Good afternoon, everyone. My name is Mike Guba. I'm the healthcare sector specialist here at Wells, and I'm pleased to have Bill Peters and Tony Marrs joining me from Amphastar Pharmaceuticals. So why don't we just kick it off? We're gonna jump right into questions, but why don't we just kick it off with some general background, you know, for those in the room and who are at home watching, you know, give us a background on the story, and how you guys differentiate yourselves from the competition. Yeah. So as background, Amphastar Pharmaceuticals is a biopharmaceutical company. Our background is that we've always been working on some of the more complex generic drugs out there. And really, I'll tell the story of our development through some of our main products that we've gotten approved over the last decade. So, about a decade ago, we got Amphadase approved. It was a hyaluronidase product that was considered by many to be the first biosimilar product, because while it was an ANDA at the time, it has since been moved to a BLA, and it gets recognized as having a great technical challenge in getting that getting that approved like that. Our second big accomplishment was getting enoxaparin approved. We fought the lawsuit on that one. We won the lawsuit, so we have good experience in winning Paragraph IV challenges. And that was one of the products that was one of the more complex ANDAs to get approved. In fact, it's considered a biosimilar in Europe and other countries as well, while it's still considered a drug in the United States. So, we got that one approved, and along the way, we learned good skills that have helped us through our products today, such as strong characterization practices, immunogenicity studies, and other clinical trial practices that help us today as we get more products approved. The next milestone for us was really getting Primatene Mist approved. That's the only OTC asthma inhaler that's approved by the FDA. That was a complicated process as well, though, where we learned more tools, such as human factors studies. It took us a while to reformulate it, because it had been taken off the market because of the propellant. CFC was banned through the Montreal Protocol because it was depleting the ozone layer. We have a more environmentally friendly propellant now in HFA. Reformulated that, did all the studies necessary and got that approved, which was a difficult one that a lot of people thought we couldn't get to. And then our last big milestone, approval from the development side was glucagon, which we got approved almost three years ago. That's another one where it was a milestone because the characterization and the impurities were very difficult to get to. In fact, when we got that product approved, the FDA actually put out a press release and touted it as one of their big accomplishments. In their annual report the following year, they listed getting that product approved as one of their big accomplishments for the year. So it's still today the only generic equivalent for the Glucagon rescue kit, and it is the only product that where we have a synthetic API that's substitutable for a recombinant API. So it just shows our ability to do these things that most other companies can't do, to be out there. That's helpful. And so, I mean, it's hard to look at the story without noticing a meaningful share price appreciation this year. So kind of just giving background over the near term, I guess, like, what do you think were the biggest accomplishments that kind of caught the investment community's attention there? Yeah, I think even though we got Glucagon approved almost three years ago, I think it took a while before people started to realize how big a product that was for us. And it improved this year as we, you know, increased our market share with some discontinuations of other competitive products in the market. We were able to double our capacity, and then we were able to take advantage of those disruptions from other players in the market and establish a larger market share than we had in the past. So we've been able to do that through, like I said, our strong manufacturing abilities and our good marketing abilities as well. Additionally, this year, I think we've also benefited from, you know, continued growth in our other core products and also with being able to take advantage of some disruptions of other competitors in the generic pre-filled syringe markets as well. That's helpful. Another major product that kind of stood out to me on Q2 was Primatene Mist. Do you mind just kind of giving investors a little background on the pushes and pulls there, specifically with regards to capacity and, you know, the dynamics that played into the quarter? Sure. So Primatene Mist is one where each of the first two quarters of this year, we had our factory-level sales were down slightly, but the way we tend to look at this product is more of what are the retail-level sales doing? And in each of the first two quarters, retail sales levels were up by about 5% each quarter. So we continue to market that product. It continues to do well for us, and we continue to see that one as being a growth driver for the company, because we know that the difference between the factory sales and the retail sales can't go on forever. So even though we believe that the retailers are destocking over these two quarters, that trend won't continue, and we expect that to turn around in the third and fourth quarters of this year. Got it. What, what do you think actually, like, drove that initially in terms of the inventory build and now the destocking? I think it had a lot to do with COVID, really. So I think when COVID hit and there were a lot of retail supply disruptions, I believe most of the retailers decided to stock up on inventory and make sure that they had enough. I think they weren't sure of their supply chains, so they built up inventories, and I guess they built up ours as well. I will say, going back to Primatene and our capacity, we actually make that right outside of Boston here, and we have plenty of capacity at that factory for that product, and we're also planning to make five generic ANDA inhalation products at that factory as well. And so we've recently doubled the capacity of that factory. We have more than enough capacity to supply Primatene Mist, plus those other products that we have coming to the market. Thank you. And then looking forward into the fourth quarter, Intranasal Naloxone. Am I saying that correctly? Yes. So