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Good day, ladies and gentlemen, and welcome to the Amphastar Fourth Quarter Earnings Conference Call. [Operator Instructions]. All statements in this conference call that are not historical facts are forward-looking statements, including, among other things, statements related 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, acquisitions and other matters related to its product candidates, the timing for completion of construction of the company's IMS facility, its share buyback program and other future events. These statements are historical facts and are rather based on Amphastar's historical performance and expectations, estimates and projections regarding Amphastar's business, operations and other similar or related factors.
Words such as may, might, will, could among 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 all not forward-looking statements contain these works, you should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and assumptions that are 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 the new number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission. You can locate these reports to the company's website at HTTP 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 for the conference call referenced above to reflect events or circumstances in the future even if new information becomes available, or if subsequent events cause the company's expectations to change.
At this time, I'd like to turn the call over to Jason gentle, please begin. Sir, your line is open. You may begin.
Thank you, Operator. Good afternoon, and welcome to Amphastar's pharmaceuticals fourth quarter earnings call. My name is Jason Shandell, President of Amphastar Dick I'm joined today with my colleague, Bill Peters, CFO of Amphastar. We are appreciate you joining us on the call today and look forward to speaking with you again in 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 decreased 5% to 64.4 million from $63.5 million in the previous year's period. Sales of enoxaparin rose to $11.3 million from $8.3 million as sales of enoxaparin were at their press in the fourth quarter of 2016, during our transitioning of retail customers from activists as we were unable to ship units from the retail market to August 2016 until the end of December 2016.
Sales of epinephrine decreased to $3.7 million in the quarter from $10.7 million as we discontinued selling over product earlier in 2017 by the FDA's request to remove these unapproved product, which no longer is on the drug shortage list. Our insulin API business generated sales of $4.4 million, a slight decrease from the $4.7 million we reported in the fourth quarter of 2016. Gross margins improved year-over-year as we have larger inventory reserves in the fourth quarter of 2016 for enoxaparin and epinephrine vials. Selling distribution and marketing expenses increased slightly to $1.6 million from $1.5 million. General and administrative spending decreased 14% to $9.2 million from $10.7 million, primarily due to decreased legal expenses now that we have 1 the jury trial. Research and development expenditures decreased 7% to $11.4 million from $12.3 million due to the timing of API expenditures for our pipeline and expenses related to Primatene inventory we purchased and expensed in 2016. The company reported net income of $1.5 million or $0.03 per share compared to last year's fourth quarter net loss of $2.7 million or $0.06 per share.
The company reported an adjusted net income of $4.8 million or $0.10 per share compared to an adjusted net income of approximately $500,000 or $0.01 per share on the fourth quarter of last year. Adjusted earnings exclude amortization from equity compensation and impairments. On December 31, 2017, the company had approximately $72.4 million of cash, restricted cash and short-term investments. In the fourth quarter, cash flow from operations is approximately $9.8 million and is positive for the 15th consecutive quarter in a row. That mean I'll review a few of the financial assumptions that we will be using as we look forward to 2018. We expect sales growth will be driven by new products, including something, and Roxy progesterone vials and syringes Welch we recently launched as well as nitric percent, which we now plan to launch in the second quarter. Each of these new launches will take a few months to ramp-up some normalized sales levels. The consensus of sales estimates for 2018 is over $313 million, which is unobtainable goal given certain assumptions.
Their recently approved products give us a good portion of the way there. We will also need to get meaningful sales from at least 2 out of three possible big approvals in 2018, which includes two large ANDAs and Primatene Mist. We expect gross margins to increase as we were able to launch new products, which we believe we'll be able to sell at higher average margins. We expect incremental G&A spending increases related to compliance costs and legal expenses associated with Paragraph IV patent challenges and our antitrust trial. We expect research and development spending will increase in both dollar terms and as a percentage of sales as we are planning to begin several expensive clinical trials for our inhalation and insulin pipeline. I will now turn the call back over to Jason.
