Insmed (NASDAQ:INSM) executives highlighted a strong 2025 and set an aggressive near-term outlook during the company’s fourth-quarter and full-year 2025 earnings call, pointing to an early “stunning” launch for BRINSUPRI, continued acceleration for ARIKAYCE, and key pipeline updates led by TPIP. Management also said it believes the company can reach cash flow positivity without raising additional capital, while leaving room to pursue business development opportunities.
BRINSUPRI launch performance and 2026 revenue guidance
Chair and CEO Will Lewis said 2025 was “an exceptional year,” emphasizing the U.S. approval and launch of BRINSUPRI and describing the early trajectory as “strongly up and to the right.” Insmed reported BRINSUPRI net revenue of $144.6 million in its first full quarter, which Lewis said exceeded internal expectations.
Management reiterated its belief that BRINSUPRI could exceed a previously stated peak sales estimate above $5 billion for its initial bronchiectasis opportunity. Lewis framed the U.S. diagnosed non-CF bronchiectasis population as roughly 500,000 patients, with about 250,000 estimated to have had two or more exacerbations in the prior 12 months—aligned with the company’s clinical trial population. Insmed said approximately 11,550 new patients started BRINSUPRI in 2025, representing less than 5% of the estimated two-plus exacerbation group.
Expanding the diagnosed population: COPD and asthma overlap focus
Lewis pointed to a longer-term effort to identify additional bronchiectasis patients among the estimated 32 million diagnosed COPD or asthma patients in the U.S., arguing many may have undiagnosed bronchiectasis and continue to exacerbate despite standard-of-care therapy. Insmed said it is building outreach and education programs and supporting evidence generation at large respiratory centers using retrospective data to identify bronchiectasis among COPD and asthma patients who continue to exacerbate.
Lewis cited a recent publication suggesting bronchiectasis could be involved in 30% to over 50% of patients with moderate to severe COPD and 25% to 40% of patients with severe asthma. He characterized this as a multi-year opportunity, but said Insmed could begin to see such patients “as early as the end of this year” in existing pulmonary practices, with a more evident impact in 2027 and beyond.
In Q&A, management emphasized that this strategy is intended to remain on-label—focused on diagnosing bronchiectasis (via CT scan and pulmonologist evaluation) in patients currently labeled as COPD or asthma who remain symptomatic and exacerbation-prone.
Prescribing behavior, persistence, and market access dynamics
Insmed described the current launch as being in an “exploration stage,” with physicians initially testing the medicine in a small number of patients. Lewis said that among the roughly 4,000 physicians who wrote a prescription through the end of 2025, nearly half prescribed BRINSUPRI to only one patient. He suggested broader repeat prescribing may follow as early patients return for follow-up visits and share their experiences.
Asked about adherence and discontinuations, Lewis said internal dashboards show metrics “at or above” targets and cited encouraging signs including manageable market access dynamics, low discontinuation rates, and reauthorizations “going through,” though the company declined to disclose specific approval-rate numbers.
On payer access, Lewis said over 90% of targeted patient lives have access to reimbursement either via documented payer policy or medical exception. He said some payers use attestation-based prior authorization and reauthorization criteria (with modest rebates), while others require documentation such as CT scans and proof of two or more exacerbations. The company said it has seen high approval rates even where documentation is required and expects processes to improve as provider offices gain familiarity.
Chief Financial Officer Sara Bonstein provided additional details on expected gross-to-net (GTN) dynamics. For BRINSUPRI, she guided to a mid-20s to low-30s GTN range in 2026, noting 2025 actual GTN was also in that range. For ARIKAYCE, she said 2026 GTN is expected to be low- to mid-20s, slightly higher than 2025 due primarily to IRA-related impacts, including the small manufacturer phase-in.
ARIKAYCE growth and ENCORE catalyst
Insmed said ARIKAYCE continued to grow globally in 2025, driven by commercial execution in Japan and Europe. Lewis highlighted Japan’s contribution as particularly strong, with 40% growth versus 2024 and accounting for more than a quarter of ARIKAYCE’s global revenues. He added that Europe grew faster from a smaller base.
Lewis said Insmed expects to announce results from the Phase III ENCORE trial in March or April. He said success could expand the addressable market for ARIKAYCE from around 30,000 patients to more than 200,000. In Q&A, he said the company will not provide “blinded data” commentary, but expressed confidence based on prior studies and highlighted culture conversion history in ARIKAYCE trials.
Pipeline updates: TPIP orphan designation, Phase III design, and business development posture
Lewis said TPIP was “significantly de-risked” by 2025 clinical data, enabling Insmed to pursue up to four Phase III programs in parallel. He also disclosed that the FDA’s Office of Orphan Products Development granted orphan drug designation to treprostinil palmitate for pulmonary arterial hypertension, quoting the FDA letter’s rationale that TPIP “may be clinically superior” and could represent a “major contribution to patient care” versus existing treprostinil options.
Lewis summarized key elements of the PALM-PAH Phase III trial design, including a 24-week treatment period (versus 16 weeks in Phase II), dosing up to 1,280 micrograms, allowance of background sotatercept capped at 20%, and six-minute walk distance measured 1–3 hours post-dose. He said Insmed expects to start the trial in the first half of the year and reiterated that FDA feedback indicated a single Phase III trial could be sufficient for a registrational submission in PAH if successful.
On business development, management said it may choose to raise capital if it identifies attractive opportunities, but maintained that its base business plan supports a path to cash flow positivity without additional funding. Lewis and Bonstein cited the company’s year-end 2025 cash position of approximately $1.4 billion and described business development as incremental to the cash flow positivity plan. Lewis also referenced INS1148—acquired in 2025—as an example of a “phase two ready” asset Insmed views as having “DPP1-like potential” across multiple diseases.
Bonstein added that fourth-quarter cash burn included approximately $70 million of one-time items, largely related to the INS1148 asset acquisition and a milestone payment to AstraZeneca tied to BRINSUPRI’s U.S. approval.
About Insmed (NASDAQ:INSM)
Insmed Incorporated is a biopharmaceutical company focused on developing and commercializing therapies for patients with rare and serious diseases, with a particular emphasis on difficult-to-treat pulmonary infections. Headquartered in Bridgewater, New Jersey, the company concentrates its research and development efforts on targeted drug delivery technologies and novel formulations intended to improve clinical outcomes for patients who have limited treatment options.
The company’s principal marketed product is ARIKAYCE (amikacin liposome inhalation suspension), an inhaled liposomal formulation of the antibiotic amikacin that is approved by the U.S.
