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All right, we'll get started with our next one. I'm Ben Burnett, biotech analyst at Wells Fargo. Pleased to be here with the Amphistar management team. We have Bill Peters, CFO, and Tony Morris, regulatory. Thank you all for being here. Thank you. Thanks for having us. I think maybe just to get us started, start us with just a quick overview of the business and just frame any near-term catalysts that we should be focused on. Yeah, so AmphiStar's history is that we've worked on some of the most complex, generic drugs across many, many lines, including Noxaparin and Glucagon are probably the two that we're most famous for. Both became very large markets for us, but after time, we've had some generic competition. So over time, I've also decided to expand into branded pharmaceuticals as well. So the first entree there was our primatine mist, which is the only over-the-counter asthma medicine that was approved by the FDA. And now we purchased Baximi from Eli Lilly, and that's also a glucagon product, a rescue inhaler. But it's one of our keystone products and helps us, you know, and we see that as a foundational step in buying that to build a branded business off of that product. And then more recently, we've in-licensed several products that are more early stage, and we have some development programs going on so that we can keep that expansion going on into some other therapeutic areas as well. Excellent. And maybe, you know, a lot of assets there to consider. When you think about revenue over sort of the near term as we exit 2026, where do you see that kind of revenue ramp going? Yes. So as we exist this year, for next year, we're seeing, you know... What we've said for this year is that we're expecting to see mid to high single-digit revenue growth in 26. And while we've been a little bit below that at the beginning of the year, we're very confident in hitting those targets. But moving on into next year, what we see is that we're going to get continued growth out of some of the things that were driving our growth this year, including Baximi, Epitroprium inhalation, and then also some of the other API products that we're selling out of China now as well. So those are going to be some of the early drivers of that growth. But then also next year, we're expecting to get insulin aspirate approved and also AMP018, which is our first GLP-1 product, generic. Okay. We'll definitely get into that. On Baximi, you know, talk about some ofthe pricing dynamics that you've experienced. And I guess the question is, you talked about kind of correcting some of those double discounting instances that were occurring. What gives you the confidence that you'll be able to get to kind of your goal of controlling that double discount? Yeah, so first of all, this 340B issue is that, you know, 340V hospitals are hospitals that are serving mostly low-income patients. And there's a government program where they can buy pharmaceutical, branded pharmaceutical products at the lowest available price out there. However, they're not also supposed to take a rebate. And so what we've seen is sometimes they're taking a discount and a rebait, and they shouldn't be. So we didn't really see that happening until about partially in the third quarter last year, but we saw more of that in the fourth quarter than the first quarter. So as we investigated it, we found out that this was something that was happening across the pharmaceutical industry. It wasn't specific to us. So we took a look at what other companies were doing and found that many of them had hired third-party consultants who were involved in supporting data-driven identification, validation, and determination of these claims. So what we did was that we engaged one of those firms at the beginning of May of this year. So our second quarter results partially reflect the impact of that contract and engaging them. So we had part of one quarter available with them, but not the whole quarter. So what мы're expecting to see is that in the third quarter, we'll see more of an impact. And according to them, and, you know, they have a bunch of references that we were able to verify with, they were ableto eliminate about 80% of the double discounting. So with that, we believe once we get that into place, which should be primarily done by the third quarter, but definitely 100% done bythe fourth quarter, youknow, we should get back to growth and vaccine because the volume increases have been, younow, very strong. OK, that's that's fantastic. And I guess this this may answer kind of this next question, but like what are the you know, it's an important product to the business. So I guess what are The biggest sort of swing factors that could impact kind of vaccine me maybe beyond kind of that that that selling price dynamic? Yes. So the biggest thing is really the prescription growth. So we've seen strong prescription growth as we've increased our marketing efforts across the country. And, you know, most of that growth is driven in the United States. So we've seen that strong prescription growth that did not change even when we were getting the pricing headwinds. So what we've seeing is that when we bought Baximi from Lilly, about 10% of people who were on insulin would get a glucagon script filled. And so that left 90% of the market untapped because everyone that is getting an