Thanks, Bill. 2017 was a great year for the company in which we had positive ongoing communications with the FDA speak the agency provided constructive feedback and was very responsive. We are encouraged by the agency's recent comments regarding the need to improve more complex generics and believe that we are in a real sweet spot given our technically challenging pipeline. We received 2 FDA approvals in the third quarter and 3 FDA approval is in the fourth quarter. These approvals will be the drivers of the company's growth in 2018. We launched our neostigmine in December, launched our and Roxy progesterone vital in January and launched our progesterone prefilled syringe in February.
We have decided to delay launching our Nitro prove side product as we are prioritizing production of our something progesterone products, which have a higher much revenue and profit potential for the company. Following our fiber recent approvals, we now have three injectable ANDAs on file with the agency, target products with a market size of over $500 million. All 3 of these applications are under a second cycle review and have GDUFA dates at varying times throughout the year. Two of the three ANDAs are a significant markets and one of them has never had a generic approved regarding our NDA prior to printing mix, we recently received a jump in, letter from the agency, which provided feedback on our proposed protocol for our human factor study. The feedback was constructive and allows us to proceed with our study. We currently are conducting a small pilot study and plan to begin about three believe will be our final study in April. Assuming that the results are acceptable, which we expect them to be, we should be in a position to resubmit the NDA in the second quarter.
With the respect to our intranasal naloxone NDA, we continue to have active and productive dialogue with the agency and have received constructive recommendations regarding that path forward. We intend to follow the agency's recommendation as we continue to address the efficiencies set forth in the CRL. Regarding our litigation against Momenta and Sandoz will be received an order from the District Court affirming the jury's verdict that momentous patent is invalid and the holding that momentum quote engaged in misleading conduct that gives rise to equitable. We expect to receive the final judgment any day, after which we will proceed the final our motion to collect on the $100 million 1. Finally, our antitrust case against Momenta and Sandoz continues forward and we are currently in the discovery phase of the case. With that update, I will now turn the call over to the operator to begin Q&A.
[Operator Instructions]. Our first question comes from David Amsellem with Piper Jaffray.
Just have a couple product specific ones. So first on Depo-Provera, can you just quantify how much higher margins on that product you think will be versus corporate margins? That's #1 my. And then secondly, on that product, what are your expectations or it regarding the potential for additional entrance as they year progresses and that sort of bearing in mind the FDA's prioritizing the approval of more complex products? Missus one such products oh how do you think about that? Last question is on Nitro press or the generic. What's your sense of when you're going to launch that and give us some color on that competitive landscape there?
So to start off with the generic margins. Right now, this will be well above where our corporate average margin right now and the good thing is that they should also be one of our top 5 selling products we hope within a year or so. So it's going to have much is the high percentage margin but also deliver real gross profits to the company.
And with respect to the second question, expectation regarding additional entrance, that is always possible. This product very much made no Mike meets our business strategy of technical barriers to entry not just in terms of getting the product approved but also the manufacturing process. So as you see, there is only 1 man generic currently on the market that's Teva. Their responsibility of others but we are confident that this is complicated product with limited competition. And then finally, for the Nitro prove side, as Bill said in his prepared remarks, we are targeting the second quarter to launch that. We originally had planned for the first quarter but as I was stating in my remarks, we are in the process of launching our NPA both their prefilled syringe and the vials and just as a note, although Teva is in the market, they are only in the market for that Depo-Provera by a. There is no approval of any generic with prefilled syringe. So we've got lot of production on those products so we are prioritizing that due to the great revenue potential and process and we'll push Nitro prove side to the second quarter. That one is highly competitive landscape. I believe, we are in the seventh entrant into that market and that's why we are putting less priority on that.
Okay. If I may just sneak in one month follow-up to the GDUFA said various point and '18. Can you just give us, I do know if you could give us the dates but if not, maybe just little more color on when in '18?
Well, at this point, we're not giving any specific dates. They are varying throughout the year. Some could be soon. Let's put it that way.
And our next question comes from Elliot Wilbur with Raymond James.
Just want to ask a couple of questions around whether the key products of enoxaparin, they sequential increase in revenue in the clip looks like there's been a pretty uptick in terms of the retail sales of that product just wanted to see what the effect was exactly happening there in terms of the retail distribution strategy?
