Insmed Q2 2026 Earnings Report

Insmed EPS Results

• Actual EPS: -$0.06
• Consensus EPS: -$0.67
• Beat/Miss: Beat by +$0.61
• One Year Ago EPS: -$1.70

Insmed Revenue Results

• Actual Revenue: $425.49 million
• Expected Revenue: $395.50 million
• Beat/Miss: Beat by +$29.99 million
• YoY Revenue Growth: +296.10%

Insmed Announcement Details

• Quarter: Q2 2026
• Date: 8/6/2026
• Time: Before Market Opens
• Conference Call Date: Thursday, August 6, 2026
• Conference Call Time: 8:00AM ET

Insmed (NASDAQ:INSM) Incorporated is a biopharmaceutical company focused on developing and commercializing therapies for patients with rare and serious diseases, with a particular emphasis on difficult-to-treat pulmonary infections. Headquartered in Bridgewater, New Jersey, the company concentrates its research and development efforts on targeted drug delivery technologies and novel formulations intended to improve clinical outcomes for patients who have limited treatment options.

The company’s principal marketed product is ARIKAYCE (amikacin liposome inhalation suspension), an inhaled liposomal formulation of the antibiotic amikacin that is approved by the U.S. Food and Drug Administration for use in adults with refractory Mycobacterium avium complex (MAC) lung disease. ARIKAYCE is designed to deliver high concentrations of antibiotic directly to the lungs, and Insmed has pursued both commercial uptake and further regulatory and clinical work to explore additional indications and geographic approvals.

Beyond its marketed product, Insmed maintains a clinical-stage pipeline focused on pulmonary and other rare disease indications, leveraging formulation science and targeted delivery approaches. The company conducts clinical trials, regulatory interactions, and commercial activities aimed at expanding patient access to its therapies. Insmed also engages in partnerships and business development efforts to support international registrations and distribution.

Insmed presents itself as a specialty biopharma organization combining R&D, regulatory, and commercial capabilities to serve patients with high unmet medical need. Its operations encompass clinical development, regulatory strategy, manufacturing partnerships for specialized formulations, and patient support programs intended to facilitate access and adherence for those living with chronic and complex conditions.

Insmed Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: BRINSUPRI launch momentum accelerated: Second-quarter revenue reached $309.2 million, up 49% sequentially, with approximately 7,000 new patient starts and more than 6,300 cumulative prescribers. Insmed raised 2026 BRINSUPRI revenue guidance to $1.25 billion–$1.4 billion from above $1 billion.
• Positive Sentiment: Insmed increased its estimated global peak sales opportunity for BRINSUPRI to more than $7 billion, citing expanding diagnosis, strong persistence and payer access, and the potential for broader use among patients with comorbid COPD or asthma. The company said prescribing depth and refill behavior are tracking at or ahead of internal expectations.
• Positive Sentiment: TPIP data strengthened the company’s confidence in its pipeline centerpiece. In a 12-month PAH open-label extension, patients maintained or improved efficacy measures, 65% reached refined low-risk status, treatment continuation was 91%, and no new safety signals emerged; Phase III programs in PAH and PH-ILD are enrolling, with PPF and IPF studies planned.
• Positive Sentiment: ARIKAYCE revenue rose 8% year over year to $116.3 million, while Insmed reiterated 2026 guidance of $450 million–$470 million. The company has submitted for a U.S. label expansion into newly diagnosed MAC lung disease and expects a Japanese submission in the second half of 2026, potentially supporting launches in 2027.
• Neutral Sentiment: Insmed reported approximately $1.2 billion in cash and reiterated expectations for cash-flow positivity in 2027 without additional capital raises, despite planned investment in TPIP Phase III trials, BRINSUPRI advertising, and Japanese commercial infrastructure. Management also noted that European commercialization is less attractive because of budget constraints and limited willingness to pay for innovation.

