Amphastar Pharmaceuticals, Inc.

Greetings and welcome to the AMPHISTAR Pharmaceuticals, Inc. 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 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 our earnings release. Please note this conference call is being recorded. Our speakers today are Mr. Bill Peters, CFO, and Mr. Dan Dishner, SVP of Corporate Communications, and Mr. Tony Mars, EVP of Regulatory Affairs and Clinical Operations. I will now turn the conference over to our host, Mr. Dan Dishner, SVP of Corporate Communications. Dan, you may begin.

Thank you, Karen. Good afternoon, and thank you all for joining us for Amphistar Pharmaceuticals' 2023 First Corner Earnings Call. Joining me today on the call are Bill Peters, CFO and Executive Vice President of Finance, and Tony Mars, Executive Vice President of Regulatory Affairs and Clinical Operations. For the first quarter of 2023, I am pleased to announce that Amphistar has begun another year on a strong note, as our continued execution in our portfolio resulted in $140 million in revenue, or a 16% increase on a year-over-year basis. Equally important, Our gross profit for the quarter saw an impressive 32% increase on an annualized basis. Once again, we attribute this success to our key high margin primatine mist, glucagon, and epinephrine products, seeing notable increases for sustained growth. Concerning primatine mist, in-store sales for the product had a 5% growth compared to the previous quarter. We remain confident that this product is on its path towards 100 million in annualized sales by the end of 2024, as we continue our strategic investment of an additional 2 to 3 million in marketing spend in 2023. This investment is already in progress, and we are increasing consumer awareness across multiple advertising platforms and remain committed to our physician sampling program. Regarding glucagon, we remain optimistic that with our recent approved capacity increase to which our glucagon output is now doubled, we can continue to meet strong demand. As such, glucagon sales have seen a meaningful 134% increase year-over-the-year and a 40% increase in sales compared to our previous quarter. For epinephrine, we continue to see significant opportunity for this product due to our previous efforts to increase our capacity to meet the increasing demand despite competitors falling short. To that end, epinephrine sales for our pre-filled syringe and multi-dose vials presentation have increased sales by 33% annually. Again, we acknowledge that this increase is due to our ability to fill the gaps left by our other suppliers. We maintain a positive outlook on this product as a growth driver and its potential to remain durable as one of our key high margin products for the duration of the year. After covering our key revenue drivers for the quarter, I'd like to shift our focus towards our pending business development opportunity, product launches, pipeline, and regulatory activities. As previously communicated, Amphistar has signed an asset purchase agreement to buy Baximi from Lilly. This move aligns with two of our strategic goals of expanding our diabetes portfolio, which is currently being developed further this year, and strengthening our proprietary products portfolio. Fulfilling these two strategic goals through Baximi comes with many advantages. Primarily, the acquisition would add significant scale to Amphistar with our future proprietary product offerings having a solid base of support in the international space. It expands Amphistar's international footprint in 26 countries and strengthens our internal marketing capabilities. Moreover, this transaction aligns with our longstanding disciplined approach to business development while fulfilling strategic goals. Our assessment of the transaction is that it is progressing smoothly, and we anticipate its closure in the second or third quarter this year. With Vaximi potentially being part of our portfolio, we are poised to accelerate our longstanding goals of being a leader in the diabetes therapeutic space and a strong contender in the proprietary product market. Moving forward, I'd like to turn our attention to our recent intranasal naloxone approval and launch of a new product in our portfolio. For intranasal naloxone, the product was approved in March with an anticipated launch in the third quarter. While we recognize that the market conditions for this product may be more competitive and thus potentially deliver incremental sales, it is important to highlight that the approval included our proprietary intranasal device technology that we have developed and will be manufacturing exclusively at our facilities. This development reinforces our unique vertical integrated business model and strengthens our commitment to innovation and quality. We believe it will enhance our intranasal pipeline and potentially strengthen our commercial capabilities. Nonetheless, the product continues to address a strong community need to address the opioid crisis. In terms of new product added to our portfolio, I am pleased to announce that our Raggedenison was recently launched in April. Likewise, we acknowledge this product will enter a more competitive market. Therefore, we expect annualized sales for this product will be incremental compared to our other key revenue drivers. Having covered our business development opportunity with Baximi, product approval and launches, I want to turn our attention to our pipeline and regulatory activity. For our diabetes portfolio, we are on track to file a BLA for insulin aspart or AMP004 by the end of 2023 with our goal of achieving interchangeable status. To our chiropractic ANDA, or AMP015, we are on track to respond to the CRL in the second quarter. As for a GDUPA date for AMP002, it remains in the second quarter of this year. As for AMP007 product, which is our second inhalation ANDA, we expect filing in the third quarter of this year. As for our proprietary product in our pipeline, AMP019, or intranasal epinephrine, we continue to work with the agency on this product as it continues to actively be developed. And finally, our AMP008 ANDA product remains on track for a third quarter GDUFA date. As a final point, we'd like to reiterate how excited we are about the upcoming opportunities ahead of us, as 2023 has been off to a great start in terms of sales performance, pending GDUFA dates, filings, and our diabetes and proprietary product portfolio possibly gaining momentum with Baximi, and our first interchangeable biosimilar insulin BLA being filed at the end of this year. I will now turn the call over to our CFO and Executive Vice President of Finance, Bill Peters, to discuss the first quarter's financial results and provide further details regarding the Baximi transaction.

Thank you, Dan. Sales for the first quarter increased 16% to $140 million from $120.4 million last in the previous year's period. Glucagon sales increased 134% to $25.7 million from $11 million to market demand. Epinephrine sales grew to $20.1 million from $15.2 million, while lidocaine sales grew 29% to $13.6 million from $10.6 million in the first quarter of 2023 on both strong units demand. Primatine mist saw sales decline 5% to $23.5 million from $24.7 million, but we saw in-store growth of 5% in the quarter, so we believe this is a timing issue. Phytonodion sales dropped to $7.7 million from $10.5 million as a new supplier entered the market. Sales of other products in our finished pharmaceutical product portfolio grew 13%, due to higher unit volumes of dextrose and a full quarter of sales of ganarelox and vasopressin, which were both launched in 2022. Insulin API sales grew to $4 million from $3.8 million in the prior year, primarily due to the timing of shipments. Gross margins increased to 53% of sales from 46% due to increased sales of high-margin products such as glucagon and epinephrine, as well as sales of ganarelox and vasopressin, These trends were partially offset by higher labor and material costs. Selling, distribution, and marketing expenses increased to $7.1 million from $5.5 million, primarily due to increased advertising costs. General and administrative spending increased to $13.5 million from $12.5 million due to increased legal costs related to our planned acquisition of Vaccimi. Research and development expenditures increased to $19.8 million from $16.2 million due to increased labor costs, increased expenses related to clinical trials for our insulin and inhalation programs, and purchases of materials and components for our pipeline. We anticipate these expenditures will continue this upward trend in the coming quarters. Non-operating income was $100,000 for the quarter compared to $7.4 million in the prior year's first quarter. when we booked a $5.4 million gain for legal avoidance costs in relation to our regadennis and patent litigation. The company reported net income of $26 million or 50 cents per share in the first quarter, compared to net income of $24.3 million or 47 cents per share in the first quarter of 2022. The company reported an adjusted net income of $32.1 million or 62 cents per share compared to an adjusted net income of $24.6 million, or 47 cents per share, in the first quarter of last year, a growth of 31%. Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets, and one-time events. In the first quarter, cash flow provided by operations was a very strong $40.4 million. We used a portion of this cash to repurchase $8 million of Treasury stock during the quarter. As you know, we have signed up an asset purchase agreement to buy back CME from Eli Lilly. At this time, I'd like to give you an update on the progress of this transaction. We completed our FTC filing on April 28th. Additionally, we are working to finalize the financing for the loan and revolving line of credit. As a reminder, we have fully committed financing from a group of seven strong banks. We are also involved in transition planning with Lilly. where we are aligned to take over operations as soon as possible after closing with the goal of enabling people on insulin to be prepared with a glucagon rescue treatment. At this point, we believe that we can close the deal either in the second or third quarter of this year. I will now turn the call back over to the operator to begin Q&A.

Thank you. Ladies and gentlemen, the floor is now open for questions. If you do have a question, please press star 1 on your telephone keypad at this time. Again, if you do have a question or comment, please press star 1 on your telephone keypad at this time. Please hold as we poll for questions.

And we'll take our first question from Tim Chang from Capital One. Please go ahead, Tim.

Hi, thanks. Maybe you could talk a little bit about Google Gone. You know, obviously you did really well in the quarter with that product. You know, how sustainable do you think the Google Gone sales run rate will be this year? Could you make some comments about that? I mean, is this a $25 to $30 million a quarter type product for you?

Yeah, we believe that this is going to be the run rate for the rest of the year. And just keep in mind that We were able to build up inventory of the product going into the quarter knowing that we were going to have increased demand this quarter, but we did not have the doubling of the capacity online until the end of the quarter. So our operations did a great job of getting the inventory built and readying for the quarter, and now that we have that additional capacity, we're able to meet that demand on an ongoing basis.

And maybe just one follow-up, 53%, 54% gross margins you guys did this quarter, is that sort of also an adequate run rate going forward for gross margins?

Yeah, so for the year, we had said that we'd be relatively flat from last year, but, you know, it's going to be, I think, close to that range. Like in the 50% to 53% range is a good number to look at for the year, for the rest of the year.

Okay, great. Great quarter.

Thanks, Tim.

Thank you. And we'll take our next question from David Anselm from Piper Sandler. Please go ahead, David.

Hey, thanks. So just a couple from me. One on primatine. Can you just talk about the weakness there, at least on the volume side? And then secondly, on I know this is something of a recurring feature where you're benefiting from shortages. It looked like it was maybe perhaps larger this quarter than others. So how are you thinking about, you know, contribution from products that are benefiting from market shortages like dextrose as the year? progresses, and can you quantify that? And then, sorry if I missed this, but on glucagon, can you say what the mix is between institutional and non-institutional is? I know that the institutional setting as a diagnostic was something that you were prioritizing in the context of the expanded capacity, so just talk about where you're getting your your orders from regarding glucagon. Thank you.

I'll take the first one on the primatine. And what I had mentioned was that while our sales, our unit sales were down in the quarter, we saw the in-store data from the retailers actually was up 5%. So I think it's primarily a timing issue of just when orders went out and maybe they bought a little bit more in the fourth quarter than than they normally would have or just lowered their inventory levels during the quarter. But what we keep an eye on is really that in-store volume to make sure that that's trending upwards. And it did continue to trend upwards, even with the price increase that we instituted during the year. So maybe it's possible that some of the retailers bought a little bit more in December, knowing that we were increasing the price in January. On the shortages side, yeah, I think there might be some. We did spike up a little bit in epi and lidocaine, and there's definitely a possibility that some of those numbers come down in the second half of the year, but probably they'll keep that level for at least some time. Also, we're still seeing strong demand for the dextrose as well. And as we've always said here, we increased our capacity a few years back to be able to take advantage of these shortages in demand, and we have the ability to move production to different products depending on where that demand is coming from at any time. Like I said, this quarter it was epinephrine, lidocaine, and dextrose. We're not sure where it will be next quarter, but it's almost certainly coming from somewhere. And the glucagon, I don't have the data here on the institutional versus non-institutional, but shoot me an email. I'll see if I could follow up with Jacob on that.

Okay, thank you.

As a reminder, that's star 1 if you do have a question or comment. And there appear to be no further questions at this time. I'd like to turn the floor back over to management for closing remarks.

Yeah, I want to thank everyone for joining us today. We look forward to updating you on our next call, and we remain excited about this year's upcoming opportunities. So thank you again, and have a great day.