Lannett Company Inc (LCI) 2017 Q2 法說會逐字稿

Welcome to the Lannett Company FY17 second-quarter financial result conference call. My name is Sherry and I will be your operator for today's call.

(Operator Instructions)

Please note that this conference is being recorded. I would now like to turn the call over to Robert Jaffe, Investor Relations for Lannett Company. Mr. Jaffe, you may begin.

Thank you, Sherry. Good afternoon, everyone, and thank you for joining us today to discuss Lannett Company's FY17 second-quarter financial results. On the call today are Arthur Bedrosian, Chief Executive Officer, and Marty Galvan, Chief Financial Officer. This call is being broadcast live at www.lanette.com. A playback will be available for at least three months on Lannett's website.

I would like to make the cautionary statement and remind everyone that all of the information discussed on today's call is covered under the Safe Harbor provision of the Litigation Reform Act. The Company's discussion will include forward-looking information reflecting management's current forecast of certain aspects of the Company's future and actual results could differ materially from those stated or implied.

In addition, during the course of this call, we refer to non-GAAP financial measures that are not prepared in accordance with US generally accepted accounting principles and may be different from non-GAAP financial measures used by other companies. Investors are encouraged to review Lanette's press release announcing its FY17 second-quarter financial results for the Company's reasons for not including non-GAAP financial measures in its earnings announcement. The reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures is also contained in the Company's earnings press release issued earlier today.

This afternoon, Arthur will provide a brief overview of the quarter, then Marty will discuss the financial results in more detail, including the Company's updated guidance for the FY17 full year, followed by Arthur's concluding remarks. We will then open the call for questions. With that said, I will now turn the call over to Arthur Bedrosian. Arthur?

Thanks, Robert, and good afternoon, everyone. Today we reported our financial results for the FY17 second quarter. Net sales increased 35% to approximately $171 million from $127 million in the prior-year second quarter. The increase was largely due to higher sales across a number of products and the addition of the Kremers Urban operation, which we acquired in November of 2015.

During the quarter, we receive four product approvals: memantine hydorchloride tablets, metaxalone tablets, morphine sulfate oral solution schedule two drug with color and flavor added, and lopinavir and ritonavir oral solution with a likely 418 days exclusivity on the hydroflaxin.

For the calendar year 2016, we received 12 product approvals. It is worth noting that among the 12 approval, several are oral solution medications. The capability to develop, manufacture, and market liquid generic drugs differentiates our product offering from many of our competitors.

This morning, the Wall Street Journal published an article about drug companies producing medicines outside the United States. I would like to mention that we are proud to manufacture 100% of our finished substance and DAs in the United States. As you know, we have been operating our API subsidiary in Cody, Wyoming for the past eight years. We believe that our skilled workforce is part of the reason our customers can and do rely upon us for high-quality products and superior customer service.

As most of you know, we previously received a notice from the FDA that it will seek to withdraw approval of our AMDA's methylphenidate hydrochloride extended-release tablets. We have requested a hearing with the FDA in an effort to convince the FDA that our methylphenidate product should remain on the market and available to patients.

We also requested, and the FDA granted, a 90-day extension to submit documentation supporting our request for a hearing. The new deadline for submitting the documentation is March 20, 2017. We remain confident that our methylphendiate products are safe and effective and we continue to market them.

Subsequent to the quarter end, we voluntarily made a $75 million payment against our outstanding revolving credit facility. This payment will save us approximately $4 million in asset-wide cash interest expense and in keeping with our goal to reduce debt levels. With that brief overview, I will turn the call over to Marty to discuss our financial results in more detail. Marty?

Thank you, Arthur, and good afternoon, everyone. As was mentioned earlier, I will be referring to non-GAAP financial measures. The reconciliation of the GAAP to non-GAAP numbers can be found in today's press release. Our earnings release also includes a schedule of our net sales by medical indication.

I also wanted to remind everyone that when comparing the current year's second-quarter results with last year's second quarter, please note that last year's second quarter only included approximately one month with KU's operations.

