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Q4 2023 Amphastar Pharmaceuticals Inc Earnings Call

Participants

Dan Dischner; Vice President - Corporate Communications; Amphastar Pharmaceuticals Inc

William Peters; Chief Financial Officer; Amphastar Pharmaceuticals Inc

Timothy Chiang; Analyst; Capital One

David Amsellem; Analyst; Piper Sandler

Glen Santangelo; Analyst; Jefferies

Serge Belanger; Senior Analyst; Needham & Company LLC

Presentation

Operator

Greetings, and welcome to the Amphastar Pharmaceuticals' fourth-quarter earnings call. (Operator Instructions) 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 performance 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 in 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 our earnings release. Please note this conference call is being recorded.
Our speakers today are Mr. Bill Peters, CFO; Mr. Dan Dischner, Senior Vice President of Corporate Communications; Mr. Tony Marrs, Executive 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.

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Dan Dischner

Thank you, Paul. Good afternoon and thank you all for joining us today. On the call with me will be Bill Peters, CFO and Executive Vice President of Finance; and Tony Marrs, Executive Vice President of Regulatory Affairs and Clinical Operations.
Throughout 2023, our strategic focus remained on driving momentum across our core high-margin offerings while bolstering our presence in the complex product segments of our portfolio. This includes our strategic acquisition of BAQSEMI and recent advancements in our interchangeable biosimilar development with our first BLA filing for Insulin Aspart or AMP-004.
Earlier today, we announced financial results for the 2023 fiscal year highlighted by our net revenues, which have surged to an impressive $644 million, representing a substantial 29% increase annually. This remarkable growth is further seen by a notable 41% increase in gross profit and a 51% increase in net income compared to the previous year. Our growth is attributed to our high-margin products, notably within our diabetes portfolio (inaudible) glucagon injection and our recent addition of BAQSEMI, alongside our other branded product, Primatene MIST. Moreover, our hospital and clinic use products such as epinephrine, dextrose and sodium bicarbonate, continue to experience heightened demand driven by shortages amongst other suppliers.
Looking towards 2024, we expect our glucagon injection, BAQSEMI and Primatene MIST products to continue to drive revenues, and we anticipate a sustained demand for our hospital and clinical use products. We anticipate potentially four product launches this year. We are excited about our upcoming launch of REXTOVYM, our intranasal naloxone, which uses our proprietary device; for AMP-015 or teriparatide, our progress towards its GDUFA date remains on track for a second quarter. This filing is undergoing a preapproval inspection, marking a step forward in the regulatory process.
As for AMP-002, ongoing dialogue with the agency in pursuit of a favorable determination indicates the agency's commitment despite a delay in a GDUFA date. The market demand for this product remains robust, presenting an opportunity as the first generic contender in a market exceeding $500 million according to IQVIA. At AMP-008, our first inhalation ANDA, which received priority review status, we have a GDUFA goal date in the second quarter of this year. And our AMP-007 inhalation ANDA, which was filed in the fourth quarter of 2023, we have a GDUFA date in the fourth quarter of 2024. There is a paragraph IV (inaudible) with this ANDA.
As for updates on BAQSEMI, the progress of the transition from Lilly continues as planned, and sales totaled $28.7 million in the fourth quarter, a figure slightly impacted by anticipated seasonality factors. As expected, the transfer is going smoothly as we took over US marketing in October. We began shipping the 2-pack of BAQSEMI in the United States at the beginning of February and will start shipping the one pack in March. Looking forward, we remain optimistic about the trajectory of this product as we continue to take over worldwide distribution from Lilly throughout 2024.
Having discussed the main drivers of our revenue and the impact of market nuances on our quarterly performance, I want to pivot the discussion towards our pipeline and regulatory affairs concerning our proprietary biosimilar and complex generic products. Starting with our Insulin Aspart filing, we firmly believe our BLA application aimed at securing interchangeable status will not only mark a significant advancement for our diabetes portfolio but will also demonstrate our commitment to leveraging our robust US-based capabilities.
This strategic move is poised to solidify our position as (inaudible) and being a proud US-finished interchangeable biosimilar insulin manufacturer and supplier. This aspect sets us apart in an increasingly competitive landscape. As the demand for more affordable options for diabetic patients continues to surge, we are poised to meet this need with our US manufacturing site.
Furthermore, we believe this milestone will pave the way for success of our other insulin products currently in development, including AMP-004M or Insulin Aspart M, AMP-005 recombinant human insulin and AMP-025 insulin degludec, which development continues to advance. Additionally, while on the topic of our diabetes pipeline, our GLP-1 ANDA in development known as AMP-018 remains on track for a filing this year. In reference to our proprietary product, intranasal epinephrine or AMP-019, this product continues to progress through the various development stages.
Concluding my remarks and looking ahead, Amphastar has significant opportunities in front of us, supported by our sustained growth and strategic initiatives. With the imminent launches of REXTOVYM and promising candidates like teriparatide, AMP-002, and AMP-008, we are optimistic about our trajectory. Our annualized performance underscores the resilience and diversity of our portfolio, signaling growth potential.
Moving forward, our dedication to growth is evident through our R&D advancements, which is the engine of our company, and our planned expansion efforts within our inhalation pipeline at our Armstrong facility, our continued API expansion at our AMP facility, which is anticipated to be completed this year, and our capacity expansion at our headquarters to capitalize on our insulin and complex injectable opportunities.
I would like to turn the call over to our CFO and Executive Vice President of Finance, Bill Peters, to discuss the fourth quarter and year-end financial results.

