Earnings Labs

Amneal Pharmaceuticals, Inc. (AMRX)

Q2 2015 Earnings Call· Mon, Aug 10, 2015

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Transcript

Operator

Operator

Good morning. My name is Tabatha, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Impax Laboratories' Second Quarter 2015 Earnings Conference 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. I'll now turn the call over to Mr. Mark Donahue. Please go ahead. Mark J. Donohue - VP-Investor Relations & Corporate Communications: Thank you. Good morning, everyone. Welcome to Impax's second quarter 2015 financial results conference call. Copy of the press release issued this morning, as well as a copy of the slide presentation are available on the Investor Relations section of Impax's website. Also, a link to a webcast of this call is available on our website. Our discussion today may include certain forward-looking statements, and actual results may differ from those presented here. Factors that could cause such a 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 non-GAAP measures is available in our second quarter 2015 earnings release and in today's slide presentation, both of which can be found on the company's website. The agenda this morning will include our President and Chief Executive Officer, Fred Wilkinson, providing an overview of the second quarter highlights and subsequent events. He will also provide an update on our…

Operator

Operator

Your first question comes from the line of Gregg Gilbert with Deutsche Bank.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst

Can you hear me okay? George Frederick Wilkinson - President, Chief Executive Officer & Director: Yes.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst

Sorry, I jumped on a little late. So I apologize if I missed this, but for RYTARY sales, can you disclose the total sales in the quarter and talk about how much was demand versus recognition of deferred revenue versus stocking? And secondly, can you quantify the impact on the gross margin from that auto-injector supply issue? Bryan M. Reasons - Chief Financial Officer & Senior VP-Finance: Well, I'll start a little bit on RYTARY. We deferred in Q1 about $3 million – $3.1 million of net sales and we've gone to full revenue recognition in the second quarter and going forward, we'll recognize revenue upon shipping.

Michael J. Nestor - President, Impax Specialty Pharma Division

Analyst

Yeah. Relative to demand versus stocking, the majority of the sales of RYTARY have been driven by demand. From an inventory standpoint, there's only a couple of months as you would expect in the pipe for product that's growing as it is at the moment. So as I said, most of its being driven by prescription demand. George Frederick Wilkinson - President, Chief Executive Officer & Director: So, turning to auto-injector, the impact was about a month's worth of activities and had we been able to ship that product, we would've far exceeded the – both the revenue and the EPS guidance previously provided.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst

And Fred, one follow-up on biz dev. Clearly, your financial bandwidth is there, but operationally, are you in a good place right now in terms of readiness to pick on additional sizable assets on brand or generics? George Frederick Wilkinson - President, Chief Executive Officer & Director: Yeah, we are. I think the teams, the integration teams are – have been pretty well shutdown. Probably, the only remaining piece that's where we're working on is the supply chain and that's the constant ongoing process. We have our hunting team out there working pretty aggressively right now and are engaged in a serious of diligent activities as we speak.

Operator

Operator

Your next question comes from the line of Andrew Finkelstein, Susquehanna.

Andrew J. Finkelstein - Susquehanna Financial Group LLLP

Analyst

Hi. Good morning, and thanks for taking the question. I was hoping you could talk a bit more about the pace and the progression for the branded segment over the next coming quarters, given the profitability of this quarter and whether that's likely to remain profitable as we go throughout the rest of the year? And then also if you could talk in terms of your business development appetite, what the interest would be in assets that might come with the expanded sales force and whether at this point, that would be a benefit to RYTARY? Thanks.

