients with bronchiectasis.
Previous wording
Our Respiratory therapeutic area also includes the clinical-stage programs TPIP and INS1148. TPIP is an inhaled dry powder formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for PH-ILD, PAH, PPF, and IPF. INS1148 is a monoclonal antibody targeting SCF248, which we plan to initially develop for PPF and IPF.
Current wording
Our Respiratory therapeutic area also includes the clinical-stage programs TPIP and INS1148. TPIP is an inhaled dry powder formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for PH-ILD, PAH, PPF, and IPF. INS1148 is a monoclonal antibody targeting SCF248, which we plan to initially develop for PPF and IPF. We are exploring additional opportunities utilizing our various technologies within the Respiratory therapeutic area.
Previous wording
The clinical-stage programs in our Neuro & Other Rare therapeutic area are INS1201, an intrathecally delivered gene therapy for patients with DMD, and INS1202, an intrathecally delivered gene therapy for patients with ALS.
Current wording
The clinical-stage programs in our Neuro & Other Rare therapeutic area are INS1201, an intrathecally delivered gene therapy for patients with DMD, and INS1202, an intrathecally delivered gene therapy for patients with ALS. We are exploring additional opportunities utilizing our various technologies within the Neuro & Other Rare therapeutic area.
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Our pre-clinical research programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue.
Current wording
We are advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates.
Previous wording
We plan to continue to develop, acquire, in-license, or co-promote other commercial products, product candidates, and technologies, including those that address serious diseases that currently have significant unmet needs. We are focused broadly on serious disease therapeutics and prioritizing those within our three therapeutic areas.
Current wording
We plan to continue to develop, acquire, in-license, or co-promote other first- and best-in-class commercial products, product candidates, and technologies, including those that address serious diseases that currently have significant unmet needs. We are focused broadly on serious disease therapeutics and prioritizing those within our three therapeutic areas. Our key priorities are as follows:
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The information below summarizes our updates and anticipated near-term milestones for our marketed products and our product candidates.
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The information below summarizes our recent updates and anticipated near-term milestones for our marketed products and our product candidates.
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•We anticipate a regulatory decision for brensocatib for the treatment of NCFB in Japan in 2026.
Current wording
•We continue to anticipate a regulatory decision for brensocatib for the treatment of NCFB in Japan in the second half of 2026.
Previous wording
•We anticipate submitting a US supplemental new drug application (sNDA) for ARIKAYCE in all patients with MAC lung disease in the second half of 2026. We also plan to review the data with the Pharmaceuticals and Medical Devices Agency (PMDA) to support potential label expansion in Japan in the second half of 2026.
Current wording
•In July 2026, wesubmitted a US supplemental new drug application (sNDA) for ARIKAYCE in newly diagnosed patients with MAC lung disease. We also plan 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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We initiated PALM-ILD, a Phase 3 study of patients with PH-ILD, in the fourth quarter of 2025 and are actively enrolling patients.
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•PALM-ILD, our Phase 3 study of TPIP in patients with PH-ILD that we initiated in the fourth quarter of 2025, continues to enroll patients.
Previous wording
•We initiated PALM-ILD, a Phase 3 study of TPIP in patients with PH-ILD, in the fourth quarter of 2025 and are actively enrolling patients.
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•In April 2026, we initiated the Phase 3 PALM-PAH study of TPIP in patients with PAH and are actively enrolling patients.
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•We anticipate initiating a Phase 3 study of TPIP in patients with PPF in the second half of 2026 and a Phase 3 study in patients with IPF in the first half of 2027.
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•We continue to anticipate initiating a Phase 3 study of TPIP in patients with PPF in the second half of 2026 and a Phase 3 study in patients with IPF in the first half of 2027.
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•We plan to advance a Phase 2 development program for INS1148, initially targeting PPF and IPF, and we are exploring other diseases where inhibition of the inflammatory functions of SCF248 may be beneficial.
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•We continue to advance a Phase 2 development program for INS1148, initially targeting PPF and IPF, and we are exploring other diseases where inhibition of the inflammatory functions of SCF248 may be beneficial.
Previous wording
Product revenues, net, consist of net sales of ARIKAYCE and BRINSUPRI. We recognize revenue for product received by our customers net of allowances for customer credits, including prompt pay discounts, service fees, estimated rebates, including government rebates, such as Medicaid rebates and Medicare Part D reimbursements in the US, and chargebacks.
