Mark Donohue – IR Frederick Wilkinson – President and CEO Bryan Reasons – CFO Michael Nestor – President, Impax Pharmaceuticals.

David Amsellem – PiperJaffray Elliot Wilbur – Needham & Company Marc Goodman – UBS Randall Stanicky – RBC Capital Markets Louise Chen – Guggenheim Shibani Malhotra – Sterne Agee Gary Nachman – Goldman Sachs Jason Gerberry – Leerink Partners Michael Faerm – Wells Fargo Sumant Kulkarni – Bank of America/Merrill Lynch Gregory Gilbert – Deutsche Bank Brian Jeep – WallachBeth Capital.

Good morning. My name is Felicia, and I will be your conference operator today. At this time, I’ll like to welcome everyone to the Impax Laboratories Third Quarter 2014 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.

(Operator Instructions) Thank you. I would now like to hand the conference over to Mr.Mark Donohue. Please go ahead, Sir..

Thank you. Good morning, everyone. Thanks for joining us. Welcome to our third quarter 2014 financial results conference call. We issued our earnings release this morning, a copy of the press release, and a link to the webcast of this call are available on the company’s website at www.impaxlabs.com.

Today, our President and Chief Executive Officer, Fred Wilkinson, will provide an overview of the third quarter and some of the recent events, and Bryan Reasons, our Chief Financial Officer, will provide additional details on the financial results. Also joining us for the question-and-answer session is Mike Nestor, President of the Brand Division.

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 provide meaningful supplementary information too and facilitates analysis by investors in evaluating the company’s financial performance, results of operations and trends.

A reconciliation of GAAP to non-GAAP measures is available in our third quarter 2014 earnings release, which can be found on the company’s website. And with that, I will turn the call over to Fred..

Good morning, everybody and I will also thank you for joining us this morning. Over the past several weeks we’ve issued a series of company’s announcements so this morning I’ll keep my prepared remarks fairly brief.

During this time we’ve been busy executing on a number of initiatives and also very proud that while there was some distraction with that, we continue to deliver strong financial results. Our second quarter net revenues increased 19% to $158 million.

And our generic division delivered another excellent quarter with revenue increasing 26% or $30 million over last year’s quarter. On the brand side, we continue to experience both, volume and sales growth for Zomig nasal spray.

As a result of targeted promotion by our sales force, revenue grew for the first nine months of 2014 by over 70% and prescription increased by almost 25% over the first nine months of 2013. This strong performance from both divisions resulted in non-GAAP earnings increasing 32% to $0.33 per diluted share for the period.

For the first nine months of 2014 were also well ahead of last year. Total revenues were up 13% to $465 million, and earnings were up 39% to $1.17 per diluted share. Our financial resources expanded by $29 million since year end 2013 as a result of this positive performance.

And with $443 million in cash and cash equivalents, we’re well positioned to fund our recent proposed acquisition while also continuing to invest both internally and externally to drive future growth.

When I joined Impax in April, now about six months ago, I set a plan to focus my attention on four areas; first, strong focus on quality; second, maximization of our brand in generic portfolio; third, optimization of R&D; and finally, acceleration of our business development program. I’ll provide some updates on all four of those areas now.

As we’ve discussed on previous calls, corporate quality initiatives remain the top priority for myself, as well as all employees at the company with the ultimate goal of vacating the warning letter at Hayward facility and removing the compliant hold on product approvals.

In August we submitted the responses to the FDA for both, the Hayward and Taiwan Form 483 as the result from our recent inspections. Although we’ve not received any official notification of any change in our status, the ongoing dialogue with FDA has been constructive.

I continue to spend significant time with our internal quality team and consultants to ensure that we focus on addressing open items, identifying any further gaps, and allocating the appropriate resources to complete quality items [ph].

We’ve also committed to the agency that we will continue to send them monthly updates on our remediation programs as well as our quality improvement initiatives; the majority of the effort is on the second area.

Last week we announced the optimization of our internal pipeline of brand and generic product, and identified opportunities for improvement for operating both business units. As a result we took steps to strengthen our R&D infrastructure by reorganizing our R&D operating model.

The overall goal of this reorganization ought; first, leverage our internal strength in brand and generic development while improving efficiency; second, to combine the functions that are similar within our generic and brand R&D operations; and third, to continue to prioritize our corporate quality initiatives within our scientific operations.

To carry these objectives we consolidate the product development and analytical functions of our generic and our brand R&D organization under one group. Our brand team will now focus on three existing late stage opportunities while the generic team will continue to concentrate on refined portfolio of high value generic products.

The near term benefit will be to align the entire scientific team towards the continued successful implementation of the quality improving initiatives and to ensure that these are the foundation for successful developments in the future.

By leveraging our resources we have improved R&D efficiency and effectiveness, and we expect to realize approximately $8 million in annual cost savings beginning in 2015 as a result of the workforce reductions and portfolio optimization.

We also use this opportunity to adjust our commercial structure to continue the effective promotion of Zomig nasal spray and to better prepare ourselves for the potential launch of RYTARY. We also combine the strategic planning, M&A, business development, and portfolio management functions into one central area supporting both brands and generics.

[Technical Difficulty] As renounced in September the FDA extended RYTARY PDUFA Date by 90 days to January 9, 2015, following our amendment to the CMG Section of the NDA.

Our focus will continue to be on supporting the FDA review of this NDA and to prepare for the commercial programs and the operational plans in order to bring this new treatment option to patients who are suffering from Parkinson’s disease.

In addition, we expect to file the marketing authorization application or the MAA for RYTARY with the European Medical Agency, the EMA later this week.

On the business development front, we announced in early October our proposed acquisition of Tower Holdings and Lineage Therapeutics, including the operating subsidiaries CorePharma and Amedra Pharmaceuticals. I’m closing this immediately accretive acquisition will offer both near and long term strategic and financial benefits.

