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Good morning everyone. I'm Sean Lyman, Head of US Mid-Cap Biotech Equity Research here at Morgan Stanley and welcome to the Morgan Stanley Global Healthcare Conference. Before we commence I'll make you aware of some important disclosures. For those disclosers please visit the Morgan Stanley Research Disclosure website at www.morganstanley.com forward slash research disclosure and if you have any questions please reach out to your Morgan Stanley sales representative. For this session we have the pleasure of hosting Bridge Biopharma with Julie Everett, COO of Bridge Bioskeletal Displasias and Chief Business Officer Chinmay Shukla. Welcome to the both of you and thank you for your time today. I've got some macro considerations, we're just talking about interest rates offline, but just some macro observations to discuss before we really dig in on bridge. But how has the rise of China-originated innovation changing your competitive positioning, if at all, and does it influence your BD and R&D playbooks? Yeah, I'm happy to talk about that. Sean, first of all, thank you for hosting us, and thank you to all the investors for joining us today and across the day as we try to tell our story. So in terms of China, we see that as an opportunity, and there are some risks, but we do see it mainly as an option. I think the speed of innovation is much faster. We do have active relationships with investigators and universities in China. A lot of it is done through our sister company, Gondola Bio, which focuses more on the early stage part of the genetic disease R&D playbook. So I think that for us, in terms of opportunities, I would say the ability to quickly set up trials and run trials, the ability to partner with an even broader number of academics, as well as get sort of genetic data from a much broader population. Those are all opportunities. I do think that there are some threats in terms of protecting our IP, and we do think about that. You know, we think about the fact that any time we publish a structure, someone can easily then make the molecule. So we are thoughtful about that, but on balance, we view more people trying to help patients with genetic diseases as better for patients in America and patients globally, as well as for our business. Sure. Thank you, Jinmei. And next question on the macro. So are you implementing AI across your business? And has it already changed the decision, a timeline, a cost, or even a POS? Yeah. So we view AI in two different buckets. AI in terms of increasing probability of success or telling us kind of what's the next big cancer drug is not something which we think is going to be that helpful. But I think that there is a ton of operational details in terms of running a biotech company, which AI can definitely make better. And that even in our own company, we see AI improving. I think the three examples that I can give you are number one, in the commercial setting, whether it's in terms OF making it easier for folks to write letters of medical necessity, whether it's analyzing data, as well as, you know, if we think about overall surfacing information to our reps in a more insightful manner, those are all areas where AI is helping in terms of biostats. It does help a lot in terms which is code generation. That's obviously a big use of AI and probably the most validated use of API. And then I think that we're also looking at other steps in the business, whether it's sort of site activation, enrolling trials, how can we use AI to speed up those elements? Those are a little bit earlier stage, but I would definitely say it's having an impact now, and I think it's going to have a bigger impact in the future. Wonderful. Thank you. And I'm going to guess your next answer to this next question will probably be all of the above, but which policy variable, is it FDA, Medicare negotiation, MFN, tariffs, or global pricing matters most to Bridges Economics, and have you changed anything because of it? Yeah, so the answer to that is all of the above, but I think we have, you know, we announced a partnership with the U.S. government recently, so for us, these policies, you know, if we've been working closely with the regulators, whether it's on the FDA side, we're very pleased to say that the FDA reconsidered their decision on NCALRET and gave it priority review, whether it's on the pricing side, you know, we announced a partnership with the U.S. government on that. We think that we're able to find ways to both help patients as well as preserve our ability to do innovation, and that is very exciting to us. Sure. Thank you. Now we'll go bridge-specific. So I have a series of questions on Atruvi because I think that's sort of the dominating investment debate, and then I'll move on to some questions on the skeletal dysplasias. if that's okay so uh the true be very strong numbers up 23 percent uh sequentially with growth led by treatment naive starts and and the switch switch pool is normalized uh the total revenue beat was largely uh driven by royalty rather than u.s atruby is the u.S line uh growing faster as you had expected yeah so we are thrilled with how um atrubby's launch has gone thus far And actually, we are even more thrilled about what's to come in the future, given all the data sets which have come out. In terms of what we think is driving that growth, let me break it down sort of near term and longer term. The biggest driver of Atruvi's growth is, number one, increasing first-line