Insmed Incorporated (INSM) Earnings Call Transcript

Thank you for standing by, and welcome to the Insmed Second Quarter 2026 Financial Results Conference Call. [Operator Instructions] I'd now like to turn the call over to Bryan Dunn, Head of Investor Relations. You may begin.

Thank you, Rob, and good day, everyone. Welcome to Insmed's Second Quarter 2026 Earnings Conference Call. Before we get started, 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 most recent filings with the Securities and Exchange Commission for a full description of these risk factors. The information we will discuss on today's call is met 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 from Insmed's quarterly performance and financial position by Will Lewis, Chair and Chief Executive Officer; and Sara Bonstein, Chief Financial Officer, respectively. After their remarks, we will welcome Martina Flammer, Chief Medical Officer, for the Q&A session. I will now turn the call over to Will.

Good morning. I want to start off today's call by framing what I believe are our 2 key accomplishments this quarter, operational excellence and positioning for our future. Across our commercial, clinical and research efforts, we have demonstrated exceptional operating performance. This has laid the groundwork for Insmed's potential evolution into a reliably consistent revenue and earnings growth story over the next decade and beyond. Let me briefly summarize what I mean. BRINSUPRI's launch continues at a truly historic pace, delivering another quarter of performance that more than doubled the results of the best specialty respiratory launches our industry has ever seen at this stage. With the potential to expand its reach with improved diagnosis of appropriate patients and a projected approval in Japan later this year, we believe the BRINSUPRI story is just getting started. ARIKAYCE continues to perform well in its eighth year of launch, growing globally by high single digits this quarter compared to the second quarter of last year. Beyond the current opportunity, there is also potential to expand the label to include all patients with MAC lung disease in the U.S. and Japan next year. From a commercial readiness perspective, we are on track to serve a broader base of appropriate patients while providing education for physicians as we enable them to use ARIKAYCE earlier in the treatment paradigm for MAC lung disease. TPIP is emerging as a potentially differentiated asset across 4 large indications, PH-ILD, PAH, PPS and IPS. We believe the data from our ongoing open-label extension study of TPIP in patients with PAH shared last month are further evidence of the strength of TPIP's profile, which we believe has the potential to be the prostanoid of choice. In addition to the progress, our top 3 assets are making, we are also positioning the company for continued success in the future. We are steadily progressing a broad and diversified early-stage pipeline consisting of multiple potential blockbuster treatments for a wide range of serious diseases. The FDA recently cleared the IND for INS1033, the first of several next-generation DPP1 inhibitors advancing within our pipeline to proceed into the clinic. The first planned indication for INS1033 will be in patients with rheumatoid arthritis, for which we have promising preclinical data. We anticipate following that with additional clinical programs in ulcerative colitis and COPD, for which there is also supportive preclinical data. These indications highlight the potential relevance of DPP1 inhibition beyond bronchiectasis in other large neutrophil-mediated inflammatory diseases. We also added new talent to our leadership team with the hiring of Samuele Butera as our Senior Vice President and General Manager of our Global Respiratory therapeutic area. Samuele brings with him a wealth of commercial experience in U.S. and international markets, having led multiple global launches at Johnson & Johnson and Novartis throughout his career. We view his hiring as a huge win for Insmed and an equally large endorsement of Insmed's future. Finally, it is important to mention that we are making all these strides while maintaining our financial strength. We continue to believe we are sufficiently resourced to fund our business through cash flow positivity next year without raising additional capital. With BRINSUPRI's remarkable performance through nearly 1 full year of launch and the latest results from our ongoing open-label study of TPIP and PAH, our confidence in the future potential of these assets has grown. As a result, we are raising our peak sales estimates for both assets. For BRINSUPRI, we now estimate global peak sales of greater than $7 billion, up from our previous projection of greater than $5 billion. This updated estimate reflects expected growth of the current addressable market, driven by earlier and more consistent diagnosis due to increased awareness among physicians and patients. Importantly, this peak sales projection does not include contributions from the potentially meaningful opportunity to identify additional bronchiectasis patients from the comorbid COPD and asthma populations, which would represent upside to this outlook. For TPIP, we believe the peak sales opportunity is greater than $6 billion, up from our previous peak sales projection of greater than $2 billion, which was provided prior to seeing the strength of our Phase II readouts in PH-ILD and PAH and before we chose to pursue PPF and IPF. This assumes clinical and regulatory success in all 4 indications and the TPIP's profile continues to distinguish itself as meaningfully differentiated versus other prostanoid with comparable efficacy to