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Impax Laboratories (NASDAQ:IPXL)

Q4 2012 Earnings Call

February 25, 2013 4:30 pm ET

Executives

Mark Donohue - Senior Director of Investor Relations & Corporate Communications

Larry Hsu - Chief Executive Officer, President and Director

Bryan M. Reasons - Chief Financial Officer and Senior Vice President

Carole S. Ben-Maimon - President of Global Pharmaceuticals Division

Michael J. Nestor - Divisional President of Impax Pharmaceuticals

Analysts

Elliot Wilbur - Needham & Company, LLC, Research Division

David Amsellem - Piper Jaffray Companies, Research Division

Dewey Steadman

Jason M. Gerberry - Leerink Swann LLC, Research Division

Shibani Malhotra - RBC Capital Markets, LLC, Research Division

Sumant S. Kulkarni - BofA Merrill Lynch, Research Division

Jim Dawson

Ami Fadia - UBS Investment Bank, Research Division

Randall Stanicky - Canaccord Genuity, Research Division

Louise Alesandra Chen - Guggenheim Securities, LLC, Research Division

Ken Cacciatore - Cowen and Company, LLC, Research Division

Brian E. Jeep - Wells Fargo Securities, LLC, Research Division

Operator

Good afternoon. My name is Kimberly, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Impax Laboratories Fourth Quarter and Full Year 2012 Earnings Conference Call. [Operator Instructions] I would now like to turn the call over to your host, Mr. Mark Donohue, Head of Investor Relations and Corporate Investments. Sir, you may begin.

Mark Donohue

Thank you, Kimberly. Good afternoon, everyone. Welcome to our Fourth Quarter and Full Year 2012 Financial Results Conference Call. Today, Dr. Larry Hsu, our President and Chief Executive Officer will focus his remarks on some of the recent events; and Bryan Reasons, the Chief Financial Officer, will briefly review the financial results and updated 2013 financial guidance. Also on the call are Dr. Carole Ben-Maimon, President of the Global Pharmaceuticals; and Michael Nestor, President of Impax Pharmaceuticals. Following Larry and Brian's prepared remarks, all will be available to take any questions you may have.

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 facilitate 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 fourth quarter and full-year 2012 earnings release, which can be found within the Investor Relations section of our website.

Should you have any questions after the call, please contact Investor Relations at (215) 558-4526. And with that, I'm going to turn over the call to Larry.

Larry Hsu

Thank you, Mark. Good afternoon, and thanks for joining us. We entered 2012 with the hopes of it being an exciting year for us. We had generated strong revenue growth in the fourth quarter of 2011, and we were close to finalizing an accretive agreement with AstraZeneca to license Zomig in the U.S., which will eventually completed in February 2012. We submitted the New Drug Application for RYTARY in late December 2011, and we're hopeful for a quick resolution of the warning letter after committing significant resources to the project. And we will making progress on growing our generic alternative dosage form portfolio.

Unfortunately, 2012 proved to be a challenging year. We were faced with an obstacle on our objective of resolving the warning letter in Hayward. While we had made progress in our remediation efforts, we still had more work to do, as evidenced by the receipt of a new Form 483, following the FDA's reinspection. The second half of 2012 presented additional challenges, including new competition of our 2 largest generic products and the notification in mid-October by the FDA to extend the RYTARY's PDUFA date by 3 months.

We started 2013 on a positive note, as we've successfully launched all 7 strength of our oxymorphone product the first week of January. We're also anxiously waiting RYTARY's PDUFA date on January 21. Optimistic about receiving approval, unfortunately we will tackle yet another obstacle, when we receive a complete response letter that further delay RYTARY's approval. In the course of our operating history, we have at times faced certain challenges and obstacles. Some of these will resolve quickly, and others have taken more time. We are committed to see through this current challenges while continuing to move ahead with our long-term growth strategy. We have been diligent with our external business development, utilizing our strong financial resources and the balance sheet for transactions that are strategically wise and financially attractive and are committed to do so in 2013. The resolution of the quality issue in Hayward continues to be top priority throughout our company.

While we currently have nothing new to report regarding the timing for resolution, we will continue to update you with the important information regarding the warning letter when appropriate. We were obviously disappointed when we received the complete response letter on RYTARY. Based on our frequent dialogue with the FDA, we were optimistic about getting approval on January 21. And in December 2012, we removed the Hayward site from the NDA as the backup manufacturing facility. However, as we previously mentioned, a final decision regarding the removal of Hayward from the NDA will be up to the FDA.

The complete response letter indicates that the FDA requires such factory with inspection of Hayward before RYTARY's NDA may be approved. After an inspection, we will follow the proper procedures and will submit a formal request for a meeting with the FDA to discuss what steps we need to take for the approval. Once we are clear to file our resubmission, we will be requesting a Class 1 resubmission, which call for 2-month review. Again, the decision on approval will be up to the FDA. I also wanted to mention that the U.S. Patent Office recently granted our second formulation patent on RYTARY. This patent provides a certain protection until the year 2028, while our first patent expires in May 2022.

We have updated our 2013 SG&A guidance, which now excludes the RYTARY launch costs, because we currently do not have a clear idea of the timing for possible approval until the FDA has completed a reinspection in Hayward. We issued our 2013 guidance on January 7, 2 weeks prior to the RYTARY's January 21 PDUFA date, which assumed approval at the launch of the product in the first quarter of this year. While we have removed the launch costs from the revised guidance, prelaunch activities are continuing. For example, we will continue to develop [indiscernible] and we'll have additional time to evaluate the responses and adjust as needed. Our internal brand group remain focused on bringing this new treatment option to patients who are suffering from Parkinson's disease.

