Amphastar Pharmaceuticals Inc (AMPH) 2018 Q3 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the Amphastar Third Quarter Earnings Call. (Operator Instructions) As a reminder, this conference call is being 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 ANP; the timing of product launches, acquisitions and other matters relating to its pipeline of product candidates; its share buyback program; 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, expect, intend, plan, project, believe, estimate and 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 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 in -- 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 turn the conference over to your host, Jason Shandell, President of Amphastar.

Thank you, operator. Good afternoon, and welcome to Amphastar Pharmaceuticals' Third 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 third quarter financials.

Thank you, Jason. Sales for the third quarter increased 30% to $75.5 million from $57.9 million in the previous year's period. Enoxaparin sales increased 183% to $18.6 million from $6.5 million in the third quarter of last year as there was a market shortage in September, which led to an increase in noncontract sales at list prices. We were also able to take a price increase on enoxaparin to partially offset the increasing cost of heparin. Medroxyprogesterone, which was launched in the first quarter of 2018, had sales of $7.6 million. Naloxone saw sales decline to $9.4 million from $12.7 million on lower unit volumes. Isoproterenol, launched in July, had sales of $2.4 million.

Our insulin API business had sales of $5.1 million, up from $4.1 million last year. Cost of revenues increased to $46.3 million from $37.4 million and gross margins increased to 39% of revenues from 35% of revenues in the third quarter of last year.

The improved gross margin was related to increased sales of high-margin products such as medroxyprogesterone and isoproterenol, as well as increased average selling prices for enoxaparin. An increase in units produced at our Amphastar facility resulted in efficiencies which also helped our gross margins.

Increased wages, new quality requirements which increased labor hours and the increased price of heparin partially offset these margin trends. Selling, distribution and marketing expenses increased to $2 million from $1.8 million, primarily due to higher freight costs.

General and administrative spending increased to $13.4 million from $11.7 million, primarily because of higher legal expenses.

Research and development expenditures increased 13% to $11.3 million from $10.1 million due to the expansion of our ANP facility and also due to increased FDA filing fees.

Looking ahead, we anticipate that fourth quarter spending will be materially higher than the third quarter as we recently began clinical trials on 2 generic drug candidates.

Additionally, we expect spending to increase significantly next year as well. Since we sold a 42% stake in our ANP facility, we will now begin reporting net income and per share statistics based on the portion of the company's income or loss attributable to Amphastar Pharmaceuticals' shareholders. On this basis, the company reported net income of $2.4 million or $0.05 per share versus a net income of $99,000 or $0.00 per share in the third quarter of last year.

The company reported adjusted net income of $5.7 million or $0.12 per share compared to an adjusted net income of $3.4 million or $0.07 per share in the third quarter of last year.

Adjusted earnings excludes amortization, equity compensation and impairment of long-lived assets. In the third quarter, we had cash flow from operations of $15.8 million. During the quarter, we used a portion of our cash to buy back approximately $7.6 million of stock.

I will now turn the call back over to Jason.

Thanks, Bill. We're extremely happy about our announcement that our NDA for Primatene Mist was approved by the FDA. This represents a very important milestone for the company as it further validates our strong capabilities to develop complex combination products and innovative inhalation delivery systems as well as performs sophisticated clinical and human factor studies.

Amphastar is very proud to bring this new and improved product back to the over-the-counter market and to be able to provide people who suffer from intermittent asthma with an OTC option to manage their mild symptoms. We are grateful to the FDA for the close and productive collaboration we shared throughout the approval process of this NDA and for the agency's robust scientific review to ensure that the product can be used safely and effectively by consumers in an OTC setting.

Amphastar's continued mission is to lead in the development of innovative pharmaceutical drugs and delivery systems that will help to meaningfully improve people's lives, and we believe Primatene Mist will do just that. We ordered labels and cartons for Primatene after an earlier communication with the FDA, but they take several weeks to receive and then pack into the product. Our plan is to ship to major retailers in late December or early January. Based on this schedule, we expect it to be on the retail shelves in January 2019.

All of our approvals over the past year had a positive impact on both sales and gross margins. As Bill discussed, in addition to our new launches in 2018, our average selling price of enoxaparin increased on higher volume in the third quarter. Now with the approval of Primatene Mist, we believe that the company is poised for significant sales growth and continued profitability in 2019.

