Amphastar Pharmaceuticals Q2 2023 Earnings Call Transcript

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August 8, 2023

There are 6 speakers on the call.

Operator

And welcome to the Amphastar Pharmaceuticals Second Quarter Earnings Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. 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.

Operator

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.

Operator

GAAP may be found in our earnings release. Please note this call is being recorded. Our speakers today are Mr. Bill Peters, CFO and Mr. Dan Dischner, Senior Vice President of Corporate Communications and Mr.

Operator

Tony Morris, Vice President of Regulatory Affairs and Clinical Operations, I will now turn the conference over to your host, Mr. Dan Dischner, Senior Vice President of Corporate Communications. Dan, you may begin.

Speaker 1

Thank you, Paul. Good afternoon, and thanks for joining us for our Q2 earnings call of 2023. Joining me today will be Bill Peters, CFO and Executive Vice President of Finance and Tony Mars, Executive Vice President of Regulatory Affairs and Clinical Operations. To start, I'm pleased to highlight the successful completion of our acquisition of Baximy, which has advanced our diabetes portfolio And added to Amphastar's strategy to focus on proprietary products, biosimilars and complex products. We are excited about this acquisitions opportunity and have experienced a smooth transition to date.

Speaker 1

In terms of sales, We ended the quarter with $145,700,000 in revenue, representing an impressive 18% increase compared to the same period Last year, this quarter's standout performer has been our glucon injection product, which has achieved an exceptional sales reaching $27,300,000 This remarkable achievement can be attributed to our expanded market share in this space, Gaining market share in the diagnostic market and our carefully planned capacity increase, resulting in an impressive 131 growth on an annualized basis. We anticipate the glucagon injection demand to remain durable. Concerning our other key high margin products that have been usual contributors to our quarterly success, Primatene Mist and Epinephrine, Sales for the quarter reached $16,500,000 $16,700,000 respectively. We note that our retail in store Primatene Mist weekly sales Maintain a positive growth trend with a 5% increase from Q2 of last year. However, retailers Having readjusted their inventory levels, leading to a decline in sales at the factory level.

Speaker 1

As for epinephrine's total sales, We note that this shift was attributable to competitors returning to their normal distribution levels. Shifting our focus to our other finished pharmaceutical products, Especially regarding our products in our portfolio benefiting from competitor shortages, we have seen a significant increase in sales, Ending the quarter with a 47% increase. While we are aware of the recent natural disaster that affected a large sterile injectable facility, We anticipate that Amphastar will play a significant role in addressing the nationwide drug shortage, especially regarding products used in the hospital setting. We are pleased to announce that the FDA has recently approved the brand name ReKTOVI for our intranasal naloxone product. After careful assessment, we plan to delay the launch of this product to the Q4 of this year because it utilizes the same manufacturing suite as products needed to supply the critical emergency products during this drug shortage.

Speaker 1

This will allow us to maximize our current capacity and augment our revenue opportunities with the impacted products. Having covered our revenue Drivers for the quarter, I would like to turn our attention to our pipeline and regulatory activities concerning our proprietary biosimilar and complex products. In a recent development for AMP002, the action date was not achieved due to unresolved regulatory matters. However, the FDA has assured us of their commitment to progress with this application swiftly and remain in positive dialogue and are hopeful of a successful response. This product continues to be without a generic with a plus $600,000,000 market opportunity based on annualized equibia sales.

Speaker 1

For our teriparatide ANDA or AMP-fifteen, we responded to the CRL and have a GDUFA date in the Q1 of 2024 with the standard subsequent quarter GDUFA date if an inspection is needed. With regard to our AMP-eight inhalation ANDA, which is classified under priority review, the filing recently received a minor CRL. We plan to respond in the Q3 of this year, which we would expect to lead to a late 2023 action date. While our second inhalation ANDA, AMP-seven, we plan to file in the 4th quarter. As for our proprietary product, intranasal epinephrine, we continue working with the FDA and progressing with the clinical development.