sotatercept while maintaining a favorable tolerability profile, which allows for higher dosing. Along with the reiterated peak sales estimate of greater than $1 billion for ARIKAYCE, the combined peak sales estimates for our 3 lead assets now exceeds USD 14 billion, up 75% from the greater than $8 billion peak sales estimate we previously provided for these 3 products. Let's now move to a deeper discussion of BRINSUPRI's ongoing launch. In its third full quarter of launch, BRINSUPRI produced $309.2 million in revenue. We believe BRINSUPRI is on its way to becoming the most successful launch in the history of specialty respiratory medicine and has the potential to become one of the top 20 medicine launches of all time in any category. This outstanding performance gives us confidence to increase our full year 2026 BRINSUPRI revenue guidance to between $1.25 billion and $1.4 billion from our previous guidance of greater than $1 billion. This quarter's impressive results demonstrate the remarkable momentum of BRINSUPRI's launch and reinforce our confidence in its future. All detailed metrics we monitor, including payer access, patient compliance and continuation rates continue to track ahead of our expectations. BRINSUPRI added approximately 7,000 new patients in the second quarter, exceeding our previous expectation of approximately 6,300 new patient starts. This result demonstrates the robust ongoing demand for the treatment. We now expect approximately 7,000 new patient starts per quarter for the remaining quarters in 2026, which is reflected in our updated revenue guidance. Strong new patient demand was driven by an acceleration in new prescribers and a deepening of prescribing. As of the end of June, we had more than 6,300 cumulative prescribers, which was an increase of approximately 1,300 writers compared to the end of March. We are also making good progress on depth of prescribing. Approximately 30% of BRINSUPRI's writers have prescribed it for at least 5 of their patients, up from around 20% at the end of March. However, there is still significant opportunity here. Many doctors, including some who treat large numbers of patients with bronchiectasis are still trialing the medicine and have considerable capacity to write for more patients if their experience is positive. This quarter, the European multicenter bronchiectasis audit and research collaboration or EMBARC announced its intention to collaborate with us to evaluate BRINSUPRI 25-milligram dose in a 3-year open-label study of up to 3,000 patients with bronchiectasis in 6 European countries. EMBARC's intention with this study is to shed light on 2 important questions. First, with the long-term use of brensocatib has the potential to modify the course of the disease. And second, whether earlier upstream use of brensocatib is effective in further slowing disease progression. We look forward to collaborating with EMBARC to address these important questions. We also have ongoing plans to support additional long-term data generation through Phase I and real-world evidence trials in the U.S. to further solidify our position as the leader in bronchiectasis and DPP1 inhibition and to show the long-term benefits of BRINSUPRI. Beyond what we have just discussed, we see a significant opportunity to expand the diagnosed bronchiectasis population by improving diagnosis among patients with comorbid COPD or asthma. This effort to identify patients with comorbid bronchiectasis is being resourced like its own separate launch and is expected to yield increased diagnosis over the next several years. Some of our initial efforts around improving diagnosis, including our support behind an ATS led initiative to analyze electronic health records across 7 large academic medical systems the suspect BE celebrity campaign with Ty Pennington and hosting the inaugural bronchiectasis and COPD Stakeholder Summit at the World Bronchiectasis Conference just to name a few, and we are just getting started with other initiatives currently being piloted, which could advance our efforts to support earlier and more accurate diagnosis of appropriate patients. We will track a variety of indicators to look for signals of progress including monitoring claims data for increased diagnosis rates and high-resolution CT scans. Given the time it takes for this information to become available and the fact that they are trailing indicators, we will have insights from these data in approximately the middle of next year. We look forward to sharing updates as these initiatives progress. We are convinced that the best of this story is yet to come as more patients receive a proper diagnosis and gain access to appropriate treatment. Now let me provide an update on ARIKAYCE. In addition to continued sales growth, we are making progress toward a potential expansion from refractory MAC into all MAC lung disease. Backed by robust clinical evidence and an experienced commercial organization, we believe ARIKAYCE is well positioned to make the transition to this larger opportunity in the U.S. and Japan. We recently submitted the supplemental new drug application to the FDA for ARIKAYCE in newly diagnosed patients with MAC lung disease, and we intend to submit an application to Japanese regulators in the second half of this year in support of potential launches in 2027. This sets the stage for a particularly dynamic time for our Japan team, who could be simultaneously launching both the expanded ARIKAYCE indication and BRINSUPRI in bronchiectasis. These products have clear synergies in terms of their call points, which we expect to benefit both launches. Given the impressive results we have seen from that team as they have executed on ARIKAYCE's current indication, we are excited to see the positive impact they can have on patients once presented with this expanded opportunity. We look forward to sharing additional updates on ARIKAYCE's progress as the regulatory process continues. Let's turn to TPIP. Last month, we announced positive 12-month data from our ongoing open-label extension study of TPIP in patients with PAH. To contextualize how unique and impressive those results were, let's begin with a recap of the randomized Phase IIb trial that preceded it. On a placebo-adjusted basis, TPIP demonstrated a 35% reduction in PVR, a 35.5 meter improvement in 6-minute walk distance and a 60% reduction in NT-proBNP at the end of 16 weeks of treatment. Recall, each of these efficacy metrics was measured at trough or approximately 20 hours after the previous dose was administered. The magnitude of these benefits support our belief that TPIP has the potential to become the clear prostanoid of choice. This study also showed good tolerability with a low 10% dropout rate and 95% of completers choosing to continue in the OLE study. Let's move now to the results of the OLE study. At 12 months, patients who remained on TPIP maintained or improved across all efficacy measures. Moreover, patients who have been on placebo in the lead-in study and switched to taking TPIP in the OLE not only improved but fully caught up to the continued TPIP group. This trend is something rarely observed in other open-label extension studies in PAH patients. At month 12, compared to the baseline of the lead-in study, patients in the OLE experience an approximately 55-meter improvement in 6-minute walk distance and an approximately 60% reduction in NT-proBNP. Like the Phase IIb study, these endpoints were measured at trough. Additionally, about 80% of patients achieved functional Class 1 or 2 with over 25% of all patients achieving functional Class I, meaning these patients no longer have symptoms of PAH. We also looked at Reveal Light 2.0 scores, which are a validated measure of the risk of morbidity and mortality in patients with PAH. Impressively, the average reveal risk status for all OLE patients improved by 2 categories, from intermediate risk to refined low-risk status. This improvement in score is associated with moving from a 5% to 10% risk of mortality in the next year to less than 5% risk of mortality in the next 3 years, along with meaningful improvements in the risk of clinical worsening Remarkably, 65% of all patients achieved refined low-risk status by month 12. Together, these efficacy benefits far exceeded anything we have seen from other inhaled prostanoids in PAH and were comparable to sotatercept. On safety, we identified no new safety signals despite longer duration of use and higher doses in the OLE. Notably, we also saw a low 15% rate of treatment-emergent cough, which was predominantly mild and only one discontinuation due to cough over the first 12 months of the study. In addition, we saw high continuation rate with 91% of patients remaining on treatment at the 12-month point. Overall, these results add to our confidence in TPIP's potential to be the next major advancement in the treatment of PAH. Our comprehensive Phase III development program is progressing well with both our PH-ILD and PAH studies actively enrolling patients. In the past, we have seen a boost in enrollment after sharing positive data updates from the program. We hope that the strength of the OLE data will once again bolster interest in our trials. We are also pleased to report the first data monitoring committee meeting for the PAM ILD study recently occurred, resulting in a positive recommendation for the study to continue unmodified. Additional Phase III studies in PPF and IPF, 2 additional large indications remain on track to initiate in the second half of 2026 and the first half of 2027, respectively. In the Phase III studies, patients begin with an initial titration phase to a target dose of 640 micrograms once daily. Upon completing titration, investigators may further escalate the dose to a maximum of 1,280 micrograms once daily when clinically appropriate. The decision to escalate is based on individualized clinical judgment, taking into account the patient's treatment tolerability and clinical status, including evidence of disease progression or the potential for additional therapeutic benefit. We believe TPIP's broad dosing range could provide physicians with the flexibility to optimize the balance between efficacy and tolerability while also allowing treatment strength to be adjusted as the patient's clinical needs change. The flexibility to quickly and safely dose to much higher levels than other inhaled treprostinil products could represent a meaningful differentiator within the class and resembles the individualized dosing approach physicians already use with parenteral therapy since patients respond differently across treprostinil dose levels and their dose requirements may increase over time. The ability to continue to dose higher could also expand the duration of time patients spend on inhaled therapy, delaying the need for patients to switch to parenteral options. As I look across our portfolio at BRINSUPRI's historic launch trajectory, ARIKAYCE's steady contributions and TPIP's potential to be the procyonid of choice in our earlier stage programs, which are steadily producing encouraging data, I am energized by what the future can hold for Insmed. I believe we are only just scratching the surface of the positive impact this company can have on patients in need. With that, I'll turn the call over to Sara, who will walk you through the financial details of the quarter.

Thank you, Will, and good morning, everyone. I'm pleased to share our second quarter 2026 financial results and updated guidance and to provide some commentary to help with your modeling. BRINSUPRI produced $309.2 million in revenue in the second quarter. up 49% sequentially from an already strong first quarter in which we saw a sequential growth of 44%. This growth was primarily driven by strength in new and existing patient demands. This quarter also benefited from better-than-expected gross to net dynamics which brought GTN towards the lower end of our previous guidance range of mid-20s to low 30s. ARIKAYCE produced $116.3 million in revenue this quarter, representing 8% growth compared to the second quarter of 2025. GTN for ARIKAYCE this quarter fell within the guidance range for the year of low to mid-20s. On this slide, you can see our current guidance ranges for BRINSUPRI and ARIKAYCE revenue for full year 2026 as well as our gross to net expectations for each product. As Will mentioned, based on the strong results we have produced in the first half of the year, we are raising our full year 2026 BRINSUPRI revenue from greater than $1 billion to a range of $1.25 billion to $1.4 billion. While we continue to expect a regulatory decision in Japan for BRINSUPRI in the second half of the year, we do not expect a meaningful revenue contribution from Japan in 2026. ARIKAYCE continues to perform as the steady reliable contributor it has been for nearly 8 years. We are reiterating our full year revenue guidance for ARIKAYCE of $450 million to $470 million. We continue to see potential for expanded label in the U.S. and Japan next year as an upside catalyst for this program. On gross to net, we are updating our 2026 gross-to-net guidance for BRINSUPRI to mid- to high 20s, which represents an improvement from our previous guidance range of mid-20s to low 30s. Given we are at the midpoint of 2026, we have confidence in this improvement as we do not foresee any large changes in our contracting strategy for the remainder of the year. Therefore, we expect gross to net for BRINSUPRI to remain within this updated guidance range for each of the remaining quarters in 2026. In addition, we are reiterating our GTN guidance for ARIKAYCE of low to mid-20s. Moving now to the other relevant financial metrics for the second quarter, which were displayed on this slide. Cost of product revenues was $67.2 million or 16% of revenues, which is lower on a percentage basis than the 26% we saw in the second quarter of the prior year, reflecting the positive contribution of BRINSUPRI to the company's gross margin profile. As expected, combined research and development and SG&A expenses increased this quarter, up 38% compared to the prior year period due to the necessary investments made to support the U.S. launch of BRINSUPRI and to continue to fund our pipeline. Let me now spend a moment on our cash position and burn rate. As of the end of the second quarter of 2026, we had approximately $1.2 billion in cash, cash equivalents and marketable securities, which represents a meaningfully lower burn rate than we have seen in recent quarters. This is attributed to higher revenue generation as well as appropriate financial discipline. While we continue to expect to increase revenue generation in the second half of the year, we simultaneously expect to invest more in important initiatives to drive future growth. including the Phase III programs for TPIP across 4 indications, the launch and branded direct-to-consumer advertising for BRINSUPRI and incremental investments in Japan to build out an appropriate sales force and other commercial infrastructure to support future launches of both BRINSUPRI and first-line ARIKAYCE. We also anticipate incurring payments totaling $50 million to AstraZeneca related to regulatory and sales-based milestones for BRINSUPRI in the second half of 2026. We believe we are sufficiently funded to support these initiatives and the current operations of the company until we reach cash flow positivity, which we continue to expect to occur in 2027. As a reminder, we do not currently intend to raise additional capital before reaching that milestone. Finally, I want to share our perspective on the long-term financial profile of this company. because I believe it is not fully appreciated. Based on the value drivers Will described, we expect our revenue trajectory to continue to grow well into the 2030s. But what makes this growth profile even more compelling is that it is driven by a largely synergistic portfolio of respiratory assets with similar infrastructure and overlapping call points. These synergies set us up to leverage our strong expected revenue CAGR into attractive and persistent EPS growth. Insmed is not simply a revenue growth story. We are building towards a financial profile that we believe will be highly compelling from both a top and bottom line perspective and one that we expect to translate into a period of lasting value creation. With that, we would now like to open the call to questions. Operator, may we take the first question, please.

[Operator Instructions] Your first question comes from the line of Jessica Fye from JPMorgan.

Congrats on a strong quarter. For the increase to BRINSUPRI's peak potential, can you expand a bit on what underpins that? Anything you can add around the earlier and more consistent diagnosis that you're seeing?

So what I would say about the increase in peak sales and our guidance for the year. They're obviously informed by what's now basically our first year under our belt. We launched last year in August. And the data, I would say, I would describe as remarkably consistent not only in terms of performance because first quarter was strong, this quarter is strong, maybe even stronger. And I would say that, that matches our internal modeling or it exceeds it. And that is what is really the core of our confidence that this is going to continue for some time. Every year at this time, we do not only our Board meeting, but we do an off-site, a strategic review of everything at the company. We take a whole day to do that with our Board. And the completion of that has resulted in our -- obviously assessing everything going on in the company and taking a longer-term view on all of those trends and directions. And as a result of that, we have the latest and greatest thinking surrounding peak sales estimates and year estimates. And that's why we've chosen this time to update everybody.

Your next question comes from the line of Joe Schwartz from Leerink Partners.

Congratulations on the strong performance and outlook. You now have a larger cohort of patients with sufficient time on therapy to begin evaluating refill behavior. What can you share about persistence, refill timing, discontinuations and adherence, and how are those things tracking relative to the assumptions you shared with us previously?

Yes. What I would say is that this is possibly one of the great strengths of this launch. Across all the metrics you just mentioned, we are at or ahead of our internal benchmarks. Not only that, but those elements are both strong, and I would say, stable. So again, giving us confidence as we look forward that this is going to continue in this favorable way. One thing I will just say about some of these forward and new numbers, things like the peak sales number that assumes a very strong DPP1 competitor introduces -- gets introduced into the market, and it also assumes the IRA health and human services price negotiation takes effect in 2035. So this is a real-world assessment of where we're going to go.