Now for the financial results on a non-GAAP adjusted basis. For the FY17 second quarter, net sales increased 35% to $170.9 million, from $127.1 million in last year's second quarter. Gross profit was $96.2 million or 56% of net sales, compared with $81 million or 64% of net sales. The decrease in the gross profit percentage was primarily due to the inclusion of a full quarter of KU's lower margin business in the current year period.

R&D expenses increased to $9.9 million from $9.1 million in the prior-year second quarter. SG&A expenses were $17 million compared with $11.6 million. Operating income increased to $69.3 million from $60.4 million for the prior-year second quarter. Interest expense was $17.9 million compared with $9.1 million. Net income attributable to Lanette was $34.5 million or $0.92 per diluted share compared with $35.4 million or $0.95 per diluted share for the FY16 second quarter.

Turning to our balance sheet. At December 31, 2016, cash, cash equivalents and investment securities totaled $259.1 million and total debt outstanding was $1.13 billion. Based on our strong second-quarter results, we are well within our required debt-to-covenant ratio.

As Arthur mentioned, subsequent to the quarter end, we paid down approximately $75 million against our revolving credit facility. Accordingly, the cash and debt amounts I just mentioned were balances prior to the pay-down of the debt.

I will now turn to our guidance, which has been revised since our last conference call. However, the net effect of the changes is not expected to have an impact on our FY17 profitability. Our outlook for the year remains strong.

Our guidance for the FY17 full year on a non-GAAP adjusted basis is the following: Net sales in the range of $675 million to $685 million, unchanged from our previous guidance; gross margin as percentage of net sales of approximately 57% to 58%, down from 57.5% to 58.5%; R&D expense in the range of $46 million to $48 million, down from $49 million to $51 million; SG&A expense ranging from $72 million to $74 million, up from $70 million to $72 million; Interest expense in the range of $69 million to $70 million, down from $71 million to $72 million; the full-year effective tax rate to be approximately 34%, unchanged from previous guidance; and lastly, capital expenditures into FY17 in the range of $55 million to $65 million, unchanged from previous guidance.

As I mentioned, we expect net effect of these changes to have a minimal impact on our profitability for FY17. Regarding the phasing of the remaining quarters in FY17, we expect net sales and profitability to be slightly higher in our fourth quarter compared with the third quarter.

We have a deep pipeline, including a large number of product applications currently pending at the FDA. Our guidance does not include sales in these products. Nor does our outlook include the benefit of any potential acquisitions or strategic alliances. Based on the guidance provided, we expect that our total debt net of cash to adjusted EBITDA will be less than three times by the end of our fiscal year.

With that, I will now turn the call back over to Arthur.

Thanks, Marty. We are aware of negative speculation with regard to our Company and we are not going to dignify it with a response. Now on to more important matters.

A year ago, as part of our plan to integrate KU, we began implementing a number of actions designed to streamline operations, improve efficiency and significantly reduce costs. We continue to make excellent progress consolidating our manufacturing sales, research and development, and distribution functions. Our efforts generated cost savings and synergies in FY16 of $33 million, exceeding our target by nearly $6 million. For the current fiscal year, we remain on track for additional cost savings. All packaging activities in Philadelphia have now been shut down and transferred to our Seymour, Indiana plant.

With respect to manufacturing, five of our high-volume products were transferred from Philadelphia and are now being produced at the Seymour plant. We have completed one additional AMDA transfer [zopamine] and [inpretafile] four more in FY17, which will allow us to transfer production of these products to our Seymour plant.

With regard to our pipeline, we're counting on timing of the FDA, 29 [inendas], including a 11 with the paragraph four certification. We are optimistic that we will receive several additional FDA approvals before the end of our fiscal year. In addition to our current filings, we have another 11 applications with the FDA through our alliance partners.

Turning briefly to the Department of Justice. In December, the Department of Justice filed criminal information against two former executives alleging anti-trust violations regarding two drugs which were not (inaudible) for sale. One day later, the state of Connecticut filed a civil lawsuit against several companies alleging anti-trust violations and civil conspiracies relating to the two drug products identified to criminal information.

