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INSMED Inc

For the period ended Sep 30, 2026. Filed Oct 29, 2026.

View on SEC.gov

About this filing

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.

Sep 30, 2026 · Filed Oct 29, 2026

INSM$114.41+5.2%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous 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 Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-10-29.

0001104506-26-000047

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 151 previous paragraphs and 146 current paragraphs.

102 unchanged; 36 reworded; 7 added; 11 removed; 2 previous and 1 current paragraphs rearranged.

Tables are not compared: 10 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 (7)

Current report

•Ensure successful commercial launch of BRINSUPRI in Japan;

Current report

•In August 2026, Japan's MHLW approved BRINSUPRI Tablets 25 mg (brensocatib hydrate) for the treatment of NCFB in adults and pediatric patients 12 years and older. We launched BRINSUPRI Tablets 25 mg (brensocatib hydrate) in Japan in October 2026.

Current report

•In September 2026, our US supplemental new drug application (sNDA) for ARIKAYCE in patients with MAC lung disease was accepted and granted priority review by the FDA as part of a combination antibacterial drug regimen, with a target action date of January 28, 2027.

Current report

•The ASCEND Phase 1 study evaluating INS1201 in DMD is fully enrolled.

Current report

Comparison of the Nine Months Ended September 30, 2026 and 2025

Current report

R&D expenses for the nine months ended September 30, 2026 and 2025 were comprised of the following (in thousands):

Current report

SG&A expenses for the nine months ended September 30, 2026 and 2025 were comprised of the following (in thousands):
Removed paragraphs (11)

Previous report

•We continue to anticipate a regulatory decision for brensocatib for the treatment of NCFB in Japan in the second half of 2026.

Previous report

•We continue to evaluate the potential effect of evolving US policies which will then impact the timing for future potential international commercial launches.

Previous report

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.

Previous 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%).

Previous 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.

Previous 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.

Previous report

R&D expenses for the six months ended June 30, 2026 and 2025 were comprised of the following (in thousands):

Previous report

SG&A expenses for the six months ended June 30, 2026 and 2025 were comprised of the following (in thousands):
Reworded paragraphs (36)

Previous wording

•failure to continue to successfully commercialize ARIKAYCE in the US, Europe or Japan (amikacin liposome inhalation suspension, Liposomal 590 mg Nebuliser Dispersion, and amikacin sulfate inhalation drug product, respectively) or failure to successfully commercialize BRINSUPRI in the US or Europe, or to maintain US, European or Japanese approval for ARIKAYCE or US or European approval for BRINSUPRI;

Current wording

•failure to continue to successfully commercialize ARIKAYCE in the US, Europe or Japan (amikacin liposome inhalation suspension, Liposomal 590 mg Nebuliser Dispersion, and amikacin sulfate inhalation drug product, respectively) or failure to successfully commercialize BRINSUPRI in the US or Japan, or to maintain US, European or Japanese approval for ARIKAYCE or BRINSUPRI;

Previous wording

•failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the US, Europe or Japan, for ARIKAYCE outside of the US, Europe and Japan, including separate regulatory approval for Lamira in each market and for each usage, or for BRINSUPRI outside of the US and Europe;

Current wording

•failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the US, Europe or Japan, for ARIKAYCE outside of the US, Europe and Japan, including separate regulatory approval for Lamira in each market and for each usage, or for BRINSUPRI outside of the US, 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 (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.

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. In August 2026, Japan's MHLW approved BRINSUPRI Tablets 25 mg (brensocatib hydrate) for the treatment for NCFB in adults and pediatric patients 12 years and older. 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. We are exploring additional opportunities utilizing our various technologies within the Respiratory therapeutic area.

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 IPF, with plans to evaluate PPF and explore other diseases where inhibition of the pro-inflammatory and pro-fibrotic responses mediated by SCF248 may be beneficial. We are exploring additional opportunities utilizing our various technologies within the Respiratory therapeutic area.