William Peters

Thank you, Dan. Sales for the fourth quarter of 2023 increased 32% from $178.1 million from $135 million in the fourth quarter of 2022. BAQSEMI contributed $22.5 million to net sales based on Eli Lilly's sales of $37.6 million less cost of revenues and transition service fees of $15.2 million. Glucagon sales increased 70%, growing to $31.2 million from $18.3 million as the discontinuation of other injectable glucagon products from 2 suppliers at the end of 2022 positively impacted demand.
Primatene MIST continued to show strong sales growth during the quarter, with sales up -- sales of $24.5 million, up 10% from $22.3 million in the prior year period. Epinephrine showed strong sales in the fourth quarter amid continued shortages by our competitors, growing to $24.6 million from $21.4 million in the previous year's period. Lidocaine showed growth of 13% to $15 million in the current quarter from $13.3 million in the fourth quarter of 2022 as we were able to increase capacity and decrease our back order.
Other finished pharmaceutical product sales increased 6% to $35 million in the fourth quarter of 2023 compared to $33.1 million from 2022 as the company recorded stronger sales due to the launch of regadenoson earlier in 2023 and increased unit sales of atropine, calcium chloride, sodium bicarbonate and ganirelix, which were partially offset by lower sales of medroxyprogesterone as the company was in the process of transferring the API production for that product to its facility in China.
Gross margins increased to 54% of revenues in the fourth quarter of 2023 from 53% of revenues in the fourth quarter of 2022 due to BAQSEMI sales, which are recorded net of Lilly's expenses, and to strong sales of higher-margin products like glucagon and Primatene MIST. These positives were partially offset by an inventory reserve of $3.6 million for insulin API due to our amended contract with MannKind, which delays required (inaudible).
Selling, distribution and marketing expenses increased to $8.6 million from $5.5 million due to the expansion of our sales and marketing efforts for BAQSEMI as we began detailing the product at the beginning of October. General and administrative expenses increased to $13.1 million from $10.6 million in the prior year due to BAQSEMI-related expenses and higher mill costs. Research and development expenditures increased in the quarter to $20.4 million from $17.2 million in the comparable quarter of 2023, primarily due to spending on materials and supplies for our inhalation programs.
Nonoperating expense in the fourth quarter of 2023 was $12.6 million, primarily related to interest expense on the debt used to finance the BAQSEMI acquisition, foreign currency fluctuations and mark-to-market adjustments on our interest rate swaps. This compares to nonoperating income of $3.4 million in the fourth quarter of 2022 due to a remeasurement gain on foreign currency.
The tax rate this quarter was lower than usual due to a mix of rent combined with an updated review of our international tax structure. The company reported net income of $36.2 million or $0.68 per share, which was up 7% and 3%, respectively, compared to the previous year's fourth quarter net income of $33.9 million or $0.66 per share. The company reported an adjusted net income of $46.9 million or $0.88 per share compared to an adjusted net income of approximately $37.6 million or $0.73 per share in the fourth quarter of the previous year.
Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets and onetime events. In the fourth quarter, we had cash flow provided by operations of approximately $23.9 million, and for the full year, cash flows from operations were $183.5 million.
Let me review a few of the financial assumptions we are using as we look to 2024 and beyond. BAQSEMI will drive sales growth in the coming year. We anticipate continued unit growth in the high single-digit range. Average selling price will be impacted slightly due to the difference between the wholesaler fee structure for Amphastar compared to that of Eli Lilly. As for Primatene MIST, we are reiterating our forecast of hitting $100 million in sales this year.
We are forecasting up to 4 product launches this year, including REXTOVYM, which will be launched in the coming weeks. We are also expecting approvals in 2024 for AMP-002, AMP-008 and teriparatide. We expect gross margins to be slightly lower primarily due to the shift in accounting for BAQSEMI from net economic benefit in which sales are booked net of cost of goods sold to typical revenue recognition with cost of goods sold, thus increasing both the sales and the cost of goods line on the income statement.
We've already begun this transition in the United States, where we began shipping the 2-pack of BAQSEMI at the beginning of February, and we will begin shipping the 1 pack in March. Last week, we also started distributing BAQSEMI in Italy, the first country outside of the United States, with the remainder of foreign countries converting to our distribution network one by one throughout the remainder of 2024.
Our selling and marketing expenses will increase due to efforts related to BAQSEMI. We expect G&A spending to increase due to expenses associated with BAQSEMI and legal expenses associated with Paragraph IV patent challenges.
Turning to research and development. We plan to ramp up spending on clinical trials, purchases of materials and supplies and FDA filing fees this year as we increase spending on our insulin portfolio to inhalation candidates and our intranasal epinephrine product. We also anticipate a significant increase in capital spending this year as we continue our project to double the capacity for our inhalation products at our Armstrong facility to align with our pipeline development.
Additionally, we plan to finish our insulin API production capacity expansion at our AMP facility in China this year. At our Amphastar facility, we are in the process of an expansion project which will significantly increase the capacity of our (inaudible) complex as we look to major insulin and complex ingestible opportunities. Spending on this major project will begin this year, but will ramp up more significantly in 2025, reaching $40 million a year for 3 years. We plan to finance this expansion with cash flows from operations.
We will use a portion of our cash this year to make the $125 million payment due to Lilly in June. At the same time, we plan to utilize our strong cash position to continue our stock buyback program. I'll now turn the call back over to the operator for questions.

