Mark J. Donohue - Impax Laboratories, Inc. Paul M. Bisaro - Impax Laboratories, Inc. Bryan M. Reasons - Impax Laboratories, Inc. Douglas S. Boothe - Impax Laboratories, Inc. Michael J. Nestor - Impax Laboratories, Inc..

Elliot Wilbur - Raymond James & Associates, Inc. Gregg Gilbert - Deutsche Bank Securities, Inc. Marc Goodman - UBS Securities LLC Gary Nachman - BMO Capital Markets (United States) Randall S. Stanicky - RBC Capital Markets LLC Louise Chen - Cantor Fitzgerald Securities David A. Amsellem - Piper Jaffray & Co. Tyler Van Buren - Cowen & Co.

LLC Timothy Chiang - BTIG LLC Andrew Finkelstein - Susquehanna Financial Group LLLP Ken Trbovich - Janney Montgomery Scott LLC Dewey Steadman - Canaccord Genuity, Inc..

Good morning. My name is Kathy, and I will be your conference operator today. At this time, I would like to welcome everyone to the Impax Laboratories second quarter 2017 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 will now turn the conference over to Mark Donohue, Vice President, Investor Relations and Corporate Communications. Please go ahead, sir..

Good morning. Welcome to Impax's second quarter 2017 earnings conference call. Copy of the slides that will be presented on this call are available within Investor Relations section of Impax's website and as part of the webcast. 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 an analysis by, investors in evaluating the company's financial performance, results of operations and trends.

A reconciliation of GAAP to non-GAAP measures are available in our second quarter 2017 earnings release and in today's slide presentation. Turn to slide 3. The agenda this morning will include Paul Bisaro, President and Chief Executive Officer, providing some remarks on our second quarter results and a business update.

Bryan Reasons, our Chief Financial Officer, will walk us through the second quarter financial results in more detail. Also on the call and available during Q&A are Doug Boothe, the President of the Generics Division; Michael Nestor, President of the Specialty Pharma Division; and Mark Schlossberg, our General Counsel.

And with that, I'll turn the call over to Paul..

Thank you, Mark, and good morning, everyone. While it has been a very interesting quarter for our industry, we are pleased to report we had a solid quarter and are making good progress on our strategic objectives, including significant progress on our consolidation and improvement plan.

Turning to slide 5 and our results for the second quarter, total net revenues were $202 million, adjusted EBITDA was $39 million, and adjusted EPS for the second quarter was $0.18 per share. Our revenues increased 17% versus last year's second quarter.

The growth was primarily driven by the addition of the generic products which we acquired from Teva last year, the successful launch of generic Vytorin, and higher sales of both epinephrine auto-injector and our flagship Parkinson's disease drug, Rotary.

While this quarter's earnings were down from last year's due to higher selling and interest expenses, we delivered improved sequential results. Total revenues grew 10%, adjusted EBITDA was up 23%, with adjusted EPS increasing 64% compared to the first quarter of 2017.

The solid sequential growth was led by an increase in generic product sales and favorable product mix. Turning to the Generics business on slide 6. In late April, we were one of only three companies that received FDA approval for a generic version of Vytorin.

Our manufacturing and sales organizations successfully collaborated on this first-to-market opportunity, which resulted in Impax capturing a significant piece of the generic market at just over 40%. Epinephrine auto-injector had another strong quarter, with revenue up 11% over last year's second quarter and up 46% sequentially.

This was primarily driven by increased volumes as a result of our arrangement with CVS. In July, we were pleased to receive FDA approval on generic Concerta and on additional strengths of Generic Focalin XR. The approval of our AB-rated Concerta arrived approximately 15 months after filing the ANDA.

This accomplishment speaks to the high quality and efficiency of our R&D and regulatory groups. We are working to secure API quota and preparing for launch by the end of the year. As a result, we don't anticipate sales of generic Concerta to meaningfully impact our earnings in 2017.

Earlier this week, we announced a settlement with Endo regarding a contract dispute involving the original formulation of Opana ER. We are pleased to have this case resolved.

With Endo's announcement that the new formulation of Opana ER is being removed from the market later this year, we will continue to focus on making sure physicians and pharmacists are aware of the continued availability of our generic oxymorphone extended release product.

Moving on to the Specialty brand business on slide 7, total sales in the second quarter were slightly higher compared to last year's second quarter. Increased sales of Rytary were primarily offset by lower sales of Albenza as a result of a shortage of inventory from our third-party manufacturer.

This issue has been resolved, and we expect normalized Albenza shipments to continue for the remainder of the year. Rytary delivered revenue growth of 27% and total script growth of 36% over last year's second quarter. Compared to the first quarter of 2017, Rytary revenue increased 10% and total scripts increased 8%.

Late last year, the dosing message was simplified and the MyRYTARY Patient Support Program was launched. We are evaluating the impact of these programs and will continue to focus our efforts on assisting patient access to the product.

Zomig sales in the second quarter were down compared to the second quarter of 2016, due to additional competition in the migraine nasal spray market. However, we saw an improvement in sales compared to this year's first quarter, and we do expect a bit of rebound in the third quarter.

