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spk04: Greetings and welcome to the Amphistar Pharmaceuticals Incorporated first 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 a discussion of numerous factors that may impact our future performance. We will also discuss certain non-GAAP measures. Important information on our use of these measures and reconciliations to U.S. GAAP may be found in the earnings release. Please note this conference is being recorded. Our speakers today are Mr. Bill Peters, CFO, and Mr. Dan Dishner, VP of Corporate Communications. I will now turn the conference over to your host, Mr. Dan Dishner, Vice President, Corporate Communications. Dan, you may begin.
spk05: Thank you, Operator. And good afternoon to everyone joining us for Amphistar Pharmaceuticals' first quarter earnings call. After my prepared remarks, I will turn the call over to Bill Peters, our CFO and Executive Vice President of Finance, who will provide an update on the company's financials. We will then open the call to Q&A. As reported in our financial results earlier, Amphistar had another strong quarter to start 2022 with the continued execution and sales of our commercial portfolio to build a solid base of support. The constant supply of our commercial portfolio has resulted in net revenue of $120.4 million for the first quarter. This represents a 17% increase over the same period in 2021, coupled with sales of higher margin products, which has led to an impressive 24% increase in our bottom line on an annualized basis. We remain optimistic that this momentum will continue as our recently approved generic Gannon Relics AMP-006 is planned to launch in the second quarter, and the final approval and launch of our generic Vazopressin product in the third quarter further strengthens our commercial portfolio. The strength seen in our first quarter can be attributed to two factors. First, strong sales of primatine mist are trending towards 100 million in annualized sales by the end of 2024, as the product has seen a 34% year-over-year growth in Q1. As stated previously, the product continues to benefit from our more frequent nationwide digital, TV, and radio marketing campaigns and our physician sampling program. Secondly, our IMS products saw a notable 34% increase on an annual basis thanks to our strategic planning and our reliable supply to these markets. On the topic of our glucagon and epinephrine, annualized sales for both the products remain on a positive trend. We believe that glucagon will be a consistent driver of profitability, while our epinephrine products will persist in benefiting from our reliable supply and manufacturing capacity to furnish the current strained market conditions for these products. Speaking on our regulatory filings, I'm pleased to announce that our first inhalation ANDA, AMP008, a paragraph four filing, has seen no legal challenge. Therefore, the traditional 30-month stay was not triggered, and our submission remains on track for a fourth quarter GDUFA date this year. Furthermore, I'm pleased to announce that the filing was recently granted priority review status, which will lend us further confidence in the direction of this filing. On the topic of our near-term GDUFA dates, we had previously stated that AMP002 received a minor CRL to which it was quickly responded to and now has a GDUFA date in the third quarter of this year. We believe AMP-002 is on track for approval in the third quarter. For AMP-015, or teraparotide, the product remains on track for a second quarter GDUFA date, as this product is still on its first review cycle. As discussed previously, this is a complex combination product. Therefore, we look forward to progressing this product towards approval. On the topic of AMPHISTAR's path towards building our proprietary and biosimilar portfolio, thereby transforming the company towards an established biopharmaceutical profile. Internasal naloxone remains on track for refiling in the second quarter, and our intranasal epinephrine product maintains its positive progression towards filing next year as we continue to benefit from fruitful discussions with the agency. Turning to our diabetes portfolio, all of our insulin candidates aim to achieve interchangeable designation. To accomplish this, We have developed a framework based on FDA guidance using our extensive complex molecule experience, most notably our sophisticated characterization technology and achievements of highly purified peptides, along with our in-house source API platform. Our clinical program is progressing and on track to file as planned. As you can see, this past quarter can be best characterized as a quarter of continued execution in light of outward pressures. Our vertically integrated platform built up by our continued self-funded investment has primarily kept these uncertainties insulated from the company. Areas out of the company's control have been mitigated by our long-established corporate strategy geared towards self-sufficiency. 2022 remains on track for an eventful year as the execution of our continued diverse commercial portfolio becomes increasingly expanded with pending launches and hopeful approvals. We maintain our confidence that outward pressures if long sustained or unexpected, will be handled in a measured and disciplined approach than one that is reactionary and short-sighted. I will now turn the call to Bill to discuss the first quarter's financial results.
spk06: Thank you, Dan. Sales for the first quarter increased 17% to $120.4 million from $103 million in the previous year's period. Primatine mist with sales of 34% to $24.7 million from $18.4 million once again led to strong performance. Continued strong sales of glucagon, which launched in February of 2021, also drove growth with sales of $11 million, up 38% from $8 million in the comparable quarter last year. Epinephrine sales remained strong, sales of $15.2 million down slightly from $15.6 million in the first quarter of 2021. Lidocaine had sales growth of 17% to $10.6 million from $9.1 million in the first quarter of 2021 on strong unit demand, while Phytonodion grew 10% to $10.5 million from $9.6 million due to higher average selling prices. Sales of other products in our finished pharmaceutical product portfolio such as calcium chloride and sodium bicarbonate, increased due to higher unit volumes as a result of market shortages. Our insulin API business had sales of $4.9 million, down from $5.5 million from the prior year, primarily due to the timing of shipments. Gross margins increased to 46% of sales from 44% due to increased sales of high-margin products, such as glucagon and primatine mist. These trends were partially offset by lower prices for anoxaparin and higher costs for labor, heparin, and certain components. Selling, distribution, and marketing expenses increased to $5.5 million from $4.5 million, primarily due to increased freight costs. General and administrative spending decreased to $12.5 million from $15.3 million due to a decrease in legal costs and lower costs in China due to the restructuring of ANP. We booked a $5.4 million gain to other income for legal avoidance costs in relation to our RegaDennis and patent litigation. Research and development expenditures increased to $16.2 million from $14.8 million due to purchases of materials and components for our pipeline. We anticipate that these expenditures will continue this upward trend in the upcoming quarters. The company reported net income attributable to AMFSA shareholders of $24.3 million or $0.47 per share in the first quarter compared to a net income of $5 million or $0.10 per share in the first quarter of 2021. The company reported an adjusted net income of $24.6 million or $0.47 per share compared to an adjusted net income of $13.6 million or $0.27 per share in the first quarter of last year. Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets, and one-time events. In the first quarter, cash flows provided by operations was a very strong $50.8 million. We used a portion of this cash flow to repurchase $1.2 million of Treasury stock during the quarter, leaving $7.3 million remaining on our buyback authorization. Last week, the company's board of directors authorized an additional $25 million to our buyback program. I will now turn the call back over to the operator to begin Q&A.
spk04: Thank you. We will now be conducting a question and answer session. 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. You may press star 2 if you would 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. One moment please while we poll for questions.
spk00: Thank you.
spk04: Our first question is from Elliot Wilber with Raymond James. Please proceed with your question.
spk01: Thanks. Good afternoon. First question with respect to primatine trends in the quarter, stronger, I think, than the consensus expected. Just wondering if you would expect the same pattern that we've seen the last couple of years where you see sort of a strong trend March quarter then followed by relatively flattish trends over the next couple of quarters continuing. Just trying to tease out whether or not there were some one-time impacts or effects that led to the relatively strong quarter in primate team.
spk06: Yeah, so we expect the trends to be very similar to last year where we had also a very strong first quarter and then it dropped off in the second and third quarter and peaked back again in the fourth quarter. And this is really driven by the first quarter of the year. There's a lot of the spring allergy season and buying to stock up on inventory at the retail level ahead of that. And then the fourth quarter, there'll be some buying ahead of the cough and cold season when other people's allergies are, you know, hitting. So we do see the same trend as last year.
spk01: Okay. And then a couple additional pipeline questions here. With respect to 002, Any feedback from the agency as of yet on whether or not an inspection will be required before approval?
spk05: Yeah, we haven't heard anything that an inspection would be required at this point, so there's nothing to report from that.
spk06: But remember, that was inspected a couple years ago, so before pre-COVID, so it's not like they haven't been here for it. That's right.
spk01: Okay. Okay. And then on 008, so we're past the 45-day window. You have priority review, but I'm assuming this would not be a first market generic. Is that correct?
spk05: Well, we haven't disclosed the product at this time, and I think we're still going to stick with that strategy. So I don't have anything to add to that.
spk01: Okay. I guess this last question, Pipeline, Terra Paratide, what are you, I guess, what are your expectations there in terms of what Lilly's competitive response may be? Obviously, they were content to simply give up their position in the glucagon market, but you can make the argument that they had a new brand franchise that they may not want to contribute to unirosion in. Are you expecting or have you heard from any of your customers whether or not Lilly has signed an authorized generic agreement with an existing Sterix player or whether or not you may see an AG on the product? We're not aware of anything.
spk04: Thank you. Our next question is from David Amsalem with Piper Sandler. Please proceed with your question.
spk03: Thanks. So I wanted to start with a question on injectable vasopressin with the launch planned for the third quarter. How are you thinking about market dynamics here? Are you expecting that there will be a couple of other entrants beyond yours after the expiry of EGLE's 180 days of exclusivity? Or do you think market dynamics might be relatively stable when you enter. So I'll start with that and then I have a few additional ones.
spk05: Yeah, so you know we are aware of other filers obviously and I think there's even one with a GDUPA date coming up shortly so we're aware that there's a possibility that there will be other competitors. We're prepared either way so we look at it as how you would look at a typical market with multiple generics competing.
spk03: Okay, and then a follow-up here. Can you just remind us how capacity shakes out here for that product? I mean, are you going to be able to supply as much of the market as demand dictates?
spk06: Yeah, this is one where we're making the API and we make the finished product both here in California. And we have plenty of capacity to take a significant portion of the market on. Given the competitive situation, I don't see capacity being any issue.
spk04: 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 comes from Tim Chang with Northland Capital. Please proceed with your question.
spk02: Hi, thanks. Just a couple questions. I guess the first one is, are you already, have you guys already launched scanner relics, or are you guys still manufacturing prelaunch quantities on that product?
spk06: Yeah, we have not launched that. Right now, we plan a June launch. And we're in the process of gearing up for that. Okay.
spk02: And then maybe could you talk a little bit about the insulin biosimilar programs that you have? Like where are you guys with your programs right now? And do you guys have any sort of targets in terms of when you might be able to file some of these interchangeable biosimilar insulin products?
spk05: Well, we haven't disclosed an exact timeline for the filing. We're still progressing through certain phases of the development and working with the agency on what they expect to see in our filings so that we can achieve, like I said, the interchangeable status. So the first one may take a little longer, but we think that the other two will follow the same framework. and we'll be able to move a lot quicker after we get the first one filed.
spk02: And is the first one AMP 03? Is that right, or is it 04, 005?
spk05: I'll have to double check, but I think that's right. I think it's 3, 4, and 5, AMP 3, 4, and 5. So we're working on 4 first.
spk04: Thank you. There are no further questions at this time. I would like to hand the floor back over to management for any closing comments.
spk05: Thank you, Paul, for hosting this today. We appreciate everybody participating in this call. We look forward to updating you on our Q2
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