Current wording
Product revenues, net, consist of net sales of ARIKAYCE and BRINSUPRI. We recognize revenue for product received by our customers net of allowances for customer credits, including prompt pay discounts, service fees, estimated rebates, including government rebates, such as Medicaid rebates and Medicare Part D reimbursements in the US, chargebacks, and co-payment assistance.
Previous wording
SG&A expenses consist of salaries, benefits and other related costs, including stock-based compensation, for our non-employee directors and personnel serving in our executive, finance and accounting, legal and compliance, commercial and pre-commercial, corporate development, field sales, information technology and human resource functions. SG&A expenses also include professional fees for legal services, consulting services, including commercial activities, insurance, board of director fees, tax and accounting services.
Current wording
SG&A expenses consist of salaries, benefits and other related costs, including stock-based compensation, for our non-employee directors and personnel serving in our executive, finance and accounting, legal and compliance, commercial and pre-commercial, corporate development, field sales, information technology and human resource functions. SG&A expenses also include professional fees for legal services, advertising costs, consulting services, including commercial activities, insurance, board of director fees, tax and accounting services.
Previous wording
Upon commercialization of each of ARIKAYCE and BRINSUPRI, the related intangible assets began to be amortized over their estimated useful lives. The fair values assigned to our intangible assets are based on estimates and assumptions we believe are reasonable based on available facts and circumstances. Unanticipated events or circumstances may occur that require us to review the assets for impairment.
Current wording
Upon regulatory approval of each of ARIKAYCE and BRINSUPRI, the related intangible assets began to be amortized over their estimated useful lives. The fair values assigned to our intangible assets are based on estimates and assumptions we believe are reasonable based on available facts and circumstances. Unanticipated events or circumstances may occur that require us to review the assets for impairment.
Previous wording
Investment income consists of interest and dividend income earned on our cash and cash equivalents and marketable securities. Interest expense consists primarily of contractual interest costs, Royalty Financing Agreement non-cash interest expense and the amortization of debt issuance costs related to our debt. Debt issuance costs were amortized to interest expense using the effective interest rate method over the term of the debt. Our consolidated balance sheets reflect debt, net of the debt issuance costs paid to the lender, and other third-party costs.
Current wording
Investment income consists of interest and dividend income earned on our cash and cash equivalents and marketable securities. Interest expense consists primarily of contractual interest costs, Royalty Financing Agreement non-cash interest expense and the amortization of debt issuance costs. Debt issuance costs are amortized to interest expense using the effective interest rate method over the term of the debt. Our consolidated balance sheets reflect debt, net of the debt issuance costs paid to the lender, and other third-party costs.
Previous wording
Product revenues, net, for the three months ended March 31, 2026 were $306.0 million as compared to $92.8 million forthe same period in 2025, an increase of $213.1 million, or 229.6%. This increase was a result of $207.2 million of US commercial sales of BRINSUPRI following approval in August 2025 and a 5.7% growth in sales of ARIKAYCE, driven by growth in international sales of 23.4%. In the first quarter of 2026, we began recognizing international BRINSUPRI revenue related to EAPs in Europe, consisting of sales to the French National Agency for Medicines and Health Products Safety, which has granted BRINSUPRI a Compassionate Access Authorisation (Autorisation d'accès compassionnel or AAC) and sales through the NPP in other countries.
Current wording
Product revenues, net, for the three months ended June 30, 2026 were $425.5 million as compared to $107.4 million forthe same period in 2025, an increase of $318.1 million, or 296%. This increase was a result of $308.6 million of US commercial sales of BRINSUPRI following approval in August 2025 and an $8.9 million growth in sales of ARIKAYCE, primarily driven by growth in international sales. In the first quarter of 2026, we began recognizing international BRINSUPRI revenue related to EAPs in Europe, consisting of sales to the French National Agency for Medicines and Health Products Safety, which has granted BRINSUPRI a Compassionate Access Authorisation (Autorisation d'accès compassionnel or AAC) and sales through the NPP in other countries.