For a number of years, we have discussed the importance of successful development -- developing a brand of [indiscernible]. We believe it is important to our future growth as a branded product provide longer product life cycle with a potential for higher profit.

Building the pipeline of opportunities is important, as there will always been those that don't survive development. Unfortunately, this is the case with IPX159. In analysis of the study data indicate that although the results show a modest improvement in addressing Restless Legs Syndrome, the result did not achieve the statistical criteria for its primary efficacy endpoint compared to the placebo and does not support advancement of the program in the Restless Legs Syndrome.

While we are disappointed, we have -- we directed our resource to our other program to continue to focus our internal effort on advancing our brand pipeline, which has 4 additional neurology programs in various stage of development, one of those being IPX218 for epilepsy. We have completed study work on IPX218 and we evaluated the competitive landscape, our 2013 R&D guidance included the funding for Phase III trial this year. We will share additional details about the trial as soon as we can.

While we can disappointed -- or while we are disappointed with the challenges I discussed earlier, we did experience some positive development in 2012 and the early part of this year. The license agreement for Zomig has exceeded our expectations, as our concentrated promotion efforts to the neurology-targeted audience has been effective, as we have seen growth in both the new Zomig prescription and the Zomig share of the target market. In mid-May of this year, the patent expires on both the tablets and OTC products, potentially leading to a generic competition. We are prepared for such a generic competition, but we have the right to an authorized generic version of this product. We will continue our promotional emphasis on the Zomig main dose, which has a patent that expires in 2021 and aggressively pursue additional current day [ph] market product opportunities for our neurology-focused sales force.

On the generic side, during the fourth quarter of 2012, we initiated commercialization on the TOLMAR alternative dosage form product, our first opportunities to commercialize ADF product alongside our existing portfolio of tablets and the capsules. And as I mentioned earlier, we successfully launched oxymorphone in January 2013 with the adequate apply in to the market of all strength. We're also pleased to have reached a settlement with Shire on the litigation of our authorized generic Adderall XR product. The agreement governs the future supply of authorized generic Adderall XR from Shire..

Following the end of the supply term on September 30, 2014, we will continue to have the right, under the agreement, to sell our product on hand or owed to us under the agreement until depleted. In addition, we will receive $48 million in connection with the settlement. The license granted to us included reformulation of our ANDA products, which we are currently doing and the filing of an amendment of supplement to our current ANDA.

With our cash balance fully enhanced in 2013 with the addition of anticipated payments from Shire and ANDA and the clean balance sheet, we are able to invest in our business. Our generics business have utilized these resources to quickly broaden alternative dosage form portfolio of a 33 products through several partnership and internal development, with 24 of these products either pending at the FDA or under development. The addition of these 24 ADF products have clearly started the process of divesting -- diversifying our product base as they represent 1/3 of our future product pipeline.

Throughout 2013, we will continue to aggressively pursue business development and M&A opportunities across both our generics and brand businesses. These resources will help position us for future growth and then effectively face competitive challenges in the future. In addition, we are fully committed to working hard to resolve the remaining challenges from 2012.

I will now turn the call over to Bryan, who will provide his comments on our financial results and other items. Bryan?

Bryan M. Reasons

Thank you, Larry. Hello, everyone. Thanks for joining us. Hopefully, you've had the chance to review our fourth quarter and full year 2012 earnings release. I won't spend a lot of time running through the numbers, as the release provides detailed review of the results. Instead, I'll focus my remarks on some additional information and our 2013 revised guidance.

In October 2012, we announced the additional competition on fenofibrate capsules and generic Adderall XR was expected to negatively impact our revenue in the fourth quarter. We anticipate that total revenues for the fourth quarter of 2012 could decline by approximately 15% to 20% from the previous quarter. While sales and market share of generic Adderall were, in fact, significant -- down significantly in the fourth quarter, the fenofibrate market proved to be more stable.

Our total revenues of $132 million in the fourth quarter of 2012 declined 9% in the third quarter and 17% compared to the fourth quarter of last year. This excludes the $9 million of OTC revenue that was previously deferred. This fourth quarter revenue decline resulted in adjusted earnings per share of $0.30 compared to $0.33 earned in the prior year. The FDA's approval of another generic Adderall product in late June of 2012 affected the overall market. We currently have sufficient supply of product and under our settlement agreement with Shire, we agree to a method that we are satisfied with to determine future allocation of the product. Despite additional competition in generic Adderall and fenofibrate, our goal is to remain competitive in both products and continue to meet the needs of our customers.

Our full year revenues of $582 million exceeded 2011 revenues, and adjusted earnings per share increased to $1.91 from $0.98 in 2011, primarily driven by sales of Zomig. This accretive transaction met our objective to increase the revenue and financial contribution of our brand business and our sales reps remain active within the neurology market as we prepared for the approval and launch of RYTARY.

Our Zomig promotional efforts will continue in 2013. We remain hopeful that we can add RYTARY to our marketed product portfolio during 2013. We continue to pursue the acquisition of additional marketed neurology products so that we effectively leverage our internal sales and marketing structure.

Our operating expenses for 2012 increased over the previous year mainly due to the expansion of the brand business infrastructure, our promotional spending on Zomig, and prelaunch planning cost for RYTARY. Our 2012 operating expenses were approximately $8 million lower than our guidance. Brand R&D was about $5 million lower than expected primarily due to an external R&D investment that we elected not pursue. SG&A was about $4 million lower than our guidance due to reduced sales and marketing activities in the fourth quarter. These savings were partially offset by higher patent litigation costs of $2 million.