Presentation

[Operator]

Thank you for standing by, and welcome to the Insmed Second Quarter 2026 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you'd like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press star one. Thank you. I'd now like to turn the call over to Bryan Dunn, Head of Investor Relations. You may begin.

[Bryan Dunn, Head of Investor Relations at Insmed]

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 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 from Insmed's quarterly performance and financial position by Will Lewis, Chair and Chief Executive Officer, and Sara Bonstein, Chief Financial Officer, respectively.

[Bryan Dunn, Head of Investor Relations at Insmed]

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.

[Will Lewis, Chair and CEO at Insmed]

Good morning. I want to start off today's call by framing what I believe are our two key accomplishments this quarter, operational excellence and positioning for our future. Across our commercial, clinical, and research effort, with demonstrated exceptional operating performance. This 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.

[Will Lewis, Chair and CEO at Insmed]

ARIKAYCE continues to perform well in its 8th 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.

[Will Lewis, Chair and CEO at Insmed]

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 four large indications: PH-ILD, PAH, PPF, and IPF. 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 prostacyclin of choice.

[Will Lewis, Chair and CEO at Insmed]

In addition to the progress our top three 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.

[Will Lewis, Chair and CEO at Insmed]

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.

[Will Lewis, Chair and CEO at Insmed]

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 one full year of launch and the latest results from our ongoing open-label study of TPIP in PAH, our confidence in the future potential of these assets has grown.

[Will Lewis, Chair and CEO at Insmed]

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.

[Will Lewis, Chair and CEO at Insmed]

This assumes clinical and regulatory success in all four indications, and that TPIP's profile continues to distinguish itself as meaningfully differentiated versus other prostanoids, 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 three lead assets now exceeds $14 billion, up 75% from the greater than $8 billion peak sales estimate we previously provided for these three 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.

[Will Lewis, Chair and CEO at Insmed]

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.

[Will Lewis, Chair and CEO at Insmed]

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 five 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.

[Will Lewis, Chair and CEO at Insmed]

This quarter, the European Multicentre Bronchiectasis Audit and Research Collaboration, or EMBARC, announced its intention to collaborate with us to evaluate brensocatib's 25 mg dose in a three-year open label study of up to 3,000 patients with bronchiectasis in six European countries. EMBARC's intention with this study is to shed light on two important questions. First, whether long-term use of brensocatib has the potential to modify the course of the disease. 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 IV 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.

[Will Lewis, Chair and CEO at Insmed]

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 seven 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. 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.

[Will Lewis, Chair and CEO at Insmed]

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.

[Will Lewis, Chair and CEO at Insmed]

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.

[Will Lewis, Chair and CEO at Insmed]

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 II-B trial that preceded it. On a placebo-adjusted basis, TPIP demonstrated a 35% reduction in PVR, a 35.5 m improvement in six-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.

[Will Lewis, Chair and CEO at Insmed]

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 had 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 experienced an approximately 55 m improvement in six-minute walk distance and an approximately 60% reduction in NT-proBNP.

[Will Lewis, Chair and CEO at Insmed]

Like the phase II-B 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 1, meaning these patients no longer have symptoms of PAH. We also looked at REVEAL Lite 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 two categories, from intermediate risk to refined low-risk status. This improvement in score is associated with moving from a 5%-10% risk of mortality in the next year to less than 5% risk of mortality in the next three years, along with meaningful improvements in the risk of clinical worsening. Remarkably, 65% of all patients achieved refined low-risk status by month 12.

[Will Lewis, Chair and CEO at Insmed]

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 a 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 PAH-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.

[Will Lewis, Chair and CEO at Insmed]

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 PALM-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.

[Will Lewis, Chair and CEO at Insmed]

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.

[Will Lewis, Chair and CEO at Insmed]

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 a 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.

[Will Lewis, Chair and CEO at Insmed]

I look across our portfolio at BRINSUPRI's historic launch trajectory, ARIKAYCE's steady contributions, and TPIP's potential to be the prostinoid 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.

