(INSM)
Q1 2026 Earnings-Transcript
Insmed Incorporated beats earnings expectations. Reported EPS is $-0.76, expectations were $-0.9.
Operator: Thank you for standing by. My name is Danica, and I will be your conference operator today. At this time I would like to welcome everyone to the Insmed First Quarter 2026 Financial Results and Conference Call. [Operator Instructions] I would now like to turn the call over to Bryan Dunn, Head of Investor Relations. Please go ahead.
Bryan Dunn: Thank you, Danica. Good day, everyone, everyone, and welcome to today’s conference call to discuss Insmed’s First Quarter 2026 Financial Results and provide an update on our business. Before we begin, please note that today’s call will include forward-looking statements. These statements represent our judgment as of today and inherently involve risks and uncertainties that may cause actual results to differ materially from the projections discussed. Please refer to our filings with the Securities and Exchange Commission for more information. The information we will discuss on today’s call is meant for the benefit of the investment community. It is not intended for promotional purposes, and it is not sufficient for prescribing decisions.
Today’s call will feature prepared comments by Will Lewis, Chair and Chief Executive Officer; and Sara Bonstein, Chief Financial Officer. After their comments, they will be joined by Martina Flammer, Chief Medical Officer, for the Q&A session. I will now turn the call over to Will.
William Lewis: Thank you, Bryan. Good morning, everyone, and thank you for joining for joining us. Insmed’s business is off to a strong start in 2026. Commercially, BRINSUPRI delivered strong sequential growth and continues to outpace all past specialty respiratory launch analogs while establishing a new playbook for excellence for a commercial launch. And once again, ARIKAYCE grew year-over-year, which is especially impressive given it is in its eighth year since launch. Both products remain firmly on track to achieve their respective revenue guidance for the year. Clinically, we made meaningful progress, highlighted by clearly positive and potentially practice-changing results for ARIKAYCE in our Phase IIIb ENCORE study. Additionally, we continue to make steady progress on TPIP’s Phase III development with PH-ILD and PAH trials now underway and trial designs for our PPF and IPF studies nearing finalization.
As we look ahead, we will continue to focus on maximizing the impact of BRINSUPRI in patients with a current bronchiectasis diagnosis while also working to increase awareness and proper diagnosis of patients with COPD and asthma who may also be bronchiectatic. In parallel, we are moving quickly to submit the ENCORE data to regulatory authorities in the U.S. and Japan, which we believe have the potential to support an expanded label for ARIKAYCE in the first half of 2027 and a $1 billion-plus peak sales opportunity for that brand. TPIP will remain a central priority for us as well as we execute on our 4 Phase III trials while also generating long-term data from our Phase II open-label extension studies. Supplementing all these initiatives is our early-stage pipeline, which we expect will continue to produce an average of 1 to 2 INDs per year.
We also intend to supplement our pipeline with select business development efforts. Financially, we are well resourced to execute on all of these initiatives as we advance toward cash flow positivity next year. Let’s turn now to discuss BRINSUPRI’s progress in more detail. BRINSUPRI’s launch continues to exceed our expectations, delivering 44% sequential growth off of an already strong prior quarter baseline. We were particularly pleased by the strength of this growth because it occurred in the calendar first quarter, which tends to demonstrate slower growth for medicines given plan changes, out-of-pocket cost resets and reauthorization dynamics. In fact, when you look at the basket of strong respiratory launches that we have cited in the past, sequential growth for those products slowed significantly during their first calendar Q1, delivering only around 9% sequential growth on average.
Of course, those past analog launches were impacted by the Medicare coverage gap, which was eliminated beginning in 2025 under the Inflation Reduction Act. But if you expand this analog analysis to include comparably strong launches since the coverage gap was removed, you’ve noticed that BRINSUPRI’s sequential growth rate is actually higher than those of WINREVAIR and Rezdiffra, which in the first calendar Q1 of their respective launches generated between 30% and 40% sequential growth versus Q4. Notably, we did not raise the price of BRINSUPRI at the start of 2026, and the impact from inventory stocking this quarter was negligible. We are extremely pleased with how BRINSUPRI has performed to date and remain confident in our 2026 revenue guidance of at least $1 billion.
If we achieve this level of revenue generation, it would place BRINSUPRI among the most impressive launches in our industry’s history. We believe that we are setting a new standard for drug launches with BRINSUPRI, which is why we intend to open our playbook and share a lot of detail with you today regarding the metrics we are tracking to gauge this launch’s success. Sharing these details is meant to simultaneously help you better understand the components driving BRINSUPRI’s performance so far and also why we are so enthusiastic about the future of this launch. As we walk through our dashboard with you, we will highlight the following key observations. BRINSUPRI has healthy organic demand, and we believe we have treated nearly all patients who are ready and waiting for treatment at the time of approval.
Payer access is excellent. We have supported a very high percentage of patients through our inLighten patient support program, reflecting strong patient engagement with their treatment. Time to prescription refill rates are ahead of industry benchmarks. Treatment continuation rates remain high. We are broadening and deepening our prescriber base with a lot more opportunity to continue to drive that forward. And our education and outreach efforts, which have already yielded positive results have really just begun to accelerate. Let’s dig deeper on each of these items and start with a closer look at patient demand. We believe BRINSUPRI’s organic demand is steadily growing. To understand what we mean by organic demand, some context is helpful.
We expanded our sales force 10 months before approval so they could promote ARIKAYCE and build disease awareness for bronchiectasis. This effort drove significant interest and helped to build a base of patients who are ready and waiting for a new treatment option at the time of BRINSUPRI’s launch. This included nearly 70,000 self-identified patients who registered on our website before approval. The vast majority of whom were being managed at larger institutions, which were involved in our clinical trials and very familiar with BRINSUPRI. Some of those physicians even shared with us that they were maintaining lists of patients for whom they wanted to prescribe BRINSUPRI when it was approved. By proactively doing this early work, we were able to successfully accelerate new patient demand into the early part of the launch.
As we noted at the time we launched, larger institutions typically take a few weeks to a couple of months to add new drugs to their electronic medical record systems before prescriptions can be written. As a result, most of these ready and waiting patients receive prescriptions in Q4 and to a lesser extent, in Q1. We estimate approximately 3,500 such patients were embedded in the 9,000 new patient starts we saw in Q4, which is supported by comparing the elevated Q4 prescribing volumes at these institutions to the steady pace we have seen in recent months. Similarly, in Q1, we estimate that about 1,500 of the roughly 7,800 new patients who started treatment in the quarter were part of this ready and waiting patient group. As we enter the second quarter, we believe this surge from ready and waiting patients is now complete.
What remains is organic demand, and that demand is growing. In fact, we believe we have seen a steady increase in organic demand in each quarter since we launched as illustrated by the dark blue boxes on this slide. While total new patient additions in Q1 came in lower than Q4, this was due to a significant influx of ready and waiting patients in Q4. Further, the growth that we have seen in the latter part of Q1 gives us confidence that BRINSUPRI’s organic growth is really just getting started. The second quarter will be the first period that we believe will not benefit from a component of ready and waiting demand, but we expect organic new patient demand to continue to grow sequentially from Q2 through the rest of the year. Now before we move on to discuss other launch metrics, I want to add a word about Symphony script data.