Yes. There really hasn't been a change there unless you are comparable from a year ago and on a year ago, Actavis was still selling, they have a lot of inventory so they distributed from throughout the entire fourth quarter of 2016 so we really didn't get any units shift in the market. There were still units they are that plus selling through the wholesalers and the early parts of the year so there hasn't really to us, there hasn't been any change in customer competitive dynamics really, in the retail markets so our sales have been relatively yet the wind relatively flat.
Okay. With respect to the pipeline may be just update us in terms of how many applications you expect to file this year whether or not there in there or NDAs I know you've added one product looks like when my product is available in the pipeline. Public commentary and maybe if you could disclose whether that's injectable or a respiratory agent.
So in terms of the findings, we still are on target to file 3 to 4 ANDAs this year. One of those being on inhalation ANDA and so that's on track right now in addition, when we talk about products on file, in my prepared remarks, I said we currently have 3 products targeting a market over $500 million. We always leave for purposes of these disclosures, our unapproved products and so as you may know, last year, we got our sodium bicarbonate approved so that took over unapproved down originally we had seven unapproved products. As a Bill stated, the enoxaparin by element of the markets, which left the six. We then got approval on sodium bicarbonate that leaves five unapproved products and currently, we do have 3 ANDAs filed on those unapproved products and we intend to file of the remaining this year as well. And on those, there will be an NDA as well.
Okay. Follow-up question is made to respect to Primatene, obviously given some of them back and forth to be the agency over the years, on that asset, once you've completed this small human factor study, what kind of interaction or clarity or communication can you help to gain from the agency in advance of resubmitting the NDA just to make sure the company and the agency are on the same page there?
Well, I feel that we have that prefiling dialogue, the advice letter that they just gave to us provided some recommendations that we do and that we make sure happened in the study before resubmitting. It's all very reasonable and feasible. So we think it's straightforward. If an issue were to occur, then perhaps we would have a follow-up with agency but at this point, we pretty much have the green light assuming we follow those recommendations, which are straightforward to resubmit shortly after the study so I don't think at this point, we have any pre-NDA meeting so to speak planned that it's pretty straightforward at this point. We've narrowed it down to a very 1 issue and we think we've got that under control. So we believe this will be a good study. If the results come out the way we expect them to be the mobile package it up and we plan on resubmitting shortly thereafter.
Just one last line of question for Bill, couple of financial items. Outside of your general commentary on the overall trends and G&A and R&D is there anything specific to think about in terms of the cadence for those numbers over the course of the year? Quarter?
Yes. The clinical trial spending we really expect to ramp-up throughout the year and as Jason mentioned with 3 to 4 filings, and also couple of other filings that are for unapproved products, our filings cease to the FDA will be going up as well and at least, one of those will be an NDA so we are going to have a significantly more credible trial spending and more filing fee in FDA fees this year. So I would expect that specially grow by the end of the year and also, some of that legal spend probably will also get larger later in the year as related to some Paragraph IV challenges.
And the next question comes from Serge Belanger from Needham. Your line is now open.
A couple of pipeline questions also. I guess, not just follow-up on Primatene. From the seatback you've gotten, you expect to Class I or Class II the resubmission and I think you had previously manufactured product in anticipation of the launch in late 60s and early '17. Is that product still usable for a launch later this year?
Yes, thanks, Serge, this is Jason. I'll answer the pipeline question. We have not raised the resubmission class survey the agency. As a company, we still believe that this is a very narrow issue that could deserve a two-month review as opposed to a six-month. We have not had that discussion. It may be worth a question prior to filing, but at this point, the agency has not indicated which class it would be. But we maintain that we think it's a straightforward review issue.
And as far as the inventory goes, we made that in November and December of '16, so it's been well over a year now. Highly unlikely that we could use any of the finished goods that we produce at that time and be able to sell those. However, at the time, we also did buy and expensed, at the time, pumps, valves and canisters and we also made APA on hand, which has no book value as of right now either. So we have significant amount of materials that will have an initial cost of 0 when we start selling the product.