Speaker 1

Turning to our biosimilars pipeline strategy, our AMP-four product or our insulin aspart is progressing according to plan and we expect to submit our BLA with interchangeable status by the end of 2023. If nothing else, This quarter shows the strength of our portfolio of products and the flexibility we have to adapt and take advantage of presented opportunities. We remain focused on our strategies to invest for growth, improve margins and cash flow and stay committed to advancing our product pipeline. Research and development remain an integral part of our future that we believe will continue to drive growth. In summary, We see significant growth opportunities ahead with new products emerging from our pipeline and we remain committed to delivering consistently strong performance.

Speaker 1

I would now like to turn the call to our CFO and Executive Vice President of Finance, Bill Peters, to discuss the 2nd quarter's financial results.

Speaker 2

Thank you, Dan. Sales for the quarter increased 18% to $145,700,000 From $123,500,000 in the previous year's period, glucagon sales more than doubled to $27,300,000 From $11,800,000 in the prior year, primarily due to continuing strong market demand as some suppliers discontinued selling glucagon. Pythonodion sales increased to $17,900,000 from $13,400,000 in the Q2 of last year as a result of supplier shortages. Primatene Mist declined to $16,500,000 from $19,000,000 in the previous year due to inventory drawdown by retailers. Sales of Primatene Mist continued to grow at the retail level, increasing by 5% in the 2nd quarter.

Speaker 2

Lidocaine and epinephrine saw sales declines as competitors returned to these markets. Our other finished pharmaceutical products category also had strong growth Due to higher unit volume sales of dextrose, atropine, calcium chloride and sodium bicarbonate, as well as sales of new products such as Ganorelix, Vasopressin and regadenosine. Since we closed our Baximy acquisition on June 30, 2023, we do not have any sales of Baximy in the quarter. However, Lilly recorded sales of $34,900,000 up 20% from the Q2 of 2022. While we usually don't talk about quarterly sales trends, there are a few items I would like to point out for our 3rd and 4th quarters.

Speaker 2

First, in the Q3, we will begin recording a net economic benefit of Baximi, which will be Lilly's sales Once we have taken over distribution, we will begin recording sales and expenses as we would for any other product. We have estimated the impact of Baximi on adjusted EPS will be $0.12 to $0.18 in 2023. 2nd, we plan to launch glucagon injection in Canada in the near future, adding to this product sales. Finally, we've had to temporarily stop selling our medroxyprogesterone, one of our larger products in the other finished pharmaceutical products category, Because our API supplier has discontinued manufacturing the product. Our A and P subsidiary Has developed this API and continued to pursue an approval of the DMF.

Speaker 2

We hope to obtain FDA approval in the first half of next year, at which time we would relaunch this product. Our Insulin API business had sales of $2,800,000 down from $3,300,000 in prior year primarily due to the timing of shipments. As we've discussed in the past, the products we've launched in the last few years, including glucagon, vasopressin, GANORELLIX and REGADENISIN have higher margins than our corporate average. While these trends continued this quarter, gross margins dropped slightly to 50% of sales in the Q2 of 2023 From 51% of sales in the same quarter last year, as we decided to impair all of our U. K.

Speaker 2

Product rates intangible assets, which were purchased several years ago, resulting in an impairment charge of $2,700,000 These products were to be made at our IMS facility, But given better market opportunities in the U. S, we've decided to focus on our U. S. Products there. Selling, distribution and marketing expenses increased by to $6,700,000 from $5,800,000 primarily due to increased advertising of Primatene Mist.

Speaker 2

General and administrative spending increased to $12,300,000 from $10,000,000 primarily because of increased personnel related costs and costs related to the Vaccimi acquisition. Research and development expenditures decreased to $16,800,000 in 2023 from $22,800,000 last year. Spending in the prior year was elevated due to purchases of raw materials and components for our AMP018 and insulin pipeline products. Non operating expenses increased to $4,100,000 from $1,700,000 due to one time costs related to our Credit agreement used to finance the back CME acquisition, currency fluctuations and mark to market adjustments related to our interest rate swaps. The company recorded net income of $26,100,000 or $0.49 per share in the 2nd quarter Compared to net income of $17,300,000 or $0.33 per share in the Q2 of 2022.

