Insmed Incorporated (INSM) Earnings Call Transcript & Summary

Thank you for standing by. My name is Dale, and I will be your conference operator today. At this time, I would like to welcome everyone to the FDA approval of BRINSUPRI for patients with Non-Cystic Fibrosis Bronchiectasis. [Operator Instructions] I would now like to turn the conference over to Bryan Dunn, Head of Investor Relations. You may begin.

Thank you, Dale. Good day, everyone, and welcome to Insmed's conference call to discuss the recent FDA approval of brensocatib in patients with non-cystic fibrosis bronchiectasis, or NCFB for short. Before we start, please note that today's call may 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 SEC filings for more information. I'm joined today by Will Lewis, Chair and Chief Executive Officer; and Martina Flammer, Chief Medical Officer. The call will begin with some opening remarks from Will before turning it over to Martina to walk us through the label in more detail. After Martina's comments, we'll return to Will, who will conclude the presentation and open the floor to Q&A, where we'll be joined by our Chief Financial Officer, Sara Bonstein. The slides we will review today are supplemented by the 8-K we filed with the Securities and Exchange Commission and can be found on the Events & Presentations section of our Investor Relations website. Let me now turn the call over to Will Lewis.

Thank you, Bryan, and welcome, everyone. I am enormously pleased to announce the FDA's approval of brensocatib for adults and adolescents, 12 years and older, diagnosed with non-cystic fibrosis bronchiectasis. Brensocatib will be commercially available in the U.S. under the brand name BRINSUPRI, in 10-milligram and 25-milligram tablets. I want to begin my remarks today with a bit of history. Bronchiectasis first appeared in medical literature in 1819. It was described by physician and inventor Rene Laennec, who was the first person to characterize the disease that it could be recognized during a patient's life instead of postmortem. In the more than 200 years that followed, no medical treatment had been approved to address this debilitating disease until today. BRINSUPRI is a first-in-class treatment with potential applicability in multiple neutrophil-mediated inflammatory diseases. Its approval in non-cystic fibrosis bronchiectasis marks the second time that Insmed will launch a first-in-disease therapy for patients with no approved treatment options. With FDA approval now secured, Insmed sales force may begin engaging with pulmonologists about BRINSUPRI across the United States. Over the last 10 months, our expanded sales force has worked tirelessly to build relationships with approximately 27,000 pulmonologists, at both academic centers and at the community level. And as we have shared on numerous occasions and the lead-up to this approval, positioning BRINSUPRI for a frictionless launch has been our #1 priority. We are incredibly excited that this important therapy is finally available for patients. Before I turn it over to Martina, who will walk us through BRINSUPRI's label in more detail, I want to take a moment to discuss BRINSUPRI's price and rebating expectations. Based on the value we believe this treatment will provide, we will launch BRINSUPRI at an annual U.S. list price of $88,000. This price is the same for both the 10-milligram and 25-milligram dose. As we've shared previously, we expect a gross to net of approximately 25% to 35% for BRINSUPRI at launch. With this U.S. price and reimbursement profile, we continue to believe BRINSUPRI has the potential to achieve global peak sales of more than $5 billion in the NCFB indication alone. Lastly, I want to set expectations regarding the launch metrics we plan to provide as we advance through BRINSUPRI's launch. In addition to providing sales results, we expect to provide updates on new patient starts and the cumulative number of prescribers. You can expect these additional metrics quarterly until we issue annual BRINSUPRI sales guidance. With that, I'd like to turn the call over to Martina.

Thank you, Will, and hello, everyone. I'm very pleased to share in this historic moment for patients. BRINSUPRI's approval is the culmination of years of hard work conducted by teams across the organization. It is because of this hard work that patients who have waited a long time for an effective treatment may finally access this therapy. I'd like to take this moment to walk you through BRINSUPRI's label. BRINSUPRI is approved for adult and adolescents, with NCFB in 10-milligram and 25-milligram tablet form. Physicians may use their best judgment to determine which dosage is best for their patients. Consistent with our expectations, the U.S. package insert does not contain a requirement of number of pulmonary exacerbations. However, we continue to expect payers to cover treatment for patients that resemble the population studied in the Phase III ASPEN trial, which required patients to have a minimum of two pulmonary exacerbations in the prior 12-month period. For the 25-milligram dose, we were pleased to see that the label includes the statistically significant benefit shown on FEV1, a key measure of lung function. On safety, we are satisfied that the label is reflective of the safety profile we observed throughout the clinical development program. The label includes warnings for known effects such as skin and periodontal issues all of which were consistent with our expectations. Finally, we were also pleased that BRINSUPRI was granted a 24-month shelf life, which allows us to make use of the significant stock of inventory that we have on hand for both doses. Overall, we feel this label positions BRINSUPRI for a successful launch. It provides physicians with the flexibility to prescribe BRINSUPRI to all adults and adolescents 12 years and older, suffering with NCFB, and preserve the option for physicians to decide which of two doses is best suited to manage their patient's condition. I would now like to turn the call back over to Will for some closing remarks.

