Everybody, welcome back to the Bank of America Global Healthcare Conference. I'm Tazeen Ahmad. I'm one of the Senior Biotech Analysts here at the bank. Our next presenting company is IDEAYA Biosciences and sitting up here on stage with me are two members from the management team. We've got Yujiro Hata, who is Chief Executive Officer, and Josh Bleharski, who is, of course, CFO. Gentlemen, thank you for making the trip to see us today. Tazeen, thank you. Thank you so much for hosting us. Tazeen, really a pleasure to have us, and Josh and I are looking forward to the discussion today. Thank you. Okay. really quickly, you know, for those who may not be as familiar with the company, can you just give us an overview of IDEAYA, sort of the platform, where you are in terms of developing some key data catalysts, and we can go from there? Sure. IDEAYA Biosciences, we're a leading precision medicine oncology company. Our lead program is darovasertib. We just recently had top-line results in first-line metastatic melanoma. We also recently just received RTOR, so we'll be submitting our first pre-submission for the NDA next week. That's all going as planned. We also have two additional phase III registrational studies that are ongoing beyond metastatic melanoma, including in the neoadjuvant setting, as well as in the adjuvant setting. Outside of the U.S. We have a global partner in Servier, which we're very excited about as well. Beyond that, Tazeen, as you know, we have a very deep pipeline in precision medicine oncology, and we're very excited about what's coming ahead as well in our next assets. Here, we're probably next focused on DLL3, our Topo-ADC IDE849. We are targeting to have sort of registrational study by the end of the year. Our partner, Hengrui, in China as well, who is planning to start a registrational study by the end of the year. Here the key indications are in small cell lung cancer as well as neuroendocrine carcinoma. We have two clinical data updates we're guiding towards as well in the second half. Beyond that, we have a deep clinical pipeline in MTAP deletion, both what we believe is our first-in-class PRMT5 inhibitor, as well as a potential first-in-class MAT2A inhibitor. Here we have a significant focus on MTAP deletion PDAC as well as non-small cell lung cancer. We are also evaluating opportunities to enter into the RAS, KRAS space in terms of combination, so more to come on that front, which we're quite excited about. Beyond that, I would say probably the next program I would mention is a phase I KAT6/7 dual inhibitor. There are only two clinical assets here. It's us and Pfizer. We have key focus here in breast cancer, prostate cancer, CRC, a lot of excitement, enthusiasm. As you can see, a very deep pipeline going after very large solid tumor indications. Okay. Yes, you've got a lot going on. Let's try to do some of these in order of near-term events. For the top line that you reported for the OptimUM-02 study, can you give us a little bit of detail on that and what the next steps are in that program? Yeah. So here for folks that may be less familiar with this study, this is a combined accelerated approval and full approval study that we designed. The primary endpoint for accelerated approval is median progression-free survival, and for full approval is OS. What we reported was a PFS of 6.9 months in the treatment arm and 3.1 months in the control arm, which led to a hazard ratio of 0.42 and a P value of less than 0.0001. Great result, really puts us on track for that NDA submission. That's really been the focus. You may also know that last fall we also reported OS data. This was single-arm OS data, just over 21 months. We think historical OS here is gonna come in roughly in that 12-13 month range. We feel also good about OS. We did note as part of the top-line results, a preliminary trend, a favorable OS trend as well. We will have an ASCO late breaker oral presentation on Monday, June 1st. That's exciting. Here we'll just provide a more fulsome update. In addition to the PFS Kaplan-Meier curve which we showed, we'll have a full CT scan waterfall, both treatment control arm, both by central review as well as investigator scoring, including just a full data, safety data set as well. Okay. Can you just talk to us about what the competitive landscape looks like here? Sure. Josh, do you want to hit that? Yeah. Actually, HLA-A2 negative setting, there really isn't anything approved. Current standard of care is checkpoint inhibitors and chemotherapy, and that was what we had in our control arm, the O2 study that we just reported out. On the HLA-A2 side, there is an approved agent, we'll also explore the efficacy of the darovasertib-crizotinib combo in that setting as well. Yeah. To engage with the authorities, with the FDA on that as well. What do you think is the total addressable market opportunity for your product once approved? Yeah, I mean, look, we think that this could be a very significant opportunity. Obviously, within the HLA-A2 negative setting, which is where we're primarily focused with O2, you know, we think there's roughly, you know, what are 1,500 patients in the U.S., you know, the majority of which are HLA-A2 negative. Again, it kind of comes down to where we land on pricing and duration. Those would be two of the major drivers that dictate kind of market opportunity there. Yeah. We think it's quite significant. When you start to factor in potential uptake in the HLA-A2 setting as well as in the primary melanoma setting, in the adjuvant setting, you know, those opportunities