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Impax Laboratories (NASDAQ:IPXL)

Q2 2012 Earnings Call

July 31, 2012 11:00 am ET

Executives

Mark Donohue - Senior Director of Investor Relations & Corporate Communications

Larry Hsu - Chief Executive Officer, President and Director

Bryan M. Reasons - Acting Chief Financial Officer

Michael J. Nestor - Divisional President of Impax Pharmaceuticals

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

Analysts

Shibani Malhotra - RBC Capital Markets, LLC, Research Division

Corey B. Davis - Jefferies & Company, Inc., Research Division

Randall Stanicky - Canaccord Genuity, Research Division

Elliot Wilbur - Needham & Company, LLC, Research Division

Gregory Waterman - Goldman Sachs Group Inc., Research Division

Sumant S. Kulkarni - BofA Merrill Lynch, Research Division

David Amsellem - Piper Jaffray Companies, Research Division

Michael Kallai Tong - Wells Fargo Securities, LLC, Research Division

Dewey Steadman

Ken Cacciatore - Cowen and Company, LLC, Research Division

Ami Fadia - UBS Investment Bank, Research Division

James F. Molloy - ThinkEquity LLC, Research Division

Operator

Good morning. My name is Reshaira, and I will be your conference operator today. At this time, I would like to welcome everyone to the Impax Laboratories Second Quarter 2012 Earnings Conference Call. [Operator Instructions] Thank you. Mr. Donohue, you may begin your conference.

Mark Donohue

Thank you. Good morning, and welcome to Impax's second quarter 2012 earnings conference call. This morning, Dr. Larry Hsu, our President and Chief Executive Officer; and Bryan Reasons, our acting Chief Financial Officer, will have some comments on our second quarter results and other business items. Following their prepared remarks, both will be available to take any questions you may have.

Also on the call and available for us for questions are Dr. Carole Ben-Maimon, President of Global Pharmaceuticals; and Michael Nestor, President of Impax Pharmaceuticals.

Our discussion today may include certain forward-looking statements, and actual results may differ from those presented here. The factors that could cause such a difference are outlined in our SEC filings and on our website. Our discussion today includes certain non-GAAP measures as defined by the SEC.

Management uses both GAAP financial measures and the disclosed non-GAAP financial measures internally to evaluate and manage the company's operations and to better understand its business. Further, management believes the inclusion of non-GAAP financial measures provide meaningful supplementary information 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 second quarter 2012 earnings release, which can be found within the Investor Relations section of our website at www.impaxlabs.com.

With that, it's a pleasure to turn our call over to Dr. Larry Hsu.

Larry Hsu

Thank you, Mark. Good morning, and thanks for joining us. The second quarter was a good revenue and earnings quarter for Impax. Total net revenue increased 32% to $166 million and adjusted earnings per diluted share increased to $0.41 to $0.60 over last year's second quarter. Our adjusted results benefited from U.S. Zomig tablets sales, which we began selling under the Impax Pharmaceutical label on April 1, and the gross profit earnings from AstraZeneca on sales of the Zomig ODT and the nasal spray formulations. These accretive transactions contributed just over 2/3 of the growth in our second quarter 2012 revenue and adjusted EPS, compared to the second quarter of 2011. Also contributing to our year-over-year growth was higher generic Adderall XR sales due to increased delivery from our third-party supplier.

This morning, we announced that the FDA recently completed a preapproval inspection of Rytary and an undisclosed generic drug at our Taiwan facility and that there were no Form 483 observations. We were pleased to receive this news, as we have committed significant resources to improving the operation of all of our production facilities and into strengthen our company-wide quality system. We continue to work at resolving the recent observation at the Hayward site and look forward to the FDA returning to reinspect the facility in order to close out the warning letter.

We are pleased with the transaction and with the transition and the launch of the U.S. Zomig franchise through our branded division. Our neurology-focused sales force initiated a concentrated promotional and a sampling after to the neurology target audience. We are optimistic that our efforts should continue to pay dividends.

Our generic Adderall XR sales have improved the past 3 quarters as we continue to receive supply. At this point, it is still too early to predict the impact of the recent approval of another generic Adderall XR product. We will be monitoring the market dynamics and should have a better picture in the next 2 to 3 months. But it is important to remember a few things: first of all, the royalty rate that we paid this quarter declined by 60% from the previous rate; second, the PEA [ph] can also play a significant role since every player will need the DA approve the quota for the purchase of this controlled substance; and third, we have been serving our customers for more than 2.5 years and understanding their needs.

While Zomig and the generic Adderall XR are significant contributors to our results, we are actively working to enhance our market of product portfolio and the pipeline of a pending product, both internally and through partnership. We recently announced an agreement with TOLMAR to commercialize up to 9 current approved generic topical prescription product. This agreement also included 2 additional generic topical products, of which one is a first-to-file product. We anticipate that after a brief transition period, we will begin marketing those products late in the third quarter or early fourth quarter. This transaction is expected to be accretive to our 2012 EPS and allow us to accelerate our entry into alternative dosage form area.