insulin prescription filled should also be getting a glucagon prescription filled as well. So what we've seen over the last few years is we've been able to increase that 10% to 12%. And our goal is to get that into the 15% to 16% range. So we think that continued growth of that compliance is really what's going to drive the growth. And then additionally, a smaller factor is that we did also take a 3% price increase in the second quarter to offset some of these pricing headwinds. Okay. And I think you've in the past talked about kind of a peak sales number that's achievable. Is it basically defined kind of by those two metrics you just mentioned, the penetration? It is. So when we take a look at where we are at the 12%, if we can get to that 15%, 16% kind of penetration, then we believe that we can get to that $250 to $275 goal and then maybe just a couple small price increases here and there. But, you know, the main driver of growth is not going to be pricing. It's going to being increased volumes as we increase compliance. Okay, excellent. Okay, I want to move on to the Ipertropium generic AMP007. I guess, first question on this, do you expect generic competition any time soon for this? It's really hard to say. We don't know of any other generic filers. So right now, we're assuming, you know, first of all, we have generic exclusivity because we were the first filer in paragraph four for this. So we have exclusivity until mid-October. So there won't be any for at least another month. After that, we really don't know if there will be or won't be, but we're always monitoring and we haven't found any data that says there would be. So the way we see it is that right now, when we forecast things, we assume that there probably will be at some point in the not too distant future, however, this year we think it's more likely that we are the only generic in it for the rest of this year. Okay. And for this product, has the revenue growth ramp, are you kind of at steady state? Right now, the market share of the generic is a little bit lower than you would normally expect to see at that point in the genericization scale. So I think that there's still room for growth where we are. However, when we gave our forecast after the last call, we said that we expected the revenues to be relatively flat from where we were at that time on a go-forward basis, that assumes that I'll say it's a hedged bet because it assumes that the generics will get more market share. However, there is some possibility of a generic entrant at some point. So it's hedged bed on that. So with some upside potential if there are no generics long-term. So that's something where we think we could have some more room to run if there aren't. Okay, fantastic. And then just moving on to the AMP004, this is the insulin aspart product. I believe the second insulin as part PK study appears to be complete. I guess any update just regarding the BLA submission and the timelines there? And do you still expect to launch that drug in 2027? Yeah, nothing has changed for the timing of the launch of that product. So we're still anticipating that. I mean, we don't really comment on the individual ups and downs with the correspondence with the FDA. We just feel that it's better for our investors and for ourselves. Just we give a target for when the launch date is and nothing's changed about that. So the trial is complete for that. Everything seemed fine and I think that's adequate for what we'll say about it. You know, in terms of the commercial dynamics, how important is the concept of interchangeability? You know there's a couple other drugs that are on the market, Kirstie and Miralog, one of which I think has interchangeability status. One of them doesn't, but I believe it came first. So I guess is that an important factor or important attribute? And is that something that the clinical trials that you've run would maybe support? Yeah, our goal the entire time with this application is interchangeability. And nothing that we've seen from the agency has dissuaded our confidence in having a product that will be interchangeable. It's an evolving dynamic with interchangeable and biosimilar. I think we all kind of follow that and how that what that leads to is uncertain. But we feel that it will give us a little bit of a competitive edge. And so we'll continue to pursue it. Keeping in mind that we manufacture the API, the raw material for it. It's a U.S. product. We have great manufacturing. So we think those are strengths of our product as well. Oh, okay. And maybe just to contextualize this a little bit, what is the swing factor in terms of getting interchangeability versus not? I mean, obviously we'll know until we get out there, but typically, like, is that – how big of a deal is that from a market share perspective? We haven't – up. So from a market share perspective, we do think that right now that there is a potential swing, but we haven't really quantified what that potential swing is to other people. But we do think it's certainly easier to get that market share if we have interchangeability. But I can let Tony talk about the compliance and the regulatory issues. Yeah, I think from a prescribing perspective, that's the dynamic that we see is potentially changing. And with the interchangeable, little bit easier to get that switch to to the interchangeable product as opposed to a biosimilar but i mean we'll it remains to be seen you know a year from now um or so yep okay okay and then i guess kind of following the same thread how important is all this for the amp005 asset yeah i think it's the same um yeah it's it's a similar product you know it's a different analog of insulin but the same interchangeability um rule would apply where where we feel it's a little bit of a marketing advantage, but it's not an essential component of our marketing. Okay, okay. And kind of just going down sort of the biosimilar pipeline, AMP 028. I guess, what can you say about this? I know there's a lot of proprietary kind of pieces built into this, but what can say about that and sort of, what can you say about your expectations regarding the launch timelines? Yeah, it's a very large product in terms of revenue and complexity. So I think this is kind of a shift in something that's going to broadcast the level of complexity as a company that we're getting into for some of these biosimilar type products. It's a great product. We're not really getting into the nuance, as you mentioned, because of competitive reasons. But as we continue to have it in our pipeline and have more solid timelines, we'll certainly show that. So does the complexity associated with some of these molecules maybe dictate, in terms of your model, the number of competitors you're kind of forecasting? Well, we think the more complex, the less competitors, although there's a limit to that, is some of the purely biotech companies maybe that are used to the larger molecules drop down. I think there's, I've always felt there's a sweet spot in the middle where some of the generic companies that are on the cusp of some of the molecules that they can get more, have more success in developing. And then you have the biotech over here and there's somewhere in the metal of like a squeeze. And I think on the more complex end of that is where I would say this fits in. And just to reiterate, one of the reasons that we decided to work on AMP 028 is that we thought we had a strategic advantage on the API manufacturing. We haven't discussed what it is specifically, but we do think that some of our current expertise fits very well with this specific product in this class of biologics. And because of that, we think that the production will be relatively easy for our API manufacturing group. and we think that the API manufacturing is the harder piece of this puzzle as opposed to the finished product manufacturing. So because of that, that's the reason we went after this. Something that we think we can do. We talked about Vaximi and some of these new products that are coming down the pipeline. What do you foresee as being the bigger determinants of revenue growth going through 2027? So, 2027 growth is going to be the continued growth of Vaximi, and now we'll have an easier comp, we think, with the first and second quarter because of the 340B. Headwinds won't be there anymore, so we'll Have some pricing benefit next year. We also see expanded growth for Primatine Mist. So, with that one, we continue to do the advertising campaign and some physician campaigning as well. So that's also going to be a strong growth. Our API sales out of the China business that we have, we think that there's some potential for growth there as well. And then when we take a look at the new product launches, the 018 and the 004, it's the last part, we think both of them will launch next year. So we think there's multiple drivers for growth next year that's layered onto the growth that we think we have in the second half of this year as well, Okay. Great. One question we get also is there's the revenue growth piece, but the bottom line growth. And so as some of these new products come into the commercial portfolio, where do you see that kind of margin? Yeah. So right now we think that the insulins are probably relatively close to our current corporate average, but other products we believe will be well above the current corporate average. So it's a mix of different things there because of that. Additionally, I should also say the API, though, the API is below the corporate average, too. So that growth will be below that. But when we take a look at some of the other things that we're working on as well, you know, they should, when they come to market, they will be above the corporate average and when we look at what we're planning to grow next year from the existing products with Baximi and Primatine Mist. Baxiomi is well above the corporate average and Primatin Mist as well. So we get that and then also with the increased manufacturing that we're expecting from some of these things like the launch of insulin aspart will enable us to utilize a significant portion of unused capacity of our API facility in China and also use a significant set that have unused capacity in our pen manufacturing area at Amphistar. So we have both API and finished product capacity that's either unutilized or significantly underutilized that will be able to help drive down the overall operating costs for the business. Right. Maybe let's turn now to sort of the medium to longer term kind of vision for the company. You have this proprietary pipeline. I guess question number one, it's a fairly comprehensive pipeline. What is sort of the most exciting thing that you're focused on within that pipeline? Yeah, I think when we think about the pipeline and some of these new products are exciting us, I think it's more of a platform for us. As a company, as we've evolved over the last decade or two, I think some of the things that we've really learned to do is have great skill sets and great capabilities, so whether it's developing peptides or proteins, you know, initially just buying it from another company and then understanding it, how does it fit in with the cell and the cell receptors and understanding the technologies needed to demonstrate that our product can align with that, so we can do things like have targeted cell therapies, whether it is cancer, or whether it's eye treatment of the eye, disease of the eye, that we can use some of these competencies. And it really has allowed us to have the ability to go into these proprietary products. So we look at some of the other successes we've had. We look at primatine mist. Primatine mist, we reformulated the product. And granted, it's a chemical. It's a small molecule, but we reformlated it. It'S an aerosol in an MDI, so it's relatively complicated in a device. And then we did the full panel of clinical trials, phase one through phase three, a large-scale trial as we did that. And we also had to do label studies to show that the label worked. So almost like a proprietary drug, not only a label study, but a label steady to be used in the over-the-counter setting, and really created a lot of complexity for that. And then you look at another product, Baximi, we're able to take a product and really expand it and grow this product, not only domestically, but internationally. And I think having all of those capabilities together creates this platform of technologies that we have and allows us to get into these exciting products, some of the oncology products and the eye diseases that are in our pipeline. Fantastic. And some of these are early stage. And, you know, as you develop these through kind of preclinical studies and phase one studies, like what are you looking at to decide what to advance and what to invest in? Well, I think for some of the early ones, we have to look at affinity, for example, finding affinity. You know, it could be as simple as that. It could be for an oncology drug. How effective is it? And there are a lot of models that we can use. We have, for example, some of them, we buy an early technology molecule, whether it's a peptide or a protein, and then it's put into these preclinical animal models that are well-established to look to see how well they are in treating a disease. And so that's an important consideration for us. Of course, we look at the market and make sure the market has the ability to do it. But if you look at wet AMD, for ejemplo, the technology that we have for that, we're very excited about it. the models that we've seen have some pretty good efficacy. And then if you look at some of our oncology products for pancreatic cancer, we see the same. We see that in these models, very, very effective. So really, those are the things that we're looking for on that. We'll get into the safety as we kind of progress. That's something, but as we're early animal studies, you know, we're working for some of these early models to give us some efficacy. Very cool. And the skill sets that you're gaining by doing this, does this unlock more on the generic and biosimilar side in terms of what you can do there, or is it the other way around? In my opinion, it's the other Way around. But it's kind of unique in the company. I mentioned how we just kept getting into larger and more complicated products. Whether it's anoxyparin, as we're developing anoxaparin, we needed to do immunogenicity studies. As we had teriparatide, we had to do immuno-genicity studies. So we needed a bio group, you know, something that you don't typically associate with a generic company, which we were. And then we needed to, as we're developing our primatine mist, we had to do some toxicity studies. And so we developed and we created our preclinical lab. And so, we have a preclINICAL lab, and we're able to do that. And we have the people to do dat. And then, as I mentioned earlier, some of the targeted therapy, like the insulin or of glucagon. We needed to learn, you know, we have an atom or we have a molecule and how does the orientation of the molecule fit into the receptors? How do we measure it? How do we do it in a way that we can explain to the FDA what we're doing? And, you know, I think it's a difficult thing for a traditional generic company doing small molecules to have it. So those steps that we took along the way gave us those capabilities. And when you combine all those capabilities, you just say, It's like, wow, we have enough of these that going into these proprietary drugs seems like a natural flow for us. Very cool. And you have a lot of, there's a lot different indications. You mentioned there's multiple kind of potential cancer oncology indications. You mentioned wet AMD. What's the right disclosure path in terms of presenting data to the investment community? Would you wait until phase one or could we see some kind of comprehensive preclinical data? kind of balancing that kind of proprietary nature versus that is something that we have a lot of conversation on um we think that there's some value in presenting some pre-clinical data but you know keep it in mind that wehave a solid foundation of manufacturing so our business is is