Michael J. Nestor - President, Impax Specialty Pharma Division

Analyst

Sure. Thanks for the question. Certainly, from the standpoint of a brand business going forward, we do expect to maintain that profitability dimension. We expect that RYTARY prescriptions will continue to grow. We're very pleased with the market response relative to Zomig Nasal Spray. As we continue to grow Zomig Nasal Spray month-on-month, for the year so far, we're about 16% up on prescriptions versus the same period last year. And the contribution of the branded products from the Amedra product line, we certainly welcome those to the brand family, if you will, and look forward to being able to implement our product lifecycle strategy for that program product set as we progress. George Frederick Wilkinson - President, Chief Executive Officer & Director: So on the business development front, obviously, we've kind of talked about this quite a bit, is that what we've seemed to find out there in the marketplace is opportunity for generic companies. Although, I think with the series of M&A transactions that occurred and that have been announced, the opportunity to pick up divestiture product kind of changes that profile and we're obviously heavily in the hunt on those. On the brand side, we can't seem to find that perfect brand company to match up with, so we've got ourselves in a series of conversations on late-stage branded products, primarily in the CNS area, and that would be something that should enhance the profile of our brand business. What I'm most pleased about actually on the brand side is not only the growth of RYTARY, but the ability to make sure that they've covered well that second product in the bag. So, during launch time, it's always a good commercial when you grow your second position product month-over-month, quarter-over-quarter. So we're very, very pleased with the performance of the group.

Operator

Operator

Your next question comes from the line of Louise Chen with Guggenheim Security (sic) [Guggenheim Securities]. George Frederick Wilkinson - President, Chief Executive Officer & Director: Good morning. Mark J. Donohue - VP-Investor Relations & Corporate Communications: Good morning. Louise? Why don't we move to the next question?

Operator

Operator

Your next question comes from the line of Marc Goodman with UBS. George Frederick Wilkinson - President, Chief Executive Officer & Director: Good morning, Marc.

Unknown Speaker

Analyst

(30:20) on behalf of Marc. George Frederick Wilkinson - President, Chief Executive Officer & Director: Okay.

Unknown Speaker

Analyst

I have a couple of quick questions. On RYTARY, I don't know if you disclosed the sales number for the quarter, if you could do that. And also, could you comment on the weekly NRx growth rate? It seems to go up and down if you look at the weekly IMS data. If you could comment on the IMS data, if that's really giving us the best view on the progress of the product. And then I have another question. George Frederick Wilkinson - President, Chief Executive Officer & Director: Yeah. So we are not going to be reporting the individual product revenues. I think we are reporting our segment revenues, which is the brand division which contains RYTARY, Zomig, Albenza and a few other legacy products. That's the approach we've taken. On RYTARY, as far as prescriptions, the lumpiness that you see many times is related to holidays. I mean, as you'll see some weeks that are down 14%, but if you look at prescription for almost all products, they are down that because there was a four-day week because of a holiday situation and generally it rebounds or recovers the following week. Weeklies I've never believed are the best indicator. Monthlies are better. But I think the weeklies have gotten – there's been an improved process so that when you start to total weeklies, you do get a monthly draw out of it. But I think what we've shown is month-over-month, quarter-over-quarter solid growth in the product, just about what you'd expect for a launched product in this category.

Michael J. Nestor - President, Impax Specialty Pharma Division

Analyst

Yeah, I would agree with Fred. There's an inherent choppiness usually in the weeklies that gets smoothed out relative to the monthly.

Unknown Speaker

Analyst

Got it. Thank you. My second question is on the next-generation versions of RYTARY and Albenza, if you could comment on the type of product profile you're exploring for both? George Frederick Wilkinson - President, Chief Executive Officer & Director: Yeah. So we've communicated very openly that we are not going to be communicating what the profile is on the next-gen Albenza primarily because we would like this to come to the marketplace and people recognize what it is at that particular point. So these are general product improvements that I think you've seen from other companies. This was work that was created by the Tower or Core team. You saw one approval during the quarter, which was a 200-milligram chewable tablet. We've elected not to launch that product because we're not sure that that provides substantial value to the customer. We are waiting for the next generation to come and we'll then be putting some promotional effort behind it. 203, which is a follow-on to RYTARY, it's really not a next-generation, is designed to continue to improve the profile that RYTARY provides, which is reducing fluctuations, enhancing the on-time, and reducing the number of doses that need to be administered.

