Good afternoon, ladies and gentlemen, and welcome to the Amphastar Third Quarter Earnings Conference 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 AMP, the timing of product launches, acquisitions and other matters relating 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,” 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 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 to 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 is launched in the first quarter of 2018 had sales of $7.6 million. Naloxone sales declined 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 margin 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 $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 two 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. 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 perform sophisticated clinical and human factors 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 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 it takes several weeks to receive an package of the product. Our plan is to shift to major retailers in late December or early January. Based on this schedule, we expect 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 margin. As Bill discussed in addition to our new launches in 2018, our average selling price for 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…

[Operator Instructions] Your first question comes from the line of David Amsellem from Piper Jaffray. Your line is open.

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. And what are your thoughts on how that's going to trend in 4Q and also in 2019. And then lastly I know that this is recent news on the CRL, and I would - is it fair to say that that is the higher value generic that you have been alluding in another words one that where there is no generic available and do you have a sense of what you need to do to get that across the finish line? Thanks.

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 terms discounts. We also anticipate or 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 we’re certain our promotional spending that you do at the drugstores which actually is a price reduction sort 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 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, cartooning 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 revenues. So that's already built into our current cost of goods lines so that margins will improve once we start observing the overhead it’s currently being charged that way. So initially this was extremely high margin product and then once we’re actually taking the full expense for it, it just becomes the high margin product. So either way it's very good. The MPA or the Medroxyprogesterone on the market competition, yes we have seen some competition there and we think it will affect our sales slightly. However, there is three players in the market and we have less than one third 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 mature as other people.

Yes and then finally with respect to the CRL you are correct, it’s the higher value product of the two 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. Your line is open.

Just I believe there is an error in the press release its says something about higher average selling prices on enoxaparin?

Yes, seems strange.

Yes indeed so the question is obviously what led to that is that innovator driven by section or is there….?

Well, there is a couple 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 either take a price increase or we were going to be selling it not only below our cost but below our variable cost. So we were able to take a price increase in the quarter and - 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 to customers that are on some sort of contract or discount of WAC, and sales are negligible of anything that 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 3 times 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 because the October sales were shipped to - October pulled from the channel was on units that were shipped in September, it actually affects the September pricing because of the way we do the chargeback accrual we do it based on the price that we believe that the products will be sold to use the actual data from early October to help determine 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 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 might not be as high as it was this quarter, but definitely much significant higher than second quarter.

Question for yourself Jason you mentioned - obviously the two new additional and the filings in the quarter - where are you sort of in the process there in terms of notification have we passed the 45 day notification period here and I haven’t picked up any litigation been 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 is 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 is not gone out yet, but it will be going out in the next couple of weeks.

And then just - and congratulations of course on the Primatene approval I know that has been long 10 year journey?

Thank you. Yes.

Exciting to see that return to market. 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 have with retailers and just so there. You're the perceptions and recollections of the product it might just seems like it's one of the very few OTC drugs that sort of can truly drive incremental traffic in front of the store. And I got to believe that there is fairly high level of interest amongst the large or just change 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 it back on the shelves and whether or not and how quickly we may see things such as media campaigns and the like post-launch?

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 section. So this is going to a big product for the retailers and they are very excited. And we have engaged in advertising agency and we’re looking to spend in the high single-digit millions of dollars. This will mostly be a digital campaign and 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 four 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 three 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 three years and that's where the $55 million came from. So the interesting thing 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's more allergies. 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 selves 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 want to move fast to breakdown the shelves and get it up there as fast as possible which we're targeting January.

And just one final question for you Jason. You mentioned the $24 retail price. How does that…

Not retail, wholesale price.

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

Well, first of all it's us that generate. When we talk about 65 - that was Amphastar. But it was about 50%

A little less than 50% of the 2480.

However, the other thing is that when Amphastar doing it they weren't couponing they weren't doing some of the discounts that goes against sales that helps drive traffic. So there's 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. Your line is open.

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 a second cycle?

This is second cycle.

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's two going on in one quarter there will be a lot of sense. So in our fourth quarter we'll have one respiratory trial going on and our first probably only the one but in our second quarter there is probably going - although this plan will have two different respiratory trials going at once and since they're both very expensive. That quarter could be lumpy just as an example.

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 David, very much.

On the respiratory trials, how long should those last? You might start one starts in the fourth quarter and the two in the first but went 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 its' successful?

