Seres Therapeutics, Inc. (MCRB) Earnings Call Transcript & Summary

Welcome, everybody. Thank you for joining us at the Goldman Sachs 44th Annual Healthcare Conference. And we're very pleased to wrap up our first day of the event here with folks from Seres; CEO, Eric Shaff; Terri Young, Chief Commercialization Officer. And I'm here together with my colleague, Stephen, who is going to help me do this discussion. We are really at so many interesting points with your company, but really probably speaking the microbiome space.

Eric, you and I go back many, many years in terms of thinking about how we're going to take this concept [indiscernible] right? And get it to become sort of pharmaceuticalize? Is that a word? We'll see what the transcript shows up when I say that, right? Just understanding that this is like literally century of thoughtfulness, documentation science, et cetera, that we're navigating. So pharmaceuticalize might not make it into the transcript. So -- but just this whole notion of addressing diseases by modulating the microbiome and taking an approach that already had kind of like a working solution as imperfect as it was and bringing to bear the discipline of the pharmaceutical industry and biotech and that's why you guys are here. And genuine congratulations in terms of being the first company to have to really the sweat equity they have pushed all the way through to all the journeys in the Phase II trial, et cetera. So at this juncture, with where you're at your own personal professional commitment to being in this field, how do you feel about the progress that's been made? And I know a lot is a reflection of sort of series on spearheading efforts. But just to feel more broadly, microbiome, et cetera, maybe you can comment?

Yes. Well, first, just thanks guys who are having us here today and at the conference. And Chris, you're mentioning kind of the notion of reflecting back, and I'm not going to go back thousands of years, but I could start with maybe 10, 12 years ago when the company was founded. And the founders of Seres said, look, there's this kind of crude proof-of-concept that FMT provides some evidence that you can interdict into the health of someone's microbiome and have a direct impact into really complex diseases like C. difficile or Recurrent C. difficile infection. But the idea back then was, look, there's got to be, Chris as you mentioned, this kind of be a better way of helping patients, right? If you could take this concept and if you could elevate some of the science, the rigor behind the science, if you could produce a product under GMP manufactured conditions, if you could do it under rigorous over -- FDA oversight when there's kind of this notion of how effective is FMT, the numbers flying around. Like if you could actually bring this field to a new level and crucially important, if you can make it oral, you can create significant value for patients and for other stakeholders in the system. So here we are more than a decade later with some twists and turns along the way. Interesting Phase I, disappointing surprise on Phase II, really stunning results in Phase III, and we're incredibly proud of the journey, and we're thrilled to be at the point with FDA approval that we announced in April 26, but also as of last Monday, announcing that we are actually shipping drug and treating patients commercially. And we're thrilled with where we are. We're really pleased with the label that we got as part of the FDA approval, but I'm hopeful that this can be a tipping point for the space, right? We've seen starts and stops. We've seen ourselves with other companies in the space. There's just simply too much evidence to not conclude that the microbiome is profoundly impactful in human health and impactful in human disease. The question is getting there. And I think everyone thought that C. diff would be the easy one. We can tell you there is nothing easy about C. diff, whatsoever. But we -- as a company, we feel that we've got the tools to -- and we're incredibly proud of what happened after the Phase II miss, which is we took a rigorous approach to why we thought the Phase II -- the Phase I was successful, why the Phase II wasn't, and it came up with some changes that we implemented. That's the approach we're going to take going forward, and we're hopeful that others will too follow the data.

Not to mention navigating a little thing called #pandemic when you were doing your Phase III.

Yes, that was the answer.

Especially doing an infectious disease related item. The sort of the ecosystem, the Tableau that you've entered into, however, it's almost as if there's like fundamental rules about whether matter can neither be created not destroyed, et cetera. Because at the same time that you guys were making definitional progress. We have sort of seen the FMT world. And I go back to different analogies at times like the Coumadin clinics before like the Factor Xa is in there and the next-generation assets came in here, right? And Terri, you've been -- you've lived through, you've been a student of so many of these sort of transitions and ultimately, people have to stop using IBM's electrics and just decide that it's just like this MacBook thing is pretty good. So how is the consequential changes that are happening across the ecosystem impacting? How you're thinking about proceeding? An immediate thought would be like, "Oh, clearly, it's helpful." But it's more complicated than that, I would think, right. Because you have to change minds, but then if they don't have a choice, maybe talk through some of the issues of how the consequences of your progress are affecting, how you're thinking about moving forward?