During the fourth quarter, we invested approximately $11 million on capital expenditures. For the full year, we made capital investments of $67 million, primarily related to the construction of our Taiwan facility. For 2013, we currently don't have an estimate to share with you. However, we expect to invest at least $36 million based on previously preapproved commitments, with $27 million of this related to the expansion of the Taiwan facility.

After our continued reinvestment in the business, we ended the year with $299 million in cash and short-term investments, a decline of about $47 million compared to the end of 2011. This decline was primarily due to the Zomig and TOLMAR transactions and investments in property, plant and equipment. Our cash and short-term investments will increase this year because we expect to receive payment of $48 million from Shire and more than $100 million from Endo under the terms of our agreements. These one-time payments will be recorded as other income. They'll be excluded from our adjusted earnings.

Our healthy balance sheet enables us to continue investing in our business internally to facility expansion improvements, and externally, to making selective investments in partnerships and M&A opportunities. Before I talk about our revised 2013 guidance, I want to touch on increased inventory levels in 2012.

As of December 31, our inventory increased almost $36 million or 66% from the end of 2011. This is related to several factors across a number of products. We added new products such as Zomig, oxymorphone and RYTARY, as well as alternative dosage form products acquired from TOLMAR. We've been building inventory on a number of products prior to their applications being transferred to the Taiwan plant. This will improve product economics by utilizing our more efficient and cost-effective facility. We also had higher levels of generic Adderall because of declining sales in the second half of 2012.

Now let's review the update to our 2013 guidance. As Larry mentioned, we had initially included RYTARY launch expenses within our SG&A guidance. With the anticipated approval and launch of RYTARY in the first quarter of 2013, we're preparing to invest in field sales marketing sampling to ensure a successful launch. In addition, we intended to add approximately 60 sales rep to our existing base of 84 reps upon approval. We believe, at this point, it's best to remove these costs from our guidance since we do not know when the product will be approved. We remain hopeful that it could get approved and launched during 2013.

Our revised SG&A guidance, excluding RYTARY launch expenses, is now approximately $115 million to $120 million, reduced from our previous estimate of $154 million to $162 million. We have reduced our 2013 R&D -- generic R&D expense and separated patent litigation expense from the generic R&D guidance. Our generic R&D is expected to be between $49 million and $53 million, and patent litigation will be about $10 million to $12 million. The reduction of generic R&D expense is based on our intent to focus on fewer projects in favor of more difficult to formulate opportunities.

We've also revised our effective 2013 tax rate to 32% to 34%, down from 34% to 36%. The reduction is primarily due to the inclusion of the 2012 R&D tax credit, which wasn't renewed by the government until after December 31, 2012. The inclusion of this R&D tax credit in our first quarter 2013 results will positively impact that quarter's rate, which we expect to be in the low 30% range.

Thanks for participating, and now I'll turn back the call to Kim for your questions.

Question-and-Answer Session

Operator

[Operator Instructions] And your first question comes from the line of Elliot Wilbur.

Elliot Wilbur - Needham & Company, LLC, Research Division

First is on trends in the Adderall XR market. Admittedly, I guess, I'm going always to be perplexed by what takes place in this marketplace. But you talked about your declining share as being more of a competitive issue rather than a supply issue. But just sort of looking Rx levels, I mean, you're running about 25% of what you were at peak. And so I guess the question is, maybe just help us understand a little bit better some of the dynamics in that marketplace. Would you -- do you still have adequate inventory supply in order to be able to serve the market at levels you previously were and it's just been an issue of losing customers to Teva and Actavis? I'm just trying to understand, why it's been so difficult, I guess, to sort of chip away its share held by the brand product, which still has well over 30% of the market?

Carole S. Ben-Maimon

So Elliott, to answer that question, I think you hit on a couple of important points. First, the acknowledgment that the brand has kept 30% of the market. And clearly, none of the 3 generics have been able to really have much of an impact on that market share. Second, we have assured everybody, I think -- and that we continue to assure everybody, that supply is not the cause. We do have supply, it's just in very competitive marketplace. And I think the other thing you need to look at is that Actavis has continued to increase its share -- most recently, I think this week's data was around 23% of the market at the expense of not us at this point, but more -- looks like Teva. And so it's still a very dynamic market. It is highly competitive. I think it will continue to be challenging. And then, outside of -- not specific to Adderall, I would also say that I think we also see a result of the fact that there's been tremendous comp consolidation in the customer base. And so one change shifting customers can really have a dramatic increase on market share. And so I think that's just a function of the generic marketplace today as the customers tend to be bigger and more concentrated. But I think you sort of hit it on the head. It's a very competitive market, and Shire has held a significant amount of share.

Elliot Wilbur - Needham & Company, LLC, Research Division

Okay. And then I have a follow-up question with respect to CONCERTA and the tie-in with the resolution of issues at Hayward. Assuming you are able to resolve issues here in the first half of the year, and you can or could get FDA approval for the product, you think that circumstances have been triggered on your settlement with J&J, such that you could actually be in the market before July 2013? And there's also been another competitive approval here. And obviously, the term exclusivity has been thrown out there quite a bit. But do you believe that Malancrat [ph] in fact has blocking exclusivity? Or do you think this is more patent by patent exclusivity which is where you could actually get approval and see simultaneous entrants in the market?

Carole S. Ben-Maimon

So obviously, we are continuing to pursue that application, and once the warning letter is resolved, we do to intend to launch that product. With regard to the exclusivity, I think we're not ready really to comment on that. Obviously, now Melancrat [ph] made some claims that they have exclusivity. We're still in the process of evaluating that, and I don't think really want to comment at this point. But obviously, once we have clarity and we know what our plans are, we will, if it's not a competitive disadvantage, straighten it out.