start adding up. Okay. For the HLA-A2 negative population, how easily are they found? Yeah. I mean, a lot of those patients are treated in concentrators, concentrated centers of excellence. Yeah. Fortunately, through the work we've been doing, most patients are. There is a long tail. There are many patients that are treated in a community setting. We're working hard to identify them, so that we can reach as many as quickly and efficiently as possible if and when we get approved. That'll rely on sort of a grassroots, kind of feet on the ground strategy, as well as data and analytical strategy that will complement our sales effort. Okay. Given that this is an ultra-rare indication, you know, what's a range of pricing that we could use as comps? Obviously, you're not gonna announce price to us today. Yes. As people try to think about, you know, range, what do you think would be good comps here? Yeah, I mean, that's work that's underway right now. I as you said, I don't think we're ready to comment much specifically around pricing. Look, I think what we wanna do is look at the totality of our data and price the drug appropriately based on the benefit that we deliver. There's obviously an approved analog out there that I think many people point to. That's not a bad place to start. Again, I think it'll have to we'll have to see how our data matures, both on the PFS and then overall survival side. We feel pretty good about the profile and the benefit that we've delivered. Okay. In terms of, you know, investment in setting up for, you know, commercial organization, how big of a footprint do you think you'll need for this indication? Yeah, that's a great question. you know, we think it's a pretty modestly sized sales force. You know, some of our peers in the industry and the model that they've employed. You know, we think, you know, this would be a pretty, conservatively sized sales force, and it will be able to effectively target this opportunity in the U.S. That work is all underway right now. Okay. How long do you think it'll take over time to expand into those larger populations that you just mentioned? Yeah, I mean, I think, again, we'll, we have those registrational studies up and running in the neoadjuvant setting. In the adjuvant setting, we will start that trial imminently with our partner, Servier. You know, that data is going to take a little bit longer to develop and mature, so those are likely several years out. Beyond the metastatic launch. However, you know, we will look at ways to accelerate getting into those patients, particularly in the neoadjuvant setting, using some of the data we've already generated in the 09 study. We're gonna be looking to publish that data and look for ways to maybe accelerate that, potentially through a compendia guideline strategy. Okay. Go ahead. I think just on the other, on the adjuvant side, you know, we'll be launching that study here shortly, 450 patients. We think enrollment should go quite rapidly for that just based on the demand. There's nothing approved in the adjuvant setting. We'll be HLA agnostic. Then also because we'll be focusing on the high to high/medium metastatic risk population, also that RFS readout hopefully will be expedited based on that as well. Okay. In the few minutes that we have left, maybe we can talk a little bit about some of the pipeline programs, Yujiro, that you mentioned. Maybe let's talk about IDE849. You mentioned, you know, DLL3-positive tumors. How should we be thinking about the opportunities there? Yeah, look, it's a very sizable patient population. In terms of the indications of focus for DLL3, I would say first is small cell lung cancer, right? You're talking about an annual incidence globally that's, you know, at least 100,000 patients or more. Here, DLL3 is broadly expressed in small cell lung cancer, we don't anticipate we're gonna need to patient select. In neuroendocrine carcinoma as well, also a very sizable population. U.S. alone, you're talking 20,000, 30,000 patients a year. I think a lot of significant interest there. Very high unmet need, as you know, in the neuroendocrine carcinoma space. You know, response rates are even in the teens range. You know, typically what's utilized is chemotherapy. The last indication we do have quite a bit of interest in is also melanoma. We know DLL3 upregulation has been high there as well. We have not evaluated patients there yet, but that's also another area that we'll be focused on. Okay. How do you prioritize which indications you wanna focus on first? I would say that right now our primary focus is in small cell lung cancer and in neuroendocrine carcinoma. I would say the first registrational study we wanna launch will be a monotherapy registrational study. We're evaluating both later-stage small cell as well as neuroendocrine carcinoma. We're also considering sort of a basket type approach as well to see if we can pull several of those populations together. In terms of frontline strategy there, I think that's gonna be mainly focused in small cell lung cancer, and for that, you will likely need to do that in combinations, looking at assets like PD-L1. You may know we've recently put a relationship in place with AstraZeneca. We're also doing a proprietary combination with our PARP inhibitor. That could also potentially enable a chemo-free regimen as well, so I think a lot of opportunity there. That will likely be more focused on for next year. Okay. In terms of data catalyst for this program, it seems like you'll have a few next year. Yeah. on DLL3? Yeah. Actually, by