We have noticed that Symphony TRx data has historically been valuable as a directional predictor for total dispenses for BRINSUPRI. Having said that, Symphony NRx data has not been as helpful in predicting new patient starts, and we don’t know if either measure will be helpful in the future, but it’s worth calling out that Symphony TRx has been proportionately well aligned with reality in past periods. Another crucial component of any healthy launch is a favorable payer access environment. Initially, in a world without established policies, payer approval rates tend to be higher. Our strategy at launch was to focus physician prescribing and payer access on patients with 2 or more exacerbations where payer approval would be most favorable. As a result of this strategy, I’m pleased to say that the initial expected high rate of payer approval has continued.
In fact, the approval rate for patients processed through our specialty pharmacies has been impressive at nearly 90% since launch. Also encouragingly, the time required for payer approval, while inherently variable has been less than a week for the majority of patients so far, which is well ahead of our internal benchmarks. Overall, we are extremely pleased by what we have seen in terms of patient access to date. These strong approval rates are aligned with our ambition to make access to BRINSUPRI as frictionless as possible for patients. Now just as important as getting patients access to treatment is supporting their successful use of the medicine. We are pleased that more than 80% of patients on BRINSUPRI have signed up for our inLighten patient support program, which is designed to help patients navigate the practical aspects of initiating and managing treatment with a specialty therapy.
Separately, we continue to hear feedback from patients that they are feeling better on BRINSUPRI. This positive patient experience, coupled with BRINSUPRI’s favorable safety profile are together driving the very high compliance rates and relatively low discontinuation rates that we have observed thus far. To be more specific on each of these measures, a reasonable industry benchmark for compliance is that a patient would refill a 30-day prescription around every 37 days. This accounts for practical logistics like remembering to take each dose on schedule and order the next prescription as well as the time it takes for the medicine to be delivered. So far, we have seen BRINSUPRI prescriptions refilled at a much faster pace, nearly every 30 days, which we believe speaks to patients’ positive experience with the treatment, motivating them to continue therapy with minimal interruption.
Turning to continuation rates. As with any treatment, there will always be patients who choose to stop taking their medicine. Daily oral tablets generally have higher continuation rates in the real world than many other classes of medicine. Well-tolerated oral medicines like generic statins, see around 70% of patients remaining on therapy at 6 months. So far, BRINSUPRI’s continuation rate is tracking slightly above these analogs. Overall, we believe this high continuation rate adds evidence that patient experience with BRINSUPRI is largely positive. Our area of greatest focus is continuing to deepen and broaden BRINSUPRI prescribing. In terms of broadening the number of physicians who have written a prescription for BRINSUPRI, we feel we are on a very strong trajectory.
As of the end of the first quarter, our cumulative total writers topped 5,000, which accounts for more than 1/4 of all pulmonologists in the U.S. There remain large institutions who still have not written their first prescription for BRINSUPRI, so there is plenty of opportunity to expand that prescriber base. We also see significant opportunity to increase prescribing depth. At the end of December, approximately 1,800 physicians had prescribed BRINSUPRI to only one patient. By the first quarter of 2026, roughly half of those physicians have prescribed it to at least one additional patient. We believe this trend represents our greatest growth opportunity, which will be reinforced by the consistently positive feedback we hear from patients and physicians about their experience with the medicine.
As awareness continues to build and patients share their experiences during office visits, we expect physicians will grow more comfortable prescribing BRINSUPRI, naturally accelerating its use. In addition, we are encouraged by the fact that more than 20% of BRINSUPRI’s prescribers have written it for at least 5 patients. And importantly, this group goes well beyond just physicians in large academic centers. This represents both the progress we have made on deepening prescribing and also the opportunity that is still in front of us to potentially expand prescribing among the remaining 80%. We anticipate the dialogue within the treating community facilitated by gatherings like the American Thoracic Society Meeting, which kicks off later this month, could further encourage physicians to trial or expand their prescribing behaviors as news of positive patient experiences spreads.
Collectively, we see expanded prescribing from existing trialing physicians and broadened physician adoption as 2 positive trends, which, if extended, could enable even greater growth than is suggested by the current $1 billion-plus guidance we have reiterated today. We are also accelerating our work to increase awareness and proper diagnosis of bronchiectasis through appropriate education. Just yesterday, we announced the launch of a new diagnosis-focused disease education campaign called Suspect BE. This campaign features Emmy Award-winning TV host, Ty Pennington, and draws on his personal experience of caring for his mother who has lived with bronchiectasis for more than 40 years, including an extended period of time before she received the appropriate diagnosis.
We also have plans for direct health care provider education and medical congress presence later this year to further support these efforts. From our point of view, we believe now is the time to elevate disease awareness to enable earlier and more accurate diagnosis of bronchiectasis. I’d also like to highlight the recently announced initiative from the American Thoracic Society aimed at addressing the underdiagnosis of bronchiectasis in the U.S. This ATS initiative will analyze electronic health records across 7 large academic medical systems to identify potential patterns of misdiagnosis. Based on these insights, the ATS initiative intends to pilot scalable solutions such as electronic health record-based prompts that automatically flag potential signs of bronchiectasis and continuing medical education modules for physicians to help improve the detection of bronchiectasis.
Importantly, it also intends to determine how many patients within these medical systems are currently diagnosed with COPD or asthma and may also have undiagnosed bronchiectasis. We commend ATS for leading this effort to identify a potentially large and underserved population of COPD and asthma patients who may also have bronchiectasis, but have not been diagnosed. By improving recognition, these insights could drive better outcomes for current and future bronchiectasis patients by increasing the likelihood they will be appropriately diagnosed and gain access to care sooner. In summary, we see strong and growing organic demand. Payer access and patient compliance and continuation rates are exceeding expectations. We see further opportunity in broadening and deepening physician prescribing, while other groups like ATS are taking the initiative with new and significant efforts to raise awareness and improve diagnosis of bronchiectasis.
Let me now shift to ARIKAYCE. Remarkably, ARIKAYCE continues to show year-over-year growth even now in its eighth year of launch, targeting only refractory NTM MAC patients. In March, we announced the clinical success of the Phase IIIb ENCORE trial in newly diagnosed NTM MAC patients, a far larger population than refractory. ARIKAYCE, in combination with a multidrug treatment regimen, delivered a statistically significant outcome on the patient-reported respiratory symptom score primary endpoint compared to the multidrug active control arm. This end point is the most important factor for U.S. regulators. The ARIKAYCE arm also demonstrated earlier, greater and more durable culture conversion throughout the study with statistically significant benefits at every prespecified time point, including at month 15 or 3 months off therapy, which is the most important factor for Japanese regulators.