Lannett was not (inaudible) as a defendant by the state of Connecticut in that lawsuit. As we've said before, the Company continues to cooperate with the Department of Justice as it had done since it was first contacted in July, 2014.

Turning to Lanett's future, our Board of Directors has approved a $50 million expansion of our facilities in Cody, Wyoming. The Board agreed to the project after reviewing the findings of a study showing the benefits of increased production of APR at our Cody plant to further strengthen Lannett's vertical integration.

Our staff in Cody has achieved extraordinary successes in product development and process efficiencies and continue (inaudible) with the overwhelming and enthusiastic support of the Cody community and the Wyoming state legislature we look forward to breaking ground as Cody's continued growth. (inaudible) represents enormous potential for our company. The US market alone exceeds $23 million. And to date no generics are available. With a major partner in (inaudible) [benefit of this project further to the] point where we can now take the reins and assemble the data for a successful filing with the FDA.

In addition, we expect to meet soon with ATC to discuss the work required to file in the EU as well. I can (inaudible) and emphatically ensure you that (inaudible) is quite healthy and as you saw in today's earnings announcement we continue to report solid financial results. The facts are (inaudible) in products, we have a deep pipeline and outstanding growth opportunities.

Lannett and its subsidiaries have operated in the generic industry for a combined 418 years without ever receiving a CGMP warning letter. We are focused on extending our prospects through internal research and development efforts as well as strategic alliances, continuing to pay down our debt, and becoming an ever more efficient US-based organization.

We remain committed to developing cost-effective in-demand medications and producing top quality products and providing exceptional customer service to our fellow Americans. With that overview, I would now like to address any questions you may have. Operator?

(Operator Instructions)

Our first question is from Gregg Gilbert of Deutsche Bank

Thanks. Good afternoon. Arthur, first question is whether Trump has asked you for a meeting yet so we can learn about how the generic industry works?

No, but I've requested one.

Okay.

I wonder if that company CEO should be invited too.

Arthur, has there been any communication with the DOJ since the last call when you gave us a pretty good summary of what had happened to date? Just wanted to confirm whether there has been any communication since then?

No, there has not been.

Okay. Two questions, then. One is, how much flexibility do you think you have in your outlook should there be competitive approvals against some of your larger products? My second question is could you go into a little more detail on the facility expansion? And how much of that has to do with opioids, for which the outlook is quite poor versus other broader initiatives at Lannett? Thanks.

Okay, well, as you know, we're in the generic drug space so I've spent a lot of years in it. And I would say I'm always ready for generic competition. The key really is our relation with our customers and our service levels. The general competitions we face, because we're a good supplier, is matching the price of a competitor.

And that happens all the time, it has been happening every year for the past 48 years, including our year now. We experience that at Lannett on a, I would say, probably a quarterly basis because prices fluctuate quite a bit in our business. So I would say we are always prepared for that eventuality.

One of the things we try to do, of course, is use the pipeline of new product approvals to offset those pair of declines that we once in a while when you have a generic competitor. But generally we don't lose our customers. It is a position where if you match prices, you generally keep the customer. As far as the expansion question, our goal is to be vertically integrated in pain management, and pain management includes quite a number of products well beyond the opioids.

We've done a lot of research and we're in the opioid field in terms of vertically integrating our own products as well as outside of the opioids where we are looking at products and processes that we are improving. So rather than, let's say, making tea the old fashion extraction way where you did a bag in a pot of hot water, we're coming up with new methodologies. The community, the plant we are in is 75,000 square feet off 15 acres currently.

If we want to expand the product, we have a limitation on the terms of production at that facility, which for competitive reasons, I don't want to mention. But that limitation would then limit by potential opportunities to make more money. So there's no sense developing new mobility technologies and new products, and then being stymied by the limitations of the facility.

