Earnings Labs

Amneal Pharmaceuticals, Inc. (AMRX)

Q1 2015 Earnings Call· Mon, May 11, 2015

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Transcript

Operator

Operator

Good afternoon. My name is Katelyn and I will be your conference operator today. At this time, I would like to welcome everyone to the Impax Laboratories First Quarter 2015 Earnings Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. Thank you. Mark Donohue, Head of Investor Relations, you may begin your conference. Mark J. Donohue - VP-Investor Relations & Corporate Communications: Thank you. Good afternoon, everyone. Welcome to Impax's first quarter 2015 financial results conference call. We issued our earnings release this afternoon after the market closed. Copy of the press release and a link to the webcast of this call are available on the company's website at www.impaxlabs.com. Today, our President and Chief Executive Officer, Fred Wilkinson, will provide an overview of the quarter and some of the recent events; and Bryan Reasons, our Chief Financial Officer, will provide additional details on the financial results. Also joining us for the question-and-answer session is Michael Nestor, President of the Brand Division. We ask that you keep to one question and one follow-up please and return to the queue. Our discussion today may include certain forward-looking statements and actual results may differ from those presented here. The factors that could cause such difference are outlined in our SEC filings and on our website. Our discussion today includes certain non-GAAP measures as defined by the SEC. Management uses both GAAP financial measures and the disclosed non-GAAP financial measures internally to evaluate and manage the company's operations and to better understand its business. Further, management believes the inclusion of non-GAAP financial measures provides meaningful supplementary information to and facilitates analysis by investors in evaluating the company's financial performance, results of operations and trends. A reconciliation of GAAP to…

Operator

Operator

Your first question comes from the line of David Amsellem from Piper Jaffray. Your line is open. David A. Amsellem - Piper Jaffray & Co (Broker): Thanks. And, I guess, I'll ask a couple on Hayward. This feels like maybe my 73rd and 74th questions on Hayward in my sell-side career on an earnings call, but here it goes. So, maybe elaborate on the nature of the Form-483s? You said they weren't repeat observations. I guess, is there anything else you can tell us about them? And then secondly, do you feel like you need to make further personnel changes out of the facility, maybe talk about that? And then just switching gears, on the 11 approved products that are up for launch, how many of these are already multi-sourced products? And how many of these are going to be at market formation, how many of these would you classify as more complex dosage forms? Thanks. George Frederick Wilkinson - President, Chief Executive Officer & Director: Yeah. So, let me start with the first, I would classify these observations as something we need to absolutely pay attention to, they were very, very specific. I mean, if you read our Form-483s and you follow the sequence of the Hayward site, which I know you have, these were very specific, they were primarily in the lab. They were focused on a lot of the investigations, and some things that we actually were aware of and we were working on. In many cases, just a matter of close-out times and completeness of the activity. Look, we have the – we're well identified, we've got answers to all of them there. The response is probably going to be the easier response that this company has written for. But, it is indicative of the fact…

Operator

Operator

Your next question comes from the line of Chris Schott from JPMorgan. Your line is open.

Dana C. Flanders - JPMorgan Securities LLC

Management

Hi. Thanks. This is Dana Flanders on for Chris. Just a question on the pre-approval inspections that the FDA did for some of your products? Maybe you can't tell us what specific products, but should we assume that these are some of your higher value generic pipeline products out of that facility, and maybe the FDA has prioritized those? Thanks. George Frederick Wilkinson - President, Chief Executive Officer & Director: Yeah. So, I think as we've described before, we put it, in a very aggressive, and we think thorough PAI-readiness program in place. We had sequenced the project as we thought they might pick them up. We have gotten about two-thirds through all the way through all the products that are pending. They did pick up all products that we thought that they would and that they sequence them in a way that was okay by us. So, we can't really go into any more specifics than that and really can't predict what the outcome will be. But, we were prepared ready and not surprised at all by the selection of products.

Dana C. Flanders - JPMorgan Securities LLC

Management

Thank you.

