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

Elliot Wilbur - Raymond James & Associates, Inc. Gregg Gilbert - Deutsche Bank Securities, Inc. David A. Amsellem - Piper Jaffray & Co. Randall S.

Stanicky - RBC Capital Markets LLC Gary Nachman - BMO Capital Markets (United States) Andrew Finkelstein - Susquehanna Financial Group LLLP Marc Goodman - UBS Securities LLC Tim Chiang - BTIG LLC Tyler Van Buren - Cowen & Co. LLC Ken Trbovich - Janney Montgomery Scott LLC.

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

Thank you. Good morning. Welcome to Impax's first 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 at www.impaxlabs.com and is part of the webcast.

Our discussion today may include certain forward-looking statements, and actual results may differ from those presented here. The 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 first quarter 2017 earnings release and in today's slide presentation.

The agenda this morning, which appears on slide three, will include Paul Bisaro, our President and Chief Executive Officer, providing some remarks on our first quarter 2017 results, a business update, and conclude with Impax's plan forward.

Bryan Reasons, our Chief Financial Officer, will review the first quarter financial results in more detail and our capital structure. Also on the call and available during Q&A are Doug Boothe, President of Generics Division; Michael Nestor, President of 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. It is a pleasure to be with you all, again, and before I talk about the results, I thought I would share some of my first impressions with you of my first six weeks here at Impax.

My first priority was to visit our sites and meet with as many of the people as possible, so I could get a sense for what the assets were of the company. And first and foremost, we have great people here. They are committed to success of the company and providing high-quality products.

We have a solid Generics business with a good portfolio of marketed products, a good generic pipeline, high-quality, reliable supply and excellent customer service. We also have a Specialty franchise with a growing neurology presence.

Of course, we have some challenges, but I believe that Impax has the essential ingredients to overcome these challenges that achieve our goals of providing value to our patients and customers and delivering long-term shareholder growth. Now turning to slide five and our results for the first quarter.

Total net revenues were $184 million, adjusted EBITDA was $32 million and adjusted EPS for the first quarter was $0.11.

Our results were down versus last year's first quarter, primarily due to the significant reduction in sales of diclofenac sodium gel, which were offset in part by higher sales of our epinephrine auto-injector, oxymorphone and Rytary.

On a sequential basis, growth from a few key generic products helped to partially offset the decline we experienced in generic pricing and softer revenue within our Specialty Pharma division.

Turning to the Generics business on slide six; epinephrine auto-injector had a strong quarter with revenue up 78% over last year's first quarter, and up 45% sequentially as a result of significant increase in volume, primarily driven by our arrangement with CVS.

Oxymorphone ER also delivered strong year-over-year results with revenue up 53% after seeing improved market share, resulting from a competing generic leaving the market last year. In late April, we were pleased to be one of only three companies that received FDA approval for a generic version of Vytorin.

The company was fully prepared for an immediate launch, securing more than 1/3 of the market. Moving on to the Specialty brand business on slide seven, results in the first quarter were weaker compared to last year's first quarter and the fourth quarter of 2016 due to lower sales of Zomig and Albenza.

Rytary delivered revenue growth of 33% and total script growth of 36% over last year's first quarter. Even with managed care plans resetting at the beginning of the year, sequential script growth was 4% and new Rxs were up 6%.

TRxs for Rytary are also currently improving based on recent weekly IMS data, which have Rytary exceeding 3,100 scripts for the week ending 4/28, a new high. Zomig sales in the first quarter compared to the first quarter of 2016 were light as a result of lower volume.

In April, we received a favorable district court decision upholding the validity for Zomig and we will continue to actively protect our intellectual property. Albenza revenue was also soft in the first quarter, primarily as a result of higher sales to the government, which are at a lower price point than our standard business.

We continue to contract with managed Medicare to improve coverage for our Emverm product as well. Finally, we are enhancing our awareness campaigns for both Zomig and Emverm by launching a tele-detailing program to select high prescribing pediatric and primary care practices.

As we evaluated the challenges facing Impax, we felt that swift action to better align our infrastructure, improve our profitability in the near term and provide additional resources to support near and long-term growth initiatives was required. As a result, we are announcing today an expanded consolidation and improvement plan.

The initial steps of this plan are highlighted on slide eight. The plan includes consolidation of our Generics R&D, U. S. manufacturing and packaging to our Hayward California facility.