[Sara Bonstein, CFO at Insmed]

Thank you, Will, 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 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.

[Sara Bonstein, CFO at Insmed]

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 a billion to a range of $1.25 billion-$1.4 billion. 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 eight years. We are reiterating our full-year revenue guidance for ARIKAYCE of $450 million-$470 million.

[Sara Bonstein, CFO at Insmed]

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 are displayed on this slide.

[Sara Bonstein, CFO at Insmed]

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 contributions 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 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.

[Sara Bonstein, CFO at Insmed]

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 four 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.

[Sara Bonstein, CFO at Insmed]

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 we'll describe, 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.

[Sara Bonstein, CFO at Insmed]

Operator, may we take the first question, please?

[Operator]

Certainly. We will now begin the question-and-answer session. If you'd like to ask a question, please press star one on your telephone keypad. We ask that you please limit yourself to one question. You may queue for additional questions. Your first question comes from the line of Jessica Fye from JPMorgan. Your line is open.

[Jessica Fye, Analyst at JPMorgan]

Hey, guys. Good morning. Thanks for taking my questions and congrats on the 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?

[Will Lewis, Chair and CEO at Insmed]

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. The data, I would describe as remarkably consistent, not only in terms of performance, because the first quarter was strong, this quarter is strong, maybe even stronger. I would say that matches our internal modeling, or it exceeds it. 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 offsite, a strategic review of everything at the company. We take a whole day to do that with our board.

[Will Lewis, Chair and CEO at Insmed]

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. 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.

[Jessica Fye, Analyst at JPMorgan]

Thank you.

[Operator]

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

[Joe Schwartz, Analyst at Leerink Partners]

Thanks. 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?

[Will Lewis, Chair and CEO at Insmed]

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, those elements are both strong and I would say stable. 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 gets introduced into the market, and it also assumes the IRA Health and Human Services price negotiation takes effect in 2035. This is a real-world assessment of where we're going to go.

[Joe Schwartz, Analyst at Leerink Partners]

Very helpful. Thank you.

[Operator]

Your next question comes from a line of Vamil Divan from Guggenheim Securities. Your line is open.

[Vamil Divan, Analyst at Guggenheim Securities]

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

[Will Lewis, Chair and CEO at Insmed]

Yeah, no, thanks for the question. That is all organic. The 7,000 number is just 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.

[Vamil Divan, Analyst at Guggenheim Securities]

Okay. Thank you.

[Operator]

Your next question comes from a line of Jason Zemansky from Bank of America. Your line is open.

[Jason Zemansky, Analyst at Bank of America]

Great. Good morning. Congrats on the stellar quarter, and thanks so much for taking our question. I wanted to dig into prescribing depth for brensocatib a little bit more. I think you said about 30% of prescribers are now writing for at least five patients, but what typically gives physicians enough confidence to reach that level? Once they 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.

[Will Lewis, Chair and CEO at Insmed]

Well, 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 trialists sort of going patient by patient to this becoming the default for the treatment of bronchiectasis. 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 five. That's now moved to 30%, 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.

[Will Lewis, Chair and CEO at Insmed]

With only 30% having written more than five 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 five to really pick up the pace. 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 to write a prescription. 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.

[Jason Zemansky, Analyst at Bank of America]

Great. Thanks for the color.

[Operator]

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

[Olivia Saunders, Analyst at Cantor Fitzgerald]

Hi. Good morning. Thank you for the question. You guys noted that the gross 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. As we think about 2027 and beyond, is that steady state GTN profile, is that how we should assume it'll be going forward in that 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. Thank you.

[Will Lewis, Chair and CEO at Insmed]

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

[Sara Bonstein, CFO at Insmed]

Sure. Thanks, Olivia, for the question. 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 one week for majority of patients, access sort of top-notch piece of this launch. As you think about 2027 and beyond, we're obviously not providing forward-looking guidance, but you should naturally what you expect to see with gross net is gross 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.