Question and Answer Session

Operator

(Operator Instructions) Jason Gerberry, Bank of America.

As this is Robin on for Jason. Two questions. From us. First, can you provide some color as to the line of sight into competitor supply shortages, namely as it pertains to the tailwind we're seeing with generic epinephrine and a handful of products in the Other finished pharmaceutical products segment. When can we expect that trend to reverse?
And then second question on vaccines growth, are you on track for the transition from Lilly in 1Q in the U. S and you any sort of headwind during this transition phase while your sales force gets more comfortable with getting out there and driving uptake with prescribers?

Dan Dischner

Thank you.
Yes, thanks for the question on.
Yes.
And in regards to shortages, as we we always seem to come across this. There's always a shortage of some product more in this portfolio at one time or another. We don't have any additional insight or color on the status of whether or not they'll be back online or come back online but what we can tell in the near future, at least for the next quarter, two that are the demand for our the products that we were talking about are still in D&O still necessary for us to provide and some of those products are supposed to be back online according to the communications that we get from the FDA.

William Peters

But the reality is and I think what I was getting to is that we've had these shortage issues for over 10 years now. Every quarter there's been some product or another for there's been a shortage. And we've been able to be there and be able to supply our customers for that. And our customers have appreciated that and supported us because of that, I think the second question was back to the mean.
Yes, we as I said in my remarks, we we started selling the two pack in the United States in February, and we're going to start selling the one pack of vaccine unionized space in March. So those that's already taken care of in Italy already transferred in February as well. And the rest of the Company countries in Europe, we're going to move on a one-by-one basis and the marketing program is going as planned in the United States.

Thank you.

Operator

Tim Chang, Capital One.

Timothy Chiang

I think some Phil, I had a question just on the net economic benefit figure, fallback semi just going forward. I know you'd indicated you expect sales to be up in the single digits single-digit growth. I mean, is that sort of the net economic benefit figure that we should be modeling on single digit growth for going forward on a quarter to quarter basis, what I'm talking about is more of the actual sales level, like when I referred to the vaccine, the sales that Eli Lilly had in the quarter was at 37 million.

