Amphastar Pharmaceuticals (AMPH) Q4 2017 Earnings Conference Call Transcript

Amphastar Pharmaceuticals (NASDAQ: AMPH) Q4 2017 Earnings Conference CallMarch 12, 2018 5:00 p.m. ET

Contents:

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  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day, ladies and gentlemen, and welcome to the Amphastar Fourth-Quarter Earnings Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions for how to participate will be given at that time. [Operator Instructions].

I’d like take a moment to read the forward-looking script. All statements in 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, acquisitions and other matters related to its pipeline of product candidates, the timing for completion of construction at the company’s IMS facility, 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 on 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 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 the company’s expectations to change.At this time, I’d like to turn the call over to Jason Shandell, president, to begin.

Sir, your line is open. You may begin.

Jason ShandellPresident

Thank you, operator. Good afternoon and welcome to Amphastar Pharmaceuticals’ Fourth-Quarter Earnings Call. My name is Jason Shandell, president of Amphastar. I’m joined today by my colleague Bill Peters, CFO of Amphastar.

We appreciate you joining us on the call today and look forward to speaking with you and answering any questions you may have. I will now turn the call over to our CFO, Bill Peters to discuss the fourth-quarter financials.

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Bill PetersChief Financial Officer

Thank you, Jason. 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, in 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 $313 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 two out of three possible big approvals in 2018, which include two large ANDAs and the 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 4 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 in our inhalation and insulin pipeline.I’ll now turn the call back over to Jason.

Jason ShandellPresident

Thanks, Bill. 2017 was a great year for the company, in which we had positive ongoing communications with the FDA. The agency provided constructive feedback and was very responsive. We’re encouraged by the agency’s recent comments regarding the need to approve more complex generics and believe that we’re in a real sweet spot given our technically challenging pipeline.

We received two FDA approvals in the third quarter and three FDA approvals 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 medroxyprogesterone vial in January, and launched our medroxyprogesterone prefilled syringe in February. We’ve decided to delay launching our nitroprusside product, as we are prioritizing production of our medroxyprogesterone products, which have a much higher revenue and profit potential for the company.

Following our five recent approvals, we now have three injectable ANDAs on file with the agency, targeting products with a market size of over $500 million. All three of these applications are under second-cycle review and have GDUFA dates at varying times throughout the year. Two of the three ANDAs are significant markets and one of them has never had a generic approved. Regarding our NDA for Primatene Mist, we recently received a general advice 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 what we 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 respect to our intranasal naloxone NDA, we continue to have an active and productive dialogue with the agency and have received constructive recommendations regarding the path forward.

We intend to follow the agency’s recommendations as we continue to address the deficiencies set forth in the CRL.Regarding our litigation against Momenta and Sandoz, we received an order from the district court affirming the jury’s verdict that Momenta’s patent is invalid and holding that Momenta “engaged in misleading conduct that gives rise to equitable estoppel.” We expect to receive the final judgment any day, after which we will proceed to file our motion to collect on the $100 million bond. 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 to the operator to begin Q&A.

Questions and Answers:

Operator

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

David AmsellemPiper Jaffray — Managing Director

Thanks. So, I 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 No. 1. And then secondly, on that product, what are your expectations regarding the potential for additional entrants as the year progresses, and that’s sort of bearing in mind that the FDA’s prioritizing the approval of more complex products? This is one such product. So how do you think about that? The last question is on nitroprusside, the generic. What’s your sense of when you’re going to launch that? And give us some color on the competitive landscape there.

Thanks.

Bill PetersChief Financial Officer

So to start off with the Depo-Provera generic margins, right now this will be above where we’re, our corporate average margin right now and the good thing is that this should also be one of our top five selling products we hope within a year or so. So it’s going to have not just a higher percentage margin but also deliver real gross profits to the company.

Jason ShandellPresident

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 one generic currently on the market. That’s Teva.

There is the 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. 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.

David AmsellemPiper Jaffray — Managing Director

And then, if I may just sneak in a follow-up just on the GDUFA, they’re at various points in [Inaudible]. I don’t know if you can give us the dates but if not maybe just a little more color on when in ’18?

Jason ShandellPresident

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.

David AmsellemPiper Jaffray — Managing Director

OK, thank you.

Operator

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

Elliot WilburRaymond James — Analyst

Thanks. Good afternoon. I just wanted to ask a couple of questions about one of your key products, Enoxaprin. Nice sequential increase in revenue and looks like there’s been a pretty big uptick in terms of retail sales of that product.

So just wanted to see what in fact was exactly happening there in terms of the retail distribution strategy.

