FULLTEXT DEL 2 AV 2
10-Q – 2025-10-30 – insm-20250930.htm
KEY COMPONENTS OF OUR RESULTS OF OPERATIONS Product Revenues, Net 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 coverage gap reimbursements in the US, and chargebacks. Cost of Product Revenues (Excluding Amortization of Intangible Assets) Cost of product revenues (excluding amortization of intangible assets) consist primarily of direct and indirect costs related to the manufacturing of ARIKAYCE and BRINSUPRI sold, including third-party manufacturing costs, packaging services, freight, and allocation of overhead costs, in addition to royalty expenses. Research and Development Expenses R&D expenses consist of salaries, benefits and other related costs, including stock-based compensation, for personnel serving in our research and development functions, including medical affairs and program management. R&D expenses also includes other internal operating expenses, the cost of manufacturing product candidates, including the medical devices for drug delivery, for clinical study, the cost of conducting clinical studies, and the cost of conducting pre-clinical and research activities. In addition, R&D expenses include payments to third parties for the license rights to products in development (prior to marketing approval), such as brensocatib, and may include the cost of asset acquisitions. Our R&D expenses related to manufacturing our product candidates and medical devices for clinical study are primarily related to activities at CMOs that manufacture our product candidates and early-stage research activities. Our R&D expenses related to clinical trials are primarily related to activities at contract research organizations (CROs) that conduct and manage clinical trials on our behalf. These contracts with CROs set forth the scope of work to be completed at a fixed fee or amount per patient enrolled. Payments under these contracts with CROs primarily depend on performance criteria such as the successful enrollment of patients or the completion of clinical trial milestones as well as time-based fees. Expenses are accrued based on contracted amounts applied to 39 Table of Contents the level of patient enrollment and to activity according to the clinical trial protocol. Deposits for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are then recognized as an expense as the related goods are delivered or the services are performed. Selling, General and Administrative (SG&A) Expenses 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 and certain milestones related to ARIKAYCE. Amortization of Intangible Assets Upon commercialization of ARIKAYCE and BRINSUPRI, we began amortizing our intangible assets 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. Change in Fair Value of Deferred and Contingent Consideration Liabilities In connection with the Business Acquisition, we recorded deferred and contingent consideration liabilities related to potential future milestone payments. Adjustments to the fair value are due to changes in the probability of achieving milestones, our stock price, or certain other estimated assumptions. The change in fair value of deferred and contingent consideration liabilities is calculated quarterly with gains and losses recorded in the consolidated statements of comprehensive loss. Our deferred consideration liabilities were fully settled in the third quarter of 2024. Subsequent to the settlement of deferred consideration, only contingent consideration liabilities exist. Investment Income and Interest Expense 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 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. Change in Fair Value of Interest Rate Swap We record derivative and hedge transactions in accordance with GAAP. In the fourth quarter of 2022, we entered into an interest rate swap contract (the Swap Contract) with a notional value of $350.0 million to economically hedge our variable rate-based term debt for three years, effectively changing the variable rate under the term debt to a fixed interest rate. Our interest rate swap was not designated as a hedging instrument for accounting purposes. We settled and terminated the Swap Contract in October 2024. All changes in the fair value of the Swap Contract were reported as change in fair value of interest rate swap in the consolidated statements of comprehensive loss. RESULTS OF OPERATIONS Comparison of the Three Months Ended September 30, 2025 and 2024 Overview - Operating Results Our operating results for the three months ended September 30, 2025, included the following: • Product revenues, net, increased $48.9 million , or 52.4% , as compared to the same period in the prior year as a result of US sales of BRINSUPRI and the growth in global ARIKAYCE sales; • Cost of product revenues (excluding amortization of intangible assets) increased $8.2 million, or 38.7%, as compared to the same period in the prior year primarily as a result of the growth in sales discussed above; • R&D expenses increased $35.6 million, or 23.6%, as compared to the same period in the prior year primarily as a result of increases in compensation and benefit-related expenses and stock-based compensation costs ; • SG&A expenses increased $67.4 million, or 56.7%, as compared to the same period in the prior year primarily as a result of increases i n professional fees and other external expenses ; • Amortization of intangible assets increased $0.3 million as compared to the same period in the prior year due to the AstraZeneca milestone achieved upon FDA approval of BRINSUPRI in August of 2025; • Change in fair value of deferred and contingent consideration liabilities increased $90.0 million, or 612.8%, primarily as a result of the relative increase in our share price in 2025 as compared to the same period in 2024; 40 Table of Contents • Investment income increased $1.3 million, or 7.7%, as compared to the same period in the prior year primarily as a result of the increase in our average cash and cash equivalents and marketable securities balances; and • Interest expense decreased $0.7 million, or 3.2%, as compared to the same period in the prior year primarily due to the redemption of the 2028 Convertible Notes. Product Revenues, Net Product revenues, net, consists of net sales of ARIKAYCE and BRINSUPRI. The following tables summarize revenue by product and geography for the three months ended September 30, 2025 and 2024 (in thousands): Three Months Ended September 30, Increase (decrease) 2025 2024 $ % ARIKAYCE US $ 73,984 $ 66,868 $ 7,116 10.6 % International 40,307 26,557 13,750 51.8 % Total $ 114,291 $ 93,425 $ 20,866 22.3 % BRINSUPRI US $ 28,051 $ — $ 28,051 NA Total $ 28,051 $ — $ 28,051 NA Total US $ 102,035 $ 66,868 $ 35,167 52.6 % International 40,307 26,557 13,750 51.8 % Total product revenues, net $ 142,342 $ 93,425 $ 48,917 52.4 % Product revenues, net, for the three months ended September 30, 2025 were $142.3 million as compared to $93.4 million for the same period in 2024, an increase of $48.9 million, or 52.4%. This increase was a result of $28.1 million of US commercial sales of BRINSUPRI following FDA approval in August 2025 and a 22.3% growth in sales of ARIKAYCE globally, driven primarily by a 51.8% growth in international sales. Cost of Product Revenues (excluding amortization of intangible assets) Cost of product revenues (excluding amortization of intangible assets) for the three months ended September 30, 2025 and 2024 were comprised of the following (in thousands): Three Months Ended September 30, Increase (decrease) 2025 2024 $ % Cost of product revenues (excluding amortization of intangible assets) $ 29,365 $ 21,170 $ 8,195 38.7 % Cost of product revenues, as % of revenues 20.6 % 22.7 % Cost of product revenues (excluding amortization of intangible assets) were $29.4 million for the three months ended September 30, 2025 as compared to $21.2 million for the same period in 2024, an increase of $8.2 million , or 38.7%. 