Insmed Q1 Earnings Call Highlights

Key Points

• BRINSUPRI delivered 44% sequential growth in Q1 and Insmed reiterated 2026 revenue guidance of at least $1 billion, citing strong access and adherence metrics — roughly 90% payer approvals via specialty pharmacies, >80% enrollment in its patient support program, and refill/persistence rates above benchmarks as organic new-patient demand is expected to grow from Q2.
• ARIKAYCE Phase IIIb ENCORE produced statistically significant improvements in patient-reported respiratory symptoms and "well over 80%" culture conversion at six months in earlier disease, prompting planned regulatory submissions in H2 2026 and a potential label expansion in H1 2027 that could expand the addressable market from ~30,000 to >200,000 patients.
• Insmed ended Q1 with about $1.2 billion in cash and said underlying cash burn is in line with the past year; management believes the company can achieve cash-flow positivity without additional capital and expects sustainable cash-flow positivity in 2027 if it does not materially expand its expense base.

Insmed NASDAQ: INSM executives said the company entered 2026 with strong commercial momentum for BRINSUPRI and continued growth for ARIKAYCE, while advancing late-stage development of TPIP across multiple Phase III studies. Management reiterated full-year guidance for both commercial products and said the company remains positioned to reach cash flow positivity without additional capital, assuming it does not materially expand its expense base through business development.

BRINSUPRI launch metrics: sequential growth, access, and persistence

Chair and CEO Will Lewis said BRINSUPRI delivered “44% sequential growth” in the first quarter off what he described as an already strong prior-quarter baseline. Lewis highlighted that calendar first quarters can be slower periods for medicines due to plan changes and out-of-pocket resets, but said BRINSUPRI’s performance continued to exceed the company’s expectations. He added that Insmed did not raise BRINSUPRI’s price at the start of 2026 and said the quarter’s impact from inventory stocking was “negligible.”

Lewis reiterated Insmed’s 2026 revenue guidance for BRINSUPRI of “at least $1 billion,” and he compared the launch’s sequential growth to other respiratory launches cited previously by the company. He also outlined a set of metrics Insmed is using to evaluate the launch, including patient demand, payer access, patient support program participation, refill timing, continuation, and prescriber breadth and depth.

On demand, Lewis said Insmed believes it has largely completed the early wave of “ready and waiting” patients—those generated by pre-approval disease awareness efforts and concentrated at larger institutions that needed time to add the drug to electronic medical record systems. He estimated that about 3,500 of the 9,000 new patient starts in Q4 were from this group, and about 1,500 of roughly 7,800 new patients who started treatment in Q1 were “ready and waiting.” Lewis said Insmed expects Q2 to be the first period without a meaningful contribution from that cohort and expects “organic” new patient demand to grow sequentially from Q2 through the rest of the year.

Lewis also cautioned investors about prescription tracking services, noting that Symphony total prescription (TRx) data has been “valuable as a directional predictor” for BRINSUPRI dispenses, while Symphony new prescription (NRx) data has been less helpful for predicting new patient starts.

On access, Lewis said payer approval rates have remained high, with approvals for patients processed through Insmed’s specialty pharmacies “at nearly 90% since launch.” He added that time to payer approval has been less than a week for most patients so far, ahead of internal benchmarks. Asked later whether more stringent contracting or prior authorization could become a bigger risk, Lewis said many policies are already in place and Insmed has not seen a material decline, in part because its launch strategy focused on patients with two or more exacerbations where coverage would be most favorable.

Lewis emphasized patient support and adherence measures. He said more than 80% of patients on BRINSUPRI have enrolled in Insmed’s inLighten Patient Support program. He also said refill behavior has been strong, with prescriptions refilled “nearly every 30 days,” compared to an industry benchmark of around 37 days for a 30-day prescription. On persistence, he said BRINSUPRI’s continuation rate is tracking “slightly above” benchmarks cited for well-tolerated oral medicines, referencing that generic statins have around 70% of patients remaining on therapy at six months.

Prescriber expansion and bronchiectasis diagnosis efforts

Lewis said Insmed is seeing broad adoption across pulmonologists, with cumulative BRINSUPRI writers surpassing 5,000 by the end of Q1—representing “more than a quarter of all pulmonologists in the U.S.” He pointed to an opportunity to deepen use among physicians who have started with limited prescribing. Lewis said that at the end of December, about 1,800 physicians had prescribed BRINSUPRI for only one patient, and by Q1 roughly half of those had prescribed it to at least one additional patient.

During Q&A, Lewis said depth may take time because pulmonologists are cautious adopting a novel mechanism for a condition that has lacked an approved treatment for a long period. He suggested repeat prescribing is likely to increase as treated patients return to physicians with their experiences and as clinicians share experiences at meetings such as the American Thoracic Society (ATS) conference.

Insmed also discussed efforts to expand diagnosis and awareness. Lewis highlighted a new diagnosis-focused campaign called “Suspect BE,” featuring TV host Ty Pennington and his family’s experience with delayed bronchiectasis diagnosis. He also referenced an ATS initiative to analyze electronic health records across seven academic systems to identify patterns of misdiagnosis and potential solutions such as EHR prompts and continuing medical education modules. Lewis said Insmed is also exploring ways AI could help, including reviewing historic CT scans and auditing patient records for missed bronchiectasis diagnoses.

