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Impax Laboratories, Inc. (NASDAQ:IPXL)

Q3 2012 Earnings Call

October 30, 2012, 12:00 pm ET

Executives

Mark Donohue - Senior Director, IR & Corporate Communications

Larry Hsu - President & CEO

Bryan Reasons - VP, Finance & Acting CFO

Carole Ben-Maimon - President, Global Pharmaceuticals

Michael Nestor - President, Impax Pharmaceuticals

Analysts

Ami Fadia - UBS

Dewey Steadman - JPMorgan

Louise Chen - Guggenheim

Ken Cacciatore - Cowen & Company

Jason Gerberry - Leerink Swann

Shibani Malhotra - RBC Capital

Greg Waterman - Goldman Sachs

Sumant Kulkarni - Bank of America/Merrill Lynch

Michael Tong - Wells Fargo Securities

Operator

Good afternoon. My name is Janice and I will be your conference operator today. At this time, I would like to welcome everyone to the Impax Laboratories’ Third Quarter 2012 Earnings Conference Call. All lines have been placed on-mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. (Operator Instructions)

Thank you. Mr. Donohue, you may begin your conference.

Mark Donohue

Thank you, Janice. Good morning everyone and welcome to our third 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 third quarter results and other business items. Following the prepared remarks, both will be available to take any questions you may have. And also on the call and available 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 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 third quarter 2012 earnings release, which can be found within the Investor Relations section of our website. And should you have any questions after the call please contact Investor Relations at 215-558-4526.

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

Larry Hsu

Thank you, Mark. Good morning, and thanks for joining us. First of all, for those that have been affected by the storm moving across the Eastern United States on behalf of all the employee of the Impax we wish to express that we are thinking of you and hoping that you and your family stay safe.

As you probably know we have two facilities in the Philadelphia area. We are closely monitoring conditions and at this time we are not aware of any damage of those facilities. We have already discussed the postponing our schedule for today, but decided to continue with the call in order to avoid potential back up of earnings report late this week.

Our third quarter 2012 results reflect the financial benefits of the accretive Zomig transaction. Total revenue increased this quarter compared to the prior year period by 21%, driven by U.S. sales of Zomig, as well as modest increase in terms of our global labeled generic products.

Our expected earnings per diluted share increased to $0.48 compared to $0.26 in last year’s third quarter. However, there were several items and adjustments within our generic and the brand business. During the third quarter 2012 that partially impacted our results compared to the prior year period; Bryan will review these items later.

We continue to be pleased with the Zomig transaction which exceeded our expectations in the third quarter. We remain optimistic that our concentrated promotional and the [center length] efforts to the neurology target audience will continue to meet or exceed our expectation as we prepare for the potential approval and the launch of Rytary in the first quarter of 2013. Our knowledge of the neurology market should be beneficial to our future sales efforts following the approval of our products.

A few words about our generic Adderall XR and fenofibrate products. For several years, receiving adequate third-party supply of generic Adderall XR to meet our customer demand proved challenging; while the supply situation has been poor over the past years, the FDA’s approval of another generic product in late June 2012 affect the overall market, and continues to be dynamic and evolving market.

Our generic Adderall XR sales in the third quarter were down from the second quarter of 2012 and expect to see continuous pressure in the fourth quarter. However, the 60% reduction in our royalty rates was helped to offset possible decline in our generic Adderall XR revenues.

We were not surprised by the recent approval of a second generic fenofibrate capsule product as we have publicly stated for several years that we expect the competition in this market. This additional entry will negatively impact our revenues in the fourth quarter. Our goal is to remain competitive in both the generic Adderall XR and the fenofibrate market and continue to meet the needs of our customers.

With only two months remaining in 2012 and with the number of events occurring between now and the first half of 2013, I wanted to highlight a few of these near-term items. In early October, we initiated commercialization on three of the nine currently approved TOLMAR alternative dosage from generic products. And in November we will commercialize the remaining TOLMAR products alongside our existing portfolio of the tablet and the capsules. Our business development activity will continue to focus on delivering growth from high value products, technology and businesses and complementary dosage forms.

We announced in the early August that we were notified by the FDA that a re-inspection of our Hayward facility will be necessary to close out the warning letter. We have since completed with respect to data review of the products on the market and to-date there have been no findings that would require any field actions. We will update you with any important information regarding the warning letter when appropriate.