We are happy to report that our pipeline continues to make good progress. We had 2 more ANDAs accepted for filing by the FDA, both of which are Paragraph IV challenges and for which there are currently no generics on the market. According to IQVIA data for the 12 months ended September 30, 2018, the market value of these 2 ANDAs represents approximately $500 million in annual branded sales.

We also made progress on our inhalation pipeline as we recently began a clinical trial for our first inhalation ANDA. That trial is expected to end in the second quarter of next year, so we anticipate filing our first inhalation ANDA shortly thereafter.

With respect to the 2 previous ANDAs on file with the agency, we just received a CRL today and are still assessing it. We have 1 more GDUFA date later this year, but that is for a less significant product. In terms of our unapproved products on the market, we now have all but 1 on file with the agency and demand remains very strong for our critical care products.

With respect to our intranasal naloxone NDA, the FDA contacted us in late October to let us know that they have completed their review of our submitted materials regarding the appropriate volume for the pediatric population. We were informed that the agency is now in the process of finalizing its recommendations and we should be receiving a response soon.

With that update, I will now turn the call over to the operator to begin Q&A.

(Operator Instructions) Your first question comes from the line of David Amsellem from Piper Jaffray.

Just a few questions here. So on Primatene, can you talk about pricing and how we should think about gross margins of the product relative to some of the newer launches that you've had? So that's number one. Number two is regarding the Depo-Provera generic with the additional competition, what are your thoughts on how that's going to trend in 4Q and also in 2019? And then lastly, I know that this was recent news on the CRL, and I would -- is it fair to say that, that is the higher-value generic that you had been alluding to? In other words, the one that -- where there is no generic available, and you have a sense of what you need to do to get that across the finish line?

Sure. As far as Primatene goes, we'll be having that go out with a WAC price of $24.80. And so the major retailers will be getting a discount off of that as far as pricing goes and also the normal -- the term discounts. We also anticipate or are considering strongly doing some couponing and -- at least in the first year as well. So depending on how much that goes, that can bring down the price. And remember that as an OTC product, there's certain promotional spending that you do at the drug stores which actually is a price reduction instead of a marketing [spend]. So that further brings down the price from there. Gross margins, initially remember that we made several hundred thousand units in the second quarter up to the point that they were filled, but not labeled or packaged yet. So we expensed the full -- the entire cost of that manufacturing at that time since the product was not approved. Therefore, the only expense on the first several hundred thousand units that we sell is going to be the labeling, cartoning and packaging for them. So the initial gross margins are going to be extremely high. Remember also that the facility there right now contributes about $1 million to the cost of goods line without any revenue. So that's already built into the -- our current cost of goods line, so the margins will improve once we start absorbing that overhead that's currently being charged that way. So initially, this was an extremely high-margin product and then once we're actually taking the full expense for it, it just becomes a high-margin product. So either way, it's very good. NPA or medroxyprogesterone on the market competition, yes, we have seen some competition there, and we think it will affect our sales slightly. However, there's 3 players in the market, and we have less than 1/3 of the market right now. So I don't think it will affect us as much as it will affect Pfizer's share of the market. So there will be a change, but not as material as other people.

And then finally, with respect to the CRL, you're correct, it's the higher-value product of the 2 that were pending, the one in which there is no generic. We literally got the CRL today and so our scientific team is assessing it. What I've heard from the initial assessment is that we are confident that it's addressable.

Your next question comes from the line of Elliot Wilbur from Raymond James.

Just I believe there is an error in the press release. It says something about higher average selling prices on enoxaparin. So the question is obviously what led to that? Is that an innovator-driven price action? Or is there...