Operator

Operator

Your next question comes from the line of Gary Nachman from Goldman Sachs. Your line is open. Gary J. Nachman - Goldman Sachs & Co.: Hi, a couple more on Hayward. So Fred, do you think these issues could be resolved without the FDA coming back to do an inspection? And do you think you'll need some outside consultants to come back in, or could you fix this internally? And then Bryan, just go a bit more into the gross margin, why that was so light for generics in 1Q, and how you are comfortable to get to the mid-50%s for the full-year? George Frederick Wilkinson - President, Chief Executive Officer & Director: Great. So, the idea – are they coming back in for an inspection, we just don't know. We think these are things that can be answered through our response and that if the responses are appropriate that there would not be a need for them to come back and re-inspect for us to have a status change or anything else occur. However, like I've done in the past, I'm going to prepare us for another inspection, I'm going to prepare us for additional PAIs. We're just going to be ready to kind of handle whatever approach the agency takes, and actually it would be – I'd welcome the process because in making these improvements, I want to make sure that the results are done appropriately. As far as consultants, we still have consultants that are within our facility. We are going to be spending a significant amount of time trying to understand how we would better utilize both the consultants and the internal staff. We're going to make sure that we've got the appropriate focus and resources of both internal or external people. We don't think that there is a need to bring in more consultants, we think, it's probably just the focus of the consultants and then maybe just a process of the mindset that we'll go through in that approach. Bryan M. Reasons - Chief Financial Officer & Senior VP-Finance: On the gross margin, several things impact it and many of them were timing, specifically in April we had five launches. Some of those we had expected to launch in March. The biggest driver on the margin was lamotrigine, that's a high margin opportunity for us. So, that's kind on the generic side, certainly deferring RYTARY – the total company margins deferring RYTARY is deferring also revenue, it's very high margin for us. The timing of the Tower, of course, impacted it, we owned them for three weeks during the quarter and we didn't control shipments, obviously, before we owned them. So, really the timing there impacted it. And as we look forward in the business, especially with these launches that are happening in April, we thought we'll get to the mid-50%s range. Gary J. Nachman - Goldman Sachs & Co.: Okay. Thanks.

Operator

Operator

Your next question comes from the line of Louise Chen from Guggenheim Securities. Your line is open.

Louise Chen - Guggenheim Securities LLC

Management

Hi. Thanks for taking my question. So, my first question is on RYTARY, just curious how we should forecast, or think about forecasting sales for the remainder of the year, if the second quarter number should be the $3 million that's deferred, or would you expect sales on top of that? And then secondly, just curious, the VAI status, that seems like a positive, so curious if you could comment a little bit more on that, and what that means for Hayward? Thank you. George Frederick Wilkinson - President, Chief Executive Officer & Director: Yeah. Let me start with the VAI status. I think, this has been probably the biggest point of confusion that, that we've had for the last little bit, if you actually went on the FDA website, you would see Hayward listed as NAI, which makes no sense, because there were observations. We've been trying to seek some clarity as to where we actually stood with that and we had several communications that the inspection from July had been slated as VAI. During the inspection, we simply asked the questions and got confirmation that in fact that previous inspection was VAI. The reason we put it out there is because of the confusion. We just wanted to make sure that everybody was starting from the starting point as to where the facility was. Regarding RYTARY, our view as we deferred the revenue from first quarter to second quarter, if we only sell $3 million in second quarter, we won't be saying that, this is successful launch anymore. A good majority of that product will be pulled through and prescriptions well early in 2Q, and we see this trending very, very nicely. I mean, we've had almost every quarter or every week, week-over-week growth and pretty good solid growth in both the news and totals and the ratio of news to totals is matching up very nicely. And, Michael, I don't know if you would like to add anything to it?

Michael J. Nestor - President-Impax Pharmaceuticals Division

Management

Now, the only thing I would add, Louise, is that, RYTARY, as Fred said earlier in his comments, we're pleased with the progress so far, it's tracking as we had anticipated it would, and certainly, our expectation is to have greater sales than $3 million a quarter, as we go forward, that's for sure. George Frederick Wilkinson - President, Chief Executive Officer & Director: I think it's – I mean, one maybe observation is, all of the wholesalers have reordered since the initial supplies, and many of them several times. So, we have the nice natural flow of products that's occurring, almost all the metrics of this are dead on target with where we'd expect things, way in the minutia of like size of scripts and refill rates and all those pieces. So, for an early read on weeklies, which most people hate to do, this looks like we're tracking very nicely.