Bill PetersChief Financial Officer

Yeah, there really hasn’t been a change there unless you’re comparing from a year ago. 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 were selling through the wholesalers in 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 a large scale in the retail market. So, our sales have been relatively, unitwise, relatively flat.

Elliot WilburRaymond James — Analyst

OK, with respect to the pipeline maybe could just update us in terms of how many applications you expect to file this year, whether or not they’re ANDAs or NDAs. I know you’ve added one product, looks like one product to the [Inaudible] pipeline since last public commentary. Maybe if you could disclose whether that’s an injectable or a respiratory agent?

Jason ShandellPresident

So, in terms of the findings, we still are on target to file three to four ANDAs this year. One of those being an inhalation ANDA. So that’s on track right now. In addition, when we talk about products on files, in my prepared remarks I said we currently have three 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 seven unapproved products. As Bill stated, the epinephrine vial went off the market, which left six.

We then got approval for sodium bicarbonate. That leaves five unapproved products and currently, we do have three 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.

Elliot WilburRaymond James — Analyst

OK. And there’s a follow-up question for you, Jason, with respect to Primatene. Obviously, given some of them back and forth with 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 hope 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?

Jason ShandellPresident

Well, I feel that we have that prefiling dialogue. The advice letter that they just gave to us provided some recommendations that we do, 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 meetings, so to speak, planned. It’s pretty straightforward at this point. We’ve narrowed it down to a very, one 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.

Elliot WilburRaymond James — Analyst

Just one last line of question for Bill on a 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?

Bill PetersChief Financial Officer

Yes. So, the clinical trial spending we really expect to ramp up throughout the year and, as Jason mentioned, with three to four filings and also a couple of other filings that are 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 NDA. So we are going to have a significantly more clinical-trial spending and a lot more filing fees and FDA fees this year. So, I would expect [Inaudible] especially grow by the end of the year and also some the legal spend probably will also get larger later in the year as I alluded to some potential Paragraph 4 challenges.

Elliot WilburRaymond James — Analyst

OK, thank you.

Operator

Thank you. And the next question comes from Serge Belanger from Needham. Your line is now open.

Serge BelangerNeedham & Company — Analyst

Hi, good afternoon. A couple of pipeline questions also. I guess, to follow up on Primatene, from the feedback you’ve gotten, do you expect a Class I or Class II resubmission? And I think you had previously manufactured the product in anticipation of the launch in late 2016 and early 2017. Is that product still usable for a launch later this year?

Jason ShandellPresident

Thanks, Serge. This is Jason. I’ll answer the pipeline question. 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 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.

Bill PetersChief Financial Officer

And as far as the inventory goes, we made that in November and December of 2016, 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 expensed 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 zero when we start selling the product.

Serge BelangerNeedham & Company — Analyst

OK. And then on the intranasal naloxone, is that heading back into clinic? Are you modifying the device? If you can give us timelines on when you’d expect some resubmission there maybe.

Jason ShandellPresident

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 and 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 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 and the four issues that we’re addressing in the CRL, I think it’s more likely to see a resubmission in 2019.

Serge BelangerNeedham & Company — Analyst

OK. 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 and business development activities?

Bill PetersChief Financial Officer

Sure. So it certainly 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’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, a nice acquisition that will fit in well with us, then we’ll certainly go after that but otherwise, our first focus is the R&D pipeline.

Jason ShandellPresident

And we could also potentially return some of the cash to shareholders and in some form or another too as well.

Serge BelangerNeedham & Company — Analyst

Thanks for taking the questions.

Operator

And our next question comes from David Maris of Wells Fargo. Your line is now open.

David MarisWells Fargo Securities — Managing Director

Good afternoon. I apologize if you’ve already answered this, as I joined the call late. Not many people have written about or talked about whether or not you’re working on generic Flovent, generic Advair, generic QVar, all these very big opportunities in respiratory, although in your pipeline chart you say you’re working in respiratory. I know you’re not going to disclose it because I asked, but under what circumstances would you disclose something like that? Is it upon filing? Is it at some point as you get closer? What’s the metric that you use for disclosing big opportunities like that?

Jason ShandellPresident

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 4s involved.

So the most likely way that this will ultimately be disclosed is when Paragraph 4 is filed and we’re sued on the product.

David MarisWells Fargo Securities — Managing Director

And then just as a follow-up, when you think about in a product like an Advair — if you are working on Advair, you can fill in the blank for any other product — if you know you’re going to be a year or two, or you think you might be a year or two 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? Thank you.