market, as well as increasing share of Atuvi in that first-lane setting. I think both of those things are big tailwinds for us. And I do think that the kidney protective data, the ESC data, as well as the real-world evidence which is starting to come out, will all help Atrubi gain more share in the future. And the drumbeat of data from all companies will expand the first-line market in the future. So I think that it will take, as we mentioned on our second quarter earnings call, it will take about 12 months or so for all of this data to percolate in the community and then start to change prescribing habits. And so in the near term, we do see steady sort of expansion of a true B of somewhere around 25 to 30 million quarter over quarter in terms of sales growth. And I think that longer term, we do expect, we've never been more confident that we will get to 4 billion in peak year sales and maybe there's even some upside beyond that. Sure, thank you. I guess you've reiterated Blockbuster worldwide sales for this product in 2026, including the partner record of Biontra sales. What U.S. only number does that imply? Yeah, so we haven't sort of, you know, since we're not giving annual guidance, we haven'T broken down U. S., X U. S., all of that. But obviously a majority of the sales that we book do come from America. And so a big portion of that blockbuster status would come from American. If you look last quarter, we had about $222 million in U. S. net product revenue. We furthermore had about $15 million or so of royalty revenue. I think we've said that our royalty from Bayer starts at about 30% and then tiers up from there. So what you would see is the product was already annualizing to a blockbuster status, right, because you take the 222 plus, you know, let's just conservatively say 15 times 345, and you can see that A, that's greater than 250, and B, you can See a majority of that revenue is coming from the U.S. We expect that to continue in the future. We think that the U.S. will be a much larger market than Europe, although Europe is a very, very important market for us. We are thrilled with how the launch is going there, and, of course, we have a very large priority that we receive. Sure. Thank you. Next question to me is quite important to your story, so I'll try and word it carefully, but I guess management has framed the CardioTransform myth as leaving the combination case scientifically dead and reinforcing stabilizer first, but the readout was arguably anti-combination rather than anti-silencer since monotherapy showed a nominal benefit. In second line, where many physicians still reach for a silencer, why is this a clean win for stabilizers? Yeah, so maybe I'll use this as an opportunity to talk more broadly about what came out at ESC and why we feel like, you know, It was a very good data set for stabilizers in general and Atrubi in particular. So I think there are a few things which are very clear now. I think the first thing is stabilizers are the first-line therapy of choice. A vast majority of the market today and in the future is going to be first- line patients. Atrубi is a differentiated near-complete stabilizer, which also has unique kidney protective effects and other core benefits. So on the first line side, the story is very clear. It's a stabilizer market, and our job there is to get as many patients on a Truby as possible. I think as I think about the second-line setting, there were physicians who were reaching for combination therapy, which I think has now been proven to be ineffective. I think that we also saw from CardioTransform, as well as some of the other presentations which came out at ESC, that the two knockdowns are very, very similar to each other. They both have very similar levels of placebo-adjusted knockdowns. We also saw that the knockdown's take a very, very long time to show an effect. It takes about 18 months to 20 months for the curves to separate. And so we put all of that data together, and we do think that knockdown will remain an important part of this market. But increasingly, even in the second line, we're going to see physicians think about, if you have a patient who's progressing on a weak stabilizer, do you just put them on a near-complete stabilizer or, you know, do try to have a different modality? So, I think that put together, we do think that all the data sets indicate that a TRUBY should keep taking share in the first-line setting and should also have a small benefit in the second-line setting, although the second line is a much smaller market than the first line. Sure. I guess on the second line, so Nilem recently reset their 2026 TTR guidance, lower on the same second line are slowing. Is the switch market shrinking for everyone or just shifting? Yeah. So I think what we have said, and we've been saying this for almost nine months now, we have always expected that the second-line market would stabilize. Because if you think about it last year when both us and Ambutra came on the market. You had a large number of Windomax patients who were progressing and who did not have a choice other than to stay on Windomix at the time. So we knew that there would be more switching earlier on. It's very hard to predict quarter to quarter how these dynamics work. And so our expectation was that that elevated switch would last probably for about two years or so. And we did see, we have seen that kind of happened where the second-line market is stabilizing. There was further fuel added to the fire because last year Pfizer pulled Vendor Quell off the market. And so all the about, you know, high teens of TAS patients were on Vendore Quell. They all had to be switched to Vendomax. And so that further, you now, made it such that everyone had a chance to get some of those patients, right? So Q4 of last year, Q1 of this year, the second line market was further elevated because of that. So you have started to see that normalize a lot in Q2 and beyond. And we've always expected the second-line market to be smaller. We've always incorporated that into our thinking, into our remarks. And so we were not surprised by it in any way. And what I would say is because a Truby is positioned so well in the first-line setting and the first line market has continued to grow, despite the second-line market being much smaller in Q3 compared to Q1 of this year, if you look at the total volume, if you Look at the neck patients added in Q1, in Q2, and our expectation in Q4 is that that neck patient added volume is very, very similar and hasn't really gone down for us. The first-line strength has overcome the smaller second- line market. Sure, thank you. Moving on slightly, talk about the post hoc renal data, and maybe just for the audience who may be unfamiliar, just give us a snapshot on the data, and what is the mechanism by which post hoc renal data could change prescribing? Yeah, so actually I'm going to let Julie comment on how it might change prescribing, because she's close to the commercial story at both Atubi and Enfi. but let me just recap the data. It's really exciting data. When we got the phase three results for a true B, we saw that there was an acute dip in EGFR in the early few weeks after starting therapy. Initially, that was concerning to us because normally an EGF-R dip is concerning. However, we looked into it a lot more closely, and what we saw is that the effect actually mimics what you see with SGLT2I inhibitors and ARBs, that it's actually a kidney protective effect. If you look at the UACR albumin ratios and other markers of kidney health, and you look at the overall nephro profile, what you See is that the kidney, which was in stress after the initiation of a true B, very rapidly starts to basically rest, and that confers a kidney-protective benefit similar to what you Se with S GLT2Is and ARBS. And we've investigated this in a lot of detail. We're very excited that now there's a peer-reviewed manuscript which is out there, so we can go and educate on this. And we have also now started to look and survey KOLs. We had a kidney summit a few months ago. Physicians are getting more and more excited about it the more they learn about this profile. It's a counterintuitive profile, so it does take a little bit of time to educate on it. But once they get it, they actually have been super excited about It, which is why we announced that we are going to go and do a rare kidney indication with a TRU-B just to further expand upon the benefit there. But in terms of how that changes the commercial... Yeah, no, I'll give a very quick answer. So I think we've gotten very positive feedback from prescribers saying that this is just one more data point that continues to build that clinical differentiated story for a TRu-B. And what's interesting is that when you look at tefamidus data, they saw a very muted impact, a very, very muted trend like this, and there was nothing demonstrated with the silencer therapies. So this is truly a point of differentiation. Whether we think it will inflect prescribing in the near term versus more the medium or long term, I think it's the latter because it's going to take our MSLs and our sales representatives a little bit of time to get in and educate prescribers on this data. And as Chinmai said, it's not a simple story. You really have to understand, you know, how this is tying to outcomes. So I think it'll be more like a one- to two-, three-year time frame that we'll see some inflection, but it just increases our confidence in the ability to execute on that 30% to 40% peak market share. Wonderful. Thank you. Next couple of questions. A lot of my inbound is around pricing and forward pricing outlooks, so I'll try and wrap these questions into one. So Pfizer has reportedly been discounting, and you said you will not chase price. Does holding price cost you share in the near term, and how would you know? And the second part is, you know, Tevamida's generics arrive around 2031. So what protects Atruvi's price and share against a generic stabilizer in the class? Yeah, so I think the first place to start on all these questions is the fact that Atruv is a second-generation, near-complete, better molecule, better stabilizer, more effective stabilizer than the first-generation molecule. And that's how pharmaceutical companies have always evolved, right? If we make the first generation molecule, then we improve upon it in our second generation molecule. So a true B is that improved upon second generation molecule. It is clinically differentiated across numerous axes, whether it's the near complete stabilization, whether it is really strong effects on key subgroups like AFib as well as variants, whether it is this unique nephroprotective effect that we have seen. And now what we are starting to see is in the real world, right? People are starting to compare these drugs, and we've already seen some early evidence that a Truby outperforms Windomax, and we know that there's going to be more real-world evidence coming out at HFSA. We're very excited to see what that shows and whether that continues this trend. So you have a drug which is clinically differentiated, and it's a, what we think is, let's say, it has unique and superior properties than the first-generation product. I think that as we think about that, that really flows to how we think about our pricing strategy, and what we think is that the way to win in this market for a true B is to win on clinical differentiation. We want to have parity access, and if we can't have parity access, we want to at least have parity process. Currently, even when Vindamax is on formulary, the process is very similar between the two drugs. one requires a prior auth, one requires a letter of medical necessity. So yes, of course Pfizer is rebating. Of course we are working through it and that's part of why over the next three to four quarters we've said we're going to grow by you know, we're gonna grow steady even though our share is increasing. However, we do think that we've been able to work through it quite nicely to date. The way I, you know you asked me how we know that is last year Pfizer put up a rebate with United Healthcare and so that's now been in the channel for almost 15 months and we've seen you know appeal rate you know when there is first of all most scripts go through just normally but even when there is a denial the appeal rates are north you know success is north of 90 percent there and the most important thing and the Most heartening thing for us is even in the United accounts our share has grown right and so I am sure it is having some effect we have not run the as I always say we've not run the control trial, which is without rebates, how much would we have grown? But we've been able to grow through it just because we are clinically differentiated. And by the way, that is also what has given us a lot of confidence that post-generic TAF entry in 2032, early 2032. We should still be able to go pretty nicely. Part of it is because the channel dynamics here do favor higher price drugs with specialty pharmacies being a key component of in the channel. Part of it is because of clinical differentiation, which we've expanded upon quite a bit today, and the fact that we're not just another stabilizer. We're a better second-generation stabilizer, and then the last thing is if you look at every single analog, when a second-to-market product is branded, better product is on the market, the first-to market going generic doesn't impact the second-market sales. Great. Sure. Thank you. A complete answer. Moving on from Atrubi, so oral infogratnate and Contraplasia, I've got a series of questions here. So I believe you've described Infogratnib as probably the most underappreciated of the three launches, and the U.S. is roughly 25% penetrated and about 75% Europe. Is your thesis upon launch more about expanding the market rather than share gains? Yeah, great question. So we believe at launch that there's three distinct patient populations, and our clinical data is resonating very well with prescribers and families across all three. So the first is those who are currently on a CNP product today, whether that is Voxogo or UV Well. The second is those Who are previously treated and have discontinued. And the third and largest category in the U.S. is those Who have not yet sought treatment. That's the vast majority of patients in the U. S. To understand how we can unlock that population, you really have to interrogate Why they're not on treatment today. And there's two primary reasons. The first is just that the CNP products are limited mechanistically and by route of administration. It's really a molecule limitation, not a category limitation. And if you think about daily injections, again, I don't know how many of you have children, but to have to actually sit down and restrain your child, try to give them an injection, whether it's daily or weekly, for something that is not acutely symptomatic, the child does not feel any different, right? So the injection, the route of administration being an injection is very limited. The second element, again, infagratinib being an oral, the second element is the clinical data. Infagratnib is the only asset of the three to show benefits beyond height. So, pause for a moment. It all shows, though, the greatest benefit on height, right? The primary endpoint being annualized height velocity, 1.74 centimeters per year versus, you know, 1,57 and 1.49. So right on primary outcome alone, the most efficacious product, but also the only agent to show within 52 weeks benefits on proportionality, arm span, and just last week at the European Society for Pediatric Endocrinology, we released data showing within 52 days, within 52 weeks, benefits on sleep apnea and otitis media. So these are very debilitating childhood complications that can be resolved with infagratinib therapy. I can walk through the data more later. But those reasons, we feel, can allow us to expand in the U.S. that 25% treatment penetration to a much, much larger number, not just compete within those who are treated today, but expand the pie. Outside of the U。S., to your question, it's much more penetrated today, depending on the country, about 60% to 75% treatment Penetration in Europe and elsewhere. So the good news is the data resonates with both the switch population, the drop, the discontinued population and the naive population. So source of business may differ slightly by geography, but those proof points of clinical differentiation are consistent across geography. Sure. Thank you. Bymarin says under 10% of VoxOgo patients switch to UV well. Your colleagues read that as evidence of low brand stickiness rather than high. Which interpretation does the data support? Good question. So, I think it's interesting if you look at that. We have to remember that UV Well has done very well, and this is very, I just want to say that, encouraging for us as we look at the unmet need that exists in the market today. I think we're highly encouraged by the UV Well launch since it is still an injection, and we know that there's a lot of patients that are injection-averse. What we're seeing is that there are a lot of patients starting VoxOgo in that infant and toddler population where they are currently the only approved product that has that indication. So it's a little bit difficult to tease out and understand how many patients are truly switching because there's new patients being added at the same time, which is good for them in terms of their source of business. I would actually read this as parents being loyal to their child and not necessarily loyal to a brand. So if you are a parent, you are going to want to choose the product that Has the most benefit for your child and that it's the least burdensome. So that's why we feel encouraged that from a stickiness perspective, we feel that when infogratinib comes to the market, we are going to see families from all three of those categories of source of business opt for infogatinib because there isn't a loyalty to a product that has such significant daily or weekly burden. Sure, thank you. A safety-related question. So FGFR3 inhibition is a systemic mechanism in growing children. What is the long-term safety monitoring commitment, and how do we expect families to weigh that against injections? None. So great question. Thank you for asking. So we were very pleased with it, not surprised, but pleased with the Propel 3 very clean safety profile, safety package. So obviously the NDA has been filed, and it is with the agency right now. But recall, all of these assets in achondroplasia are approved with the subpart H accelerated approval pathway, and then they require conversion to full approval down the line. So there is no, at this time, additional safety monitoring anticipated. We will not know for sure until we receive FDA approval and any post-marketing requirements or commitments. But recall, all patients who were in the pivotal Propel 3 study will continue to be followed to allow that conversion to whole approval. So all long-term data will continue be captured there. We anticipate no monitoring requirements in the commercial setting. Sure, thank you. NDA submitted accepted for priority review, I think a mid-27 launch, if I've got that right. So we should hear back in the next couple of months in terms of a PDUFA date and whether it's standard review or priority review. But recall that infogratinib, just given its significantly differentiated profile, the FDA has previously glanted fast-track and breakthrough, fast-track status and breakthrough designation. So I think we're encouraged by that and the likelihood of priority review, but we should know imminently here in the next couple weeks. Sure, thank you. And how should investors consider the cadence of an ex-U.S. rollout for infographic? Great question. So I Think, obviously, U.S., first market. So MAA, the marketing authorization for Europe, will be filed in the fourth quarter here coming up as well. So we're Encouraged by that. Slightly different cadence of review timeline for U. S. and Europe. Obviously, the procedure in Europe is very structured, very rigid, so we'll slot right in there. We anticipate, if all goes well, a European approval end of next year or beginning of 27, and then a launch in Europe in early 27 as well. Sure. Thank you. And hypochondriplasia in the infant and toddler segments are the expansion. Where do those sit in sequence, and how does the overlay look against BMN333 and TYRA3? Maybe I can quickly take those, just in the interest of time. So, yeah, we are actually, to build on one of your other questions on safety, the agency has allowed us to go into infant and toddler even before they've seen the Propel 3 data, right? So that tells you just how convinced the agency is in terms of the safety profile here. The trial's enrolling really well. I think that the great thing about the infant and daughter study is that we're going to go down sequentially. So first we will do the two- to three-year cohort, and then we'll go below two years. and I think that we'll be filing and expanding the label as soon as the data for each of those cohorts is available and then I think similarly for HypoCon we are currently in the dose expansion phase. Recall we designed that trial before we saw the Propel 3 results and so we are only testing two doses right now and we're thinking about whether we should test more doses or not and you can expect an update on that later this year. Thank you, Chinmay. Moving on to BBP418, PDUFA is set for November 27 with priority review, population roughly around 7K patients in US and Europe, and concentrated prescribing about, I think, 150 MDA centers. So what does a successful launch curve look like, and how quickly does it reach steady state? Yeah, so I think that we're very excited about the limb girdle launch. I think we have PDUFA upcoming here in just about two months or so, so it's a near-term opportunity for us. We've already identified 500 patients, mapped them to their