Good afternoon. Welcome to Needham's 23rd Annual Healthcare Conference. I'm Serge Belanger, one of the healthcare analysts here at Needham, and we're happy to have with us this afternoon the Amphastar Pharmaceuticals team. Joining us is Bill Peters, the CFO, Dan Dischner, Corporate Communications, and the VP Regulatory Affairs and Clinical Operations, Tony Marrs. So before I hand it over to Dan for a brief overview of the company, just want to mention that we do have the capabilities to do Q&A. Those watching online can submit questions via the portal you are watching on. So, to get started, I guess I'll hand it over to Dan, who can give us an overview of Amphastar before we jump to fireside chat questions.
Great. Thanks, Serge. Appreciate it. Happy to be here. Amphastar is a fully integrated biopharmaceutical company, and when I say fully integrated, I mean we develop complex, generic, and novel products. We manufacture API and/or key components, and we make all our finished products in the United States with a complete front-end integration, including marketing and distribution. The main purpose for this strategy is to maintain control over quality and compliance throughout the product development and manufacturing cycle. We believe we've built a strong reputation on quality and innovation and reliability under our vertically integrated model. We've developed a diverse portfolio of generic and proprietary products across multiple therapeutic areas, highlighted by Primatene Mist and BAQSIMI, and then also our generic glucagon injection, with a shifting profile towards proprietary and biosimilar products as we move forward.
We kind of have a dual strategy, growth model with a primary focus on a robust internal pipeline, and then coupled with that with an inorganic strategic acquisition type of growth strategy. We're headquartered in California, and as I said, we're proud we proudly manufacture all our finished product in the United States. However, the recent acquisition of BAQSIMI has provided us with a more global presence in key markets worldwide. I know there's a lot to unpack there, but that's Amphastar at a high level.
Great. Maybe we'll start with BAQSIMI. So, as Bill knows, I've covered the company for a long time. The company was always active on the BD front, but mostly on the smaller deal side. So BAQSIMI acquisition was, I'd say, a departure from Amphastar's long-term strategy. Maybe just talk first about the reasoning and strategy behind that, the transaction.
Yeah. So really, a few years ago, we decided that we wanted to focus more on proprietary products. And part of that was because of the, you know, the uncertainty around some of the complex products when we brought them to market, uncertainty being, you know, how many competitors that we would have. So because of that, we said, "Let's take some of that risk off the table by focusing on some proprietary things." So when we saw this, we thought it was a great proprietary product for several reasons. One, it was a glucagon product, and we're already very big in the glucagon market. We understand that market very well. Secondly, when we took a look at the formulation, we thought it was a really well-done product, really well-formulated. The device was really good.
And we also thought that it was probably the best glucagon product on the market today, so that we thought it was a great product to buy and bring into our portfolio. We also realized it was going to be very hard to genericize. So we think that the product will have a very long life to it, well beyond the patent life, which goes out to 2036. So there's a lot of things that we did like about the product, and we thought that Lilly, while they had launched the product very well, it didn't you know, it wasn't meeting their threshold, so they took it out for their focus. So because they weren't focusing on it, it really provided an opportunity for a company that was smaller to focus on that product and really bring it further along to market.
So, an inhaled glucagon. Maybe just talk about the market opportunity. I think you mentioned in your. Bill, you mentioned in your comments that you think it's a better product out there for this indication. Maybe just talk about the competitive field.
Yeah. So right now, historically, glucagon was distributed as a product that was a lyophilized powder, and people would have to reconstitute it before they could utilize it. So, you know, taking our glucagon that's just currently on the market, it's a kit, and it contains a vial of lyophilized powder. It contains a syringe with a diluent. So you have to take the syringe, inject the liquid into the vial, reconstitute it, and then withdraw the liquid from that vial back into the prefilled syringe, and then inject it. It's a complicated process, especially for someone that might not be familiar with it. If a person has an episode where they are hypoglycemic, they might not be responsive, might not be able to communicate and do it themselves. So you're relying on someone else to do this.
So with a product that's already ready to go, all you have to do is take it out of the container and then spray it into the person's nose. It's, it's just a much, much easier product. So we, we really like that much better. And, and so with us, for us, we see it as a large market opportunity. And right now, we think one of the biggest reasons it's underserved is that it's underserved. So right now, only 10% of the people who are on insulin are getting a glucagon script, whereas everybody, the doctors recommend that everybody get one. So, so we see there's a 90%, you know, unserved market right now, and we hope to tap into that.