Current wording

•Drive continued momentum in the US commercialization of BRINSUPRI;

Previous wording

Prior to 2019, we had not generated significant revenue and, through June 30, 2026, we had an accumulated deficit of $5.8 billion. We have financed our operations primarily through the public offerings of our equity securities, debt financings and revenue interest financings. Although it is difficult to predict our future funding requirements, based upon our current operating plan, we anticipate that our cash and cash equivalents and marketable securities as of June 30, 2026 will enable us to fund our operations for at least the next 12 months.

Current wording

Prior to 2019, we had not generated significant revenue and, through September 30, 2026, we had an accumulated deficit of $5.9 billion. We have financed our operations primarily through the public offerings of our equity securities, debt financings and revenue interest financings. Although it is difficult to predict our future funding requirements, based upon our current operating plan, we anticipate that our cash and cash equivalents and marketable securities as of September 30, 2026 will enable us to fund our operations for at least the next 12 months.

Previous wording

Our ability to reduce our operating loss and begin to generate positive cash flow from operations depends on the continued success in commercializing our marketed products and obtaining full approval of ARIKAYCE in the US. Our continued success also depends on bringing additional clinical stage products, such as TPIP, INS1148, INS1201, and INS1202, to market, and advancing our pre-clinical research programs. We expect to continue to incur substantial expenses related to our research and development activities as we conduct trials of TPIP in PH-ILD, PAH, PPF, and IPF, and fund development of our clinical and pre-clinical programs. We also expect to continue to incur significant costs related to the commercialization of our marketed products. Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our marketed products; the scope and progress of our research and development efforts; and the timing of certain expenses. We cannot predict whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such products and whether or when we may become profitable.

Current wording

Our ability to reduce our operating loss and begin to generate positive cash flow from operations depends on the continued success in commercializing our marketed products and obtaining full approval of ARIKAYCE in the US. Our continued success also depends on bringing additional clinical stage products, such as TPIP, INS1148, INS1201, and INS1202, to market, and advancing our pre-clinical research programs. We expect to continue to incur substantial expenses related to our research and development activities as we conduct trials of TPIP in PH-ILD, PAH, PPF, and IPF, and fund development of our clinical and pre-clinical programs. We also expect to continue to incur significant costs related to the commercialization of our marketed products. Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our marketed products; the scope and progress of our research and development efforts; and the timing of certain expenses. We cannot predict whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such products and whether or when we may become profitable. Due to the challenging healthcare funding environment in Europe and evolving policies in the US, we do not plan to pursue a traditional commercialization model in Europe for the foreseeable future. However, there are certain other pathways available for patients to receive treatment.

Previous 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.

Current wording

•We also plan to submit data to the Pharmaceuticals and Medical Devices Agency (PMDA) in the fourth quarter of 2026 to support potential label expansion in Japan.

Previous wording

•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.

Current wording

•In July 2026, we reported positive 12-month data from the ongoing open-label extension study of TPIP in patients with PAH.

Previous wording

•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.

Current wording

•PALM-ILD, our Phase 3 study of TPIP in patients with PH-ILD, and PALM-PAH, our Phase 3 study of TPIP in patients with PAH, each continue to enroll patients.

Previous wording

•In April 2026, we initiated the Phase 3 PALM-PAH study of TPIP in patients with PAH and are actively enrolling patients.

Current wording

•In September 2026, we initiated the Phase 3 PALM-PPF study of TPIP in patients with PPF.

Previous wording

•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.

Current wording

•We continue to anticipate initiating a Phase 3 study of TPIP in patients with IPF in the first half of 2027.

Previous wording

•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.

Current wording

•We continue to advance a Phase 2 development program for INS1148, initially targeting IPF, with plans to evaluate PPF and explore other diseases where inhibition of thepro-inflammatory and pro-fibrotic responses mediated by SCF248 may be beneficial.