We will close our Middlesex, New Jersey Generic R&D site in addition to the previously announced closure of the manufacturing site there and continue our reorganization of certain other functions.

By consolidating these activities in a single site, we expect to achieve operating efficiencies, facilitating and sharing of best practices, improving manufacturing utilization, and most importantly, reducing our overall costs. We also made a difficult decision to exit the Taiwan manufacturing facility.

We will quickly review our options, which include the sale of the facility or in the alternative, a closure of that facility. We are also rationalizing our generic portfolio to eliminate low-value products in an effort to further improve our profitability.

Turning now to slide nine; we currently expect these initiatives to realize annual cost savings of approximately $85 million. Combined with the previously announced cost efficiencies, we expect to deliver annual cost savings of approximately $130 million. We expect that up to $65 million of one-time cash cost may be incurred to achieve these results.

Slide 10 provides further information regarding an estimated timeline to achieve the expected cost savings. The biggest factor in achieving these savings is the timing associated with the disposition of the Taiwan facility. We will continue to update you on our progress in achieving these initiatives.

As I said before, these were very difficult decisions to make, but the board and the executive committee is fully aligned, and we believe that these actions are best for the long-term success of Impax. We also know that these decisions will impact a number of our employees who played an important role over the years with our company.

Our priority is assisting those employees impacted by these events to help them manage through this difficult transition. Turning to our pipeline on slide 11; year-to-date, three new ANDAs have been filed, and we received FDA approval on four generic products, including two from external R&D partnerships.

As demonstrated in this slide, Impax has built a diversified generic pipeline of solid, oral and alternative dose form products. Generic applications pending at the FDA include 22 products, with nine of these products being a potential first-to-file or first-to-market opportunity, including generics for Concerta, Renvela and Welchol.

Our Generic R&D group is working on another 19 products with almost all of these currently having the potential to be a first-to-file or first-to-market opportunity. Within the Specialty Pharma pipeline, the Phase 2b multi-dose study for IPX203 is ongoing, and we now expect to complete this study some time during the second half of the year.

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

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, first quarter of 2017 compared to the fourth quarter of 2016. Starting with our Generics division results on slide 13.

Total revenues in the first quarter 2017 were $134 million, a decline of $5 million from the fourth quarter, primarily due to a sequential decline in generic pricing of 11%, partially offset by a 7% increase in volume. We delivered higher sales and volumes from the epinephrine auto-injector franchise, principally driven by our arrangement with CVS.

In addition, the first quarter included higher sales of generic Adderall and authorized generic OxyContin. Our limited AG supply of OxyContin was replenished by our partner, which allowed us to restock our customers after exhausting our available inventory in last year's third quarter.

Our adjusted gross margin improved sequentially to 39% from 33%, primarily a result of product mix such as OxyContin.

Despite the $5 million decline in revenues in the first quarter, we delivered an improvement of more than $6 million in adjusted operating income from the Generics division as a result of a combination of increased sales of higher-margin products and cost controls. Moving to slide 14 and our Specialty Pharma division results.

Total revenues were $50 million, a decline of $9 million over the fourth quarter of 2016. The decrease is primarily due to lower sales of Albenza.

This is a result of higher government customer sales and a restocking of customer inventory in the fourth quarter of last year, as a result of the third quarter supply disruption resolved in early fourth quarter. Sales were also negatively impacted by lower sales of Zomig, as a result of slightly lower volume and higher PBM utilization.

We currently expect both to return to normalized revenue trends in the second quarter. Gross margin in the first quarter fell to 74% compared to 79% in the fourth quarter of 2016, primarily due to product mix and an increase in short-dated inventory reserve related to Rytary.

As a result of the lower sales and gross margin, adjusted operating income for the Specialty division declined $15 million compared to $26 million in the fourth quarter of 2016. Turning to slide 15 and our consolidated results.

While total net revenues declined $40 million in the first quarter 2017 compared to the fourth quarter of 2016, the decline in adjusted EBITDA was limited to approximately $5 million, a result of favorable product mix and effectively managing our operating expenses.

Our adjusted earnings per diluted share were $0.11 in the first quarter compared to $0.16 in last year's first quarter. Our adjusted tax rate was 30.8%, down from 34.7% in the fourth quarter, primarily due to state income tax benefits from losses at CorePharma and favorable jurisdiction mix, which we expect to reverse over the remainder of the year.