Okay. On the competitive side, Gvoke is kind of the main competitor, or are there other ones?
Yeah. So Gvoke is definitely one of the main competitors. It's also a ready-to-use product, and so, you know, we think the market should be shifting to the ready-to-use products. We think our formulation's better because it's an intranasal product, which we think works very well and doesn't have to deal with, then people don't have to deal with needles. Because remember, it might not be the person who's a diabetic that has to use this. It might have to be a friend or a family member or someone else that doesn't regularly use needles, might be hesitant to use a needle. So that's why we think that the nasal spray opportunity is much better for us, for the market.
Got it. Okay. And you mentioned there's only 10% usage right now. I mean, that leaves a significant market opportunity open for you. Where do you think that number can get to?
Yeah. So what right now, what we've said is that we believe that we can get the sales of this product, BAQSIMI, up to $250 million-$275 million from where it is today. So we see it as really having a significant growth from where it is. And most of that growth is going to be unit growth.
Okay. All right. So even at those levels, there's still significant upside just because that 10% number can move the needle pretty quickly, right?
Absolutely.
Okay, so transition of the product into Amphastar, I guess, is still ongoing, but has achieved some significant steps. Maybe just give us an update on where that is.
Yeah. So remember, initially, when we bought the product, Lilly continued for the first three months to do everything that they had been doing. So they were detailing the product. They were distributing the product. They were managing the supply chain globally. Then after, in the fourth quarter of last year, we took over the selling of the product. So we have a sales force that's an external sales force, but solely dedicated to BAQSIMI. So they're out there, selling BAQSIMI and detailing it to physicians. In the first quarter, we had several important things happen. One, we began the process of transferring the marketing authorizations around the world from Lilly to Amphastar. We also began distributing the product in the United States. So in February, we began distributing the two-pack, and in March, we began distributing the one-pack. Also, we began distributing the product in Italy.
So now that we have, you know, remember, the United States accounts for about 80% of the BAQSIMI sales. So as of the end of the first quarter, we're now distributing over 80% of the BAQSIMI, from a sales perspective worldwide. So the impact that also has is, first of all, we've done that. The second thing is that, it affects the accounting because remember, we were recognizing revenue on a net economic basis, which means that, Lilly was doing all those things for us, and what we would do is we would receive they would send us a check at the end for the net amount. So, the sales that they got less all of their expenses. So that net amount is what we were recognizing as revenue, in the third and the fourth quarter last year.
Now, in the first quarter of this year, there, we're still going to have that net economic benefit for most of the world, but in the United States, it's going to be part net economic benefit, part a normal sales model that we would for any other product. So it does make things a little bit more confusing, especially in this first quarter where we have that transition. But after the first quarter, it'll be, you know, in the United States, so over 80% of our sales will be on a normal sales model. So I think that'll help people understand the product a little bit better from an accounting basis.
Got it. And what kind of sales efforts are you putting behind the product in at least the U.S.? Does it compare to what Lilly was doing?
Yeah. So it's very different. So we have a much smaller sales force, but they're solely dedicated to BAQSIMI. It's the only product that they're detailing. Whereas BAQSIMI had a much larger sales force, but it was the third product in their bag. So they were only answering questions. So if a doctor had a question about BAQSIMI, they would answer it, but they weren't doing anything proactively. So now that we're proactively detailing it, we think that there's much more opportunity to increase the sales of the product.
Okay. Maybe I'm assuming too much here, but did all the contracts and existing business from Lilly transfer over, and that gives you a base to build on?
So some of you know, some of the things worldwide transferred, some of the pricing models that we had from the governments around the world that set pricing, some of those transferred over. But we had to reestablish the individual payer relationships within the United States. But we, you know, Lilly had already set those things up for us ahead of time, and so we were able to make those transitions relatively easily. But that's also why it took a little longer for some of the distribution to happen in the United States.
Okay, so we should expect BAQSIMI to be one of the growth drivers for 2024 and.
Absolutely. So, you know, what we've said so first of all, we only had sales of it for six months last year, so we'll have the full month, this year. That, that's a big part of it. The other thing is that we've said we expect to have, single-digit high single-digit unit growth from BAQSIMI, but low single-digit pricing decline. And the pricing decline is because of the wholesaler fees that we have to pay. So Lilly gets to pay a much lower fee than we do to the wholesalers because they have much more bargaining power than we do with a larger, variety of things that they're negotiating with. So, because of that, we will have that, that pricing hit, but overall, we still see product, revenue growth from that product this year.