We’re excited about this transaction as it will provide a growing revenue and earnings stream, as well as a portfolio of growing high margin complex generic and brand products.

In addition, Core will enhance our generic pipeline with near term opportunities including five approved generics that are not yet launched, 11 applications pending approval, and more than 35 products in various stages of development.

We will be adding a leading franchise in a new specialty brand therapeutic area which will allow us to more efficiently utilize our brand commercial infrastructure and provide upside growth potential.

We will also diversify and expand our manufacturing and supply chain capabilities while strengthening our global quality improvement program with the addition of an experienced team.

Since the announcement of this acquisition, and during the quiet period while we operate our companies independently, we’ve been aggressive with planning for the integration in order to execute on these programs immediately and close. We have also been focusing on the financing activity as well as the required fillings with the government agencies.

Before I turn it back over to Bryan to handle the financial information, I would like to thank all the employees for the hard work and the dedication as we continue to execute on many of these growth strategies. So thank you, and Bryan, let me turn over to you..

Thanks, Fred. Let me begin by providing a few highlights on the quarterly results compared to last year’s third quarter, as well as provide some update to our full year guidance. Total company revenues increased by $25 million to $158 million.

Our third quarter results reflect a positive impact of several new product launches including authorized generic RENVELA launched in mid-April, our recently acquired generic product Ursodiol which we launched in July, and generic Solaraze launched last November. These products contributed $36 million of sales in the third quarter.

We also benefited from higher sales of Digoxin and Oxymorphone. Partially offsetting these increase in revenues were lower sales of authorized generic TRILIPIX as a result of increased complication, as well as lower selling prices and several other generic products.

As previously disclosed, we’ve been selling a specified allotment of authorized generic RENVELA in April. During the recent third quarter we shift and recognized revenue on the remaining allotment of product.

While our agreement to sell an authorized generic has expired we continue to pursue approval of our own generic and are not aware of any new approvals at this time. As Fred noted, we remain pleased with our commercial performance of Zomig nasal spray as volume and sales continue to increase.

Zomig nasal spray sales were up 54% in the third quarter and 73% year-to-date. Our share of the triptan nasal prescriptions has increased to 30% as of September, up from 23% since August 2012, when we began our promotional efforts. Total company adjusted gross profit margins increased 2% to 57%.

This is primarily due to favorable product contribution from higher margin generic products. The adjusted gross margin of 57% excludes the following items; Hayward facility remediation cost of $3.5 million, and amortization cost of $2.5 million resulting from our business development agreements with TOLMAR, AstraZeneca and Perrigo.

Total expenses in the third quarter increased approximately $11 million; this includes $5.2 million incurred as a result of business development activities including expenses related to the proposed acquisition of Tower Holdings and Lineage Therapeutics.

Total operating expenses excluding this charge increased approximately $6 million due to increased R&D and SG&A expenses, partially offset by lower litigation expenses. Total adjusted R&D increased almost $3.7 million in the third quarter, primarily due to an increase in brand initiatives.

However, consistent with our recently announced reorganization activities, R&D spending is down $2.3 million in the third quarter on a sequential basis. Total adjusted SG&A increased approximately $5.7 million.

This was due to the following 2014 fees and expenses; higher information technology expenses, higher corporate litigation expenses, higher generic and brand FDA fees, and inclusion of transitional expenses related to the appointment of our current President and CEO.

Partially offsetting the R&D and SG&A increases were the $3.4 million decline in patent litigation expense. Moving now to our updated 2014 guidance, we made several changes to reflect our current expectations for the remainder of the year.

Our R&D expense guidance decreased to approximately $76 million to $78 million from our previous guidance of $82 million to $88 million, primarily due to the reallocation of resources for facility remediation and quality improvement initiatives.

In addition, we expect to realize savings of about $1.5 million in the fourth quarter as a result of last week’s reorganization of the generic and brand R&D teams. We also reduced patent litigation expense guidance to approximately $7 million to $8 million, a decline of about $4 million.

Offsetting the low R&D and patent litigation expense is an increase in selling, general, administration expense. This is due to higher executive and other compensation cost, higher corporate legal fees, and increased spending on information technology activities.

Our revised 2014 SG&A guidance is approximately $127 million to $129 million from our previous guidance of $115 million to $120 million. Although we’ve made selected adjustments to our 2014 annual guidance for individual expense items, overall operating expense remains flat from our last update in August.

We also made adjustment to our 2014 capital expenditures, Hayward facility remediation, and cash rate guidance. Please refer to our earnings release for the updated estimates.

We ended the third quarter with almost $443 million in cash and short term investments; this represents an increase of approximately $30 million from the second quarter of 2014, driven by higher sales.

We remain well positioned with both cash and balance sheet flexibility to invest in our facilities, continue to fund R&D, and pursue [Technical Difficulty] strategic business development and M&A opportunities. Thanks for your attention. I’ll now turn the call back to Felicia for questions..

(Operator Instructions) And your first question comes from the line of David Amsellem with PiperJaffray..

Thanks, just a few questions.

First, can you talk about Taiwan and maybe give us some details on where things stand there and maybe how we should think about spend related to quality there? And then secondly on expense cuts, what is the extent to which you can intentionally [ph] cut further? And then as part of that on the brand business, given the extent of the sales infrastructure, are you profitable or can you be profitable now with the addition of new brand assets like Albenza or do you still need to add additional brand assets to make the brand business profitable? Thanks..

So let me update on Taiwan first. Obviously, Taiwan has been no change at all in the ability to supply product and continued processes going on there.

The 43s have been responded to, we’re waiting for final communication from the agency on our response and we’re implementing our quality systems, both in Hayward and Taiwan because the initiatives are really global initiatives, the activities that are going here are the same activities that are going there, but no change really in the status of Taiwan.

On the brand side, I think we have not given guidance as to what we will look like in 2015, we will do that sometime in early 2015, we’ve also not given guidance on what the combined business will look like down to the segments.