No, there's -- well, there's a couple of things going on there. One was that, as we saw the price of heparin going up as quickly as it was, we knew that we had to either take a price increase or we were going to be selling it not only below our cost, but below our variable costs. So we were able to take a price increase in the quarter and where we've -- that did stick. I think as -- we think that other people also increased price in the quarter. It helped that Sandoz dropped out of the market at the same time this was happening. So it was good timing from that standpoint. Secondly, because Sandoz dropped out, they stopped shipping or I think left the market early in the quarter. At the end of the quarter, there was a market shortage, and we saw -- normally, most of our sales are 2 customers that are on some sort of contractor discount off of WAC, and sales are negligible if anything that's at the list of the WAC price. And we saw that the WAC price sales actually ticked up into the high single-digit percentage of our sales. That might not sound like much, but that pricing is 2 to 3x higher than what other people are paying. So that was enough to really bump up the average price. So that really happened in September, but we saw that trend continue into October. And it's because the October sales were shipped to -- October pull from the channel was around units that were shipped in September. It actually affects the September pricing because of the way we do the charge-back accrual. We do it based on the price that we believe that the products will be sold to and we use the actual data from early October to help to turn that accrual. So the pricing impact in October was actually in this quarter. Additionally, we saw that -- we started the fourth quarter with fairly low volumes in the wholesale channel. So the unit demand in October has remained fairly strong, but we've seen in the last week or so that I think it's kind of moderated now. So I think we're not really getting those noncontract sales anymore, and -- but the good thing is that we were in fact able to pick up a little bit of market share on contract. So our volumes will be higher than they were in the second quarter on a going-forward basis. And the price will be higher than it was in the second quarter. So it might not be as high as it was this quarter, but definitely much -- significantly higher than the second quarter.

Okay. A question for yourself, Jason, you mentioned -- you referred to obviously the 2 new additional ANDA filings in the quarter [pre-force], where are you sort of in the process there in terms of notification? Have we passed the 45-day notification period here and have there -- I haven't picked up any litigation being filed, but just sort of curious kind of where we are in that process?

Yes. So one of them, we are well past that 45 days. We sent out the notice and actually there's only several days remaining before the innovator can sue us. So we'll see what happens there. And then on the second one, the notice has not gone out yet, but it will be going out in the next couple weeks.

Okay. And then just -- and congratulations, of course, on the Primatene approval. I know that's been a long 10-year journey. So exciting to see that return to market. I mean, anything else you can share with us with respect to sort of the go-to-market strategy or return to market strategy here in terms of some of the initial engagement you've had with retailers and just sort of their perceptions and recollections of the product? I mean it just seems like it's one of the very few OTC drugs that sort of can truly drive incremental traffic into the front of the store. And I've got to believe that there's a fairly high level of interest amongst the large chains out there. So I'm just sort of curious kind of on the qualitative commentary you're getting from the retail trade and sort of what you're thinking about in terms of some of the initial upfront investment getting that back on the shelves? And whether or not -- and how quickly we may see things such as media campaigns and the like post-launch?

Yes. Good question. So you're exactly right with respect to getting foot traffic into these major retailers. They are extremely excited. I mean, over the years, they have kept in contact with us and have been very anxious to see this approval, and so they are going to make a big push. They want us to really beef up the spending on advertising. And as we've discussed on past calls, they've talked about having it in multiple sections of their stores, cough and cold, behind the counter, as the allergy sections. So this is going to be a big product for the retailers, and they are very excited. And we have engaged an advertising agency and we are looking to spend in the high single-digit millions of dollars. This will mostly be a digital campaign and a lot of paid search. So we've engaged them. We're going to start this right away in terms of our digital campaign. We're excited because the last full years of sales for Primatene was $65 million, but when we used to sell this product, we bought it in 2008 from Wyeth and then essentially sold it for 3 years knowing that it was going to sunset per the Montreal protocol. So we really did not spend any marketing dollars or do any advertising for those 3 years and that's where the [$65] million came from. So it'll be interesting to see with an advertising campaign and whether or not we increase some of the ad spending during certain seasonal times of the year where there is more allergy, it may be interesting to see how much marketing can help sell this product. But overall, the retailers are very excited. And in terms of getting it on the shelves, typically, they don't want to really do anything in the first quarter. After Thanksgiving, they've got their shelves all set up for the holiday season, but they want to make an exception for Amphastar. So we are looking to ship in December and then they want to move fast to break down the shelves and get it up there as fast as possible, which we're targeting January.

Okay. And just one final question for you, Jason. You mentioned the $24 retail price, how does that...

Not retail, wholesale. Wholesale price.

Wholesale, sorry. How does that compare to the per unit price that was in place when Wyeth generated the peak number of $65 million?

Well, first of all, it was us that generated -- when we talk about $65 million, that was Amphastar.

That's right.

Okay. But it was about 50%.

A little less than 50% of the [$24.80].