Got it. Okay. Moving on to your, your other glucagon product, I think it was a pretty significant growth driver in, in 2023.
Yeah.
Like you had expected. But maybe talk about how, obviously, it addresses a different market opportunity than BAQSIMI.
Yeah. So there's two things. First of all, it was a huge growth driver last year. We more than doubled our sales from the year before, and part of that was from people exiting the market. We were able to do that because we doubled the capacity for the product previously, and we got that doubling approved by the FDA early on in the year. So we had proactively done that, and we were able to take advantage of that significant growth. So right now, though, what's the interesting thing is because of that growth, we had gone from a market in the United States for the glucagon kit where we were selling 2/3 of it for the antihypoglycemic market and one-third to the diagnostic market. That's flipped now.
So now 2/3 of our product is sold as antihypoglycemic or to the diagnostic, and one-third is to the antihypoglycemic. And so the good thing about that is that the diagnostic market, we believe, will be more stable and, and grow slightly over time. And so that's, whereas the antihypoglycemic market, because we have these better products to use, like BAQSIMI, we see that declining over time. So what we've also said is, while that is going to decline in the United States, that decline will be offset because we're now going to begin selling the product in Canada. So we began in the fourth quarter, but had a very small amount of sales in the fourth quarter. So, in the first quarter, that's going to take effect and will impact that decline, that we have in the U.S.
Okay.
Will offset that.
In terms of manufacturing capacity, that's not really an issue at this point?
No, it's not an issue. After we had doubled it, we've got plenty of capacity now to take up the market size that we had last year. So.
Okay.
We probably don't have room to double again, but we did have room to double.
Right. But from the U.S. growth perspective, it sounds like you still expect growth, but nothing like we've seen over the last couple of years.
Exactly. So it's really going to be muted because, like I said, that 2/3 is going to stay relatively flat, maybe have very low single-digit growth. The one-third is going to shrink domestically, but that shrinkage will be offset by the Canadian sales. So there might be a little bit of room for growth when you combine the Canadian sales might more than offset the U.S. decline.
Okay. Let's talk about Primatene Mist. I think you had set a target of reaching $100 million in peak sales by 2024, and I think you more or less already achieved that.
Well, I'll let Dan talk about that, but let me clarify that it's not peak sales. It was just a target for this year, so.
Yeah. So we definitely remain focused on and believe that the $100 million this year is achievable.
Okay.
When we originally set a goal of $65 million, that was our first milestone. That, that's when we set the $100 million mark. So we feel like, "Let's get to the $100 million mark first, and then maybe we'll set another milestone after that.
Okay. But clearly, it's still growing.
Yeah.
I think initially, you spent a lot of time establishing these, you know, various distribution agreements to be in all, all the major retail points. So what's driving growth now? Where should we expect additional volumes?
Yeah. We think it's a volume growth, as we move forward. Mostly, it's the positive trend in the in-store sales. In Q4, we saw well, I think we had $24.48 million in sales, which is a 10% increase year-over-year. So we see a good positive trend in-store sales, so we'll just keep kind of our commercial efforts focused there.
Okay. So not ready to set a new goal above 100 yet?
Not yet. But, you know, let's get to the end of this year, and, when we announce earnings next year and the final sales next year, we can,
We'll look at the.
We can talk, we can talk about it and see what we see, coming into the future.
Got it. Got it. I think another place of success with the company has been addressing product shortages. I think you've been well set up to do that in terms of expanding manufacturing capacity at the right time and in the right places. I guess, is there still room to capture additional ones at this point? Or should we think that the ones you have now will continue being opportunities?
Yeah. I mean, we expect some of our competitors to come back into the market, maybe in the second half of this year, and, you know, maybe fully in a year from now or so. But the truth is that for the last 10 years, we've seen some shortage in, you know, in some capacity, with a lot of these critical care products that we make at our IMS facility. So I think we anticipate it kind of being the same as we move forward with some more competition in some of the products, obviously, you know, some of the suppliers coming back into the market. But it's hard to predict, really, where that competition will be, but we always see it.
Okay. I think the last quarterly update, you talked about expectations for some new product launches. Some of them require FDA approval of ANDAs, but one of them's already approved, REXTOVY. Is that launch ongoing at this point, or it's still kind of getting ready?