you pushed that on the 2Q call, you pushed that launch into 4Q. Can you just kind of discuss what drove that decision and maybe, you know, how it was related to the other aspects of your business? Sure. Just as a background, we make our, or we plan to make our Intranasal Naloxone product at the same factory where we make many of our other prefilled syringes, and we have two lines that are dedicated to epinephrine, lidocaine, phenylephrine, atropine, another supplier for those. We know, we have a very good relationship with Lilly, so, we decided that because there was such a demand in the country for those products and we were the only ones, our other suppliers aren't today. So, we did decide to delay that. And while we're on the subject of that drug shortage, maybe Tony can talk a little bit about why, you know, that's such an important thing, working well with them is such an important thing for our company. Yeah. As Bill said, we do have a good relationship with the drug shortage group at the FDA, and we're able to leverage that to some of the other products that we have that might be a quasi-shortage product and educate the drug shortage group on some potential shortages of other products. In some cases, be able to convince them about potential shortages due to other supply changes, and then based on that conversation, get them to interject into other divisions to help speed up the process for some of the supplement applications that we may have. For example, increasing capacity in a certain line. We're able to leverage that relationship to get them to go to that review division and ask them to help facilitate expediting that process. Got it. Well, FDA and the medical community, I'm sure, thank you for that. Turning to another kind of major headline for you guys this year, the Baqsimi acquisition. Do you mind just kind of giving us an overview of that acquisition, what excited you about the asset, how the deal was structured, and anything there? Yeah. Well, for us, it was a really exciting asset because we know the Glucagon molecule very well since we already make the Glucagon Emergency Kit, and we're one of the leaders of that product right now. So we knew that molecule very well, so we also knew it was a difficult-to-do product. So when we took a look at Baqsimi, we saw that as really the next generation and moving forward, and we saw it as really the premier product in that space. So for us, it was an opportunity to get the best product in that space. So it works, you know, it works as well as the rescue kit, but the one of the benefits, there's many benefits for it, but one of the big benefits is that, it's easier to use and also easier to carry. So for a person that needs a rescue medication, having it with them and having it easy to use is very good. And when we take a look at the Glucagon kit that we make right now, it's a kit in a relatively large plastic box, has a vial in it and a prefilled syringe with a diluent. So you have to mix the diluent into the vial, the freeze-dried powder vial, and then extract it and then inject it. Whereas with the nasal spray, it's just a simple thing where you open up the package, you take out the nasal spray, and you spray it in your nose, and you're done. So it's a much faster, easier, more compact solution. We think that the ease of this, the ease of use, the ease of transferability, we believe it will increase compliance, because one of the problems in the anti-hypoglycemia market today is the lack of compliance. So the Diabetes Association recommends that every patient who takes insulin should also be prescribed a Glucagon rescue medication as well. So, but when we take a look at the actual number of scripts that are filled for that product, only about 10% of the people are doing that today. So with only 10% compliance, there's a significant opportunity to increase the compliance level, and we think that having a medicine that's easy to use, quick to use, easy to carry, is one of the answers to that. So we believe that there's a lot of upside to that market, over time, and we believe that focusing on some of the younger patients, we're going to be focusing a lot on the pediatric endocrinologists, can help compliance and help, you know, save lives by making sure that the people have a rescue medication that's with them. One of the things I like about this product, it's an international product. W ith a well-established supply chain, something that Amphastar doesn't have a big presence internationally. And so this product is going to allow us to set up those supply chains, set up the regulatory contacts in the different countries and territories to allow us in the future, when we see good opportunities for products that have that international presence, whether it's only outside of the U.S. or completely international, including the U.S., to take advantage of some of those opportunities. Something that in the past, when we may see a product that has high potential, but because it has that international presence, primarily, we would shy away from those. So it gives us the opportunity to expand into those as we see those opportunities. Going back to your question about, you know, why we did this. First of all, it fits very well with our strategy going forward to move more towards proprietary products, also focus more on the diabetes area. We have other products that are intranasal products, such as our Intranasal Naloxone, and we're also working on an intranasal epinephrine. So it really fit all of the areas where we wanted to be and where our, where we wanted to go as a company. Additionally, when we ran the numbers on this, in almost every scenario, it was a very positive NPV project for us. We think that it's going to be something that we, we do make a lot of money on, and, it's going to be very, very beneficial for our shareholders in the long run. Because when we also took a look at this, you know, being the only company that's been able to genericize the Glucagon rescue kit, we realized that this would be a difficult product to genericize. So given the formulation would be very difficult, the molecule is very difficult, and also the device is very difficult as well. So when you add all of that complexity to it, we see this as something that's going to have a very long life to it. So while we're investing a lot of money right now, and I think some people might have been worried initially that it was a very large percentage of our market capitalization, we really believe in this