Slide 16 provides a snapshot of our capital structure. Our total net debt was $783 million at the end of the first quarter. In late March, we revised our maintenance debt covenant. Previously, the covenant was calculated using total net debt to trailing 12 months pro forma EBITDA.

In working with our lenders, the covenant was revised to include only four – only our senior secured debt, which was $340 million as of March 31 to our trailing 12 months pro forma EBITDA. The revision provides us with additional operating flexibility as we pursue growth initiatives. I'll now turn the call back to Paul..

Thanks, Bryan. Before we move to questions, I want to provide an update on our 2017 guidance, which appears on slide 18. Our guidance excludes the new cost savings initiatives that I outlined earlier.

Our guidance is essentially consistent with the guidance we provided on March 1, with only modest revisions to our adjusted interest rate, interest expense and tax rate as noted on the slide. For 2017, we expect adjusted earnings per share to be between $0.55 and $0.70 per share.

We anticipate the earnings will be weighted more to the second half of the year versus the first half, primarily due to the seasonality of our epinephrine auto-injector product and expected continued growth of Rytary. In summary, we're setting a path forward that is intended to position Impax for sustainable long-term growth.

Our plan is highlighted on slide 19. We will invest for growth, both internally and externally by pursuing development opportunities across our Generic and Specialty businesses.

Within Generics, we will pursue opportunities to expand and diversify our portfolio, while the Specialty brand franchise will continue to focus on differentiated products targeting movement disorders and other CNS opportunities. We must maintain customer focus.

This includes ensuring we continue to focus on the highest levels of quality, providing superior service levels across all departments and delivering differentiated products to our customers. Next, we intend to achieve the cost savings identified in our consolidation and improvement plan without business disruption.

We will continue to explore other cost savings efficiencies in order to provide further resources to reinvest in our business. Finally, we will pursue creative business development. Opportunities that improve the depth and breadth in both our Generic and Specialty franchise. I'm excited about the future of Impax.

I know that our team is ready to embrace change and build the company that will prosper for many years to come. Finally, I want to thank all my new colleagues at Impax for their continuing hard work and dedication. And with that, I'll turn it back to Mark to open up for questions..

Thanks, Paul. We'd appreciate if you could limit yourself to one initial question and one follow-up, so that we can get to as many of you as possible. Thank you very much. Operator, we'll now take our first question..

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

Thanks. Good morning..

Good morning, Elliot..

Welcome back, Paul..

Thanks..

Sort of like – I think I introduced or is it something in effect of – reminds of when Joe Montana done, the Kansas City Chief Jersey when you took over the role of Watson CEO versus your long career at Bar. Now I don't know the bread far of analogy is sort of coming to mind here..

Let's just hope I can do as well as bread far, okay?.

So just – maybe just, get a little bit more color comment from – commentary from you on sort of what initially intrigued you about the opportunity at Impax, and as a follow-up to that, maybe just some commentary on the current macro environment.

And I guess, other than maybe twice as many manufacturers and half as many customers is what the industry has had historically, just maybe some commentary on the current pricing dynamics and cycle and what you think may be or maybe not different this around versus what you've seen historically? Thanks..

Sure. That's a mouthful. But I will try to do that. I think, to start with your first question, I think Impax intrigued me on many levels. First of all, as I said in my prepared remarks, the people and the assets here are strong and solid, and I think the best days are ahead of us, not behind us.

And I think we can, as I said, embrace change and move forward. I also think that on a macro level, this is a very interesting time. I mean, there certainly are unique challenges and some unique and some not so unique.

Certainly, the consolidation of the purchasers has created some very interesting challenges in the generic side and the economic requirements now on the Specialty side have created new challenges there. But I still think the fundamentals are the same.

If you deliver solid products that are needed by your customers, you have good customer service, high-quality, you can perform very well. I also think that as you said this industry is probably – need some consolidation as we look out across the industry. I would expect that will continue and things will happen that way.

I think Impax can be part of that discussion, whether we are – we hope to be participating in that discussion, as I said, as the leader, one of the leaders. And we look forward to building our franchise on both the Generic as well as the Specialty side.

And we tend to focus mostly on to Generics, but I do think on the Specialty side, there're some great opportunities as well to take a good solid platform that we have, with a good solid sales force that we have in place and build from that. And we intend to do that.

So, the live activity going on, both internally and externally, and I think we will do our best to navigate that in the best possible way..

Thank you, Elliot. Next question, please..

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

Thanks.

Couldn't get enough of retirement, Paul?.

Couldn't play golf well enough, Gregg, that was the problem..

Mark, I'll honor the single question follow up, I have 20-or-so, but I'll start, maybe Paul, with just what underpins your commitment to having both Generics and brands under one roof and within Generics, what would you say the internal capabilities are at Impax in your past formulation expertise and first-to-files and creative settlement were part and parcel of success.

I'll ask what you're studying with here versus what you've had in the past. My follow up for Bryan is just what's the expense base that the $85 million of net savings comes off of just to avoid any confusion? Thanks..

Yeah, with respect to the Impax strength, I think the historic strength of being able to do high-quality, difficult to manufacture extended release, unique products is a key component and will continue to be a key component of the internally-generated assets.

Probably what we're going to do a little differently here, and I'm sure we're going to do a little differently here than we did in other places that I've worked is use more outside partners to help us achieve alternative dosage form capabilities.

We want to become the state a phrase, the partner of choice of people who are developing those alternative dosage forms because we have a good, solid sales capability, we have strong market position as demonstrated by our Vytorin launch.

We can, obviously, get market share and hold that market share, and that's important to – it should be important and will be important to those kinds of suppliers and partners.

You also asked why under one roof, I still believe that there are synergies to be had and gotten from having both a brand or specialty brand and generic component under one roof. Unlike in my past where when the asset gets big enough, you need to sell it. We're not in that position right now.

I think we can comfortably coexist and benefit from each other going forward. Our Specialty franchise, as you know, has been built around really formulation capabilities. We're going to try to apply a lot of those formulation capabilities and will apply those formulation capabilities to both sides of the business and then drive synergies from there.

So I think we're well positioned to do that. It's only been five weeks, but I think we've got a pretty good plan to drive that forward..

And the $85 million of savings related to this new initiative is based off of the – compared to the original 2017 guidance that we gave on March 1..

Thanks..

Thanks, Gregg..

Your next question comes from the line of David Amsellem with Piper Jaffray..

Thanks. So, just a question on the brands business, Paul. I mean, you alluded to life cycle management strategies for Rytary. And it sounds like you're committed to the business, but I wonder if you could elaborate on your thinking on a long-term focus in CNS or other brands.

And I guess, as a corollary to that, you talked about creative business development. Does that also contemplate potential asset acquisitions in the brand space? So, I guess, how is your long-term thinking on the brand business coming into play in the overall strategy? Thanks..

Yeah. Thanks, David. I think, again, after five weeks, I think we will be further developing our thinking across all of these strategies. But with respect to the Specialty franchise today, I think we're focused on movement disorders and maybe ancillary CNS activities.

I think what we really have to do today, and we have capacity within our sales force, we need to leverage that capacity. And so we're looking for opportunities that let us do that.

To the extent we can't develop internally-generated opportunities or we don't have internally developed opportunities, we are going to look for development opportunities outside. And we will invest in those.

I do think that, as I said, it's important to leverage the assets that we have and we have a very solid asset with our sales force and our sales team and I think we need to just provide them more things to work on. With respect to asset acquisition, so the answer to that is clearly yes. We would look for asset acquisition in the Specialty side.

We will, of course, look for asset acquisitions on the Generic side. Given our size, we're going to have to be creative, and that's where the creative comes from. We have certain limitations, but we also have some strengths. Today, we have some limitations with respect to our leverage and what we're facing on the balance sheet.

But by doing some creative activities there, perhaps we can give ourselves a little bit more headroom, and we will look to – again, as I said, look for creative ways to do asset acquisitions for both pieces of the business..

Okay. That's helpful. Thank you..

And your next question comes from the line of Randall Stanicky with RBC Capital Markets..

Great. Thanks. Paul, a bit of a déjà vu factor here..

Thanks, Randall..

When you went to Watson, one of the things that you did pretty quickly was you did a number of private company deals, deals that a lot of folks haven't heard of, weren't on people's radar.

So, my question for you now is, as you're looking at the landscape, possible acquisition targets, how does the private company landscape look to you? And then to Bryan, how much realistically – how much capacity do you have to do deals with the current covenants and the capital structure?.

Well, Randall, it is similar to our days back at Watson back in 2007. And I think the private spaces are very rich area for potential opportunities. One of the assets we have is we're a public company, and we have assets to the capital markets. And those assets are intriguing to some private companies.

