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spk05: Greetings and welcome to the Amphistar Pharmaceuticals Inc. third quarter earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note that certain statements made during this call regarding matters that are not historical facts, including but not limited to management's outlook or predictions for future periods, are forward-looking statements. These statements are based solely on information that is now available to us. We encourage you to review the section entitled Forward-Looking Statements in the press release issued today and the presentation on the company's website. Also, please refer to our SEC filings, which can be found on our website and the SEC's website for discussion of numerous factors that may impact our future performance. We will also discuss certain non-GAAP measures, important information on the use of these measures, and reconciliations to U.S. GAAP. may be found in our earnings release. Please note that this conference call is being recorded. Our speakers today are Mr. Bill Peters, CFO, Mr. Dan Dishner, Vice President of Corporate Communications, and Mr. Tony Mars, Senior Vice President of Regulatory Affairs and Clinical Operations. I will now turn the conference over to your host, Mr. Dan Dishner, Vice President of Corporate Communications. Dan, you may begin.
spk06: Thank you, Paul. And I'd like to thank everyone for joining us today. On the call with me will be Bill Peters, CFO and Executive Vice President of Finance, and Tony Mars, Senior Vice President of Regulatory Affairs and Clinical Operations. Following my prepared remarks and Bill's financial update, we'll open up for Q&A with the management team. I want to start by highlighting our third quarter's financials at a high level and then provide some remarks regarding our products and our pipeline with further discussion on glucagon's evolving market dynamics. We remain encouraged by our progress, with net revenues of $120.1 million, up 7% from the same period last year. Our balance sheet is stronger than ever and provides us the flexibility to continue investing in our robust pipeline. Therefore, R&D investments, as seen in the third quarter, continue to be a priority for us as we remain committed to advancing our pipeline toward approval and launch of special regard to our inhalation, internasal, and insulin products. As stated in previous calls, our existing products, primatine mist, glucagon, and epinephrine, have once again provided a solid baseline of support. Primatine mist continues to perform as projected with some seasonality in demand. Glucagon and epinephrine have grown at 21% and 8%, respectively, compared to the previous quarter. Likewise, we remain confident that the demand for these products will remain robust for the remainder of the year and into 2023. Regarding our pipeline and regulatory activities, I'd like to bring our discussion towards our AMP-008 inhalation filing, which received a CRL last month during its first cycle review. We believe the issues raised are relatively simple and addressable and are within the scope of our pipeline's focus on developing complex products with innovative delivery systems. As such, we intend to respond to that CRL in the fourth quarter of this year. Likewise, with our teriparatide application, we believe the issues are clear and we plan to refile in the first quarter of 2023. Turning to our generic pipeline product, AMP002, the CRL we received in July has been fully responded to with the new GDUFA action date scheduled in the second quarter of 2023. I want to note that our AMP002 and teriparatide ANDA filings are for products that remain without a generic due to the product's complexity. As stated previously, if a pre-approval inspection is needed for any of our filings, the goal date is typically extended to the following quarter. Our second inhalation generic pipeline product disclosed on our last call, AMP007, remains on track for filing in the first quarter of 2023. As for AMP004, our interchangeable generic insulin Aspart product in development, We continue to maintain a positive dialogue with the agency as we finalize the details of our application and remain on track for a filing in 2023. As we turn to our proprietary pipeline products, our intranasal naloxone refiling in September has been issued a goal date in the first quarter of 2023. Our intranasal epinephrine product remains on track for filing in 2023 and we anticipate further discussion with the agency on this product in the fourth quarter of this year. Before I turn the call over to Bill, I want to speak in more detail with Glucagon. As you may be well aware, the Glucagon market dynamics have increasingly evolved towards a strong position for the company due to Eli Lilly's planned discontinuation of their product by the end of this year. and Nova Nordisk or Boehringer Ingelheim's planned discontinuation of their glucagon product. These changing market dynamics in the retail and diagnostic spaces equate to significant potential growth for our glucagon product. With this evolving glucagon market, we are working closely with the FDA to increase our production capacity for glucagon and remain in fruitful dialogue with the agency to provide a reliable supply to accommodate this changing market. We are committed to maximizing our opportunity to supply glucagon's projected increase in demand. I would