the end of this year, we'll have two. One will be our partner Hengrui's update from their phase I China study. Okay. That'll be over 100 patients. It'll be a pretty robust data set, both small cell and neuroendocrine carcinomas. I'd expect that to be a pretty fulsome update from what they showed last year at the World Conference on Lung Cancer, including potentially an OS cut, so landmark OS data for the first time. That's exciting. Then in parallel, we'll look to provide an update on our phase I. IDEAYA-sponsored trial, with DLL3, and that’ll be obviously small cell and neuroendocrine carcinomas. We’d be hoping to show response rates in different tumor types and just probably get a sense of initial activity. It’ll be probably too early for PFS data. Okay Hopefully we'll get to see safety and some preliminary signs of activity. How many patients worth of data would that be? Hopefully it's 30 to 40. Okay. That's what we're hoping for. It's basically a basket study. Correct. Yeah. Okay. Sorry, Yujiro, you were gonna say something. Yeah, no, in Hengrui's data it's gonna be over 100 patients, so in aggregate it's gonna be, you know, a large data set. I think the other piece we can mention, even based on the early data, the data's been very consistent. In China and outside of China. Yeah. How de-risking is that Hengrui's data going to be for your own study? We think it's gonna be very de-risking. You know, look, we think a lot of the key questions around the DLL3/Topoisomerase space is around durability. You know, we did share some preliminary PFS data at the World Conference on Lung Cancer last year, but there wasn't a lot of follow-up. Now there's a year more follow-up, a much larger denominator. We're seeing consistency with the China and non-China data. Now, for the first time, we'll also have some landmark OS data. We're gonna answer a lot of questions. In our view, based on what we've seen, is we believe we've got a potential best-in-class asset here. Definitely one to pay attention to. Okay. Are there other companies looking at the same mechanism? In terms of DLL3/Topoisomerase, there's us, there's another biotech company. Roche is also in phase I. With their asset. On the T-cell engager side, there's Amgen's and Imdelltra. There're several other pharmaceutical companies. A lot of activity here. I think our view is we have the opportunity to have a best-in-class DLL3/Topoisomerase, but also potentially have a backbone type therapy brought across all of DLL3 in small cell lung cancer. Okay. Last question is how do you think about the toxicity profile? So far it's been very, very solid. I mean, I think here it's been mainly around myelosuppression. I would say consistent with what you've seen with Topoisomerase. I think the advantage we may have with the DLL3 antigen versus, let's say, B7-H3s, is I do think we are seeing less ILD in particular, and which we think makes it potentially the preferred antigen target for small cell lung cancer. That could become important as you start thinking about other combinations, whether that's with PD-L1, with T-cell engagers. Okay. Perfect. With that, our 15 minutes is up. Thank you guys for making the trip over here. We appreciate you taking the time. Thanks everybody for listening. Great. Thanks so much, Tazeen. Thanks, Tazeen. Bank of America. Really happy to introduce ATEC Spine for our next presentation. We have CFO, Todd Koning. Thanks, Adrian. Appreciate you guys having me, and thanks for coming. You know, I'm Todd Koning, CFO here at ATEC, and, you know, I think there will probably be some forward-looking statements, so be aware. You know, we'll talk about our growth algorithm, our, you know, how we continue to grow and some of the catalysts that we have in the business. You know, we've clearly demonstrated the ability to leverage the growth that we've seen and, in the business implied in the way we've built the business, and we'll talk a bit about that, and we had the opportunity to strengthen our balance sheet as well. First, I wanna talk about the overall market opportunity. We size the market to be about $10 billion in total. Again, given our size, we're just slightly under 10% of penetrated. We think there is so much opportunity for us to continue to grow at outsized rates above the market growth. You know, the overall market, we feel is healthy, kinda a low-to-mid-single-digit growth rate, which really in the context of maybe the last 5 or 6 years seems to be, like, in recovery mode and feels good from our standpoint. When you look at that market in terms of the $10 billion, I think what has been really the focus of the company for a fair amount of time has been the lateral market, we size the lateral surgery market to be about $1 billion. We think it's one of the faster-growing segments of the market. It's one of the faster-growing segments of the market because ultimately, it allows for, you know, lower blood loss, less morbid procedure, and essentially like a faster recovery for patients. There's a lot of good reasons to do lateral surgery, and we think lateral surgery is a great alternative to address the traditional posterior approach surgery market, which we size at about $2 billion. Traditional posterior approach surgery can be addressed through a lateral surgery approach, fundamentally, we think that ultimately gives better results and allows surgeons to do better surgery and patients to get better care in the long run. We'll talk more about our lateral offering and how that ultimately addresses that market as well and continues to