Operator

Your next question comes from the line of David Amsellem.

David Amsellem - Piper Jaffray Companies, Research Division

I'll start off with a question on RYTARY. So I know you're not providing a lot of details regarding the complete response. But just that -- is there anything that's come up in the complete response with your dialogue in the FDA regarding concerns, regarding equivalence between the RYTARY supply use in the clinical trials out of Hayward, and the commercial supply in Taiwan? And maybe just remind us what kind of info and data you've provided to the agency regarding the batches from the 2 different facilities?

Michael J. Nestor

David, this is Michael Nestor. In answer to your question, there are no issues with bioequivalency of the 2 formulations between Hayward and Taiwan. So no issues at all in that regard. And your second question was around the -- remind me again?

David Amsellem - Piper Jaffray Companies, Research Division

So just walk us through again what the equivalence data you've provided to the agency. So basically just a related question. Do you feel you have enough info and you've provided enough info to the agency to their satisfaction on that front?

Michael J. Nestor

Oh, absolutely.

David Amsellem - Piper Jaffray Companies, Research Division

All right. And then my second question is just regarding Adderall with Teva getting their product approved. Is that, in any way, changed the market dynamics for your product if Teva is shipping their own product versus taking supply from Shire? How do you think about that?

Carole S. Ben-Maimon

So prior to March of 2014, it really doesn't change anything for us at all. But subsequent to that, after that, you may remember that we actually thought that we might have a period of 6 months between March and end of September where we would be alone or with Actavis at this point -- with Actavis and Shire. And obviously, that will be the case. I would assume -- and again, I have no competitive intelligence on Teva, but I would assume the fact that if they have an approval, they will launch and remain in the market at least at that point.

David Amsellem - Piper Jaffray Companies, Research Division

But to be clear, for '13, you're agnostic as to whether Teva's taking supply from Shire or shipping their own products?

Carole S. Ben-Maimon

Yes.

Operator

Your next question comes from the line of Dewey Steadman.

Dewey Steadman

And I hate to bring this up, but should the warning letter extend for a prolonged period through calendar '13, or should Hayward, God forbid, not pass inspection, is there a contingency plan in place both for the generic products that are sort of pending at this point and for 066? And then what assurance can you give us that an inspection is more near-term than a longer-term event?

Larry Hsu

Okay. If you look at this situation, obviously, that you would know that some of the pending product we are still using the Hayward alongside, it will be difficult to get approval. But as far as the existing market of product, you know that we have a strategy for the last 1 year, 1.5 years to continue to transfer the product to Taiwan. The 066, obviously, is going to be a challenging at this point. At this point, as we indicated, we'll probably -- we'll have a meeting with the FDA as a result of this completed response letter, and we'll find out more in the meeting with the FDA, what takes to get approval on that.

Dewey Steadman

Okay. And then, with the TRICOR business, it was great to see relatively flat performance with increased competition. But now with the newest doses of TRICOR going generic, what do you expect to happen with that market as we progress through 2013?

Carole S. Ben-Maimon

So I assume when you refer to the TRICOR market, you're talking about the fenofibrate market in general?

Dewey Steadman

Yes.

Carole S. Ben-Maimon

Okay. So as you know, we had fenofibrate tabs and caps. We've had competition on the tabs for some time. We've had the launch of Mylan into the caps earlier or late last year. And that market has actually remained relatively stable. We did give up some market share, but we've been able to defend a lot of our business and maintain a lot of our market share, as you can see from the IMS data. With regard to TRICOR, we've announced that we have to reformulate. And we haven't seen a lot of dynamic with the launch of -- or a lot of change in our market with the launch of the generic TRICOR. And then, there's also TRILIPIX, which is out there, which we can launch in January 2014 or as early as July 2013, potentially. And it's yet to be seen what will happen with that product.

Operator

Your next question comes from the line of Jason Gerberry.

Jason M. Gerberry - Leerink Swann LLC, Research Division

Just another Adderall question. It would seem like the -- and I know the extension of the authorized generic agreement looks unlikely now with the Teva approval. I wonder if you can comment on that. And comment on whether do you need to amend your ANDA in order to get an approval? That's something Shire has commented on in the past, I'm wondering if you could provide a commentary there.

Carole S. Ben-Maimon

So I don't think that I would assume -- again, we obviously have said that in the settlement we don't have an extension. But what Shire will do at the end of the term of our agreement, I have no idea. The fact that Teva is out there, obviously they're not going to extend that agreement with all likelihood. So I don't know what will be in 2014, time will tell. With regard to the ANDA, our pending ANDA, under the license agreement that we just signed, we do have the ability to reformulate the product and amend their application -- our current application, and we will be pursuing that.

Jason M. Gerberry - Leerink Swann LLC, Research Division

Okay. Great. And then just one follow-up on the Endo cash payment related to Opana. Is there any thing -- any more contingencies on that payment? Or have you -- I mean, will you fully recognize or realize that full amount now?

Bryan M. Reasons

We'll recognize that upon receipt. The accounting rules around recognizing a gain are pretty strict.

Jason M. Gerberry - Leerink Swann LLC, Research Division

But it has something to do with your performance in the market at this point? I mean...

Bryan M. Reasons

Yes. We've met -- we've done everything we need to do.

Operator

Your next question comes from the line of Shibani Malhotra.

Shibani Malhotra - RBC Capital Markets, LLC, Research Division

So just a follow-up on Opana. We noticed that you followed, I think, a response to Endo's citizens petition or the supplemental information around the abuse deterrent -- or deposition kind of value of Opana. So could you just address this and all the recent information that we've received on Opana, and on your comment that you filed with the agency? And also based on the feedback you are getting from customers, how confident are you that generics, your generic for Opana will be allowed stay in the market? And then would you expect other generics to be approved as well or just your own?

Carole S. Ben-Maimon

Shibani, thanks for the question. Obviously, you saw the citizens -- response to the citizens petition. As our position, we hired an expert to actually look into all of the data that has been submitted. And he and we are of the opinion that there's not a lot of data to support the fact that the new Opana formulation is abuse deterrent effect -- is an effective abuse deterrent product. Clearly, it is up to the agency to make the ultimate decision as to whether or not the old formulation was removed for safety. But we all know they've let us launch, and they have said that they will make their decision prior to the end of May at some point -- at some time. And so I will defer to the agency. I think we very much are of the opinion in our citizens petition that the data is not as strong as Endo would like to suggest that it is. But that's our opinion. That said, at least until May, we will be able to remain on the market or until FDA makes a decision. I'm optimistic, having reviewed the data and been involved in the drafting of that petition that we will continue to be able to be on the market. But again, it is FDA's ultimate decision as to what they decide to do. And I also believe that assuming we are allowed to stay on the market, the agency will be -- do what they deem is appropriate with regard to the other products. And I don't really feel comfortable, because I don't know anything about their applications, the formulations or anything else, really commenting on what the agency might do on others with a capital case.

Shibani Malhotra - RBC Capital Markets, LLC, Research Division

Okay. But can you comment on your -- on the feedback that you're getting from -- by patients, et cetera, on your generic?

Carole S. Ben-Maimon

Well you saw -- I think you've seen our market share probably. We were over 17% on the 7.5 and 15, which does have an RLD. The Actavis product is in the RLD. We have been continuing to increase on the other strength, the other 5 strength which does not have RLD, we're somewhere around 7% this week. And so, again, I don't -- I can't predict where it's going to go and where it's going to level off. But at least as of the first 6 weeks or so after the launch, we've continued to gain market share.

Operator

Your next question comes from the line of Sumant Kulkarni.

Sumant S. Kulkarni - BofA Merrill Lynch, Research Division

The first one is on RYTARY. Could you tell us what the chances are of the FDA requiring additional clinical data? And I know that you said that equivalence was the same, but what about the chance of additional clinical data?

Michael J. Nestor

At this point in time, we've had no communication from the agency that would indicate they'd looking for us to conduct any additional clinical trials.

Sumant S. Kulkarni - BofA Merrill Lynch, Research Division

And a component of the launch cost that were removed from SG&A, the Fed assumed that the only recurring part of that was the contingent sales force that has not been hired so far?

Bryan M. Reasons

So to pull those at is the contingent sales force that has not been hired, sampling and other marketing materials.

Sumant S. Kulkarni - BofA Merrill Lynch, Research Division

And do you still expect the generic approval of Solaray is to be an any time event? Or why has that not happened yet?

Carole S. Ben-Maimon

We do. Obviously, that's not our application, it's our partner's application. But based on what they have told us, it is moving along at the agency, and we're hopeful that it will be approved in the near future. It's a very complicated product, obviously involves clinical trials and some other issues. And so, the FDA and our partners are working through it, but we are optimistic.

Sumant S. Kulkarni - BofA Merrill Lynch, Research Division

And this is more of a general question on the nature of the warning letter at Hayward. We noticed that there's -- and correct me if I'm wrong, but I don't think we've seen any recalls on your products after that warning letter. Should we read anything into that, either being positive or otherwise on the nature of the warning letter itself?

Larry Hsu

Well, as I indicated in my remarks, if there is anything significant, we'll let you know. At this point, we don't really have anything to report.

Operator

Your next question comes from the line of the David Buck.

Jim Dawson

It's Jim Dawson for David Buck. Yes, I just want to drill down a little bit on the Hayward warning letter and just on the impact, could you just review what approvals need Hayward to be resolved, including the generic Concerta? If you just go through that, that would be helpful.

Carole S. Ben-Maimon

Well, generic Concerta, Sevelamer, which is not until 2014 or so.

Mark Donohue

March 2014.

Carole S. Ben-Maimon

And then, we've also stated that there are quite a number of other products that are pending that we have not actually discussed because they're smaller and there hasn't been any litigations so they're not public. That as we would hope that once the warning letter is removed, we'd start to move through the pipeline and began receive approval, and we can launch. So in and of themselves, they're not like g Concerta which is a huge product. But they are, together, significant and would have a meaningful impact on our sales.

Jim Dawson

Okay. And then you also just mentioned just about -- hoping to get RYTARY approved and launched this year. Would you -- what are your thoughts on sales in 2013? Could you give just some additional detail on that?

Michael J. Nestor

I think the only way one could ever get any sales of RYTARY for 2013 would be if we had approval in 2013, and we're able to ship and sell product. While at this point, we remain optimistic and hopeful that we will be able to launch this year. We do not know for certain on that and that will be up to the discussions that we have with the agency. So at this point, I don't think it'd be an appropriate number to throw out there.

Operator

Your next question comes from the line with Ami Fadia.

Ami Fadia - UBS Investment Bank, Research Division

I had a couple of questions. Firstly, on Concerta, could you clarify how confident you are that the only thing really blocking an approval is the warning letter? Or in another words, could you give us some commentary around your interactions with the FDA and whether the application is moving forward or not? Secondly, just on RYTARY, was the excipient question that the FDA had in the previous interaction with you completely resolved? And is the warning letter the only thing that's really blocking it at this point? And if you could just sort of quantify the number of products that are currently in backlog on the generic side, that would be great.