William Peters

Oh, so that's the level that we're looking at. And as I mentioned in the United States, which makes up 80% of the sales of vaccine. We transitioned to the two pack in February, and we're planning to transition to the one pack in March for the first quarter is going to be a mix and know of both the NEB and our regular sales and for the US and for Italy, the rest of the world will still remain on the NEB, mostly until the third quarter, and that's when we expect most of the transitions from most of the other countries to occur in the third quarter.
I see.
And then you you mentioned a higher sales and marketing expenses going forward on Keno, is it too early to sort of peg just sort of a ballpark on increase rate for selling and marketing expenses?
This year?
Yes. So what we've said is that the increased SG&A costs are going to be similar to what Tom said, pharma, which is around 17% of revenues. I think have you taken a look at something that's in that neighborhood of back Caemi revenues is going to be the range of that increase.

Dan Dischner

Okay.
And maybe just one pipeline question, which is from AMPO. one five, teriparatide. Obviously, there's some other existing generic companies in that market. I mean, do you still think you'll have the ability to get meaningful share in that market once you get approval sometime in the second quarter?
Yes, what we've said is that we sort of expect it to be as what you would expect from a generic that has multiple candidates. Three, it's three other generics in the market at the same time. So it's a market opportunity for us. We still think that is significant, but the other are we are we do recognize that there are other people that got approval.

Timothy Chiang

Thank you.

Operator

David Amsellem, Piper Sandler.

David Amsellem

Hey, thanks. So on few pipeline questions, our MPC was there were two, um, what is underlying your confidence in getting it across the finish line and Elestat there?
The action they came and went and nothing has happened there. So I guess can you talk more about your interactions with the FDA or what just gives you confidence that you can get there and then on on the inhalation products or eight, I just want to clarify that it is indeed a first to market opportunity and how you're thinking about that and particularly to the extent it is a first market opportunity, what are margins going to look like relative to the overall business?
And then lastly, on the GLP-1, I guess I'll just ask it straight up? Is it liraglutide on or is it something else?

William Peters

Thank you. David. Thanks for the question. For our MP. zero zero two product. We continue to have discussion with the agency. We view it as positive movement on. They have not asked us for any new information or any new data on as of yesterday or today is as of that so we just continue to I'm engaged with them and have discussions with them, and we're optimistic about it and we feel we understand what the issue is and just work with them as they tried to overcome that issue. So from our perspective, we remain optimistic about it.
And on the second one for MPOA, we haven't said whether or not it's a first to market. And for the third one, the GLP is on we haven't said what the molecule is on, but it will be subject are likely to be subject to a Paragraph four litigation. So after it's filed, that's likely to be come known. And also, as Dan had mentioned, our NPEs are seven is also subject to paragraph four filing. So it's possible that that becomes known through that process at some point in the not-too-distant future as well.

David Amsellem

If I may ask a follow-up on Sears or two. So you characterize it as an exit quote issue, but there's no CRL here. So is that should we interpret that as and a good thing or just this is just a complete one-off that sort of confounds any attempt a comparison?

Dan Dischner

Yes, I think maybe you know, it's just a one-off, just a one-off issue. We have what we believe what we believe is our and we have an understanding that we think is the issue that they're trying to overcome and we engage them on that and tried to just keep pressure on keep discussion. Keep keep engaging with them. But we think that it's just the one issue that when they're able to address that issue, that that's the only thing on that that is holding up this application. And once that's relieved and then it should be very positive.

David Amsellem

Thank you.

Operator

Glen Santangelo, Jefferies.

Glen Santangelo

Yes, thanks for taking my questions. A follow-up on a couple of modeling questions. I mean, you gave some color on back Caemi, but I just kind of curious if you could maybe help us frame out 2020 for a little bit more clearly in terms of this TSA that's in place and how that's gone up phased in over the different countries and because it's obviously going to have a pretty material impact on your revenue and your expenses at the same time. And I just any help you can sort of give us a high level from a model perspective to think about that transition throughout 2024 would be helpful.
Then maybe a follow-up. So it's actually a little bit confusing to us, too. So but here's what I'll say is that as I mentioned, you know, 80% of the revenues from vaccine come from the United States. And part of part of that, we're making that transition partway through the year. The way we're budgeting on this internally is we're just assuming there is no any being we just go straight on the straight sales and the straight expenses because we know that the net income impact is going to be the same way. So there's going to be the same amount of money spent on same amount of sales at the very top line from that. And our revenues will be slightly just but we know that the income will be it will end up being the same. So so with 80% of the sales being transitioned in the first quarter. The way I would look at it is that no, no half of the quarter is going to be any being half. That's not for 80% of it. Then the most of the rest of the countries will come online in the third quarter, but that's only about 20% of the sales worldwide. So and done so I don't know I can't help, but feel free to answer some follow-up because we don't exactly know what that exact date for most of these transitions, either part of this has to do with inventory levels and winding down in Lilly inventory labeling versus the Amphastar labeled products and making sure that we have sufficient inventory of us to get launched. So it's a little bit of a confusing process. So we don't have exact dates either.
All right.
Well, listen, we can maybe we can maybe explain a little bit more offline. But maybe as my follow-up, I wanted to ask about glucagon obviously been posting some pretty sizable growth in 23 as a couple of those players exit the market late in 22. Did the comps get much different here now as you enter into the first quarter and as I think about maybe growth slowing in that product and for new product launches and sort of back Caemi sort of phasing in as we just discussed, you said we should expect gross margins to be trending down this year. Could you maybe just give us a little bit more color on the direction of glucagon and the impact of all these launches on gross margin?