Yes. Maybe I'll start and then Terri can add. But the first is, where I think we have an advantage is just the profile of the drug, right? What you hope for in drug development is a solution which is effective which can be well tolerated and which is oral, which allows you to bring in all sorts of places that in effective and efficient manner. So that's a great place to start. We also have the benefit of really powerful publications with our New England Journal of Medicine Article or a JM Article or a more recent journal, JM [ Insert ] with the durability of the data. So from a medical education perspective changing hearts and minds doesn't happen overnight. It takes time. But we've got a hell of a start with the profile of the drug, with the receptivity that it's had in terms of physicians who are tired of suboptimal choices. But maybe Terri can comment further just on some of the more strategic and taxable items of giving this drug broadly to patients.

Yes. And actually, I'll turn to Stephen to sort of like organize some of the questions around that. But specific to, for instance, like the donor location in the Cambridge or whatever, that has kind of well and by the wayside. I think there was a university in the Midwest that took over ownership of that sort of it's almost as if it's become a little vintage to be able to donate FMT.

I don't think it's the -- we include donation as part of the front of the supply chain we have. So to me, it's a fecal transplant versus something which is oral and effective and well tolerated, do the kind of the mother choice, which is what would you choose for your mother. I know what I would chose for my mother.

And how your mother?

Yes, you're right. So yes, and then she would choose to do. So I just -- I feel like there's a recognition from some of our key stakeholders that the science is going to a different place. Like this is not kind of blunt force instruments. And I hope we talk about later, where our science is going with SER-155 as an example of going from donor stores or donor-derived therapeutics to cultivate therapeutics. So like everything else, we will evolve. And I think we've got tools and insights that allow us to serve patients in a different way.

And then for the disclaimer, just to clarify the reason I know Eric's mother is that his mother, Dr. Leslie Shaff, also a JD, incredible woman, was one of my mentors and leaders when I was training in Anesthesiology, at the Massachusetts General Hospital, too many years ago. But let's talk about VOWST, and the launch and let's do it in organized thoughtful way. Turn it over to my colleague here, Dr. Stephen Sloan.

Great. Sure. And yes, we're very happy to have you, and congrats again on the approval VOWST. So yes, let's just jump right into it. Obviously, the label came out fairly broad. Can you just speak to really what that means for the commercial potential relative to maybe if that was restricted to what you study as the primary endpoint in the Phase III, obviously, recruited earlier patients in the open-label extension. But does you speak to your thoughts on the label overall and what that means for your Commercial potential?

Maybe I can start with that one and Terri can take you on that, but -- so it's funny. I don't know if something by definition can be base case but celebrated at the same time. The label is base case and celebrated, right? So Lisa, our CMO, has for some time made the case that physicians tend to look at this disease as a primary occurrence and then a recurrence. And if you've recurred, it means that your microbiome is possibly injured and susceptible to further recurrences and needs repair. So that's how these are interacting with physicians, they look at it. That's how we looked at it. And we were very pleased to finalize the label that suggests that the FDA looked at it that way as well. So for us, that provides, I think, the greatest line of sight to treating patients broadly with Recurrent C. diff and we believe that if you've had a recurrence, you're kind of marks where you can go 1 of 2 ways. You either can naturally repair and restore the health of your microbiome or you can kind of head down the path of the spiraling recurrence. And maybe Terri can comment further.

Yes. I think it's really important when you're launching a product to be able to talk to physicians in the language they use and in a way that mirrors how they see the disease, right? So -- this means with the broad label that we can go for all 156,000 cases that we estimate will have annually just this year in the U.S. And we can talk to physicians, our customer-facing teams deploy out of Nestle can talk to physicians about all the patients they see. Again, and then we can define them as recurrent patients versus this somewhat artificial definition of first, second, third, that we are -- we basically articulate ourselves in terms of clinical trial recruitment criteria. But it's not necessarily meaningful to physicians.

Okay. No, I think there are interesting payer implications potentially based on how they see the number of occurrences, which I'll talk about in a second. First, I wanted to ask about the launch, like you mentioned earlier, it was announced last week that the product is now available. We just love to hear trends you're seeing to date and anything you can comment as this is probably one of the first public venues to talk about the launch.

Yes. I'll ask Terri to comment. I will just qualify the risk of stating the obvious, it's been 1 week. So we've learned certain things in 1 week. I think we'll learn more next week and the week after that and so forth. But maybe Terri can comment further.