Okay. And then on the intranasal naloxone, is that heading back in the clinic? Or are you modifying the device? I guess just if you can give us timelines on whether you expect some resubmission there maybe.
Sure, sure. So yes, we're still in the process of modifying the device, and we showed the prototype to the agency when we met them in person, November. They seemed to like it. We've received some recommendations since that point. Some of the recommendations were around human factor study. So we'll do another human factor study once we have this easier-to-use device, and we think the study will be much easier, given there will be no assembly required. That being said, I do not see resubmission in 2018. We're still finalizing the prototype of the device. We're still collecting data, real-world data from hospitals regarding the volumes and pediatric populations. Likely provide that information to the agency in the second quarter. Once we come to an agreement on the volume and the device development is complete, we then need to do stability. As I said on the last call, in the November meeting, they made -- they emphasized the point that they're willing to work with us on stability and perhaps accelerate that as an exception, given the importance of the product. But that being said, having to put on stability even if they decreased it six months, three months, given all the development in the 4 issues that we're addressing in the CRL, I think it's more likely to see a submission in 2019.
Okay. And then one last one. On the $100 million bond, it sounds like that's something that will move forward at some point this year. How does that impact your CapEx plans in terms of -- and business development activities?
Sure. So certainly, you could go a long way financing a lot of our CapEx and clinical trials that we have planned over the next couple of years. That would certainly be a good thing on. And with more cash on the balance sheet, then we could be more likely to make a bid for something all cash. We're looking at some business development opportunities. But right now, as we've always said, our focus is on our R&D pipeline. So if we find a good business development activity, nice acquisition that will fit in well with us, then we'll certainly go after that. But otherwise, we will definitely -- our first focus is the R&D pipeline. And we could also potentially return some of the cash to shareholders and then some form of another, too, as well.
And our next question comes from David Maris of Wells Fargo.
I apologize if you've already answered this as I joined the call late. But not many people have written about or talked about whether or not you're working on generic flow venture, generic ADVAIR, [indiscernible] all of these very big opportunities in respiratory. Although in your pipeline, which you say you're working in respiratory. So I know you're not going to disclose it because I asked, but under what circumstances would you disclose something like that? Is it on the filing? Is it at some point as you get closer? What's the metric that you use for disclosing big opportunities like that?
Yes, it's a good question, and we've discussed this in the past. I mean, for a lot of products like this, we try to be secretive for competitive reasons. A lot of times, the brand will do things to slow the generic down. That being said, for some of our inhalation products, there are Paragraph IVs involved. So the most likely way that this will ultimately be disclosed is when the Paragraph IV is filed and we're sued on the product.
And then just as a follow-up. When you think about a product like in ADVAIR, if you are working under ADVAIR, you can fill in the blanks for any other product. If you know you're going to be a year or 2 or you think you might be a year or 2 behind, how does that go into your thinking of whether or not it still makes sense to do it? Is it when you think of the number of competitors? And for some of these larger ones, do you think that it'll be crowded or there'll be a limited number of competitors?
Yes, sure. All these products you mentioned are very big products, very big markets. We do have limited resources of the company. And as we look to prioritize products, one of the things that goes into our calculus is what do we see as our market potential. On the market potential, certainly, a function of people that we know that are in it and that we know that there are people ahead of us on something that might make that part a lesser priority. And it might move other products that have similar characteristics up to a higher level. So that's something to keep in mind as that -- we keep in mind when we're doing this because our thoughts are that we -- with six inhalation products, they're going to have clinical trials that range between $10 million to $20 million each. Three of those are partnered with another company where we'll share the costs with that other company for the clinical. But we don't want to run all of those at once, and we also have limited amounts of R&D capabilities at any one time. So when we prioritize products, it's how I would take a look at that.
And just as a follow-up, as you know, a big part of our business strategy is to focus on technically challenging products where approvals are difficult and there's barriers to entry. So especially in the inhalation market, to this day, there is no generic HFA out there. And so the thinking is that although there may be some companies ahead of us and some of the inhalation products, these are extremely large markets. And as Bill said, we'll continue to monitor to see approvals but, sometimes, filings don't worry us as much because we know how complicated these products are.