In just 2 years, we have partnered with 4 different companies on numerous alternative dosage form products. In this short time, we now have a shared portfolio consist of 9 approved generic product and the 15 pending, all in the development stage. These 15 products have brand and the generic sales of approximately $2.5 billion, with a number of them still having the potential to be first-to-file or first-to-market opportunities.

Even more important is that many of these alternative dosage form products are expected to have a good market sustainability due to the difficulty in the development and the making of these products. With the 46 internal and external pending ANDAs at the FDA, with a total brand and a generic sales of $20 billion, our pipeline should provide meaningful enhancement to our base beginners in the future.

Currently, the outstanding warning letter inhibits our ability to obtain approval for a number of our pending ANDA products. We expect that upon the resolution of the warning letter, we should begin to see approval for products and backlog, and we'll look to commercialize those opportunities, assuming the market dynamics remain attractive.

We continue to make progress in 2012 on pre-launch priming for Rytary. As you probably know, the PDUFA date of October 21 is quickly approaching. And we have had a dialogue with the FDA, primarily in answering questions. There have been no outstanding issues at this point. But of course, it is too early to tell. We continue to be excited about this product and its marketing potential. The Phase 2b clinical trial for IPX159 continues on schedule, while still targeting release of the top line results by the first half of 2013.

In closing, we will continue to explore investment opportunities that can deliver growth and the progress impacts towards its long-term generic and brand region goals. The [indiscernible] development team for both of these divisions remains [indiscernible], revealing such opportunities. We recently hired Brandon Smith, formerly at Amgen, to spearhead our strategy and the corporate development activities. And while we look externally for development opportunities, our internal R&D remains the driving force for our future growth.

I'll 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. Good morning, everyone. Second quarter 2012 revenue increased almost $41 million to $166 million compared to prior-year quarter, driven by the $28 million earned on U.S. sales of Zomig tablets as we begin stocking our customers with Impax Pharmaceutical label products. This accretive transaction is meeting our objectives to increase the revenue and financial contribution of our brand business, while offering an attractive commercial opportunity for us to create value via our neurology focused sales force as we prepare the brand franchise for the launch of Rytary.

Our second quarter 2012 revenues exclude U.S. Zomig orally disintegrating tablets and nasal spray sales by AstraZeneca. However, we did receive the benefit of $16 million of gross profit from the sales of these products during the second quarter, which was recorded as a reduction of the $130 million purchase price payable by us to AstraZeneca during 2012. Under the terms of the agreement, we paid $30 million in the second quarter and have paid $55 million of the $130 million in the first half of 2012.

We've completed the transition of the Zomig tablets -- orally disintegrating tablets and nasal spray. Beginning July 1, all sales of these -- of the 3 products were sold under the Impax Pharmaceutical label and were recorded as revenues within our brand division.

Also contributing to the higher sales in the second quarter 2012 was a $12 million increase in generic Adderall sales compared to the prior-year quarter. This is principally the result of increased deliveries from our third-party supplier and customer buying patterns increase. Our sales of the product over the past 3 quarters have meaningfully improved, and we'll continue to diligently work to secure as much supply as possible.

Our gross profit margin in the second quarter 2012 was 47%, in line with last year's second quarter margin despite being impacted by several events. Included in the second quarter 2012 cost of goods sold is a $14 million charge for amortization- and acquisition-related costs related to the Zomig transaction. This item had an 8% negative impact on the second quarter mark. In addition, the $16 million in gross profit received during the second quarter 2012 from AstraZeneca on their sales of the ODT and nasal spray products was not included in our GAAP results.

Adjusting for these 2 Zomig items, our gross margin in the second quarter 2012 would have been 59%. Each of these matters has been appropriately reflected in our reconciliation of non-GAAP income included in the earnings release.

Total operating expense in the second quarter 2012 increased approximately $6 million or about 14% compared to the prior-year quarter, driven primarily by higher SG&A costs, partially offset by lower R&D cost.

SG&A expense for the second quarter of 2012 increased $9 million compared to the prior-year quarter, driven by higher selling and marketing costs associated with the U.S. Zomig franchise, including the addition of 20 sales reps to our existing base of 64 reps. Also contributing to the increase in SG&A was a charge related to employee severance, as well as increased employee-related expenses, including the expansion of our brand division's infrastructure and market research activities. These increased costs were partially offset by a decline in corporate litigation expense.

R&D expense for the second quarter 2012 declined $4 million compared to the prior-year quarter. Higher R&D in last year's second quarter related to pre-NDA clinical trials for Rytary, partially offset by a $1.6 million charge for an in-process R&D, related to our recent TOLMAR agreement.

We've revised our full year 2012 expense guidance for patent litigation due to increased activity on a number of our pending ANDAs. Our revised patent litigation expense guidance increased to a range of $10 million to $13 million, up from $10 million.

Our effective tax rate of 38% in the second quarter of 2012 was higher than last year's second quarter rate of 29%. This was primarily due to the absence of a federal R&D research and development tax credit in this year's results.