Yes. Well, what I would say, I'll kind of rewind to the last week in March, we actually spent with the entire Nestle customer-facing team and Nestle organization down in Atlanta, training the customer-facing team. So Eric and I, and Matt Henn, our CSO, were on stage with Greg Behar, Moreno Perugini, their Head of the U.S. in our opening session. It was a great week. We really got the teams hyped up and excited because this is a team -- if you talk about the gastro sales force, which is the bulk of the people, they don't launch the products in like a decade. So they are really jumping at the bit for something new. Asked great questions. So we did that because what if you get an early PDUFA, earlier approval, we wanted to be prepared. So we felt prepared, jazzed up the sales force, so we get approval. We deployed those customer-facing teams within hours or receiving approvals because we got that label. We expected -- so we basically had to do a cursory certification based on the receipt of the final label and then we could deploy them. So they've been out there engaging physicians now even prior to product availability. And as you might imagine, the #1 question that we're getting right out of the gate is when is it available? Right, which we view as a very good sign. So I think we're in a great place now with product available to start serving patients. Our hub is operational, and that was up the day after PDUFA as well. You probably may have noticed our websites are up where they were up the night of approval. So the team is really executing very well.

Great. And maybe on this point, too, can you talk about any promotions that you're doing? Or what type of marketing campaigns at this point, that would be really helpful to set the frame. And then maybe beyond that, I'd just like to talk about, I know your strategy has been focusing on like the hospital home segment as well as the hospital segment. If you could kind of walk through those patient journeys and how they actually would get the drug?

Sure. So in terms of marketing campaigns, one of the beauties of having a data package that is a strong and straightforward as ours is that it makes promotions very simple. The fact that we can go out with a now approved campaign, highlighting the 88% recurrence-free at 12 weeks and then a sustained response at 6 months. With the safety profile we have in a 3-day oral regimen, that's a highly impactful launch campaign right out of the gate. So we're very excited about that. So as I said, all of the digital materials were up with the very nights of approval and then the reps were out of the gate with their digital sales aids and so on and so forth. So we feel really good about the marketing materials and the marketing campaign and the strength of it. That's really supported by the data that we have.

No, I just going to note that we had a -- I think a really interesting campaign done for good that actually won an award, and maybe Terri can comment about that.

Yes. Well, this is our disease education campaign that we've deployed0 out of our commercial teams jointly with Nestle prior to launch. And the purpose of that campaign was really to highlight that the root cause of C. diff coming back was the disruption of the microbiome and so the campaign was called "Endless Sequels". It was sort of a play kind of a play on the Friday the 13th, #13. And -- so it did won -- sorry, won a national award actually called the Manny Award. And so we were quite proud of that, because it was the first thing that we had educated out theories. Nestle sort of came in at the tail end of the campaign development, and we brought them on board and watched it together. But really, it was -- that was a campaign that was for in a Seres.

And it kind of speaks to the #1 unmet need in the eye of physicians is recurrent. Like if you've had this disease, there can be a PTSD type of fear of it coming back. And again, once you've hit this truck in the road and you've gone the wrong way, patients fear the idea of it coming back again and again and that's what has resonated most with physicians in our research and our discussions.

Okay. Yes. And that ties into my question, which I can kind of rehash. Like can you describe the patient journey that those patients had CDI before, they don't want to recur, their physician doesn't want them to recur. Describe that patient journey and then how they're going to get on VOWST?

Sure. Yes. So it's pretty simple. This is a disease where it's so impactful to the patient, and it has such a discrete presentation that it's very obvious to the physician what the patient has. So relatively all of C. diff is diagnosed and then treated. So initially, it's treated out of the gate with an antibiotic, most frequently vancomycin is used. And what that does is it tamps back the vegetative toxin-producing bacteria and relieve symptoms within a few days typically. So let's go back a little bit to patient presenting to physicians. There are quite a few patients, actually 40% we estimate that present and will be fully treated in the outpatient setting. So for that patient profile and that patient group, we estimate that when the patient comes in, they're diagnosed, the physician writes vancomycin, they also write VOWST. So the patient will leave the office with both. There is also a patient prototype that we estimate is 30%, which you referenced as hospital to home and I use that language, whereby the symptoms are either so severe or the physician is worried about a comorbidity decompensation. And that patient has been admitted to the hospital. And the antibiotic has begun in the hospital. It works within a few days' time. That patient is discharged. This is 30% of our patient opportunity. For that patient when they get the discharge prescribed for vancomycin, we want them to get the discharge script for VOWST. So essentially, wherever they're getting the prescription for outpatient use of antibiotic, we want the outpatient use of VOWST. That's how I simply think of it.