Michael J. Nestor - President-Impax Pharmaceuticals Division

Management

And going forward, our goal and expectation would be to recognize revenue upon shipment. So, we deferred the initial launch quantities; but going forward, we'll recognize upon shipment the way we do all our products.

Louise Chen - Guggenheim Securities LLC

Management

Okay. Thank you. Donald C. Wood - President, Chief Executive Officer & Trustee, Federal Realty Investment Trust: Next question?

Operator

Operator

Your next question comes from the line of Gregg Gilbert from Deutsche Bank. Your line is open.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Management

Thanks. Bryan, can you help us with the gross to net to apply to RYTARY, and whether you would expect that to change going forward? And secondly, back to the gross margin improvement, can you confirm that there are no additional launches – not yet approved launches factored into the gross margin prediction for the year? And lastly for Fred, I hope I'm not putting words in your mouth, but are you still predicting a material deal announcement in 2015? Thanks. George Frederick Wilkinson - President, Chief Executive Officer & Director: Why don't I start. I am hopeful of a material deal announcement, and you can put words in my mouth anytime. So, we are very actively working on transactional side. And as we've mentioned, we've got several irons in the fire for, not only product acquisitions but both brand and generic side, but large corporate transactions along the line. So, with that, I'll turn the other questions over to the other folks.

Michael J. Nestor - President-Impax Pharmaceuticals Division

Management

On gross margin, in the guidance, we have assumed no net new launches out at Hayward. But, we do have partnered launches and some core launches in that plan. So, no new out of Hayward. What was your second – your third question?

Gregg Gilbert - Deutsche Bank Securities, Inc.

Management

Gross to net on RYTARY?

Michael J. Nestor - President-Impax Pharmaceuticals Division

Management

Yeah. I mean gross to net on RYTARY. I think we've kind of guided toward a 28% to 30%. And I think, it appears so far that is about in range.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Management

Okay. Thank you.

Operator

Operator

Your next question comes from the line of Marc Goodman from UBS. Your line is open.

Marc Goodman - UBS Securities LLC

Management

Hi, a couple questions, I guess, on RYTARY. Can we talk about where the scripts are actually coming from, and how many pills per script we're seeing so far? Second question is, there was an approval for Opana by a competitor, Sun . Do we expect them to launch? I know there's like all these things that are potentially blocking, so I just wasn't sure whether you're expecting them to launch or not. And then just on Hayward, one other question, so in the past, I guess Fred, just in your experience, when you've seen a situation like this, I mean, three doesn't seem like that much observations. I mean, it makes a lot of sense that we could see them, not need to come back and do an inspection. But, I was just curious, given just the issues, and how long they've been going on with Hayward, just your experience just looking at other companies historically, what's your best guess? I mean, do you think, they have come back in the past in those situations? Or how should we think about that? George Frederick Wilkinson - President, Chief Executive Officer & Director: Why don't we start with RYTARY, because Michael's chomping a bit to talk about RYTARY, so this is good.

Michael J. Nestor - President-Impax Pharmaceuticals Division

Management

Okay. So, the prescriptions primarily coming out of the neurology segment, as we look at total prescriptions, it's probably on the order of 75%, 80% of those being written by neurologists or physicians' assistant or nurse practitioners within their practice. In terms of number of capsules, latest data we have is that the number of caps per prescription is averaging around 220 capsules. So, that averages about seven capsules, so figure a range from seven capsules to 10 capsules or so, maybe 11 capsules. Keep in mind that we do have four capsule strengths available, 95 milligram, 145 milligram, 195 milligram and 245 milligram, the degree to which a physician would prescribe a higher strength capsule would have an impact on the number of capsules per prescription. George Frederick Wilkinson - President, Chief Executive Officer & Director: This is a similar prescription positions, as we saw in our clinicals and as we anticipated in our models.