Previous wording
Cost of product revenues (excluding amortization of intangible assets) for the three months ended March 31, 2026 and 2025 were comprised of the following (in thousands):
Current wording
Cost of product revenues (excluding amortization of intangible assets) for the three months ended June 30, 2026 and 2025 were as follows (in thousands):
Previous wording
Cost of product revenues (excluding amortization of intangible assets) were $47.4 million for the three months ended March 31, 2026 as compared to $21.3 million forthe same period in 2025, an increase of $26.1 million, or 122.9%. This increase was primarily attributable to the increase in total product revenues discussed above. Cost of product revenues as a percent of revenues decreased in the current period due to sales of BRINSUPRI, which has lower manufacturing costs than ARIKAYCE.
Current wording
Cost of product revenues (excluding amortization of intangible assets) were $67.2 million for the three months ended June 30, 2026 as compared to $28.1 million forthe same period in 2025, an increase of $39.1 million, or 139%. This increase was primarily attributable to the increase in total product revenues discussed above. Cost of product revenues as a percent of revenues decreased in the current period due to sales of BRINSUPRI, which has lower manufacturing costs than ARIKAYCE.
Previous wording
All product costs for BRINSUPRI incurred prior to FDA approval on August 12, 2025 were expensed as R&D expenses. We expect our cost of product revenues (excluding amortization of intangible assets) to benefit 2026 and beyond, as we sell through inventory that was expensed prior to FDA approval of BRINSUPRI.
Current wording
All product costs for BRINSUPRI incurred prior to FDA approval on August 12, 2025 were expensed as R&D expenses. We expect this to benefit our cost of product revenues (excluding amortization of intangible assets) in 2026 and beyond as we sell through inventory that was expensed prior to FDA approval of BRINSUPRI.
Previous wording
SG&A expenses were $247.3 million for the three months ended March 31, 2026 as compared to $147.5 million for the same period in 2025, an increase of $99.7 million, or 67.6%. This increase was primarily due to a $74.4 million increase in professional fees and other external expenses and a $19.8 million increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, both driven by commercial activities for BRINSUPRI.
Current wording
SG&A expenses were $247.5 million for the three months ended June 30, 2026 as compared to $154.8 million for the same period in 2025, an increase of $92.7 million, or 60%. This increase was primarily due to a $76.5 million increase in professional fees and other external expenses and a $19.2 million increase in compensation and benefit-related expenses due to an increase in headcount, both driven by commercial activities for BRINSUPRI.
Previous wording
The change in fair value of contingent consideration for the three months ended March 31, 2026 was $47.0 million and was primarily due to the decrease in our share price and change in probabilities of success, partially offset by an increase in the obligation associated with the reauthorization of the PRV program. The change is related to the fair value of the potential future consideration to be paid to former equityholders of the businesses we acquired.
Current wording
The change in fair value of contingent consideration for the three months ended June 30, 2026 was $99.8 million and was primarily due to the decrease in our share price and to a lesser extent, the change in probabilities of success. Contingent consideration is the potential future consideration to be paid to former equityholders of the businesses we acquired.
Previous wording
Investment income was $12.0 million for the three months ended March 31, 2026 as compared to $13.9 million for the same period in 2025, a decrease of $1.9 million, or 13.4%. This decrease was primarily due to lower interest rates in 2026 relative to the same period in 2025.
Current wording
Investment income was $11.0 million for the three months ended June 30, 2026 as compared to $13.2 million for the same period in 2025, a decrease of $2.2 million, or 17%. This decrease was due to lower average cash and marketable securities balances and lower interest rates in 2026 relative to the same period in 2025.
Previous wording
Interest expense for the three months ended March 31, 2026 was $20.1 million as compared to $21.6 million for the same period in 2025, a decrease of $1.5 million, or 6.9%. This decrease was primarily due to the redemption of the Company's outstanding 0.75% Convertible Senior Notes due 2028 in the second quarter of 2025. See Note 10 - Debtand Note 11 - Royalty Financing Agreement in this Quarterly Report on Form 10-Q for further details.
Current wording
Interest expense for the three months ended June 30, 2026 was $20.3 million as compared to $21.2 million for the same period in 2025, a decrease of $1.0 million, or 5%. This decrease was primarily due to the redemption of the Company's outstanding 0.75% Convertible Senior Notes due 2028 in the second quarter of 2025. See Note 10 - Debtand Note 11 - Royalty Financing Agreement in this Quarterly Report on Form 10-Q for further details.