Perfect. And can you talk about the payment system early in launch and how you expect that to progress throughout the launch? And then relatedly, do you expect that payers will have reimbursement for a broad recurrent population? Or do you think they would have step but it's like, okay, we need to see another round of Vancomycin and some other antibiotic before we get to VOWST.

Yes. So I'll actually start there with your final question. We have been engaging payers since receipt of the ECOSPOR III data back in 2020. Starting with the traditional pre-commercialization methods like market research, payer advisory board, so on and so forth. And we expanded that when we deployed the Nestle payer field team in April of last year. So we have now a full year prior to approval of pre-information -- pre-approval information exchange under our belt. So really broad and deep engagement. And consistently, what we hear from them is appreciation of the clinical profile and the strength of it. We have taken the time, particularly when we deployed the payer field team to educate them and remind them about how costly this disease is. Intuitively, they know that it's expensive, but we remind them of what the drivers of that are, and that the annual cost that we estimate today. So that's obviously going to be very helpful when we engage them in coverage decision, conversations post approval, and those conversations are just starting now. So the feedback that we hear from them is; number one, they worry about budget listings, right, in general, that's not unique to VOWST. But we're 156,000 patients in annually. Which is why they haven't really been monitoring this space to begin with and why we have to remind them of the cost and the cost drivers. They're not really engaged because it's not big, it's not cholesterol. But what they are worried about is the garden variety PCP, utilizing this for garden variety diarrhea or trying it out in ulcerative colitis, then you start to get into really large populations very quickly. So we do anticipate that, like many specialty medicines will be priorized indication. We definitely expect that. There's a chance that some payers choose to require specialist involvement. That happens today that in the normal practice of treating these recurrent patients. So we don't worry too much about that. So those are kind of the common utilization management tools that come up at this point in time. And I'm sorry, I forgot now for your first question.

How many specialists that have been getting involved? Is that specialist suggesting get involved, typically at GI dock, which seems to be the primary interface of the Nestle folks and with infectious disease as well, right? So what is your reach into that group of specialists?

It could be either. And we really see a lot of geographic diversity in terms of who's the quarter back. It varies by geography. It has to do with kind of who knows who on the ground at the local level. So -- but either -- I don't -- I've heard that they're going to restrict to 1 specialty or another, just a specialist. Again, thinking about that kind of primary care, maybe didn't get the diagnosis right, maybe using it outside of the label. It's another way to control that.

I believe in the announcement that product is now available, I referred to a co-pay assistance program or patient assistance program. Can you just overview that program and kind of what level of assistance you are giving patients and how long you expect this to last for?

That's right. So for commercially insured patients, and those patients we estimate at 54% of our opportunity, so quite the bulk of it is and we're focused there. We're very focused there. Early in the launch period as well because you can get reimbursement and you can get coverage quicker in that population. So very focused there. We will have a co-pay program that buys it down to 0 for eligible patients. We'll also have a traditional patient assistance program for other patients who may qualify per income criteria. So we'll have, I think, very robust patient assistance programs because our idea is to make it as easy as possible for physicians who are trying the product right out of the gate on the patients that they deem need it the most.

Maybe I'll just double down on that. I think that there's a group of physicians that we think could be meaningfully influencing in the uptake of the drug and ultimately, the value potential of the therapy. And as Terri said, we're trying to make it as easy and successful for them as possible in the early stages of this launch. A number of physicians that will be prescribing VOWST will work through the medical exception process and some of these are GI dots, that are not, aren't familiar with the process. But we certainly want to make it as easy and successful for these early adopting physicians as possible.

And I believe Galen, some of the cadence of getting broader payer access about 12 months for broad commercial access and then 18 months from Medicare, is that correct?

Yes. Typical for specialty products that launched within this time window. Right? We've missed the Part D contracting window for 2024.

And given you have -- you're targeting patients in both the hospital setting and outpatients heading in home to hospital, come under Medicare would this be Part D, Part B -- Part B or both?

Part D, yes, because it's traveling through the outpatient benefit, and we're not requiring physicians to purchase the product and then dispense it to patients. That product will be dispensed directly through specialty pharmacies.

Got it. Okay. And then going back to, I think, something you just commented on, the physician feedback you have these potential early adopters that really want to just broadly you've been to, I think, a few GI conferences since approval. Can you just comment on physician feedback. And this is somewhat of a paradigm shift in how they're treating patients. How receptive are maybe not these super early adopters, but maybe the I don't know, more common garden variety GI and ID?