Yeah. Well, we planned the launch by the end of April this year, so we're really excited about this launch. You know, obviously, going back to the shortage issue, that was one of the reasons we delayed the launch of REXTOVY so that we could meet the demand for a few of the products because they use the same filling suite as we use for REXTOVY. So we had to build up some inventory, do some validation batches, and we're looking to launch that product here in the second, you know, by the end of this month.
Okay. And, I mean, is there a significant opportunity here without having to go OTC?
Well, it's a very competitive market, as you know. There's a lot of players in it. We think, we're going to really focus on the first responders marketplace because we kind of have a foot in the door with our injectable product in that market. We also see possibly a lot of states have been procuring this product to supply to different clinics and such. So we'll focus on that. But it is a competitive market, so we're not really forecasting it to be a huge product for us.
Okay. The process to get to an OTC product approval, is that fairly straightforward?
Yeah, it is. The FDA's voiced to us that they want to have our product go to OTC. We've done, if you recall, for Primatene Mist, we had to do the switch, if you will. They went through kind of a switch platform to bring the product back to market. So we're familiar with the process. We've been very engaging with the FDA. We've had meetings with them already to go over the process. The Primatene Mist experience for us has really paid off for that process, this process because we're able to, for example, send a protocol to the FDA with a list of 100 questions, for example, about, you know, questions of where it could be difficult as we run a trial, as we run a label trial. And as we did that, the FDA gave us very, very good feedback.
The value of it is just to get to that level of granularity where the end result for us or the end goal for us would be to do one study to address all of the potential questions in a study that the FDA's looked at the protocol and all questions were answered before we started it. And we think we've achieved having that understanding with the FDA. So for us, the next step is just simply to run these label-type studies and submit the update request to the agency. They've clarified with us that that's essentially all they're looking for. And the other thing is there are two other companies that went through that process and so we can get a sense of what their requirements were for that.
Okay. Is that a filing you're expecting this year?
Yeah. We think it should be something we'd be able to put together and file this year.
Okay. And would the sales effort behind the product change drastically once you have OTC status?
Well, as we said, I think our sales team believes that a lot of the sales focus is going to be towards maybe the municipalities and the states and so on. So I think they're going to stay focused on that, and OTC would just be another option.
Got it. Okay. And the other product approvals you're anticipating, it's from your ANDA pipeline. Any updates on AMP-002?
No, we continue to, you know, push where we can push, and do what we can do. But essentially, I mean, the FDA has missed their deadline. We continue to ask and get relative same answer. They're working on it. There haven't been any new requests for data or information or anything. So we're just sitting on our hands, patiently waiting, and doing what we can do, but really no updates on that.
Okay. They haven't approved any other similar product, so?
No, no. We definitely are keeping our eyes on that. And, I mean, this is a product that there's just no patent. There are no patents, much like our glucagon product, no patents on it, just a difficult-to-manufacture product. We think we met all of the requirements there and just kind of waiting to see, in this interesting case, you know, no meeting and action date, and then what? And there's just from a statutory perspective, it's in the black hole, so to speak, of the FDA's, statutorily, they we don't have any means that there's an appeal process for us. So we're just going through, doing what we can do to help encourage them to get that through.
Okay. So, more or less, one day, you'll wake up to an email that says you've received approval?
Approved. Yeah. That's the way we want to wake up one morning. So that's essentially where we think it will probably be, that they'll figure out what their issue is and give us positive approval.
Okay. I think there's two other products, AMP-008 and AMP-015, that have PDUFAs, I think, this quarter.
This quarter? Yeah. Yeah. Very positive. The teriparatide product, we've gone through, and the agency did a PAI inspection, and they're done with it, and essentially, no issues from that, as expected. Now we're just waiting for them to hopefully approve the product. It's this quarter is the PDUFA, so hopefully, we'll have some news on that. There are two other generic products that were approved within the last couple of months, within the last six months or so. So, you know, it's going to be a little bit more crowded than we'd like, but.
Yeah.
still a large market, as far as the potential sale, so we're encouraged by that. Our other product, AMP-008, same thing this quarter is the P DUFA date. And we're very encouraged by anticipating approval on that product. As always, we don't have the FDA crystal ball, but we're very positive about this product, so. And we haven't disclosed what this product is for, for obvious competitive reasons, but.
Okay.
Yeah. So we're positive about those two. We're very, we feel very positive about those products.