Michael J. Nestor - President, Impax Specialty Pharma Division

Analyst

Yeah. What we're looking for relative to 203 is a clinical improvement over RYTARY, so that's the objective for that.

Unknown Speaker

Analyst

All right. And my last question is just on the Hayward, the progress there. Did I hear you say that you submitted the response to the FDA and they came back saying that the inspection has been officially closed in response to that, or could you just clarify the order of events there? George Frederick Wilkinson - President, Chief Executive Officer & Director: Yeah. So sequence was receiving 483s. We then received documentation that while we were responding – we actually responded in the 30-days, so they had our response. There were some continued commitments that are generally made in those responses. And during that timeframe, while we were completing our commitments, we did receive written correspondence that this inspection had been closed.

Unknown Speaker

Analyst

Got it. Thank you. George Frederick Wilkinson - President, Chief Executive Officer & Director: Okay.

Operator

Operator

Your next question comes from the line of David Amsellem of Piper Jaffray. David A. Amsellem - Piper Jaffray & Co (Broker): Thanks. I joined late, so I may have missed some of this. But maybe talk about RYTARY, the managed care landscape, covered lives in terms of unrestricted access. I also wanted to get a sense of what kind of traction you're getting on Part D and just remind us what your exposure to Part D is in terms of percentage of the addressable market you're targeting on RYTARY. Thanks.

Michael J. Nestor - President, Impax Specialty Pharma Division

Analyst

Sure. Thanks, David. So relative to your question, Medicare Part D comprises about 52% of the Parkinson's population. It's about 46% on the commercial side. In terms of covered lives, we have about 80% on the commercial side. And from Medicare Part D coverage, we have coverage already at Express Scripts, Coventry, Kaiser and Aetna. And that's in the non-preferred brand, no-restrictions category, so there's no step-edits, so it's probably comparable to about a Tier 3 and a Tier 4 plan. What we see is that from an overall perspective, about 82% of the prescriptions for RYTARY that have been written in the commercial sector have been filled. And I think that number is around about 75% in the Medicare Part D side. That percentage of prescriptions for RYTARY have been filled as well. So we're extremely pleased with the coverage that we're getting coming out of the Medicare Part D as well as the commercial realm at this relatively early stage in the launch of RYTARY. David A. Amsellem - Piper Jaffray & Co (Broker): Okay. That's helpful. And then just another one on RYTARY. I realize this may be a little bit early to address this, but you're probably going to start getting a lot of questions about your intellectual property and potential Paragraph IV challenges on RYTARY. So I guess the question here is, obviously, you're going to say that you could defend your – your IP is defensible. But the real question here is can you give us some color on whether or not you're looking at line extensions, and maybe when we may get some more color on your thinking about life cycle management? Thanks. George Frederick Wilkinson - President, Chief Executive Officer & Director: So you're right, we will be vigorously pursuing. We're not surprised – defending the patent. We're not surprised by a P IV filing. I mean, we had anticipated that this would come, not surprised by who it came from, so I think there's no real surprises here. And we've been working since well before launch on how the defense over the IP would occur. As far as follow-on, we don't have a true line extension for RYTARY. What we have is a next-generation, which is IPX203 that we mentioned. It is a Parkinson's product and it's designed to build on the benefits of RYTARY and enhance the overall outcome that the patient receives, meaning fewer doses, more on-time, and less fluctuations. And that's going into Phase II as we speak. David A. Amsellem - Piper Jaffray & Co (Broker): Thank you.

Operator

Operator

Your next question comes from the line Chris Schott with JPMorgan.

Dana C. Flanders - JPMorgan Securities LLC

Analyst · JPMorgan.