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 a lower manufacturing cost than ARIKAYCE. All product costs incurred prior to FDA approval of BRINSUPRI on August 12, 2025 were expensed as R&D expenses. We expect our cost of product revenues (excluding amortization of intangible assets) to benefit during 2025 and 2026, as we sell through inventory that was expensed prior to FDA approval of BRINSUPRI. R&D Expenses R&D expenses for the three months ended September 30, 2025 and 2024 were comprised of the following (in thousands): 41 Table of Contents Three Months Ended September 30, Increase (decrease) 2025 2024 $ % External Expenses Clinical development and research $ 46,457 $ 39,117 $ 7,340 18.8 % Manufacturing 37,415 31,562 5,853 18.5 % Regulatory, quality assurance, and medical affairs 10,030 6,533 3,497 53.5 % Subtotal—external expenses $ 93,902 $ 77,212 $ 16,690 21.6 % Internal Expenses Compensation and benefit-related expenses $ 63,817 $ 50,778 $ 13,039 25.7 % Stock-based compensation 15,399 12,586 2,813 22.4 % Other internal operating expenses 13,297 10,233 3,064 29.9 % Subtotal—internal expenses $ 92,513 $ 73,597 $ 18,916 25.7 % Total R&D expenses $ 186,415 $ 150,809 $ 35,606 23.6 % R&D expenses were $186.4 million for the three months ended September 30, 2025 as compared to $150.8 million for the same period in 2024, an increase of $35.6 million, or 23.6%. This increase was primarily due to a $15.9 million increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, a $7.3 million increase in clinical development and research costs, and a $5.9 million increase in manufacturing costs. External R&D expenses by product for the three months ended September 30, 2025 and 2024 were comprised of the following (in thousands): Three Months Ended September 30, Increase (decrease) 2025 2024 $ % ARIKAYCE external R&D expenses $ 9,214 $ 16,370 $ (7,156) (43.7) % Brensocatib external R&D expenses 19,355 17,288 2,067 12.0 % TPIP external R&D expenses 28,754 16,635 12,119 72.9 % Other external R&D expenses 36,579 26,919 9,660 35.9 % Total external R&D expenses $ 93,902 $ 77,212 $ 16,690 21.6 % SG&A Expenses SG&A expenses for the three months ended September 30, 2025 and 2024 were comprised of the following (in thousands): Three Months Ended September 30, Increase (decrease) 2025 2024 $ % Compensation and benefit-related expenses $ 62,287 $ 47,578 $ 14,709 30.9 % Stock-based compensation 16,034 12,959 3,075 23.7 % Professional fees and other external expenses 83,447 42,204 41,243 97.7 % Facility related and other internal expenses 24,608 16,189 8,419 52.0 % Total SG&A expenses $ 186,376 $ 118,930 $ 67,446 56.7 % SG&A expenses were $186.4 million for the three months ended September 30, 2025 as compared to $118.9 million for the same period in 2024, an increase of $67.4 million, or 56.7%. This increase was primarily due to a $41.2 million increase in professional fees and other external expenses and a $17.8 million increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount , both driven by commercial readiness and commercial activities fo r BRINSUPRI. 42 Table of Contents Amortization of Intangible Assets Amortization of intangible assets was $1.5 million for the three months ended September 30, 2025 as compared to $1.3 million for the same period in 2024, an increase of $0.3 million. This increase was due to amortization of the AstraZeneca milestone achieved upon FDA approval of BRINSUPRI in August of 2025. Change in Fair Value of Deferred and Contingent Consideration Liabilities The change in fair value of deferred and contingent consideration liabilities for the three months ended September 30, 2025 was $104.7 million and was primarily due to the increase in our share price. The change is related to the fair value of the potential future consideration to be paid to former equityholders of the businesses we acquired. Investment Income Investment income was $18.3 million for the three months ended September 30, 2025 as compared to $17.0 million for the same period in 2024, an increase of $1.3 million, or 7.7%. This increase was primarily due to an increase in our average cash and cash equivalents and marketable securities balances in the 2025 period relative to the same period in 2024. Interest Expense Interest expense for the three months ended September 30, 2025 was $20.4 million as compared to $21.1 million for the same period in 2024, a decrease of $0.7 million, or 3.2%. This decrease was primarily due to the redemption of the 2028 Convertible Notes in the second quarter of 2025. See Note 10 - Debt and Note 11 - Royalty Financing Agreement in this Quarterly Report on Form 10-Q for further details. Change in Fair Value of Interest Rate Swap Prior to settlement and termination of the Swap Contract in October 2024, the change in fair value of interest rate swap was due to changes in interest rates during 2024 relative to the interest rate of the Swap Contract as of September 30, 2024. RESULTS OF OPERATIONS Comparison of the Nine Months Ended September 30, 2025 and 2024 Overview - Operating Results Our operating results for the nine months ended September 30, 2025, included the following: • Product revenues, net, increased $83.3 million , or 32.1% , as compared to the same period in the prior year as a result of the growth in global ARIKAYCE sales and US sales of BRINSUPRI; • Cost of product revenues (excluding amortization of intangible assets) increased $19.1 million, or 32.1%, as compared to the same period in the prior year primarily as a result of the growth in sales discussed above; • R&D expenses increased $97.5 million, or 23.3%, as compared to the same period in the prior year primarily as a result of increases in compensation and benefit-related expenses and stock-based compensation costs; • SG&A expenses increased $170.1 million, or 53.4%, as compared to the same period in the prior year primarily as a result of increases i n compensation and benefit-related expenses and stock-based compensation costs; • Amortization of intangible assets increased $0.3 million as compared to the same period in the prior year due to the AstraZeneca milestone achieved upon FDA approval of BRINSUPRI in August of 2025 • Change in fair value of deferred and contingent consideration liabilities increased $75.5 million, or 70.9%, primarily as a result of the relative increase in our share price in 2025 as compared to the same period in 2024; • Investment income increased $9.4 million, or 26.0%, as compared to the same period in the prior year primarily as a result of the increase in our average cash and cash equivalents and marketable securities balances; and • Interest expense decreased $0.2 million, or 0.3%, as compared to the same period in the prior year. 43 Table of Contents Product Revenues, Net 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, 2025 and 2024 (in thousands): Nine Months Ended September 30, Increase (decrease) 2025 2024 $ % ARIKAYCE US $ 206,942 $ 187,010 $ 19,932 10.7 % International 107,587 72,255 35,332 48.9 % Total $ 314,529 $ 259,265 $ 55,264 21.3 % BRINSUPRI US $ 28,051 $ — $ 28,051 NA Total $ 28,051 $ — $ 28,051 NA Total US $ 234,993 $ 187,010 $ 47,983 25.7 % International 107,587 72,255 35,332 48.9 % Total product revenues, net $ 342,580 $ 259,265 $ 83,315 32.1 % Product revenues, net, for the nine months ended September 30, 2025 were $342.6 million as compared to $259.3 million for the same period in 2024, an increase of $83.3 million, or 32.1%. This increase was a result of the 21.3% growth in sales of ARIKAYCE globally, and $28.1 million of US sales of BRINSUPRI following FDA approval in