Previous 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.

Current wording

Product revenues, net, for the three months ended September 30, 2026 were $524.4 million as compared to $142.3 million forthe same period in 2025, an increase of $382.1 million, or 268%. This increase was a result of the $370.0 million growth in US commercial sales of BRINSUPRI following approval in August 2025 and the $10.1 million growth in sales of ARIKAYCE, primarily driven by growth in international sales. We recognize international BRINSUPRI revenue related to EAPs in Europe, primarily through the named patient program in certain countries.

Previous 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.

Current wording

Cost of product revenues (excluding amortization of intangible assets) were $78.2 million for the three months ended September 30, 2026 as compared to $29.4 million forthe same period in 2025, an increase of $48.9 million, or 166%. 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

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.

Current wording

R&D expenses were $270.0 million for the three months ended September 30, 2026 as compared to $186.4 million for the same period in 2025, an increase of$83.5 million, or 45%. This increase was primarily due to a $48.5 million increase in manufacturing costs and a $14.3 million increase in clinical development and research costs, both primarily related to TPIP, and a $14.2 million increase in compensation and benefit-related expenses and stock-based compensation costs due primarily to an increase in headcount.

Previous wording

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.

Current wording

SG&A expenses were $253.0 million for the three months ended September 30, 2026 as compared to $186.4 million for the same period in 2025, an increase of $66.7 million, or 36%. This increase was primarily due to a $48.6 million increase in professional fees and other external expenses and a $18.2 million increase in compensation and benefit-related expensesand stock-based compensation costs due to an increase in headcount, both driven by commercial activities for BRINSUPRI.

Previous wording

Amortization of intangible assets was $2.1 million for the three months ended June 30, 2026 as compared to $1.3 million for the same period in 2025, an increase of $0.8 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 wording

Amortization of intangible assets was $5.1 million for the three months ended September 30, 2026 as compared to $1.5 million for the same period in 2025, an increase of $3.5 million. This increase was due to amortization of the AstraZeneca milestone for the pending achievement of $1.0 billion in net sales of BRINSUPRI in a calendar year as of September 2026, and the FDA, EC and MHLW approvals of BRINSUPRI in August 2025, November 2025, and August 2026, respectively.

Previous 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.

Current wording

The change in fair value of contingent consideration for the three months ended September 30, 2026 was $7.5 million and was primarily due to the increase in our share price. Contingent consideration is the potential future consideration to be paid to former equityholders of the businesses we acquired.

Previous 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.

Current wording

Investment income was $11.1 million for the three months ended September 30, 2026 as compared to $18.3 million for the same period in 2025, a decrease of $7.2 million, or 39%. 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

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 wording

Product revenues, net, consists of net sales of ARIKAYCE and BRINSUPRI. The following table summarizes revenue by product and geography for the nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

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 wording

Product revenues, net, for the nine months ended September 30, 2026 were $1,255.9 million as compared to $342.6 million forthe same period in 2025, an increase of $913.3 million, or 267%. This increase was a result of an $885.8 million growth in US commercial sales of BRINSUPRI following approval in August 2025 and a $24.3 million growth in sales of ARIKAYCE, primarily driven by growth in international sales.

Previous wording

Cost of product revenues (excluding amortization of intangible assets) for the six months ended June 30, 2026 and 2025 were as follows (in thousands):

Current wording

Cost of product revenues (excluding amortization of intangible assets) for the nine months ended September 30, 2026 and 2025 were as follows (in thousands):

Previous wording

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 wording

Cost of product revenues (excluding amortization of intangible assets) were $192.8 million for the nine months ended September 30, 2026 as compared to $78.7 million forthe same period in 2025, an increase of $114.1 million, or 145%. 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

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.