Bill PetersChief Financial Officer

Yes, sure. All these products you mentioned are very big products with very big markets. We certainly 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 is certainly a function of people that we know are in it and that we know that there are people ahead of us on something, 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 that we keep in mind when we’re doing this, because our thoughts are that 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 cost 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 is how I would take a look at that.

Jason ShandellPresident

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 are barriers to entry. So, especially in the inhalation market, to this day there is no generic HFA out there. 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 says, 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.

David MarisWells Fargo Securities — Managing Director

Thank you very much.

Operator

Thank you. And our next question comes from Gary Nachman with BMO Capital Markets.

Gary NachmanBMO Capital Markets — Analyst

Hi. Good afternoon. 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?

Bill PetersChief Financial Officer

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.

Gary NachmanBMO Capital Markets — Analyst

OK. And I’m assuming Primatene is in there as well for the second half of the year?

Bill PetersChief Financial Officer

Yes. So, as I mentioned, in order to hit that goal, which we believe is obtainable, we’d have to get two out of three large approvals and those large approvals include two ANDAs and the third one’s Primatene. So, if we get two out of three of those reasonably early or in time during the year to get meaningful sales from those products, then we believe that that goal is obtainable.

Gary NachmanBMO Capital Markets — Analyst

OK. 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-ranging.

Bill PetersChief Financial Officer

Yes. So if you take a look at, I’d say, the six months data here, and then some of that, 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.

Gary NachmanBMO Capital Markets — Analyst

OK. So, averaging about $8 million a quarter or so, in the $8 million, $9 million range?

Bill PetersChief Financial Officer

Yes. Probably $8 million, maybe a little higher.

Gary NachmanBMO Capital Markets — Analyst

OK. 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?

Bill PetersChief Financial Officer

Yes, good question. So, there’s a bunch of one-time 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 basically for the company in the quarter, as we had more expense for tax than we did for book. The second thing is we had a couple of returns or provisioned items that were beneficial to us that we didn’t book until we had filed the return in October.

And there were also, we did a tax change of methodology for a certain thing, which led to a one-time 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 high-tax states as well, and not all of our benefit 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.

Gary NachmanBMO Capital Markets — Analyst

OK. And then just last question for Jason just to follow on David’s question before. Are there any areas where 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? Thank you.

Jason ShandellPresident

Yes. I think we are doing it the way that we would like to. We have limited resources for a company of our size and 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.

Gary NachmanBMO Capital Markets — Analyst

OK, thank you.

Operator

Thank you. And our next question comes from David Steinberg with Jefferies. Your line is now open.

David SteinbergJefferies — Managing Director

Thanks very much. 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 planning on 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 get to peak?

Bill PetersChief Financial Officer

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, 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 is 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.

David SteinbergJefferies — Managing Director

Great. Thanks a lot.

Operator

And our next question is from Elliot Wilbur with Raymond James.

Elliot WilburRaymond James — Analyst

Thanks. 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.

And if you look at the history of generic development with these assets, there seems to be a constant shifting of timelines, request for information, and just a pathway that seems incredibly uncertain on the generic side. And given the fact that you obviously have not filed on these assets, wondering how you guys internally think about the different pathways between ANDA and NDA. NDA obviously may be more expensive but certainly gives you some more certainty, at least 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 I’m just wondering if you’re still optimistic about the ANDA pathway versus considering something more on the 505(b)(2).

Jason ShandellPresident

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, 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.

Elliot WilburRaymond James — Analyst

OK. And just two quick follow-ups for Bill. Bill, can you just talk a little bit about cash movement of the quarter? I think you said cash flow from operations was just under $10 million and I don’t know if that was expended primarily toward share repurchases, but talk a little bit about cash movement. Then 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 and receptive to ED opportunities. That’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 you’re thinking about maybe some larger opportunities or maybe I just didn’t interpret your comments last call correctly.

Bill PetersChief Financial Officer

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 are 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.

Elliot WilburRaymond James — Analyst

All right.

Operator

Thank you. 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.

Jason ShandellPresident

Thank you, operator. So this concludes our call. I hope everyone has a great day.

Operator

Ladies and gentlemen, this does conclude the program and you may all now disconnect. Everyone, have a great day.

Duration: 42 minutes

Call Participants:

Jason Shandell — President

Bill Peters — Chief Financial Officer

David Amsellem — Piper Jaffray — Managing Director

Elliot Wilbur — Raymond James — Analyst

Serge Belanger — Needham & Company — Analyst

David Maris — Wells Fargo Securities — Managing Director

Gary Nachman — BMO Capital Markets — Analyst

David Steinberg — Jefferies — Managing Director

More AMPH analysis

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