Yes. Maybe we can both add commentary, but there's folks that we've been working with for some time, right? And they're highly familiar with the therapy, maybe they were participants as part of the study. And as we said, I think that those will be meaningful in the uptake of the curve and heavily influencing of how the drug does is in the initial phase of launch. But we are focused on the other side as well. And I think that we've got tools that are available to us, including the publications, which are really best case. But also, look, Nestle is, one of their real strengths is the ability to market. And we know that these are patients that are active on the Internet. They're looking for resources and we think we can provide those resources in those assets to the patients. Terri, maybe you can comment further.

Yes, I think there are kind of tried and true tools that we have to create broad physician awareness. You mentioned 1 publications presence at congresses beyond just GI and ID or just a few of those. What I'll add is one of the aspects of this disease state that has really struck me as I talk to physicians is that whether a physician sees 5 patients a year or 50, the physician's experience is very much the same. It's literally no one of those when the patient comes back and they have a recurrence. It's just a resignation. It's here we go, we're on the hamster wheel. I don't have good tools to get off this thing, I don't know if it's going to come back. I don't have anything to make it gone for good. And so whether you're part of the KOL group, FMT users that absolutely know all the science behind it, or you're a guy seeing 5 patients a year, your motivation is the same, to try something that will make this patient go away and live their life. So that, you can get back to doing your job. So I think that's a really powerful motivator for us.

Got it. Chris, any other questions on VOWST?

I think we've covered quite a bit here, and you touched upon the pricing dynamic as well, right? And you framed in terms of the selection of the price. Historically, you had referenced other kind of transformative therapies, perhaps C treatment, first of all, et cetera, a lot of pharmacoeconomic discussions typically went into describing how your team was planning that. 17,500. Any initial feedback on that price, particularly from the payer side?

No, I think that we've heard comments that there's maybe some surprise we didn't go higher and some surprise we didn't go lower, which maybe suggests that we and do it in the right place. But obviously, there's a ton of work that went into landing in that zone, Chris. And for us, of course, we had scenarios where we might have had a higher price with a more narrow segment of the patient population. We ended with the broadest possible label. And the price is indicative of the value that we expect to create. We care deeply about access, including with the tools that we put in place with patient assistance. We care about the innovation, right, the innovation that we're bringing to this product to this patient population as well as future products that we expect to create through our development efforts. So far, I think the feedback has been positive.

Great . I think we did want to spend a few minutes on the rest of the pipeline, including SER-155. I guess before we get there, maybe just one last thing on VOWST which maybe also include some of the pipeline. I think in recent investor conference, you mentioned that you'll be closing 1 of the 3 donor facilities. Can you just talk about what that facility was being used for, is that purely for VOWST or is that also for pipeline applications. And what does that implicate for the longer-term supply outlook?

Yes. So we have decided to close 1 of 3 donor centers that we use for collection of the raw material that gets processed into therapeutics. There's a couple of factors that went into that decision. First was one of the aspects of the label, which was really best case was stability and shelf life. So with 3 years of shelf life, it affords us considerable flexibility in the supply chain in general. We were hoping for that. We were happy to land there. As a result of that, as we model each revenue scenario that we have, we are fully capable of supporting those sceneries with 2 versus 3 donor centers. So with an eye towards the efficiency that can be -- that can result from the decision of closing the facility, we made the choice mindful of the resources that we have and in terms of cash. Mindful of the environment. And certainly, we will continue to make those types of choices where we can build in efficiency without sacrificing value potential.

Got it. Okay. And would you like to frame any of those revenue scenarios for us?

No, maybe not at this meeting. But look, I think that with the profile, with the label, with our reimbursement strategy, I think we're really optimistic about what we can do for patients with this drug.

Got it. Okay. So maybe moving on to SER-155. Recently with your first quarter earnings, reported some positive initial Phase I data, Phase Ib, I should say. Can you maybe just highlight the key takeaways from that and kind of how you see this program progressing and how important this is to Seres overall longer-term outlook?