During the second quarter of 2012, we spent approximately $18 million in capital expenditures. For the first 6 months of 2012, we have spent $25 million on CapEx. We still expect that our full year 2012 CapEx will be approximately $78 million, principally due to the construction of our manufacturing facility in Taiwan, continued improvements and expansion of our research and development and manufacturing facilities in Hayward and our packing and distribution facilities in Philadelphia.

We ended the second quarter 2012 with over $354 million in cash and short-term investments with no debt. Our healthy balance sheet provides significant resources, enabling us to continue to invest in our business, both internally, through facility expansion and improvements, and externally, through our preferred approach of making selective investments and partnerships or M&A opportunities.

Each of our generic and brand business development teams, which are managed by our presidents of their respective business units and supported by the finance department, will continue to focus on niche products and products with technology bearers that offer market sustainability.

We remain diligent by making smart investments with accretive returns, such as Zomig and TOLMAR transactions.

We look forward to updating you on future business development activities as they occur. Thank you for your participation, and we'll now turn the call back to the operator to open the line for questions.

Question-and-Answer Session

Operator

[Operator Instructions]

Bryan M. Reasons

[Operator Instructions]

Operator

Your first question comes from Shibani Malhotra with RBC Capital.

Shibani Malhotra - RBC Capital Markets, LLC, Research Division

The first one is for you, Larry. In terms of the approval for IPX066, can you just talk about how important it is that you get Hayward approved or resolved before then, and why, I guess, is Impax not been moving that block as a backup, given that, that could potentially hold up the approval or at least [indiscernible] the approval? And then, second question for Bryan on PD, I know you talked about updating us as we move forward during the year, but can you just talk about the [indiscernible] you're looking at and has anything changed in terms of the direction Impax is going in for the next few years?

Larry Hsu

Okay. Let me try to answer part of the first question and then turn over to Michael and see whether he has any additional on that. In terms of the facility tied into the IPX066, I think the most important is that you recognize that we have the pre-approval inspection at Taiwan with no observation. Obviously, that's the most important clue. The Taiwan is the primary manufacturing facility for Rytary. Now as far as how critical the Hayward is, at this point, obviously, and one of the options -- or, as the public allows, result from our opponent here is to withdraw the Hayward side from the MDA. Of course, it's not as simple as just going to the FDA and withdraw it. We need to work with the FDA and make sure that does not prevent the approval. Even by withdrawing, it does not prevent the approval of the Rytary at this point. So we have not had a conversation with the FDA at this point on that. And as I mentioned to you, obviously, we'll continue working on trying to communicate with the FDA in terms of resolving the warning letter issue. Our first part is resolving the combined issues so we can close out the warning letter as quick as possible before we worry about anything else at this point. Michael, is there anything you have to add?

Michael J. Nestor

No, I mean, I think you've covered it pretty well, Larry. I mean, it's just [indiscernible]...

Shibani Malhotra - RBC Capital Markets, LLC, Research Division

Can I push you a bit on that, Larry? I just want 2 things, and I guess I'm happy to go back in the queue if I'm taking up too much time. But can you confirm that IPX066 can get approved even without Hayward? And just talk us through the process, because I guess in the past, management has indicated that the approval of Hayward is not required for the approval of IPX066, and investors really care about that.

Larry Hsu

Well, I think it's very difficult for us to make a definitive answer at that point. And as I've mentioned, we have not talked to the FDA about this, okay? And we do not believe it's appropriate to talk to the FDA at this point while we continue to focus on resolving the warning letter issue. It is important for us to put an effort on the first party. And as I mentioned earlier, getting close to the warning letter, if we feel there is a need for us to bring the issue to the FDA, we will. But at this point, we think it's not a good timing for us to talk to the FDA about that yet.

Bryan M. Reasons

This is Bryan. On your question about BD, there's no change to our BD strategy. It's being led by Larry and Carole and Michael. Finance's role has been and will be to support them on modeling a financial analysis of a potential transaction, as well as structuring of the deal. And I was -- I've been doing that for the last 6 months and our finance team will continue to do that.

Operator

Your next question comes from Corey Davis with Jefferies.

Corey B. Davis - Jefferies & Company, Inc., Research Division

I have 2. First, now that Purdue has filed the Citizen's Petition on what they think a generic should do to prove tamper equivalents on OxyContin. Couple of questions: number 1, do you think what they proposed is reasonable? Or number 2, have you done any of these types of studies already for your ANDA that's on file? And number 3, when, if ever, do you think the FDA actually provides official guidance on this?

Carole S. Ben-Maimon

So, this is Carole. So I think, I don't really want to comment on what we have or we have not done. Clearly, tamper resistance has been an issue. It's been not only in the news, but it's been an issue at the government level, at the federal level. And these tactics have been tried for many, many years. I think what's really important is, there is nothing in the labeling for any of the tamper-resistant products at that time that allow them to claim tamper resistance. In addition, non-tamper-resistant products at the brand level still remain on the market, and there are even non-tamper-resistant generics still on the market for the lower strengths of the Opana ER. So although I know that it's an issue, and clearly, we can't predict what the agency is going to do. I think the jury is still out and we won't know until the agency actually takes action. When do I expect them to take action? That's up to the agency. They have said they're targeting the end of this year, which would make some sense, given the patent expiries and the potential launches that are about to occur. But again, I don't think they're going to make any -- take any action until they're actually comfortable with what that decision is. And we can't forget also that there is now a new head of OGD starting, and that may impact their timing as well, because I'm sure he's going to want to weigh in on it.