However, the other thing is that, when Amphastar was doing it, they weren't couponing, they weren't doing some of the discounting that goes against sales that helps drive traffic. So there was very little promotion going on. So I think you're going to see a bigger gross-to-net adjustment now than you would have back then.

Your next question comes from the line of David Maris from Wells Fargo.

Congratulations on the approval yesterday, that's great news. I have a bunch of short answer questions. First on the CRL, was this a first cycle review or second cycle?

It's a second cycle.

Okay. On the sustained profitability for 2019, would you expect that to progress through the year? Or is it going to be lumpy just given the timing of spending and the like?

That's going to be a little bit lumpy, but right now, our forecast is that all quarters will be profitable. What will be lumpy is the timing of certain clinical trials, in particular the ones for the respiratory ANDAs because those are extremely expensive. And in fact will probably be more expensive than we had originally anticipated, which is why if there is 2 going on in 1 quarter, there'll be a lot of spend. So in our fourth quarter, we'll have 1 respiratory trial going on -- in our first, there will probably only be one. But in our second quarter, there is probably going to -- although there is plan to have 2 different respiratory trials going at once. And since they're both very expensive, that quarter could be lumpy just as an example.

Okay. And is it fair to think of the profitability that this is still a building period for the pipeline, that it's not -- you're not managing for maximizing profitability, but investing in the pipeline?

Absolutely.

Very much.

Okay. On the respiratory trials, how long should those last? You mentioned they might start -- one starts in the fourth quarter, and the 2 on the first, but when should they end?

So yes. So this one that I was referring to already started, and we're expecting it to end in the second quarter.

And so what's the anticipated filing for those, assuming that they are successful?

Assuming that it's successful and ends in the second quarter, we should be able to file in the third quarter.

And what's the branded value of those products?

We -- of the total -- I don't have the one product in front of me right now, but hold on. Yes, it's a multibillion-dollar product.

Okay. On the Paragraph IV challenges, are you partnered on those? Or are you alone? Are those your own?

Yes, it's a good question. We've talked about our partnership on Paragraph IV, but those are all for inhalation. So this is our injectable and so this is our own Paragraph IV.

Your next question comes from the line of David Steinberg with Jefferies.

I guess I'm semi-amazed you've got this approval after [3 tries].

Third time is the charm.

I was just reading an e-mail from the FDA that they put out this morning, it looks like the FDA Commissioner and also Janet Woodcock got involved sending out an e-mail, which begs the question, did -- were they involved in the process? And did they -- at the end of the day, did they end up overruling other people at the agency, given the panel where you had some of the safety concerns?

Yes, we don't know about the internal process. I mean, we do know that Dr. Woodcock is acting Director of New Drug, so that is under her. So we mostly dealt with the division. And as we've said on previous calls, it was very collaborative. We had multiple meetings. Last year, we had a face-to-face. And I think the dialogue back and forth and really the discussions around the product and the bench studies that we've done. And as that email from FDA this morning conveyed, it was really a rigorous evaluation on the human factors. Because of the advisory committee decision in 2014, we've really had to focus on the comprehension of the label and getting it right. And we really do want to give credit to the FDA, who helped us with those studies by suggesting that we put the label on the actuator itself, and this was a really unique idea. And we think once it's in the retailer, they will be really helpful for people because typically you buy a product, you throw the box away, you throw the instructions away, but those critical tasks will be right there on the actuator for people to see. So as I said in my prepared remarks, we believe it was very collaborative. Obviously, it's always frustrating to get 2 CRLs, but we understood the issue that the agency was grappling with, and we really worked together to get this to the finish line.

Right. So I know you've been asked a few questions on the commercialization strategy, I just want to delve into a little bit more. So all your products are generics. This is completely different. It's an OTC brand. So could you help us with a couple of things? One, I would think this might have a different launch trajectory, could you help us with sort of this -- how many years you think you might get to peak? Number two, it was one of the most widely recognized brands when it was a CFC product, given the advertisements. And could you just remind us and give us some granularity on sort of what kind of -- what level of advertising will you use to pull patients in to buy this? And then thirdly, roughly what sort of sales levels would you estimate you need to breakeven on Primatene?