unique in the sense that we we have well-established um commercial manufacturing portfolio. And so these pipeline products, although important, are one component of it. So we kind of balance between the two of how much do we want to disclose on this. And so we think it's important when we have some significant preclinical milestones that we'll share some of that information. If you look at our slide deck, it's evolved. And you'll see pages that will talk about things like when do we file the IND and how much clinical data that we present. I think it's kind of therapeutic. Maybe we'll look at whatever the therapy is for that and kind of see what the industry typically does. Those are the conversations that we often have. What's pretty common that investors see for a product like this? So it's unique that way, but it's something we certainly grapple with quite often. And it feels like the proprietary pipeline is kind of offering this sort of opportunity for maybe evolution or change for the company overall. So I guess to both you and Bill, like, how do you think about investing in that pipeline? Is the goal focused on revenue growth in the future or is it revenue growth with an eye towards maintaining profitability? Well, definitely revenue growth, with the thought on maintaining profitability. So when we take a look at this, the way I see it is that we've got four different products that are relatively early stage. We're going to invest in all of those at amounts that are preclinical slash phase one kind of spending level. So these are in the millions and up to maybe tens of millions per molecule over a couple year period. And so we believe that we have the capacity to do that from the cash flow that we're generating right now. But as we get to each step, we can see where we are with each of these and decide whether we want to continue or not to continue. Our goal would be to get all of these through phase two for sure. Some of these we believe we would eventually keep ourselves and bring to market so there would be more significant R&D spending at some point. However, with some of these, it's also possible that we partner with them after we get to phase two. Because especially if we take a look at the oncology products where there's more specialized marketing and more specialized tests and potentially some significant expense associated with getting those through phase three and also significant risk, I think they would be probably better off partnered at that point. So when people say, do you have enough money to spend on all of these programs, first of all, they're all early stage, and the probability that they all work is relatively low. But if they do all work and we are spending, I think then we are going to be in a position in a few years to say, hey, these couple assets have made it this far. They look great. We're going to partner on these and work with someone who can bring money to the table and potentially marketing expertise in those areas where we're not as big on yet. Okay, that's fantastic. I just, one kind of last question, just regarding your IMS subsidiary. I think there was a warning letter associated with that plan. How impactful is that? Yeah, so it's impactful in a couple ways, short-term and long-term. First of all, we have engaged consultants, so we are spending some money on that consultant that's doing a very thorough business review to make sure that we have all the right controls in place and that we are making sure that the quality is what it should be for a facility like that. Secondly, because we added some more quality controls along the way, we did have a slight slowing of the release of certain products. So that's put a very short-term slowdown in those releases that we could then ship. That should create a little bit of a bottleneck, but we're getting through that by adding a couple more resources, a couple of more heads to that area to help get through that backlog. But then when we take a look at it long term, you know, in talking to the consultants, what they said was, we've seen multiple warning letters just like this at other firms that have traditional clean rooms. And so we have a clean room that's, you know, 40 plus years old. So when you take a look at this, I think the FDA is going around and giving warning letters to many companies that have the older clean rooms. So our goal is then to potentially modernize that. So what we've decided to do is increase our capacity there by adding some more modernized, newer, or new clean rooms at that facility. We'd previously announced a large CapEx expansion at our Amphistar facility. So what we've decided to do, though, is hold off on a lot of what we are going to do there and shift those resources to IMS. So when we take a look at the big CapEx plan that we had announced probably two years ago, we're still looking at the same CapEx spending plan over the next few years. We're just going to shift where we're spending it. So there's really no change in the cash flow of the business due to that. Okay. Okay. Are there any questions from the audience? So the question is, will we be the first approved for the recombinant human insulin? Right now, we could be, but I'm not sure that that... It's always hard to say whether we will be or we won't be. Okay, fantastic. Well, thank you both for the time. I appreciate it. Great, thank-you. Thanks for having us, man.