August 2025. Cost of Product Revenues (excluding amortization of intangible assets) Cost of product revenues (excluding amortization of intangible assets) for the nine months ended September 30, 2025 and 2024 were comprised of the following (in thousands): Nine Months Ended September 30, Increase (decrease) 2025 2024 $ % Cost of product revenues (excluding amortization of intangible assets) $ 78,718 $ 59,591 $ 19,127 32.1 % Cost of product revenues, as % of revenues 23.0 % 23.0 % Cost of product revenues (excluding amortization of intangible assets) were $78.7 million for the nine months ended September 30, 2025 as compared to $59.6 million for the same period in 2024, an increase of $19.1 million , or 32.1% . This increase was primarily attributable to the increase in total product revenues discussed above. R&D Expenses R&D expenses for the nine months ended September 30, 2025 and 2024 were comprised of the following (in thousands): 44 Table of Contents Nine Months Ended September 30, Increase (decrease) 2025 2024 $ % External Expenses Clinical development and research $ 128,245 $ 126,766 $ 1,479 1.2 % Milestone payment to AstraZeneca — 12,500 (12,500) (100.0) % Manufacturing 100,832 62,025 38,807 62.6 % Regulatory, quality assurance, and medical affairs 28,500 18,814 9,686 51.5 % Subtotal—external expenses $ 257,577 $ 220,105 $ 37,472 17.0 % Internal Expenses Compensation and benefit-related expenses $ 173,764 $ 136,146 $ 37,618 27.6 % Stock-based compensation 48,749 34,222 14,527 42.4 % Other internal operating expenses 36,092 28,167 7,925 28.1 % Subtotal—internal expenses $ 258,605 $ 198,535 $ 60,070 30.3 % Total R&D expenses $ 516,182 $ 418,640 $ 97,542 23.3 % R&D expenses were $516.2 million for the nine months ended September 30, 2025 as compared to $418.6 million for the same period in 2024, an increase of $97.5 million , or 23.3%. This increase was primarily due to a $52.1 million increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount and a $38.8 million increase in manufacturing expenses, partially offset by a $12.5 million milestone payment to AstraZeneca in 2024. External R&D expenses by product for the nine months ended September 30, 2025 and 2024 were comprised of the following (in thousands): Nine Months Ended September 30, Increase (decrease) 2025 2024 $ % ARIKAYCE external R&D expenses $ 32,338 $ 45,192 $ (12,854) (28.4) % Brensocatib external R&D expenses 73,576 74,612 (1,036) (1.4) % TPIP external R&D expenses 58,556 45,190 13,366 29.6 % Other external R&D expenses 93,107 55,111 37,996 68.9 % Total external R&D expenses $ 257,577 $ 220,105 $ 37,472 17.0 % We expect R&D expenses to increase in 2025 relative to 2024 primarily due to our clinical trial activities, manufacturing costs and related spend, including our confirmatory clinical trial of ARIKAYCE in a treatment setting for patients with MAC lung disease, our TPIP and brensocatib clinical trials, and other research efforts for our product candidates. SG&A Expenses SG&A expenses for the nine months ended September 30, 2025 and 2024 were comprised of the following (in thousands): Nine Months Ended September 30, Increase (decrease) 2025 2024 $ % Compensation and benefit-related expenses $ 168,443 $ 115,250 $ 53,193 46.2 % Stock-based compensation 64,922 36,059 28,863 80.0 % Professional fees and other external expenses 190,813 121,898 68,915 56.5 % Facility related and other internal expenses 64,506 45,394 19,112 42.1 % Total SG&A expenses $ 488,684 $ 318,601 $ 170,083 53.4 % SG&A expenses were $488.7 million for the nine months ended September 30, 2025 as compared to $318.6 million for the same period in 2024, an increase of $170.1 million, or 53.4%. This increase was primarily due to an $82.1 million increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount and a $68.9 million increase in professional fees and other external expenses, both driven by commercial readiness and commercial 45 Table of Contents activities fo r BRINSUPRI. We expect SG&A expenses to increase in 2025 relative to 2024 due, in part, to commercial readiness and commercial activities for BRINSUPRI. Amortization of Intangible Assets Amortization of intangible assets for the nine months ended September 30, 2025 was $4.1 million as compared to $3.8 million for the same period in 2024, an increase of $0.3 million. This increase was due to amortization of the AstraZeneca milestone achieved upon FDA approval of BRINSUPRI in August of 2025. Change in Fair Value of Deferred and Contingent Consideration Liabilities The change in fair value of deferred and contingent consideration liabilities for the nine months ended September 30, 2025 was $182.0 million and was primarily due to the increase in our share price. The change is related to the fair value of the potential future consideration to be paid to former equityholders of the businesses we acquired. Investment Income Investment income was $45.4 million for the nine months ended September 30, 2025 as compared to $36.1 million for the same period in 2024, an increase of $9.4 million, or 26.0%. This increase was primarily due to an increase in our average cash and cash equivalents and marketable securities balances in the 2025 period relative to the same period in 2024. Interest Expense Interest expense for the nine months ended September 30, 2025 was $63.2 million as compared to $63.4 million for the same period in 2024, a decrease of $0.2 million, or 0.3%. This decrease was primarily due to the reduction in interest expense related to the redemption of the 2028 Convertible Notes in the second quarter of 2025, partially offset by the interest income related to the Swap Contract in 2024. See Note 10 - Debt and Note 11 - Royalty Financing Agreement in this Quarterly Report on Form 10-Q for further details. Change in Fair Value of Interest Rate Swap Prior to settlement and termination of the Swap Contract in October 2024, the change in fair value of interest rate swap was due to changes in interest rates during 2024 relative to the interest rate of the Swap Contract as of September 30, 2024. LIQUIDITY AND CAPITAL RESOURCES Overview There is considerable time and cost associated with developing potential pharmaceutical products to the point of regulatory approval and commercialization. We commenced commercial shipments of ARIKAYCE in October 2018 and BRINSUPRI in August 2025. We expect to continue to incur consolidated operating losses, including losses at our US and certain international entities, as we plan to fund R&D for ARIKAYCE, brensocatib, TPIP, INS1201, INS1202, and our other pipeline programs, continue commercialization and regulatory activities for ARIKAYCE and BRINSUPRI, and engage in other general and administrative activities. In June 2025, we completed an underwritten offering of 8,984,375 shares of our common stock at a public offering price of $96.00 per share. 1,171,875 of the shares of common stock were issued pursuant to the exercise in full of the underwriters' option to purchase additional sh ares. Our net proceeds from the sale of the shares, after deducting the underwriting discounts and estimated offering expenses of $39.2 million, were $823.3 million. In May 2024, we completed an underwritten offering of 14,514,562 shares of our common stock at a public offering price of $51.50 per share. 