Hi. Thanks. This is Dana Flanders on for Chris. Just on the Generics business, can you talk about the price outlook for the remainder of this year and heading into next year? Are things getting better or worse, kind of staying the same? I guess, we've just had a couple of companies mention some greater price erosion. So any just comments on your base business would be appreciated. Thanks. George Frederick Wilkinson - President, Chief Executive Officer & Director: Thank you. We've not seen anything – any dramatic shift. I mean, obviously, most of this is product related. A new competitor on digoxin caused some incremental price reductions and so, therefore, some margin decline. We're seeing a little more aggressiveness on a couple of our competitors on some of our other products that we have to respond to. But there's nothing that is out of line from what we've seen in the last six quarters sequentially. So price declines are anticipated in the industry. And as more competition comes in and as competitors sharpen their pencil, obviously there's a need to respond to pricing. But nothing that's out of the ordinary.

Operator

Operator

Your next question comes from the line of Elliot Wilbur with Raymond James. Elliot Wilbur - Raymond James & Associates, Inc.: Thanks. Good morning. First question is with respect to the Specialty segment sales reported in the quarter, just trying to get a sense as to whether or not you think those reflect kind of normalized end market demand, whether or not there were sort of any under or over-accumulation of inventory that you found in connection with the Tower acquisition? George Frederick Wilkinson - President, Chief Executive Officer & Director: Yeah. So let me just kind of jump in on that. The Tower acquisition, there was no impact on that. Clearly, we had managed the inventory as it went out. And actually if you saw, they were a little bit light in first quarter and kind of made up the demand side in 2Q. For RYTARY, the only thing that's unusual for 2Q is that it did have revenue recognition from products sold in the first quarter. As you remember, we launched this and stocked it with not a broad stocking plan, but more of a geographically-based stocking plan, so we put products near where the movement disorder centers were. All of that's been pulled through, which is why we're now on revenue recognition based on demand and there's no unusual amount of product that's in the marketplace today. We've been watching that very closely.

Michael J. Nestor - President, Impax Specialty Pharma Division

Analyst

Yeah. So to underscore Fred's point, Elliot, it's pretty much driven by demand. Elliot Wilbur - Raymond James & Associates, Inc.: Okay. Thanks. And then, just a follow-up question on digoxin. You've called this out now, I think two quarters in a row in terms of base product that has undergone maybe more than normalized competitive erosion. I guess, sort of two-part question. At one point there was some chatter about API issues around that product, suggesting there may be some shortages at some point. Obviously, it doesn't look like that's happening. I'm just wondering if that's sort of still kind of an active dynamics there that might actually result in some improvement? And then, I guess, sort of exiting 2Q, I mean, nothing happened on the API front. You think that that product has normalized or at least stabilized relative to sort of rates that existed kind of on average to the quarter? George Frederick Wilkinson - President, Chief Executive Officer & Director: Yeah. Well, we called this product out because for probably four quarters, five quarters, it's been called out because of the opportunity that was there. Obviously, both the API supply and some of the other issues around the product resulted in a market disruption of which there were two of us left out there, substantial price increase and then as competitors resolved both their API position and reignited interest in the product, they came back in. This is now probably the poster child of products that had a lot of competitors, then few and then a lot. I think it's probably pretty well stabilized, although the new competitor will need some share. And so, we should anticipate that there will be a slight diminution of all of our share and price as everybody makes room for…

Operator

Operator

Your next question comes from the line of Gary Nachman with Goldman Sachs. Gary, your line is open. George Frederick Wilkinson - President, Chief Executive Officer & Director: Good morning, Gary.

Divya Harikesh - Goldman Sachs International

Analyst

Hi. This is Divya Harikesh on behalf of Gary Nachman. George Frederick Wilkinson - President, Chief Executive Officer & Director: Hello.

Divya Harikesh - Goldman Sachs International

Analyst

Hello. Can you hear me? Bryan M. Reasons - Chief Financial Officer & Senior VP-Finance: Yes. Go ahead. George Frederick Wilkinson - President, Chief Executive Officer & Director: Difficult, but yes.