So wiser to say though I think we’re clearly managing the operation to make sure that we effectively promote Zomig, effectively prepare ourselves for the addition of the Albenza line into the commercial structure, and most importantly, they prepare for the potential successful launch of RYTARY..

Furthermore, if I may follow-up.

Is the brand business profitable now?.

I don’t think so..

So if you are fully loaded with all the R&D costs, it’s not profitable but certainly the Zomig product line covers the commercial infrastructure..

Thank you..

And your next question comes from the line of Elliot Wilbur with Needham & Company..

Thanks, good morning, just a couple of questions. If I could first maybe ask a line of question around some of the key current base products, specifically Adderall XR, obviously the supply agreement now has ended.

Shire has suggested on their conference call they believe you have a significant level of inventory and I think you guys have said that you have some and sales will continue through 2014 but I was just wondering if you could maybe elaborate a little bit further on that and what we should be thinking about in 2015? And also on RENVELA, assuming that you’ve sold through all of your allotted quantities, I just wanted to make sure that, that product opportunity has been fully recognized in the third quarter.

And then maybe just some comments around – the digoxin market obviously have been very strong performer, just whether or not you could in fact confirm that Mylan is expected to enter that market or not? And then I’ve got an additional follow-up question as well..

Sure. So, you are correct on the Adderall XR, we have sufficient supply to carry us through all of 2015, it’s a basic assumption that market share stays essentially the same as it is right now.

So we have acquired sufficient quantity to carry us throughout all of 2015, there is some upside, we remind that [ph] but our plan is to absolutely manage to our market share and be able to supply continuous supply at the similar levels that we have today, and all that supply is in-house right now.

You are also correct that at RENVELA we did sell through our allocated lot, our allocated quantity, and I guess Bryan mentioned all of that product has been out, is now out in the marketplace, it was all recognized in second and third quarter, as well remaining product in our hands commercial in fourth quarter and beyond.

We are still anxiously awaiting the opportunity to get the approval of RENVELA generic sometime in the first quarter where we can take advantage of our exclusivity period that begins January 2nd. And then finally on digoxin, this has been a healthy market as you have recognized also.

We do anticipate Mylan coming into the marketplace, in fact they are there now, have not seen much impact from their introduction as of yet but are prepared for following through that process in our forecast..

Okay, thanks. Then I – Fred I wanted to ask a question on the pipeline as well.

If you have the numbers in front of you, could you just maybe give us sort of latest stats on the constitution of the A&A pipeline at FDA, and I don’t know if you have the numbers in front of you but if you could break them down between the code release and alternate dosage form, that would be helpful.

And then I just want to sort of explore the issue or as you maybe comment on sort of – some of the moves you’ve taken on the generic side of the business.

I know you mentioned last conference call that you were going to dig deep into the pipeline here, I’m just wondering kind of where you stand on that initiative if we see the actual project rationalization and some of the moves you made on the R&D side reflect that.

And I guess sort of what I’m pondering here is, it looks like in the last three years I mean there has been incredible amount of R&D spend, it doesn’t really look like the pipeline has progressed much and obviously the company has been focused on other things but it just seems like maybe there could be a lot more to do on the generic side and a lot of things that comes.

So I just want to get sort of your observations on that comment..

Great, so I do happen to have the numbers in front of me as you would expect [ph]. So we have 23 products that are sitting at FDA right now. Four of those are alternative dose/products, and they are through partnerships, so those are sitting at the agency right now.

We also happen to have 23 products that are in development, at the same time about 12 of those are alternative dosage with nine of those being with in partnerships.

I think underlying your question really is it seems numbers that have moved from 43 with FDA down to 35, with FDA down to 23, part of what we’ve done is we rationalized the portfolio over the last four months, we look at those products that have essentially lost value or which they work to have them put through the agency would distract us from the quality improvement activities that are of high priority for us.

We’ve withdrawn several ANDAs, we’ve stopped work on others, and are aiming ourselves at those that we still have value and valuing the timeframe that we think we can bring them to market.

It’s a typical scenario that you do for any ANDA development program as well as any commercial product portfolio where we’re continuing to prone the assets and make sure that we’re taking advantage of those that will provide the highest revenue opportunity and the highest gross margin..

Alright, and I’m sorry I have to ask but I think it’s safe to assume the company still believes that CONCERTA has economic value?.

We do, yes..

Alright. Thank you..

Next question comes from the line of Marc Goodman with UBS..

Good morning, Marc..

Hi, Fred.

So you’ve done this deal, obviously everyone’s excited, can you tell us what’s next, what are you focused on as far as M&A, and how quickly you think you can bring something else in? And then just on the new brand products that are being brought in, just so I understand there will be no change in the sales reps as far as what you have today, and then once RYTARY is approved, we’re obviously going to make some change.

Just give us a sense of how you’re thinking about now that you have little bigger footprint in brand?.

So on the M&A front I think we’re essentially ready to go now, I mean this will not leverage us to any great extent, I think our overall leverage is around 2, and net leverage is 1.5 times.

I think that’s a very optimal position to be and if you’re not out in the hunt for additional product, we would like the balance sheet and I think that will put us in a place where we’re utilizing the balance sheet more efficiently.

There are several assets that are out there and available, being looked at or being – perhaps I’ll never know other things that are in our target that turn the profile that we are in active discussions on. So I think you will not see us simply do a single transaction, integrate it, and then sit still.

I think you should expect us to continue activities and that could be on individual brand assets, brand organizations or generic organizations..

So on the brand side we shouldn’t be surprised if you acquire a small company with the product on the market or bring in a product or two that are already on the market, this is very much a focus..

I think we’ve said very, very consistently that what we’re not going to do is buy an R&D portfolio, we’re going to – if there is an opportunity, the focus would be on those that provide revenue and earnings potential [ph] and Core fits that category, Core happens to do a nice job for us and addressing both brand and generic.