Your next question comes from the line of Vamil Divan from Guggenheim Securities.

Congrats on the impressive results here. So I just have a question on the new patient starts. You mentioned the 7,000 new patient starts this quarter. And then sort of the guidance thing to sort of expect around that number remaining quarters of the year. So that's obviously quite a bit higher than the 6,300 that you were expecting just a little bit ago. So I'm curious, the confidence you have on that number staying flat and not continuing to rise as they're still relatively early in the launch. And if you can just comment was all of the 7,000 and the so-called organic patients? Or was there still some of that ready and waiting group that you talked about previously?

Yes. No, thanks for the question. That is all organic. The 7,000 number is just -- it's an impressive expansion from the 6,300 we thought we were going to get. And it speaks to the strength of the commercial team and the performance they've delivered I fully expect that, that 7,000 will remain. Is there room for it to increase? Of course. We'll see how that goes, but our current guidance for the year assumes it will be 7,000 every quarter for the remainder of the year.

Your next question comes from the line of Jason Zemansky from Bank of America.

Congrats on the stellar quarter. I wanted to dig into prescribing depth for BRINSUPRI a little bit more. I think you said about 30% of prescribers are now writing for at least 5 patients. But what typically gives physicians enough confidence to reach that level? And once they do, do you see prescribing accelerate as they gain experience with the drug. I guess is there a point at which BRINSUPRI shifts from being evaluated patient by patient to becoming the default treatment within a practice?

Thanks for the question. I think your final line conclusion is exactly what we anticipate will ultimately happen. that there will be a point at which this switches from the trial is sort of going patient by patient to this becoming the default for the treatment of bronchiectasis. And I think that is something we see taking place in the future. Right now, we're pleased to see the improvement. Remember that last quarter, we had 20% of physicians who had written more than 5. That's now moved to 30%. And and the impressive results this quarter reflect that. However, what I'm particularly excited about is that there's so much more room to run here. with only 30% having written more than 5. And remembering that our Tier 1 physicians have over 100 patients each. There is a lot of room for even our Tier 1 physicians who are writing more than 5 to really pick up the pace. And that's something we're focused on very much in terms of our commercial calling effort. Some of the very metrics that we're putting out today actually go into the hands of our therapeutic specialists to inform physicians, "Hey, look, 26,350 new patient starts since this drug was launched." There are 28,000 physicians of whom we have managed to convince 6,300 right prescription. So there is a lot of room to run here. And that's why we see this guidance for the year and the ultimate peak sales number increasing the way we have just reflected.

Your next question comes from the line of Olivia Saunders from Cantor Fitzgerald.

You guys noted that the gross to net obviously came in at the lower end of the range this quarter. And I know you've tightened full year guidance to the mid- to high 20s. So -- as we think about 2027 and beyond, is that steady-state GTN profile? Is that how we should assume it will be going forward in that kind of mid- to high 20s? Just trying to think through where that number could eventually settle and whether we're already at that point in the launch.

Sara, you want to take that? Thanks for that. Sara, do you want to take that question?

Sure. Thanks, Olivia, for the question. Yes. Now that we're obviously at the midpoint of the year, we have a clear line of sight. We don't expect any changes for the remainder of this year. and expect that the coming quarters this year will be within that range. payer access has been really favorable about 90% approval rate approval in less than a week from majority of patients, so access sort of top-notch piece of this launch. As you think about '27 and beyond, we're obviously not providing forward-looking guidance but you should naturally what you expect to see with gross to net as gross to net does naturally go up a little bit each year, again, not going to provide forward-looking guidance. But for this year, we have confidence in the mid- to high 20s.

Your next question comes from the line of Ritu Baral from TD Cowen.

And I want to add my congrats on these metrics. One of the things that we have been watching on Symphony TRx is seemingly an improved compliance rate or at least fill rate. Can you go over sort of what initiatives you may be conducting to promote compliance? Is it patient focused? Is it insurance focused? Is it doctor focused? And if you could just comment on continuing Symphony TRxs and how accurate they'll be through the end of the year?