1,893,203 of the shares of common stock were issued pursuant to the exercise in full of the underwriters' option to purchase additional shares. Our net proceeds from the sale of the shares, after deducting underwriting discounts and offering expenses of $34.3 million, were $713.2 million. In the first quarter of 2024, we entered into a sales agreement with Leerink Partners, to sell shares of our common stock, with aggregate gross sales proceeds of up to $500.0 million, from time to time, through an ATM program, under which Leerink Partners acted as sales agent. During the year ended December 31, 2024 , we issued and sold an aggregate of 5,022,295 shares of common stock through the ATM program at a weighted-average public offering price of $75.64 per share and received net proceeds of $371.3 million . In November 2024, we terminated the sales agreement. We may need to raise additional capital to fund our operations, commercialization of ARIKAYCE and BRINSUPRI, clinical trials for brensocatib, TPIP, INS1201, and our future product candidates, and to develop, acquire, in-license or co-promote other products or product candidates, including those that address orphan or rare diseases. While we believe we currently have sufficient funds to meet our financial needs for at least the next 12 months, we may opportunistically raise additional capital and may do so through equity or debt financing(s), strategic transactions or otherwise. Our cash requirements for the next 12 months will be impacted by a number of factors, the most significant of which we expect to be expenses related 46 Table of Contents to our commercialization efforts for ARIKAYCE and BRINSUPRI, development costs for our clinical-stage assets, and, to a lesser extent, our pre-clinical research programs. Cash Flows As of September 30, 2025, we had cash and cash equivalents of $334.8 million, as compared to $555.0 million as of December 31, 2024. In addition, as of September 30, 2025, we had marketable securities of $1,345.2 million, as compared to $878.8 million as of December 31, 2024. The net increase in cash and cash equivalents and marketable securities was primarily due to the June 2025 underwritten offering of common stock, which provided us with $823.3 million in net proceeds, partially offset by our cash used in operating activities . Our working capital was $1.5 billion as of September 30, 2025, as compared with $1.3 billion as of December 31, 2024. Net cash used in operating activities was $687.4 million and $487.9 million for the nine months ended September 30, 2025 and 2024, respectively. The net cash used in operating activities during the nine months ended September 30, 2025 and 2024 was primarily for the 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 increase in cash used in operating activities for the nine months ended September 30, 2025 as compared to the same period in 2024 was primarily due to the increase in net loss, excluding the adjustments to reconcile net loss to net cash used in operating activities. Net cash used in investing activities was $454.0 million and $714.9 million for the nine months ended September 30, 2025 and 2024, respectively. During the nine months ended September 30, 2025 and 2024, net cash used in investing activities consisted primarily of purchases of marketable securities, partially offset by maturities of marketable securities. Net cash provided by financing activities was $920.2 million and $1,181.7 million for the nine months ended September 30, 2025 and 2024, respectively. During the nine months ended September 30, 2025 and 2024, net cash provided by financing activities consisted primarily of proceeds from the issuance of common stock in our underwritten public equity offerings, and proceeds from the exercise of stock options and ESPP. Contractual Obligations There were no material changes outside of the ordinary course of business in our contractual obligations during the nine months ended September 30, 2025 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, 202 4. Off-Balance Sheet Arrangements We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources. We do not have any interest in special purpose entities, structured finance entities or other variable interest entities. CRITICAL ACCOUNTING ESTIMATES There have been no material changes to our critical accounting policies and estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 202 4 . For the required interim disclosure updates related to our accounting policies and estimates, see Note 2 - Summary of Significant Accounting Policies in this Quarterly Report on Form 10-Q. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK As of September 30, 2025, our cash and cash equivalents were in cash accounts and money market funds. Our investments in money market f unds are not insured by the federal government. As of September 30, 2025, we had $1,345.2 million in marketable securities. As of September 30, 2025, we had the $500.0 million Term Loans and a $150.0 million Royalty Financing Agreement outstanding. The Term Loans accrue interest quarterly at a fixed rate of 9.6% per annum. The Royalty Financing Agreement requires us to pay a Revenue Interest Payment of 4% of ARIKAYCE global net sales prior to September 1, 2025 and 4.5% thereafter, as well as 0.75% of brensocatib global net sales, which includes global net sales of BRINSUPRI. If a 10% change in interest rates had occurred on September 30, 2025, it would not have had a material effect on the fair value of our debt as of that date, nor would it have a material effect on our future earnings or cash flows. The majority of our business is conducted in US dollars. However, we do conduct certain transactions in other currencies, including Euros, British Pounds, and Japanese Yen. Historically, fluctuations in foreign currency exchange rates have not materially affected our results of operations and during the nine months ended September 30, 2025 and 2024, our results of operations were not materially affected by fluctuations in foreign currency exchange rates. 47 Table of Contents ITEM 4. CONTROLS AND PROCEDURES Evaluation of Disclosure Controls and Procedures Our management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities and Exchange Act of 1934, as amended (the Exchange Act), means controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit with the SEC is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and to ensure that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. Based on that evaluation as of September 30, 2025, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective at the reasonable assurance level. Changes in Internal Control Over Financial Reporting There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. PART II. OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS From time to time, we are party to various lawsuits, claims and other legal proceedings that arise in the ordinary course of our business. While the outcomes of these matters are uncertain, management does not expect that the ultimate costs to resolve these matters will have a material adverse effect on our consolidated financial position, results of operations or cash flows. ITEM 1A. RISK FACTORS Our business is subject to substantial risks and uncertainties. You should carefully consider the information contained in this Quarterly Report on Form 10-Q, the risks and uncertainties below, and the risk factors and other information contained in our other public filings in evaluating our business, including our Annual Report on Form 10-K for the year ended December 31, 202 4 , which was filed with the SEC on February 20, 2025. Any of the risks and uncertainties described herein and in our other filings with the SEC, either alone or taken together, could materially and adversely affect our business, financial condition, results of operations, prospects for growth, and the value of an investment in our common stock. In addition, these risks and uncertainties could cause actual results to differ materially from those expressed or implied by forward-looking statements contained in this Form 10-Q (please read " Cautionary Note Regarding Forward-Looking Statements " in this Quarterly Report on Form 10-Q). Our prospects are highly dependent on the successful commercialization of our approved products, ARIKAYCE and BRINSUPRI. If we are unable to successfully market, commercialize and maintain approval for ARIKAYCE and BRINSUPRI, our business, financial condition, results of operations and prospects and the value of our common stock will be materially adversely affected. Our long-term viability and growth depend on the successful commercialization of ARIKAYCE and BRINSUPRI. ARIKAYCE was approved in the US 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, as defined by patients who do not achieve negative sputum cultures after a minimum of six consecutive months of a multidrug background regimen therapy. Subsequently, ARIKAYCE was approved in Europe for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have CF, and in Japan for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatments with a multidrug regimen. We refer to NTM lung disease caused by MAC as MAC lung disease. BRINSUPRI was approved in the US in August 2025 as an oral, once-daily treatment for non-cystic fibrosis bronchiectasis in adults and children 12 years and older. We have invested and continue to invest significant efforts and financial resources in the commercialization of ARIKAYCE and BRINSUPRI. Our ability to continue to generate revenue from ARIKAYCE will depend heavily on successfully commercializing and obtaining full regulatory approval for ARIKAYCE from the FDA by conducting an appropriate confirmatory post-marketing study. Our ability to generate revenue from BRINSUPRI will depend heavily on successfully commercializing BRINSUPRI in the US as well as obtaining additional regulatory approvals outside of the US. In order to continue to commercialize ARIKAYCE and to commercialize BRINSUPRI, we must continue to establish and maintain marketing, market access, sales and distribution capabilities on our own or make arrangements with third parties for its marketing, sale and distribution. We are commercializing ARIKAYCE in the US, Europe and Japan and BRINSUPRI in the US using our sales force, but we may not continue to be successful in these efforts. The establishment, development and 48 Table of Contents maintenance of our own sales force is and will continue to be expensive and time-consuming. As a result, we may seek one or more partners to handle some or all of the sales and marketing of ARIKAYCE and/or BRINSUPRI in certain markets following approval by the relevant regulatory authority in those markets. In that case, we will be reliant on third parties to successfully commercialize ARIKAYCE and/or BRINSUPRI and will have less control over commercialization efforts than if we handled commercialization with our own sales force. However, we may not be able to enter into arrangements with third parties to sell ARIKAYCE and/or BRINSUPRI on favorable terms or at all. In the event that either our own marketing, market access, sales force or third-party marketing, and sales organizations are not effective, our ability to generate revenue would be adversely affected. We may not be able to obtain regulatory approval for ARIKAYCE in front-line NTM lung disease, for ARIKAYCE or BRINSUPRI in additional markets or for our product candidates, including brensocatib in additional indications. Any such failure to obtain regulatory approvals may materially adversely affect us. We are required to obtain various regulatory approvals prior to studying our products in humans and then again before we market and distribute our products, and the failure to obtain such approvals will prevent us from commercializing our products, which would materially adversely affect our business, financial condition, results of operations and prospects and the value of our common stock. While we have obtained accelerated approval for ARIKAYCE in the US, approval for ARIKAYCE in the EU and Japan and approval for BRINSUPRI in the US, seeking any future regulatory approvals for our product candidates, including for brensocatib in indications other than bronchiectasis, as well as approval for ARIKAYCE in front-line NTM lung disease or for ARIKAYCE or BRINSUPRI in other jurisdictions presents significant obstacles. Approval processes in the US, Europe, Japan and other markets require the submission of extensive preclinical and clinical data, manufacturing and quality information regarding the process and facility, scientific data characterizing our product and other supporting data in order to establish safety and effectiveness. These processes are complex, lengthy, expensive, resource intensive and uncertain. Regulators will also conduct a rigorous review of any trade name we intend to use for our products. Even after they approve a trade name, these regulators may request that we adopt an alternative name for the product if adverse event reports indicate a potential for confusion with other trade names and medication error. If we are required to adopt an alternative name, potential commercialization of our product candidates could be delayed or continued commercialization of ARIKAYCE or BRINSUPRI could be delayed or interrupted. We have limited experience in submitting and pursuing applications necessary to obtain these regulatory approvals. Data submitted to regulators are subject to varying interpretations that could delay, limit or prevent regulatory agency approval. Even if we believe our clinical trial results are promising, regulators may disagree with our interpretation of data, study design or execution and may refuse to accept our application for review or decline to grant approval. In addition, the grant of a designation by the FDA or EMA or approval by the FDA, EC or MHLW does not ensure a similar decision by the regulatory authorities of other countries, and a decision by one foreign regulatory authority does not ensure regulatory authorities in other foreign countries or the FDA will agree with the decision. For instance, although ARIKAYCE received orphan drug designation in the US, ARIKAYCE did not qualify for orphan drug designation in Japan due to the estimated number of NTM patients in Japan exceeding 50,000. Similarly, clinical studies conducted in one country may not be accepted by regulatory authorities in other countries. Approval procedures vary among countries and can involve additional product testing, including additional preclinical studies or clinical trials, and administrative review periods. The time required to obtain approval in these other territories might differ from that required to obtain FDA approval. We may never obtain approval for our product candidates in the US or other jurisdictions, for ARIKAYCE outside of the US, Europe and Japan, or for BRINSUPRI outside of the US, which would limit our market opportunities and could materially adversely affect our business. Even if any of our product candidates is approved, if ARIKAYCE is approved outside of the US, Europe and Japan, or if BRINSUPRI is approved outside of the US, regulators may limit the indications for which the product may be marketed, require extensive warnings on the product labeling or require expensive and time-consuming additional clinical trials or reporting as conditions of approval. We may also encounter delays or rejections based on changes in regulatory agency policies or resources during the period in which we develop a product and the period required for review of any application for regulatory agency approval of a particular product. Resolving such delays could force us or third parties to incur significant costs, limit our allowed activities or the allowed activities of third parties, diminish any competitive advantages that we or our third parties may attain or adversely affect our ability to receive royalties, any of which could materially adversely affect our