[Operator]

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

[Ritu Baral, Analyst at TD Cowen]

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

[Will Lewis, Chair and CEO at Insmed]

Yeah. 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, 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.

[Will Lewis, Chair and CEO at Insmed]

It is something that makes many patients feel better, 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, where there are patients who stop taking the medicine, they are inevitably going to have one of those flares or experiences, that's going to drive them right back into the physician's office with a question of, "What can I do about it?" The answer being, "You can take BRINSUPRI." 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. Just to address your other question on Symphony TRXs, yes, that continues to track very tightly with what we see internally through its most recent report.

[Ritu Baral, Analyst at TD Cowen]

Thank you.

[Operator]

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

[Gavin Clark-Gartner, Analyst at Evercore ISI]

Hey guys, thanks for taking the question. Could you just help us understand the 2026 BRINSUPRI guidance a little more? We're sitting here in August, and it's still a fairly wide range for the course of this year. 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? Thank you.

[Will Lewis, Chair and CEO at Insmed]

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-$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 three full quarters under our belt, and we have just raised that guidance by 25%-40%. 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 in saying, there's a lot of opportunity here.

[Will Lewis, Chair and CEO at Insmed]

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. I think right now we feel comfortable raising to this new level of 1.25-1.4, and as we move through the rest of the year, we'll certainly provide guidance on where we might end up within that and how that might change. That's as much as we can really say at this point.

[Gavin Clark-Gartner, Analyst at Evercore ISI]

Great. Thanks.

[Operator]

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

[Leonid Timashev, Analyst at RBC Capital Markets]

Hey, guys. Thanks for taking my question. Just wanted to ask on the TPIP guide, actually, and the $6 billion. I guess, how are you thinking about the components there? 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 how you get to that $6 billion across all the components? Thanks.

[Will Lewis, Chair and CEO at Insmed]

I think, it's very important for people to understand, we assume that we will be approved in all four of the indications, PAH, PH-ILD, IPF, and PPF. We assume we do overcome the orphan status for IPF. 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 produced 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.

[Will Lewis, Chair and CEO at Insmed]

I'm very excited about where these results, should they continue, where they will take us in each of those four indications. We're not breaking down what part of the six 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, 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.

[Operator]

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

[Faisal Khurshid, Analyst at Jefferies]

Hey, guys. Thanks for taking the question. I wanted to ask you made some comments in the past about the BRINSUPRI ex U.S. launch sort of pending clarity on MFN. Can we just get an update on your latest views on that? Also, how the Japan launch plays into that potentially? Thank you.

[Will Lewis, Chair and CEO at Insmed]

Sure. MFN is but one component part of the assessment of how to bring the medicine to Europe. It's relevant, but it is not controlling. I would say the bigger issue going on in Europe right now is the lack of apparent willingness or interest on the part of most of the European countries, because of budget constraints, to really lean in and pay for the innovation that all these years and billions of dollars require. That lack of willingness makes it less attractive to go there with a traditional commercial approach to Europe. Nonetheless, we have tested this drug in the European market. We want to find ways to make sure that the drug can get to patients who are appropriate, and we have some ideas about how we're going to accomplish that.

[Will Lewis, Chair and CEO at Insmed]

There's no doubt that the European opportunity is less today than it was in the distant past, and that's true not just for us, but for everybody. In contrast, Japan, where we have just come from the launch meeting for BRINSUPRI, in terms of getting ready, the senior team was over there visiting with our team, getting the review of where they are and how they're positioned for both the BRINSUPRI launch when it gets approved and the ARIKAYCE label expansion, and I can reflect my own enthusiasm for the capabilities of that team and what they're going to be able to produce. Overall, international sales and revenue for this kind of a product tend to be in the sort of 10%-15% range.

[Will Lewis, Chair and CEO at Insmed]

I would expect the majority of that will come from Japan, and I couldn't be more excited about what that team is able to deliver. Based on their history and the expanded efforts they've made, including increasing the sales force, I think there is a very good reason to believe that Japan is going to deliver starting next year.