So the community has been extraordinarily cooperative and actually, I would say, more than cooperative, solicited us to expand, and has made some very generous opportunities available to us both on a local level by the city of Cody, Wyoming and of course from (inaudible) of the state legislature. Last Thursday, I met with the governor of Wyoming, and clearly the entire state, as you know, it's a very small state in terms of the number of people, but a beautiful country, and I encourage people to visit it.

There's a lot of anxiety about being dependent on the oil and gas industry. So they see the opportunity that we bring to them as an enormous opportunity for the state. And for us, we find the atmosphere out there very friendly to business and look forward to expanding that facility to give us more opportunities to make more product. And those products would encompass not only the opioids, but other non-opioid products. But most of those products would be considered schedule drugs.

All right. Thanks I have others. I will get back in line. Thank you, Arthur.

You're welcome. Thank you.

Thank you and our next question is Andrew Finkelstein of Susquehanna.

All right. Thanks for taking the question. I was hoping you could talk a little bit more about your expectations for the coming quarters in terms of the potential impact from launches of approved products and the recent performance of customer product (inaudible)? And then on the gross margin was a little lighter this quarter. Your guidance reflects a rebound. Can you talk a little bit about the mix affects there?

I'll go ahead and start with the gross margin topic. So the gross margin at the 56% level for the quarter was a bit less than we were expecting. The main drivers of that were two products. We had methylphenidate sales in the quarter which were greater than what we were expecting, back in our previous guidance call back on November 3.

So methylphenidate came in a bit stronger, which is a good gross margin product for us. But that favorable benefit was altered by lower fluphenazine sales, which at a higher-margin product offset and more than offset the methylphenidate gross margin benefit. So it was essentially those two products, a mix of those two products, which brought gross margin down by about 2 percentage points in the quarter.

And then for the rest of the year, it was basically mix again, as we were [particularly] optimistic about the performance on the, generally speaking on the Lannett side of the business, the legacy Lannett product as compared to the Kremers products and that continues then to drive the gross margin higher in the third and fourth quarters compared with the second.

Could you characterize your visibility on fluphenazine at all?

I'm sorry, say that again?

Could you characterize your visibility on fluphenazine for the rest of the year? Is there any incremental visibility on the sustainability there?

Right now, we have adjusted our numbers and our expectations for the rest of the year on fluphenazine. What we saw in the quarter gave us reason to recast the numbers a bit lower for FY17 for the product and right now, we've still got with just five months left in our fiscal year, we feel we're pretty good on the mark now for what's a reasonable expectation for the product for the rest of the year. So we are not expecting any further change to our full-year outlook for fluphenazine. I think you had some other questions, Andrew. Did you want to repeat that perhaps?

Oh, what you are thinking about the contribution from launches in the back half of the year. There's no recent launches and approved by unlaunched products.

Well, those we'll just add to the comments that Marty said about the fourth quarter being stronger than the third quarter. One of the issues that we faced as we were handling the synergy and moving production and closing it down in Philadelphia, we would receive approvals for some of the products in our Philadelphia facilities.

So the question became, do then go ahead and make the product in the facility you are planning to close or not interrupt you synergy and move to Seymour, Indiana and postpone the manufacturer of those products and move them to Seymour? And that's what we've been doing.

We made the decision to essentially not going manufacture the products that we had approved in the Philadelphia plant, because would interfere with our plants for success to move our plant to Seymour; so that has caused some of the delay in some of those launches. But those should be now recovering in the third and fourth quarter and that should give us strength in addition to our regular sales growth.

That's helpful. Thank you.

Our next question comes from Elliot Wilbur of Raymond James.

Thanks, good afternoon. Art, did you break out the John Travolta suit for that intro song or --?

I have to lose about 10 more pounds, then I can.

Well, I'm glad that you still have it though. First question is just with respect to Levothyroxine; obviously, it was another very strong quarter. Can you talk a little bit about price volume trends in the quarter?

Last couple of periods, you faced negative headwinds on price that moderated somewhat last quarter and you've more than made up for volume. I'm just curious now if you're kind of back in a position where price is more of a neutral and it's pure volume, and maybe just a little bit of color commentary and sort of the price volume dynamics on that product?