So to the extent that we can find appropriate private parties and private companies that want to participate with us in developing and building a bigger organization, we're absolutely going to be looking for that..

And as far as room to do things, obviously, if it's some sort of transaction that's straight levered, it depends on the target EBITDA, right, because you get credit for that. Certainly, these cost savings would free up capacity as well. We talked about my flash down leverage, I don't like to tick up much above four and stay there very long.

So it has a clear pathway to delever. And then beyond that, there has to be more creative ways to structure though. But just a straight debt deal, we do have some capacity, but not to do a very, very large acquisition..

Okay, great. Thanks, guys..

Thanks, Randall..

Your next question comes from the line of Gary Nachman with BMO Capital Markets..

Hey, Paul, good to have you back..

Thanks, Gary..

What types of conversations have you had with the Impax customers since you joined? So what did you hear in terms of what Impax does well and maybe it doesn't do well? And how much do you think your relationships with customers might help in this situation?.

Well, I've had a number of conversations with customers and in fact, some as recently as yesterday.

And I think to the extent that we can have access to the highest levels of those organizations, just because of the past, I certainly know those folks and Doug knows a lot of them as well, so it's not like we didn't have access before, but perhaps we are having a different set of dialogues now than we did before. So I think that's been useful.

I don't know how much that can generate but – how much value that can generate, but I think most importantly, the things that we have here is strong customer service, strong client and customer understanding about how we have to deliver products. What we have to do to be – in many cases be creative.

And I do think certainly the auto-injector example is a – it was really an example of being creative. And whether that idea comes from our customers or comes from us, we're prepared to listen and participate in creative ways to create a win-win. And that, without question, created a win-win for us.

And I think that's going to be our path forward, at least, certainly in the short term as we look to bring the products that we have in the pipeline to market, some of which we'll be facing competition before we get there. So we're going to have to be creative on that front, and I think we have the capacity to do that with Doug and the team.

And as I said, we'll continue to look for opportunities, either generated by our customers or by us. Hope that covers your question, Gary..

And your next question comes from the line of Andrew Finkelstein with Susquehanna Financial..

Hi. Good morning. Good to hear from you as well Paul..

Thank you, Andrew.

I was hoping you could talk a little bit more about consolidation. We're seeing some activity from a number of companies in this sector. I mean, can you give any thoughts on whether the moves you're seeing among some of your peers is echoing in the right direction.

Is it about scale in Generics, and that's longer term what needs to be achieved? Or is there a room for a different approach in terms of how to create value longer term? And then just on the risk reward that you see in terms of taking on this opportunity.

You, obviously, have more information than we do, but for some of the things like Opana or Albenza that are big cash flow drivers or just pricing pressure in general, how – what it is it that gives you greater confidence in the sustainability of sort of the base earnings that you're starting from versus what maybe you're seeing externally? Thanks..

Well, with respect to consolidation, clearly, I think everyone's heard – is hearing the rumors and yes, many of our peers are exploring the same things that I've just discussed about consolidation in the industry and longer term, the necessary or need for longer-term consolidation. Look, scale, U.S.

is about scale, scale is clearly important, and that's what's driving the consolidation. Four major customers buying 80%-plus of the generic products in the United States is a very challenging environment if you are a small company. That is just the fact.

And you need to have the depth and breadth of product line that gives you the ability to withstand the ebbs and flows of that kind of situation. I do think there's value to still be generated in Generics business. I also think that in some ways, we've seen this cycle happen before.

The days of daily auctions occurred at one point and then people realized that that wasn't a really good idea.

In today's environment, with almost perfect information about pricing in the market with Generics, I think people need to be mindful of the fact that everyone knows that everybody else is going to price the product at and it's about kind of understanding how best to position yourself and your company for profit and growth.

We provide a great service to the American public by providing low-cost, high-quality products and reducing overall health care costs, but we also need to generate enough profit to be able to continue to do that. And I think we've got to get the balance right.

Our customers have to get the balance right and if everybody does that, there's an opportunity for everybody to generate a win-win. With respect to the risk reward of our product lines, look, nobody can guarantee the long-term value of any particular product. I think it's about the number of shots on goal that we have within our generic pipeline.

I think we have some very interesting product opportunities in there. Vytorin, the very launch of Vytorin, the approval and launch has certainly increased my confidence in the company's ability to get products approved, get them out the door on day one and meet our customers' needs.

If we continue to operate that way, we can be successful in this environment. It will certainly be challenging, but we can be one of the players, and we expect to be one of the players..

Thank you..

Next question, please..

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

Hello, Paul..

Hi, Marc.

How are you doing?.

Still working on plumbing (34:17)?.

I can't tell you, Marc..

So, two questions, really.

One is, if Taiwan is going to go away, then we're going to be manufacturing products in the United States and I was curious your thoughts about just the cost structure and the viability of doing that over the long haul and if you have a different strategy? And second, maybe you can just help us a little bit on one of the questions you've already started to talk about a little bit, which is the consolidation in the customer channel and maybe can just give us your big picture view of quantitatively, how much has this really per pricing? I mean, is this adding an extra 5% of discounts, 10%? How much? And where are we in this Claris-1 bid cycle this year? Thanks..

Okay. Well, with respect to Taiwan, yes, that was a very difficult decision to have to exit that facility, but frankly, given the structure that we're facing here and the fact that Hayward is a controlled substance manufacturing location, we wanted and felt that it was appropriate to bring everything back into Hayward.

We will bring as many products as we can into that facility, of course, that will improve our overall cost structure.

And I think if we can increase our capacity utilization there, we can get ourselves into a position where we can be competitive, maybe not as competitive as some other manufacturers and suppliers who are in the lower cost locations, but we can be competitive enough in the products that we're manufacturing to not be at a huge disadvantage.

I can't predict what the longer-term U.S. manufacturing facility may provide for us. Hopefully, as we go forward and do hopefully, some transactions down the road, we'll probably collect other manufacturing sites, most likely some in the United States and some outside the U.S.

So I don't anticipate that this will be our final manufacturing footprint, but at least for the time being it is the way we have to go.

And with respect to sort of big picture and pricing discounts, and then I'll turn it over to Doug to talk about the Claris One (36:40) bid, I mentioned earlier that the bidding wars that were created a few years back, I think everybody kind of learned pretty quickly, that that didn't help either side very much.

The customers didn't do particularly well with it and the suppliers certainly got damaged by it. I think we're in another period of learning as people adapt to this new environment with, as I said, the four big purchasers. And we will find ways to get through it. Again, creativity is going to be paramount in making this happen.

You need to have good relationships with those four customers and I know we do. But we also want to make sure they understand that we're in it for the long haul, we're partners with them and we need to find structures that work for both of us, because that's how the long-term works.

We both have to be winners, and I think a lot of those customers are coming around to it. The people I've spoken to have said that that's what they want.

The people on that side of the equation, and I take them at their word, and so we're going to continue to work very hard at finding these creative ways to get more products in, and hopefully do well for both of us. Doug, I'll turn it over to you for the Claris One (38:02)..

Yes, thanks, Marc, for the question. Thanks, Paul. Yes, I mean, we are still deep in discussions. Their bid cycle is sort of wrapping up. We've heard on many products, and we're still negotiating terms and conditions on others. And as I said in the last call, I mean, all these bids are opportunities as well. It's not just the pricing grab.

We have several high value items that are not in our core distribution with McKesson and Claris One (38:23) that we see as opportunities. So, I always try to find an opportunity to counterbalance the new terms and our challenges with an opportunity for expansion on our core high value items, which is where we are right now with Claris One (38:37)..

Can you give us any flavor for how these consortiums have put pressure on pricing just quantitatively.

I mean, even like just the impact that they put on you last year?.

I mean, the reality is Generic drug business, there's always impact on pricing and it's a combination of both supplier consolidation and new approvals.

So looking at the breadth of our portfolio, we certainly are excited with the go-forward opportunities on several new products that will help counterbalance the pricing pressure and the customer consolidation pressure on our existing portfolio.

I think, we've done quite well the last six to nine months managing through those challenges as we anticipate, again, new products coming later this year and into 2018..

And your next question comes from the line of Tim Chiang with BTIG..

Hi, thanks. Paul, congrats on getting back into the saddle..

Thanks, Tim..

My question, really, is just tied to how do you view the existing Impax pipeline on the Generics side and what you think you can do to sort of enhance the visibility of that pipeline or i.e.

get more of these more significant products through the FDA? Certainly, there's some significant products, but they seem to have been sitting there for years and I know you've probably had more experience in the generic industry than probably anyone I know.

What can you do to get some of these big product opportunities through the FDA?.

