Q1 2022 Amphastar Pharmaceuticals Inc Earnings Call

Operator: Greetings and welcome to the Amphastar 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.

Anyone should require operator assistance during the conference, please press star zero on your telephone keypad.

Operator: 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 US 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 Dischner, VP of Corporate Communications. I will now turn the conference over to your host, Mr. Dan Dischner, Vice President Corporate Communications. Dan, you may begin.

Dan Dischner: Thank you, operator, and good afternoon to everyone joining us for Amphastar 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, Amphastar 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 Ganirelix ANP 006, planned to launch in the second quarter, and the final approval and launch of our generic Vasopressin 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 Primatene Mist are trending toward a 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 television 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 of 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 on benefiting from a reliable supply and manufacturing capacity to furnish the current strained market conditions for these products.

For these products.

Speaking on our regulatory filings, I am pleased to announce that our first inhalation ANDA ANP 008, a paragraph four filing has seen no legal challenge. Therefore, the traditional 30 months stay was not triggered, and our submission remains on track for a fourth quarter [inaudible] date this year.

Furthermore, I am 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 [inaudible] date, we had previously stated that ANP 002 received a minor CRL, to which it was quickly responded to and now has a good [inaudible] date in the third quarter of this year. We believe ANP 002 is on track for approval in the third quarter. For ANP 015, our Teriparatide.

Todd.

The product remains on track for a second quarter [inaudible] 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 Amphastar path towards building our proprietary and biosimilar portfolio, thereby transforming the company towards an established biopharmaceutical profile, intranasal Naloxone remains on track for re-filing 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 aimed 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 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 ilBl to discuss the first quarter's financial results.

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 ilBl to discuss the first quarter's financial results.

Will be handled in a measured and disciplined approach than one that is reactionary and short-sighted. I will now turn the call to ilBl to discuss the first quarter's financial results.

Bill Peters: Thank you Dan.

Sales for the first quarter increased 17% to $120.4 million from $103 million in the previous year's period.

Primatene Mist with sales of 34% to $24.7 million from $18.4 million, once again led the 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 Phytonadione 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 in 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 Primatene mist. These trends were partially offset by lower prices for Enoxaparin 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 dollar gain to other income for legal avoidance cost in relation to our [inaudible] 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.

$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 infrastructure shareholders of $24.3 million or 47 cents per share in the first quarter, compared to a net income of $5 million, or 10 cents per share in the first quarter of 2021.

Shareholders of $24 $3 million or <unk> 47 per share in the first quarter compared to a net income of $5 million or fifth or <unk> 10 per share in the first quarter of 2021.

The company reported an adjusted net income of $24.6 million or 47 cents per share, compared to an adjusted net income of $13.6 million or 27 cents 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.

Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad.

A confirmation tone will indicate your line is in the question queue. You may press star two 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.

Yeah.

Thank you. Our first question is from Elliot Wilbur with Raymond James. Please, proceed with your question.

Elliot Henry Wilbur: Thanks, Good afternoon.

First question, with respect to Primatene trends in the quarter, stronger I think.

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 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 affects that led to the relatively strong quarter in Primatene?

The same.

The same pattern that we've seen the last couple of years, where you see sort of a strong.

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 your affects that.

That led to the relatively strong quarter.

In private team.

Bill Peters: 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.

Bill Peters: The retail level are 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 hitting. So, we do see the same trend as last year.

The cough and cold season, among other peoples allergies are.

Yeah.

So we do see the same trend as last year.

Elliot Henry Wilbur: Okay, and then a couple of 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?

Multiple speakers: [Bill Peters] Yeah, we haven't heard anything that an inspection would be required at this point. So, there's nothing to report from that. [Dan Dischner] But, that was inspected a couple years ago, pre COVID-19. So it's not like they haven't been here for it that's right.

Yeah.

Elliot Henry Wilbur: Okay. And then, on 008.

Yeah.

And then on 008.

Elliot Henry Wilbur: So, we're past the 45 day window, you have priority review, but, I'm assuming this would not be a first to market generic, is that correct?