So yes, Elliot, I will take that first start. So on the product, the good news there that we don't -- volume continues to be very strong. It's not -- price is pretty much holding, as you've heard us mention over the last couple of calls, that some months ago, we reached duration with a certain customer where it was basically price concessions in return for commitments on purchases.

So now, fast-forward several months and the product volume is doing very well. And we think that volume will continue for the rest of the fiscal year; price we're expecting just to hold about where it is now. Art, I don't know if you want to add anything to that?

No, not really. It's hard to position which one of your products when you go up and down. We do the best we can at the beginning of our fiscal year when we assemble our budget. And then at the end of the year, everyone looks back and says, you know we weren't specifically right on each product, but overall, the numbers were right. So it's hard to sit there and tell you that you know we would change the numbers.

We are comfortable with where we are. We see the movement. We know there will be additional competition. We always expect that. But we also anticipate that some of that competition doesn't impact us very long either. And as we move products to the line, sometimes it setting in a new growth, and new products, it may just offset a decline or revenue in one of the older products.

But in the end, our growth is there, so it doesn't really matter whether it's the old product is strong, or the new products adding to the growth. We see the products in the market rather stable for ourselves, quite frankly. We're not anticipating anything different. I think it's business as usual.

I've been running this Company for 15 years and it's really been nothing extraordinary going on with the exception and the operation of price increases for a couple of years. It has always been spiraling prices that goes down, and opportunities here and there where you have a price increase where you're the only one with the item.

And you have good products coming through from the FDA. With the FDA approving them, as we believe they are coming, we will certainly see a lot of value to our benefits as well. So it's hard to be too negative about the marketplace. Actually, I can't be negative at all.

Okay. And a question for you, Art, with respect to the generic pipeline. I think last conference call, you had said that you are hopeful that you could possibly get as many as 10 to 12 approvals in the current fiscal year. But I think you also alluded to potentially one sizable opportunity or opportunities that you seemed to be -- I think was quite promising in the pain management area.

I want to get just maybe an update on that product, and then whether or not any of the approvals you are hopeful for in the balance of the year could be considered relatively meaningful versus some of the smaller niche year products that have rolled out year to date.

Well, actually, the pain product, it's our product we are still awaiting that approval, and that is the one we have a lot of expectations from, not only for this year, but going forward. We think that will be a significant product for us because it's also one of our products that [we're thinking of] integrating. So it is kind of important from two points of view.

But no, we still haven't received that. We are getting approval; we believe some more are coming. We did predict we'd have 12 by year end. So we did receive, I think, five in this fiscal year; if I'm correct, gentlemen? Which leaves about seven more -- I think we'll probably still get those seven by June 30.

Okay. Then just the last question, Marty. I may have missed this in your prepared comments. I just wanted to get some detail on the [IP R&D] write-off? What that was tied to specifically?

Yes. That was -- we did not talk -- you did not miss that on the prepared remarks. It was $23 million, that is related to one of the projects in the KU IP R&D portfolio. One of the projects we've decided to discontinue, that project had a value of $23 million and that became the impairment charge.

Okay. Was it a filed asset, filed product, or not filed asset?

No. It was something that was in the works; it was in the process of R&D.

Okay. All right. Thank you.

Thank you.

Our next question comes from Scott Henry of ROTH Capital.

Thank you and good afternoon. I just wanted to start with a couple of questions on the categories, cardiovascular looked down a little bit sequentially, and thyroid deficiency was a little stronger than I might have expected. How should we think about those going forward?

In cardiovascular, the decrease that you are seeing was pretty much driven by to Digoxin, which has been still coming down for the last several quarters now. So that was the Digoxin coming down, and then meanwhile, the product category was picked up because we had two months of KU -- I'm sorry two additional months of KU business versus last year and then this quarter, we had just one month.

So going forward, you would continue having the KU sales for three months of the quarter, I think as we just had in this previous quarter. Digoxin would pretty much hold steady, so I would say for the remaining two quarters, it should be about those same levels.

