INSM — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• •our inability to obtain full approval of ARIKAYCE from the FDA, or our failure to obtain regulatory approval to expand ARIKAYCE’s indication to a broader patient population;

• •risk that healthcare legislation or other government action materially adversely affects our business;

• conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

• We are a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. Our commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammatio…

• Our two commercial products, ARIKAYCE and BRINSUPRI, are both part of the Respiratory therapeutic area. ARIKAYCE is approved in the US as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590mg (amikaci…

Text removed vs the prior filing · source: 10-Q · 2025-10-30

• •our inability to obtain full approval of ARIKAYCE from the FDA, including the risk that we will not successfully or in a timely manner complete the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE, or our failure to obtain regulatory approval to expand ARIKAYCE’s in…

• •risk that government healthcare reform materially increases our costs and damages our financial condition;

• of Financial Condition and Results of Operations” in this Quarterly Report on Form 10-Q and included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revis…

• We are a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. Our first commercial product, ARIKAYCE, was approved in the US in September 2018, in the European Union (EU) in October 2020 and i…

• Prior to 2019, we had not generated significant revenue and, through September 30, 2025, we had an accumulated deficit of $5.3 billion. We have financed our operations primarily through the public offerings of our equity securities, debt financings and revenue interest financings. Although it is dif…

Text added vs the prior filing · source: 10-Q · 2026-05-07

• As of March 31, 2026, we had our $500.0 million Term Loans outstanding. The Term Loans accrue interest quarterly at a fixed rate of 9.6% per annum. If a 10% change in interest rates had occurred on March 31, 2026, it would not have had a material effect on the fair value of our debt as of that date,…

Text removed vs the prior filing · source: 10-Q · 2025-10-30

• 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 glo…

Text removed vs the prior filing · source: 10-Q · 2025-10-30

• 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…

• 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 …

• 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 …

• 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 …

• 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 affec…

Text added vs the prior filing · source: 10-Q · 2026-05-07

• In addition, during the period covered by this Quarterly Report on Form 10-Q, each of our officers entered into grant agreements relating to RSUs and PSUs that included “sell-to-cover” arrangements constituting “non-Rule 10b5-1 trading arrangements” (as defined in Item 408 of Regulation S-K), requir…