Michael J. Nestor - President-Impax Pharmaceuticals Division

Management

Yeah. Yeah. Nothing – not... George Frederick Wilkinson - President, Chief Executive Officer & Director: Marc, let me do the next, I mean, OPANA I think, there is going to be a lot of movement on this through the next several weeks and months. We have seen a couple of other approvals. We got a very solid share position on that product and have seen no wavering there. We're going to watch the events that occur and are in a position to take advantage of something changes and also be prepared for competition if it comes. And then regarding Hayward, I think, we've been living with these Form-483s for now three days. So, including Mother's Day, so it made an interesting day yesterday. They are observations that we are taking very seriously, because if the FDA writes to the extent that they wrote and with the specificity that they wrote and things that we need to absolutely dig to the bottom and make sure our responses are completely appropriate. Whether they come to re-inspect or not, I don't know, all I know is to be prepared for that advantage that happens and be well ahead of the curve on anything that was identified here that could lead into anything else. So, I just think that this is appropriate planning to say, they may come. We are hopeful that our responses will suffice them and we're hopeful that FDA inspections were appropriate, and that we can come to the tunnel the other ways. Obviously, we're preparing for everything, and are making sure that we focus all of our attention in our responses.

Marc Goodman - UBS Securities LLC

Management

Okay. Thanks.

Operator

Operator

Your next question comes from the line of Randall Stanicky from RBC Capital. Your line is open.

Randall S. Stanicky - RBC Capital Markets LLC

Management

Great. Thanks. Fred, just a quick follow-up, and hopefully the last question on this. But, are you going to – do you expect that you're going to learn whether they need to re-inspect, based on communication you have with FDA in the coming weeks? And if you do learn that, are you going to let us know, or should we just effectively watch for new approvals to come through via press release? And then, I have one follow-up. George Frederick Wilkinson - President, Chief Executive Officer & Director: Yeah, I think the – I don't know if we'll learn, we will simply – we will ask that, we do all the time. I think our communication was pretty good on this inspection. So, I think we will continue to try to get clarity on both sides, right. I mean, they should see everything that we're working on too. And probably the best marker for you, is watching for the approval process. If we get to that point, then I think you'll get a picture of it, or I think we'd probably, if there is a formal status announced about the site, which could lead to anything – any change in the existing warning letter we would clearly be announcing that.

Randall S. Stanicky - RBC Capital Markets LLC

Management

Got it. And one for Michael, can you just comment so far in your – in terms of what you're seeing on RYTARY, how are you seeing the breakdown in terms of moderate and severe? Are you guys reaching into that moderate market, and maybe just any color you can provide there would be helpful?

Michael J. Nestor - President-Impax Pharmaceuticals Division

Management

Randall, we don't actually have, if you will, independent characterization as to where we're penetrating into that marketplace. Anecdotally, what we are hearing from key opinion leaders, movement disorder specialists, as well as our sales reps, is that most of the prescriptions are coming from that moderate to advanced type patient. Does that answer your question?

Randall S. Stanicky - RBC Capital Markets LLC

Management

Yeah. No, that's helpful. Thanks, guys.

Michael J. Nestor - President-Impax Pharmaceuticals Division

Management

Sure.

Operator

Operator

Your next question comes from the line of Jason Gerberry from Leerink. Your line is open.

Jason M. Gerberry - Leerink Partners LLC

Management

Hi, good evening. Thanks for taking the questions. Just on Tower, can you just remind us, are you done identifying new synergies? Just trying to get a sense of whether we could expect to see any incremental synergies? And, Bryan, should the Tower revenues be kind of flowing through our models at roughly about a 60% gross margin? I think that's a number that I had written down, but I want to make sure I was thinking about the contribution there correctly. George Frederick Wilkinson - President, Chief Executive Officer & Director: Yeah. It will be difficult probably for us to identify and be able to communicate additional synergies, because another month to two months from now, we'll be operating the company as a single company. So, it will be a little bit harder to figure out, whether there are synergies coming from the deal or whether we're just optimizing our spend. I think what we've found in this though is that there were some very clear wins that we could go a little farther with, in some of the areas where we had dug early. And that people kind of signed up for and helped us do that work to make sure that we could get faster recognition of the activities that we put in place and then a little deeper dive into it. So, things like supply chain, I think, there was a lot of improvement in that area that allowed us to get comfortable with a little larger number and a little larger acceleration and synergies. The next question on gross margin. Bryan M. Reasons - Chief Financial Officer & Senior VP-Finance: And I think we've said that the Tower gross margins are looked very similar to legacy impacts gross margins. Yeah, we saw early on a little bit of unfavorable mix, but still think that they'll be reasonably in line.