Now I'd like to update you on the progress of our consolidation and cost improvement initiatives. With the recent closure of Middlesex, New Jersey's, manufacturing facility, all pre-2017 announced initiatives are now completed. Slide 8 highlights the estimated cost savings from these various pre-2017 initiatives.

Our 2017 guidance reflects approximately $12 million of savings that we expect to realize in the second half of this year from the closing of the Middlesex manufacturing facility. Turning to slide 9, we are making good progress on the new CIP initiatives announced in May.

We recently completed the closure of the Middlesex R&D site and consolidated our generics R&D group in the Hayward, California, facility. The last remaining item to be completed in Middlesex is the closure of the packaging facility, which we expect to complete by the end of the first quarter of 2018.

We have also made significant progress toward the rationalization of our generic portfolio by selling a number of ANDAs and one NDA. These non-strategic products were sold for $12 million. The vast majority of the ANDAs that were sold were not currently marketed by us.

Additionally, we are evaluating our existing commercialized portfolio and plan to discontinue low-value, slow-moving products by the end of the first quarter of 2018 in an effort to further improve our long-term profitability.

Based on our progress to date, we currently expect to realize approximately one-half of the $85 million in annual run rate savings by the end of 2018. We could achieve even greater potential savings in 2018 if our exit from our Taiwanese facility is accelerated.

Regarding Taiwan, we continue to work towards an efficient and timely exit, with a preference to sell the facility. A number of interested parties have toured the facility, and we are currently in discussions with several potential buyers. We will keep you posted on our progress.

Turning to our pipeline on slide 10, year to date three new ANDAs have been filed, and we received FDA approval on six generic products, including two from external R&D partnerships.

With the recent approvals, we now have 19 applications pending approval at the FDA, with more than half of these having the potential to be first to file or first to market. The R&D group is working on an additional 18 products, with almost all of these currently having the potential to be first-to-file or first-to-market opportunities.

With that, I'll now turn it over to Bryan for further discussion of the financials.

Bryan?.

Thanks, Paul. Good morning, everyone. As we covered our year-over-year performance in this morning's earnings release, my remarks will primarily focus on our sequential performance on an adjusted basis – therefore, second quarter of 2017 compared to the first quarter. Starting with our Generics Division results on slide 12.

Total revenues in the second quarter of 2017 were $151 million, an increase of $17 million from the first quarter, primarily due to higher sales of epinephrine auto-injector, sales from the products acquired from Teva, and the launch of generic Vytorin.

For the second quarter of 2017, we saw minimal price deterioration for our existing products on an aggregate basis from this year's first quarter, which were more than offset by higher volumes on such products.

On a year-over-year basis, selling price for existing products in the second quarter of 2017 decreased total generic revenues by 34%, while volumes for existing generic products increased revenues by 32%. The decline in price and increase in volume was primarily related to two products, our epinephrine auto-injector and generic Adderall.

Excluding epinephrine and Adderall, prices was relatively stable in the second quarter compared to the prior-year period. Regarding epinephrine, our agreement with CVS to supply our epinephrine auto-injector across their network is a significant driver of higher product sales and volume in 2017.

Epinephrine sales increased 11%, and volume increased 128% for the second quarter of 2017 compared to the prior-year period. Generic Adderall sales declined 17%, while volume increased 140% for this year's second quarter compared to last year.

The decrease in sales was a result of a new competitor, which entered the market in July of 2016, leading to a significant decline in pricing. However, we are successfully capturing – captured additional business and expanded our share of the segment from the mid-single digit percentage range to the low teens.

Our adjusted gross margin improved sequentially to 43% from 39%, primarily the result of product mix compared to the first quarter of 2017.

We delivered an $11 million or 39% improvement in adjusted operating income from the Generics Division compared to the first quarter of 2017 as a result of a combination of increased sales and higher volumes of key products. Moving to slide 13 and our Specialty Pharma Division results.

Total revenues were $51 million, an increase of approximately 2% over the first quarter of 2017. Individually, Rytary, Zomig, and Emverm delivered double-digit revenue growth during the second quarter compared to the first quarter.

Collectively, the growth of these products was primarily offset by a mid-30% decline in Albenza revenue as a result of a third-party supply disruption in May. The Albenza stock-out was resolved during the quarter, but we are closely monitoring our inventory from our third-party supplier.

Adjusted gross margin in the second quarter fell to 71% compared to 74% in the first quarter of 2017, primarily due to lower sales of Albenza and higher sales of lower-margin Zomig, for which we pay a royalty to AstraZeneca.

Adjusted operating income for the Specialty Division declined $2 million to $13 million in the second quarter compared to the first quarter of 2017 due to the decline in gross margins and slightly higher expenses. Turning to slide 14 and the consolidated results.

With the solid top line growth of 17% in the second quarter, adjusted EBITDA increased $7 million to $39 million, and adjusted earnings per diluted share increased $0.07 to $0.18 compared to the first quarter of 2017. As of June 30, we had cash and cash equivalents of $171 million, a $14 million increase from March 31.

Cash flows from operating activities have increased approximately $30 million for the first six months of 2017 compared to last year. Additionally, year to date we've paid $60 million of principal on our term loan. I'll now turn the call back to Paul..