like to turn the call over to our CFO and Executive Vice President of Finance, Bill Peters, to discuss the third quarter's financial results. Bill Peters Thank you, Dan. Sales for the third quarter increased 7% to $120.1 million from $112.2 million in the previous year's period. Primatine Mist saw sales growth of 11% to $18.4 million from $16.6 million in the third quarter of last year, with strong sales on all of our current customers. Leucagon sales increased 17% to $14.2 million from $12.2 million on strong back-to-school sales. Phytonodion saw stronger demand this quarter as sales increased 21% to $14 million from $11.6 million. Epinephrine sales increased to $19.5 million from $13.9 million on strong sales of both the multi-dose vial and the pre-filled syringe, the latter of which saw strong demand due to competitor shortages. Other finished pharmaceutical products saw sales decrease of $3.4 million to $23.6 million, as lower sales of atropine and calcium chloride were partially offset by increased sales of dextrose and the recent launches of Ganirelix and Vazopressin. Our insulin API business had sales of $3 million, down from $3.2 million last year, primarily due to the timing of orders. Cost of revenues increased slightly to $61.6 million from $61 million. Gross margins improved to 49% of revenues from 46%, as increased sales of higher margin products, such as glucagon, primatine mist, betonadione, and epinephrine, as well as sales of newly launched ganarelics and vasopressin more than offset higher labor costs. Selling, distribution, and marketing expenses were relatively unchanged at $4.8 million. General and administrative spending increased 10% to $12 million from $10.9 million due to increased legal and compensation expenses. Research and development expenditures increased 72% to $18.5 million from $10.8 million as we had significant clinical trial and material expenses related to our insulin and inhalation products. Our non-operating expense of $400,000 compares to a non-operating income last year of $12.9 million as the 2021 amount included a one-time gain on the divestiture of 80% of ANP's subsidiary Hansen. The company reported net income attributable to Amphistar shareholders of $15.9 million, or 30 cents per share, in the third quarter, a decrease from the $29.5 million, or 59 cents per share, in the third quarter of 2021, which benefited from the one-time gain on the divestiture of Hansen. The company reported an adjusted net income of $20.2 million, or $0.38 per share, compared to adjusted net income of $23 million, or $0.46 per share in the third quarter of last year, primarily due to increased R&D spending. Adjusted earnings exclude amortization, equity compensation, impairment of long-lived assets and one-time events, including the gain on the divestiture of the 80% of our interest in Hansen in 2021. In the third quarter, we had cash flow from operations of approximately $20.4 million, and we used a portion of our cash to buy back approximately $14.5 million of stock. We also announced today that our Board has authorized an additional buyback program of $50 million. I will now turn the call back over to Dan. Thanks, Bill, for the update. With that, we will now take any questions you will have. Paul, please open the line for Q&A.
spk05: Thank you. We will now be conducting a question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
spk02: One moment please while we poll for questions. Thank you. Our first question is from David Anselm with Piper Sandler.
spk05: Please proceed with your question.
spk04: Hey, thanks. So just had a few. So wanted to come back to your comments on glucagon market dynamics. I'm just wondering out loud, I mean, wouldn't the discontinuation of the kits by Lilly and Novo ultimately benefit the ready-to-use formulations that are available like Xeris' GVOC or the intranasal product rather than the generics of the kits. I'm just trying to understand your thought process there. So that's number one. Number two, on 002 with the complete response, can you just talk about whether there's any human factor work that needs to be done? And I guess the question here is with a quick turnaround, Do you anticipate an FDA action, a target action, sooner rather than later in 2023? Just help us understand what might be the issues there on the whole weight. Thanks.
spk06: Sure. Let me start with the glucagon question. And you're right. We think that some of that market will very likely shift to some of the newer entrants. However, right now we're in a position where our price is lower than those other entrants, and that we believe that some people have a more cost-conscious effort. It's hard for us to say exactly what percentage will move over to our product and what percentage of the new scripts will go to the other products, but we believe that this provides a significant opportunity for the company to potentially increase sales next year. As for the second question, I'd like to turn that over to Tony Mars to answer that one.
spk03: Yeah, hi. As far as AMP002 goes, it is not related to a human factor study or any device-related issue. I'd say more so it would be a label-type issue. And as far as the FDA's turn on when their action date is, it's difficult for us to predict. Of course, we always want a speedy turn time, but we're not really – I can't really predict what it might be for them.
spk02: Okay, that's helpful.
spk04: Viatris disclosed that they have a glucagon product that's in the queue at the FDA. So, you know, let's suppose there is competition there. You know, how does that play into your long-term thinking about your glucagon opportunity?
spk06: Well, I think we're in a good position because we're there now and, you know, we have an opportunity as this product, as the other competitors discontinue their product, we have an opportunity to gather market share. You know, other companies may get approval, and, you know, we can't control what happens in the market. But, you know, as far as taking advantage of the opportunities we have, we're expanding our capacity to meet our projected or what we think the demand might be. and take advantage of the opportunity we have now.
spk02: All right. Thanks, guys.
spk05: Thank you. Our next question is from Serge Bellinger with Needham & Company. Please proceed with your question.
spk01: Hey, good afternoon. A couple questions. First, on primatine, you just talked about recent trends. I think you mentioned there was some seasonality in the third quarter. Does that mean we should expect a significant rebound in the fourth quarter? And then secondly, maybe just talk about the recent launches for Gineralex and Basalpressin and what kind of competitive outlook you're seeing for both these products now that you're on the market. Thanks.
spk06: So with Primatine, yeah, you know, looking at the seasonal trend, has been sort of difficult since we launched it. You know, we had COVID-19 situation. So we were trying to read some tea leaves as we progressed through that situation. But now we are seeing a little more seasonality with that project or more clearly seeing seasonality with that product. And as we move into the fourth quarter, fourth quarters have always tend to be pretty good on primatine. So I think we're sort of expecting a little bit of a rebound there. Yeah, and just to comment, if you take a look at the seasonality on the private team last year, the third quarter was the lowest quarter and the fourth quarter was the highest, and so we're expecting something that will probably follow that trend again. And as far as the recent launches go, we've launched both those products into competitive markets, haven't gained as much market share as we thought, but we do see some opportunity for growth in both of those products going forward.
spk05: As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. Our next question is from Elliot Wilbur with Raymond James. Please proceed with your question.
spk07: Thanks. Just want to go back to your earlier commentary around glucagon. Looks like the company currently has around 65% share of injectable units. So as you think about the balance not being able to be supplied or chosen to not be supplied by some of your competitors, What are some of the supply chain limitations that would prohibit you from capturing a significant portion of that balance? Is it API or finished capabilities, or do you not really see any limitations? Then on a couple of the products where you had overperformance, at least versus external estimates, some of it seems to be primarily due to price, epinephrine and Just wondering if you think that with the recent price increases or pricing levels on those products that run rate in the quarter for both is relatively sustainable going forward.
spk06: Let me take the glucagon question first. So, API is definitely not an issue. We have plenty of that. Right now, there is an issue, though, of our capacity. So we have to, in order to take on much more volume, we will need to increase our capacity, but we already have been planning for that from earlier in the year. And so we believe that by the end of the first quarter, we will have the ability to have the capacity to take as much of that share of that market as needed. So, yeah, so not in the fourth quarter, not really in the first quarter, but after that we think we'll have you know, a very large capacity increase. And on the second thing, the overperformance, the epi and the phytonodione, generally the phytonodione is not too seasonal and we're, I don't see any pricing, more price increase there. We have taken some in the past on that product. Epinephrine is one where there have been shortages from our competitors. and there continue to be shortages for our competitors, and we see those shortages continuing well into 2023 at this point.
spk07: One additional question on 008. Can you just talk about regulatory hurdles there with respect to potential facility inspection, if there are any?
spk06: Tony, do you want to handle that one?
spk03: Yeah, sure. From a regulatory hurdle, it's just a CRL. It's our first CRL we've received for the product. It's something that we view as relatively simple. It's kind of part of the complexity of the product that is something that we don't think will take us very long. So we're anticipating to have in this quarter a resubmission to respond to that CRL. As far as the inspections go, we are not anticipating those any additional inspections. We've gone through a number of inspections already for our, for example, our clinical trial, the sites that we did our clinical trials at. And we've had a recent GMP inspection at the manufacturing facility. And when we went through the initial stage of the application, they chose not to do an additional inspection there.
spk02: So we don't anticipate an additional one.
spk05: Thank you. There are no further questions at this time. I'd like to turn the floor back over to management for any closing comments.
spk06: Again, I want to thank everybody for joining us today. We have an exciting end of the year and 2023 ahead of us with the glucagon market development in addition to our upcoming GDUFA dates. We look forward to updating you all on the next call.
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