Previous wording
R&D expenses were $209.5 million for the three months ended March 31, 2026 as compared to $152.6 million for the same period in 2025, an increase of$56.9 million, or 37.3%. This increase was primarily due to a $25.2 million increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, a $16.3 million increase in manufacturing costs, and a $7.4 million increase in clinical development and research costs.
Current wording
R&D expenses were $419.5 million for the six months ended June 30, 2026 as compared to $329.8 million for the same period in 2025, an increase of $89.8 million, or 27%. This increase was primarily due to a $42.2 million increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, and a $22.1 million increase in clinical development and research costs and a $12.6 million increase in manufacturing costs, both primarily related to TPIP.
Previous wording
As of March 31, 2026, we had cash and cash equivalents of $582.2 million, as compared to $510.4 million as of December 31, 2025. In addition, as of March 31, 2026, we had marketable securities of$641.3 million, as compared to$919.6 million as of December 31, 2025. The net decrease in cash and cash equivalents and marketable securitieswas primarily due to the cash used in operating activities and the$15.0 million milestone payment to AstraZeneca following EC approval of BRINSUPRI, partially offset by proceeds from the exercise of stock options. Our working capital was $1.3 billion as of both March 31, 2026 and December 31, 2025.
Current wording
As of June 30, 2026, we had cash and cash equivalents of $544.8 million, as compared to $510.4 million as of December 31, 2025. In addition, as of June 30, 2026, we had marketable securities of$615.5 million, as compared to$919.6 million as of December 31, 2025. The net decrease in cash and cash equivalents and marketable securitieswas primarily due to the cash used in operating activities and the$15.0 million milestone payment to AstraZeneca following EC approval of BRINSUPRI, partially offset by proceeds from the exercise of stock options. Our working capital was $1.2 billion and$1.3 billionas of June 30, 2026 and December 31, 2025, respectively.
Previous wording
Net cash used in operating activities was $222.7 million and $262.1 million for the three months ended March 31, 2026 and 2025, respectively. The net cash used in operating activities during the three months ended March 31, 2026 and 2025 was primarily driven by commercial, clinical, and manufacturing activities related to ARIKAYCE, commercial and commercial readiness activities for BRINSUPRI, as well as other SG&A expenses, and clinical trial expenses related to brensocatib and TPIP. The decrease in cash used in operating activities for the three months ended March 31, 2026 as compared to the same period in 2025 was primarily due to the decrease in net loss, excluding the adjustments to reconcile net loss to net cash used in operating activities.
Current wording
Net cash used in operating activities was $311.6 million and $467.7 million for the six months ended June 30, 2026 and 2025, respectively. The net cash used in operating activities during the six months ended June 30, 2026 and 2025 was primarily driven by commercial, clinical, and manufacturing activities related to ARIKAYCE, commercial and commercial readiness activities for BRINSUPRI, as well as other SG&A expenses, and clinical trial expenses related to brensocatib and TPIP. The decrease in cash used in operating activities for the six months ended June 30, 2026 as compared to the same period in 2025 was primarily due to the decrease in net loss, excluding the adjustments to reconcile net loss to net cash used in operating activities.
Previous wording
Net cash provided by investing activities was $265.5 million and $80.4 million for the three months ended March 31, 2026 and 2025, respectively. During the three months ended March 31, 2026, net cash provided by investing activities consisted primarily of maturities of marketable securities, partially offset by the$15.0 million milestone payment to AstraZeneca following EC approval of BRINSUPRI. During thethree months ended March 31, 2025, net cash provided by investing activities consisted primarily of maturities of marketable securities, partially offset by purchases of marketable securities.
Current wording
Net cash provided by investing activities was $290.0 million and $308.2 million for the six months ended June 30, 2026 and 2025, respectively. During the six months ended June 30, 2026, net cash provided by investing activities consisted primarily of maturities of marketable securities, partially offset bypurchases of marketable securities andthe$15.0 million milestone payment to AstraZeneca following EC approval of BRINSUPRI. During thesix months ended June 30, 2025, net cash provided by investing activities consisted primarily of maturities of marketable securities, partially offset by purchases of marketable securities.
Previous wording
Net cash provided by financing activities was $29.5 million and $29.0 million for the three months ended March 31, 2026 and 2025, respectively. During thethree months ended March 31, 2026 and 2025, net cash provided by financing activities consisted primarily of proceeds from the exercise of stock options.