Importantly, the ENCORE data make a very compelling case for using ARIKAYCE earlier in the treatment paradigm for patients with an NTM MAC lung infection. As a reminder, in our Phase III CONVERT study in refractory NTM MAC, we observed the treatment with ARIKAYCE resulted in about 30% of patients clearing the bacteria from their sputum after 6 months on treatment. ENCORE showed us that if you treat earlier, you can convert well over 80% of patients to negative sputum cultures in that same period of time. And this conversion is likely to be durable. ARIKAYCE was also better tolerated in the earlier NTM MAC lung infection setting with much lower rates of discontinuation compared to the CONVERT study. Now that we have these data and a well-defined target product profile, we will be conducting market research to understand how the product might be perceived and used by the prescribing community, which will give us a clearer view of the opportunity.
We are working to submit the ENCORE data to regulators in the U.S. and Japan in the second half of this year. If successful, these label updates could increase the addressable market for ARIKAYCE from around 30,000 patients today to more than 200,000 patients next year, potentially turning ARIKAYCE into a blockbuster brand with no new competition on the horizon of which we are aware. Let me now turn to TPIP. TPIP represents a very substantial late-stage opportunity where we are pursuing 4 Phase III trials with very meaningful addressable patient populations for each. We are very excited to announce that last month, we opened our first site in the Phase III PALM PAH study of TPIP. Based on the FDA’s feedback, this study, if successful, will be the only registrational trial required for potential regulatory approval for the treatment of PAH.
Additionally, data from our Phase IIb 24-month open-label extension study in PAH is now expected in the third quarter of this year and will include safety and certain efficacy measures through the first 12 months of the open-label period. As a reminder, this OLE gave investigators the option to continue to increase the dose of TPIP beyond the 640-microgram maximum dose allowed in the initial Phase IIb trial. During the OLE, we have not required or encouraged uptitration. That said, we are pleased to report that about 1/4 of the participants in the OLE have achieved doses that are higher than the 640 micrograms, and that 7 out of the 91 patients who entered the OLE have gone on to reach the new maximum dose of 1,280 micrograms. Given the absence of a placebo group in this open-label portion to which we can compare TPIP’s effects, a good outcome for this update in our view would be to see that patients are able to sustain the best-in-class improvements in 6-minute walk, NT-proBNP and functional class measures that were demonstrated in the 16-week randomization portion of the trial over this much longer treatment period.
For those who have increased their dosage since starting the OLE, we would want to potentially see some discernible improvement in those efficacy measures compared to what was shown in the randomized trial, along with a consistent safety profile with what we’ve seen in the Phase II trials. We will also be interested to see the impact of treatment with TPIP for the patients who are initially randomized to the placebo arm of the trial. We look forward to sharing these data once available. Moving now to our other 3 TPIP studies. In the ongoing Phase III PALM-ILD study, we are encouraged by the trial’s progress with patients having been randomized in 7 different countries so far. We are also pleased to see that we are recruiting patients even in the U.S. despite competition from other marketed treprostinil products that could discourage physicians from enrolling patients into a placebo-controlled trial.
We believe this willingness to enroll patients reflects excitement for the clinical trial results shown for TPIP to date, given that doctors know their patients will gain access to TPIP either at the start of the trial for those randomized to the TPIP arm or after the 24-week study period completes for those who are initially randomized to the placebo arm. We believe this represents a very positive early sign for future adoption should the medicine continue to show positive results and gain regulatory approval. We also continue to anticipate initiating a Phase III study in PPF in the second half of this year to be followed shortly thereafter by a study in IPF. Recent positive clinical data in IPF from another treprostinil product has added to our enthusiasm about the potential opportunity for TPIP in both PPF and IPF.
The mechanism by which benefit may be seen in these patient populations is not fully understood yet, but it is believed that treprostinil demonstrates its antifibrotic effects via multiple pathways, including inhibitory impacts on fibroblasts and that those effects may be dose dependent. As a result, we believe TPIP may be more beneficial by virtue of being able to deliver a greater dose of treprostinil. In this way, we think TPIP could represent the optimization of treprostinil therapy, enabling continuous delivery of much higher doses of treprostinil directly to the lung using once-daily administration. As a result, since treprostinil has now been shown in other studies to deliver positive results for patients with IPF, we believe TPIP has the potential to provide even greater benefits for those patients.
So let’s recap. In a year that will be defined by execution, we remain focused on delivering across our commercial and late-stage clinical programs. BRINSUPRI is setting the bar for commercial success with exceptional progress across each of its key launch metrics, keeping us on track to achieve our ambitious full year revenue guidance of at least $1 billion in global net revenues. ARIKAYCE continues to grow in its current indication. Looking ahead, we see the potential for substantial growth next year if the FDA and PMDA approve a broader label for all MAC lung infection patients in each of these regions. And for TPIP, we have recently initiated our Phase III study in patients with PAH while continuing to enroll patients in our ongoing PALM-ILD study and finalize our trial designs for PPF and IPF.
We anticipate announcing data from our open-label extension programs in PAH in the third quarter of this year. I have not spent any time today on our pipeline beyond our 3 most advanced programs, but these continue to progress as well. INS1148, INS1033 and gene therapies for DMD and ALS are all advancing to or in the clinic, and we look forward to future updates about these programs as clinical data becomes available. We believe in continuing to build out our pipeline through research and select business development and efforts in both areas continue at a robust pace. With that, I’d like to now turn the call over to Sara.
Sara Bonstein: Thank you, Will, and good morning, everyone. Based on the strength of our performance so far in 2026, I am pleased to reiterate our guidance for this year, which can be seen on this slide, including full year revenue and gross to net guidance for BRINSUPRI and ARIKAYCE. I would add that the actual gross to nets we saw for both products this quarter also fell within these respective ranges. Let me now spend a moment on our cash position. As of the end of the first quarter of 2026, we had approximately $1.2 billion in cash, cash equivalents and marketable securities. Excluding cash received related to stock option exercises in the period, our underlying cash burn for the quarter was within the range of quarterly burn that we have seen over the past year.
We believe this burn will continue to decline as company revenues ramp at a quicker pace than spending in the future. Importantly, we continue to believe we can achieve cash flow positivity without needing to access additional capital to support our existing business. Presuming we do not add to our expense base through business development, we would expect to achieve sustainable cash flow positivity in 2027. Now moving to other relevant financial metrics for the first quarter, which are displayed on this slide. Cost of product revenues in the first quarter of 2026 was $47.4 million or 15.5% of revenues, which is lower on a percentage basis than our historical performance, reflecting the positive contributions of BRINSUPRI to the company’s gross margin profile.
Additionally, as expected, research and development and SG&A expenses increased this quarter compared to the prior year period due to the necessary investment made to support the U.S. launch of BRINSUPRI and to continue to fund our pipeline. In closing, Insmed continues to execute, both clinically and commercially and remains in a strong financial position, providing us with the capacity to pursue our ambitious goals on behalf of patients and to maximize the opportunities for value creation we have ahead. We would now like to open the call to questions. Operator, may we take the first question, please?