And our next question comes from Gary Nachman with BMO Capital Markets.
On the consensus revenue of $330 million, you said it's obtainable if a few things happen. But there are a lot of moving parts there. So maybe you guys could just reconcile the $240 million revenue run rate in the fourth quarter to get another $70 million of revenue to achieve that. How much from already approved products versus new approvals that you would need to get this year?
Sure. So the already approved products get us more than halfway there, we believe. And the remainder will be from products that have to be approved during the year.
Okay. And I'm assuming Primatene is in there as well, right, for the second half of the year?
Yes. So as I mentioned, we need to get -- in order to hit that goal, which we believe is obtainable, we'd have to get 2 out of 3 large approvals, and those large approvals include two ANDAs, and the third one's Primatene. So if we get 2 out of 3 of those reasonably earlier or in time during the year to get meaningful sales from those products, then we believe that, that goal is obtainable.
Okay. And then on the enoxaparin sales, I know you said units have been relatively flat, but there was a big delta between the third quarter and the fourth quarter of this year. So what's the right run rate that we should be thinking about for 2018? It seems like it's a pretty wide ratio.
Yes. So if you take a look at, I'd say, the six-month data here, and then some of that -- yes, so if you take a look at the last six months as opposed to the last quarter or the third quarter, that's a better way to look at it.
Okay. So averaging about $8 million a quarter or so, in the $8 million, $9 million range?
Yes. Probably $8 million, maybe a little higher.
Okay. And then just can you explain, Bill, the tax benefit in the fourth quarter? What drove that? And then should we be thinking about a 21% tax rate now going forward for the company?
Yes, good question. So there's a bunch of onetime things that really went into the fourth quarter. The biggest single one was that there's a significant number of options exercised in the quarter, which led to a tax deduction base for the company in the quarter as we had more expense for tax than we did for book. Second thing is there were some -- we had a couple returns or provisioned items that were beneficial to us that we didn't book. And so we have booked and filed a return on October. And there were also -- we did a tax -- change of methodology for a certain thing, which led to onetime increase as more of a timing issue there, but it led to a benefit in the fourth quarter as well. As far as the going forward rate, 21% is too low because we do operate in tax -- high tax states as well. So -- and not all of our benefit will be -- we will be able to take really in the first year. So I think more of a 25% to 28% tax rate for 2018 is the right number and then, probably going forward, closer to 25% after that.
Okay. And then just last question for Jason, just a follow-on to David's question before. Are there any areas of very you feel like you could be investing more to advance the pipeline? Have you guys been holding back? Or are you really spending and moving forward all the programs the way you would like to?
Yes. I think we are doing it the way that we would like to. We have limited resources as a company our size. And we are -- we do want to stay profitable as a company. So we've sort of prioritized the products based on the revenue and profit potential. We can't run clinical trials in parallel for all of the products, but we have a good five-year plan for the pipeline, and we are executing on it.
Our next question comes from David Steinberg with Jefferies.
It's encouraging to hear about the progress with Primatene and that you think you're going to do your final human factor study and that you're going to file in Q2. So my questions revolve around the sales and marketing effort. The product clearly has a different profile than just about all your other products. It's a consumer product. When it was on the market previously as a CFC, it was one of the most well-known brands in the United States and had a heavy direct-to-consumer component. So I'm just curious, given that you're launching it this year, how much spend will you put behind it? Are you going to use direct-to-consumer, TV and print advertising? And what kind of peak sales do you think it could generate? And because it's such a well-known brand, how quickly do you think you could go to peak?
Yes, good question. So in terms of the sales and marketing, we are planning a multimillion dollar marketing spend at launch. And we did meet with a firm last year. We have a good plan in place. Television ads are extremely expensive. I mean, you could spend $100 million on something like that. So most of it will be online, which seems to have a lot of good pull these days. And of course, the retailers will be promoting it as well. This brings in a lot of good foot traffic for the retailers. And they've been excited about this product for several years and awaiting the approval. So yes, we definitely need to let people know it's back, and we'll be spending millions of dollars at launch, mostly on online advertising and, obviously, in mailers for the regions, for out of the retailers. In 2010, that was our peak sales for the CFC product. That was $65 million in peak sales. And looking at what's out there OTC right now, there's a number of nebulizers that are on the market through the monograph.