business, financial condition, results of operations and prospects and the value of our common stock. The commercial success of ARIKAYCE and BRINSUPRI depend on market acceptance by physicians, patients, third-party payors and others in the healthcare community, and the commercial success of our product candidates, if approved, will similarly depend on market acceptance. Despite receiving FDA, EC and Japan's MHLW approval of ARIKAYCE and FDA approval of BRINSUPRI for the specified indications, market acceptance may vary among physicians, patients, third-party payors or others in the healthcare community. ARIKAYCE was the first product approved in the US via the LPAD pathway, and its approval under this pathway may impact market acceptance of the product. The degree of market acceptance of ARIKAYCE, which we launched in the US 49 Table of Contents early in the fourth quarter of 2018, in Europe in the fourth quarter of 2020, and in Japan in the second quarter of 2021, and of BRINSUPRI, which we launched in the US in the third quarter of 2025, is also dependent on a number of additional factors, including the following: • The willingness of the target patient populations to use, and of physicians to prescribe, ARIKAYCE and BRINSUPRI; • The efficacy and potential advantages of ARIKAYCE and BRINSUPRI over alternative treatments; • The risk and safety profile of ARIKAYCE and BRINSUPRI, including, among other things: with respect to ARIKAYCE, physician and patient concern regarding the US boxed warning and other safety precautions resulting from its association with an increased risk of respiratory adverse reactions; whether patients experience adverse events, including adverse events that did not occur or went undetected or unreported in our clinical trials; and any adverse safety information that becomes available as a result of longer-term use of ARIKAYCE and BRINSUPRI; • Relative convenience and ease of administration, including any requirements for hospital administration of ARIKAYCE and BRINSUPRI; • The ability of the patient to tolerate ARIKAYCE and BRINSUPRI; • The pricing of ARIKAYCE and BRINSUPRI; • The ability and willingness of the patient to pay out of pocket costs for ARIKAYCE and BRINSUPRI (for example, co-payments); • Sufficient third-party insurance coverage and reimbursement; • The strength of marketing and distribution support and timing of market introduction of competitive products and treatments; and • Publicity concerning ARIKAYCE and BRINSUPRI or any potential competitive products and treatments. Our efforts to educate physicians, patients, third-party payors and others in the healthcare community on the benefits of ARIKAYCE and BRINSUPRI have required and will continue to require significant resources, which may be greater than those required to commercialize more established technologies and these efforts may never be successful. If approved, the market acceptance of our product candidates may vary among physicians, patients, third-party payors or others in the healthcare community and will depend on substantially similar factors. If we are unable to obtain adequate reimbursement from government or third-party payors for ARIKAYCE, BRINSUPRI or our product candidates, if approved, or if we are unable to obtain acceptable prices for ARIKAYCE, BRINSUPRI or our product candidates, if approved, our prospects for generating revenue and achieving profitability will be materially adversely affected. Our prospects for generating revenue and achieving profitability depend heavily upon the availability of adequate reimbursement for the use of ARIKAYCE, BRINSUPRI or, if approved, our product candidates, from governmental and other third-party payors, both in the US and in other markets. A portion of our current ARIKAYCE revenue in the US comes from Medicare reimbursement, and we expect that trend to continue. Similarly, we expect a portion of our BRINSUPRI revenue in the US to come from Medicare reimbursement. Reimbursement by a third-party payor depends upon a number of factors, including the third-party payor’s determination that use of a product is: • A covered benefit under its health plan; • Safe, effective and medically necessary; • Appropriate for the specific patient; • Cost-effective; and • Neither experimental nor investigational. Obtaining a determination of coverage and reimbursement for a product from each relevant governmental or other third-party payor is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products to each payor. Payors in the US have evaluated ARIKAYCE for inclusion on formularies. Going forward, we may not be able to provide data sufficient to gain positive coverage and reimbursement determinations or we might need to conduct post-marketing studies in order to demonstrate the cost-effectiveness of ARIKAYCE to such payors’ satisfaction. Such studies might require us to commit a significant amount of management time and financial and other resources. Payors in the US have yet to fully evaluate BRINSUPRI and/or write policies related to access. If we are unable to successfully shape access requirements or the prior authorization process proves too onerous, physicians and patients may develop a negative view of ability to access BRINSUPRI, which, in turn, could affect our ability to successfully commercialize BRINSUPRI and adversely impact our business, financial condition, results of operations and prospects and the value of our common stock. Even when a payor determines that a product is eligible for reimbursement, the payor may impose coverage limitations that preclude payment for some uses that are approved by the FDA or non-US regulatory authorities and/or may set a reimbursement rate that is too low to support a profitable sales price for the product. For example, in France we agreed with the French authorities to a reimbursed price for ARIKAYCE which was lower than the price in our temporary authorization for use (Autorisation Temporaire d'Utilisation or ATU) and are required to refund the difference. As a result, we recorded a revenue reversal in the fourth quarter of 2022, related to revenue recorded in prior periods. In addition, in 2023, we experienced a one-time, prospective price decrease for ARIKAYCE in Japan of 9.4%. In the US, payors have restricted and continue to restrict 50 Table of Contents coverage of ARIKAYCE by using a variable co-payment structure that imposes higher costs on patients for drugs that are not preferred by the payor and by imposing requirements for prior authorization or step edits. Subsequent approvals of competitive products could result in a detrimental change to the reimbursement of our products. The occurrence of any of these events likely would adversely impact market acceptance and demand for ARIKAYCE and/or BRINSUPRI, which, in turn, could affect our ability to successfully commercialize ARIKAYCE and/or BRINSUPRI and adversely impact our business, financial condition, results of operations and prospects and the value of our common stock. There is a significant focus in the US healthcare industry and elsewhere on drug prices and value, and public and private payors are taking increasingly aggressive steps to control their expenditures for pharmaceuticals by, among other things, negotiating manufacturer discounts and placing restrictions on reimbursement for, and patient access to, medications. These pressures could negatively affect our business. We expect changes in the Medicare program and state Medicaid programs, as well as managed care organizations and other third-party payors, to continue to put pressure on pharmaceutical product pricing. One significant example of applicable legislative action is the IRA, which was signed into law on August 16, 2022. The IRA gives the HHS the ability and authority