Thanks, Bryan. As you can see on slide 16, we made a couple of small adjustments to our 2017 forecast based on first-half actuals and projected investment in generic R&D in the second half of the year. All in all, we're comfortable with our estimates and have reaffirmed our 2017 EPS guidance of $0.55 to $0.70 per share for the full year.

In summary, slide 17 clearly lays out our path forward, and we're making progress on our strategic objectives in order to position Impax for sustainable, long-term growth. We will invest for growth both internally and externally across our Generics and Specialty businesses.

Within Generics, we will continue our internal investment in R&D and pursue external opportunities to expand and diversify our portfolio. On the Specialty side, we will continue to focus internally and externally on bringing to market differentiated products targeting movement disorders. We must maintain customer focus.

This includes ensuring we continue to maintain a high level of quality and compliance, providing superior service levels across all departments and delivering differentiated products to our customers.

Next, we need to achieve the estimated $85 million of additional cost savings identified in our 2017 consolidation and improvement plan without business disruption. At the same time, we will continue to explore other cost savings and efficiencies in order to provide further resources to reinvest in our business.

Finally, we will pursue creative business development, potentially transformational opportunities that improve the depth and breadth in both our Generic and Specialty franchises. Lastly and most importantly, I would like to thank all of our employees for their hard work in helping us achieve the solid performance we had in the second quarter.

We have a busy second half of 2017 ahead of us, and we look forward to continuing that solid performance and making additional progress on our strategic objectives. And with that, I'll turn it back to Mark to open up for questions..

Thank you, Paul. Before opening the lines up to your questions, we would appreciate it if you could just limit yourself to one question and a follow-up, so that we can get in as many possible within the hour. And of course, feel free to put yourself back in the queue.

With that, Kathy, may we have our first question, please?.

Okay. Your first question comes from the line of Elliot Wilbur with Raymond James..

Hey, thanks. Good morning. Paul, you characterized the quarter as an interesting one. I was wondering if I might have missed something..

No, I don't think you missed it, Elliot. It's been interesting..

Yeah. Good, good, good. Hey, just two questions – or one question and one follow-up, and I guess it's probably most appropriately directed to yourself. But first on the Opana ER settlement, seems to be kind of a wide range of opinions as to sort of what may happen there going forward in terms of the impact to your profitability.

Maybe you could just sort of walk us through your thought process around the settlement and then some of the pushes and pulls and kind of how numbers could move around based on sort of the market dynamics and the terms of the settlement.

Then as a follow-up – big-picture question, of course – obviously, given events the last couple of weeks, we're going to hear the term "consolidation" a lot, and everyone seems to think that's kind of a fix for issues in the generic industry.

But I guess my thought process at this point is you've got $200 billion in M&A in the space in the last 20 years, and if you look at the market share of the top 10 guys today, it's the same as it was 20 years ago.

So the question is, is it really even possible to consolidate share in this space, and do you think we're at a point where we sort of see kind of the end of these mega-generic houses or kind of a one-stop shop for everyone, and maybe a reset and just kind of a return to sort of smaller, more nimble growth platforms?.

Well, that's a tall order, Elliot, the last two question there. So let me start with the Opana ER settlement. First of all, we're very pleased to have the litigation behind us. I think it's good for both companies to have that over with and moving forward. We see this is a – obviously a good settlement for Impax and Endo, as well as consumers.

We maintained an oxymorphone extended release product on the market; it is a generic product. I think our challenge will be to make sure that patients and caregivers understand that, if their patients are on oxymorphone extended release product because they prefer that, that that product remains available.

And that was what we will focus our efforts on is continuing to do that. We will be the only product in the marketplace with the extended release oxymorphone, and provided there's no disruption in the Endo patent portfolio, we would expect that protection to continue through 2029.

So I think for both parties it was a win-win, and again it was a win for patients, because the product remains available, and it's priced as a generic. Then, with respect to your consolidation in the marketplace, I do think consolidation will continue to some degree.

I also think the mega-companies, as you described them, do have the ability to – they have some abilities that smaller companies don't have. Smaller companies are only nimble and effective when they have differentiated product portfolios like we have. And that's what makes us a solid performer right now.

We do have a differentiated portfolio, and therefore we can maintain ourselves through these ups and downs maybe better than other companies of our size. But I do think consolidation will naturally continue, because there's only three or four buyers.

If you're the sixth or seventh product to the market, you're stuck with a different equation than you used to be stuck with, and that is, do I even bother to launch because who do I sell to? And I think what has to be fixed in this process is the distribution network, at the moment.

And by that I mean there will necessarily need to be new distribution channels. As the buyers consolidate it, they will naturally force us to look for other avenues to get our products to market. And it'll take a little while, but I suspect people will find creative ways to do that. We're certainly looking at creative ways to do that.

Because with only three people out there, you're going to have limited access. Again, I will not go as far as to say the FTC missed one, but I think they missed one..

Thank you, Elliot. Next question, please..

Okay, your next question comes from the line of Gregg Gilbert with Deutsche Bank..

Hi, Gregg..

Good morning. It only took you one question to get the word "FTC" out. I like it..

My favorite agency..

My fake question is, have you met with Jeff Bezos yet? Okay, my real question. Paul, the first reduction plan you announced was about five weeks into the job and focused mostly on COGS and where facilities are, et cetera.