Like the growth story that can come from the generic existing line as well as the ANDAs that are working its way through the process. We also think that the brand positioning through – this is your second question, these products will – we think we can grow them and add some value to them through the way we’ve commercialized products.

And as many people know that one of the hardest things about building a brand business is not the upfront sales reps, it’s the background infrastructure that’s required to make sure that you’re doing everything appropriately.

Core did not have that, Core was considering the development of partnering that process in order to support those brands, we happen to have that and we think this is a nice opportunity to get some good synergies out of it.

The plans for promotion behind the Core brands are clearly not out in the marketplace because they’ve not described those, we will get into greater detail of that as we get little cautious but it’s wiser to say that what they were looking to do is sometime in the first half of 2015 to find a way to support the brands with active personal promotion, we will do the same, it’s not a large number of people, and decide whether that’s an addition of staff or whether within our current footprint, and a lot of that really depends on the timing of the RYTARY launch..

So how many reps do you have right now?.

We have 64 representatives, we are working through the analysis to see how many representatives we want for our RYTARY launch and that will be part of our guidance as we get into 2015.

We believe we could handle the current product we have in our hand, as well as the addition of products coming essentially with that footprint but evaluating what we would do on an extension opportunity planning on success for the RYTARY approval..

Thanks..

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

Great, thanks guys. The question is quick one for Bryan, and two for Fred. Bryan, on the SG&A step up, it looks like lot of that’s corporate G&A stepped up significantly, sequentially.

Is that the right run rate we should be thinking about going forward for that line item? And then two quick ones for Fred, any update on the European partnering outlook, how we should think about the opportunity given that you’re about to file your M&A.

And then one quick one on the Taiwan Lineage jump, getting several questions still on EBITDA outlook for next year just given your accretion forecast, should we be thinking about step up in EBITDA significantly above that $80 million to $85 million given some of the launch opportunities that you called out on your previous call. Thanks..

Thanks, Randall, I’ll handle the SG&A first. We’re still working through the 2015 operating plan and we’ll give guidance in early January.

There is in SG&A right now and the guidance we do for quite a bit of information technology project is going on a lot specifically around the QIP program, and generally about 35% of the IT cost, operating expense to capital, corporate litigation cost is heavy this quarter and kind of into the fourth quarter, and you can see we disclosed we had a settlement recently.

So those are the two main drivers and then we do have some CO transitional costs that will go into the fourth quarter, but we’ll get updated guidance in January..

So let me start the EU partnering process on RYTARY and then Mike will jump and then help out there. We took the opportunity as we were responding to the RYTARY specific observations from Taiwan to – we believe that we’re in a position where we can see a path forward on manufacturing for both the U.S. and for ex-U.S. as we’re preparing that plan.

So what we did is we’ve reinitiated the aggressive look for a partner outside of The United States actually kick in full gear, have a consulting that’s helping us with that and are starting to now take meetings and visits from folks who would like to help us.

And Michael maybe you want to add on that a little bit?.

Yes, I think what we’ve seen relative to the re-engagement, if you will, as the partnering process. The folks that have initially expressed interest in partnering with us outside of the U.S. for RYTARY remain interested.

So that process is very much ongoing, and I think at least thereof the way that we’re approaching RYTARY overall, especially given the 90-day extension relatively to the PDUFA Date as we are looking at it from the perspective of planning for success, not only outside of the U.S. but also within the U.S.

Obviously we don’t know for sure yet but we have at least the confidence to re-engage the process ex-U.S..

And as we’ve said in this script here in the discussions, we’ve always had a plan to file outside of The United States during the fourth quarter was in the second half I think of 2014, we’ve always said there this will better [ph] happen this week, so we’re very excited and we think that, that in combination with now the partnering activities that we should be able to provide some insight as to who maybe our partner and how that name will carry off through the remainder of this year.

Regarding your EBITDA question, I think it’s the hardest thing for people because we are [ph] not a publicly traded corporation that we’re buying, the $80 million to $85 million of EBITDA is an estimate that we used during our diligence, in order to get there obviously there needs to be some sequential quarter-over-quarter growth from that organization which has been occurring.

I think on top of that we see a nice opportunity for revenue and earnings growth out of the launches that right now involved in which there are five, the 11 ANDAs that are working their way through the process which we hope many of those to be 2015 introductions.

And we also think that our commercial effort will help intensify some of the growth that’s been going on within the organization, not only on the generic side but on the brand side..

Got it, thanks guys..

And your next question comes from the line of Chris Schott with J. P. Morgan..

Hi, thanks. This is Dan Frenders [ph] on for Chris, just a follow-up on the Taiwan facility. I know RYTARY has been dealing now from Hayward, and I believe on your last earnings call you said that you expected – you would need a reinspection at Taiwan for a RYTARY approval.

I just wanted to confirm that, that is still the case, and if so, if you feel like at this point you’re ready for a reinspection or maybe that you’ve already addressed those issues as your response to the FDA and that’s good enough for an approval.

And then maybe just another question here on, can you talk about Carole’s position to step down and if you started a search process now for someone to run the generics business and what you’re working for, that’s an external candidate, maybe somebody internal, just – some of the qualities you’re looking for as you start that switch process. Thanks..

Let me start with the correction, we actually do not anticipate that there will be a requirement for reinspection in Taiwan. We’ve never described that so maybe there is just another misinterpretation.

We think that the response for the 483s are sufficient, the two that were specific to RYTARY, we’ve put a lot of attention on them, spend some time with the division itself that previews the NDA, and with a 90-day extension our entire focus is to make it sure we answer all the questions that may be required to get an approval on the PDUFA Date which is now January 9.

So we’re sure that’s correct, we really don’t anticipate that they will come back for reinspection in Taiwan and the next inspection, that’s probably two years from now when they do their typical two year ex-U.S. facility inspection. Regarding Carole’s departure, I mean it was announced Carole left for some family reasons, she will be missed here.

She has been great guidance for the generics group and that’s created a terrific team. I think that’s what gives me comfort that she has created a terrific team in both the commercial side and in the R&D group.

The commercial – the evidence of that is how successful we’ve been commercially over the last four to six quarters, so they’ve done an outstanding job of continuing growth, there is not a lot of product approvals as new opportunities.

On the R&D front, I think Carole’s departure does give me a chance to get a little bit closer to the overall R&D effort and make sure that we’re focusing in a way that will optimize our utilization of the staff there.

I mean there is a terrific group of people that I would like to have focused on finishing all the remediation that’s fully implementing the quality improvement programs and then getting back to the good solid R&D work that they’ve been doing over the last several years.

We have a penta [ph] group of ANDAs that are sitting with FDA now, and we have other products that are working their way through the approval process. So there is still plenty of work to do as we coupled out with much – with the remediation work and the quality of improvement work that’s going on.

As far as the search, I’ve not put a formal search out, I think this industry is small enough that we kind of know who is out there, who is available, and who might be interested and might see our profile.

We also are going through a transaction that will bring some well qualified staff that makes nicely into the organization and ongoing discussion along those lines. So I think at this particular point, we’re early in the look but are starting to think as they approach as to how do we refocus on that Carole leaves open as she departs..

Great, thanks for the color..

Your next question comes from the line of Tyler Weinbern [ph] with Cowen and Company..

Hi, thanks for taking my question. So I guess keeping the minor synergies gain from Taiwan Lineage acquisition, I guess I would just want to get a sense of the infrastructure that was gained in future deals if you’re looking to add products to that infrastructure where you can potentially capture additional synergies.

And also related for the January 9 PDUFA for RYTARY, has everything on your side been submitted or is there additional gating factors we should consider, and I’m assuming that the responses to the 43s and RYTARY in this situation will be considered separate from the resolution of the 483, just a clarity on that would be great. Thanks..

Let me do the synergy discussion and setup for the next potential acquisitions and I’ll have Michael handle the RYTARY question.

So as we announced during the call on the acquisition, this is really not a synergy, both companies are fairly lean in their organization, so there is not the typical process where you go in and you have got two of everything so you’re going to be looking at some reductions in the organizational structure in order to get some synergy.

It’s also now when with those multiple facilities that are underutilized, we’re excited about the addition of the footprint that they have in New Jersey with campus spread as of R&D, manufacturing, as well packaging and distribution but it’s small and our facilities are small and we think that by putting them together we’ll now have a manufacturing footprint and a supply chain footprint that allows us to focus different facilities on what they are good at doing as opposed to putting our products where we have capacity.

I think our Ops team is going to enjoy that process much more, our first process much more than the second process.

As far as setting, it’s up for future acquisitions, I think we’ll see where our two R&D groups will have an operational footprint that’s a little bit wider, whereas commercial structure that can handle both the brand and the generics, there is some unique capabilities that they have that we’re looking to bring into our organization and look forward to bringing the team over and essentially having them part of our group.

If there is a future transaction, depending on what that transaction is, that maybe one where we look a little more aggressively at synergies and some opportunities to save some cost savings. But this is not one of those, this is one where we believe most of the opportunities will be an upside revenue and upside earnings.

Michael, wanted to handle it that time [ph]..

Yes, so Tyler relative to RYTARY, all of the responses relative to the 483 observations for Taiwan, as well as those from Hayward previously are all at the FDA. In fact, part of the reason or the reason that we got the 90-day extension from October 9 to January 9 for the PDUFA Date was part of the response relative to the Taiwan 483.

So that’s all taken care of and relative to the separation of RYTARY from Hayward, that in fact has occurred, in fact that was the impetus for FDA telling us that we could refile the NDA for RYTARY back in April. So hopefully that answers your question..

Yes, thanks..

Sure..

Thank you.

Next question, please?.

Your next question comes from the line of Louise Chen with Guggenheim..

Hi, thanks for taking my question.

So some of your competitors have been able to raise prices for generic drug significantly, do you see any opportunities to impact [indiscernible] and do you have any thoughts on the government investigation into rising prices of generic drugs? And also if you can give us any thoughts on tax inversion, what do you think of it and if you think this is something that you would look to in the future?.

Sure, let me address pricing.

We really don’t talk much about pricing publicly, and whether we’re going for competitive reasons but surprising to say we’ve done what most of the other generic competitors have done, we look at opportunities, we look at how competition shifts, we look at where there may be some market movement that will allow us to take advantages on price increases and we’ve implemented those and we’ll continue to evaluate our line product-by-product probably a week and monthly basis to see if there are some opportunities to participate in that practice.

As far as the Federal investigation, look, I think there has always been an analysis ongoing for looking at pricing within the pharmaceutical industry, sometimes they focuses on brand, sometimes they focuses on generic, sometimes on transfer prices, they were constantly under scrutiny and I think the most important thing is to make sure that all practices and our approaches are well within all the guidelines and the rules and regulations that we believe they are.

As far as inversions, one of those favorite topics of everybody, I think inversions are still alive, I think they have been limited in their value and if you’re trying to get trapped cash back into United States, that’s been closed off but it doesn’t appear and based on some of the deal flow that’s still going on, there still seems to some opportunity if appropriately managed to complete an inversion and evolve your overall tax position.

Our view on this has been we would never do a transaction for inversion process only, it would need to have strong strategic rationale and that the inversion came along with it and that’s just an extra cost. Thank you.

Next question, please?.

And your next question comes from the line of Shibani Malhotra with Sterne Agee..

Hi, thanks for taking the question..

Good morning, Shibani..

Good morning. So, can I confirm that you said you have enough Adderall to carry you through all of 2015, and I guess we’ve always calculated the run rates for 2014 to be run $105 million, are you saying that’s how much you have for next year as well.

And then the second question on Hayward, has there been any conversation between you and the FDA, and they responded to your – I mean anything to say that they are more comfortable with the remediation progress on that plant as well..

Shibani let me answer the second one first because I think that’s been a focus of our discussions quite a bit.

There has been substantial ongoing dialogue between us and the FDA, and I think formally they were going to announce today until we’ve got the appropriate documentation and appropriate position upright, but there has been substantial discussions, couldn’t characterize that everything’s been rectified, couldn’t characterize that there is still outstanding issues but there has been good constructive discussion between us and the division, the district, as well as the foreign inspection group.

So ongoing dialogue, we were kind of in the normal process that occurs after response to 483s and as soon as we know anything clearly we’ll give an answer formally.

On your first question, yes, I think this maybe the first time we formally announced that we had sufficient supply of Adderall to carry us through all of 2015, the assumption around that is that we’ll hold approximately the same share that we right now and that share position has been pretty solid, it’s been a pretty normalized marketplace over the last several [ph], there is room for some growth but we’ve got sufficient supply that will see in the Adderall business throughout all of 2015..

Okay.

If you don’t see growth in the market, would we just see the revenue fall into 2016 instead since you have fixed inventory?.

Yes, if we have no growth in the market, we’re allowed to sell our current inventory off. We’ve said before we – based on script data we’re hovering around 10% or 11% of the market..

Okay, great. Thank you..

Your next question comes from the line of Gary Nachman with Goldman Sachs..

Hi, good morning. Fred, could you comment, have there been any changes to the key leadership responsible for the remediation or the consoles that you’ve been using, or it is essentially that the same team in place that you’re comfortable with that they are going to be able to resolve everything.

And then for future M&As, you scaled the landscape, do you think there are more opportunities on the branded or generic side, do you have a preference at this point, how it’s unusual not to give you both? And then also comment on deal prices, Tower seemed pretty reasonable but how challenging is it for you to find good deals out there?.

Let me do the first actually, broadly [ph] asked the question. I think we do have the right team internally to pull us through this program on remediation and the implementation and full implementation on the quality improvement program.

Over the last three to four months, I think you’ve seen it in the finances, we’ve seen a shift from the use of outside consultants, two more use of our internal personal, that’s by design, I mean a lot of the activities we’ve been doing, they are partnering up our internal group with the outside consultants so that not only can we learn from what they do and what they see and what they identify and the suggestions they make, but also allows us to kind of takeover the function from them as we go forward.

And I think essentially that’s the foundation of your quality proven to that, you need to be your own auditor and you need to be your own investigator, and you need to be – the people in your own staff to be able to do this because you can’t maintain consultants in your facility for the last period [ph].

So we’re pleased with that process, we think this is good, this transition has been going very appropriately and very judiciously, we still argued the rise in consultants to assist on certain areas but we’re turning it more over to the internal team to assist us with that.

It’s part of the reason also of the restructuring and the optimization of our R&D portfolio just that we’re making sure that the R&D team is fully engaged in not only the work that’s being done but in some of the training and learnings that are going on that we’ve had the opportunity to gain by having the consultants within our organization.

On the M&A front, we think that the core transaction is really nice transaction for us, we think the price is a good price, an appropriate price for that asset.

We think it fits us perfectly which is why both parties agree that we’re the right party to give them the acquirer, we hope to optimize many of the programs that they have in place and for us each one of these products is meaningful, I mean none of them is meaningful to other but we like this one.

As far as our future transactions, I think you see pricing all across the board, there are some very expensive deals out there and many of them we’ve might have been involved and decided not to pursue. There are also still opportunities and I think it’s all about the assessment, the analysis and the eventual negotiation of the deal.

So I think there are still deals to that are very reasonably priced, there are probably some deals that could be done at a very high price too..

And are you seeing more opportunities on the branded side, on the generic side, can you give us a little flavor just so we could expect….

It’s the ninth mix, we see a few more brand asset sales than we do generic asset sales, and probably more generic companies than brand companies.

But having said that next we’ll probably do would be a brand company, but as always said, I’m not sure the planning for – you’re focusing only on X when your outlooking at both X & Y to get through that transaction first.

So we’re very interested in growing both pieces of business, we like to do a business strategy and we’ll continue to build them both through internal growth and external growth..

Okay.

And the Tower transaction also got you a facility which was nice, is that still a priority or do you think having that in place and then Taiwan and Hayward will be enough?.

I think increasing our footprint as far as the capacity and capabilities of manufacturing facilities would be a benefit still.

We will not be over – we would not expand our position [ph] where we’ve got a lot of excess capacity, most of these facilities will be operating at almost full capacity, the core facility does operate at almost full capacity right now, not a lot of excess room there.

They are appropriately sized for the products that have and I think we are too, so the next transaction would come with a lot of products, it’s going to have to come with facility, the manufacturing one..

Okay. Thank you..

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

Good morning, thanks for taking the questions. I guess just first question for Fred, just a follow-up on the tax inversion topic. Just curious, any commentary you can provide us on the supply of company’s out there that meet both the strategic criteria and size requirements, just sort of curious if you have any color you can provide there.

And then second, your comments regarding ability to get VAI status at this point in 2015. Just sort of curious, if you guys can provide any color in terms of your confidence level to get VAI status and unlock some of the value from some of those legacy impacts ANDAs.

And then third, IPX239, could you just comment on your plans for next year, I guess the next step of Phase 3, next year, or two Phase 3 to sort of curious how that – speaking [ph] about the R&D spend. Thanks..

On the inversion position, I think we have gone through kind of a phase where for most of the spring and summer anybody who is operating in Europe that was interested in selling an asset that was selling him as inversion, I think that has softened a bit because I think the total benefit is – so, but there are still plenty of assets available with the strategy and products that you want to take.

So we haven’t seen really any reduction or any demonization of the number of companies or potential opportunities out there. Inversions are just one plank cutting on in flank of M&A so I don’t want this call to be seen as we’re going to do and inversion is simply in all we are allowed to something we’re continuing to move [ph].

As far as – I don’t remember the second question but I’ll do 239. We have successfully completed our Phase 2, we’re happy with the results that we’ve got from the Phase 2, we are right now evaluating and in discussions with FDA as what it would take to take it to the next step.

We’re reminding in way that this is a product that has orphan drug status, so it could have orphan drug status so the objective here is to make sure that we’re optimally evaluating what the ultimate clinical program would be putting at the front of our set of activities and making sure before we buy then we know what the full plan is.

And then VAI status, actually for us the goal is not as much of status of the inspections but making sure we get the warning letter lifted. I think they go hand-in-hand a bit but our focus is really more on lifting the warning letter which then kind of gives you getting product approvals..

Okay, great. Thank you..

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

Question regarding Hayward, last quarter you had talked about the possibility of FDA returning for preapproval inspection as a way to sort of shorten the timeline versus more typical timeline to a next round of inspection.

What are your current thoughts on the possibility of that and how long that might take?.

Great question. So that’s been the primary focus of our activities here and the facility is not only implementing a continuous improvement program but stick by focusing ourselves on making sure that any inspection, whether it be a full inspection or PAI, would be our successful inspection.

So we have spent in a nominal amount of time making sure that we are ready for PAI and that we’re prepared that those – the goal of those PAIs would be successful.

The FDA will show up when the FDA shows up, we really don’t have any insight as to whether they are going to show up next week or whether those show up next quarter, but we’re right now preparing for an inspection and have been preparing for an inspection whether it be on PAI or whether it be a second J&T [ph]..

A question on Velcao [ph], just given where you stand in the overall process with FDA, is there any possibility that you get an approval on that in time to capitalize on your exclusivity there?.

Yes, so we are preparing for that, we’re making sure that we’re operationally ready and we’re making sure that from a regulatory standpoint we’ve got all the documentation and file prepared.

It would be our hope that they would come and inspect on that, and it will be our hope that we could seek approval and take advantage of the 90-day exclusivity position that we have..

One last question on pipeline, I believe the last comment on Addarell [ph] was that you were potentially starting Phase 3 before the end of the year, is that still the plan?.

No, what we said was that, after meeting with the FDA we’re in discussions with them about what the clinical path forward would be. And once we’re in a position relative to those discussions with the FDA to disclose what that is, we’ll let you know..

Great, thank you..

Sure..

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

Good morning, thanks for taking my questions. The first one is for Bryan, you mentioned $36 million in sales from RENVELA, Solaraze and other products that are this year and were not in the last year’s quarter.

Is it fair to assume that a lion’s share of that came from each generic RENVELA authorized generic?.

That is the larger of them that is the largest, yes..

And then on the Hayward’s remediation cost, I noticed that you’ve trimmed the upper end of the range, does that signal some sort of confidence on your – having all your issues behind you?.

I think Fred touched on that, it’s – as the consultants have been working in here we’ve had employee side-by-side with them, and we started to transition some of the work in the ongoing remediation as well, QIP work to employees which [indiscernible] is the best thing to do.

As we do that the consulting cost related to remediation we pull out of our non-GAAP earnings but the employee peace stayed an underlying cost of goods sold..

And then on the brand R&D and this might be more of a question for Fred, conceptually RYTARY has been filed for some time now, so in the $36 million to $37 million guidance range that you have, could you talk about some of the specifics on where that spend is going in what kind of programs?.

Obviously, what you saw as we trim the R&D portfolio for at least have stance where you actually shifted some of that personal that were in that group. So what I think you said in third and going in the fourth quarter is an anticipated reductions spend on the brand side.

And then as we go into 2015, I think the spend of levels will be determined on any follow-up work that will need to be done on RYATRY in a face forward commitment and it worked, it will be necessary to assist in the education of the EMA filing and then third is work that we will go forward with on 239 or anything else that we might brush up..

And the other thing Sumant, I think you need to keep in mind if at this year there is about $4 million in drug safety and pharmacovigilence, that’s built in today R&D numbers that previously what was separated our for the generic side of the business, and little bit obviously on our brand side.

So that’s all being absorbed now into kind of central location within the brand R&D group. And so what we’re not operating as if I can central service function not only for products, within the brand commercial but on the generics side as well..

And then could you talk about the logistics of specifically transferring some of your highly extended the lease products to perhaps the quote facility.

Is there a possibility in near to mid-term?.

Yes, I think when we announced Core we said that there would be probably very little near term transition of product from Core to us or from us to Core.

I think they are both – the way both companies are managing their operational assets, size their facilities and they’ve put the equipment and trained them in appropriate processes to manufacture the products that they have.

And so we don’t see a lot of value in those around, and so I think you won’t see this wholesale move that sometimes you see with some acquisitions of whole series of products from Core coming to Hayward and vice versa..

And my last one for Fred, you mentioned that there are a lot of assets out there, some expensive, some not so expensive, but how would you characterize the current level of competition that you face when you go after these assets?.

That’s pretty high, I mean there is a lot of people talking, so – it’s almost everything that we’ve been involved in, including the closed transaction or the transaction that we announced in October has been a fairly competitive environment. So you got to do your work well..

Thank you..

Your next question comes from the line of Orn Weavenut [ph] with JMP Securities..

Hi, thanks for taking the question, I have a couple.

So you’ve indicated you will be giving as usual guidance in early January and obviously, historically, you’ve got an OpEx and gross margin – I’m just wondering is there any chance we can hope for some sort of conservative lower topline visibility and so in the scenario that you don’t have any warning letters lifted from January when you’re giving guidance, given the trend that you’re aware of the Core pharma business and your own legacy business that maybe you could let us know.

This is sort of where we’re at if nothing happens on the other front took out to revenue. And separately, I just revisited the SG&A question from a way at the beginning of this call about – I guess the run rate that we’re at now or implied in your guidance for Q4 is dramatically above, where to begin the year Q1, I mean maybe 40% up.

And so I’m just trying to understand baked into that with our new Executive compensation etcetera, how much that is, maybe one tinnish [ph] in nature and that as we look to next year we’re not at the guidance point yet that there is a reason to think that it wouldn’t be up materially if some of the stuff will next year..

Sure. So obviously 2015 guidance has going to be wrapped around, not only what we’re doing, not after the [ph] has left. Product improvement capabilities, but also the integration of Core and so there is a lot of moving parts, we’re evaluating what we might be providing in guidance next year as we get there.

And second congestions from the market as to where it would be most appropriate. I think that’s the topic in January. So probably will be an appropriate for me to go there now.

Bryan, you want to do the SG&A?.

So I guess your question is one time.

I mean we spend a lot of time on what we should pull out and take it serious and try to look at what is not part of our underling business? So in SG&A this time it’s certainly some accelerated stock compensation from our prior CEO and some other higher than normal, if you look historically, litigation cost, but we do feel like that’s part of doing business so we choose not to pull it out..

Okay. So I guess just when we talk about the run rate going forward….

I think it’s kind of difficult for us to give you a run rate for 2015 as we sit here today because it will be also where are we with our remediation or how much of that now has been put into cost of goods or SG&A. And then third piece is, what we’re going to look like on the other side of Core.

But I think – I hate to push this but I think this is probably a better discussion if they have we’re prepared to give better appropriate guidance for 2015..

That’s fair, I appreciate it..

Okay, thank you..

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

Good morning, Greg..

Good morning, guys.

Fred, how would you describe the effects of the consolidating generic buyers on your business this year? It seems like most companies have talked more about or at least suggested more inflation than in prior year’s and no one seems to really be complaining about the increasing class of those customers and curiously, you can say about it relative to impacts.

And my second question is about Taiwan, other than the fact that facility [ph] part of the mix when you arrived, how would you describe its importance for the long term strategy and impacts? Thanks..

I would say Taiwan is critical to us for one key product if not the rest of the things they do but Taiwan will be the manufacturing site for RYTARY, and it will be the manufacturing site for RYTARY, both U.S.

and ex-U.S., so those are real core assets that’s going to come out of that facility, it’s important for us to continue in less than quality programs and making sure they are efficiently read.

There are several other products that they manufacture there and as our Ops team defines, products going to either Hayward or Taiwan, our viable manufacturing site in Taiwan has been a nice benefit for us, so it allows us to kind of operate some of the activities that are here.

I think with the addition on Core grown out, it replaces although I think most of the feed for each of our individual facility is going to come out of our own R&D program in [indiscernible] plant today. The first question on….

The salvation of large share price..

Yes, so we spend a lot of time focusing on that, that’s been last time with our commercial team to make sure that we’re staying ahead of/and engaged in the discussions that are happening with our key customers, consolidation continues as I think the whole industry sees.

We’ve not seen dramatic impact that people were concerned about for smaller or mid-sized generic houses maybe getting squeezed a bit by the relationship between large houses and some of the increasing size of our customers.

We paid lot of attention to it but I think it all goes to product mix if you’ve got ability to supply product that they need and you appropriately pricing it and you appropriately managing inventory so that constant supply, you provide a real value to those customers who want to keep doing that, we think they will keep buying products from us..

Thanks..

And your next question comes from the line of Brian Jeep with WallachBeth Capital..

Good morning.

Fred, if you could comment on your stocks about where we are in terms of I guess, what you can achieve with Zomig nasal spray, how is its full potential and how likely are you continue to draw sort of in a way out in the recent past? And then secondly, when are you willing to qualify your conference [ph] that the Taiwan 483 will not prevent entire approval in January, I’m just looking for 50%, 75%, 100% in confidence..

Let me start and I will turn it over to Michael. I’m not going to give you any confidence level on this, obviously predicting FDA is really a bad idea for any fee or anybody in the management of the company.

We’re working to try to meet the needs of the FDA, we’ve responded to the two observations related to RYTARY that were part of the inspection that occurred in July.

The dialogue has been constructive between us and the agency but until that January 9, the date comes and the righteous paper comes cross back saying we’re really not going to put a predictor out there.

We are preparing for success but we are making sure that we’re appropriately prepared to manufacture product, we’re preparing the commercial strategies for it and we’re preparing before in assisting the FDA in the final review of the NDA. So – but I’m not going to give a prediction on that.

Regarding Zomig, I’ll give you my view and then Michael can drive the next step on this one.

I’ve been extremely pleased with the results that this team has put up, I mean remember, they had a full Zomig line with the generization of the oral products, they were then took on the challenge on focusing entirely on the nasal spray, and they have grown this business beautifully, and I think it’s through a very targeted promotional effort from a set of highly skilled people, and so just under – as far as potential, Mike if you can tell us where the filling is or maybe we describe what we believe is going out there..

Brian, I mean Fred is right, I mean we’ve been very pleased with how Zomig nasal spray has responded to the promotion that we’ve put behind it. In fact the – I guess the sales results, the top line results that we’re seeing with that product are very consistent with the model that we had laid out when we in fact licensed Zomig from AstraZeneca.

So yes, there is still, there is still more to come, the growth won’t be necessarily at the same clip as it has been in the past but we’re not to the point where we have projected a maxed out sales volume at this point in time. So there is definitely more room to come in terms of growth..

And also if you comment on what’s your next volume might look like?.

I beg your pardon?.

Will you be willing to comment on what your thoughts are as far as maxed out sales volume might look like on Zomig?.

No, we don’t..

Sorry Brian, we won’t give that kind of guidance..

Alright, thank you. Brian Jeep – WallachBeth Capital:.

Thank you. That concludes our call for today. Thank you very much for joining us. We look forward speaking to you soon. Take care..

Thank you. And this concludes today’s Impax Laboratories third quarter 2014 earnings conference call. You may now disconnect..