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Operator: [Operator Instructions] Your first question comes from the line of Vamil Divan with Guggenheim.
Vamil Divan: Thanks for details on the launch. It seems to be going well. So the question we’re getting, I think, just because of the additional detail you provided is how to think about sort of the sequential growth from here. I know you don’t give quarterly guidance, but I know you reiterated your views for the full year. But just given some of these dynamics with maybe this initial bolus of patient and now the more sort of organic demand, if you can provide any visibility on how we should think about sort of 2Q, 3Q, 4Q, especially given some of the unknowns around 1Q? And all the issues that we sometimes see in this quarter, that would be very helpful.
William Lewis: So I know I’m going to disappoint by not providing a forecast on a quarterly basis other than what we said in our comments, which is that we expect organic demand to grow from Q2 throughout the rest of the year. What I would tell you about the inbounds that we’ve had, are you going to raise guidance? Are you going to adjust peak sales, all those sorts of things. We have 2 quarters under our belt, and we are a cautious company, as you all have learned by now. So while we are extremely enthusiastic about the performance we see here, and importantly, a lot of the metrics we’re covering today are designed to convey the notion that the fundamentals are being put in place for what will be a sustained growth of this product launch.
I think it’s the breadth, it’s the opportunity for additional depth and all of the metrics being above our respective targets that gives us that enthusiasm. So there may be a time when we want to come back and explore what those peak numbers are. I just think after 1 quarter in the year, the calendar year, it’s a little premature. And we only have 2 quarters under our belt. But I do want to just remind you that in the first 2 full quarters, we’ve done $350 million of revenue, which, by any measure, is an impressive result.
Operator: Our next question comes from Ritu Baral with TD Cowen.
Ritu Baral: Another one on BRINSUPRI dynamics. Will, any thoughts on right now, whether breadth of prescribers or depth of prescribing within prescribers is more important to increasing demand? And as you think about that depth, what are you finding that drives that depth? Is it just sheer patient experience, the number of months that the Sentinel patient is on the drug? Is it detailing? Is it just patient flow thoughts?
William Lewis: Yes, sure. So look, I think both are important. When we look at breadth, we know that we’ve already reached 25% of all pulmonologists that have written — they’ve already written at least one prescription. So I think it’s important to highlight that, that includes not just large academic centers, but we are already successfully in the community physician pool and convincing them to — this is a prescription they want to write. That, to me, is a very positive sign because the sustained growth will come on the back of those physicians being participants here. We know that our Tier 1 call points have at least 100 patients and in some cases, more each. So when we talk about 1,800 physicians who have written one prescription in the fourth quarter, and half of those have written at least one additional prescription in the first quarter set against what that Tier 1 profile looks like, it gives you some sense of the enormous opportunity that is available to us in terms of depth.
I think depth will come our way. It may take a little longer than we would like in the sense that we love for everybody to be writing this for 10 or 50 of their patients. But pulmonology community we’re learning, particularly for this disease, where there’s been nothing approved for more than 200 years since it was identified, are slow to adopt the new novel mechanism of action, and they’re a little bit cautious. The good news is that the medicines profile has resulted in feedback that is very positive. Patients feel better on the medicine, and it is certainly doing a job consistent with what was seen in the Phase III data. That, to me, is the critical element. If you look at strong blockbuster launches, almost all of them share the common feature that the medicine’s perception in the early days was very positive, and we’re fortunate to be able to enjoy that kind of a status.
So as physicians have more experience with the medicine, I think they will naturally turn to write the prescription more frequently. They certainly have the patients. The need is clearly there. We intend to draw attention to this dynamic through our communications efforts, and I am very bullish that whether it’s in the next months or quarters, we are going to see organic demand kick up as physicians shift from a mindset that this is a novel medicine that they are going to consider using to this is the default medicine for the treatment of bronchiectasis. And I think that dynamic is going to be very powerful.
Operator: The next question comes from the line of Joe Schwartz with Leerink Partners.
Joseph Schwartz: Thanks for all the great color on the BRINSUPRI launch. Where do you see the organic demand coming from most now and going forward? Community or academic practices, the KOLs that many of us speak with at the experienced bronchiectasis centers seem to have prescribed BRINSUPRI to many of their highest need patients and note that community palms are still often referring patients to them. And as you think about the durability of the launch, what evidence are you seeing that this isn’t likely to be a bottleneck and community physicians are moving beyond first prescriptions towards repeat independent prescribing?
William Lewis: Yes. So this is really important. When we talk about the academic centers, and we talk about ready and waiting demand, what we tried to articulate in the commentary was this notion that it was very clear in the fourth quarter that the physicians at the academic centers were waiting for the electronic medical records systems to update at their institutions before they could write prescriptions. How do we know this? Because 1 week, there were no prescriptions coming from the institution and the next week or 2 weeks thereafter, we saw literally hundreds. So it is the arrival of that ability to prescribe using the electronic medical system that enables that turning to the list of patients that they had in many cases and addressing that demand.
And that is what we refer to as the ready and waiting components of the 70,000 folks who have registered on our website. We look at the first quarter in comparison to the fourth quarter, and we see a steady state and cadence at those larger institutions that may have exhausted their initial lists, but that steady state continues. And importantly, there are many institutions who have yet to write a single prescription. And as we tried to highlight, even though we’ve already reached 1/4 of all pulmonologists, the vast majority of those have not written multiple or scores of prescriptions, and many of them have that kind of patient count, in fact, almost all of them. So there’s a lot of breadth and depth opportunity here, but I would say depth is the one that I’m more focused on.
And I would just refer to sort of 3 dynamics in the launch itself and its durability. The first is the basic blocking and tackling that we’ve gone into in detail today. How do you execute a launch well? And I think continuation rates, refill rates, all the sort of stuff that we’ve gone over in detail today, payer access, inLighten support, all that is extremely positive. So the basic blocking and tackling is going well. The commercial team and the customer-facing part of our organization has done an exceptional job in executing on those basics. The second dynamic is the one we were talking about a moment ago, which is that physicians will ultimately adopt this as the standard of care for bronchiectasis. As that process takes hold, it’s less about the promotion and communication interaction and it becomes more the default practice of the pulmonologist to write the prescription.
When that starts to take hold, then it will be the volume and traffic through the office that will generate prescriptions and less of the promotional side. And then the third and final substantial contributor to this launch over the middle to longer term is the comorbid populations that have yet to be appropriately diagnosed. Those are COPD or asthmatic patients who may also be bronchiectatic and would fill the top of the funnel in very large numbers. And so there’s some efforts underway to raise awareness about that, not just our own, but those made by ATS. The combination of all 3 of these things, I think, paints a very robust picture for the potential of this drug in the next quarters, but also the coming years.
Operator: Our next question comes from the line of Jessica Fye with JPMorgan.
Jessica Fye: I was just wondering how you’re estimating which patients were ready and waiting versus which fall into that organic demand bucket? And yes, I appreciate all the detail on the patient adds this quarter. Should we continue to expect to get patient metrics?
William Lewis: So on the ready and waiting versus organic, this is always a little bit of a tricky business because it’s not as if someone shows up and it self-identifies as one or the other. But what we try to do, as we described, is triangulate through a couple of different measures. The expected yield from the 70,000 registered patients on the website, the behavior of patients at the large institutions and the lumps that came through clearly once the electronic medical record system was cleared and then the steady state that we’ve seen over the course of the fourth into the first quarter. And I think we also had an anticipation that this would be the case, and it was contained within our own modeling. So we’ve triangulated through all of this to arrive at the numbers that we shared today, roughly 3,500 in the fourth quarter and roughly 1,500 in the first quarter as ready and waiting patients.
We continue to see organic demand improve throughout the first quarter. And I think as we go through from Q2 through the rest of the year, we certainly expect that will continue. So I think those dynamics are all positive. What was the other part of your question? I can’t remember what it was?
Sara Bonstein: If we’re going to continue to provide patient numbers.
William Lewis: Well, patient numbers, yes, that’s why I forgot it. No. So I would say what we are trying to do is provide the best approach to transparency so that you can model and understand the fundamental dynamics of the launch. That may or may not include patient numbers, it really just depends on the dynamics that are unfolding, but hopefully, today, you’ve understood that we are quite genuine in our ambition to make sure you understand what is driving the launch and why we have the enthusiasm we do for where we are.
Operator: Our next question comes from the line of Jason Zemansky with Bank of America.
Jason Zemansky: Congrats on the solid progress. Will, you’ve spoken about potential in the COPD and asthma patients. But I was hoping you can provide a little more color on what gets you there? In terms of the potential friction points, is it just awareness? Do you see any pushback from payers? Do you see any, I guess, unwillingness from prescribers to expand the polypharmacy in these patients? I mean what drives you to that population?
William Lewis: So we know from our own clinical trial work that roughly 15% to 20% of patients in the ASPEN trial and the WILLOW study were comorbid with asthma and COPD. And those patients responded just as well as those that did not have those comorbid indications. So the presence of these patients, their existence is understood. It’s not documented to a refined degree. And as a consequence, the literature is sort of all over the place as to what percentage of COPD patients, for example, are also comorbid with bronchiectasis, and what percentage of those patients have had 2 or more exacerbations and are continuing to be symptomatic because those are the low-hanging fruit that should definitely be on the top of our funnel. How do we get there?
We get the pulmonologists or the primary care physicians, whoever they are, to refer them for a CT scan to look for the diagnosis of bronchiectasis. Once that has happened and a pulmonologist has done a workup on the patient, they’re eligible for treatment, and they are on label. And so that process, we think, is going to take some time, but I think we’re going to get there. And I’m very excited about the potential for these patients. In the U.S. alone, there are roughly 20 million COPD patients. And when we speak to KOLs, they estimate somewhere in the 20% to 40% range are comorbid with bronchiectasis. Now some smaller population of that are experiencing exacerbations despite on max treatment, and it may be that they’re misdiagnosed. It may be that they are comorbid.
We don’t know, and honestly, we don’t really care. What we want is for them to get the appropriate treatment and if BRINSUPRI can play a role in helping them, we certainly want to facilitate that. But I think that serves as a top of the funnel feeder that is quite substantial, and it may take time to bring it about, but we are investing in it almost like a second launch within the company with dedicated people focused on that area, and we think that’s going to yield benefit over time. So we’re pretty excited about that.
Operator: Our next question comes from Gavin Clark-Gartner with ISI.
Gavin Clark-Gartner: So I wanted to ask on the discontinuation rate in a very specific way. For the 11,500 patients who started on therapy by the end of 2025, for that same cohort of patients, how many were still on paid therapy at the end of the first quarter? Because in order to square the revenue versus the strong new patient starts you reported, I’m seeing there’s probably 2,500 or more discontinuations from that cohort, which is in the 22% to 25% realm for a 6-month discontinuation rate. So I’m wondering if that’s roughly on track with what you’re seeing? And if we should be expecting that same rate of discontinuations moving forward? Like should we expect 40% discontinuations in a year? Any clarity there would be really helpful.
William Lewis: Yes. It’s hard to walk through the particular math that you’re framing out here because I want to make sure that we’re conveying accurate information. What I can tell you is that — and I’ll invite anyone else in the room to comment on this. What I can tell you is that we are tracking above trends for small molecule product use in terms of discontinuation rates. Statins are around, I don’t know, 2%, 3% per month that tend to drop off. And the dropout rate is heavier in the first 6 months than the second 6 months, typically. So I think we feel like we’re well ahead of industry benchmarks there. I don’t know if we can give greater clarity. Would you…
Sara Bonstein: Yes. The only other thing I would comment on is, in the prepared remarks, Gavin, we shared that statins had continuation in the first 6 months of around 70-ish percent. If you look at that over 12 months, it’s about 60%. So as Will said, if you’re going to have discontinuations, it tends to be earlier, but you do continue to see a level of discontinuations with statins.
William Lewis: So hopefully, those numbers are helpful. I can’t go through the particular calculations you’re running over the phone, but we’d be happy to do that at sidebar. But in the meantime, I would just draw attention to that discontinuation rate that we’ve cited for statins and indicated that we’re slightly ahead of that, which is about as good as you can hope to do.
Operator: Our next question comes from the line of Olivia Brayer with Cantor Fitzgerald.
Olivia Brayer: Yes, I appreciate the color around new starts and underlying demand. Sorry to ask another follow-up here. But the fact that you guys are pointing to sequential growth, I actually think is a really positive sign for 2026 numbers. So maybe a couple of questions there, is where is that confidence coming from? I’m assuming you’re seeing some good growth in April trends? And then how long do you actually expect that sequential growth to continue until you start to see some of those new starts level off? And then I hate to ask a competitor question, but on TPIP, how quickly do you actually think you can enroll some of those studies like PAH in particular? I only asked given some disclosures yesterday around trying to expedite a once-daily DPI program from United.
William Lewis: Yes, sure. So on the sequential growth point, what I would describe for everybody is that there is a massive opportunity that we still have before us with physicians, large practices, community docs and many, many patients, even within practices that have already written prescriptions that are available to us to access. So the opportunity for growth remains and will be there for some time. It’s typical that in launches, you see companies get to a steady state after a certain period of time. You can look at the analogs to sort of define where you think the average is. But we would expect certainly to follow that sort of a profile, maybe a little bit better because of the opportunity that we think is before us. All of the metrics we’ve defined speak to the execution excellence of the team, and I think portend very positive things for when we’re able to get those patients into the funnel in terms of our ability to execute and bring them through.