Corey B. Davis - Jefferies & Company, Inc., Research Division

Okay, great. And second question, do you still expect to be able to launch your generic Opana ER in January of 2013? And at what point can you start actually getting DEA quoted to be able to start manufacturing inventory to be prepared for that launch in January? Is it something you can start on now-ish through purchase orders or is it closer to the end of the year when you would actually start building inventory for that?

Carole S. Ben-Maimon

So as you know, we have approval. So as long as that approval is not withdrawn because the FDA decides that the product was removed from the market, the brand product was removed from the market for safety reasons, we will continue to have approval. We obviously don't want to provide a lot of competitive information to anybody who we'll be competing against, and so I don't want to really comment specifically on what our plans are. We're obviously aggressively evaluating the market, and if we think there is an opportunity to launch the product and sell appropriately into the market, we will. With regard to quota, we can -- you can get a quota in anticipation of a launch. I don't want to give you details about what we are or aren't doing, but clearly, we're aggressively evaluating the market, and if we deem it appropriate, we will launch in January.

Operator

Your next question comes from Randall Stanicky with Canaccord Genuity.

Randall Stanicky - Canaccord Genuity, Research Division

Two questions. Larry, I just want to go back to Shibani's questions because I'm a little bit confused. We're now less than 3 months to the PDUFA date for Rytary, and not going to the FDA now, are you suggesting that you have a high level of confidence in getting this warning letter completed or closed out before then? And can you help us just understand, what are we waiting for? We need a reinspection, is this just on the lab side?

Larry Hsu

Okay. That's a fair question. So let me try to answer it this way. First of all, as far as the FDA resolve this -- the warning letter issue, obviously, we don't have a control on the timing. As much as we're confident that we have done a lot to improve the quality stuff, but -- and again, coming back to the key issue is whether FDA is going to come back to do the reinspection and give us the closure on the warning letter, we don't have a control on the timing for that. But on the other hand, we don't want the FDA to start to misunderstood that we were trying to find a way out, okay, at this point. We do know how much time we need, although I'm not going to address that issue, but we do have looked into that, and we know that at a certain time, when we need -- when we raise the question to the FDA and get the answer to start the action to pull the Hayward out of the NDA, and as long as we give ourselves enough time and there's no benefit by waiting the -- to question to the FDA, too early from that point of view. So at this point, I think, again as I mentioned, we want to focus on the communication with the FDA on resolving the warning letter issue, close out the warning letter. That's the most important to us.

Randall Stanicky - Canaccord Genuity, Research Division

Well, I just want to be clear, because you had the reinspection before there were no repeat concerns, it sounded like, going to back to your last earnings call. And so when we talk about the warning letter, are we talking about the manufacturing side or are we talking about the new observations on the lab side? And then with those observations, have you now fully completed that work and are you just waiting on the FDA to come back and then give you the green light?

Larry Hsu

Okay. Obviously, the only outstanding question that we know of are the questions related to QC lab, okay? So we, obviously -- that's the focus. We've been putting effort in the last several months. On the other hand, when the FDA comes in, obviously, you know that well. FDA inspector can look in anywhere they wanted to look into that. So I would not want to tell you that that's the only area or departments that they agreed to look at. But we think that's probably one of the most important areas, talking a lot. So that's where we've been putting the focus on, try to resolve the issue as much as possible. Now, but as far as the work we have done, we have done majority of the work, and I think I mentioned that in the past. As far as to moving forward, we have changed the SOP. We turned out the chemist even before the inspector left the facility. But we also promised FDA we will with respect to the company go back to look at the product on the market, and which we are doing it, and we have completed most of the work. But again, still with all the communication with the FDA, says no executive knows where we are in terms of those reviewing process on that.

Randall Stanicky - Canaccord Genuity, Research Division

Just to be clear, though. You expect the -- this close out and then reinspection to happen before the October timeframe for the PDUFA.

Larry Hsu

We don't know. We don't know at this point. I mean, obviously, we can always hope that we can get this in time, but again, it's really totally up to the FDA.

Operator

Your next question comes from Elliot Wilbur with Needham Capital -- & Company, I'm sorry.

Elliot Wilbur - Needham & Company, LLC, Research Division

First question I guess would be for Carole. I think that one of the areas in which investors have been somewhat disappointed with the Impax story over the past couple of years is just sort of the, perhaps, perceived lack of aggressiveness in terms of going after some of the generic acquisition opportunities that are -- have been out there in terms of platforms or larger product lines. And certainly from our position, we can look at the financials and sort of assess whether or not the company has the balance sheet and cash resources in order to be able to make an acquisition. But can you maybe just sort of describe to us, sort of given your perspective at this point, what you think the company's strategic capabilities are in terms of making acquisitions? I mean, do you think the company is in a position where it could acquire a larger entity and actually go through more of a more significant integration process, or do you think at this point the company's going to be more relegated to product line acquisitions? And then probably another question for you, Carole, as well. The recent TOLMAR topical deal seems like a nice little deal for the company, a couple of very attractive product assets that came in the door anyway with the incumbent having fairly significant market share in a couple of the products. Now I assume that they're not anxious to lose a lot of that business and are probably fighting pretty hard to keep it. I'm just wondering sort of how successful you think you can be in sort of maintaining the market share that existed prior to the acquisition of the products?

Carole S. Ben-Maimon

So I -- to make it really short, I mean, we absolutely can do a major acquisition. I think the biggest issue is making sure that the acquisition is valuable and fits our business model. And so, I don't think it's a matter of capability. I think we have the financial wherewithal. IB [ph] team has been built out over the last 2 years quite significantly. I've joined and we have Brian now, who's new. And as you've heard from Larry's discussion, we've hired somebody who's running corporate strategy and will help us be doing some of the analysis. We have general counsels. So I think the team is very much in place to be able to grow the business significantly. But obviously, we want to make sure that what we do takes the successes that we've had in the past, which are high barrier to entry products, and applies them to new areas like the alternate dosage forms. So I think what you're probably going to see is a methodical and logical approach to M&A where we consider all opportunities, but when we come across something we really think is strategic, it can really add value to the business, we won't be afraid to take advantage of it and move ahead. And then you'll also see some of these very strategic partnerships. And I think TOLMAR is a really good example where we have a partner that we know and has a proven track record to be able to develop and get approved and produce these products in order to make us competitive. We're really excited about it because it gets us very significantly into an alternate dosage form, and we do think that we can maintain market share. There might be some compromising on pricing in order to maintain the business, but these products will be profitable for us. They will be accretive this year, as we've said in the past. And we have at least one very significant, I think, P4 opportunity in the G solar aids [ph] that we talked about when we put out the press release. And so, although I think the old owner of these products will be aggressive, I think that we will be able to be very, very easily and very aggressively compete. It's right in the retail channel. It's right where we're used to. It's where we play every single day with our current marketed products. And so I'm actually very excited and optimistic about it.

Operator

Your next question comes from Greg Waterman with Goldman Sachs.

Gregory Waterman - Goldman Sachs Group Inc., Research Division

First, a quick follow up on the Hayward facility. You mentioned some additional work is still underway. Just so I'm clear, are you ready for reinspection? And if not, when do you expect to be? And then second, could you just characterize the end of backlog in a little bit more detail, size of opportunities, timing on approvals and how we should think about that?

Larry Hsu

Okay. On the first question, on the reviewing the bad record on these things. Again, I'm -- not that [indiscernible], I'm sorry -- on the QC lab related to the bad release of these stuff. At this point, we do not believe the FDA is looking for us to finish all the work. And as I mentioned earlier, we have finished majority of the work anyway, but it is clear that FDA has full understanding of what the protocol we use, the schedule we have and everything. So at this point, again, we do not expect the FDA will wait until everything is finished before coming back, but that doesn't mean that we know when they're going to come back. Again, you all know that, they do come back whenever they want to come back. So that's as much I can give you update. What was the second question?

Carole S. Ben-Maimon

With regard to the pending applications, I think we've told you in the past that we do have several applications that are pending that we think will be approvable once the warning letter is resolved. And they're not huge opportunities, but they are profitable opportunities. And together, they are -- they will help us grow our business. I mean, you know as well as I do the generic business is a business of new approvals. And so, we're always looking to launch something new. We are actually preparing for launch on a lot of these products in anticipation of the warning letter being resolved. And so, once that happens and we start to get approvals again, we will be prepared to launch these products right into the marketplace.

Operator

Your next question comes from Sumant Kulkarni with Bank of America.

Sumant S. Kulkarni - BofA Merrill Lynch, Research Division

Could you remind us as to how Impax's IPX066 or Rytary is different versus the old Vadova product? And apart from product nomenclature, what led to non-approvability on that product and what have you learned from that experience to make the IPX066 approval process potentially smoother this time around?

Michael J. Nestor

Well, I think relative to the differences between IPX066, Rytary and Vadova, they are completely different products. Vadova, when it was originally formulated, was just the immediate release carbidopa-levodopa joined with controlled-release carbidopa-levodopa, and FDA's concern there was that there would be confusion on the part of physicians because in many cases when the controlled-release carbidopa-levodopa is given, typically, it's also given with an immediate-release carbidopa-levodopa. And with Vadova having both components, they were concerned that physicians would additionally, as they had consistently with the generic controlled-release carbidopa-levodopa, add yet another immediate release carbidopa-levodopa to that mix. And they therefore felt that the potential downsides relative to the benefit were not there. So IPX066, Rytary, however, is a completely different product in the sense that it is a specific formulation of carbidopa-levodopa that contains within it various release drivers, if you will, for carbidopa-levodopa that allows us to extend the effect of carbidopa-levodopa that we believe in part is consistent and leads to the very good results that we've seen with the clinical trials that we've done with Rytary. Now in terms of differences relative to Vadova and Rytary and why we believe Rytary would be approved whereas Vadova was not. First off, it's the basic fundamental formulation for the product. As I said earlier, this is very different from what Vadova was. Secondly, we have completed the Phase III clinical trials; the apex PD trial in levodopa-naïve patients; the advanced PD trial, which was a head-to-head comparison with Sinemet CR or immediate release carbidopa-levodopa, where we showed statistically significant improvement over the immediate release carbidopa-levodopa. And thirdly, with our [indiscernible] PD trial, which was a head-to-head comparison with carbidopa-levodopa intact component, where we also showed highly statistically significant improvement over the CLE formulation. Based on that, we feel that what we're looking at here is a very different scenario for Rytary relative to what the whole Vadova concept was. So we think it's 2 totally different realms to consider, and the only one that's really on the table for any approval, obviously, at this point and for which the appropriate data points exist is Rytary.

Sumant S. Kulkarni - BofA Merrill Lynch, Research Division

This is a question for Bryan. Are the 2012 guidance metrics for gross margin and operating expenses on a GAAP or an adjusted basis and, if not adjusted, how much would they move?

Bryan M. Reasons

They're on an adjusted basis.

Operator

Your next question comes from David Amsellem with Piper Jaffray.

David Amsellem - Piper Jaffray Companies, Research Division

Just a couple. On Adderall, how do you think we should interpret the recent IMS data showing pretty limited volume share for the Actavis generic. I know it's early, but maybe you can help us kind of understand the dynamics there, and how should we think about the volumes trajectory for the op generic and deliveries from Shire in the third quarter? And then secondly, any new updates on generic Concerta, specifically, once you get the warning letter lifted at Hayward, how close do you think you'd be to getting the potential tentative approval, anything new on the case with J&J?

Carole S. Ben-Maimon

So with regard to Adderall, I think you have to be cautious how you interpret the script data for us as you were alluding to. And I think the real issue with Adderall at this point is it's a very early market, but what I think the script data actually suggests is that this is not a normal generic market where you have 9 players and the whole -- the price is going to tank and the brand share is going to go to 10% or 5% in 6 weeks. And so that's all I would really interpret from the script data, that it's going to be a more gradual uptick. It's going to take a little bit more time for this market to sort itself out. And at this point, it's really hard for us to predict exactly where it's going to end up. With regard to supply, obviously, we really can't predict. We have had, as you all well know, problems in the past. But I do have to say that in the last 6 to 9 months, the relationship has -- between us and Shire has dramatically improved, as well as the reliability of our supply. And I really hope that, that will continue going forward. I think we can't tell you that it will, but we would like to believe that it will. And I think as we've gotten supply, you see reflected in our market share our ability to sell, and I think that will continue and to compete. With regard to Concerta, I think that was your second question, right, David?

David Amsellem - Piper Jaffray Companies, Research Division

Yes.

Carole S. Ben-Maimon

Again, I don't want to comment on a pending application. It's really up to FDA what they choose to do. But again, we are pursuing the approval and we will continue to pursue the approval once the warning letter is resolved. The litigation has been stayed until September, I think, if I recall. And so, that's pretty much on hold. And again, we hope that eventually we will get approval and we'll be able to launch the product. But that will take some time.

Operator

Your next question comes from Michael Tong with Wells Fargo.

Michael Kallai Tong - Wells Fargo Securities, LLC, Research Division

Larry, I certainly appreciate your confidence in getting the warning letter and all the Hayward facilities resolved in a short time. But if we've learned anything, it's that we can't be sure when and how the FDA is going to act. So my question is, why take the risk? You've got the pre-approval inspection in Taiwan with no 483. Why not just go ahead and move with it instead of taking the risk of suffering a further delay? And then my second question with respect to Opana ER, as you think about potentially launching the "non-tamper-resistant formulation" does your decision affect in any way, shape or form what you might receive from Endo in the first quarter of 2013 in the form of $110 million payment?

Larry Hsu

Okay. I'll answer the first question and let Carole answer the second question. At this point, Michael, I do not believe there's any risk, and by delaying and asking FDA to question about withdrawal the Hayward side. As a matter of fact, I think if we ask a question too early, it can present a risk by the fact that given the FDA impression that we try to either delay the inspection or try to hide something or try to do something, which is typical to them. So at this point, and again, we had a lot of discussion internally and our decision is that we know how much time we need to give ourselves in order to withdraw this out of the NDA submission and we really don't see any benefit to we go ask FDA before that time.

Carole S. Ben-Maimon

And with regard to the payment from Endo, our decision has no impact on the value of that payment at all.

Operator

Your next question comes from Dewey Steadman with JPMorgan.