Divya Harikesh - Goldman Sachs International

Analyst

I have two questions. One is on the Hayward facility. You've highlighted your pipeline opportunities from current and under development. I'm just curious to know how much of that is kind of out of Hayward and how do you think about that pipeline as you look out in to 2016? Then you spoke about how the opportunity has changed based on consolidation that's happening in the sector. I'm just curious to know what kind of challenges you faced as you try and close any of these transactions in this atmosphere as well as where you are when it comes to leverage and how much are you willing to use your balance sheet in order to do a transaction? George Frederick Wilkinson - President, Chief Executive Officer & Director: Yeah. Okay. So if I understood the question, it was what are opportunities in our ANDA pipeline coming out of Hayward versus outside. Obviously as we put on slide 9 I believe it is, it lists both the internal and the external opportunities that are pending down at FDA in slide – and then the products that are under development right now. So from a pipeline position, you can see the mix there. From a launch perspective, you can see that on slide 7 we have seven more launches that we could potentially put into the marketplace that we've communicated, of which there are eight that are internal, but only three that are coming out of Hayward. And two of those actually are – or one of those is actually an approved product. I think the next question was on divestitures if I heard you correctly. And, obviously, there's – depending upon how people are treating the divestiture process, there's a multitude of transactions that have occurred that will inevitably result in some form of a divestiture. We have been a recipient of a couple of products through that process in the past and we are actively at the table trying to become the ideal partner for the different parties that are conducting those transactions.

Operator

Operator

The next question...

Divya Harikesh - Goldman Sachs International

Analyst

And then on your leverage? George Frederick Wilkinson - President, Chief Executive Officer & Director: Excuse me?

Divya Harikesh - Goldman Sachs International

Analyst

On your leverage and how much you'd be willing to go up to? Bryan M. Reasons - Chief Financial Officer & Senior VP-Finance: So, on leverage, I mean we said this in the past. We're willing to go up to 4.5 times EBITDA as long as the target acquisition allows us a clear pathway to de-lever quickly, and that's our position. Mark J. Donohue - VP-Investor Relations & Corporate Communications: Thank you.

Divya Harikesh - Goldman Sachs International

Analyst

Thank you. Mark J. Donohue - VP-Investor Relations & Corporate Communications: Next question, please.

Operator

Operator

Your next question comes from the line of Jason Gerberry with Leerink Partners.

Jason M. Gerberry - Leerink Partners LLC

Analyst · Leerink Partners.

Hi. Good morning. Thanks for taking my question. So I guess, on the M&A side, it sounds like CNS specialty brands is the focus. Just kind of curious, with the Teva-Allergan acquisition. If you see divestitures as an opportunity to pick up any interesting products on the generic side? And then on IPX203, you indicated Phase II as the next step. Can you just confirm because I guess this is a full clinical program, and what would you look at – see as sort of a timeframe to market for that program? Thanks. Bryan M. Reasons - Chief Financial Officer & Senior VP-Finance: Yeah. So on the divestiture front, I mean obviously, there are at least five transactions that divestitures could be a part of, and you've mentioned one of them, the Teva, Actavis. I'm sure we won't be the only people lining up to have a discussion with those parties. So I think the idea is – and the critical piece is how efficient are you on the negotiations? How effective you are putting the appropriate price forward and how well do you work on making sure that the tech transfers and whatever supply arrangements need to be made in an appropriate timeframe to make the party want to bring those products to you. But there are a myriad of products that could land in that list of divested products, and we're waiting to – and are currently participating in many of the processes that are ongoing. Regarding 203, I'll turn it over to Michael.

Michael J. Nestor - President, Impax Specialty Pharma Division

Analyst · Leerink Partners.

So, relative to 203, obviously, it's our intent to move through the clinical trial process as quickly as possible. As a frame of reference, we took RYTARY through the clinical process and filed the NDA in three-and-a-half years, so that's our benchmark and that's kind of the timeframe we would anticipate. Obviously, we'd be looking to clip out any timing that we'd be able to save in that regard.

Jason M. Gerberry - Leerink Partners LLC

Analyst · Leerink Partners.

Okay. Great. And if I could just squeeze in a follow-up, just on the Adderall XR and having sort of two shots on goal with the Core and the Impax ANDAs. My recollection is that there were generic settlements with Shire in place. I think they have IP out to 2018-2019. So does the CorePharma ANDA have a license through Shire to access the market or would that product be gated by expiry of Orange Book patents? Thanks. Bryan M. Reasons - Chief Financial Officer & Senior VP-Finance: So, they do not. We have not had a settlement effective in the – from the Core ANDA. But that does not necessarily mean that it'll be gated by the patents that are sitting there.

Jason M. Gerberry - Leerink Partners LLC

Analyst · Leerink Partners.

Great. Thank you.

Operator

Operator

Your next question comes from the line of Sumant Kulkarni with Bank of America.

Sumant S. Kulkarni - Bank of America Merrill Lynch

Analyst · Bank of America.

Good morning. Thanks for taking my questions. The first one is a clarification. I am sorry if I missed it. But could you talk about the most recent annualized sales rate of Daraprim? Do we know how much Tower sales can be reduced by? And the second one is on a conceptual one in business development. Based on your prepared remarks, I guess it's fair to say that Impax has been involved in the mix in most of the recent small to mid-transactions out there. Specifically, on the generics side, on the transactions that others have been involved and closed on, what has held Impax back from making those purchases? Bryan M. Reasons - Chief Financial Officer & Senior VP-Finance: Okay. So, let me do the second one first. We've been engaged in some of the transaction discussions. We've done some evaluation of some of the companies and have watched some of the – and have watched those products go in through at least announcement of a transaction. There was one process that was – I think everybody's well aware of that was shortened and was cut off and many of us did not get a chance to continue in the process, so we were – there were several of us left on the sidelines. There were others that we watched the prices kind of move away from us. We have not seen anything that we wanted to close transaction on that we've not been able to proceed on appropriately, short of the one that was abruptly stopped. And then, as far as Daraprim, Bryan? Bryan M. Reasons - Chief Financial Officer & Senior VP-Finance: Daraprim, the last 12 months, it was sales of under – a little under $4 million and it's not a growth asset for us. It was a – it's certainly not strategic on the brand side.

Sumant S. Kulkarni - Bank of America Merrill Lynch

Analyst · Bank of America.

Thank you.

Operator

Operator

Your next question comes from the line of Louise Chen with Guggenheim Security (sic) [Guggenheim Securities].

Brandon R. Folkes - Guggenheim Securities LLC

Analyst

Hi. It's Brandon Folkes on for Louise. Could you just give us some color on what's the uptake for RYTARY has been in mild to moderately severe patients? And then just a follow on, maybe just any update on a U.S. partner for RYTARY and the potential economics there? Thank you. Bryan M. Reasons - Chief Financial Officer & Senior VP-Finance: Okay. Thanks for the question. In terms of the designation of the patient for whom a prescription is being filled, we don't actually get that data. Anecdotally, what I can tell you since we have approval for RYTARY for early through advanced patients. Anecdotally, what I can tell you is that the movement disorder specialists seem to be pushing RYTARY towards the more advanced end of the spectrum at this point. Our push is to have RYTARY utilized in that more mild to moderately advanced patient who is starting to experience wearing off of their control of the motor symptoms prior to the next dose because we think that's actually the best spot for RYTARY. From a standpoint of a partner for Numient outside of the United States, we are continuing in the process. We hope to be able to have a partner this year, and we are hopeful that the approval of Numient by the EMA will in fact help to trigger the closing of the transaction.

Brandon R. Folkes - Guggenheim Securities LLC

Analyst

Thanks very much. Bryan M. Reasons - Chief Financial Officer & Senior VP-Finance: You're welcome. Mark J. Donohue - VP-Investor Relations & Corporate Communications: Thank you. Well, that concludes our call for today and we appreciate your time. And should you have any questions, follow-ups, please contact Investor Relations. Thank you very much.

Operator

Operator

Thank you. That does conclude today's conference call. You may now disconnect.