AMPH
#Thank you, operator.
Good afternoon, and welcome to Amphastar Pharmaceuticals Fourth Quarter Earnings Call.
My name is <UNK> <UNK>, President of Amphastar.
I'm joined today with my colleague, Bill <UNK>, 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 <UNK>, to discuss the fourth quarter financials.
Thank you, <UNK>.
Sales for the fourth quarter decreased 5% to $60.4 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 depressed in the fourth quarter of 2016 during our transition of retail customers from Actavis, as we were unable to ship units for the retail market from 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 our vial product earlier in 2017 per the FDA's request to remove this 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 had 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 won 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 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, 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 was approximately $9.8 million and was positive for the 15th quarter in a row.
Let me now 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 Neostigmine, Medroxyprogesterone vials and prefilled syringes, which we recently launched as well as Nitroprusside, which we now plan to launch in the second quarter.
Each of these new launches will take a few months to ramp up to normalized sales levels.
The consensus sales estimate for 2018 is over $330 million, which is an obtainable goal given certain assumptions.
The recently approved products get us a good portion of the way there.
We will also need to get meaningful sales from at least 2 out of 3 possible big approvals in 2018, which include 2 large ANDAs and Primatene Mist.
We expect gross margins to increase as we were able to launch new products, which we believe we will 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 <UNK>.
Thanks, Bill.
2017 was a great year for the company in which we had positive ongoing communications with the FD<UNK>
The agency provided constructive feedback and was very responsive.
We are encouraged by the agency\
So to start off with on the Depo-Provera generic margins.
Right now, this will be well above where we're ---+ our corporate average margin right now.
And the good thing is that this should also be one of our top 5 selling products, we hope, within a year or so.
So it's going to have not just a high-percentage margin but also deliver real gross profits to the company.
And with respect to the second question, expectation regarding additional entrants, that is always possible.
This product very much 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's only 1 generic currently on the market.
That's Teva.
There is possibility of others, but we are confident that this is a complicated product with limited competition.
And then finally, for the Nitroprusside, as Bill said in his prepared remarks, we're targeting the second quarter to launch that.
We originally had planned for the first quarter, but as I was stating in my remarks, we're in the process of launching our MPA, both the prefilled syringe and the vials.
And just as a note, although Teva is in the market, they're only in the market for the Depo-Provera vial.
There is no approval of any generic with prefilled syringe.
So we've got a lot of production on those products, so we're prioritizing that due to the great revenue potential and profit.
And we'll push Nitroprusside to the second quarter.
That one is a highly competitive landscape.
I believe we're the seventh entrant into that market, and that's why we're putting less priority on it.
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.
Yes.
There really hasn't been a change there unless you're comparing from a year ago.
And a year ago, Actavis was still selling, they had a lot of inventory so they distributed from ---+ throughout the entire fourth quarter of 2016.
So we really didn't get any units shipped into the retail market.
There are still units there that we're selling through the wholesalers in the earlier parts of the year.
So there hasn't really ---+ to us, where we see it, there hasn't been any change in customer and competitor dynamics really on the large scale in the retail market.
So our sales have been, relatively, unit-wise, relatively flat.
So in terms of the filings, we still are on target to file 3 to 4 ANDAs this year.
One of those being an inhalation ANDA, and so that's on track right now.
In addition, when we talk about products on file, so in my prepared remarks, I said we currently have 3 products targeting a market of over $500 million.
We always leave out, 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 our unapproved down.
Originally we had 7 unapproved products.
As Bill stated, the epinephrine vial went off the market, which left 6.
We then got approval on Sodium Bicarbonate.
That leaves 5 unapproved products.
And currently, we do have 3 ANDAs filed on those unapproved products, and we intend to file the remaining this year as well.
And on those, there will be an NDA as well.
Well, I feel we've had that prefiling dialogue.
The advice letter that they just gave to us provided some recommendations that we do and that we make sure happen in the study before resubmitting.
And 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 the 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; we ---+ it's pretty straightforward at this point.
We've narrowed it down to a very ---+ 1 issue, and we think we've got it under control.
So we believe this will be a good study.
If the results come out the way we expect them to be, we'll package it up, and we plan on resubmitting shortly thereafter.
Yes.
So the clinical trial spending, we really expect to ramp up throughout the year.
And as <UNK> mentioned with 3 to 4 filings, and also a couple other filings that are on the [b] for our unapproved products, our filing fees to the FDA will be going up as well, and at least one of those is going to be an ND<UNK>
So we're going to have a significantly more clinical trial spending and a lot more filing fees and FDA fees this year.
So I would expect the R&D [spend] to especially grow by the end of the year.
And also the ---+ some of the legal spend probably will also get larger later in the year as I alluded to some potential Paragraph IV challenges.
Yes, thanks, <UNK>.
This is <UNK>.
I'll answer the pipeline question.
So we have not had ---+ we have not raised the resubmission class with the agency.
As a company, we still believe that this is a very narrow issue that could deserve a 2-month review as opposed to a 6-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 produced at that time and be able to sell those.
However, at the time, we also did buy and expense at the time pumps, valves and canisters, and we also have API on hand, which has no book value as of right now either.
So we have a significant amount of materials that will have an initial cost of 0 when we start selling the product.
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 in November.
They seemed to like it.
We've received some recommendations since that point.
Some of the recommendations were around the 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 a 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 in pediatric populations.
We'll 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 6 months, 3 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.
Sure.
So certainly, it 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.
And with more cash on the balance sheet, then we could be more likely to make a bid for something all cash if we were 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, a 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 in some form or another, too, as well.
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.
Yes, sure.
All of these products that you mention are very big products with very big markets.
We certainly do ---+ we do have limited resources at 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.
And the market potential, certainly, a function of people that we know are in it and if we know that there are people ahead of us on something, well, that might make that product 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 don't ---+ and with 6 inhalation products, they're going to have clinical trials that range between $10 million and $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, sir, and we also have limited amounts of R&D capabilities at any one time.
So when we prioritize products, is 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 in 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.
Sure.
So the already approved products get us more than halfway there, we believe.
So ---+ and the remainder will be from products that have to be approved during 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 2 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.
Yes.
So if you take a look at, I'd say, the 6-month data here, and then some of that ---+ yes, so if you take a look at the last 6 months as opposed to the last quarter or the third quarter, that's a better way to look at it.
Yes.
Probably $8 million, maybe a little higher.
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 was 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 returned or provisioned items that were beneficial to us that we didn't book, until we had booked ---+ filed the return in October.
And there were also ---+ we did a tax ---+ a change of methodology for a certain thing, which led to a onetime increase.
It was 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.
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 5-year plan for the pipeline, and we are executing on it.
Yes, good questions.
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.
And 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.
Sure.
It's a very good question.
And we've had a 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.
And 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.
Sure.
So first of all, on the cash, we ---+ I don't have the number in front of me for CapEx, but we did have 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 us 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.
Thank you, operator.
So this concludes our call.
I hope everyone has a great day.