I do think that our efforts in terms of communication and advertising and those sorts of things are going to amp up materially from here. And it takes time to get that stuff through the FDA and cleared and set up once we understand the launch dynamics. We are in that place now. And the Ty Pennington campaign as an example, is the first of what will be additional efforts made to raise awareness. And I think that will activate what is already a very vocal population of patients and probably drive additional demand. So lots of different vectors that give us this confidence. It starts with the capabilities of the team to execute, but it is complemented by the enormous availability of additional patients and physicians and all of the different efforts we’ve made to raise awareness and bring people into the funnel.
On TPIP, the enrollment timing, we’re going to go as fast as we possibly can. We have a good track record of accelerating our enrollment in trials better than standards, certainly in the industry. And I would expect that to be the case here. We tried to highlight today that we’re already hearing some positive feedback from physicians even in the U.S. where there are available approved treatments for their patients. They’re choosing not to put them on that treatment and instead putting them in our trial where their patient may be on a placebo for 6 months. So I think that speaks to the enthusiasm that is in existence already for our medicine and what it may be able to do for these patients. A comment on the other programs that are out there.
I’m sure we’re going to see a lot of talk about different programs and what they may be able to do. We are all about the data. And the data will lead the way, certainly for the physicians and the treatment of their patients, and the data we have so far is second to none in this category. So I think as long as that continues, we’re going to be in a very strong position. The sooner we can get it out there, the better for everybody. The fact that we have to run through Phase I, II, III programs is because this is a novel differentiated compound. It is not a copycat, it is not a rewarmed version of an already existing drug. This is a very different drug that is breathed in inertly and then becomes active once in the lung. It has longer residence time, has a lower peak, a longer trough, once-daily coverage for patients, including nighttime with really excellent results.
So I think its profile is very distinct from everything else that is in the prostanoid class, and we hope that, that will continue.
Operator: Our next question comes from the line of Ellie Merle with Barclays.
Eliana Merle: Can you elaborate a bit more on sort of the half of the single patient prescribers in 2025 that have not written an additional script in Q1? I guess why do you think that was the case? And are there any indicators that, that’s changing? And I guess, from the organic growth that you’ve seen in 1Q, I guess, what is the mix that’s coming from some of these higher volume prescribers versus some of these sort of like lower volume writers?
William Lewis: Yes. So the half that have not written, there’s an interesting dynamic in this therapeutic area and with these particular physicians. There’s a conservatism, I think, that is now in evidence with the new mechanism of action and a new treatment for a disease that they’ve known about forever, but for which they’ve never had a treatment. And so I think what we’ve seen is great physician engagement. We have 1/4 of all pulmonologists who’ve already written a prescription. So they’ve crossed the hurdle or the rubicon of being willing to put their patient on the medicine. We now have to have the cycle of time take place where they go and they are on the medicine for perhaps 3, maybe as long as 6 months before they come back through the office and tell the physician of their experience.
We are hearing a flood of positive feedback, and we read it in the social media as well. And it’s not universal, but it’s pretty overwhelming. And I would tell you that, that, I think, is the most powerful motivator for these physicians to write again. When they hear that 1 or 2 of the patients they put on medicine have had a good experience, they want to write again and more broadly, and that becomes a narrative and a dialogue that they share with their peers at places like the American Thoracic Society. So I think we’re going to see this pick up throughout the year as physicians who have trialed the medicine have success and get good feedback from their patients and decide to continue to write prescriptions for others. Once they’re over a hurdle, I don’t know what the breakpoint is, a couple, 2, 3, 5 patients perhaps, we think that the rest of their practice is going to pick up.
And so that just provides a really interesting opportunity for us. We haven’t really broken out the organic versus — between the high writers and the lower writers, that’s even harder to discern, but what I would say is it’s across the board. The vast majority of the ready-and-waiting patients came through the large centers where physicians had lists of patients and those are the ones that are easily identifiable as, if you will, ready and waiting versus those who are steady state. So hopefully, that’s helpful.
Operator: Our next question comes from the line of Graig Suvannavejh with Mizuho.
Graig Suvannavejh: We’ve got ATS coming around the corner. I know that the ATS put out a statement just on new efforts to improve diagnosing of patients. I was wondering if you could comment just on how much of a potential springboard ATS might be, particularly from a prescribing perspective. And if you could also remind us of past comments that you’ve made around how maybe AI can help with increasing diagnosing of patients?
William Lewis: Yes. So there’s going to be a lot — we’re going to be quite loud at ATS, as you might expect, and also ERS and other academic meetings. And I think you will see both positive feedback stories that are shared by physicians from their experiences just in the hallways, but also a very deliberate effort to talk about the disease, raise awareness. We certainly will have a big presence in that regard. I think what ATS usually represents, you asked if it’s a springboard, you take physicians and patients — or pardon me, physicians and our commercial-facing group out of the market for a week, you tend to see a little bit of a drop during that week because of that, but then it tends to accelerate in the aftermath. How much?
We don’t know. But again, we pointed to the Symphony data, TRx has been fairly accurate for what we’ve seen proportionately in our own tracking. So hopefully, that may be something that can give some insight. With regard to AI, we are looking at a number of different ways to bring that to bear, most prominently in the area of examining historic CT scans and also doing sort of audits of patients — patient records to try to understand what the diagnosis rate and identification of these patients might be able to be in a world where we bring that to bear in a more broad basis. I think you could expect us to be talking about a lot of different programs running in parallel to try to raise awareness and identify the appropriate patient and help with the diagnosis.
And AI certainly is going to play an important part in that, not just for bronchiectasis, but generally. Hospitals are looking to bring that into the radiography field to help them get to more accurate and timely diagnosis.
Operator: Our next question comes from the line of Matt Phipps with William Blair.
Matthew Phipps: I appreciate all the additional color today. At the beginning of this year, you all cited a couple of potential risks to the launch as hypotheticals, including particularly more stringent payer contracting, more prior auths, things like that, that could come into account some point in 2026. First quarter, it doesn’t look like that was an issue, still getting good payer coverage and time lines to dispensing. But just curious as you’re now 5 months — getting into 5 months into the year, if you still see that as a risk at some point this year? Or if you think you’re at a good point with payer contracting that, that’s not a concern?
William Lewis: Yes. So through the specialty pharmacies, we’ve seen an approval rate of 90%, which is extraordinary. Now we don’t expect that, that will sustain for the entirety of the launch. In fact, typically launches, you see that tend to trend down over time. We’ll have to see where it goes. But I’m still very excited to be in possession of that kind of an approval rate. I think that speaks volumes about the perceived value of the medicine as well as the physician desire to push to ensure that it gets approved. Collectively, that lays a very positive forward view for where we may be able to go. I don’t think there’s as much risk for us in the payer approval collapsing, if you will, because of contracts and policies that are finally put in place.
Many of them already have been put in place, more will come, but the point of that is because at the outset, we were focused on the moderate to severe patient for approval, there is not a big shift in what those policies will result in, in terms of holdback of patients. In fact, it may accelerate in some cases, the approval process. So one of the things we’re trying to highlight today is that while whenever you start a medicine, it’s always medical exception in every way, and you get higher approval as a result without a lot of scrutiny. Because of the way we channeled physicians and focus people on 2 or more exacerbations, we haven’t seen a material decline with the implementation of these new policies. So that’s a very positive thing.
Operator: Our next question comes from the line of Leonid Timashev with RBC Capital Markets.
Leonid Timashev: I wanted to ask on the international side and MFN. I know historically, you guys have been very conservative on how to approach an international launch. Just curious sort of what your latest thoughts there are? How much you expect some of these other governments to work with you around pricing? And then just given the discussion we’ve had around sort of the ready and waiting patients, how much of that dynamic you might be seeing in other geographies?
William Lewis: Sure. So the interesting thing about MFN is, it does — it has caused us to pause our launch efforts in Europe and the U.K. We are approved — BRINSUPRI is approved for use in Europe and the U.K., but we need to be very cautious because the normal logic for selling in those regions is that if you can sell above the marginal cost of production of your medicine, it makes financial sense to do so. It is not intended to be a way for us to ensure that Europe pays the same that the U.S. does. We do not hold that bargaining power. We have 2 medicines that are approved. If I go to Germany and insist that they pay more for the medicine, they’re simply going to say no. So we’re not in a position to extract a higher price abroad than what we get currently from them.
I think the pressure that’s being brought to bear is causing Europe to reconsider some of those positions. But there’s not a lot we can do about it, to be blunt. And so that puts us in a place where, if there’s a risk that someone is going to import a price control into the U.S. at a fraction of what we’re currently able to command based on the impact that is positive for patients, then that’s something we simply cannot permit to happen. So we have 2 choices. We can either try to get a much higher price, which we do in Europe, or we sell — we don’t sell the medicine abroad. And in the latter case, I don’t think that really serves anyone’s interest because the intent behind MFN was to lower prices in the U.S. And at least for the mid-cap biotech companies, that’s not going to be the result.
The result is we simply won’t sell the medicine abroad. And then the copycat medicines that are made in China are going to take our place. And then the result of MFN will be to bankroll the Chinese biotech market, which I don’t think is really in anyone’s interest. I appreciate and align with the notion that it is frustrating for Europe to pay far less than what the U.S. pays for the medicine, but we are not in a position to force them to pay more. And as a consequence, we have to be very cautious. Practically speaking, we will wait for clarity on where MFN is going to go in the coming months, and that will inform whether or not we’re able to move forward as we would like to. Because the goal of the company is to make its medicine available to those patients who can benefit from it.
And we need to work within the financial constraints that exist in these other countries, but we can’t dictate them. Certainly, we think of Japan as a very exciting market opportunity. Europe has a role to play as well, but we need to sort of get to the heart of what MFN is going to be and how it’s going to operate first.
Operator: Our next question comes from the line of Danielle Brill with Truist Securities.
Danielle Brill Bongero: I wanted to ask on — a follow-up on discontinuations. Of the discontinuations that you are seeing, can you comment on what’s driving them? Like what’s the relative contribution of Medicare out-of-pocket resets and payer dynamics versus other variables? And then given the recently unveiled competitor programs, how important is it for TPIP to now demonstrate enhanced efficacy to support the thesis?
William Lewis: We don’t really have a breakdown of the reasons for the discontinuation that we can share today. We can step back and take a look at that and see if there’s commentary we can provide, so we’ll do so. But there isn’t something I can tell you right now about the profile of discontinuations and where they’re coming from. I think that given that they’re at — sorry, that they are above the best benchmark rates out there, certainly, it is not driven by the medicine. I think it’s fair to conclude, this is driven largely by patients having other motivations. When we talk about the competitor programs, I don’t — we’re not particularly focused or worried about them at the moment. The Phase II data we saw from the BI program was not particularly compelling in our mind, and we’ll have to see what Phase III looks like.
It’s going to be several years before they’re on the market. So we have a lot of room to run here and really to establish ourselves. We’ll have to see what BI’s data looks like. I want to remind everybody, BI has targeted 30% enrollment of Asian patients in its Phase III program. That is very deliberate. That is — it is 8% of the population in the U.S. They are over-indexing to that group because as we saw in our trial, the Asian patient population is a hyperresponding group in terms of reduction of exacerbations. We had a 20% reduction in pulmonary exacerbations in our Phase III results. If we look at the subpopulation of Asian patients, it was north of 60%. So you can expect the headline number coming from BI to be better than ours. Certainly, that’s what we would expect given the over-indexing to the Asian patient population.
But when we tease through the data and see what is really there, we’ll know what kind of profile that product represents.
Operator: Our next question comes from the line of Max Skor with Morgan Stanley.
Maxwell Skor: I was just wondering, have you seen any change in the severity mix or overall profile of the bronchiectasis patients on treatment through the early stages of the launch? And as the commercial base builds, how are you prioritizing business development?
William Lewis: So on the mix of profile of patients, as I was commenting earlier, we really focused on those patients with 2 or more exacerbations, and so that continues to be the phenotype that we really want to advance for attention. We think they’re going to benefit the most. Certainly, we saw that in our Phase III study very definitively. I don’t expect that to change very much. You are right to highlight that our label is much broader than that. It actually is available for any patient with bronchiectasis, regardless of the number of exacerbations they’ve had in the last 12 months. This is just trying to work with the insurance companies and their policies, which will be focused primarily on those with 2 or more exacerbations.
Sara Bonstein: Prioritizing BD.
William Lewis: Prioritizing BD. So BD, let me just comment on this. I’m a big believer, and we are collectively as a company that the right time to do BD is when you don’t need it. This is a particularly interesting time for us because we have 3 programs that are in excellent position to really be blockbusters or in at least 2 cases, potentially mega blockbusters. That gives us a very strong runway for revenue generation over the next 5 to 10 years. We could sit still and do nothing and perform, I think, exceptionally well. The opportunity is to augment our pipeline and to look for ways in which we can leapfrog from our current position into one of greater strength. We have done that with INS1148 at the end of last year for a very modest investment.
That is a novel mechanism of action that we think has potential applicability in multiple disease states. We will look for similar programs like that. We will be certainly developing our China strategy, and we will be looking for other potentially even more substantial acquisitions if they fit all of our criteria, which is, number one, can it provide an asymmetric return opportunity for our shareholders. And that’s the #1 criteria we have for BD that we’re pursuing. Simply adding a program that targets a single disease is not interesting to me, unless it has the ability to go into broader disease states. So we may end up doing nothing. We may end up doing a lot. We don’t know. What I can tell you is we are very active in looking, and this is a time when there are a lot of really interesting companies and technologies out there that I think are ripe for potential acquisition.
Operator: Our next question comes from the line of Faisal Khurshid with Jefferies.