to directly negotiate with manufacturers the price that Medicare will pay for certain high-priced drugs and set caps on the negotiated price of such drugs, among other changes. The IRA also requires manufacturers of certain Part B and Part D drugs to issue to HHS rebates based on certain calculations and triggers (i.e., when drug prices increase and outpace the rate of inflation), which may influence the pricing of current and future products. At this time, we believe that ARIKAYCE will be excluded from price negotiation due to its orphan drug designation, but BRINSUPRI could in the future be subject to IRA price negotiation. We cannot predict other potential implications the IRA provisions will have on our business or the pricing of our product candidates, if approved. Similarly, we cannot predict the impact on our business of the current Administration’s proposed “most favored nation” drug pricing policy. These types of laws may have a significant impact on our ability to set a product price we believe is fair or market and sell our approved products in certain jurisdictions and may adversely affect our ability to generate revenue and achieve or maintain profitability. We expect further federal and state proposals and healthcare reforms to continue to be proposed, which could limit the prices that can be charged for the products we develop or may otherwise limit our commercial opportunity. In addition, in connection with various government programs, we are required to report certain pricing information to the government, and the failure to do so may subject us to penalties. In markets outside the US, including countries in Europe, Japan and Canada, pricing of pharmaceutical products is subject to governmental control. Evaluation criteria used by many government agencies in European countries for the purposes of pricing and reimbursement typically focus on a product’s degree of innovation and its ability to meet a clinical need unfulfilled by currently available therapies. The Patient Protection and Affordable Care Act (ACA) created a similar entity, the Patient-Centered Outcomes Research Institute, designed to review the effectiveness of treatments and medications in federally-funded healthcare programs. An adverse result could lead to a treatment or product being removed from Medicare or Medicare coverage. The decisions of such governmental agencies could affect our ability to sell our products profitably. We continue to have discussions with third-party payors regarding our price for ARIKAYCE and BRINSUPRI, and our pricing may meet resistance from them and the public generally. If we are unable to maintain adequate reimbursement for ARIKAYCE in the US, Europe and Japan, or for BRINSUPRI in the US, the adoption of ARIKAYCE and/or BRINSUPRI by physicians and patients may be limited. If we are unable to negotiate acceptable prices for ARIKAYCE and BRINSUPRI, we may be unable to generate sufficient revenue to achieve profitability. Both of these risks, in turn, could affect our ability to successfully commercialize ARIKAYCE and BRINSUPRI and adversely impact our business, financial condition, results of operations and prospects and the value of our common stock. We have limited experience operating internationally, are subject to a number of risks associated with our international activities and operations and may not be successful in our efforts to expand internationally. We currently have limited operations outside of the US. As of September 30, 2025, we had 214 employees located in Europe and 153 employees located in Japan, although we have clinical trial sites and suppliers located around the world. In order to meet our long-term goals, we expect to grow our international operations over the next several years, including in Europe and Japan, and continue to source material used in the manufacture of our product candidates from abroad. Additionally, a substantial portion of our commercial supply of ARIKAYCE is currently manufactured in Canada and commercial supply of BRINSUPRI also is manufactured in Canada. Consequently, we are and will continue to be subject to risks related to operating in foreign countries, including: • Limited experience with international regulatory requirements; • An inability to achieve optimal pricing and reimbursement for ARIKAYCE and/or BRINSUPRI, if approved in another jurisdiction, or subsequent changes in reimbursement, pricing and other regulatory requirements; • Any implementation of, or changes to, tariffs, trade barriers and other import-export regulations in the US or other countries in which we, or our third-party partners, operate; • Unexpected AEs related to ARIKAYCE, BRINSUPRI or our product candidates occurring in foreign markets that we have not experienced in the US, Europe or Japan; 51 Table of Contents • Scrutiny from customers, regulators, investors and other stakeholders related to environmental, health and safety, diversity, labor conditions, human rights and other concerns in the countries in which we, or our third-party partners, operate; • Economic and political conditions, including foreign currency fluctuations and inflation, could result in reduced revenue, increased or unpredictable operating expenses and other obligations incident to doing business in, or with a company located in, another country; • Geopolitical events, such as conflicts, war and terrorism, could cause disruptions in our international operations, including planned or ongoing clinical studies; and • Compliance with foreign or US laws, rules and regulations, including data privacy requirements, labor relations laws, tax laws, anti-competition regulations, import, export and trade restrictions, anti-bribery/anti-corruption laws, regulations or rules, which could lead to actions by us or our distributors, manufacturers, other third parties who act on our behalf or with whom we do business in foreign countries or our employees who are working abroad that could subject us to investigation or prosecution under such foreign or US laws. These and other risks associated with our international operations may materially adversely affect our business, financial condition, results of operations and prospects and the value of our common stock. If we are unable to protect our intellectual property rights adequately, the value of ARIKAYCE, BRINSUPRI and our product candidates could be materially diminished. The patent position of biotechnology and pharmaceutical companies generally is highly uncertain and involves complex legal, technical, scientific and factual questions, and our success depends in large part on our ability to protect our proprietary technology and to obtain and maintain patent protection for our products, prevent third parties from infringing our patents, both domestically and internationally. We have sought to protect our proprietary position by filing patent applications in the US and abroad related to our novel technologies and products that are important to our business. This process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Our existing patents and any future patents we obtain may not be sufficiently broad to prevent others from using our technologies or from developing competing products and technologies. Even if our owned and licensed patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection or otherwise provide us with any competitive advantage. Any conclusions we may reach regarding non-infringement, inapplicability or invalidity of a third party’s intellectual property vis-à-vis our proprietary rights, or those of a licensor, are based in significant part on a review of publicly available databases and other information. There may be information not available to us or otherwise not reviewed by us that could render these conclusions