Dewey Steadman

How should we view the TOLMAR transaction in terms of revenue and gross margin impact in the near term, and then as the agreement matures, as these products mature? And should we expect more deals like TOLMAR, kind of these bolt-on deals. I know Carole spoke to it a couple of minutes ago, but especially so if the warning letter becomes more of a prolonged issue, and would you consider acquiring another company or facility just to expedite ANDA approval flow?

Larry Hsu

Carole?

Carole S. Ben-Maimon

Yes. So the TOLMAR deal is, as we said, it's accretive from 2012. These products are quite mature products, with -- there's one we've said that will be filed and then there's the one that's pending, the P4. But the other products are quite mature, and I don't expect much to change with them. I mean, I think we'll maintain our market share, I think we may have to compete on price because they are older and they are somewhat mature markets and there are others ANDAs out there. With regard to if the warning letter becomes more prolonged, I hope that's not going to happen. I think we're doing everything we possibly can not to make that happen, and you can never predict what's going to happen, but we clearly are taking the steps to avoid that. That said, I think in the interim and not only in the interim, if there are attractive opportunities with additional ANDAs that we can get approved or we can launch, we will be very aggressive in looking at them, and we've -- I've told you that we're looking at partnerships, we're looking at strategic opportunities and then, of course, we're look at significant M&A activity. And so we will continue to do that, and I don't know really that -- whether or not the warning letter is resolved or not is actually the driver. It's really the ability to grow our business.

Dewey Steadman

Okay. And then with SG&A and R&D, basically operating expenses, to get to your guidance numbers for the year, it would imply a significant step up in the second half of the year. Should we view that as a pronounced step up between 2Q and 3Q or is it more of a ramp through 3Q and 4Q?

Bryan M. Reasons

This is Bryan. It will be a ramp up. A couple of things are happening in SG&A, obviously. We'll have fully promoting Zomig for the full 6 months. We didn't have that for the full 6 months in the first half. And obviously, we'll be ramping up a lot of sales and marketing activities in front of the -- preparing for the launch of Rytary. So I think it will be a ramp up throughout the second half.

Operator

Your next question comes from Ken Cacciatore with Cowen.

Ken Cacciatore - Cowen and Company, LLC, Research Division

I just had a couple of follow-up questions on Adderall XR. I was wondering if you didn't have the manufacturing issue, do you believe you have an approvable drug? Why wouldn't you have gotten approval? Is there any reason to believe that Actavis has exclusivity or do you think you would've gotten approval if there was no manufacturing? And then on Concerta, just your read of the Citizen's Petition, is there anything that you think you need to now refile as they have outlined the requirements for approval? And then I was wondering, and I have no good way of asking this question, have you ever heard of TPG? Did they ever call you and what do you make of the Par transaction?

Carole S. Ben-Maimon

So Ken, I'll start with the easier ones first, not the last one. The Adderall application, I'm not really going to comment on. We have the AG, we are not going to be launching with that product at this point, and so there's really not -- we're going to continue to sell the AG for now, and it's been very profitable for us. With regard to Concerta, obviously, we've looked at the Citizen's Petition. We are continuing to pursue the approval of that product, and once the warning letter is lifted, we'll continue to pursue it, and hopefully, it will get approved. But again, I don't want to comment on a -- the specific science within an application. I'll let Larry talk to Par, but of course, we have -- we are aware of what happened to Par. Larry, you want to?

Larry Hsu

Well I guess the point is, obviously, we're not making any specific comments on this type of things. And again, at this point, the company's interest is to stay independent, okay? And -- but like all of the other public companies, we have to keep the shareholders, the interest in mind. So if anyone, any company interested in us, if they're curious or whatever, we have to look at it. But again, the management at this point is looking at the strategy to continue to grow the company and take up [ph] the company independent at this point. I think that we believe we have a very strong management team. We have a focused strategy. We just need to get out of the warning letter, and then start to get the company back to the growth curve we have, at this point.

Operator

Your next question comes from Ami Fadia with UBS.

Ami Fadia - UBS Investment Bank, Research Division

I've got a couple of follow-ups. First one is for Larry. You've said a couple of times in the previous questions that you know how much time you need to withdraw the Hayward facility out of the application. Could you give us some more clarity around the process and the steps involved in doing that and how much time do you think you need to do it? I mean, we've got 3 months to the PDUFA date and that's where the question comes from. Second one is just on the Adderall XR, as you've commented that your relationship with Shire has improved in the past few quarters and so has the supply, what does that mean for your litigation with them? Do you think you would put that aside for the time being, and how are you thinking about it?

Larry Hsu

Okay. I will try to answer your first question and let Carole address the second one. Again, I mentioned that and I emphasize again that we do know how much time we need to resolve the issue with the FDA and we prefer to wait until the last minute to take the action on that. Now, I do not want to get into the details beyond what I have said here, exactly what the timing and all of this, but I can tell you, we definitely plan to give ourselves plenty of time to resolve the issue by then. The warning letter has not been closed out yet. So that's probably the best I can tell you at this point.