drive that growth and really our outsized growth in that space. I think if you went back, six, seven years, I've been with the company about five years now, but if you went back to the remake of the company in 2018 when Pat Miles, our CEO, and Luiz Pimenta, our CMO, came over, to remake ATEC, you know, they set out to really answer the question of: Why did lateral surgery only address about a third of the total opportunity? Like, what got in the way of a broader adoption of that surgery if that surgery is so much better? You know, the, the three tenets of our strategy have not changed in that time. The first thing is really to create clinical distinction. What do we mean by that? We mean allowing surgeons to do better surgery. When you do that, you ultimately compel their adoption. There's no better way to have sticky share taking, if you will, than to compel somebody by virtue of the quality of what you provide them. Our approach has been to really attack the spine market through a procedural view. A surgeon doesn't see a patient and say, "What screw, what pedicle screw am I gonna use? Or what interbody will I use?" They look at the patient, they then understand their pathology, and then they say, "What procedure am I gonna apply to that pathology to treat the patient?" In the context of that, you have all the components of a surgery. We've focused on the procedural adoption and the procedural approach to solving some of spine's greatest problems. In the process, we've compelled surgeons to adopt our procedure. When you do compel a surgeon to adopt your procedure, you get the attention of the best sales talent in that area to support that new surgeon adoption. I think that's been well demonstrated by the volume of surgeons that we've seen, which you can see here on the left-hand side of the screen, the consistent growth in surgeon adoption and the increased utilization in each one of the cohorts on an annualized basis. Here you can see that on a quarterly basis, going all the way back to 2024, we've seen approximately 20% growth each quarter in the number of surgeons who ultimately are utilizing our procedure. I think that underpins the point of compelling surgeon adoption through clinical distinction. You know, where it all started was really lateral surgery. When we created PTP and our lateral approach, it was through a very deliberate view on how to tackle some of the hurdles of a broader lateral adoption. Part of that was positioning, part of that was the repeatability and the reproducibility of a lateral procedure. You've seen us invest in things like a patient positioner, things like neural monitoring, which allows us to monitor the patient, not just to avoid hitting a nerve when you create or when you place your retractor in and create the surgical corridor, but also monitor the health of the nerve intraoperatively so that you can avoid the most common complication associated with lateral surgery. We're the only company who can do that. You look at all of the procedural elements. When you create a procedure, oftentimes you set the requirements and really set the rules for surgical engagement. When you create a procedure and you set the rules, people oftentimes follow those rules. That's one of the things that allows us to ultimately architect a highly productive or highly reproducible and predictable experience from a lateral standpoint or a procedural standpoint. Also, it enables us to capture the lion's share of the revenue opportunity for that procedure, which is why you see our revenue per procedure at probably $12,000 on average over the past 12 months. Because that represents our ability to ultimately capture a large portion of the revenue share in the procedure that goes on. You can see on the slide a number of the different components of those procedures. What happens is, as a surgeon adopts your procedure and you think about lateral surgery, they will apply that platform approach, the PTP approach or LTP approach, to a broader set of pathologies, the more confident they get in utilizing the procedure. As they do that, they have greater adoption, and as they do get more and more confident with PTP and LTP, they ultimately expand their adoption to other parts of our portfolio, like ALIF or cervical or increasingly deformity. Speaking of deformity, EOS is an imaging system that we bought in early 2021. It was well established in many of the leading academic settings and since then has continued to be evident in our ability to access those academic settings. It is widely accepted, is as the standard, the best image for spine care. It's a standing full body weight-bearing biplanar, meaning you get a picture from the front and a picture from the side, low-dose radiation image. What that image is, it's a standard image. We ultimately can create a structure, a set of structured images through the EOS image that allows us to ultimately understand what is the image and what is the patient's, what are the pathologies they have, take that, apply our AI algorithm to create the automated alignment measures. We can compare those alignment measures to normative values. We can then create a plan for the surgeon, do all that in a very clinically integrated way that will then generate a patient-specific rod to support the intervention. They can order that rod, we'll deliver that rod for surgery, and then they'll intervene on the patient based on the plan that they created. After the operation, they can measure the patient again through EOS. Because it's a standard structured set of data from an image