In a fourth-quarter conference call, Insmed CEO Will Lewis admitted that it was “audacious” that his company would project sales of newly approved respiratory drug Brinsupri to reach $1 billion in 2026. Then he laid out the case of why the forecast isn’t so cheeky at all.
“We have a number of different data sources we examine,” Lewis said on Thursday morning. “Across all the metrics, we’re seeing [numbers] at or above our targets and that’s very much behind why we have a conviction that we’ll do at least $1 billion in revenue in Brinsupri this year.”
Approved in August with much fanfare as a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor, Brinsupri was pegged by analysts at Mizuho Securities for a peak sales potential of $6.6 billion, but even they were surprised by its dynamic launch. Last month at the J.P. Morgan Healthcare Conference, Insmed revealed sales of $145 million in the fourth quarter, prompting Mizuho to call it “a ginormous result.”
On Thursday, Lewis added that the launch “surpassed even our most ambitious expectations,” which were based on “a basket of historically strong respiratory launches as our guide.”
Of the 500,000 patients in the U.S. who have been diagnosed with non-cystic fibrosis bronchiectasis (NCFBE), Insmed initially figured that half would be candidates for the oral daily pill, as it was tested in the clinic on those who had suffered at least two exacerbations over the course of a year. Insmed based its initial peak sales estimate of $5 billion on that addressable patient population of 250,000.
“In addition, we believe over time that more of the remaining 250,000 currently diagnosed patients with less than two exacerbations will start to move into the category of those who have had two or more exacerbations in a 12-month period,” Lewis said. “This is due to the progressive nature of the disease and better patient reporting and documentation of exacerbation events now that there’s an available treatment.”
Additionally, Insmed believes that many with NCFBE have been inaccurately diagnosed as having COPD or asthma in the U.S. Lewis said that Insmed is reaching out to physicians to alert them to the possibility of this misdiagnosed group.
“The potential additional patients from these populations, which would be on label for Brinsupri if they are confirmed to have bronchiectasis, dwarfs the total addressable market we have just been discussing,” Lewis added. “We are currently working on a number of different programs to advance the exploration and quantification of these patients.”
As for potential launches of Brinsupri in Europe and Japan, the company is playing a waiting game to find out the impacts of President Donald Trump’s Most Favored Nation (MFN) drug pricing plan, the CEO explained. Brinsupri is priced at $88,000 per year in the U.S.
“We want clarity on the MFN policies that are coming forward now. I think we’re going to have that in the coming weeks and at the most, months,” Lewis said. “But until that’s clear, it seems to us that the prudent thing to do is to put things on hold until we know what that’s going to look like.”
In May of last year, Trump signed an executive order that introduced the MFN plan, saying it would cut the price of drugs in the U.S. by up to 90%. The policy aims to tie drug prices paid by the U.S. government to the lowest prices paid by other economically advanced countries.
So far, there have been indications that some companies are treading carefully with EU drug launches during the MFN era.
Overall, last year, Insmed reported (PDF) 2025 sales of another of its respiratory drugs, Arikayce, at $434 million, and projects it to generate between $450 million and $470 million this year. It was approved in 2018 to treat a narrow group of patients with lung disease caused by the mycobacterium avium complex (MAC) family of bacteria.