Jason M. Gerberry - Leerink Partners LLC

Management

Great. Thanks.

Operator

Operator

Your next question comes from the line of Michael Faerm from Wells Fargo. Your line is open.

Michael Faerm - Wells Fargo Securities LLC

Management

Hi. Thanks for taking the question. My question's on the sector M&A more generally, as potentially some of the big are getting bigger here, how do you think about the impact on smaller U.S. generics players like yourselves, when it comes to things like pricing, potential products becoming available, and other factors? Thanks. George Frederick Wilkinson - President, Chief Executive Officer & Director: Yeah. So, we're a rooter for something to happen with the big three that are in discussions here, because we think that there will be opportunities for acquisitions, with some of the necessary divested products. We've been at the table for those before and most recently got with the Actavis transaction before us. And so, those are the nice opportunities that come out of it. I'm a believer that a mid-tier generic house is going to be required to by the customers, in order to keep pricing and keep supply and keep competition appropriate. So, that they don't rely on one, on possibly two suppliers, but they have a range of suppliers to come from. And what is most important for a company our size is to make sure that we have a portfolio of products that are coming that is unique and diverse and has some unique items in it that we may be one of one or one of two. And so, therefore, the customers are always going to need to have an interaction with you. So, my – I think the industry is shaking the way, it looks like it was going to shake. The larger guys are getting larger and the mid-tier are getting a little bit larger and probably the people who are going to struggle the most are those that are in the bottom part.

Michael Faerm - Wells Fargo Securities LLC

Management

Thank you.

Operator

Operator

Your next question comes from the line of Sumant Kulkarni from Bank of America Merrill Lynch. Your line is open.

Sumant S. Kulkarni - Bank of America Merrill Lynch

Management

Thanks for taking my questions. The first one is, given that we're in the days of limbo between the voluntary action indicated, and some other status that you still have to receive, have you received any target action dates from the FDA? Or is that something that the FDA does not issue for a plant that's under a warning letter? And secondly, it looks like the shares on the epinephrine auto-injector have been going up slightly in the past few weeks. What are you doing differently there, if anything? George Frederick Wilkinson - President, Chief Executive Officer & Director: Okay. So, target action dates, you're right. They generally are not supplied to companies who have some kind of action against it. But, it is actually site specific. So, for the previous Core company or the Middlesex site, as well as the partnerships that we have in place. We have been receiving target action dates. And I believe we actually may have received one target action date for a Hayward-related product. So, it's slowly kind of working its way and the consistency there, we're starting to see more and more of it from the agency, it's greatly appreciated to get to those target action dates. So, I would hope that at some point we would have those on all of our products. But, all those products are in third-party hands or are in the middle – out of the Middlesex R&D group there are target action dates related to those. And then second question...

Sumant S. Kulkarni - Bank of America Merrill Lynch

Management

Epinephrine auto-injectors... George Frederick Wilkinson - President, Chief Executive Officer & Director: Yeah. It's actually we've – that was one of the opportunities that we could do some planning on it, some preparation for in our integration planning prior to the close. I think that there are more opportunities for the epinephrine product. We are right now trying to hone down our position in promotion, making sure that we'll have a supply channel that will be supportive of that. And that our – just to remind everybody, our base model was really defined on us having a Dx status throughout the year. That could change, but that's essentially the way, we're driving this model. So, the increase that you may be seeing or that we are seeing may be related to the fact that we're just simply making a little more noise with it. But, it's only going to, maybe 1.5 month, since we've done anything with this product, as long as we have owned the company.

Sumant S. Kulkarni - Bank of America Merrill Lynch

Management

Thanks. George Frederick Wilkinson - President, Chief Executive Officer & Director: Okay. With that, let's close up. I do want to remind everybody that we still are actually with all the events going on, focusing on the four key areas, that we've identified for the last year, that being heavy focus on our quality initiatives, trying to take advantage of every commercial opportunity we have, refocusing our R&D programs although it's optimized and then heavy, heavy involvement in business development, whether that will be M&A or product selection. So, we look forward to reporting Q2 and all the events that go on in between, so thank you very much.

Operator

Operator

This concludes today's conference call. You may now disconnect.