Dan Dischner: Well, we haven't disclosed the product at this time.

Dan Dischner: And I think we`re still gonna stick with that strategy.

Dan Dischner: So I don't have anything to add to that.

Elliot Henry Wilbur: Okay, and I guess, just last question pipeline Teriparatide. 

Elliot Henry Wilbur: What are you, I guess, what are your expectations there, in terms of what Lilli`s competitive response may be, obviously, they were content to simply give up their positioning in the Glucagon market, but you could make the argument that they had a new brand franchise that they may not want to contribute to in erosion. And are you expecting or have you heard from many of your customers whether or not Lilly  has signed an authorized generic agreement with existing genetics players, or whether or not you may see an AG on the product?

they are positioning in the Glucagon market, but you could make the argument that they had a

new brand franchise that they may not want to contribute to in erosion. And are you expecting or have you heard from many of your customers whether or not Lilly  has signed an authorized generic agreement with existing genetics players, or whether or not you may see an AG on the product?

 has signed an authorized generic agreement with existing genetics players, or whether or not you may see an AG on the product?

existing genetics players, or whether or not you may see an AG on the product?

whether or not you may see an AG on the product?

Dan Dischner: We're not aware of anything.

Operator: Thank you. Our next question is from David A. Amsellem them with Piper Sandler. Please, proceed with your question.

David A. Amsellem: 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 entrance beyond yours after the expiry of the Eagle`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.

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.

After the expiry of the Eagles 100 day 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.

Dan Dischner: Yeah. So you know, we are aware of other filers, obviously and, I think there's even one with a good [inaudible] date coming up shortly.

So you know we are aware of other filers, obviously and.

I think there's even one with a good <unk> date coming up shortly so.

So, we're aware that there is 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.

Competing.

David A. Amsellem: Okay. And then, follow up here. 

A follow up here.

Here can.

Can you just remind us how capacity shakes out here for that product. I mean, sure you can be able to supply as much as a market as demand dictates?

How capacity shake.

Shakes out here for that product.

I mean should you can be able to.

Supply as much as a market as demand dictates.

Dan Dischner: Yes. This is one where, for vasopressin, 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.

Situation I don't see capacity being any issue.

Operator: As a reminder, if you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.

Our next question comes from Tim Chiang with Northland Capital. Please, proceed with your question.

Tim Chiang: Hi, thanks. Just a couple of questions. I guess the first one is:

Have you guys already launched Ganirelix, or are you guys still manufacturing prelaunch quantities on that product?

Have you guys already launched <unk> or are you guys still.

Any factoring prelaunch quantities on that product.

Bill Peters: Yeah, we have not launched that. Right now we plan the June launch.

Dan Dischner: And we're in the process of gearing up for that.

Tim Chiang: Okay, 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 you guys have any sort of targets in terms of when you might be able to file some of these interchangeable biosimilar insulin products?

<unk>.

The insulin biosimilar programs that you have like where are you guys with your programs right now and you guys have any sort of targets in terms of when you might be able to file some of these.

Interchangeable biosimilar.

Biosimilar insulin products.

Dan Dischner: Well, we haven`t disclosed exact timeline for the filing.

Exact timeline for the filing.

We are 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 will be able to move a lot quicker after we get the first one filed.

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 will be able to move a lot quicker. After we get the first one filed.

Tim Chiang: And is the first one ANP 003. Is that right? Or is it 004/005?

Is that right or is it.

All four or five.

Dan Dischner: I`ll have to double check, but I think that`s right. I think it's three, four and five ANP. Three, four and five.

Bill Peters: So we're working on four first, 004 yes.

Yes.

Operator: 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.

Bill Peters: Well, thank you, Paul, for hosting this today and we appreciate everybody participating in this call. We look forward to updating you on our Q2 financials next quarter. Have a wonderful day.

Updating you on our Q2.

Financials next quarter.

Have a wonderful day.

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

Okay.

Yeah.

Yeah.

Operator: [music].