These are epinephrine products that are priced quite high. And so based on their pricing as well as the improvements with our product, our product used to be in glass, which tended to break and had no dose indicator, this new one, it's a patented product, it's aluminum, it has a dose indicator. Not that we purposely did it this way, but because there is an indicator, there's less headspace. So the product actually does not have as many doses as the CFC version, which will lead to most likely more purchases. So we think it will take some time. I think getting it on the shelf, no problem, but then having people actually purchase it and having the retailers reorder, that will take some time. We do believe, in the long run, that we will exceed the $65 million in peak sales.
And our next question is from Elliot Wilbur with Raymond James.
I wanted to ask a follow-up question around some of your early commentary, Jason, with respect to the respiratory pipeline. You mentioned obviously the fact that there is no HFA generic product currently approved in the U.S. market. If you look at the history of generic development them these assets, there seems to be constant shifting of timelines, request for information and just a pathway that seems uncertain on the generic side. And given the fact that you obviously have not filed these assets, wondering how you guys internally think about the different pathways between ANDA and NDA. NDA obviously maybe more expenses. But certainly, gives you more certainty in terms of approval. We've seen some products like the Teva combination agent do quite well, even though it's not a true AB-rated product. So ii just wondering if you're still optimistic about the ANDA pathway versus considering something more on the 505B2 side.
Sure. It's a very good question, and we've had conversation recently with some of our FDA consultants along this line and had some controlled correspondence with the agency as well. And there seems to be a push by the agency to try to get ANDAs out there that are interchangeable. Although it's not within the FDA's purview, but we all know that pricing has been on the radar lately. And I think they're coming about it in a good way in terms of saying, "Look, if we can get more competition, that's what brings prices down." And interchangeability would be an important aspect of that. So in some of our controlled correspondence, we have been encouraged that we can continue with the ANDA route. And we do believe, and we've heard that there will be guidance coming out shortly that will actually allow for interchangeable ANDAs even in circumstances where the device is slightly different as long as you can do the bridging studies and show the safety and efficacy. So in essence, if you show that A equals B equals C, you can still potentially get the interchangeability with your product, albeit slightly different because as we all know, the brands are constantly making slight changes to try to delay generics. It seems the FDA is aware of this gaming of the system, and they seem to be working with generic companies to help combat that.
Okay. Just two quick follow-ups for Bill. Can you just talk about the cash movement of the quarter? I think you said cash flow from operations was about $10 million. And I don't know if that was expended primarily through share repurchases, but talk about cash movement. And your commentary on business development was interesting because either I misinterpreted your commentary last call or there's been sort of a change in tone. You seem to be much more open receptive to opportunities like, I guess, what's my interpretation coming out of last conference call. So I don't know if there's been kind of a change internally in what you're thinking about in terms of asset size and scale, if maybe you're thinking about maybe some larger opportunities or maybe I just didn't interpret your comments last call correctly.
Sure. So first of all, on the cash, I don't have the number in front of me for CapEx, but we did a pretty large number for CapEx in the quarter, and we did have about $6 million of share repurchases in the quarter. So that's where the cash went. And we hope to have our 10-K out Wednesday morning, so all the final numbers will be in that. So that answers that question. As far as acquisitions go, I will say, with more cash on the balance sheet, we might be a little more attuned to potentially making an acquisition. But really, the second part of my comments is the right part to think about it for our company, which is we're an R&D focused and driven company, and that's where we believe our core strength is. So that's definitely going to be the priority.
And I am showing no further questions in the queue at this time. I'd like in turn the call back over to Jason Shandell for any closing remarks.
Thank you, Operator. So this concludes our call. I hope everyone has a great day.
Ladies and gentlemen, this concludes the program and you may all now disconnect. Everyone, have a great day.