With the benefit of more time, do you see additional opportunities to right-size the cost structure of the company and make the company more efficient than what you've already outlined? And I realize you saw some execution on what you've already announced. That's question one. And the follow-up would be a bit more environmental.

When we met with you a few months ago, the U.S. generics environment was also tough then, but you seemed less terrified than some others.

Given what you've seen over the course of your career, some similar things and acknowledgment that some things are different, but what would you say now a few months later, now that you've been in the trenches at Impax? And how is that view shaping your strategy for Impax going forward? You continue to mention the potential for transformation.

I would love to understand what that might mean on BD? Thanks..

Sure. With respect to cost reduction – and I would actually describe them more as cost efficiencies now going forward – we're going to continue, and we will always continue regardless of what mode we would be in, to make sure we're running at the most efficient level possible. I think there will be some additional efficiencies that we can grab.

However, I think now we're going to be looking more toward reinvesting in the business; as you saw, our R&D numbers are up slightly. We think we need to probably continue investment.

And we also are thinking about what 2018 brings for our Specialty Brand franchise with the potential for – potentially moving our IPX203 to the next phase of its development. So we're going to be using those efficiencies probably internally to drive additional R&D spend, but we will continue to look at that.

With respect to the generics environment, look, I think I've already made the comment about the three purchasers or four purchasers. And others that have reported have talked about the RFP processes, which are very disruptive, and most of them being completed for the year.

I would also point out that the first RFP process of a new entity, like Claris One's was, is the most disruptive RFP process and that they become less disruptive going forward.

You will – I think we would expect to continue to see one-off pricing issues with respect to specific products as products get approved and the like, but that's no different than what we've always faced. I think the RFP process has been the most challenging. Differentiation is critical.

And, finally, I think the most important thing that we all need to focus on is different distribution outlets to get our products to market. That will be a way for us to deal with the consolidation and bring some access back to the manufacturers to potential pharmacy outlets and – or patients, really, even more or so. And I think that was everything.

That was it?.

So the environment, how that's shaping, what kind of transformational deals are you considering? And does that relate to the generic environment we're in, or is that just the same as it would have been before, just we need more brands, we need more generics, or we need to be international, (24:40)?.

Well, look, I think we're focused – I mean, if we could – we can't write the perfect script because transformational deals by definition are dependent on opportunities. I think we will look at both Generic and – continue to look at both Generic and Specialty opportunities.

We hope to be able to do something in the relatively near term that would increase one or both of those franchise. So – I think that's a little feedback there, sorry. But I think those opportunities can exist and do exist.

And again it's going to require both parties to be creative, and we stand ready to be creative, and hopefully the other parties do as well..

Thank you. Just avoid solar panel..

Will do..

Okay, your next question comes from the line of Marc Goodman with UBS..

Good morning..

Good morning, Marc..

Paul, just the continuation on that discussion. Is there any way you can help us just quantify like how much this Claris One was disruptive to your business, specifically the RFP issues separate from the one-offs of a new approval for like an Adderall, which I would – we all understand that's been going on in Generics forever.

If you could help us with that. And then just second question, there was a comment about failure-to-supply fees in the SG&A line, which was a negative this year, positive last year. Can you give us a sense of just like how much was that? Was it a big number? I mean, why would you put it in the press release? Thanks..

Sure. I think with respect to – I'm going to start on it and hand it over to Doug.

I think when any organization, whether it's Red Oak, Webad, (26:27) or Claris One, starts their first bid cycle, it creates the biggest disruption, because you're working through not only the product selection, but also the underlying contractual obligations that at least the suppliers are providing to the purchasers.

And that is the most disruptive part of the whole thing, really, is trying to get those terms correct. As you can imagine, it's very challenging for manufacturers, because now everybody has their own – of the three groups, they all have specific terms and conditions, none of which actually can work with each other.

So they create a situation where they could actually put us in breach with our other purchasers. So it is not a well-run process, necessarily. So it creates difficulties, and that's probably what drives the biggest disruption of everything.

But, Doug?.

Yeah. I just want to add, I mean, I would say that the Claris One bid had the potential to be actually more disruptive than it ended up being for our business. It may have been more disruptive for our other competitors.

I mean, certainly we had the advantage of several quite several quite differentiated products, like our oxymorphone and our auto-injector, that were really not part of the bid process. So some portion of our business was affected by the new Claris One terms, but not really out to bid, so to speak.

The rest of our portfolio, we had products which we thought we were in the right position on, and we maintained, and the opportunities we sought, we thought we had good opportunity to get some additional distribution. Some panned out and others did not.

So as I always say with a bid process is, I try to find a way to find incremental revenue opportunities in our portfolio to offset some of the incremental fees that are part of these consolidations. And in this situation, we didn't quite achieve that, but not nearly as disruptive I think as others have described in their releases..

I mean, if there wasn't a Claris One RFP process, would you have had 2 or 3 percentage points better on pricing on the portfolio? I mean, I'm just trying to see if you could help quantify that..

I mean, that's obviously very hard to say. But I would think that, but for a big RFP process, I would suspect everybody's pricing would have been better for the quarter. That -.