Carole S. Ben-Maimon

And with regard to the litigation with Shire, we are continuing to pursue litigation. We still believe we have a very strong case and we still believe that -- and we're still requesting a trial date from the judge. That said, our primary focus is to ensure that we have continued supply. And so, we've told you in the past, I think, that we are in settlement discussions. We won't disclose what those discussions entail. And -- but our biggest focus is to make sure that we continue to have supply on an ongoing basis.

Ami Fadia - UBS Investment Bank, Research Division

If I could just ask a follow-up on the warning letter. Now, I think, Larry, you mentioned earlier that you don't think that the FDA is specifically looking for you to complete some of the work in Q3. Do you have a confirmation from the FDA that you don't need to complete it before they come back from a -- for a reinspection?

Larry Hsu

Well, and again, I don't think that we -- I can tell you one way or the other on 2 things. All I can tell you that we constantly have a conversation with the FDA on a very regular basis because they know exactly what we're doing and we keep them posted on the progress report on these things. So I have to say, though, for example, if you're using the pre-approval inspection we had early this year in February where we had a warning letter, and when FDA show up, actually we did not finish all the work yet at that time. And FDA knew then exactly where we were and how much we have completed. And -- but they still decided to come in. And again, I think the overall impression I had was that it is important for FDA to agree with your approach, agree with your protocol, the action of our plan. Once they agree with that and they're not always looking at it, you have to complete the work before they do that.

Operator

Your next question comes from Jim Molloy with ThinkEquity.

James F. Molloy - ThinkEquity LLC, Research Division

Can you address the article in the Journal about the bill on how Islam [ph] is looking to deter a pain killer abuse and introduce some legislation to make all abuse -- all of these opioids have abuse-deterring safeguards? I mean, how does that impact -- I know it's a long way to go, but I think your insight may be certainly relevant to how this may impact the opioid industry in general? And you guys in particular, given what might happen in January?

Carole S. Ben-Maimon

Yes. So, I mean, there is a bill on the table, as you know. There is a lot of activity to -- both -- on both sides trying to push the bill or not push the bill. I think what's really important to note is that the FDA has recently approved the REM protocol, the Risk Evaluation Mitigation process, for extended-release opioids. And with that said, that process is not even in place yet, and it hasn't been given a chance to work. So GPhA has been very aggressive at talking about the REMs program, talking about the fact that there are other alternatives to restricting access to opioids. There's a lot of concern that these products, although tamper-resistant, we all know that drug abusers are incredibly creative and find easy ways to get around tamper-resistance. The agency has not allowed claims for tamper-resistant for any of the products in the labeling, so clearly, they don't necessarily buy in to the fact that they are going to prevent abuse. And then if you also look at data that's out there, there really isn't a lot of data supporting the fact that these products prevent abuse. In addition to that, Opana ER, the old Opana non-tamper-resistant, is still in the market and still being sold by Endo. They have not completely transitioned that market. So although there is a bill there, although it is a risk, there's a lot of activity, and I think the jury is still out on what is actually going to happen and what FDA is actually going to do decide.

James F. Molloy - ThinkEquity LLC, Research Division

Okay. And we have a follow-up. Any update -- now, Bryan has done a fantastic job acting as CFO, any update on -- is he stepping into the role full-time, or when will there be a decision on that?

Larry Hsu

Well, let me try to answer that question. I think Bryan is taking the full responsibility as acting CFO at this point. And as you well doubt, we're also doing the searching outside, trying to replace the permanent CFO as quick as possible. And with that said, and you all know that Bryan is very interested in this job. Definitely, he will be one of the candidates in this pool. And we working very aggressively, hopefully, within the next few months, we will have a permanent CFO in place at this point.

Operator

We have a follow-up question from Elliot Wilbur with Needham & Company.

Elliot Wilbur - Needham & Company, LLC, Research Division

All right, so this is for Bryan, and this is the $64,000 question. What were generic Adderall sales in the quarter, if you wouldn't mind?

Bryan M. Reasons

$70 million.

Elliot Wilbur - Needham & Company, LLC, Research Division

You get that one right, then the job is yours. All right, $70 million. See how well he answered that? And then follow-up question is just with respect to gross margin guidance. You guys left it unchanged at 60%, but on an adjusted basis, you're slightly ahead of that for the first 6 months of the year. If I think about what's going to happen with Adderall, obviously, margins should go quite a bit higher, assuming that generic Adderall stays at roughly the same levels over the balance of the year. So I'm not sure necessarily kind of why you haven't sort of moved that up. I can't -- other than just maybe uncertainty on Adderall sales, I can't really think of where any downward pressure would be on margins. So maybe just comment on the degree of conservatism there.

Bryan M. Reasons

This is Bryan. You partially answered it. The kind of the uncertainty of where the market's going to land on Adderall was certainly one of the drivers in not changing our gross margin guidance. And then in the base business, obviously, as it matures, there's gross margin pressure on the base business. And until the warning letter and 483 are cleared, we won't have new approvals. If all goes well and the Adderall market's really favorable and we clear our manufacturing issues, we might revise that going forward.

Thanks, everyone. And that concludes our call for today.

Operator

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

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