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

And what' the branded value of those products.

Of the total - I don't have the one product in front me right now but - it's a multi-billion dollar product.

On the Paragraph IV challenges, are you partnered on those or are you alone, are those your own?

Yes, it's a good question and we talked 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 Jeffries. Your line is open.

I guess I'm semi amazed you got this approval after - 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. Were they involved in the process and did they - at the end of the day did they end up overruling other people, the agency given the panel 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 Drugs, 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 e-mail from the FDA this morning conveyed was really a rigorous evaluation on the human factors because of the advisory committee decision in 2014 we 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 its in the retailers 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 test 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 two CRLs but we understood the issue that the agency was grappling with then. We really work together to get this to the finish line.

I know you've been asked a few questions on the commercialization strategy, I just wanted to delve into little bit more. So all your products are generics? This is completely different 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 the peak? Number two, it was one of the most widely recognized brands when it was CFC product given the advertisements and could you just remind us and give us some granularity and 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.

Let's start out year's 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 two to three years to get the peak sales but hopefully it's a 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 it is our plan for advertising and the other thing 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 year of the Internet and online advertising and we see companies like Google and Facebook is the biggest companies in the world. And we’re now realizing why you know a lot of our spend will go towards digital search and we’ll have to assess that as we go in terms of you 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 is going to be a lot of online campaigns using social media such as Facebook. And then of course working with the retailers and 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 the breakeven as I mentioned initially there's almost no cost associated with - that the sales we’re having from 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 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 label, getting the boxes package everything and having them ship out at 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. Your line is open.

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 tenets might be you said, it will be reasonably higher just give 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 there could be a little bit of stocking in the fourth quarter more of it will happen in the first quarter of next year. And as we 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 along to the shelves and paying for shelf space or anything like that, we’re just really pulling it off the shelves once it's there. So we have - our website is already live Primatene.com and on the bottom it says it coming soon to Walgreens and CVS. So it will be at those two chains initially one of them in early January the other hopefully late January and then there will be at other retailers once we've had enough - once we’ve done enough manufacturing to be able to stop all of their needs and some of the wholesale need. So I do anticipate that first quarter will have a lot of stocking though.

Yes, and then in terms of meeting market demands we have really good capacity at Amphastar. So we believe that we will be more than able to meet the demand.

And Bill, I also asked about the gross to net I don't if you can put just the framing a little bit, is it like 30%, 40%, 50% like just give a range maybe how to think about initially.

Yes so it’s going to be - I’ll say it's going to be more like 30% to 40% maybe 50% so yes. So it's just going to depend on the retail and the larger the retailer and two chains will have two biggest chains will have a pretty big discount. And I said we 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 have 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 turn out to be a marketing expense 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.

And then to that point is that on the gross margin, it sounds like directionally going into next year, it should definitely improve. And I know that I don't know if you want to put there's so many moving pieces in there is going to help and Primatene for sure, but maybe you could speak to some of the other products that might be down a little bit just to have a right expectation.

So first of all enox kind of did very well this quarter because of the large surgeon the noncontract sales so that will not continue into next year. So we expect that to trend to moderate and so that the gross margin on enoxaparin drops. And then once again we’ll see gross margin on that we did make a profit on that this quarter, but that was only because of the reserves that we put on the inventory - last year or last quarter we 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 then 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 is almost no expense associated with it. 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 one or two of these other generic products on the market next year the one that that’s the bigger opportunity that we got the 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.

Yes 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 - and assuming it's addressable, you don’t think that anyone is going to front run you there you pretty confident that you could be first to market on it?

Yes, we’re very confident. This is an extremely complex products and we do believe will be first to market.

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

A couple of questions on the end of pipeline. It looks like you met your goal for 2018 filings. What do you think in terms of the cadence for filings in 2019, as well as potential approvals in 2019 outside of this recent CRL?

Yes sure. So the way we talk about filings is filing 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 cadence we’re looking at 3 to 4 ANDAs for 2019. And was there a second part of that question? Yes, so we’re really encouraged with the FDA as the new GDUFA and the ten-month approval of even with the multiple cycles you sell with our generic Isuprel, we got our 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 approval, we've 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.

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

Yes, we did get an update - I believe it was in May when we had first submitted our actual used 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 yes, we always know that the agency's 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.

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

Sure. 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 from $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 the 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 in the antitrust which would provide treble damages which would be much in access of the $100 million bond.

I am 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.