standpoint, we can now compare the patient's experience on a longitudinal basis through EOS images. That really then, as you think about more and more EOS imaging and that longitudinal dataset becoming more and more prevalent across more and more sites and surgeons, we will have a very proprietary structured dataset for us to really understand based on a pathology, based on patient demographics, what was the intervention, how did that intervention get reflected after the surgery, and then how did the patient fare over time. Ultimately, that can then turn into some sort of predictive modeling as well. You know, what we've seen in our early experience with EOS Insight, and EOS Insight is the software application layer that does all of the work that I just described, outside of the imaging, of course, that experience over the last 18-24 months has been very good for us. You can see the graph on the right-hand side of the slide. It'll tell you that after 6 months of implementing EOS Insight, the sites that we have that, their volumes have grown about 30% relative to the prior 6 months before EOS Insight was implemented. We think that's a very promising signal and sign for the influence that information and data has on the surgical decision-making process, and we think that's obviously value-added. Otherwise, you wouldn't see the increase in the volume post-implementation. Here we wanna talk a little bit about Valence. Valence is our navigation and surgical robot that we've just launched here in this past quarter. Valence has been a surgical navigation platform that we have integrated into PTP. Whereas most spinal robots have been built to place pedicle screws, which is great for the placement of pedicle screws and it reduces, you know, some surgeon burden from a physical burden as well as a mental burden and really just gives confidence in terms of knowing where you're gonna place the pedicle screw, whether that's through a navigation component or for a surgical robotic placement. I think that becomes more and more prevalent over time. What we've done is we have integrated our navigation and surgical robot platform into PTP to ultimately create a more predictable and reproducible experience in lateral surgery such that it can be made available to a wider set of surgeon skill sets. Imagine that you can now place your retractor, can navigate the placement of your retractor. You can navigate your discectomy and your end plate preparation. You can navigate your inner body placement and all of that. You can, of course, navigate and robotically place your pedicle screws. We think that ultimately gives a surgeon who may not have a great history or amount of lateral experience, gives that surgeon more confidence that they can intervene a patient in a lateral way in a more precise and predictable manner. Our international experience has been one of being narrow and deep has been our strategy. A couple of years ago, we entered Australia and New Zealand, and that has been a good experience for us, continued to grow. About a year or so ago, we entered Japan. In March, we did our first PTP in Japan. We're very excited about the international experience. I think what our strategy internationally is to be in a narrow set of countries to go deep so that we can build a direct sales organization. We can reflect the clinical thesis of the company, which should allow us to get greater penetration and drive a higher profitability profile in those markets. Speaking of profitability, you've seen the company deliver on its profitability commitments over the last number of years. We've significantly improved our profitability profile, largely because of the way we've built the company. We invested in infrastructure and scaling the business over the early years of the company's build-out. You can see in 2023 and then into 2024, our profitability went from negative to positive, so we became positive adjusted EBITDA in 2024. We're now positive cash flow here in exiting 2025 and now here in 2026. You know, the strong profitability growth you're seeing here, 44% growth is the implied growth in EBITDA on our 2026 guidance for adjusted EBITDA. Like, ultimately, the way we've built the company, the leverage comes through the business because we've built a very scalable organization. We've invested in the infrastructure, so the growth that is to come can drop through at a greater rate in the future. I think that gives us great confidence in our ability to continue to grow profitability at a meaningful rate here in the future. We also had the opportunity, because of the increased profitability and cash flow of the business, to refinance our term debt. We had about $200 million of term debt that we refinanced. I think we're super happy with that because we saved about 300 basis points of interest, which is about $6 million a year, as well as I think it sends a strong message to have great partners like we did, underwrite the quality of the business. I think that speaks volumes from where we came. Finally, you know, our overall guidance for the year, 15% top-line growth at $882 million, $134 million EBITDA and $20 million of free cash flow on the year. You know, I think we're uniquely positioned to deliver outsized growth in excess of the market growth, continue to drive profitability expansion, which ultimately I think leads us to greater and greater cash flows as we go. Couldn't be more excited about what we're building, what we're doing for patients and surgeons and how that's translating into a financial outlook. Thank you very much.