Ongoing pricing is part of the leaky bucket..

Yeah, yeah..

I mean, so certainly we try to find ways through product launches, like the Vytorin one, and expanded distribution like we saw with DBS (28:53) on epinephrine auto-injector to offset the expected downside in the business..

Yeah..

I'll jump in, Marc, on the failure-to-supply. So on a year-over-year basis in the current quarter, we have about $1.5 million to $1.8 million of what I'll call unusual failure-to-supply claims. And then when you compare it to the prior-year quarter, we had a couple million of good guys on the failure to supply.

So the way this works is, when the customer claims failure to supply we accrue them, and then we dig into them and we go back and forth, and sometimes they're correct and sometimes they're not correct. And when they're not correct, then we reverse that accrual, and when they're correct, we pay them.

So it just happens to be when you compare year over year, you're comparing to a quarter where we had favorable failure-to-supply to a quarter where we had some unusual failure-to-supply charges. So we thought that was significant enough to call out in the release..

Yeah. Just add to add that, it's also at 100% margin..

That's right..

That's why it's important.

And then I think to Gregg's comment earlier about continued cost efficiencies, I mean, we're putting a lot of emphasis, both within our sales and marketing organization and our logistics distribution organization, to – both by having great supply, but also making certain we deliver the product in time to avoid these sorts of penalties.

And we have made progress on that. We will continue as part of our ongoing activities to improve the efficiency of our organization and our partnerships..

Thanks..

Thanks, Marc. Next question, please..

Okay, your next question comes from Gary Nachman with BMO Capital Markets..

Hi. Good morning.

In terms of FDA and pipeline, are you optimistic you can Renvela or Welchol approved sometime soon? Have you had any discussions with FDA recently on those? And what's the longer-term goal for the generic pipeline in terms of how many filings you should have every year? And then with Concerta, that one you got approved very quickly, so that was a good outcome.

How much quota can you get? So what's a realistic target in terms of share for that product, I guess, in a good scenario?.

I'll start from the bottom up with that, Gary. On Concerta, our challenge will be getting the product prepared for launch, and we are in the process of doing that. And then we will judiciously approach the market and try to maximize our volume price ratio with this product. So I don't think quota will be the limiting factor with that.

I think we'll get enough quota to achieve the market share we want to achieve. And as I said our challenge will be balancing the price-volume ratio to not be a massively disruptive player here, but one that is smart about attacking that market. With respect to the generic numbers of filings, we're looking around the 20 range.

That may change here and there depending on how many external products we can get done. What I mean is an annual run rate, okay? Not necessarily this year, but on an annual run rate, because that's I think which you asked me, what is our normal run rate. Probably around there.

We could – some years a little more, some years a little less, depending on the price of each one of those and the complexity of those, which is not too unusual.

And we think that our Generics business can be a very nice contributor and cash flow generator to help support additional growth in our Specialty franchise, which has been our consistent plan all the way along.

And if we're successful at continuing to grow our Rytary sales, we can arrest some of the decline in the Zomig sales, and continue to license in new product opportunities or develop new product opportunities there, we'll continue to see higher growth rates in the Specialty franchise.

I guess with respect to the pipeline of Renvela and Welchol, we continue to prepare for launch. We are optimistic that we will see activity this year. We hope to see activity this year. And I – very excited that the FDA has decided to try to accelerate these complicated types of approvals.

I would caution, though, that it would be really important for the FDA to continue to make sure that they observe fairness across all the applications that are being presented.

Because we have seen – many of you don't remember, but I'm old enough to remember – that there were certainly times when people couldn't explain why some applications moved faster than others, and I think the agency needs to makes sure it stays vigilant about making sure filers are treated similarly across the board. And I'll leave it at that.

But we are optimistic we'll be able to achieve these approvals..

Okay. Just a follow-up.

Generally speaking, though, you think that your dialog with FDA has improved from what you've seen over the years at a high level?.

Definitely the agency is much more open to discussions now. Certainly under GDUFA they have moved to that, and that has certainly been the case. They certainly reach out, we talk with them, we do have, I would say, a good dialog..

Okay, great. Thanks..

And your next question comes from Randall Stanicky with RBC Capital..

Great. Paul, just a couple questions. One of your smaller, India-based peers, Natco, talked earlier this week about stepping away from the U.S. market given some of the headwinds. There are 18 companies with at least 50 ANDA pipelines out there.

Is there an opportunity to partner or step in and take over some of those pipelines or businesses of a couple of the big public companies that have been clear about not wanting to be in this business given those headwinds? How big of an opportunity is that, and what are the challenges in getting over the finish line in terms of the a like that? And then I have one follow-up..

Well, yes, I think you're right, Randall. That is an opportunity that we look to explore, and we continue to look to explore it. I think the challenge is always in this particular marketplace valuation of generic pipelines is probably as hard as it's ever been.

I think we all saw what happened following the Teva divesture of the products and how the companies that purchased those were disappointed in what ultimately revenue creation and profitability they got from those. And I think that will be a challenge for anybody who's facing a kind of question you just described.

That's why I described creative deals, right? People have to – they have to be realistic about what the value is of their organization, and then there needs to be a thoughtful creativity discussion to make sure that both parties are protected from the possibility of less-than-anticipated outcome. So it's challenging.