Speaker 2

The company reported a 68% increase And adjusted net income to $34,800,000 or $0.65 per share compared to an adjusted net income of $20,700,000 or $0.39 per share in the Q2 of last year. Adjusted earnings excludes amortization, equity compensation, Impairments of long lived assets and one time events. In the Q2, cash flows provided by operations was $54,900,000 bringing our year to date cash flow provided by operations to $95,300,000 I will now turn the call over to the operator

Operator

Thank you. Our first question is from Tim Chiang with Capital One. Please proceed

Speaker 1

with your question.

Speaker 3

Thanks. Maybe just a few questions on the branded side. Obviously, Pacsimi, you've just recently closed that product acquisition. Could you talk a little bit about the marketing strategy with that product? When is the switchover going to happen in the Q3?

Speaker 3

And do you expect to benefit from the new school year with that product? And then on Primatene Mist, Maybe just talk about, do you expect a recovery in sales in the Q3 given demand trends?

Speaker 2

Yes. So on the branded side of Vaccsimi, let me start there. Right now, This transition is going in phases. Currently, we're in the phase where Lilly is doing everything that they were doing prior to the acquisition, and that will continue until the end of September. At that time, we're going to begin taking over the marketing of Baximi From Lilly.

Speaker 2

We've already hired a contract sales force to begin detailing that product for us. They've begun the hiring process and they're going to begin training relatively shortly after that, so they can hit the ground running on October 1. As far as the school year goes, BaXimi is a product that does see seasonal trends with the back to school Timeframe usually resulting in higher sales. So this is our 1st year, but we've seen in the past that The August, September time frame usually shows an increase in sales of that period and the Q3 is usually the Key quarter of the year for that product. As far as Framatene Mist goes, we do expect it's hard to say from the second quarter to the third Quarter, whether sales will be down, up or flat.

Speaker 2

Historically, going from the Q2 to Q3, they've been flat to down slightly. But this what we've seen in the trend is each of the last two quarters, we've seen increasing Sales at the retail level, but decreased sales at the factory level. So we believe that Trend can't continue forever. So at some point, the destocking that the retailers are doing right now will have to come to an end. So Eventually, the sales will have to match the factory sales will have to match the store sales.

Speaker 2

So, whether that takes another quarter or 2 quarters, it's Hard for us to say right now, but at some point, the sales growth we expect to continue.

Speaker 3

And maybe I'll just squeeze in one follow-up. Obviously, you're still benefiting from a lot of the supply shortages that are ongoing in the U. S. On the generic side. I mean, are there Specific products that you think you'll be able to benefit from outside of the products that you're currently selling At this point?

Speaker 2

So I'm not sure what you mean products that we're not selling at this point. Because In the shortage area, there's a lot of products that we have benefited from the past. We expect to see those benefits in the future. There's a number of products that Right now, we're the only company selling into the hospital market for at least time being. So our plan is to ramp up production of those to Help out the country as best we

Speaker 3

can. Okay. That helps a lot. I'll jump back in queue And ask another question after.

Speaker 2

Thanks, Tim.

Operator

Thank you. Our next question is from David Amsellem with Piper Sandler. Please proceed with your question.

Speaker 4

Hey, thanks. I've got a few. On belukagon, Can you talk about the mix between retail and institutional in terms of your sales mix? And Talk about also how penetrated you are in the institutional setting. I'm just trying to get a sense of how Big this opportunity could be.

Speaker 4

I'm not talking about vaccine here, just the glucagon injection. And then secondly, on the CRL for AMP 8, can you provide a little more color on the nature of that CRL? You know how complex or not complex the issues that were raised there? Just Any color there would be helpful. And then on shortage products, as we move through the back half of the year, How should we think about the impact of the damage at the Pfizer, North Carolina facility?

Speaker 4

And how that could How you could benefit from that? And I guess maybe the other the best way to ask it is, Should we see even more of an impact from shortage products in the back half of the year compared to what we've seen thus far In the first half of twenty twenty three? Thanks.

Speaker 2

Let me take the first one, which is the glucagon question. In the retail versus the institutional market, the last we looked, it was about over 60 percent retail for us. And so we feel that we have penetrated some of the other markets. But remember, our product Slightly higher priced than some of the alternatives. And while we think it's a more convenient package, the kit is more convenient, There are some people that would be unwilling to pay that little bit extra for that.