Carole S. Ben-Maimon

So I guess I'll start on the g Concerta. Obviously, we can't. We don't comment on the actual conversations we're having with the agency. I can tell you that we are pursuing that application aggressively. We are continuing to do whatever we need to do to ultimately obtain the approval. We believe that the application is approvable and meet the criteria, but I cannot tell you whether the agency is going to agree with that. And obviously, they have the pen, and they'll sign the approval letter or not sign if they choose to. So we are continuing to move towards approval. But I can't give you any real assurance that it's only the warning letter. Clearly, without the lifting of the warning letter, we can't get approval. But once the warning letter is lifted, it will be up to the center to really make the final decision about the application.

Michael J. Nestor

And then so far as the excipient issue, we provided FDA the response to the questions that they had relative to the excipient question. We've not heard anything back from FDA following the submission of that information. So at this point in time, we don't believe it's part of the complete response letter. I think ultimately, it will be, once we get approval for RYTARY.

Mark Donohue

Ami, what was your last question please?

Ami Fadia - UBS Investment Bank, Research Division

Just if you could tell us how many products -- generic products you have in backlog at the FDA currently? Maybe just a number, without...

Carole S. Ben-Maimon

I think it's hard to say backlog, and that's where we're sort of struggling because obviously, it's not going to be that all of a sudden day one, these things are just sitting and waiting on somebody's desk to get signed. It's going to be a process. And as they go back and start to sign or look at approvals, they will review the applications and there maybe things that we need to do. So it's not that there's a pile of products. We've had, as we've said, quite a number of pending applications. And so of those pending applications, quite a few of them have moved pretty far through the review process. And we'll start, hopefully, once the warning letter is resolved, then will start to be getting approved over a period of say, 3 to 6 to 8 months. But it's not that there's all of these products just sitting and waiting on somebody's desk for signature.

Ami Fadia - UBS Investment Bank, Research Division

Got it. If I could just have one more question, just on the tax rate, how much of the R&D tax rate was included in the -- in your new tax rate guidance? And here, I'm asking because I'm trying to think of how to model the 2014 tax rate.

Bryan M. Reasons

How much of the R&D credit. So Q1 will recognize the full 2012 R&D credit in Q1 of 2013. And then for the current year R&D cash credit is actually between 100 and 200 basis points for the 2013-related R&D tax credit.

Mark Donohue

Correct. For the year, we said our full year tax guidance will be 32% to 34%. And Bryan said in his prepared remarks that at first quarter of 2012 R&D tax credit would impact first quarter, which would put us in the low-30% range.

Bryan M. Reasons

As we've recognized that discreetly in the first quarter.

Ami Fadia - UBS Investment Bank, Research Division

And then -- so that is 100 to 200 basis points? Or is it ...?

Bryan M. Reasons

So just the current year, so the 2013 R&D tax credit is 100 to 200 basis points. And then we'll recognize the 2012 all in Q1 of 2013 discreetly.

Ami Fadia - UBS Investment Bank, Research Division

And how much is the 2012 tax credit in basis points?

Bryan M. Reasons

About the same. It's about the same.

Operator

Your next question comes from the line of Randall Stanicky.

Randall Stanicky - Canaccord Genuity, Research Division

A couple of follow-ups. Larry, first for you. Given that you haven't talked to FDA yet post the CRL. Obviously from this call, several questions that we still have, what's giving you guidance to or comfort to guide to a 2-month review at this point? I'm just wondering if there's something that we're not catching here.

Larry Hsu

The what review?

Bryan M. Reasons

In two-month review. The type and versatility...

Larry Hsu

It is obviously at the preceding as with this FDA at this point. But if you look at the guidance in terms of a 2-month review versus which is considered class one versus a 6 month review, which is considered as a class 2. I think those are guidance for the maybe kind of an overlapping gray area and so a lot of the decision will be up to the FDA. But at this point, we are hoping that once we get the issue -- we expect the issue resolved and all these, we will be able to convince FDA that's a class one review. But again, emphasize the decision is really in the FDA.

Randall Stanicky - Canaccord Genuity, Research Division

But we just don't know yet. You're just hoping for a class one review, correct?

Larry Hsu

Yes. That's correct.

Randall Stanicky - Canaccord Genuity, Research Division

Okay. Carole, for you. When are you going to refile your Adderall ANDA?

Carole S. Ben-Maimon

I'm not going to disclose the timing. Obviously, we just signed the agreement a couple of weeks ago, and we're moving towards the goal for reformulating a new filing.

Randall Stanicky - Canaccord Genuity, Research Division

Okay. Let me ask another question. Obviously, you're guaranteed a certain amount supply from Shire. And it sounds like based on demand, you're selling under that supply level. And based on the agreement, if I understand it correctly, you have the right to continue to sell beyond October '14. And so if demand dynamics remain unchanged as we are now, how far post October of '14 do you think you could be selling the marketplace out of your Adderall?

Carole S. Ben-Maimon

So that's a really difficult question because right now, the only thing we know is the 2013 annual further grant rate. And there's always supplemental grants, and there will be a 2014 grant as well. So it's really impossible for me to be able to predict, because we can't. We don't know what the FDA is going to do. We don't know whether there's going to be another approval in the market, which could clearly happen. And we don't anticipate that. We don't know of any other litigation. But we didn't know about, none of us knew about [indiscernible] either, so it's very difficult. I think your characterization of what we are permitted to do is accurate. And I do -- and as you can imagine, we'll move as quickly as we possibly can to make sure we have an approvable application.

Randall Stanicky - Canaccord Genuity, Research Division

Okay. Great. And Larry, one last question for you. How do you plan to communicate to us when the FDA does go back and reinspect? Obviously, we're now 3 months away for another quarter. If that happens intra quarter, could we expect a press release or intra quarter update from you?

Larry Hsu

Well, as I pointed out in my remarks, if any significant happens, we will communicate to you and all the investor.

Operator

Your next question comes from the line of Louise Chen.

Louise Alesandra Chen - Guggenheim Securities, LLC, Research Division

First question back to the RYTARY Hayward warning letter issue. I just wanted to get a sense of you, based on your read of the second CRL, do you feel it's basically the resolution or the reinspection on the warning letter side, that's keeping a potential approval? Or are there new things that came up in the CRL when you received it? And then secondly, what gives you confidence that the resolution of your Hayward warning letter is really just a matter of time? We've heard that the FDA's been really busy just because we've gotten that question and not indicative of something deeper here just because it's taking a lot of time. And then earlier on, you had mentioned this epilepsy product, I was just wondering what phase it's in and what is the market opportunity for your product?

Michael J. Nestor

Okay. So Louise, relative to RYTARY and the CRL. It is the reinspection of the facility that appears to be gating item at this point in time.

Mark Donohue

Epilepsy product.

Michael J. Nestor

And the epilepsy product, we haven't disclosed anything really on where that program is at this point in time and the reason we've chosen not to is for competitive reasons. And I think, if I were -- if I would to answer those questions for you we had a pretty good hint as to what kind of product we'd be looking at and I'd just assume not at this stage.

Mark Donohue

We have said, that our 2013 guidance does include a Phase III trial for that product. We'll update you with information about that when appropriate.

Louise Alesandra Chen - Guggenheim Securities, LLC, Research Division

Is it a compound that's been approved elsewhere, maybe for different indication, can you say anything like that?

Michael J. Nestor

Can't comment on that on that, Louise.

Louise Alesandra Chen - Guggenheim Securities, LLC, Research Division

And what about the resolution of your warning letter, and if it's just a matter of time and what gives you confidence versus indicative of a deeper problem?

Larry Hsu

Let me make a comment on that, Louise. I think that you know that trying to resolve the warning letter is of really high priority in the organization. We have to commit to it, okay? And we'll continue to do the best we can to resolve the resolution, plus the timing and difficulty at this point, okay? And also, at the end of the day, it's really up to the agency, what they decide to do.

Operator

Your next question comes from the line of Ken Cacciatore.

Ken Cacciatore - Cowen and Company, LLC, Research Division

I was a little late getting onto the call so I have probably what might be a couple of naive questions. But first, why no scheduled meeting yet on RYTARY? I'm a little confused by why it's not actually on the calendar by this time. And then also, on Adderall XR, confused why you already wouldn't have the products reformulated if you thought it wasn't approvable in its current form so that you could just go ahead and file it now? Could you give some explanation as to why we would be reformulating it at this point in time? And then I have a follow-up question.

Michael J. Nestor

Okay. So as to the RYTARY and the meeting on the docket with FDA, according to the complete response letter, that would be to follow an inspection of the facility. So once we've had an inspection of the facility, then we would submit a request for a Type A meeting with the FDA to get clarity from the FDA if there were any issues arising from that inspection. At which point then, we would look to do a resubmission of the application consistent with FDA guidelines.

Carole S. Ben-Maimon

And Ken just to be clear, the terms of our agreement -- any agreement we've signed with Shire have been kept confidential. But I can -- what I can say is that when and how and what we do with regard to the reformulation is dictated by the terms of the agreement. And under the current agreement, we have the ability to reformulate and amend our current ANDA.

Ken Cacciatore - Cowen and Company, LLC, Research Division

Okay. And just -- and maybe a direct question that I feel I'm not going to get an answer to. But if the FDA actually in the facility now, can you answer that question?

Larry Hsu

Well, as I mentioned, anything significant that will happen, we'll let you know.

Ken Cacciatore - Cowen and Company, LLC, Research Division

Okay. And that will be -- that would not be characterized as significant?

Larry Hsu

No. We're not going to make a comment on that.

Ken Cacciatore - Cowen and Company, LLC, Research Division

Okay. That's fine. And then just lastly on maybe assets available. You all have a nice cash balance sheet now and just wondering, can you give us some thoughts about what you're seeing and looking at? And maybe a sense of timing or kind of any context around your business development?

Larry Hsu

I think, obviously, for the last couple of years now, we have been -- we are looking very aggressively on the opportunity -- either from the opportunity like the Zomig, which would give us a very nice accretive product on the market right away. We're looking at the M&A of the company, and we're going to continue pursuing on the path. I think the most important is that, as I mentioned in the past, whatever the product or the company will try to acquire, but in my sense has to meet our strategic goal, and it's pretty important from that point of view. So we'll continue looking and put a lot of effort on that. And so as soon as we have a good news, we will let you know.

Operator

You're next question comes from the line with Elliot Wilbur.

Elliot Wilbur - Needham & Company, LLC, Research Division

Maybe just a follow-up on Ken's question. Larry, it seems like everyone in the small, mid-cap pharma space is trying to do the same thing, and look for assets and/or platforms to acquire. Some companies seem to do a great job of finding something to buy every week and then, other companies seem to make much longer periods of time. So I guess the question is, are you seeing a lot of things that meet your strategic criteria but just don't pass various financial metrics? Or there's something you think you need to do in terms of maybe accelerating or getting access to more opportunities than what you have historically been able to see?

Larry Hsu

Well, if you look at the availability within the price range, that we can have assets to, there are some opportunities, no question at all. However, as I pointed out earlier, that we are very selective. We want to make sure the company or the product we try to target on acquisition fit in to our strategy well. It is a very important criteria for us. Therefore, although there are opportunities out there but when you go through the selection criteria, the target sites becomes much smaller after that. But again, we'll continue looking for it. We actually, in the past, have several times when opportunity to be able go in depth on these things. But at the end of the day, unfortunately, some of the opportunity is not been ours as much as we'd like to. But again, it's a high priority currently in the company, and we're going to continue to pursuing that.

Elliot Wilbur - Needham & Company, LLC, Research Division

Okay. And just one quick follow-up for Carole. It would seem as if you guys are going to chip away at the Opana ER market here slowly over time. But is there anything we should be thinking about in terms of quota limitations that would limit your ability our cap your ability to obtain a much larger portion of that market?

Carole S. Ben-Maimon

I think, what I would say is that the limitations are probably not about our supply at this point, it's about -- it's really about the uptake in the market that we're not now. If it were to take off and turned out to be 60% of the market that we took over, obviously, we've work with the DEA, and hopefully it would not be a problem. But clearly, at this point, we don't anticipate any real supply issue.

Operator

Your next question comes from the line of Michael Tong.

Brian E. Jeep - Wells Fargo Securities, LLC, Research Division

Brian Jeep, on for Michael. First question on, I guess with IPX159 not going forward and no change to branded R&D guidance, should expect there's some thing beyond IPX218 might be accelerated? And if so, could give us any color on what those might be?

Michael J. Nestor

It's possible there could be. The reality is no we won't give you any idea as to what that might be at this point in time. The approach we've taken is that we don't disclose any detail on our projects unless they've gone through a proof of concept.

Brian E. Jeep - Wells Fargo Securities, LLC, Research Division

Okay. And then secondly, about $40 million came out of the SG&A guidance for 2013. I'm curious though if RYTARY were to be approved and launched in 2013, would the lion share of that come back into 2013 expenses?

Bryan M. Reasons

Brian, it depends on the timing of the approval, right? So a lot of these costs are the contingent sales force, the sampling and the marketing materials. So obviously, depending on the timing of the approval, we drive what portion of that comes back into the guidance.

Brian E. Jeep - Wells Fargo Securities, LLC, Research Division

Okay. And so the proportionate with the portion of the year that remains after it comes in?

Bryan M. Reasons

I think -- generally, though, when you initially launch a drug, there's a lot of sampling, and there's a lot of marketing materials going out. So it's -- I'd say it's slightly front ended. Is that fair, Michael?

Michael J. Nestor

That's fair.

Operator

Yes. We do have a question from Jason Gerberry.

Jason M. Gerberry - Leerink Swann LLC, Research Division

Just another M&A question. It seems like the investor community seems to think there's a preference for Impax doing a branded neurology-type deal? And I'm kind of curious if you can comment on that. And how big of a transaction would the company consider taking on? And would the company think about taking on development risks and taking something that's pre-proof of concept or are you strictly looking at marketed assets?

Larry Hsu

We look at actually both, at this point. I think on one end, we're looking at marketed product, which is accretive marketed product, which would give us the added -- the EBITDA right away. But on the other hand, there is part of the R&D program. We also look at the product which in the development stage, particularly in the late stage, that Phase III study and that to continue to beef up our pipeline. Again, our philosophy has always been, while we continue to look at internal product idea, but we also compare it with the available product in the pipeline outside. If the product outside has a better chance to be successfully developed, has a better market value, we'll have no hesitation to and license that to extend our R&D pipeline.

Bryan M. Reasons

I think on the side, it just depends on the target. If you -- if we're buying something that has significant EBITDA that it's immediately creating, we'd be willing to make a larger deal and be able to finance more of that as opposed to a development stage-type company.

Jason M. Gerberry - Leerink Swann LLC, Research Division

Great. And could you perhaps give a leverage ratio that you might go up to? Or am I pushing my limits there?

Bryan M. Reasons

I think 3.5x combined EBITDA is on a still well within industry standards.

Operator

We do have a follow-up questions from Sumant Kulkarni.

Sumant S. Kulkarni - BofA Merrill Lynch, Research Division

The first one on Hayward again. Would you characterize the plant as being totally inspection-ready and is the ball completely in the FDA's court or is there still something that needs to be done on Impax's part?

Mark Donohue

Could you just repeat that?

Larry Hsu

Can you repeat?

Sumant S. Kulkarni - BofA Merrill Lynch, Research Division

Would you characterize Hayward as being completely inspection-ready from an FDA point of view? And is the ball totally in the FDA's court on that?

Larry Hsu

What was the...?

Mark Donohue

Are we completely....

Carole S. Ben-Maimon

Completely inspection-ready?

Larry Hsu

It is a tough to respond. Obviously, we put a lot of effort on this, and with the goal that we'll be ready for the inspection. But again, you know when the FDA comes in, they look at the more than just these -- what other citations in the previous inspection. They will look at a lot of a few other things as well. So from that point of view, again, we will prepare ourselves as much as we can.

Sumant S. Kulkarni - BofA Merrill Lynch, Research Division

And how should we think about the European filings for RYTARY? How are the discussions with Glaxo there? And any clarity you can give will be appreciated.

Michael J. Nestor

Yes. With that Sumant, that's totally up to GSK. European filings typically are not contingent on FDA filing in the U.S. That's a question that are just to GSK than to us, I think.

Larry Hsu

Thank you.

Mark Donohue

Thanks a lot, everyone, for joining us today. And that concludes our call, Kimberly?

Operator

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

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