Faisal Khurshid: I just wanted to ask you, you cited that the, I think, persistency rate on oral meds like statins at 6 months are around 70%, and that you’re sitting a little bit above that. Just wanted to clarify that comment and also ask if you’re seeing any meaningful differences that you can tease out between the kind of ready and wait patient population and your organic new demand patient population to the extent you’re able to tell?
William Lewis: Yes. So that is, in fact, the benchmark that we’re using. The statin discontinuation rate of 70% is at the 6-month mark. After a year, it’s about 60%, as you heard Sara referred to earlier, and we are above that benchmark. So we feel very good about what that portends for our — for keeping patients on drug and of course, the benefit of that that inures to our shareholders. I think as we think about where we can go from here, we’ll certainly continue to emphasize trying to keep patients on drug. I think the storylines that come back from the use of the medicine are going to help support that more than anything. And patients that come into their physicians’ offices and report having their life back or feeling better again, I mean we have very dramatic stories.
These are not necessarily indicative of how everybody responds to the medicine. I want to be really clear about that. But we do have quite dramatic stories of patients coming in and breaking down in tears and telling their physician how they couldn’t take a short walk and now they’re out doing a 4-mile hike. So I think there’s a lot to like there.
Sara Bonstein: Yes. The only other thing I would comment on is, I’ll just remind you of the benign safety profile for this product, and Will mentioned it earlier, but the best launches in our industry start off with really these positive launch dynamics and experiences, and that is what we’re hearing and seeing consistently through. And you guys are all seeing it too on the social media posts and just the feedback loop from the patients themselves, and that is sort of the building blocks of really successful launches. And so very pleased with the continuation rate that we’ve seen. As Will said, we’re a little bit better than statins. So we’re encouraged by that.
Operator: Our next question comes from the line of Adam Walsh with ROTH Capital Partners.
Adam Walsh: Going into the quarter, your guidance was $1 billion plus for BRINSUPRI, and consensus was at $1.2 billion. What will you need to see to be able to give more granular guidance going forward as we progress through the 2026 quarters?
William Lewis: Yes. I think we always tend to take a conservative approach to guidance. If things — dynamics are expected to continue to be positive, and certainly, the — all signs are pointing in that direction, we’ll come back and revisit this every quarter. I’m less focused on giving a higher estimate or putting out new guidance and much more focused on the execution. The execution is there, the numbers will come. And I’m just here to tell you that the execution is there. Our team is doing an excellent job. And my enthusiasm for where this product is in its launch, if it’s not apparent by this point in the call, let me be explicit. I could not be happier about where we are. We are in a fantastic spot, not just for the performance in the first 2 quarters, but what it portends for the future because the building blocks for a long-term sustainable growth of this drug in this disease indication, they’re all there.
And that’s probably the thing that’s the most exciting about what we’ve seen and why we shared so much detail today.
Operator: Your next question comes from the line of Ben Burnett with Wells Fargo.
Benjamin Burnett: Just a question on TPIP. Great to hear that higher doses were tolerated in the Phase II OLE. But I guess, is this — is it fair to assume that this will be reflective of sort of the Phase III doses? I guess really the question is, will patients have enough time to titrate up to those doses as high as what you’re seeing in the Phase II OLE?
William Lewis: Yes. So I think they are going to have enough time. We thought about that issue very particularly because the top dose is 1,280 micrograms in the Phase III studies. And our experience and our dialogue with physicians has made it very clear that they do have the ability to titrate up all the way to that max dose should they wish to. It is important to emphasize that in the OLE, we did not push physicians to increase the dose. That was a decision they made completely independently of us. And it was an option that was given, but it was not one that was encouraged or pursued. So what you’re looking at is true organic decision-making that has driven these patients up in dose. And as we said, I think a total of 7 of them actually went all the way up to 1,280, which I find remarkable given that 640 was the original max dose of the Phase II study.
So in all of the Phase III studies, we’re going up to 1,280 as an option, and there’s plenty of time to titrate up to that level. And of course, more drug to date has certainly shown better performance. So that’s a very exciting dynamic.
Operator: Our next question comes from the line of Andy Chen with Wolfe Research.
Andy Chen: Just a follow-up regarding the diagnosis rate and expanding the pie. I know you’re very excited about your diagnosis initiative and raising awareness, but that’s still very qualitative, and we may not see results until sometime in the future. So can you please provide some timing expectation around this diagnosis expansion? Or maybe, in other words, can you maybe speak more regarding the appropriate industry analogs for this diagnosis expansion?
William Lewis: Yes. It’s a difficult question to answer accurately at this stage. I think what we believe is that through these efforts, we should begin to see, in the case of the COPD and asthmatic, comorbid patient populations. And we can look at things like CT scan rates or diagnosis rates of bronchiectasis, like there are lots of little markers out there that we can track to see if they’re having impact. I would expect that by the end of this year and certainly more robustly in 2027 that these efforts will begin to result in some positive results. And we would expect to be able to look at that and hopefully share that with you at some point. I’m not concerned with whether it’s the fourth quarter of this year or the second quarter of next year, because the size of this opportunity is so significant, potentially that I think it warrants patience for those patients to come around.
And the process here is very straightforward. It’s a CT scan and a diagnostic workup by a pulmonologist and the patient is at the top of the funnel. So it isn’t that far to go. And I think as we think about low-hanging fruit, many of these patients already have CT scans from their interaction with pulmonologists over the years. In many cases, they were simply not asked at the — the radiologist was not asked to look for bronchiectasis. So unless they identified it and sua sponte decided to report it, with no treatment available. There’s not a lot of reason to do that. So what does that mean? It means that there’s a slew of CT scans out there we can go back and look at retroactively to see if there’s evidence of bronchiectasis already, and that is really at the heart of the ATS initiative.
They see this opportunity as well. They see the risk of under diagnosis. And so they’re running this effort at 7 different centers, and that should yield some very interesting information. And 1 of their 4 priority goals of this was to be sort of loud in terms of the discovery that they have. So I would look to them as a third party for information as well on diagnosis of bronchiectasis and the potential for underdiagnosis and what that will all look like. So I’m sure they’ll have some time lines around their publications and the expectation of that. But end of this year, certainly in ’27, I would want to see some evidence.
Operator: Our final question for today comes from the line of Ash Verma with UBS.
Ashwani Verma: Can you confirm the 1Q BRINSUPRI gross to net that you mentioned? Is it at the top end of the range, the mid-20s to low 30s? And then just trying to get a sense if there’s any other extraneous factor like free goods or if the delta from the sales that you printed and new patient adds is just primarily the discontinuation that you talked about?
William Lewis: So I’ll ask Sara to address that.
Sara Bonstein: Yes. So on GTN, what I can reiterate is the guidance that we provided for BRINSUPRI mid-20s to low 30s and the actual for Q1 was within that range. We’re not providing additional clarity than that, but we were within that range. Same goes for ARIKAYCE, low to mid-20s, and we were within that range for Q1 actuals.
Operator: Thank you, everyone. That concludes today’s call. Thank you for joining. You may now disconnect.
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