Tim, you're making me feel old, okay? So, here's how I view the pipeline. As I said, I think the pipeline has got some very interesting opportunities. We have solid – I would describe them as solid growth opportunities.

I don't think they're going to be Grand Slams, but they're good solid growth opportunities, a few of which have the potential to be more important than others.

I do think it's going to be more about the long-term growth of our pipeline, so as I look at not just this year, this coming year, where we've got in the next 12 to 18 months, or hopefully even sooner, but it all depends on the FDA, things like Renvela, Welchol and Concerta coming.

We look out now, the team is looking out now into 2017, 2018 and 2019 and looking for opportunities in alternative dosage forms, things like – which wouldn't surprise anybody that we're talking about things like nasal sprays, we're talking about patches, gels, creams, other kinds of injectables. A lot of people are doing that.

It's not – and as you point out, not everyone is being successful doing that. And I think that's always been the challenge in the generic industry. Everybody knows what they need to do. It just is about doing it.

And I think this company's got the people in place and to the extent we need to bring more firepower, and we will, to be able to achieve those – to be able to actually deliver on those products and I think that's the key to the success, right, is delivering on the products.

And we're going to continue to work with the agency like we always have to try to move things forward. It's good to see that GDUFAs are – those things are getting done and passed and now, we're getting dates in place, and that's a huge upgrade from where we were five years ago.

So, I'm optimistic, and I think Impax is in a good place to be successful with that..

Paul, just one quick follow-up. Do you have any near-term priorities that you've set just between now and year end? I mean, it seems like you want to try to increase capacity at the Hayward facility, which has been underutilized. It's got an FDA compliance green light.

How long do you think it will take to get that capacity to where you want it to be?.

Well, that's a great question. The team is under Jeff Nornhold, who's working very hard to do that, to get that capacity up. We're looking to bring products in from our – some of our outside suppliers. If we can't achieve the right pricing balance with an outside supplier, we'll try to bring it in-house and do it that way.

I think we're going to try to achieve good utilization rates by the end of, I would say, 2019 probably, 2018, 2019. It does take a little while to move things in, as you know, but we could surprise ourselves.

We could get some upside, and we could get some interesting product approvals, we could get a little lucky sometimes, and that's always a positive. The good news is we have plenty of capacity to absorb there in Hayward, and we're going to work hard to do that. So, hopefully, that answers your question..

Yes. Thanks, Paul..

Your next question comes from the line of Tyler Van Buren with Cowen and Company..

(43:50) questions and great to see you as part of the team, Paul..

Thanks, Tyler..

I guess, with respect – there's been a lot of great questions, obviously, already asked and maybe piggybacking on Marc's question with respect to the pricing environment and just to be more specific. If I recall correctly last quarter, management noted that they expect price deflation this year of about the high single to low double digits.

So just wanted to hear, see if you could reiterate that or if maybe given what's happened in Q1 and the ongoing discussions that it might be more in the low double digits? And then also, somewhat related to that and the ongoing business, as we look at revenues next year in 2018, given the other opportunities, do you believe that revenues could be up without assuming approval or launch from potential generic Concerta, Renvela or Welchol.

Just wanted to get your thoughts there?.

Yes, I think the pricing environment, I think you articulated it right. I think, we're still, for the year, in the idea of high single digit, low double digit. We're going to do everything we can to maintain that or at least even do better than that.

A little bit of this, remember, pricing, as Doug indicated, is a binary event, right? It happens when somebody does something or somebody launches, there's a bid cycle or whatever and to the extent that those bid cycles are coming to an end, we should see some stability in pricing for at least some period of time. So hopefully, that happens.

With respect to revenue generation in 2018, I think we are in fact driven a lot on the revenue front by our Generics business. And I think you may have noticed and people may have noticed that we didn't give revenue guidance.

For those of you who've known me for a long time, I don't traditionally like giving guidance on the Generics side on revenue because I don't think revenue's a good surrogate for profitability. What really matters in our business is the bottom line on the Generics side.

But I certainly agree that revenue was a good surrogate for profitability on the Specialty side, and we will, in fact, probably start thinking about what we want to do for providing longer-term guidance on revenue guidance for our brand products, but that comes later.

So the question on your revenue for 2018, it wouldn't be reasonable to assume we could maintain our Generic revenue line without new launches. So I have to assume that we will – and we do assume that we will have launches in 2018, and we haven't given any guidance for 2018 yet, and we're not doing that now.

But we would anticipate new product approvals clearly coming, some this year, some next year that'd add value in 2018..

Great. Thank you..

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

Thanks.

Just a quick follow-up on the incremental cost-saving initiatives that you announced today, so I'm assuming that simplistically, I can't just look out at our 2019, 2020 numbers and just subtract out $85 million from the total cost basis, I mean, there's going to be reinvestment there, but just want to get maybe a little bit of perspective on sort of how much of that you expect to kind of flow through the bottom line versus potentially be reinvested in particularly in R&D? And then within that, the $85 million, you sort of suggest that depending on the varying outcomes around the Taiwanese facility, that number could shift around a little bit.

I'm just curious, it doesn't seem like that could be all that impactful to that number. I mean, either the facility is sold or it's closed, I mean, but essentially you're eliminating the old fixed costs associated with it.

But just wanted to see how important in fact those different outcomes may be to that number?.

Right. Let me just touch on that second question first, and then I'll turn it over to Bryan, and he can provide a little bit more color. I think the way I think about the Taiwan facility, particularly is, we've talked up to using up to $65 million in cash to be able to achieve this consolidation.

Depending on the disposition of the facility and our clear preference is having somebody come in and maintain and continue to manufacture products in that facility, even potentially provide us products for a while, we would reduce that need for cash – that cash contribution pretty dramatically if we were able to achieve that.

And so, that's kind of one of our top objectives, Elliot, and making sure that we achieve the most efficient consolidation possible. And before I turn it over to you, I will address just quickly how we're going to sort of use this improved cash flow.

I think some of that is in COGS, so that should generate cash, of course, and it gets developed that way. But as I think about deploying capital over the next months and years, we're clearly looking to invest in the business.

I think the business needs to be invested in, and we will invest on both sides of the Street and the business as we talked about. We're also going to be mindful of our debt covenants and the like, and we will, of course, maintain our debt position and pay down debt as we need to.

And then finally, some of it will flow to the bottom line, because just as a matter of timing, we're not going to be able to probably achieve everything we want to achieve as quickly as we like.

So we haven't set out specific percentages to each, but again, I think the clear preference for me is to drive growth in the company, but being mindful of the debt covenants.

Did you want to talk a little bit more about the cash?.

Cash cost?.

Yes..

Yes. So, when we disclosed the estimated cash cost of this, that's I would call the conservative and depending on the outcome of Taiwan, those costs could vary quite a bit, come down quite a bit.

And then as far as savings, when we look at the components of the savings, we feel really good about realizing the savings, and I think the movement is going to be around timing of realizing the savings especially around Taiwan like Paul said..

Thanks, Elliot. Next question, please..

And our final question comes from Ken Trbovich with Janney..

I got a question.

Just curious, do you see any opportunity in the near-term front with regard to authorized generics or perhaps companies that have received an approval on perhaps the specialty side, but lack sales and distribution experience, so where you might be able to leverage some of the core expertise of the firm?.

I'm sorry. I missed the first part of that question. I heard the back....

Yes, I'm just curious about whether or not you see any near-term opportunities with regard to authorized generics.

So are there any situations where you see a possibility with no AGs in place where you might be able to approach a branded company and certainly, obviously, the economics would be particularly favorable, but the cost structure to you folks would be somewhat minimal. I'm just wondering if there's any opportunities you feel like that on the horizon..

Yes, I would say that to the extent that those exist, we will certainly pursue them, although they are very rare.

On the specialty side though, I think as you pointed out in your question, that's more likely using our – leveraging our current infrastructure and sales force to achieve greater utilization is an opportunity, and we are currently pursuing opportunities in that area. And we hope to be able to land a couple of those relatively soon.

These could be late-stage specialty products. Obviously, focused on movement disorders we're seeing in CNS-related areas. And as I've said, hopefully, we can get some of those done in the short-term and provide more product opportunities to our representatives to be able to call in and provide more value to their calling physicians.

So we're very active looking on both sides, but probably in the short-term, it would be specialty rather than the authorized generic..

Okay. Thank you..

Thank you, Ken. And that concludes our call. I'm available today and also this week to fill any of your questions or e-mails. Thank you, again, and that concludes our call..

Ladies and gentlemen, that concludes the Impax Laboratories first quarter 2017 earnings conference call. You may now disconnect..