Current wording

R&D expenses were $689.5 million for the nine months ended September 30, 2026 as compared to $516.2 million for the same period in 2025, an increase of $173.3 million, or 34%. This increase was primarily due to a $61.1 million increase in manufacturing costs and a $36.4 million increase in clinical development and research costs, both primarily related to TPIP, and a $56.4 million increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount.

Previous wording

External R&D expenses by product for the six months ended June 30, 2026 and 2025 were comprised of the following (in thousands):

Current wording

External R&D expenses by product for the nine months ended September 30, 2026 and 2025 were comprised of the following (in thousands):

Previous 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.

Current wording

SG&A expenses were $747.8 million for the nine months ended September 30, 2026 as compared to $488.7 million for the same period in 2025, an increase of $259.1 million, or 53%. This increase was primarily due to a $199.5 million increase in professional fees and other external expenses and a $51.2 million increase in compensation and benefit-related expenses due to an increase in headcount, both driven by commercial activities for BRINSUPRI.

Previous wording

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 wording

Amortization of intangible assets was $9.2 million for the nine months ended September 30, 2026 as compared to $4.1 million for the same period in 2025, an increase of $5.1 million. This increase was due to amortization of the AstraZeneca milestone for the pending achievement of $1.0 billion in net sales of BRINSUPRI in a calendar year as of September 2026, and the FDA, EC and MHLW approvals of BRINSUPRI in August 2025, November 2025, and August 2026, respectively.

Previous wording

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 wording

The change in fair value of contingent consideration for the nine months ended September 30, 2026 was $139.2 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.

Previous wording

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.

Current wording

Investment income was $34.1 million for the nine months ended September 30, 2026 as compared to $45.4 million for the same period in 2025, a decrease of $11.3 million, or 25%. 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 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.

Current wording

Interest expense for the nine months ended September 30, 2026 was $60.8 million as compared to $63.2 million for the same period in 2025, a decrease of $2.4 million, or 4%. 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

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.

Current wording

As of September 30, 2026, we had cash and cash equivalents of $396.6 million, as compared to $510.4 million as of December 31, 2025. In addition, as of September 30, 2026, we had marketable securities of$750.1 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 $1.1 billion and$1.3 billionas of September 30, 2026 and December 31, 2025, respectively.

Previous 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.

Current wording

Net cash used in operating activities was $348.0 million and $687.4 million for the nine months ended September 30, 2026 and 2025, respectively. The net cash used in operating activities during the nine months ended September 30, 2026 and 2025 was primarily driven by commercial, clinical, and manufacturing activities related to ARIKAYCE, commercial 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 nine months ended September 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 $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.

Current wording

Net cash provided by investing activities was $154.4 million for the nine months ended September 30, 2026, as compared to $454.0 million net cash used in investing activities for the nine months ended September 30, 2025. During the nine months ended September 30, 2026, net cash provided by investing activities consisted primarily of maturities of marketable securities, partially offset bypurchases of marketable securities and fixed assets andthe$15.0 million milestone payment to AstraZeneca following EC approval of BRINSUPRI. During thenine months ended September 30, 2025, net cash used in investing activities consisted primarily of purchases of marketable securities, partially offset by maturities of marketable securities.

Previous 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.

Current wording

Net cash provided by financing activities was $80.3 million and $920.2 million for the nine months ended September 30, 2026 and 2025, respectively. During thenine months ended September 30, 2026, net cash provided by financing activities consisted primarily of proceeds from the exercise of stock options and ESPP. During the nine months ended September 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 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.

Current wording

There were no material changes outside of the ordinary course of business in our contractual obligations during the nine months ended September 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 (1)

Current report — wording carried from elsewhere

Interest expense was $20.4 million for both the three months ended September 30, 2026 and 2025. See Note 10 - Debtand Note 11 - Royalty Financing Agreement in this Quarterly Report on Form 10-Q for further details.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

•We continue to enroll patients in the Phase 1 ASCEND clinical study of INS1201 for patients with DMD.

Previous report — wording carried 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.