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.

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.

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…

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…

[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?

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?

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.

Your next question comes from the line of David Amsellem.

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?

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?

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?

Oh, absolutely.

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?

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.

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

Yes.

Your next question comes from the line of 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?

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.

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?

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

Yes.

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.

Your next question comes from the line of Jason Gerberry.

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.

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.

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?

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

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

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

Your next question comes from the line of Shibani Malhotra.

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?

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.

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

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.

Your next question comes from the line of Sumant Kulkarni.

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?

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.

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?

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

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

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.

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?

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.

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

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.

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

March 2014.

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.

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?

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.

Your next question comes from the line with Ami Fadia.

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.

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.

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.

Ami, what was your last question please?

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

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.

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.

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.

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.

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

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

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.

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

About the same. It's about the same.

Your next question comes from the line of Randall Stanicky.

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.

The what review?

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

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.

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

Yes. That's correct.

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

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.

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?

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.

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?

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

Your next question comes from the line of Louise Chen.

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?

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.

Epilepsy product.

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.

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.

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

Can't comment on that on that, Louise.

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?

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.

Your next question comes from the line of Ken Cacciatore.

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.

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.

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.

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?

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

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

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

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?

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.

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?

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?

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.

Your next question comes from the line of Michael Tong.

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?

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.

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?

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.

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

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?

That's fair.

Yes. We do have a question from Jason Gerberry.

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?

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.

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.

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

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

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

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?

Could you just repeat that?

Can you repeat?

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?

What was the...?

Are we completely....

Completely inspection-ready?

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.

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.

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.

Thank you.

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

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