inaccurate. Our competitors may also be able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner. Additionally, patents issued to us or our licensors may be challenged, narrowed, invalidated, held to be unenforceable or circumvented through litigation, either in district court, the US international trade commission (ITC) or US patent office (USPTO), or in analogous foreign courts and patent offices, which could limit our ability to stop competitors from marketing similar products or reduce the term of patent protection for ARIKAYCE, BRINSUPRI or our product candidates. US patents and patent applications may also be subject to interference or derivation proceedings, and US patents may be subject to re-examination proceedings, reissue, post-grant review and/or inter partes review in the USPTO. Our foreign patents have been and may be in the future subject to opposition or comparable proceedings in the corresponding foreign patent office, which could result in either loss of the patent or denial of the patent application or loss or reduction in the scope of one or more of the claims of the patent or patent application. Changes in either patent laws or in interpretations of patent laws in the US and other countries may also diminish the value of our intellectual property or narrow the scope of our patent protection, including making it easier for competitors to challenge our patents. If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of ARIKAYCE, BRINSUPRI and our product candidates could be materially diminished. We rely on trade secrets to protect our proprietary technologies, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality and restrictive covenant agreements with our employees, consultants, advisors, collaborators, and other third parties and partners to protect our trade secrets and other proprietary information. These agreements may not effectively prevent disclosure of confidential information or may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, third parties may independently develop or discover our trade secrets and proprietary information. Regulators also may disclose information we consider to be proprietary to third parties under certain circumstances, including in response to third-party requests for such disclosure under the Freedom of Information Act or comparable laws. Additionally, the FDA, as part of its Transparency Initiative, continues to consider whether to make additional information publicly available on a routine 52 Table of Contents basis, including information that we may consider to be trade secrets or other proprietary information, and it is not clear at the present time whether and how the FDA’s disclosure policies may change in the future. Further, several states have limited or prohibited the use of post-employment non-compete agreements, and the Federal Trade Commission issued a federal-level prohibition on such agreements (which prohibition cannot currently be enforced due to ongoing legal challenges), which could increase the difficulty of protecting trade secrets and other proprietary information. There are similar risks outside the US, such as the risk that a foreign regulatory agency would make available information we consider to be proprietary to third parties or the public, and the risks arising from other factors making it difficult to protect trade secrets, such as prohibitions or restrictions on post-employment non-compete agreements and other rules and regulations. Our shareholders may experience dilution of their ownership interests because of the future issuance of additional shares of our common stock. In the future, we may issue additional equity securities for capital raising purposes, in connection with hiring or retaining employees, to fund acquisitions, or for other business purposes. We have previously funded, and expect to continue to fund, acquisitions using shares of our common stock as consideration. The future issuance of any additional shares of common stock will dilute our current shareholders and may create downward pressure on the value of our shares. ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS None. ITEM 5. OTHER INFORMATION Rule 10b5-1 Trading Plans Our policy governing transactions in our securities by our directors, officers and employees permits our directors, officers and employees to enter into trading plans complying with Rule 10b5-1 under the Exchange Act. The following table describes the written plans for the sale of our securities adopted , modified or terminated by our officers and directors (each as defined in Rule 16a-1(f) of the Exchange Act) during the third quarter of 2025, each of which was entered into during an open trading window and is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) (each, a Trading Plan). Name and Title Date of Adoption of Trading Plan Scheduled Start Date of Trading Plan Scheduled Expiration Date of Trading Plan (1) Maximum Shares Subject to Trading Plan Date Plan Terminated S. Nicole Schaeffer Chief People Strategy Officer 08/29/2025 01/02/2026 08/14/2026 87,290 N/A William H. Lewis Chair and CEO 09/04/2025 12/04/2025 08/04/2026 237,351 N/A (1) A Trading Plan may expire on an earlier date if all contemplated transactions are completed before such Trading Plan’s expiration date, upon termination by broker or the holder of the Trading Plan, or as otherwise provided in the Trading Plan. 53 Table of Contents ITEM 6. EXHIBITS Exhibit Index 3.1 Articles of Incorporation of Insmed Incorporated, as amended through June 14, 2012 (incorporated by reference from Exhibit 3.1 to Insmed Incorporated’s Annual Report on Form 10-K filed on March 18, 2013). 3.2 Amended and Restated Bylaws of Insmed Incorporated (effective as of May 11, 2023) (incorporated by reference from Exhibit 3.1 to Insmed Incorporated’s Current Report on Form 8-K filed on May 11, 2023). 10.1 Amendment No. 1 to Amended and Restated Loan Agreement, dated July 10, 2025, between Insmed Incorporated, BioPharma Credit PLC, BPCR Limited Partnership and BioPharma Credit Investments V (Master) LP (filed herewith). 31.1 Certification of William H. Lewis, Chair and Chief Executive Officer (Principal Executive Officer) of Insmed Incorporated, pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002 (filed herewith). 31.2 Certification of Sara Bonstein, Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) of Insmed Incorporated, pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002 (filed herewith). 32.1 Certification of William H. Lewis, Chair and Chief Executive Officer (Principal Executive Officer) of Insmed Incorporated, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002 (furnished herewith). 32.2 Certification of Sara Bonstein, Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) of Insmed Incorporated, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002 (furnished herewith). 101 The following materials from Insmed Incorporated’s quarterly report on Form 10-Q for the quarter ended September 30, 2025 formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024, (ii) Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2025 and 2024, (iii) Consolidated Statements of Shareholders' Equity for the three and nine months ended September 30, 2025 and 2024, (iv) Consolidated Statements of Cash Flows for the nine months ended September 30, 2025 and 2024, (v) Notes to the Unaudited Consolidated Financial Statements, and (vi) Cover Page. 104 The cover page from the Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, formatted in iXBRL and contained in Exhibit 101. 54 Table of Contents SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. INSMED INCORPORATED Date: October 30, 2025 By /s/ Sara Bonstein Sara Bonstein Chief Financial Officer (Principal Financial and Accounting Officer) 55