Yes. So the first and most important point to understand as it relates to persistence, which again is both strong and stable, is that the medicine itself, I think, is the greatest form of advertising. Patients, many of them feel better taking this medicine. And so they want to stay on the medicine. The physicians are hearing that, that becomes something that they reflect to future potential patients and that they themselves trial and experiment with. That then dovetails and extends out into our education of the insurance and physician and patient efforts that we undertake in compliant ways. This medicine is simply put, it's a good medicine. It has a low dropout rate. It is something that makes many patients feel better and the avoidance of what we refer to as the heart attack for the lung, an exacerbation or a flare is a very meaningful thing for these patients. Interestingly, those -- where there are patients who stopped taking the medicine, they are inevitably going to have one of those flares or experiences, and that's going to drive them right back into the physician's office with a question of what can I do about it? And the answer being you can take BRINSUPRI. So I think we really have a very sort of unique ecosystem around this medicine in terms of its profile and how it's perceived and taken up. And just to address your other question on Symphony TRx is, yes, that continues to track very tightly with what we see internally through its most recent report.

Your next question comes from the line of Gavin Clark-Gartner from Evercore ISI.

Could you just help us understand the 2026 price guidance a little more? I mean we're sitting here in August, and it's still a fairly wide range for the course of this year. So you noted 7,000 patient adds moving forward. beyond that, what takes you to the high end or the low end of this BRINSUPRI guidance?

Well, I think it's important to remember that at the beginning of the year, we had gone from what was a referenceable indication of what success looked like that was $500 million to $700 million in revenue in the first full year. That was based on other specialty respiratory launches. We then increased guidance to over $1 billion at the beginning of the year. And here, we sit with only 3 full quarters under our belt, and we have just raised that guidance by 25% to 40%. So that is a way to capture the journey that we have gone on. We're now more than double what we initially thought we might do in the first full year. We will see what the next quarter holds. But I think the guidance is trying to be responsible and saying, there's a lot of opportunity here. We can't assume it's going to fall into our lap. I have tremendous confidence in the commercial team and I'm convinced that whatever can be accomplished with this medicine, they're going to bring it over the finish line. But I think right now, we feel comfortable raising to this new level of [indiscernible]. And as we move through the rest of the year, we'll certainly provide guidance on how that might -- where we might end up within that and how that might change. That's as much as we can really say at this point.

Your next question comes from the line of Leonid Timashev from RBC Capital Markets.

Just wanted to ask on the TPIP guide actually in the $6 billion. I guess how are you thinking about the components there? And then specifically on IPF. Are you assuming that you succeed in breaking orphan designation there? Is it sort of probability adjusted weighted? I'm just trying to understand sort of how you get to that $6 billion across all the components.

Yes. So I think it's very important for people to understand, we assume that we will be approved in all 4 of the indications, PAH, PH-ILD, IPF and PPF. We assume we do overcome the orphan status for IPF, and we assume that we have a profile that is not only clearly superior to other prostanoids but is comparable to sotatercept. One of the interesting comments made when we were reviewing our Phase II open-label extension data was the description by the key opinion leader we had invited to join the call that from his point of view, not only does the profile we produce represent the holy grail, to use his words, of data, but it represents something that causes him to rethink the positioning of this prostanoid relative to something like sotatercept. So I'm very excited about where these results should they continue where they will take us in each of those 4 indications. We're not breaking down what part of the 6 comes from where. I will just observe that I've seen some published estimates that sotatercept alone in PAH will achieve somewhere in the neighborhood of $7 billion in revenue. From that perspective and assuming comparability and hearing the instinct of the KOL that Insmed may be with TPIP in a place to compete there, I think the $6 billion feels pretty comfortable.

Your next question comes from the line of Faisal Khurshid from Jefferies.