There's no doubt that reaching an agreement is challenging, but I think it's doable..

And I'll jump in. The pure pipeline transactions are tougher from a balance sheet standpoint, too, because they're by definition dilutive early on. Right now. (36:26).

That's fair. And if we shift over to the brand side, Paul, I mean, Rytary showed some nice growth, but it's clearly been a disappointing asset over the last couple of years.

As you look at that overall platform – and this might be for Bryan as well – are you, a, happy with the cost structure of that platform? And, b, is that the right platform for you to grow a brand business off of, or is there a reevaluation that could be a little bit more significant?.

Well, I think there would be people in the room, including Michael, who would say that Rytary's done well since the product has launched. But, look, I think we will continue to look at, as my predecessors have looked, at ways to continue to drive growth in the franchise, including our flagship products, as I said, Rytary.

So that will be a main focus for us through the rest of the year and into 2018. As we think about long term where we want to be as a specialty company, we will need to carefully think about CNS and potentially other categories that, as you say, might be easier for a company of our size to grow in than potentially the CNS marketplace is.

The challenge, of course, is we have a very solid asset with Rytary, we have a pipeline, we have Zomig, we have additional opportunities that we're working on. So we are extremely focused on it right now, and we'll continue to stay focused on it.

But we're mindful of the fact that there may be other opportunities out there that could help us augment our Specialty business that wouldn't be in CNS. So we're thinking about all of those things. We haven't concluded anything yet, but we're still working on that thought process..

Got it. Thanks a lot..

Okay, your next question comes from Louise Chen with Cantor Fitzgerald..

Hi. Thanks for taking my questions..

Hi, Louise..

Hi. So first question I had was on Opana ER. Just curious, when we do the math here, it looks like the headwind could be neutral to 2018 numbers in that you pay a royalty but you also get access to a larger market opportunity.

So I was wondering if you could comment if our math makes sense there? And then also, if Endo were to launch an authorized generic, would you still have to pay that royalty? And then I just have one follow-up. Thank you..

Sure. Well, I'll answer the second one first because it's easiest. The answer is no. We wouldn't be paying them any royalty. So.

And with respect to the headwinds, I think the challenge for us, as I said earlier on, is to making sure that patients, physicians, pharmacists recognize and understand that an oxymorphone extended release product remains available on the market for those patients who do better on oxymorphone for pain relief than other potential products for pain relief.

And we're going to be focused on getting that message out and making sure that everybody understands how to write for it and continue that challenge – or that process. With respect to 2018, we'll give you some guidance on 2018, what we think we can do, later on. But right now we're going to stay focused on getting the message out..

Okay. Thank you. And then the second question's just on Rytary. Given your increased investment behind the product, do you feel that the sales have met your expectations here? And then just are you still expecting data for this IPX203 follow-on in the middle of this year? Thank you..

I'll let Michael take those questions..

Yeah. So, Louise, relative to IPX203, we have only just now had our last patient out. We're going through the data on that. And once we've got all that sorted out, we'll let you know what those results were. From the standpoint of Rytary, I would say overall it has met our expectations.

However, we do recognize we have a bit of a challenge with dose conversion from immediate release carbidopa-levodopa to Rytary. Our sales reps are communicating that dose conversion approach and continue to do so..

Yeah, Louise, I would add one thing. I think that what I see as a very positive factor here is that Rytary is covered in over 90% of the plans now. And that, I think, is a milestone that we hit fairly recently, and I think that's going to help continue to drive growth of the product..

Yeah, and, Louise, that's typically a milestone that – it takes more than a couple of years to achieve..

Okay, thanks..

Thank you..

Your next question comes from David Amsellem with Piper Jaffray..

Thanks. Just a couple of product-specific questions, and I joined late so I may have missed these, so apologize.

So first on Albenza, are you still expecting generic competition later this year or next year? And then secondly, on Welchol and Renvela, I guess realistically, once you do get to market, do you have a realistic sense of how crowded it may be for both products at market formation? Maybe set our expectations there.

And then lastly with Zomig nasal spray going off patent in 2021 – and I know you talked about the brand business earlier in the Q&A, Paul, – but maybe give us a sense of how you're thinking of bolstering the CNS portfolio given that you've got a patent expiry four years from now? Thanks..

Sure. I'll answer the Albenza question and then turn the Welchol and Renvela over to Doug, and then we'll come back to Zomig. On Albenza, our guidance contemplates the possibility of generic competition for Albenza in 2017.

If it doesn't occur, we will be on the happy side of our guidance, and if it does then we'll have to deal with it through other means. But we do expect that it would fall within our guidance range.

And then with Welchol and Renvela?.

Yeah, so, David, on those two items, I mean certainly we have seen one approval on Renvela already, which is the Aurobindo approval, which a little bit was a surprise.

We are aware of other companies that are working on both these items, and the extent to which they aren't approvals gives a sense that if we're in the next wave or the first wave of approval on Welchol, we should be in a strong position, which is why we have been investing in launch inventories, and we're ready to go.

Certainly getting out in that first wave will do us much better than being late to the party, and we think we're strongly positioned..

And then I think you said with respect to Zomig, yes, we're obviously keenly aware of the patent-off dates for the products in our portfolio. We will continue to look for opportunities to license in new products from third parties. We're actively engaged in discussions with several parties on that front.

And we're also continuing to look at our own internal pipeline, of course the IPX203, which Michael just discussed. So I think we're obviously keenly aware of the impact of genericization on our portfolio. So we're going to continue to work to make sure we have something to replace those revenues..

Okay, thanks..

Okay. Your next question comes from Tyler Van Buren with Cowen & Company..

Hi. Good morning. Given the IPX203 data that's due potentially later this quarter, just wanted to dig into the potential results a little bit further.

When you speak with Parkinson's docs on Rytary, they'll definitely suggest despite the titration challenges that it's a superior carbidopa-levodopa and it lasts at least three to four hours for the severe patients.

So conceptually with IPX203 what's the goal here in terms of increasing off time? Is it additional one or two hours on top of Rytary? And then maybe as a follow-up you could just remind us of the trial design and the comparator and what the primary objectives and a positive result would be?.

Michael, do you want to take that?.

Sure. So relative to what we'd be looking for with IPX203, clearly the objective would be to be able to offer a clinical benefit over and above Rytary and immediate release carbidopa-levodopa.

So we would be looking for probably around a one-hour increase over Rytary or approximately a two-hour increase in on-time control of motor symptoms relative to immediate release carbidopa-levodopa with a simplified dosing regimen.

Now, the Phase 2b – I think it was the Phase 2b study design you were asking about – is a crossover design where patients come in on immediate release carbidopa-levodopa and are optimized and then put on either immediate release carbidopa-levodopa or IPX203.

They're on product for about two weeks, and then there's a washout period where the patients are given immediate release carbidopa-levodopa, both sets of patients, on the prior drug. And then, at the end of that week, they are converted to the other product. So the IPX203 patients would be put on immediate release carbidopa-levodopa and vice versa.

And so those will be the results that we anticipate reporting out shortly..

Okay. That's helpful.

And in terms of just rationalizing R&D spend, assuming the results are successful, is the current R&D spend entirely due to IPX203, and how would you expect that to increase over time in Phase 3, and when do you think it would potentially reach the market?.

Well, primarily our R&D spend is on people and IPX203.

We would expect it to – if we started a study in 2018, we would expect to see an increase in that spending, and then we would look to, depending on when we start the study and how quickly we can get it completed and how many factors we try to address in that study, including potentially a Rytary competitor, we would be looking to get that product to market sometime in 2022, 2021-2022, depending on timing..

Thanks for taking the questions..

Sure..

Your next question comes from Tim Chiang with BTIG..

Hey, Paul..

Hey, Tim..

I had some supply questions. Just on epinephrine, you guys pretty comfortable with your supply? It looks like you're continuing to gain share and increase volume there.

How quickly can you meet the demand that CVS has sort of put forth in front of you?.

Yeah. Hey, this is Doug. I'll take that. Well, certainly, yes, we are continuing to improve both the reliability and the quantity of our supply from our partnerships.

We've invested in expanded line capacity, and you see our share has maintained its base, it's grown, and in fact right now we're in really the peak season, and we're seeing very, very strong pulls for (49:06) our products.

We're comfortable and confident in our current position, and of course we're looking to sustain and maybe slightly expand upon that as we go into 2018 from a share perspective. But as we've described in the past, we have no intention of trying to be 100% of the market.

Certainly we understand the capability of our product as well as our unique positioning, vis-à-vis the other auto-injector products out there..

And, Paul, maybe just one question for you. You seem to – I think of you as sort of the expert when it comes to generic Concerta, given your track record there.

And how do you think this market will form when you guys hit the market late this year? How many competitors do you think there'll be there? Do you think this will still be a meaningful product for you?.

Well, thanks for the boost of confidence there on the Concerta, but I think this product is one of those products we've talked about in the past that should form in a rational way, because it's challenging to get approved, it's challenging to manufacturer, it's challenging to get quota, and that people should come to the market in sort of a rational, controlled way.

That's what we hope. We also think that it'll be staggered, so we will see people come in over time. I think what makes this launch different from the launches in the past with products like this is, as I said before, there was only three or four meaningful buyers that can really affect major markets.

So if you're not one of that early group, the followers who come with the fifth, sixth, or seventh products are going to be struggling with the idea of do I spend the money to make product, get launch product, and not be able to potentially sell it. So I think that remains a question that we will have to see how it all plays out..

Okay..

And I guess there's one other point here, and I think – and Doug reminds me – that there is the BX-rated products out there, so we'll have to wait and see what happens with those. If those are not going to be on the market for long, that changes the dynamic a bit, too..

And, Paul, this is going to be manufactured at your own Hayward facility, is that right?.

No. We have a third-party manufacturer for this product..

Okay..

Thanks, Tim..

And your next question comes from Andrew Finkelstein with Susquehanna..

Hi. Good morning, and thanks for taking the question. Just a quick one on guidance.

Did the change with the Opana withdrawal affect your outlook for what that product's going to do towards the end of the year at all? And then, on the branded side, with the IPX203 data coming up, is that a gating item for you to think about some of the business development deals you're considering, given your discussion about the therapeutic focus within the Specialty business? Thanks..

Sure. With respect to Opana ER, we don't expect to see any – we do expect to see some market dynamics changing, because of Endo's statement that they're not going to continue to sell product past September 1. But there clearly will be Opana ER in the marketplace from Endo probably through the end of the year or almost to the end of the year.

So we wouldn't expect to see much of an impact in 2017 of this settlement on our numbers. With respect to IPX203 and kind of what we're thinking about on a business development front. Yes, it does impact our decision making.

We will factor in the results of the 2b study, and we will factor in where our opportunities appear to be from potentially outsourcing or licensing in other CNS drugs, as well as what other specialty areas might be presented to us.

All those factors will be part of our decision about kind of what our next steps are with IPX203 and what our next steps are with the CNS franchise was generally..

All right. Thanks very much..

Thank you..

Your next question comes from Ken Trbovich with Janney..

Thanks for taking the question.

I guess, Paul, you've twice mentioned the idea that you're going to try to get the message out to the physicians and patients that the extended-release oxymorphone would still be available even after Opana ER is pulled, but how do you actually do that without a sales force?.

Well, I think we'll be using non-direct, obviously non-direct promotion through obviously ads and printed work and printed things. We will look to see if we can do some drop-off work. We'll look to see if we can do some call centers.

We'll look at all of those options and see which ones are most cost-effective, and we'll employ those that we think make sense.

Doug, did you want to anything to that?.

Yeah. I was just going to add that we've done this before.

So from Impax back when we launched our original Opana ER, which was the equivalent to the prior version, we did do communication plans to physicians and pharmacists to make them aware of our offering, and of course we've been quite successful in maintaining and gaining script share on that product over the last several years.

So it's something – we already have a plan in place about communication messages, and certainly we're happy with the settlement. And of course part of that also is we have access to a collaboration of some of the information that Endo has about the key physicians, the key pharmacists, and such.

So we will work as part of that activity to have a better, more tightened, focused message to physicians about our awareness campaign..

Okay.

And then just quickly on the issue of abuse-deterrent formulations, can you guys give us a sense of the filings with oxycodone ER and certainly the new formulation of Opana ER? Should we think of that new formulation as coming off the table because of Endo's determination to pull the product, or how does the difference in abuse deterrence between your formulation and theirs alter that view? And then generally about the industry, how do you feel about the development of abuse-deterrent formulations overall?.

Well, I'll start, and, Doug, feel free to jump in. I think we see the probability of moving forward with the Endo abuse-deterrent formulation ANDAs as highly unlikely. We haven't made a final determination yet, but we will obviously evaluate whether it makes sense, and I'm sure others who have filed on the product are contemplating the same thing.

With respect to abuse deterrence and the opioid question of the abuse epidemic, as people talk about, I think manufacturers will continue to do whatever they can do to try to help in this process. And we will continue to make it clear that we are – well, we supply the products – we are not the major problem here.

I think perhaps we need to look at other areas of distribution, what can we do to work on appropriate measures to get products back off the street? Our distribution channels are very tight, and the DEA has worked very hard with us across not just manufacturers, but the wholesalers and those folks, to track shipments and tighten down on – pretty much as much as we could possibly do.

I think that the area has to be addressed with treatment centers and helping people get off of these problems, as opposed to looking for the manufacturers to do something, because we're really sort of at a loss of what else we can possibly do. But we're going to continue to talk about that. Our trade associations will continue to talk about that.

And we'll continue to help in any way we can to avoid opioid abuse. That is not our intention, never was, and we'll do our best to help in any way we can..

Okay. Thank you..

And our last question comes from Dewey Steadman with Canaccord..

Hi, thanks for fitting me in..

Hi, Dewey..

I got an email yesterday from a pharma CEO, and all it said was, "Generics are dead." And given that the largest generic has a leadership vacuum, and the second-largest generic generally doesn't give thoughtful answers to these kind of questions, Paul, you're sort of a standard-bearer now for the industry.

And do you think generics are dead? And what can you do to assure investors that generic is still a decent, investable play? Thanks..

Well, thank you again, Dewey, I appreciate that. But I would say that – one of the things that is – I obviously don't believe generics are dead. I think – generics are roughly 90% of the prescription volume in the United States. Hard to believe that they're dead. We are going through a rough patch right now.

We have some things to work through, including the difficulties always surrounding the consolidations of purchasers and consolidation of anything, frankly. But we still see very – we're still optimistic that there are still good products to genericize that have potential value, a lot of potential value.

And then we have of course the next-generation opportunities that exist in biosimilars, and as our brand colleagues continue to innovate, we will continue to have new opportunities. And we are enthusiastically supporting their innovation, because we know that their innovation is where we get our pipeline from.

So I don't think that's changed at all, and I think we just have to work through the challenges we face. This industry has faced challenges before. It always come out and done well, and I think it will continue to do that..

Great, thanks..

Thanks, Dewey. Thank you all for joining us today. I'll be available the rest of today and the remainder of the week to answer any follow-up questions you have. So again thanks, and that concludes our call..

Thank you. And this concludes today's call. You may now disconnect..