product, and we think it's going to be very beneficial for the company over the long run. That's helpful. And then, you know, kind of in a related note, I believe you guys take over marketing responsibilities from Lilly in early October. How are you thinking about kind of that marketing strategy go, on a go forward? I know it's probably neither of your core competencies, but something that I was interested in, in learning a little more about. Yeah. So you're right. We don't have that type of sales force right now. Our current sales force is mostly focused on the generic drug market and the hospital market, working a lot with the different buying groups that supply those. So we'll use some of that existing sales force for this product. However, we are in the process of signing up a contract sales force. So we actually signed them up. We're in the process of hiring them, and in the next couple of weeks, we'll be training them as well. So, excuse me, October first, we can hit the ground running, and we'll transition over to our sales force. While the good thing about our sales force for this product versus the Lilly sales force, and Lilly's sales force is, of course, very talented and very active in this, but, you know, for them, Baqsimi was really a third-level product for them, so it wasn't something that they put very much focus on. For us, it's going to be our most important product. So we're really going to focus on this product and focus on the patients and focus on the compliance for this product. And because of that focus, we believe that, you know, we can really drive the utilization of the product. That's helpful. And then kind of like circling back, circling back to that, you know, focusing on a younger patient cohort. You know, the question that always comes up with, in terms of these products is the back-to-school seasonality. So I know, you know, this transition is still happening, so you might not necessarily have direct line of sight there, but any commentary there that you're willing to provide would be appreciated. Yeah. So when we take a look at... You know, we took a look at the IQVIA data for this year versus last year. And it—there always is an uptick in scripts this time of year as people get the extra rescue medication to take to their school. You also see a similar effect in, like, the EpiPens. So we've seen that same kind of angle of uptick in this year as compared to last year. So we do see the scripts increasing rather significantly in the July, August time frame. Well, that's good to hear. Then moving over to pipeline. You know, earlier you mentioned kind of the move over to more proprietary products. Do you mind just giving a general overview of some of the more exciting assets in your pipeline? And, you know, what, what should we focus on in the go forward? Yeah, I think the branded products are a good area that we're kind of moving towards. And I think as far as our pipeline goes, we have a number of products in the intranasal line that we see there are certain advantages to going from an injectable to an intranasal. So we see good opportunity for development of those type of products. One of the products in the near term that we're excited about is our teriparatide, this AMP-015. The excitement of this, it's Eli Lilly's $600+ million product. There's currently no approved generic for this product. It's a complex product. It's a peptide. It's on one of the FDA's list of complex products that they'd like to see approval, so we have the momentum there. And it's a combination product with the device component to it as well. So it's a complex product that we think will provide some good barriers to having a lot of entrants into it. We've responded to a first CRL to that earlier this year, and we have an action date for the first quarter of next year. So we see that as a near-term great opportunity for us, very high-margin product. Second, we also have AMP-002, another product that we are excited about. This is a product that has a GDUFA date the FDA has missed back in the first quarter, the second quarter of this year. So it's been a number of months with essentially no activity. The FDA hasn't asked us for any data. We haven't provided them any since that, and we're kind of in a holding pattern, if you will, of just corresponding with the project manager, trying to get updates for it. And this product could have an approval at any time. We're I think the FDA is looking for some sort of roadmap to approval of this product. We haven't disclosed what it is, but it's just a... It's one of the complex products with a number of hurdles to overcome. So hopefully soon the FDA makes a decision and finds that path forward. We're also excited about the insulin products. We're about to submit our first biosimilar interchangeable, where our desire is interchangeable biologic license application for this product. So later this year, we'll be submitting that application, so we're very excited about that as well. Got you. And how do you plan on releasing or updating the market in terms of when that submission happens, or is it a press release, or, you know, how do you usually approach that communication? We usually do it in our next public communication. Mm-hmm. So whether it be, you know, if there's a press release with earnings or, at a conference or something. You know, if we had submitted it yesterday, we could announce it today, but- Okay. No, we have not yet. So, but we will give an update at some appropriate time. Got it. Now kind of turning over to the clinic. You know, when I was going through the deck, I noticed that you kind of hope to, or plan, on shifting kind of the proprietary mix to 50% of your business, by 2025. That's still on track, and, you know, what is, you know, the strategy behind that? Yeah, as I mentioned, a big part of that is intranasal route of administration. If you look at our Naloxone 505(b)(2) route of approval and our Primatene Mist 505(b)(2) approval, we've figured out a methodology for using 505(b)(2) as an effective strategy for approval of these type of products. And a big component of is the characterization of the molecule, the defense of why it's important to make that switch, but also the characterization showing the bioequivalence for whatever your reference product may be. And I use the term reference product because you're referencing the efficacy portion. So you have to do a clinical component of that, to show that your product is equivalent or superior to the product you're