Insmed CEO Defends BRINSUPRI Launch as Sales Surge, TPIP Pipeline Gains Focus

Key Points

• Insmed defended the BRINSUPRI launch after investors worried about discontinuation rates, saying the drug’s $208 million in sales rose 44% sequentially and that persistence remains “best in class.” CEO Will Lewis said the company believes the launch is tracking well against internal models and clinical expectations.
• The company said prescriber adoption and market growth are supporting the launch, with 25% of pulmonologists having written at least one prescription and specialty-pharmacy access near 90%. Insmed also highlighted strong patient engagement in its support program and said bronchiectasis diagnosis rates and the addressable market may keep expanding.
• TPIP is emerging as a major pipeline catalyst, with Insmed running four Phase 3 trials for the inhaled treprostinil prodrug. Lewis said Phase 2 data were strong, open-label data are expected in the third quarter, and the company still expects to become cash flow positive next year without raising capital.

Insmed NASDAQ: INSM Chair and CEO Will Lewis said the company remains confident in the launch trajectory of BRINSUPRI, despite investor concerns over discontinuation rates that followed the company’s latest update. Speaking at a Bank of America healthcare conference, Lewis said the company intended to provide “anchor points” around what he described as “one of the strongest launches in recent years.”

Bank of America analyst Jason Zemansky noted that Insmed recently reported BRINSUPRI sales of $208 million, up 44% sequentially, while some investors focused on discontinuation rates. Lewis said Wall Street was “not prepared to hear that metric” and that the company could have done more to educate investors about how to interpret it.

Lewis said discontinuation was only one metric among many and should be viewed alongside the company’s operational performance and the growth of the bronchiectasis market. He said Insmed is “at or above” every metric in its internal models and that the company’s original pre-launch model has been “remarkably accurate.”

Lewis Says Persistence Remains Strong

Lewis pushed back on the idea that persistence represents a problem for the launch. He said Insmed is “essentially best in class” on persistence and that the company is performing “exceptionally well” on the metric.

He said the drug’s profile remains predictable and consistent with clinical trial results, where discontinuation was comparable to placebo. Lewis said physicians, particularly those already familiar with the medicine, have been enthusiastic, which he said supports efforts to expand prescribing both in breadth and depth.

Lewis also highlighted Insmed’s inLighten Patient Support program, saying more than 80% of patients opt into the program, compared with an industry benchmark he described as “comfortably below 50%.” He said that level of engagement gives the company a way to support patients during treatment.

Market Growth and Prescriber Expansion Cited as Launch Drivers

Lewis said the total addressable market for bronchiectasis is growing due to population trends, increased diagnosis and the fact that patients can live with the disease even as their health declines. He said Insmed’s prior estimate of the bronchiectasis market was based on data from three years ago and will need to be updated as the company learns more.

The company has previously discussed a population of about 500,000 patients, including about 250,000 with two or more exacerbations. Lewis said the diagnosis rate could continue to increase and create “a lot of wind in our sails” during the launch.

On prescribing trends, Lewis said 25% of pulmonologists had written a prescription by the end of the second quarter, which he called “fantastic.” He said prescribing is occurring not only at large institutions but also among community physicians, which he described as important for the middle phase of the launch.

Lewis said reimbursement is not a meaningful reason patients stop therapy, calling it a “very, very, very small component.” He said market access through specialty pharmacies is about 90%.

The company is focused on increasing both breadth and depth among prescribers. Lewis said that in the fourth quarter, 1,800 physicians wrote one prescription out of a total of 4,100 prescribers, and by the end of the first quarter, 900 of those 1,800 had written at least one additional prescription. He also said about 20% of reached physicians have written five or more prescriptions, leaving a large group with room to increase usage.

Insmed Holds Guidance Steady Despite Positive Trends

Lewis said Insmed has tried to guide investors to first-quarter organic demand of 6,300 patient adds, a figure he said could be “straight lined” through the rest of the year and still produce more than $1 billion. He said the company is not representing that it will improve on that pace, noting that many launches plateau by the second or third quarter.

Still, Lewis said prescription data remain encouraging. He said Symphony Health total prescription data have continued to track proportionally with Insmed’s internal numbers and that April weekly TRx data moved “up and to the right.”

Asked why Insmed has not raised guidance, Lewis said the company wants to see more than one quarter of performance in the calendar year before making that kind of change. He said future updates could be provided at investor conferences to help reduce speculation and volatility around quarterly results.

TPIP Viewed as Potential Next Growth Driver

Lewis also discussed TPIP, Insmed’s inhaled treprostinil prodrug program, which he described as “probably the single most overlooked item at the company.” He said Insmed is running four Phase 3 trials for TPIP, including studies in pulmonary arterial hypertension and PH-ILD, with IPF and PPF trials expected to begin later this year or potentially early next year for IPF.

Lewis said Phase 2 data showed a 34% reduction in pulmonary vascular resistance and described the results as “best in class in prostanoids.” He said Phase 3 trials are targeting a maximum tolerated dose of 1,280 micrograms, double the 640 micrograms used in Phase 2.

Open-label data are expected in the third quarter. Lewis said investors will be watching whether patients maintain benefit, what happens when placebo patients move to active drug and how patients perform at higher doses, including those who reached 1,280 micrograms.

Lewis said he expects the market to remain a combination-treatment setting, particularly with sotatercept now available. He said Insmed has not conducted combination work but expects physicians may want to use therapies together given the severity and mortality risk of the disease.

Pipeline and Cash Flow Outlook

Lewis said Insmed’s broader pipeline includes several research programs, including gene therapy work and INS1033, a DPP1 inhibitor distinct from brensocatib that is targeting rheumatoid arthritis and inflammatory bowel disease. He said INS1033 is expected to enter the clinic this year.

He also said Insmed expects to become cash flow positive next year without raising additional capital. Lewis said the company will remain disciplined in research spending as it moves toward an earnings-per-share transition, adding that Insmed’s standard is to discontinue any medicine that is not first or best in class.

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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