[Faisal Khurshid, Analyst at Jefferies]

Got it. Thanks, Will. That implies Japan pricing is comparable to the U.S.?

[Will Lewis, Chair and CEO at Insmed]

The assumption is that we get a price from Japan that is acceptable. That is a process that is still underway, and when it's resolved, that's when we'll give full-throated support to the launch in Japan and its expected success.

[Faisal Khurshid, Analyst at Jefferies]

Great. Thank you so much.

[Operator]

Your next question comes from a line of Matt Phipps from William Blair. Your line is open.

[Matt Phipps, Analyst at William Blair]

Thanks for taking my question and congrats on great execution here. Last quarter, there was a lot of talk about ready and wait patients versus organic demand. Just wondering if this 7,000 patients you feel really fits into that organic demand category you described previously, and if that should be the assumption for the rest of the year. Thank you.

[Will Lewis, Chair and CEO at Insmed]

Yeah, it is 100% organic demand. Ready and waiting patients are gone. They are no more. That was a comment we made last quarter, and we stick to it from now and going forward. All the 7,000 new patient starts that we saw this quarter and expect to see in future quarters will be organic demand.

[Matt Phipps, Analyst at William Blair]

Great. Thank you.

[Operator]

Your next question comes from a line of Ben Burnett from Wells Fargo. Your line is open.

[Ben Burnett, Analyst at Wells Fargo]

Hey, good morning. I wanted to ask one on TPIP. Just back to one of your prior comments that the sales potential that you outlined could include IPF, among other things. With regards to IPF, I guess what gives you the confidence that you would be able to navigate around a potential TYVASO ODE?

[Will Lewis, Chair and CEO at Insmed]

I'll ask Martina to chime in here in a second. I think there are many ways you can, I guess, the way to say it is to break the orphan status of a particular product. We feel we have a number of different levers and approaches we can use there. Certainly the phase II data, the once-a-day dosing, many different features of this product and what it can do for patients, I think presents an almost self-evident case for why we're superior. Martina, do you want to add any comments?

[Martina Flammer, Chief Medical Officer at Insmed]

I think one thing I would add here is that you've seen that the agency, the FDA here, has also recognized the potential and plausible hypothesis that TPIP is clinically superior. We don't know, but we assume, and we've seen some of those that there may also be better safety and tolerability that we can show. The third element is how you might impact patient care. Now, a once-daily drug with a better PK profile certainly would be one of them. That's the reason we have received also the PAH Orphan Drug Designation because the agency already recognized the potential for TPIP. Again, I want to emphasize that we are a molecular different design as a pro drug, has that potential opportunity for superiority.

[Ben Burnett, Analyst at Wells Fargo]

Thanks so much.

[Operator]

Your next question comes from a line of Maxwell Skor from Morgan Stanley. Your line is open.

[Maxwell Skor, Analyst at Morgan Stanley]

Great. Thank you very much for taking my question. You reiterated cash flow positivity in 2027, even with increased second half spend on DTC and launching in Japan. Can you just give a sense of what's the BRINSUPRI level that underpins that? How much flexibility do you have if you pursue BD? Thank you.

[Will Lewis, Chair and CEO at Insmed]

Sara, do you want to take that one?

[Sara Bonstein, CFO at Insmed]

Sure, happy to. Thanks for the question, Maxwell. We reiterated cash flow positivity in 2027, where I obviously will not comment specifically on what revenue guide that is implying for BRINSUPRI for 2027. We feel like the trajectory of this launch is going extremely well, as you could see in our revenue guide increase for this year and our peak sales revenue guide overall. We have confidence in cash flow positivity through 2027 to fund our current business, as well as the items that we have in our pipeline without raising additional capital.

[Operator]

Your next question comes from a line of Andy Chen from Wolfe Research. Your line is open.