referencing. It's kind of a tricky thing to match there. You don't want it to be... So what you try to do in the clinical trial is to match the PK profile of that product with some defense about what's an appropriate marker to use as an efficacy surrogate. And we've been pretty effective in that strategy. So we see for our intranasal products, a whole slew of products that we have in various stages of development, that we can brand as branded products. Intranasal epinephrine is one example, and we see that it's certainly a superior route to the patient to be able to, instead of giving an injection, to be able to give a spray into the nose to reverse that anaphylaxis. And there are a lot of other opportunities like that. Another item is Baqsimi, and we see Baqsimi through the acquisition of products as another way to get these branded products. And one of the advantages, and you touched on it, of Baqsimi, is the marketing aspect. We don't have a large marketing department currently in sales force. To be able to use Baqsimi to transition that way... And if you think—Think about it, Baqsimi is an Eli Lilly product with a very mature sales and marketing department that have marketed this product. They've established methodologies to do it and the contacts. And so we're leveraging that and the relationship we have with them, and the agreement that we have is over up to 18 months to transition that. And so being led, if you will, by Lilly for this sales and marketing force, to be able to have a product with that established and not having to start from the ground up, is very advantageous to us. And we see the ability to leverage some of that sales force for some of these other branded products as we progress to approval for them. Super helpful. Then I guess, you know, I'd be remiss if I didn't bring up the GLP-1 dynamic here, especially within Glucagon. Not necessarily front and center in terms of current, like, debates in the market right now, but probably too early to tell. How should the market think about that? Or, you know, is it too early? Yeah, it's interesting. I mean, we can predict for the Type 2, I think that one, we're anticipating to be a decrease in that. And I mean, great for us as a civilization to have those products. Certainly will affect the Glucagon, as there's less dependency on the insulins for that population. The Type 1, I think, is a population that remains to be seen. And certainly, the article this morning is kind of touching on the possibility of the impact to those. But to me, I think it kind of remains to be seen what the real impact to the Glucagon market would be. And the other thing you have to remember about the Glucagon market when you go back to our injection kit, that right now almost 40% of our sales are for the diagnostic side. So in the diagnostic side, it's being used to help physicians when they're doing a scan of someone's gut. So it slows down the body at that point. So they need an injectable medicine to do that. So that's gonna be, you know, that's independent, completely independent of the diabetes patient. So there's still a large market for that, and that's a lot of what we've picked up this year as there's been a disruption in that market. Got it. There's. That's, I mean, at least that percentage is a very durable aspect of the- Yeah -channel. All right, so kind of in the final few minutes here, is there anything I missed? Like, what are the primary questions people are asking today? You know, anything you'd like to cover? You know, I think that we haven't spent probably enough time talking about, you know, just. And we've spent a little bit of time talking about it, but the, you know, the focus of what the company is going to, and the, and the complexity that we're going to, and some of the things that we've done. And we've talked about the drugs we've gotten in the past, but I think all of the things, the products that I mentioned earlier that got us to where we are today give us the tools to be successful in the future. Whether that be the characterization, the factor, human factor studies, immunogenicity studies, all those things that we've learned along the years that to get to the products that we have, will help us with these products that we're working on in the future. The other thing is that I know a lot of attention has been put this year on our Baqsimi acquisition, and it should be, because it's a very large acquisition for us. But that said, our primary, I'll say, value generation is from our internal science and our internal research and development, and the work that we put into that group. So it's really, you know, while we might do acquisitions in the future, and if we do, they'll have to be very strategic and very, I'll say, NPV positive, because we don't want to focus as being a company that just buys things, and so it's a little bit different for us this year. But we're gonna be a company that develops things and puts our science, our strong science, to use, and that's gonna be the value generation for the company. So, Tony? Yeah, and I think insulin, there's a reason that, that there's a lot of chatter about it. And so we've been developing insulin for a long time, and our strategy has been measuring, measuring, measuring before we cut, and I'd view cutting as, as submitting our application to the FDA. We have had numerous meetings with the agency, really trying to make sure that we're on the same page with them on how we're characterizing the product. Our true goal is to have this product approved as an interchangeable. We don't want to go the route that we've seen of biosimilar and then eventually, interchangeable. We think that's, that's not a, a, a good strategy for us. We want it just to be interchangeable from the beginning and really focusing on our relationships with the FDA and how we've characterized some of these other larger molecules, like Glucagon and enoxaparin. And really using that and the lessons learned from that to put together the package, submit it to the FDA for their review, and meetings with the FDA, and let them comment on it and let them ensure that we're on the same page with that. That's really something that's delayed our insulin, but we've done it strategically so that we would be in the position where when we file it, the FDA has a very clear picture of what we're doing and how we're planning to characterize it. Awesome. With that, I think we'll wrap up. Really appreciate it, Bill and Tony. Thank you very much. All right. Thank you.