William Peters

Yes. As you look out a couple of things are the comps are tougher now. So now we've now the opposed to the last kind of big up quarter. So that's the that's the end of that trend. So what we do have, though is our expectation is that with for glucagon being having now gone to one-third empty hypoglycemic fit into thirds, and that is going to be for the diagnostic market. We see that the hypoglycemic market continuing to shrink as products like back Caemi, which we think are much better product for that and take more and more market share over the coming years. So we see that that portion of the market declining. However, Tom, as we mentioned in our presentation, and then we mentioned briefly, we are launching the glucagon product in Canada now. So on some of the U.S. declines that U.S. decline should be offset by the pickup in Canadian business. And the way to think about it is that Canada is about 10% and the United States business, and we'll have we'll have that offset from the decline. So we're not one of the reasons we didn't mention glucagon as a growth item. It's just because of that we think a little bit of decline in the US offset by the Canada business.

Dan Dischner

And then going back to the gross margins on a like on a GAAP basis, we will have cost of goods for vaccines, which we didn't have last year. So that's the biggest impact. Second biggest impact is going back to GAAP again, as we'll have a full year of amortization of the intangible for vaccine. Now that gets pulled out for the adjusted cost of goods. But that's going to be in there for the cap cost of goods. And then overall, we're probably not seeing prices decrease across our product line very much, whereas we do have some costs cost pressures. So there is going to be a slate, slight decline for some of those products. Now once we can launch some of these newer products, though, on rest to the and AMP. zero zero two zero zero eight and teriparatide, all of those should have gross margins that are above the corporate average. So those will all help output pull down gross margin back up against the there's definitely different forces point, both ways on that gross margin this year.

Glen Santangelo

Thank you.

Operator

Serge Belanger, Needham & Company.

Serge Belanger

I could ask and answer the first question. Can you just talk about your outlook for shortage opportunities this year? And I guess whether the ones you've been able to capture will remain and if you have a capacity to take on additional ones that may materialize.
And then secondly, on teriparatide, what's your level of confidence for us approval at the second quarter could differ and how does that market opportunity look like now that there's been a couple of other approvals and back to the shortage opportunities as we anticipated, these are a long time and one of the reasons we invested in expanding our manufacturing capacity at Iovance. It seems like one or several of these products every quarter have some shortage issue and we're happy to pick it up. We're happy to take it and take it on and provide when we need it. We don't have been.

Dan Dischner

Oh, yes, I think Bill mentioned that and there is data that they may come back one or these products, but they will probably create a shortage in another product somehow. So we always look at it as probably about at $20 million. Why is what we forecasted with the expansion of our capacity, but we're definitely in that ballpark around that. And I think we'll still see I think we're still going to see similar scenarios in the future.
As for teriparatide, yes, we remain confident in this CRL that we address. I'm related mostly to a study which we performed and we performed studies of that nature before. So we remain optimistic about the approval for that.

William Peters

And as far as the market opportunity is there are two other participants in that now two new generics. So the market is crowded and definitely the price has come down pretty significantly and will come down even further with ours. But that said, it's still a product that has a relatively high price and relatively high margins. So we still see this as a good opportunity, but not as big an opportunity as same six months ago, if there are no further questions at this time, I'd like to hand the floor back over to management for any closing comments.

Operator

And I want to thank you all for joining us on today's call. We are excited about the opportunities ahead with the upcoming launches like Rex, Toby and other potential launches with teriparatide AMP. zero two and AMP. zero zero eight, and we look forward to updating you all on the next call. Have a great day.