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| Statement |
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| In closing, I believe Insmed is in a very strong financial position with over three quarters of a billion dollars on its balance sheet and multiple near term clinical catalysts on the horizon |
| Despite this expected seasonal pressure, trends coming out of 2023 were very positive and we believe set us up well for another strong year of performance in 2024 |
| So if we can be that first entrant, that’s a very exciting opportunity for us |
| And given the safety we’ve seen to date, which is very compelling in WILLOW and is at least that good in ASPEN to date, as it was in WILLOW, we think that the penetration rate being very healthy is something you can rely on in your modeling efforts |
| And so for those reasons, we feel good about the backdrop of what a large study can collect and how these things are not likely or expected to be an influence |
| I think you’re going to see a very rapid uptake in the use of this drug, not only because it’s the first ever approved medicine for this condition, but because the treatment burden of a once a day pill and the safety profile suggested by WILLOW and what we’ve seen in ASPEN so far is very positive |
| And what was exciting to us at that time is that that paralleled what we saw in the WILLOW study, which as you all know was very successful |
| Importantly, this result reflects not only the continued strong demand for ARIKAYCE, but also the effectiveness of our sales personnel and infrastructure in the U.S., Japan and Europe |
| As I continue to see our commercial team outperform expectations, it gives me greater confidence in the ability to realize the commercial potential of brensocatib |
| What we’ve set for a threshold for success here is a clear, superior profile to what is already out there |
| We continue to be excited about the strong results shown in our Phase 3 ARISE trial in patients with newly diagnosed or recurrent NTM MAC lung disease who have not started antibiotics, which readout last year |
| And consequently, I think we’re in a strong position as we enter the clinic and we’ll be able to produce data that while it isn’t designed for direct comparison, people will inevitably do that |
| So we continue to make good progress there |
| And so that provides a real opportunity for us to leverage the excellent work the commercial and medical teams have done over the past years |
| Importantly, enrollment in ENCORE remains strong |
| We say, how effective is the drug and then is the safety tolerable? For the FDA, the do no harm mandate really is, can patients take this drug safely? And there we have a real advantage, because so far, the safety profile has looked really encouraging |
| I expect the work that’s coming out of Cambridge, New Hampshire and New Jersey to be equally impressive and impactful |
| And from that perspective, it is a very exciting new chapter of Insmed’s research and development operation |
| As a reminder, we have said that we believe this drug has a peak sales potential of greater than $5 billion, presuming ASPEN is a clear success |
| as in a very good growth mode |
| I think we feel very encouraged coming out of 2023, that 2024 as a year will do very well |
| The quality and effectiveness of their leadership gives me continued confidence in the growth trajectory for ARIKAYCE in Japan in 2024 and beyond |
| All of these indicators add to our enthusiasm for ASPEN’s readout |
| I want to acknowledge, the strong new leadership team we put in place in Japan in early 2023, which led to such a remarkable outcome this year |
| To be in the sixth year of a drugs launch and be looking at double-digit growth is really quite unique and rare and a testament to the strength of our commercial team |
| And the work that they’re doing is really exceptional and incredibly promising |
| This growth was fueled by the strong execution of our teams to continually identify new eligible patients who may benefit from ARIKAYCE treatment, making 2023 the highest year of new patient starts that we’ve ever had |
| But that is a very robust set of opportunities |
| This result is even more impressive when you recall that this range had already been raised earlier in the year due to the strong performance of ARIKAYCE, which had outpaced our internal expectations |
| More than 90% of those who have completed the study so far have opted to join the open-label extension, which is another encouraging sign in our view |
| Statement |
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| As you think about the quarterly cadence for our sales this year, I will remind you about the deductible and copay resets for Medicare patients in the U.S., which typically lead to a sequential drop in sales in the first quarter compared to the fourth quarter |
| In addition, the timing for when hospital budgets reset in Japan commonly lead to lower first quarter sales in that region as well |
| It does permanent damage, and it is a major negative for the patient |
| Having spoken with many of you recently, I know that there are concerns that we may choose to do a large equity raise prior to our upcoming data readouts |
| And the effects we’re talking about here are, we believe going to be profound |
| So we’re cautious and optimistic based on the success of Phase 2, because no one had really ever produced data as strong as what we saw in Phase 2 |
| I think that’s a miss |
| I would also say that what we’ve heard from physicians, and this is perhaps a significant point to emphasize, there is a general skepticism out there that we’ve encountered from people who say no one’s really been able to conquer the bronchiectasis market |
| So they don’t have to worry about us not following through, which is a common concern at FDA |
| We know from what’s going on in this marketplace and the challenges of treating NTM patients, this is an incredibly difficult disease to treat and to treat effectively |
| We haven’t spent a lot of time talking about that because there’s this phenomenon going on at the company where really, the ASPEN data is overshadowing everything else that’s going on, both at ARIKAYCE and in TPIP, and then, of course, cascading down to the fourth pillar |
| And sometimes results are unexpected, right? So I suppose that is one issue that we’ll be showing |
| At that level, I think going down to as low as perhaps 10%, it would still make sense to file, if the safety is very good |
| And one of the trends that you will see evolve in the next year or two is that it’s quite likely we won’t be able to bring all of these forward |
| Could it go higher if we’re higher? I guess we’ll have to revisit that |
| And indeed, our conditional approval for refractory MAC was granted because of the profound impact we saw on culture conversion |
| I have never been more confident in the future of Insmed than I am today |
| They could go below it |
| If either dose gets below that 0.01 threshold, it’s a clear win |
| So the probability of having those kinds of influences or aberrations in our study is extremely low |
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