Pressed on timing for diagnosis expansion, Lewis said Insmed expects to monitor markers such as CT scan rates and diagnosis rates and would expect “by the end of this year, certainly, more robustly in 2027” to see evidence of impact.

ARIKAYCE: ENCORE results and label expansion strategy

Lewis said ARIKAYCE grew year over year despite being in its eighth year on the market in refractory NTM MAC patients. He then highlighted Phase IIIb ENCORE results in newly diagnosed NTM MAC patients, describing them as “clearly positive” and “potentially practice-changing.” According to Lewis, ARIKAYCE plus a multidrug regimen achieved a statistically significant improvement on the patient-reported respiratory symptom score primary endpoint versus multidrug active control, which he called “the most important factor for U.S. regulators.”

Lewis said ENCORE also showed “earlier, greater, and more durable culture conversion,” with statistically significant benefits at each pre-specified time point, including month 15 (three months off therapy), which he described as most important for Japanese regulators. He contrasted ENCORE with the Phase III CONVERT study in refractory disease, where ARIKAYCE led to about 30% culture conversion at six months; he said ENCORE showed “well over 80%” conversion at six months when treated earlier, and ARIKAYCE was better tolerated with lower discontinuation than in CONVERT.

Insmed said it plans to submit ENCORE data to regulators in the U.S. and Japan in the second half of 2026. Lewis said the company believes an expanded label could be possible in the first half of 2027 and could expand ARIKAYCE’s addressable market from around 30,000 patients today to more than 200,000 patients next year.

TPIP: Phase III execution and higher-dose experience

On TPIP, Lewis said Insmed opened its first site in the Phase III PALM-PAH study last month and stated that based on FDA feedback, the trial would be the only registrational study required for potential approval in pulmonary arterial hypertension if successful. He also said Insmed expects data from the Phase II-B 24-month open-label extension (OLE) study in PAH in Q3 2026, including safety and certain efficacy measures through the first 12 months of the OLE.

Lewis said physicians have been able to increase doses beyond the 640 microgram maximum used in the randomized Phase II-B portion, with about a quarter of OLE participants exceeding 640 micrograms and “seven out of the 91 patients” reaching the new maximum of 1,280 micrograms. He said Insmed will look for sustained improvements over time in measures such as six-minute walk distance, NT-proBNP, and functional class, while acknowledging the limitations of an open-label dataset without a placebo comparator.

For PALM-ILD, Lewis said patients have been randomized across seven countries and that recruitment in the U.S. has continued despite competition from marketed treprostinil products. He framed that as a positive sign for potential future adoption if TPIP is approved, because physicians are enrolling patients into a placebo-controlled trial with the expectation of access to TPIP for all patients after the study period.

Lewis also said Insmed continues to anticipate initiating a Phase III study in progressive pulmonary fibrosis (PPF) in the second half of 2026, followed shortly thereafter by a study in idiopathic pulmonary fibrosis (IPF). He noted recent positive IPF data from another treprostinil product and said Insmed believes TPIP’s ability to deliver higher doses directly to the lung with once-daily administration could be advantageous.

Financial update: guidance reiterated, cash position, and path to cash flow positivity

CFO Sara Bonstein reiterated Insmed’s 2026 guidance for revenue and gross-to-net ranges for BRINSUPRI and ARIKAYCE, adding that Q1 gross-to-net results for both products fell within those ranges. Later, responding to a question on gross-to-net, Bonstein said BRINSUPRI guidance remains “mid-20s to low 30s” and ARIKAYCE “low to mid-20s,” and that Q1 actuals were within each respective range.

Bonstein said Insmed ended Q1 2026 with approximately $1.2 billion in cash, cash equivalents, and marketable securities. She said underlying cash burn (excluding proceeds from stock option exercises) was within the range seen over the past year, and the company expects burn to decline as revenues ramp faster than spending. Bonstein said Insmed believes it can achieve cash flow positivity without additional capital for its existing business, and, “presuming we do not add to our expense base through business development,” expects “sustainable cash flow positivity in 2027.”

Bonstein also said cost of product revenues in Q1 2026 was $47.4 million, or 15.5% of revenues, and described the lower percentage versus historical performance as reflecting BRINSUPRI’s positive contribution to gross margin. She said R&D and SG&A expenses increased year over year due to investment in the BRINSUPRI U.S. launch and pipeline funding.

In response to questions about raising guidance or providing quarterly forecasts, Lewis declined to provide quarterly revenue guidance, emphasizing that Insmed is “a cautious company” and prefers to focus on execution. He noted that across the first two full quarters of BRINSUPRI commercialization, Insmed generated $350 million in revenue.

Separately, Lewis said uncertainty around “MFN” has caused Insmed to pause its launch efforts for BRINSUPRI in Europe and the U.K., despite approval in those regions, as the company assesses potential implications for U.S. pricing dynamics. He said Insmed will wait for more clarity in coming months before determining how to proceed internationally.

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.

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