provider. We know that there is high intent to treat in this segment. And again, to start with, the data has been transformational, right? Because not only are you seeing a stabilization of the disease, you're actually seeing patients on the drug improve and regain function. What we have said is we expect to penetrate the 500 patients in about two to three years. That's what good launches do. We also expect in the meantime over the next two to two years to grow from 500 identified patients in the U.S. closer to the two to 2,500, which is the prevalent population in the US. We would like to close that gap. We'll see how far we get there. and so that should sustain our launch starting years two to three and forward. So yeah, we do expect that that's what the launch curve would look like. Normally these drugs peak at around year six or seven. We think that between the US and Europe this is a billion dollar opportunity and there's no competition. So I do think every patient we find we should be able to get on our drug. Sure, wonderful, thank you. I do have more questions on that one but in the interest of time I do want to have a few more and incalorate and then move on to the caporal structure. So incalorit and the hyperparathyroidism are opportunities. So we've got a PDUFA for May 8th next year, my mom's birthday, with priority review and no advisory committee and the EMA has accepted the MAA. You've got more than 2,200 U.S. patients that have been identified under the ADH ICD-10 code at roughly 70 new diagnoses a month. What proportion convert to treatment? Yeah, so I think that ADH1 is a very severe disease. If you look at the symptoms of the disease, they really limit your day-to-day functioning. And actually having low levels of calcium in the blood or high levels of potassium in the urine, they both affect you either day-today or in case of high urine calcium, it affects your kidney long-term. So for a disease as severe as this, I do expect that, you know, there will be high intent to treat. Of course, we are focused on educating on this front, focused on really making sure that physicians understand that this is a disease where you do want treatment. And again, it helps us a lot that N-caloride is able to basically normalize function there. Both urine and serum calcium were normalized in more than three quarters of our patients. And so I do expect that, you know, a large majority of the patients that we identify will get on drug. We have, you Know, about 2,200 patients on the claims database. We have 500 that we have already genetically confirmed and identified map to a provider. And, of course, the prevalence here is about 12,000 just in the U.S. And so, I think that that's going to be another strong launch. Hopefully we'll, you know, the Purdue is on May 8th and hopefully we'll celebrate your mom's birthday a little bit earlier. Thank you. Just in the interest of time, I will move on. I've got more questions on that one. But I'll move on to capital structure and the path to profitability. So you closed $1 billion of preferred equity, taking pro forma cash to about $1.7 billion. Total liabilities just over $3.7, including $8.79 million of deferred royalty obligations against stockholders' deficit of $2.5. What is the blended cost of capital across that structure? Yeah, so I think that we've always tried to think about what is the right form of capital to take and what helps prevent, you know, what's best for our shareholders who already own the company today but also something that will attract more shareholders in the future. I think I'm not going to put a number on our cost of capitol, but I think it has reduced over time. I still think our equity cost of capital is quite high given where we see the intrinsic value of the company. But, you know, we're focused on trying to tell our story and hopefully given that right now we don't need any capital for the bridge biobusiness in any way whatsoever. We think that as we tell our study better and investors appreciate these next three launches as well as the profile of a Truby, you know there's $10 billion of peak year sales in this pipeline alone, as that gets recognized, our cost of capital should keep decreasing. So that's what I would say there. Right. Last question. So I should remember this, but I have to be honest and say I don't. So management guides to operating break-even in 2027, still true. Yeah. And while funding three launches. So what has to be true and a true be for that to hold? Yeah. So I think what we have said is a couple of things on this front, right? I think we've said that for the bridge biobusiness as it stands today with these four molecules as well as the depleter, the Canavan program, we think that our operating losses last couple of quarters have been about 100 million. I think that that's going to stay at that rate, you know, in Q3, start to come down from Q4, probably break even late 27, early 28, and then transition to being cash flow generative. Or Truby is already in margin expansion phase. And I think that the next three products, just given the profile of those launches, can quickly transition from being a source, being a place where we have to invest cash to actually generating cash in 28. So that's what I would say. We, you know, like I said, excited about the profile for both Trubly and these next three launches. Wonderful, given we're out of time might be a great place to stop it but thank you Jermaine, thank you Julie for your time appreciate it. Thank you Sean