Current wording
Net cash provided by financing activities was $56.7 million and $886.8 million for the six months ended June 30, 2026 and 2025, respectively. During thesix months ended June 30, 2026, net cash provided by financing activities consisted primarily of proceeds from the exercise of stock options and ESPP. During the six months ended June 30, 2025, net cash provided by financing activities consisted primarily of net proceeds from the issuance of common stock and proceeds from the exercise of stock options and ESPP.
Previous wording
There were no material changes outside of the ordinary course of business in our contractual obligations during the three months ended March 31, 2026 from those disclosed in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Contractual Obligations” in our Annual Report on Form 10-K for the year ended December 31, 2025.
Current wording
There were no material changes outside of the ordinary course of business in our contractual obligations during the six months ended June 30, 2026 from those disclosed in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Contractual Obligations” in our Annual Report on Form 10-K for the year ended December 31, 2025.
Rearranged current paragraphs (8)
Current report — wording carried from elsewhere
Product revenues, net, consists of net sales of ARIKAYCE and BRINSUPRI. The following table summarizes revenue by product and geography for the six months ended June 30, 2026 and 2025 (in thousands):
Current report — wording carried from elsewhere
Product revenues, net, for the six months ended June 30, 2026 were $731.5 million as compared to $200.2 million forthe same period in 2025, an increase of $531.2 million, or 265%. This increase was a result of $515.7 million of US commercial sales of BRINSUPRI following approval in August 2025 and a $14.2 million growth in sales of ARIKAYCE, primarily driven by growth in international sales.
Current report — wording carried from elsewhere
Cost of Product Revenues (excluding amortization of intangible assets)
Current report — wording carried from elsewhere
Cost of product revenues (excluding amortization of intangible assets) were $114.6 million for the six months ended June 30, 2026 as compared to $49.4 million forthe same period in 2025, an increase of $65.3 million, or 132%. This increase was primarily attributable to the increase in total product revenues discussed above. Cost of product revenues as a percent of revenues decreased in the current period due to sales of BRINSUPRI, which has lower manufacturing costs than ARIKAYCE.
Current report — wording carried from elsewhere
External R&D expenses by product for the six months ended June 30, 2026 and 2025 were comprised of the following (in thousands):
Current report — wording carried from elsewhere
Amortization of intangible assets was $4.2 million for the six months ended June 30, 2026 as compared to $2.5 million for the same period in 2025, an increase of $1.6 million. This increase was due to amortization of the AstraZeneca milestones achieved upon FDA and EC approvals of BRINSUPRI in August 2025 and November 2025, respectively.
Current report — wording carried from elsewhere
The change in fair value of contingent consideration for the six months ended June 30, 2026 was $146.7 million and was primarily due to the decrease in our share price and to a lesser extent, the change in probabilities of success, partially offset by an increase in the obligation associated with the reauthorization of the PRV program.
Current report — wording carried from elsewhere
Interest expense for the six months ended June 30, 2026 was $40.4 million as compared to $42.8 million for the same period in 2025, a decrease of $2.5 million, or 6%. This decrease was primarily due to the redemption of the Company's outstanding 0.75% Convertible Senior Notes due 2028 in the second quarter of 2025. See Note 10 - Debtand Note 11 - Royalty Financing Agreement in this Quarterly Report on Form 10-Q for further details.
Rearranged previous paragraphs (8)
Previous report — wording carried elsewhere
•In November 2025, the EC approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months.
Previous report — wording carried elsewhere
We are exploring additional opportunities utilizing our various technologies within the Respiratory therapeutic area.
Previous report — wording carried elsewhere
We are exploring additional opportunities utilizing our various technologies within the Neuro & Other Rare therapeutic area.
Previous report — wording carried elsewhere
Our key priorities are as follows:
Previous report — wording carried elsewhere
In March 2021, Japan's MHLW approved ARIKAYCE for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. In July 2021, we launched ARIKAYCE in Japan.
Previous report — wording carried elsewhere
We anticipate initiating a Phase 3 study of TPIP in patients with PPF in the second half of 2026 and a Phase 3 study in patients with IPF in the first half of 2027.
Previous report — wording carried elsewhere
Change in Fair Value of Contingent Consideration
Previous report — wording carried elsewhere
Change in Fair Value of Contingent Consideration