Okay, great. So yes, let's start out, years to peak, that's an interesting question and we'll have to sort of continue to assess as we do the ad campaign. We want to be conservative and assume that it could be 2 to 3 years to get to peak sales, but hopefully with good ad campaign, we can actually exceed those sales in a shorter period of time. And that goes to your second question in terms of sort of, like, what is our plan for advertising? And as I was saying earlier, we're not looking to spend tens of millions of dollars, but definitely in the high single-digit. But unlike back in the '60s or '70s with some of the commercials back then, which are very expensive to run, this is a new era of the Internet and online advertising. We see companies like Google and Facebook as the biggest companies in the world, and we are now realizing why. A lot of our spend will go towards digital search and we'll have to assess as we go in terms of when to put the most money into that and if it's seasonal or not. But -- so basically, we will be paying. So When somebody puts a search term into Google that Primatene will pop up. There's going to be a lot of online campaigns using social media such as Facebook and then of course working with the retailers and -- in the couponing and some of the local papers that can also be helpful. But the real focus will be a digital advertising campaign.

Yes. And as far as breakeven, as I mentioned, initially there's almost no costs associated with the sales we're having for the first several hundred thousand units. So it's not going to take much to breakeven. And we do have a little bit of a spend in the fourth quarter, but -- and we're not exactly sure whether we'll be able to ship products in December or whether that might slip to January just based on the timing of getting the labels, getting the boxes, packaging the things and having them ship out with the holidays and all. But this is going to be extremely profitable. And even with a multimillion-dollar ad spend that we have planned over the next 12 months, I think that it will be very profitable.

Your next question comes from the line of Gary Nachman from BMO Capital Markets.

My congrats as well on the Primatene approval. So first, a few there. Should we expect a big stocking number when you ship to pharmacies? And Bill, could you quantify what the gross to nets might be? You said it'll be reasonably high, just maybe put a number or range on it? And then, can you supply the market to meet demand, assuming there is significant demand for it? Talk about your manufacturing capability for it.

So as far as stocking goes, there will be initial stocking. However, it's unlikely that much of that will happen in the fourth quarter, as there could be a little bit of stocking in the fourth quarter and more of it will happen in the first quarter of next year. And as we've said on previous calls, we know this product is going to be very easy to get into the retail channel. So our problem is not getting it onto the shelves and paying for shelf space or anything like that, it's really just pulling it off the shelves once it's there. So the -- we have -- our website is already live, Primatene.com. And on the bottom, it ways that it's coming soon to Walgreens and CVS. So it will be at those 2 chains initially, one of them in early January, the other, hopefully late January. And then they'll be at other retailers once we've had enough -- once we've done enough manufacturing to be able to stock all of their needs and some of the wholesale needs. So I do anticipate that first quarter will have a lot of stocking them.

Yes. And then in terms of meeting market demand, yes, we have a really good capacity at Armstrong. So we believe that we will be more than able to meet the demand.

Okay. And Bill, I also asked about the gross to net, so I don't know if you could put a -- just to frame it a little bit, is it like 30%, 40%, 50%? Like just give a range maybe when we think about initial?

Yes. So it's going to be -- I'll say it's going to be more like 30% to 40%, maybe 50%. So yes, it's ...

I got it right.

Yes. So it's just going to depend on the retailer, and the larger the retailer -- the 2 chains will have -- the 2 biggest chains will have a pretty big discount. And as I said, we'll also have some couponing. We don't know how much couponing will go in, but it's going to be some tests. We're going to do some tests with that and see how that goes. And then also some of the spend at the retailers is actually a sale of deduction depending on what type of spend it is. So depending on what those -- how that goes and how we allocate, we've a certain amount of money that we've allocated towards expenditures at the retail level. And so some of that will turn out to be a sales reduction, some of that will be turn out to be a marketing expense. And we haven't finalized which will be which. So in either case, it's going to be a highly profitable product in either case, so no matter which it comes from.

Right. Okay. And then to that point, just on the gross margin, it sounds like directionally going into next year, it should definitely improve. And I don't know if you want to give us order of magnitude? I know there's so many moving pieces in there. Enox is going to help and Primatene for sure, but maybe you could speak to some of the other products that may weigh it down a little bit? Just so we have the right expectations for next year.

Yes. Well, so first of all, enox kind of did very well this quarter because of the large storage in the noncontract sales, so that will not continue into next year. So we don't -- we expect that trend to moderate. And so that the gross margin on our spend drops. And then once again, they'll figure gross margin on that. We did make a profit on that this quarter, but that was only because of the reserves that we had put on the inventory at the last year or last quarter were a little bit higher than necessary given the average selling price was higher than anticipated. So that still is a product which loses money. And while we are making more units of it and selling more of it, that will actually help offset that and help make it so that we're losing less money per unit, we are still losing money on that product. Primatene, as I said, will be extremely profitable for the first several hundred thousand units because there's almost no expense associated with them, after then it will become a product that still has gross margins that are well above our average in either case. So as that grows, so will our gross margins. And if we're able to get 1 or 2 of these other generic products on the market next year, the one that's the bigger opportunity that we got to CRL on today, we think will be a very high-margin product as well given the lack of -- there are no generics on the market now, and we don't anticipate there will be many if any by the time we get to the market.

Okay. That was actually going to be my last question. Just on that CRL that you got today. And you mentioned before that it was your second CRL. So I'm assuming it's addressable. You don't think that anyone's going to front-run you there? You're pretty confident that you could be first to market on it?

Yes, we're very confident. This is an extremely complex product, and we do believe we'll be first to market.

Your next question comes from the line of Serge Belanger from Needham & Co.

A couple of questions on the ANDA pipeline. It looks like you met your goal for 2018 filings. What are you thinking in terms of the cadence for filings in '19 as well as potential approvals in '19 outside of this recent CRL?

Yes, sure. So the way we talk about filings is filings that are accepted, and so we actually plan on filing more this year, but we will count that for 2019 by the time that they are accepted. And so in terms of our cadence, we're looking at 3 to 4 ANDAs for 2019. And was there a second part of that question?

Yes, potential approvals.

Yes. So I mean, we're really encouraged with the FDA and the new GDUFA and the 10-month approvals. Even with multiple cycles, you start with our generic Isuprel. We've got a CRL. We turned it around in a matter of weeks and had an approval several months after that. So looking at our pipeline and sort of the trajectory for approvals and we talked about this on past calls, we want to continue to replenish our ANDA pipeline with 3 to 4 products a year and we want to continue and we hope to achieve 3 to 4 approvals per year.

Okay. And have you gotten any updates in the intranasal naloxone product? And any visibility on when we could see that back I guess in clinical development or a filing?

Yes. So we did get an update -- I believe it was in May when we had first submitted our actual use data. So that was where we went around the country and collected information from pediatricians regarding the volume that we proposed to FDA. And so after collecting that on other intranasal products, it was very compelling to show that the concern regarding our volume is not a concern with pediatricians around the country. So we had submitted that and we've been waiting for a response. We finally got an update just a few weeks ago, at the end of October, where they explained that they actually have completed their review and they said that they would be providing recommendations, I believe they said in several weeks. So we know -- we always know that the agency is busy and sometimes things get delayed, but we do think that we will get a response on that soon and hopefully can provide an update on the next call.

Okay. And one last one. On the $100 million bond, any new developments on the -- if and when you can collect?

Sure. So on that one, I think I might have given an update in the past, but just to refresh. Basically Momenta is appealing the patent case, which is as expected, and so we've been going through that briefing. You never know how long it will take for an appellate decision, but based on historical data, we believe that we can get a decision in the summer of 2019. And so on the $100 million bond, we had moved on that immediately after the final judgment with the court. Momenta petitioned the court that they should wait pending the appeal and the court agreed. So with respect to the $100 million, it would have to be after the appeal is resolved, which would be the summer of 2019, is my estimation. However, in parallel, the momentum is really building in our antitrust case. We completed discovery in that case at the end of October, and now we are going through depositions. And the trial for that case is in September of 2019. So it's a matter of whether they want to go to another trial with us. This time we are the plaintiffs, and we are willing to accept a global settlement, where we would dismiss the antitrust case and basically all cases would be dismissed for some substantial amount of money to Amphastar. But if that does not happen, we're prepared to go to trial on the antitrust, which would provide treble damages, which would be much in excess of the $100 million bond.

I'm showing no further questions at this time. I would now like to turn the conference back to our host.

Thank you very much, operator. This concludes our call.

Hope everyone has a great day.

Ladies and gentlemen, this concludes today's conference. Thank you for your participation, and have a wonderful day.

You may all disconnect.