Thanks, Martina. Today is a historic day for patients with NCFB. Prior to today, Insmed only had the potential to serve around 30,000 refractory NTM MAC lung disease patients with ARIKAYCE worldwide. BRINSUPRI's approval presents us with the opportunity to serve an additional 500,000 U.S. patients diagnosed with NCFB, roughly half of which we believe have had at least two pulmonary exacerbations in the prior 12 months. With an approved treatment now available, we expect the number of reported NCFB diagnoses and documented pulmonary exacerbations to increase steadily in the U.S. We also anticipate that BRINSUPRI's availability in the U.S. will encourage a larger portion of the approximately 32 million patients with asthma, or COPD, to get tested for NCFB. As I reflect on the many years of hard work, teams across the organization invested in preparation for this approval, I continue to believe we are well resourced and ready to execute a successful launch of BRINSUPRI. As always, patients remain at the center of everything we do at Insmed, and we look forward to continuing to fulfill our mission of transforming the lives of patients with serious diseases with BRINSUPRI. Before I open the call to questions, I want to thank all the patients and investigators who participated in our NCFB trials, and the hundreds of Insmed employees who worked tirelessly to shepherd BRINSUPRI through this approval. With that, we'd like to open the call to questions. May we take the first question, please?

Your first question comes from the line of Jessica Fye of JPMorgan.

Congrats on the approval on the clean label. Just wanted to confirm when we should expect product to kind of reach the channel, and when patients will actually start being able to fill prescriptions here?

Thanks, Jess. So if we go by what we saw with ARIKAYCE, it took about a month, plus or minus, to pull product all the way through and be able to recognize revenue.

[Operator Instructions] Your next question comes from the line of Ritu Baral of TD Cowen.

Well, I want to ask Martina -- first for congratulations. I want to ask about the 10-milligram dose and the decision to commercialize both doses. How -- why did you do this? Do you anticipate that it may complicate coverage in any way that we need to keep in mind while modeling? And where do you think 10 milligram will be used?

So to be really clear, no, not at all. I don't think it's going to complicate things. In fact, just the opposite. I think it's going to give the flexibility to the physicians to choose how they want to engage with their patients, wrestle with whatever issues may be in their mind relating to safety or what have you. I think this gives maximum flexibility. Most important point from my perspective is that, that information about FEV1 was included on the 25-milligram dose because we think that holds a great deal of interest for a lot of the -- certainly thought leaders. And as time goes on, it's our hope that we'll be able to explore whether or not that continues over time, which would really be an additional leg of information and opportunity for the company. I don't think it's going to have any issue with regard to how payers or anyone else thinks about it. And of course, as we mentioned on the call, or the opening remarks, that both doses are priced at the same level. So we're indifferent to which dose is used.

Your next question comes from the line of Andrea Newkirk of Goldman Sachs.

Congrats on the approval. Will or Martina, just a question for you here. When we speak to physicians, the definition of an exacerbation appears pretty vague, and it seems like it's a little bit at the discretion of the doctor. Just curious, based on your payer conversations, do you expect them to provide a clear definition of what constitutes an exacerbation? Or do you expect this to be somewhat fluid and dependent on each provider?

Well, I think however, physicians choose to discuss it with people on call, there is a medical definition of what constitutes an exacerbation that I think is widely understood. I don't anticipate that there's going to be anything specific that will regulate around that. Obviously, we haven't completed all of our payer discussions, and we'll learn more as time goes on. But I think we're in a very good position with regard to this. And yes, I think the definition of exacerbation was tightly controlled in the trial to ensure that we got the appropriate measure. I don't anticipate that, that will be what is brought forward here. I don't know, Martina, if you have anything you want to add to that?

Yes. No. I think patients also -- as in the protocol defined an exacerbation that is clearly, from a time perspective, 48 hours, patients have to have symptoms like breathlessness, cough increased sputum. Patients also experienced that a little bit different. Not everybody has the same symptoms for the same amount of time. But physicians know their patients and when a patient describes a flare up to them, I think they will be very clear what that means.

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

Congrats on the approval and solid label and really appreciate you taking our question. Will for you, can you discuss some of the puts and takes around your selection of the price point, specifically with regards to -- does this potentially limit you in the broader population of those with comorbid asthma, COPD? And then secondarily, I guess, does -- are you anticipating payers looking for a simple at a station of a prior exacerbation? Or is it something potentially more intense?

Sure. So I think -- no, I don't think it's going to have any impact on the so-called comorbid patients. The issue here and the appropriate patient is one who is specifically diagnosed with bronchiectasis. We know from our experience in the WILLOW and in the ASPEN trial that roughly 15%, sometimes a little bit higher, more comorbid with both COPD and asthma. And we know that the literature, while it ranges broadly from around 4% to 60% of COPD patients are comorbid with bronchiectasis. Most of the consensus that we've heard ranges in the 20% to 40% range. . We're going to learn a lot more as time goes on. And as people explore whether patients who, for example, have COPD or asthma, continue to experience exacerbations are, in fact, also suffering from bronchiectasis. If they are diagnosed as such with a CT scan and a pulmonologist visit, then they are on label for this drug. And I think the important point is that they will benefit from it. The good news is that I don't think that, that's going to limit in any way the use of the medicine in this comorbid population. Second question is the attestation requirement, or how that will operate from the payer perspective? And again, while this isn't finalized, one of the things we're doing in the negotiation with payers is trying to ensure that, that is a consistent assessment and requirement from the payer side of the physician and their office so that it can be an attestation, not necessarily the requirement of CT scan and all the other documentation, which frankly doesn't really help in the diagnosis or treatment of the patient, it just slows the process of them getting access to the medicine. And for that reason, we don't think that, that should be a requirement. And that's something that we're in the process of negotiating for, and I think we're going to be successful in doing so.

I would just add one more point there. In those conversations with payers, it's on that initial script as well as the reauthorization given the chronic therapy for patients to ensure that they, again, can have that frictionless access to their medicine on day 1 as well as throughout their journey.

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

I wanted to follow up on an answer you provided to a previous question, Will, regarding the FEV data on the label for the 25-milligram dose. I'm just curious, what ability do you have to track whether lung function improves longer term? And then what about the structural aspects of the disease, given that's how it's often defined?

So I'll ask Martina to comment.

Yes. So usually, pulmonologist look at lung function. That is an important key measure for patients with any lung disease. And they will -- when they think it is important, or when they see changes, and want to see how these patients improve, how are they tolerating it. Take FEV1, or lung function as a measure. As we continue and we -- after the launch, and we will get more information in our discussions also with physicians and with patients, we will get a better understanding of do we want to see where is lung function, where this measure is going over a longer period of time? But that is a very standard measure that pulmonologists can take with patients with lung disease.

And I do think it's something we're going to be looking at, but that will require a trial to examine specifically changes over time. That's not underway at the moment, but it is certainly something that we've given a lot of consideration to.

Your next question comes from the line of Kelly Shi of Jefferies.

Congrats on the approval and the broad label. First, do you plan to segment different patient groups for targeting given the broad label? And also if there is any pushback from payers for certain patient groups despite a phenomenal clinical profile in broad label. What would that be, and your strategies?

I think the question about segmenting patients and targeting. Absolutely segmenting the market is the standard part of any commercial launch process. So there's a lot of complexity that surrounds that. But I have confidence that because we have had our therapeutic specialists and our forward-facing teams in the market for literally 10 months, there is a very good relationship that exists there. There's been a lot of disease state awareness that's been provided. And I think there's a really good comprehension on our part of where the patients are, and the physicians who are likely to prescribe right out of the gate, and we'll learn more as obviously, the launch unfolds. From the payer side, once again, we're still in negotiations, but I think we've been in negotiations since around March of this year, with a pretty narrow price corridor and a pretty specific discussion of the data available from the ASPEN study and the WILLOW study, and that has enabled us to have very advanced discussions with all of the major payers across the board. And I think the byproduct of those discussions to date has been a growing confidence that we're going to end up in a really good place with all of them.

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

Congrats on the approval as well. Just a quick one for me. I guess are there any seasonalities around patient flow dynamics, or with bronchiectasis itself that we should be thinking about as you gear up for the launch? I mean, are there any things like weather, allergy season and the cold that can impact exacerbations, CT scan timing?

So I'll ask Martina to address that.

Yes. So there is seasonality with regards to the patients have, for example, viral infections, which will -- always can trigger an exacerbation. But we have seen over time the patients, the really best predictors for exacerbations is what patients have experienced in the past. So yes, there is an element of seasonality. The triggers may be an exacerbation, but you always know if a patient had previous exacerbations, it is very likely that they continue to exacerbate.

And to address the question from the point of view of seasonality on a different dimension. Remember that the IRA operates to cap out of patient -- patient out-of-pocket expenses. And as the year progresses, it's quite possible that many of these patients who have comorbidities will have already exceeded the max limit of out-of-pocket expense that they have to pay, and consequently BRINSUPRI for those patients, who are Medicare patients is essentially going to be free from an out-of-pocket point of view. So that's an encouraging aspect of launching in the second half of the year.

And we have commented, we believe about 60% of the patient population will be the Medicare patient.

Your next question comes from the line of Jennifer Kim of Cantor Fitzgerald.

Given the 88k list price, is it fair to approximate the higher end of the 25% to 35% gross net? When do you expect to be in a position to narrow down that discount? And what are the main levers that would affect that?

I'll let you take that.

Sure. Thanks, Jennifer. I will just clarify that the 25% to 35% gross to net that we provided, that is not formal guidance. The way we sort of extrapolated that is if you look at other specialty launches and then the impact of IRA for the catastrophic coverage, that's what you would expect that launch. And we are doing appropriate and targeted rebating with payers to ensure that frictionless launch. But within that 25% to 35%, we feel confident that launch, we'll be able to have adequate access for patients.

Your next question comes from the line of Maxwell Skor of Morgan Stanley.

Congratulations on the approval. So given the broad label and your payer discussions, have any of the anticipated barriers to adoption in the community pulmonology practices versus academic centers changed with the final label? And what strategies are you implementing to address any of these remaining gaps?

So I appreciate the question. No, we don't anticipate that there are going to be any issues with regard to that label and its interpretation by any physician anywhere. And I think the key to understanding that is knowing that it's very unusual for our company to have their sales reps trained in the field for 10 months prior to launch. We had the advantage of deploying those folks and detailing ARIKAYCE for refractory MAC patients in an appropriate way, while also doing compliant disease state awareness efforts. But I think we learn a lot through that process. And I would just describe that we are extremely excited at where we sit now with the approval in regards to this launch and the potential to really deliver.

Your next question comes from the line of Trung Huynh of UBS.

Congrats on the approval. So after given the prescriber help on the initial launch, how do you plan to help the Street on the ongoing tracking of brenso prescription trends ahead of the quarters?

Thanks for the question. I can address that. So what we commented on is metrics perspective on what we'll provide. We will obviously provide sales numbers on a quarterly basis. And during the launch period, we will provide a number of new patients and cumulative prescribers that we will provide up until we provide revenue guidance for BRINSUPRI. Once we provide revenue guidance for BRINSUPRI, we do not plan on continuing providing those additional launch metrics.

To be clear, we do not anticipate providing any information intra-quarter. So month-to-month, there's not going to be any additional information provided. And I would caution anyone to look for a script information because those are things we're going to be blocking with specialty pharmacies. I know that stuff sometimes somehow leaks out anyway, or at least people think they gain access to it. I would just be cautious about interpreting those data, particularly in the early parts of the launch.

Your next question comes from the line of Graig Suvannavejh of Mizuho.

Congrats on the approval. I had a question just on maybe some of the survey work that you've done previously. And wondering if you have a sense of usage, or percent of docs, that might prescribe the drug with maybe one or less exacerbations? I know that the comment is the label doesn't have any restriction, but that payers may limit these to patients as clinical trials had basically defined. But just wondering if you could give us a sense of what the use could be like beyond that restriction?

All we can say at this point, Graig, is that in our survey work, more than 90% of physicians indicated they were going to be inclined to use BRINSUPRI. So that's a pretty compelling number, how that will unfold and which patients they will target, I can't say specifically. We have always guided toward focusing on those with two or more exacerbations in the last 12 months as a byproduct of the practice of the payer community, something which we're happy to engage with and support. I think this gives us an incredible opportunity, one we've sized on the call in our opening remarks very specifically. But this is just the beginning for us with this drug from our point of view.

Yes, to have 90% of the intent to prescribe physicians that they plan to prescribe for those patients with 2 or more exacerbations is really encouraging, as well as we had around 69,000 patients who have identified itself as high-value, self-identified patients, high-value action that will now get communication that there is the first and only approved therapy for this condition that has been as Will mentioned in his prepared remarks, has been around for quite some time.

[Operator Instructions] Your next question comes from the line of Andy Chen of Wolfe Research.

I know you're standing by your gross to net numbers. But you did the pre-approval payer engagement in the dark, not knowing your broad label. But you also mentioned that you will likely see a payer requirement for pulmonary exacerbations as a criteria. Is that unchangeable? Or do you foresee upside surprises? And if not, then what is the value of having a broad label, at least in the U.S.?