Yes. So maybe if I step back to Chris's original question, we think that the applications of the microbiome are incredibly broad and -- we're believers in the covering access. We're believers in metabolic disease and inflammatory disease. We have decided that we will continue to focus on infection where we've had not just proof-of-concept, but just an incredible data set with VOWST, right? So for us, 155 is next. And just for background, 155 is a cultivated consortium bacteria, so it's not sourced from healthy human fecal matter, but actually it's fermented as a clostridium bacterial strains from our bacteria library. So we're studying SER-155 in patients undergoing HSCT with the hope of preventing infections and potentially severe GvHD. So what we announced in our Q1 earnings was that we had completed a first cohort of our Phase I study and had initial results, safety and engraftment. And we're really pleased by what we saw. So from a safety perspective, the DSMB had already given the go ahead at the end of last year to go into the second cohort that we were expecting it to be favorable. But -- it's not -- I think it's actually quite important to note that these are really fragile patients who have all sorts of infections in terms of antibacterial -- antibiotic therapy. Delivering a bolus of bacteria and seeing that it was well tolerated, that's actually a pretty meaningful win for us. And it gives us really an opening to think about other ways in which we can approach this consortium and actually similar diseases. The second is we saw some really interesting, not just in graftment data, which is positive, but actually colonization data, which we think is applicable. So literature is full of the association of colonization of, call it, bad actor bacteria with infections and in particular, GvHD. So working with MSK who's been a partner for a number of years, they have compiled the reference database, which is kind of a cohort where we would expect to see approximately 60% of patients having an overgrowth of certain types of infections. We saw one patient, right? Incredibly small numbers, incredibly early, but we saw what we had hoped to see. And that actually, that 1 overall growth was transient. So it actually dissipated over time. So for us, this is what we had hoped to see with kind of an early set of data. It gives us excitement to go into the second cohort which will actually have a placebo-controlled arm, about 60 patients. And for us, this is the next step for us in terms of infection after VOWST. And we're excited to see what we will see in the second quarter in the second -- in the middle of next year.

And I think we're getting close here on time. These are only the questions I would like to ask, but maybe a key 1 as we're thinking about clinical development this Cohort 2 reading out next year and on 60 patients. Obviously, we can start to get a sense for the clinical efficacy. What sort of signal or can you frame kind of what sort of signals you would like to see in order to further advance this compound into maybe a registrational study or talk about if this Phase II could be registrational.

Yes, I don't think we're quite there yet. I would say a couple of things. One is it's still a Phase I study, so we're looking at safety and engraftment. But it is a sizable number of patients, especially for this indication. So we'll be looking for signals of what we can see, particularly in comparison with the placebo arm. But we're actively thinking about and talking about next steps if we see what we hope to see in the second cohort if we see what we saw in the first cohort, decolonization is an interesting end point as we think about potentially ways that we can accelerate. And maybe Terri can comment quickly on the commercial need of this patient population and others.

Yes. I think all of these patient populations are not actually too dissimilar from the Recurrent C. diff population in that, these are patients who are vulnerable to begin with. They're interacting frequently with the health care system. And for HSCT patients, they're trying to tackle a deadly disease, right, that could claim their life. And all of a sudden, they're taken off track with this infection that could ultimately claim their life instead of the cancer. And it's a huge distraction. Because the system a lot of money, a lot of patient burden. So there are a number of different medically vulnerable patient populations that we've identified that could benefit from an approach like this. Cirrhosis patients, for example, cancer neutropenia patients and so on and so forth.

Got it. Okay. I think we're getting end of time, Chris, do you just wrap.

As we think about on the forward, monitoring the launch help us understand with what preliminary decisions you've made in terms of how we'll follow this. I don't think there will be -- I give you a scripts. The net revenues you post are inevitable sort of mix of patient assistance, et cetera. But how can we be on the same page with you of reasonably assessing the launch as we go through, say, the back half of this year?

Yes. So first, we will have three-odd weeks in Q2. So I think that from a revenue perspective, we'll see what we have with Q2, but I wouldn't expect that to be -- sorry, Q2. So I wouldn't expect that to be terribly informative. We have not rolled out the metrics that we will use, Chris, but maybe I can ask Terri to kind of provide some perspective on the types of questions that we'll be looking to answer for you and for others.

Yes. I think there are really 3 areas that I continue to focus on with my colleagues at Nestle and with my team and the first -- we talked about all of them today. Physicians' awareness of a new transformative approach, physician adoption and trial then there's getting through the payer processes, right, in a timely and effective manner to protect patient access for our broad label. And then the third piece is the hospital to the home segment, really paving the on-ramp for that hospital outflow such that it's consistent and easy for patients and the physicians who are treating them. So those are really the kind of the 3 areas that we're looking at.

Okay. It's going to be a perennial question. So we look forward to asking it and following all your progress. Eric, Terri, thank you very much for joining us. Stephen, excellent job.

Thanks for having us.