Okay. And I think you also have disclosed that you have, you've been working on a GLP-1 ANDA. Any additional details you can provide on that one?
Yeah. We're getting ready to file it. We've been in the arena of these type of products, these glucagon-type products, you know, GLP, peptides and proteins, so it just seemed natural for us to just drop in another product that is very similar to the other ones we've been working to develop and have developed. And so, you know, we're excited to submit this application.
The insulin biosimilar program, you've also filed the first BLA there. Maybe just, you know, give us a quick overview of the program. I think it's, it's one of the opportunities that, I think, remains misunderstood at, at Amphastar.
Yeah. We're, we're excited. Many, many years ago, we, we had the idea of, of insulin products, and we, we purchased a facility in, in France that makes insulin API, commercially as, as an API to a number of U.S. a, a number of, of companies throughout the world, including in the U.S. And we learned the, the capabilities of, of producing it. We also have our API facility in China, that we greenfielded, you know, from the ground. We brought our U.S. quality system in there from the beginning and have been producing API, that facility, commercial API, for, for many of our products, for quite some time. And as we had the capability and the knowledge of producing the insulin products, partially learned through the, France facility, we've continued to expand that facility in China to be able to produce some of these insulin APIs.
As part of that, as we've seen some of the FDA's desire to bring more insulin products, specifically, interchangeable products to market, the FDA's provided a lot of guidance documents to help manufacturers to be able to bridge that gap, very technical needs and requirements on what it would take to do that. We've been very engaging with the FDA throughout this process. As the API manufacturer, we're able to tailor the manufacturing process of the API to meet those very, very stringent requirements so that we'll, in the end, have a highly purified, very high-quality API that would, in our minds, meet the criteria for, having it to be interchangeable. In order to do that, we've had to work very, very extensively with the FDA, in order to properly characterize the product, as we compare it to the reference drug.
So throughout that process, it's been quite extensive engagement with the FDA. We've had many, many meetings with them, where we would provide our methodology and some of the protocols for performing those type of studies in order to meet those requirements. And they've been very encouraged. The FDA has been very, very open with us of what those expectations are, and we've throughout that time worked extensively with them. We filed our application with them earlier this year. The FDA has asked us to make a few modifications and resubmit it, which we're planning to do this quarter. And we view that as very encouraging as well, as a continuum of the FDA's engagement with us. It wasn't simply just resubmit. It was, "Here's what we'd like to see in it," very extensive, minor nuances in many cases.
And we view it, again, as something that this engagement process has allowed us to have this communication method to do it, because we have the technical capabilities and this pathway that we're developing with the FDA and how to get the interchangeability and the characterization. We also have a number of other products that are in our pipeline that we will start bringing forward that are these other insulin products. And so we have the first one that we're submitting, which is the aspart that we've been working with, but we also have a longer-acting form of that. And then we have degludec and also the recombinant human insulin that we'll be following through after this. And I think the cadence is maybe every 12-18 months.
We'd anticipate to have a new filing with the agency. And again, it's following the footsteps of what we're learning through the process of this product. All these other insulin products largely will follow this methodology. And, and so once this path is developed, it's just, like, bring them in and just start with that cadence and get it.
I assume when this gets approval, you can drop it in the same bag as the reps that are selling BAQSIMI?
Yes, but no, because it's, you know, our goal is to have an interchangeable product so that we don't think we really need to detail it. So when we originally, you know, going back 10 years, we thought we might need to do some kind of marketing for it. But now that the FDA has this pathway, this interchangeable pathway, we think it's much simpler than that and also less expensive than that to bring it to market.
Okay. So technically, that opens up that bag to additional other products. I'm just curious what the appetite is to keep adding new products via BD here.
Yeah. So it, it's definitely something that we've got our eyes on right now. As you mentioned when we talked about BAQSIMI, the acquisition at the beginning of the presentation, you know, we've generally focused on smaller business development opportunities because we have such a good R&D program and a good pipeline that we don't need to. And that's still our focus today is on the R&D program. However, we would supplement that with other acquisitions, and we have looked at some. The primary thing that we would be looking at is something that would fit in well with BAQSIMI, so a second product to go along and in the bag with the people that are detailing BAQSIMI. So we are definitely focused on things that are focused on endocrinologists and endocrinology systems and so products like that.