Well, I think from the point of view of how payers operate, it's very traditional for them to focus on the entry criteria of the Phase III trial that establish the efficacy and safety of the drug. So that's not new nor a surprise, nor is it any different from anything we've expressed historically. We've always guided toward patients with two or more exacerbations in the U.S. Those diagnosed today that we feel fit the criteria are about 250,000 in number at launch. We do believe that there are other patients out there who will benefit from this drug, including those who may be comorbid with COPD or asthma, who have two or more exacerbations in the last 12 months, but have not yet received their CT scan or their pulmonology visit to give them the definitive diagnosis of bronchiectasis that would allow them to be on label for BRINSUPRI. So that operation is something we've been thinking very carefully about for the last several years, and I'm confident that as time goes on, as is common with a first-in-disease drug approval, you will see more patients diagnosed. You will see more exacerbations reported, and you will see greater sensitivity on the part of the 27,000 pulmonologists in the U.S. who are now aware of a disease that has been around since 1819 and has its first drug approved to treat it. This is one of those patient populations that is very sizable, but which has been a frustrating point for physicians because they've had nothing to treat the patient. And so it hasn't been a high point of focus or motivation to diagnose them as such. Because there's nothing more frustrating for a physician than to diagnose a patient with a condition and not have a medicine available to treat them. For bronchiectasis patients that changes today.

Your next question comes from the line of Andrew Fein of H.C. Wainwright.

I guess one question would be, given the now commercial availability of the drug, how is the company thinking about investigator responsive studies going forward to try and flesh out what ought to be the broad applicability of the drug in a post neutrophil-mediated diseases?

So I appreciate that, Andrew. Good to hear from you. I would just say that I think there's going to be a lot of interest because bronchiectasis is the first approval for this drug, and we're super excited about that. But we do believe that we have unlocked a novel biological mechanism that is broadly applicable to neutrophil-mediated diseases. And indeed, the appetite to explore its use in other places, other therapeutic uses, is already underway at our company between both the CRS study, which we'll read out by the end of this year, and the HS study, which will read out at least the first 100 patients in the first part of next year. But those are also the first two additional indications for this formulation of the drug. We're looking at other formulations of DPP1 and their potential applicability to a broad range of neutrophil-mediated diseases including things like rheumatoid arthritis, COPD, asthma, IBD and others. And you'll be hearing a lot more about that in the next year plus as we bring those into the clinic. But many of them have already seen testing done in animal models, which are considered gold standard for these different diseases, and that's why we have a high degree of confidence that as we enter the clinic, we're going to see some real progress made. Obviously, we'll have to look at the data to make a final judgment. But I would say this is the beginning of a broad potential applicability of DPP1 and we intend to pursue the clinical trials to validate that assumption. And yes, we will see a lot of input from physicians who will want to do the same thing, and we'll be working with them very carefully to enable that where it's appropriate.

Your last question is a follow-up from the line of Ritu Baral of TD Cowen.

Will, can I ask about time to fill and how you expect that evolve? Is this something that you expect to evolve as the drug is added to formularies? Or do you think it will be defined by navigating the exception process on a patient level?

Yes. So as it relates to formulary versus the medical exception process, this always begins with the medical exception because the negotiation is still ongoing with the payers. Ultimately, once that's concluded, that will give us a good sense of what are the requirements for physicians in order to secure a prescription and a reimbursement approval for the patient. Formulary is particularly relevant when the -- when there's a competitive landscape. You want to get into that, jockey into that position for a better formulary spot. It's not as relevant here because for the next several years, we anticipate there is going to be no competition. This is our field entirely to ourselves. So from that point of view, I'm less focused on arriving on the formulary, and more focused on ensuring that the process of attestation and authorization is as frictionless as possible. The time to fill concept will vary, obviously, as we negotiate these various dimensions. But particularly out of the gate, there is this 1 month-ish delay as we put product in the channel, get labels printed. There's a front-end logistical hurdle we need to clear now, which is, frankly, underway as we are sitting here on this call, so that we're out in the market as quickly as possible and patients can get their medicine as quickly as they can.

And I would just remind folks that with ARIKAYCE, we have been, for the last 7-plus years of launch going through the medical exception process. So our team knows that process very, very well. And the other thing I would just comment on is the sales force is ready to go, as they were with ARIKAYCE immediately after launch. So we're excited for them to engage in those conversations.

That concludes our Q&A session and conference call. We thank you for your participation. You may now disconnect.