Okay. And that is on the cardiovascular category?

Was it cardio or the thyroid?

The thyroid deficiency; obviously, Levo.

Levo, it is just a continued strength, Scott, of the Levo product as we just -- I just talked about in your previous question.

Okay. So you do think that Q2, the number was representative of demand; there was no stocking variability in that number?

That's about right, yes.

Okay, great. Now in the other category, anything -- any levers that we should be expecting? I know -- I thought respiratory was going to pick up in Q2. Should we expect that in Q3?

I think what we said was on respiratory was it was really again last year second quarter was really this whole piece with KU business, one month versus three months. So what we think we can work with is using the second quarter as a run rate, it would be a reasonable run rate.

Okay. And then final question, you spoke a little bit in detail about the R&D projects with regards to generic insulin and the codeine expansion. My question is, what is the timeline to convert those projects into revenue? How long should we be thinking about it?

Well, for the expansion, I think two to three -- the second and third year, we will probably start to see some benefits. And then on the insulin, roughly two years.

Okay. So you would -- I assume generic insulin, you would file in about two years? Is that fair?

No, we should be on the market in two years. Both cases, on the market in two years.

Okay. Thank you for taking questions, guys.

Thank you, Scott

Our final question comes from Matt Hewitt of Craig-Hallum Capital Group

Good afternoon, gentlemen. Few -- a handful of questions for me. First and foremost, you gave us the 29 NDAs that are currently submitted at the FDA and then you've got 11 partner products. What is the addressable market opportunities for those two baskets?

Do you have that number, Frank? No, I don't have that number. I know we gave out that number previously but I don't have it, I can get back to you by phone with that number. But I know we've previously talked about the 11 that we had there with the alliance partner; what the market potential was for those.

On the other 29, because it changes as we get products approved. I would have to go back and ask my colleagues to do the calculation again. So let me get back to you with an answer on that.

That's no problem. As far as the four products that were approved here last quarter that you're shifting production, how quickly do you expect those to launch? Is that -- have some of those already launched here this quarter? Or is the cadence going to be by the end of the quarter you get one or two and then the rest launch at the start of the fourth quarter?

Well, I don't know specifically every one of them but I would say by June 3, by the 2, it should be by our fourth quarter, we would have probably launched maybe two or three of them. I just don't have a schedule handy. Hold on. I think there's going to be four products maybe by the end of June.

Because remember two of them, I know we're moving out there, so those two I know we'll have ready by the end of June. The other two, I just don't recall. I don't want to jump to conclusions. But I know some of them were already being produced. But they have to produced them, put them on [slowly], and get the [change] (inaudible) approved by FDA. We're trying to get approved very quickly, but there's still work to do.

So I don't want to make a prediction and then be wrong. Let me answer that question too later, because I will have to talk to the production people to see where we are, and regulatory as to when they think they are filing. But I am comfortable to say that by the end of June, most of those products will have been moved, manufactured in Seymour, and then launched.

Okay, great. So setting up for 2018, or FY18?

Essentially yes, because these approvals hurt our synergy plans and then we would have stopped and the worst thing you can do is just stop the synergy plan and delay it, because it makes more sense to just complete the transaction on these, essentially all put together and ready to go. And it's working like a Swiss clock, so why mess with that?

The other products, while we want to launch a product and get it approved, the launch is only (inaudible) going back to that and starting something into the plant that we're closing, which would then work into the packaging, because we close packaging. It's more than timing, actually.

The synergies are more valuable, more important than any one of these products being delayed to the market. (Inaudible) single products I know it could launch and in some cases, there's been no deterioration in the market while we haven't launched. So I thought it would be more competitive to jump in.

Okay. I have two more. One more for you, Arthur, and then one for Marty. For you, Arthur, do you feel like you're getting more comfortable, or you're getting better at understanding the way that the FDA is moving these applications through the pipeline in a way that you can maybe expedite the time from approval to launch?

Obviously, this situation is little bit different in shifting facilities. But you feel like you have a better grasp today that will allow you once the facility -- the Seymour is already to go, where you can get an approval and have that product launch within weeks, or a month or two versus having to wait?