Speaker 2

And then for the CRL, I'll turn to Tony.

Speaker 5

Sure. Hey, David. For AMP008, as Dan said, it's a minor CRL. And I think the most notable Item on that is we've said that our response is going to be in the Q3 this year. So from a complexity perspective and kind of the Final analogy that I use, I think just the timeliness of our response should give an indication

Speaker 1

And in regards to the shortage product, David, yes, we actually are Anticipating, having to pick up some of the work there. So we do think, especially in The products in the hospital setting and the CCD products, we should see an increase there. And that's why we decided to postpone the launch of our Intranasal naloxone product. And while we are going to

Speaker 2

see an increase, it won't be too material because we were already running Those suites pretty much fall out on this. So there is a little bit of room and we are looking for ways to increase the capacity that we can push through there by doing Some small steps to increase things here and there, but this isn't going to be something where we can boost sales by 20% out of that factory. It's It's going to be incremental because, we were already running effectively Full shifts on the two lines at that IMS factory that produced product for that. And as Dan mentioned, unfortunately, we were planning To start manufacturing the intranasal naloxone, ReKTOVI this quarter, but we postponed that because of shortages that are out there. And so we've had to stop that process.

Speaker 4

Okay. And just on glucagon, just going back there. On the institutional piece of the glucagon business, can you say how Or quantify what the opportunity is there just on the institutional side?

Speaker 2

I think a significant portion of the pickup that we've had, there has been on the institutional side. So the increase Okay. So, from compared to a year ago, because remember, a year ago, we already had 80% of pretty much the retail market. Let's say, if you say that we've more than doubled, so a big portion of that doubling Just picking up some of the retail,

Operator

I mean the institutional side.

Speaker 4

Okay. That's helpful. All right. Thanks.

Speaker 2

Thanks, Matt. Thank you.

Operator

Thank you. Our next question is from Tim Chiang with Capital One. Please proceed with your question.

Speaker 3

Hey, thanks. I think you mentioned on AMP-two, there's a slight regulatory A question that the FDA had asked, is it still possible that you could respond and then get that product onto the market At the end of this year?

Speaker 5

Yes, Tim. It's not that the FDA is waiting for us to respond to anything. We haven't had a response that we provided to them in some time So it's not that that's that the FDA is waiting for us to do anything. The way we have Had our conversation with the agency, is they're assuring us that they're working diligently on the application, And we view that as seeing a path forward with this. And we do see this as Something that we're very optimistic that we will have a path forward for this.

Speaker 5

I mean, we do anticipate having positive news For this, and it's just based upon just dialogue that we're having with the agency and we are hopeful of that.

Speaker 3

I see. Okay. And then I guess just back on Baximy, I mean, obviously, you're inheriting a lot of the formulary access that Vila Lilly has already established For the product, I mean, is there anything else you think you will need to do once the handover occurs Around what October?

Speaker 2

Yes. So they do have we're basically following their playbook And following the actions that they did and plan to keep marketing very similar to the way they did, we're also working with different Groups throughout the country like the Juvenile Diabetes Foundation and other groups that are working with Patients with diabetes. So, we're we think they set up a good playbook. We have a lot to learn from them and we're in the process of Taking, what Dave done and implementing it here. So it's we don't expect anything significantly different from what they did.

Speaker 3

Got it. Okay, great.

Operator

Thank you. There are no further questions at this time. I would like to hand the floor back over to Dan Dischner for any closing comments.

Speaker 1

I want to thank everyone for joining us today. The The second half of twenty twenty three remains to be a highly anticipated period in terms of our filings, our progression of our recent acquisition of Vaccimi, Our role in helping address the nationwide drug shortage in addition to our upcoming launch of Rexgovy in the 4th quarter. We look forward to updating you all again. And again, thank you. Have a great day.

Operator

This concludes today's conference. You may disconnect your lines at this time. Thank you for your

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Earnings Conference Call
Amphastar Pharmaceuticals Q2 2023
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