[Analyst at Wolfe Research]

Hey, this is Brandon for Andy, thanks for taking the question. Curious to know, what was the reason for the lower GTN? Was it Medicare patients fewer than previously anticipated? Rebates less stringent than previously anticipated? Curious to know on that front. Thank you.

[Will Lewis, Chair and CEO at Insmed]

Sara, over to you.

[Sara Bonstein, CFO at Insmed]

Sure. We obviously provided a GTN earlier in the launch. Now that we're in the midpoint of the year and we have a clear line of sight into contracting for the year, we have confidence in being able to narrow that range, tighten that range to the mid to high 20s. Importantly, access for patients is going great. I commented earlier around 90% payer approval, less than a week for the majority of patients, and that is the most important. We're able to have this sort of narrow, tightened GTN and patient access is exactly where we want it to be.

[Operator]

Your next question comes from a line of Stephen Willey from Stifel. Your line is open.

[Stephen Willey, Analyst at Stifel]

Good morning, congrats on the execution. Just given what we know about treprostinil dose dependency, can you comment on how you're powering in the phase III TPIP trials might contemplate the percentage of patients that you're expecting to be titrated up to the highest 1,280 dose? Are you expecting those percentages to be meaningfully different across the different disease states? Thanks.

[Will Lewis, Chair and CEO at Insmed]

Yeah. I'll put this one over to Martina to talk about. It's really important that people understand that the objective of the trial is not per se to push people up to the highest possible dose. It's for the physician to know that they have the flexibility that they can increase dose to achieve the ultimate, best outcome for that particular patient. Patients respond to these drugs differently; it's a very unique and unusual disease state where the FDA permits that kind of a dosing regimen. What we can do with 1,280 micrograms as the upper end is give them that room, that head space, to continue to increase the dose should they not be able to achieve the best possible outcome at a lower dose.

[Will Lewis, Chair and CEO at Insmed]

If we look at just some of the recent data that we've put out for TPIP, 25% of these patients in PAH in the OLE study get to Class 1, which means they have no symptoms of the disease. That is a remarkable increase in outcome for what is a fatal condition, it is facilitated by this medicine and that extra room you have to increase dose. That is something we want physicians to understand can happen with a modest side effect profile here. That too was one of the remarkable things in the open-label extension study. Let me flip it over to Martina, who can perhaps dive a little deeper.

[Martina Flammer, Chief Medical Officer at Insmed]

Yeah. When you think about how we designed the trial, you designed the trial from a regulatory perspective, what do we need to show functional improvement? That is the six-minute walk test. That's what we are also powering for. We're powering the trial with a very high confidence of 96% to get a due treatment difference of 30 m, that is in a P value of 0.05. What we're looking for is that patients in the trial have the opportunity to reach the dose that they need to be in a better clinical state and to reach a better functional class as well as a risk score. In the real world, that is how physicians decide whether they will change or increase a treatment for patients when it comes to prostanoid treatment.

[Martina Flammer, Chief Medical Officer at Insmed]

If you think about what we looked at in the open-label extension, which is over 12 months, 77% of these patients have not only reached doses of at least 640, but they also maintained that dose. What's important for us and for these patients are to have a runway that they can increase dose if they need to. That enables patients and physicians to potentially keep patients on a drug like TPIP for longer. They may not have to go on a pump and that of IV or parenteral to prostinoids. That is a huge burden. That is what we're really looking for, to put patients in a better clinical state, but we're powering for an approvable endpoint that is functional improvement.

[Stephen Willey, Analyst at Stifel]

All right. That's helpful. Thank you.

[Operator]

Your next question comes from a line of Qize Ding from Rothschild & Co Redburn. Your line is open.

[Qize Ding, Analyst at Rothschild & Co Redburn]

Congrats on the results. Thanks for taking my question. I have one on the capital allocation. Given your balance sheet and active internal programs going forward, how do you balance the development of your internal pipeline assets versus looking now for external opportunities?

[Will Lewis, Chair and CEO at Insmed]

Yeah, I appreciate the question. I think this is always the challenge that every biotech company faces, especially as it progresses. We are in the enviable position that we have three very substantial franchises that are in the same therapeutic area in the respiratory field. We also have, for the last four years, a very developed research program across four different platforms that are now beginning to yield clinical drug candidates. The criteria for internal development and advancement is that the medicine in question is either first or best in class.

[Will Lewis, Chair and CEO at Insmed]

Next year, we will be able to share with you the clinical trial results of our first programs emerging from this research area, which include a gene therapy for ALS, a gene therapy for Duchenne muscular dystrophy, and as we mentioned today, entering the clinic just now, INS1033, a new next-generation DPP1 for the treatment initially of rheumatoid arthritis and then ulcerative colitis and COPD. There is more to come from this internal research pipeline. However, at the same time, we are constantly evaluating what is out there because we want to make sure that capital gets deployed against the best opportunities available. That too is a high bar. It must be first or best in class that we're bringing aboard. We will continue to look and evaluate for those opportunities as well.

[Will Lewis, Chair and CEO at Insmed]

This is going to be something we're going to return to again and again as we update you on the progress of the programs coming out of our research department and their progress through the clinic set against what we see in the landscape of business development.

[Qize Ding, Analyst at Rothschild & Co Redburn]

Okay, thanks.

[Operator]

Your final question comes from a line of Danielle Brill from Truist. Your line is open.

[Danielle Brill, Analyst at Truist]

Hi, guys. Good morning. Congrats on the execution, thanks so much for the question. I did have a follow-up on the peak sales assumption. You noted the high-level rationale, but I'm curious if you could break down what specific assumptions changed to move the needle from $5 billion-$7 billion at peak. Was it expansion of the diagnosed population, penetration, persistence, duration on therapy or anything else? If you could just comment on what assumptions changed the most meaningfully, that'd be helpful. Thank you.

[Will Lewis, Chair and CEO at Insmed]

Thanks for the question. I think when it comes to BRINSUPRI, yes, we assume that the addressable market will continue to grow over time, that's going to be driven by not only population growth but increased diagnosis. We anticipate patients who are in the 1 or fewer exacerbation category to shift to a certain degree into the two or more exacerbation category, that's because of improved awareness and reporting of exacerbations. We also think that over time, as this medicine's reputation continues to expand, that the default will be to turn to bronchiectasis patients and think of BRINSUPRI in their treatment. I would also say that as we look internally at our modeling efforts, what we have seen is remarkable alignment with what our commercial effectiveness team has forecast. I have to call them out for the exceptional work that they have done associated with this launch.

[Will Lewis, Chair and CEO at Insmed]

It allows us to be confident in our presentation of today's new and improved numbers, it is driven by both strong and stable performance across all the main metrics that we track.

[Operator]

This concludes today's conference call. Thank you for your participation. You may now disconnect.

Participants

Executives

• Bryan Dunn, Head of Investor Relations
• Will Lewis, Chair and CEO
• Sara Bonstein, CFO
• Martina Flammer, Chief Medical Officer

Analysts

• Jessica Fye, Analyst at JPMorgan
• Joe Schwartz, Analyst at Leerink Partners
• Vamil Divan, Analyst at Guggenheim Securities
• Jason Zemansky, Analyst at Bank of America
• Olivia Saunders, Analyst at Cantor Fitzgerald
• Ritu Baral, Analyst at TD Cowen
• Gavin Clark-Gartner, Analyst at Evercore ISI
• Leonid Timashev, Analyst at RBC Capital Markets
• Faisal Khurshid, Analyst at Jefferies
• Matt Phipps, Analyst at William Blair
• Ben Burnett, Analyst at Wells Fargo
• Maxwell Skor, Analyst at Morgan Stanley
• Analyst at Wolfe Research
• Stephen Willey, Analyst at Stifel
• Qize Ding, Analyst at Rothschild & Co Redburn
• Danielle Brill, Analyst at Truist