And we've looked at a few things, but, you know, right now, it really has to, one, fit in well with BAQSIMI, but, two, also be the right price. So we don't want to you know, we're not a company that's going to be out there that, that's going to shift that focus as well to suddenly become a serial acquirer. We're going to be very careful and very diligent as we have in the past and focus on the opportunities that fit in well with that and are also priced right.
Okay. I don't know if you, you want to elaborate on that, but, like, given where you are with the, the leverage associated with the BAQSIMI acquisition, what does that leave you with in terms of dry powder for, BD?
Yeah. So when we closed the BAQSIMI acquisition, our leverage was about 2.5x EBITDA. And we're including the adjusted EBITDA as defined by the banks, I'll say. So as we, you know, we included the first payment that we have to make to Lilly of $125 million that we have to make in June of this year as debt, even though it's not really debt. So once we make that payment, we'll be below 2x. So because of that, we believe that we have significant opportunity to apply more leverage to the company should we find the right opportunity. And I'll also say as a corollary to that, because Jack and Mary are founders and CEO and COO, are very dedicated to the company, and they have a 25% stake in the company, they don't want to dilute the company.
So we're unlikely to have to or want to do any acquisition that would require equity financing. So, the debt financing is definitely the way we would go if we were to find another opportunity and it needed to be financed. Now, it might not even need to be financed given the fact that we do have right now over $300 million of cash and investments on the balance sheet right now, and we're very cash flow positive and generating a lot of free cash flow. So because of that, you know, we might not even need to do that.
Okay. And Bill, I know I know you don't give official guidance, but usually give color. Just curious, if you feel the current consensus numbers are in line or you're comfortable with them?
Yeah. So let's start with the revenue side. And that's, I think we're comfortable with that, and there's a few different ways we can get there. I think the easiest way to get to that number is by bringing some of these products to the market, starting with REXTOVY, AMP-008, teriparatide, and hopefully AMP-002. If we can get all of those to market, in the second half of this year, then I think that that's the first way we get to those numbers. Additionally, the other way to get there is that if BAQSIMI outperforms expectations, glucagon outperforms expectations, who are in our internal projections, we assume that the supply interruptions that our competitors have had stop after the second quarter so that they return to the market.
If there's other supply interruptions and shortages that we have to take care of, that's another way we can get to those numbers. There's multiple ways to get there, but, you know, we think that they're definitely very achievable.
Okay. Maybe just to wrap up, well, I guess I think last quarter last quarterly update, you mentioned some pretty important capital expenditure plans. I think.
Yeah.
Looking to expand manufacturing capacity. If you can just highlight those plans for now.
Yeah. So right now, the way I like to look at it is that, you know, we had a base of CapEx spending last year, which was relatively high, but that's to do capacity expansion and also to do some enhancements to our productivity around the world as well. But on top of that, we're layering a large project here in Rancho Cucamonga, where we're going to be significantly increasing the capacity that we have here for products by building a new sterile suite that will have the opportunity to have five new sterile facility that will have five sterile suites involved as well, plus packaging areas as well, plus executive offices too, and the equipment for the first three of those five suites built out.
That project is underway right now, but we're in the architectural phase still, so there's not a lot of money to be spent on that this year. But starting next year in 2025, what we've said is that we're going to be planning to spend about $20 million a year on that project for the next three years. So $120 million in total for that. But it's a really big project. And we're doing that because we're really focused on the future of the company and where we're going to need to be five years from now, to build out and manufacture all the items that are currently in our pipeline that we've announced and some of the things that we haven't announced as well.
Okay. Maybe just lastly, anything you feel about the Amphastar story that remains misunderstood or underappreciated by investors? We only have a few minutes.
The way the stock's been trending, I think they missed the boat a lot. But that said, I think look, we focus on these very complex products. So it takes time sometimes to develop them. And interaction with the FDA, we've gotten better and better and better at it. And I think the BLA application that we referenced for that we submitted earlier this year and the FDA's quick comments back to us asking us, they you know, I think it really helps, you know, our development process with these complex products. And I think just having an understanding that these are not things that you just punch out. They're just not cookie-cutter products.
So I think a lot of times when we have meetings with people, it's really hard to get that story to resonate, is that these are difficult products sometimes, and it takes more interaction with the agency. Yeah.
Okay. All right. Well, I think we're out of time, so I'm going to let you gentlemen go to your next meeting. But anyway, thank you. I thought it was a very productive fireside chat, so.
Great. Thanks, Serge. Appreciate it.
[audio distortion] thank you.