Well, generally in our product history, I can't think of any -- I think we got something like 40 products approved in only 15 years. And I can only think of two products that weren't launched after they were approved. It's generally not a question of understanding the FDA per se because in some [cases] it's more difficult to know from the timing when you're going to get approvals.

The biggest problem is, the FDA has been throwing new requirements at all -- on old applications. So let me use the worst example. The product was supposed to be approved in January. It's been at the agency six years. Now it's in its seventh year. Still not approved and when they wanted it, they wanted an additional Fed study done.

Mind you, this drug is supposed to be taken on an empty stomach. A brand and the generics were not required to do this study so when someone throws a new requirement at you, you can lose a year just getting the study set up and in this particular case this drug has a lot of licensing that needs to be dealt with, because it comes from another country where it is being made for us.

As a result -- the raw material that is and the dosage from another location. So there's a lot of logistics on that one. So when the government asked for a additional study, we did it. We tried to appeal it and lost. We did the study, and now we still have to get that study submitted and approved. So that has delayed that product.

Almost every one of the applications, without exception, that we have not been able to get approved through the Agency is because they come to us with deficiency letters requesting new requirements that were not required at the time the NDAs were submitted. So let's say in 2014, the requirements was A. They added D and C before they approve the application, they ask us to submit D and C; that delays the application.

That is one of the things we complained about. Because it would have been easier for the government to say -- look, we're approving this subject to you doing these additional studies or additional work to be done, rather than hold up the whole application. We have complained about this to the most senior levels of the FDA, because it is really not fair to impart new requirements on old applications.

And that is not a question of whether we understand the FDA. Because the target keeps moving, no one's going to be able to get a shot at it. We are asking them to just stop moving the target. So (multiple speakers) -- I believe they know what to do, but they won't be able to keep doing that either because then they will be falling behind on their commitments to Congress.

So it's a catch-22 for them now. So if they keep doing that, they won't meet their requirements, so I suspect it's going to get better. We certainly do a better job on our end. I'm not going to say we [don't] improve year after year after year, but we are not really failing because of our filings being poor or insufficient, nothing like that.

All right, yes, and based upon the President's comments yesterday, it sounds like he might be trimming some of those new regulations to expedite the drug approvals in the first place, so that's good news.

I'm happy to buy him some scissors. Do all the trimming you want.

Marty, one last one for you regarding the guidance and I know that you guys don't guide to earnings specifically. But you just beat expectations here by a healthy margin, roughly $0.08. You also announced the paydown of the debt, which implies a tailwind for the second half of the year.

Yet your guidance is calling for, basically that it is going to have minimal impact. That would seem to imply that there is going to be a headwind in the second half of the year. Is that the gross margin impact? Or what am I missing?

Well, there were two things. It's -- the gross margin impact is one of them, and that's -- and we lowered the gross margin guidance. That's primarily reflecting the reduced (inaudible) in the forecast going forward with our guidance. That one [part] we broke down, as I mentioned in an earlier question.

The other thing is on SG&A expense. We increase the guidance for SG&A and that is predominantly due to higher interest -- I'm sorry, higher legal expenses that we're incurring right now. So as a matter of fact, though, there was a lower gross margin and the additional expenses of SG&A that gets offset lower R&D expense and lower interest expense.

From our guidance perspective the profitability that one has, the after-tax net income should really be about similar to what we were -- what is similar to what we were projecting in our previous guidance.

Okay. Just --

The anomaly is that amongst the different analysts, there's a wide range of expectations, but I think some of the numbers, they're reflected different perspective at different points in time on the methylphenidate outlook. Our own expectations now for the overall mix of products and the Company's outlook, like we are saying, the profits should be about the same as the last guidance.

Okay, great. Thank you, Marty.

You're welcome.

With no additional questions, I will turn the call back to you for closing remarks.

We look forward to sharing our progress on our next scheduled conference call in May. Thank you again for joining us today.

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect.