Good day, ladies and gentlemen, and welcome to the Amphastar Fourth Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call may be recorded.

All statements on this conference call that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, including the DMF of AMP, the timing of product launches, acquisitions and other matters related to its pipeline of product candidates, its share buyback programs and other future events.

These statements are not historical facts but rather are based on Amphastar's historical performance and its current expectations, estimates, and projections regarding Amphastar’s business, operations, and other similar or related factors.

Words such as “may,” “might,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” or other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words.

You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and in some cases, beyond Amphastar’s control.

Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar’s filings with the Securities and Exchange Commission. You can locate these reports through the Company’s website at ir.amphastar.com and on the SEC’s website at www.sec.gov.

Amphastar undertakes no obligation to revise or update information in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause Amphastar's expectations to change.

I would now like to introduce your host for today's conference, Mr. Jason Shandell, President of Amphastar. Sir, you may begin..

Thank you, operator. Good afternoon, and welcome to Amphastar Pharmaceuticals fourth quarter earnings call. My name is Jason Shandell, President of Amphastar. I'm joined today with my colleague, Bill Peters, CFO of Amphastar. We appreciate you joining us on the call today, and look forward to speaking with you and answering any questions you may have.

I will now turn the call over to our CFO, Bill Peters to discuss the fourth quarter financials..

Thank you, Jason. Sales for the fourth quarter increased 48% to $89.7 million from $60.4 million in the previous year's period. Sales of enoxaparin rose to $19.1 million from $11.3 million.

The enoxaparin market shortage we experienced during the third quarter continued into November and we sold more units at higher noncontract prices again in the fourth quarter. Medroxyprogesterone launched in January 2018 had sales of $7.4 million during the quarter.

Perhaps most importantly, we launched Primatene Mist and recorded sales of $3.6 million as we loaded our product nationally into Walgreens and CVS. Gross margins improved year-over-year due to sales of newly launched higher margin products such as medroxyprogesterone, Primatene Mist and isoproterenol.

Selling, distribution and marketing expenses increased to $2.6 million from $1.6 million on higher freight costs and the initial expenses in the marketing campaign for Primatene.

General and administrative spending increased 50% to $13.8 million from $9.2 million primarily due to increased legal expenses and higher expenses at our Chinese subsidiary, Amphastar Nanjing Pharmaceuticals.

Research and development expenditures increased 47% to $16.7 million from $11.4 million due to increased clinical trial expenses, increased expenses associated with API development and higher FDA filing fees.

The company reported net income of $1.9 million or $0.04 per share compared to last year's fourth quarter net income of $800,000 or $0.02 per share. The company reported adjusted net income of $6.2 million or $0.13 per share compared to an adjusted net income of approximately $4.1 million or $0.08 per share in the fourth quarter of last year.

Adjusted earnings excludes amortization, equity compensation and impairments. Let me review a few of the financial assumptions that we will be using as we look towards 2019. We expect sales growth to be driven by Primatene Mist and one or two ANDAs which may be approved later this year.

The consensus sales estimate for 2019 is nearly $350 million which will be difficult to reach without strong Primatene sales and at least two ANDA approvals.

Annualizing the fourth quarter sales trend is not a good way to estimate 2019 because part of the sales increase in the quarter was due to supplying products which were in market shortage situations including enoxaparin. Several of these shortages were rectified by the end of the year.

So sales of those products will not continue at those high levels into 2019. We expect gross margins to increase as we sell more Primatene Mist. Remember that we had expensed all of our API and component inventory for this product prior to its approval. Therefore sales of Primatene will be at high margin levels until we sell through this inventory.

However, the continued price increases of heparin will have a negative impact on the margin of enoxaparin. Our selling, distribution expense will increase significantly as we plan to spend at least $1 million dollars every quarter on marketing expenses related to Primatene Mist.

We expect G&A spending increases related to compliance costs and legal expenses associated with tariff [ph] or patent challenges at our upcoming trial. Additionally we will have to comply with Sarbanes-Oxley 404(b) this year, so we'll be devoting more resources to internal controls.

We expect research and development spending will continue to increase in both dollar terms and as a percentage of sales as we currently have one inhalation clinical trial ongoing and a trial for our first insulin product is planned for later this year.

During the quarter the company repurchased approximately $2.6 million of stock to bring total repurchases for the year to over $25 million. I will now turn the call back over to Jason..

Thanks, Bill. 2018 was a great year for the company. We had multiple ANDA approvals and launches throughout the year culminating in a milestone FDA approval of our NDA for over-the-counter Primatene Mist in the fourth quarter.

We are very excited by this approval and believe the Primatene could return to peak sales of $65 million in the next two to three years. The pipeline continues to make very good progress as can be seen from the recent recent increase in R&D expenses. We now have five ANDAs on file targeting products with a market size of over $750 million.

Three biosimilar products in development targeting products with a market size of over $14 billion and 11 generic products in development targeting products with a market size of over $12 billion. Of the five ANDAs on file, four of them were granted competitive generic therapy designations.

This designation applies for drugs with inadequate generic competition.

FDA will provide a priority review for ANDAs under this designation which includes more active communications with the sponsor and striving to act on the ANDA as soon as possible including prior to GDUFA go date, furthermore it allows for a new type of 180-day exclusivity even if the brand product is not protected by a patent and there is no Paragraph IV certification.

We plan to file an additional two to three ANDAs this year including our first inhalation ANDA for which we have begun bioequivalence clinical trials. In the first quarter we had two preapproval inspections for our ANDAs on file with the agency.

With respect to our remaining four grandfathered products demand remains very strong and all are now on file with the agency with one GDUFA date later this year. We had mentioned on the last call that we had just received a CRL for a very complex ANDA that has no generic approval to date.

We fully responded to the agency and have received a GDUFA date for late this year. We are also making good progress on our insulin programs and are planning to file an IND on one of the products this month.

With respect to our intranasal naloxone NDA we received a general advice letter from the agency and currently are working on improving the product based on FDAs advice. Finally, we are very happy with the launch of Primatene Mist and are now selling the product in the three largest drugstore chains, Walgreens, CVS, and Rite Aid.

We have been receiving regular reports on retail sales and the trend is looking positive. We believe that our digital marketing strategy is working well in terms of building awareness of the brand. The major components of this advertising campaign include paid search, display banners and paid social media.

Our media agency provides us with metrics showing the click through rates to our website and then further to the online retailers and these metrics show that we are making good traction with consumers. With that update, I will now turn the call over to the operator to begin Q&A..

Thank you. [Operator Instructions] Our first question comes from David Amsellem with Piper Jaffray. Your line is open..

Thanks, so just a couple.

First on Primatene, can you talk about your plans for selling the product in other stores as the year progresses, what about the big box stores like Walmart and how we should think about that? And then secondly on Primatene, can you just mark specifics on how we should think about your gross margins this year and how much higher the expense which is going to be higher than your corporate gross margins? And then help us understand steady-state beyond this year for gross margins? And then lastly on the injectable that you had a CRL on are you still expecting by the end of this year into next year that there will not be competition or if there is will be only a limited competition product? Thanks..

Yes, thanks for those questions. This is Jason. I'll start out with the question about the other big box stores. So definitely our original strategy was with the brick-and-mortar, the drugstores especially Walgreens and CVS and Rite Aid. We've been building inventory because Walmart obviously is a big percentage of our sales.

Based on prior history Walmart actually made up 35% of the sales of Primatene and so we are in discussions with Walmart right now and should be launching to Walmart in the coming months..

As far as the gross margin on Primatene goes, the only expenses for the first, the launch in December and really most of the sales for the first quarter had to do with buying the packaging materials and the label inserts and the labels and then the labor and overhead associated with packaging the product because we had already made several hundred thousand units expensed all of that at the time they were manufactured.

Additionally we have probably two more quarters worth of components and two more years worth of API that we had previously expensed.

So I'd say just to give you a range that the gross margins this year should be in the 80% to 90% range but then drop after this year as we get the components as we work through those, but it still will remain a product that has much higher than our typical gross margins..

And this is Jason again. Yes, with respect to the CRL, the product that has no generic approvals, I've discussed this product in the past. It's a very complex product. There is no patent or exclusivity.

It has been out patent for quite a while and I have said as well that I think upon approval some may be surprised that it's not a 505(b)(2), and so we are very confident and don't believe that we would see competition on the horizon. That being said you never know, but we don’t believe there is competition for quite a while..

Okay, thanks Jason, thanks Bill..

Thank you, David..

Thank you. And our next question comes from Elliot Wilbur with Raymond James. Your line is open..

Thanks, good afternoon.

Given some of your commentary around topline trends and then some of the expectations for accelerated spending in 2019, how should we be thinking now about your commentary from last quarter I suppose in terms of expecting profitability in 2019 and expecting I guess each of the quarters to be profitable as well, does that still hold in light of some of the updated or revised expectations around them, topline trends and spend guidance?.

Yes, so I'll say that we don’t want to say that we will definitely be profitable every quarter, but our goal is to be profitable for the year this year and a lot of it will depend on the timing of approvals.

The sooner we can get some of these products approved, if the larger one that we've been talking about is supposed to be later in the year, I think at the time we were hoping we'd probably get that earlier this year than we think we will now, so that's going to put a delay on some pretty meaningful sales there and that kind of what we had been thinking just probably a quarter ago..

Okay, and then just a couple of questions on the pipeline as well.

I think last quarter we had, or you had talked about your two new filings and both being P4s, one of them obviously you've been sued on, but I thought the other I guess based on the timing of your last discussion where you are still kind of within the 45-day window, so not sure what's happened there.

It does not seem much has been any litigation around that product, I just wanted to get some color on that?.

So, yes just to clarify from the last call, so the one we were sued on that's the Vasopressin product by par. The other one that I had referred to we did not get sued on, so there is no 30-month stay..

Okay, but that's an asset that already has existing generic competition?.

No..

It does not, okay..

It does not..

Okay, and then I believe and I didn’t catch any referred commentary, but you had also expected to begin a second inhalation or respiratory trial sometime I believe in the second quarter?.

Oh I'm sorry, yes just to clarify on that. I talked about two trials, one is already ongoing and that's inhalation, the next trial that was referred to in the prepared remarks is for insulin..

Okay, but I guess my expectation was based on prior commentary, there will be a second inhalation trial initiated this year, am I just, you mind correcting that?.

Yes, there will be this year the one that we're expecting to file on this year is currently ongoing, but we are planning to start another one later this year..

Okay.

And just one last question, any update with respect to epinephrine and the vial formulation? I know you continue to sell I believe it's…?.

We continue to sell in the prefilled syringe and that's one of our grandfathered products and at this point all of our grandfathered products are on file with the agency. However, we have not talked about the vial in terms of the status of the re-filing. It possibly could be one of the products on file, but we have not confirmed that..

Okay, all right, thank you..

Thank you. Our next question comes from David Maris with Wells Fargo. Your line is open..

Hey, congratulations on a great quarter.

A couple of questions, so the first, so given that we're pretty much done with the first quarter at this point is the benefit of reporting so late, can you tell us, give us a little update on how Primatene Mist is doing this quarter? Is there anything that makes you think that getting to the historical levels of sales might be more difficult or less difficult than you though? You mentioned earlier that you are still hopeful in the next two to three years, but any color around how or what new retailers you added in the first quarter or any activities around that would be helpful? The second is, I see you have the DMF for protamine sulfate and you also have a DMF for insulin.

Are you planning on using these together for Humalog or is there a different use that you are aware of, of a marketed drug for protamine? And then I just wanted an update on the Sandoz litigation, thanks. .

Sure, let me start with the Primatene question. So we did begin selling to Rite Aid in the first quarter, so that is a first quarter event and so we did stock all over their stores across the United States. Clearly that's a lot smaller than stocking Walgreens and CVS which is what we did in the fourth quarter. The sales trends are very positive.

We've seen – we're seeing lot of feedback from the retailer that we get regular reports from retailers that trends are, the product is growing week-by-week and as Jason had mentioned earlier to another question, we are in discussions with Walmart, so loading that in Walmart would be a big sales event that we think would be coming in the next few months.

It's way too early to tell you about the $65 million sales number which is what we used to sell of the product and we still believe two to three years and it's really hard to say whether it is two or three years, but we see no reason what that target won't be met in that timeframe..

And this is Jason, so yes David, as usual you are very good at identifying the DMFs and how they play into the pipeline. So it is correct that protamine is used in insulin.

We have discussed the different products that we're working on in terms of the insulins, but we are working on three insulins and actually protamine can be used for some of our other pipeline products as well. And then with respect to the Sandoz litigation, it's progressing.

The litigation, the trial is scheduled for September, but we remain confident that this could be settled before the trial..

Great, thank you very much..

Thank you..

Thank you. Our next question comes from Gary Nachman with BMO Capital Markets. Your line is open..

Hi good afternoon.

First also a few on Primatene, what are the gross to net discounts right now? How much are you giving up in terms of discounts or rebates to the retailers and how should that trend this year? And any seasonality that we should be expecting over the course of the year for that?.

So as we have said before the WAC price is 24.88 and the gross to net should be around 25% to 30% that's where we expect it to be for the initial term and that could change over time, but that's where, it's kind of in that range right now. There's really been no change in the trend. We're just only a few months into this.

And as far as seasonality goes, we have heard that there is an uptick in trends around the allergy season, but our sales of Primatene prior to it coming off the market did not have a strong seasonality component to it. So it was - there was a very small seasonal component..

Yes.

And it's interesting, so to the seasonality using the paid search and our digital campaign we're going to explore that further and perhaps add a little bit more dollars to the spend during that allergy season and see if that maybe does make a difference from back when we sold Primatene CFC version which we knew that it was sun-setting at the end of 2011, so we were not actively marketing it.

So it will be interesting to see if now that we're marketing the product, if we do see an uptick in sales in those periods..

Okay that's helpful.

And then on the pipeline, could you just describe the clinical trials for both the inhalation product and the insulin that you're expecting, like what would you hope to see from those, and just the update on intranasal naloxone, what you guys think will be the path forward there based on the FDA’s advice?.

Sure. So for the innovation trial, that's an ANDA, so it's a bio equivalence trial. So we're just looking to see that it has the same effects as the RLB. And for the insulin trial, we're looking to file the IND this month and so we'll begin with a pilot clinical trial.

But given how insulin is a protein and can cause allergic reactions that's something that we need sign out from the FDA before we begin the pilot clinical. And then finally on….

Yes, naloxone, yes..

Yes naloxone, so yes, we had talked about that previously, so we finally did get feedback from the FDA regarding the data that we submitted and they honed in on a few specific aspects of our data and they asked for some further analysis which we're currently working on, but it is feasible..

Okay, actually I have one more quick one for Bill, just the enoxaparin, so what should we be thinking about as a normalized run rate, because it's obviously been a little muddied the last couple of quarters with the non-contracted sales, so does it go back to where it was in 2Q or you actually probably got some benefit right?.

Adequate share in price..

Yes, we - the share is kind of mixed I'll say the price is a little higher than it was back then, so it will be definitely above the second quarter, but well below the third and the fourth quarter, somewhere in the middle there..

Okay and it's a big range, so I mean should we think like low teens or something per quarter, is that fair?.

That's a fair place to start..

Okay, all right. Thanks guys..

Thank you..

Thank you. [Operator Instructions] Our next question comes from Serge Belanger with Needham and company. Your line is open..

Hi, good afternoon. Just a couple of questions from me. Bill, you had a couple products that had some pretty strong fourth quarters.

I mean you touched upon enoxaparin, but what about Lidocaine and the vitamin K product, was there some seasonality there or how much of that strength can follow through in 2019?.

Yes, those things are pretty typical of what we expect to see going forward for Lidocaine and for Phytonadione, there is no seasonality. I think maybe one of the season Lidocaine had a little bit of a shortage from a competitor, but Phytonadione we expect that to keep going the way it is..

Okay, and then on an R&D, I mean how should we look at the progression of that line through '19? So you have the inhalation trial, one of them will complete in the second quarter and then you talked about the insulin program, should we expect any lumpiness?.

Yes, there's definitely - just really depends on the timing because we're not exactly sure when that insulin trial starts, but it could overlap with some of the inhalation product and then later on in the year we should have both the insulin and the next inhalation product overlapping, so it goes. [Audio Gap].

…how will it be phased in this year and roughly what would you be spending on them?.

So the first question on business development, yes we're always looking at things and we've probably looked at more things recently than there were in the past, over the past year, but really we really are looking for things that fit in very well with the business.

And we really haven't found a lot of things that really even make sense for us to bid on. So haven't, while we've done a little bit more work recently there's been some things out there that we're interested in, nothing has really come to a point where we think it's at a price where it makes sense for us to do a deal on.

Our core strategy is to rely on our pipeline and focus on that..

And in terms of the advertising marketing campaign, it really did just kick off last month and this is because the spend for television is so high, we are focusing it as a digital campaign which includes paid search, display banners, paid social media. Our strategy we figure is when we launch in Walmart which will be soon.

We will then ramp up our spend on the advertising and so Bill alluded to that in his prepared remarks where we'll wrap it up to about $1 million per quarter and then we may even take it further if we see that we're getting good return on investment.

And so, right now we get a lot of good metrics from the digital media company and we're seeing based on the benchmarks that they're used to in terms of total conversions and the cost per conversion it seems to be going well. And so, that's where we stand right now with the advertising..

Okay. And then just a couple of brief questions on your P&L, Bill I think you had said we shouldn't take the fourth quarter and multiply it by four for next year on the revenue side.

But I was just curious on the cost side for the fourth quarter you spent about $60 million or so in R&D which is a pretty big uptick from previous quarters, is that a reasonable run rate for each quarter as we move into 2019? And then secondly, you quoted the Mankind's disclosures. They paid you $2 million amendment fee related to the insulin.

Is that a one off and is that the big reason why your diabetes line item was much higher than expected?.

Yes, so I'll start with the last question, so the $2 million amendment fee was paid in December, so that is in that line item. That's one of the big drivers and that's a one-time event.

So we did have an amendment fee, it's a similar amount, maybe a little less a couple of years ago, but right now we don't envision any further amendment fee so we'd consider that as a one-time event. As far as the R&D run rate, I think I'd mentioned one of the other questions.

We do expect some lumpiness this year and we do expect that if things go as planned, we could have both insulin and inhalation clinical trials overlapping later on in the year in the third and fourth quarter.

So the first half of the year might be closer to where we were in the fourth quarter, but the second half of the year we expect the R&D spend to ramp up well above where that is right now.

I also wanted to add one more thing to the other question about the Primatene ad spend because it's not just the ads on the digital but we also have in-store promotions as well, so we're working with the drugstore chains to do in-store promotions and special display centers, special advertising in stores, couponing, discounting and some other things, some of, most depending on what the expense is, some of those are gross to net items that could bump, make that higher gross to net, but some of those other things are in the advertising line, some of the displays and promotional activities that we're doing there, that we're working on..

Okay. Thank you..

Thank you. Our next question is a follow up from David Maris with Wells Fargo. Your line is reopened..

Hi, I just had a question on the ANP, maybe if you could give us an update on currently where the activities are and what the plant expansion progress looks like? Thank you..

Sure. So yes, we're excited by ANP and the financing that we did last year and so that money went right to work and so the real focus right now is on the construction of the finished product lines.

And so the goal is to complete that over the next one to two years with the long term goal of selling finished product in China and other international geographies..

Great thanks very much..

All right, thanks David..

Thank you..

Thank you. And I'm not showing any further questions at this time. I'd now like to turn the call back over to Jason for any closing remarks..

Great, thank you operator. This completes our call and just hope that everybody has a great day. Thanks a lot..

Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program and you may all disconnect. Everyone have a wonderful day..