Quality and compliance is not just the near-term item, it is an area we have committed significant resources to ensure we consistently maintain current good manufacture practice in the U.S., because the outstanding warning letter inhibit our ability to obtain approval for a number of our pending ANDA products satisfactory resolution of the warning letter as soon as possible continues to be a top priority for us.

Our product not held by the warning letter, one product side, one product not held up by the warning letter is our approved formulation of the original Opana ER. Our settlement agreement, we can begin marketing this product on January 1, 2013, because we were first-to-file and we expect to have six months of the generic exclusivity. However, marketing of original Opana ER is harder to protect at this point AND it depend on a number of factors that we are closely monitoring.

A couple of weeks ago, we announced that the FDA extended the Rytary’s PDUFA date by three months to review our September submission of request information. The new PDUFA date is now January 21, 2013. No new clinical trial or studies have been requested by the FDA. This delay is not related to [lower] levels. While we are disappointed in the delays, we continue to have a dialogue with the FDA and are continuing to prepare for the first quarter 2013 launch. We are also looking forward to complete the Phase 2B clinical trial or IPS 159 by the end of this year. We now expect to report top line results no later in the first quarter of 2013.

While these near term events commend our attention, we are also focused on the long term growth of the company. This includes such things as the successful launch of new generic products, ongoing investments in internal and external R&D and the capitalizing our business development opportunities. Our ANDA internal and external portfolio of 45 products are pending, as the FDA contains a number of [potential] launches in addition to the numerous undisclosed [product] opportunities.

As is typically the case, eventually product launch would depend on achieving FDA approval and the market dynamics at the time of approval. Some of the potential launch opportunity over the next three years that we are frequently asked about including original (inaudible) in January 2013 and further in July 2013. If I look at January 2014 RENVELA tablets in March 2014 which is supposed to file opportunities and it would produce the entirety of the six month of exclusivity. And the (inaudible) tablet in January 2015 where we settled for three months of exclusivity.

Between our internal developed ANDAs and the addition of the numerous alternative dosage from external partnership products, we have a pipeline of opportunities in the years to come. While Zomig, generic Adderall XR and the fenofibrate are significant contributors to our current results, we are actively working to enhance our market product portfolio and the pipeline of pending products both internally and through partnership. We will continue to explore investment opportunities that can deliver growth and move impacts towards its long term generic and [blend] division goals. The business development team for both of these divisions will remain busy reviewing such opportunities.

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

Bryan Reasons

Thank you, Larry. Good morning everyone. As Larry mentioned our third quarter 2012 results improved over the prior year period, reflects several items that impacted comparisons. The addition of $43 million of sales of our Zomig was the leading driver of the $26 million increase in total revenues. This accretive transaction is meeting our objectives to increase the revenue and financial contributions of our brand business. The first nine months of the Zomig transaction has added 71 million of revenues, in addition to the 46 million of gross profits received from AstraZeneca during the transition period.

Under the terms of the agreement, we paid 35 million in the third quarter and paid 90 million of the 130 million under the agreement for the first nine months of 2012. Compared to the third quarter last year, we also had a modest increase in our generic product revenue of 2% due primarily the higher sales of fenofibrate, partially offset by decline in generic Adderall sales.

The addition of another generic Adderall competitor, the royalty rate that we paid Shire declined by 60% from the previous rate, and the lower rate is reflected in our third quarter 2012 results. Average sales in generic Adderall in the third quarter 2012 were down about 10% over the prior year and down sequentially about 40% from the second quarter 2012.

As Larry mentioned, the market for generic Adderall continues to be dynamic and evolving. We currently have supply and our goal is to remain competitive, while continuing to meet the needs of our customers. The 26 million increase in total revenues was achieved despite several events including 9.4 million in lower generic RX partner revenues from a non-recurring profit share adjustments last year and a current period charge for the voluntary market withdrawal of generic [DPX]. 2.4 million in lower generic research partner revenues due to the extension of deferred revenue recognition period for the MediSys agreement, and 3.5 million in lower brand commercial partner revenues due to the June 2012 completion of a co-promotion agreement.

Gross profit margin in the third quarter was 54%, an increase compared to last year’s margin of 52%, despite being impacted by several events. The primary event item impacting this year’s third quarter gross profit margin is a $22 million charge for amortization and acquisition related costs, primarily related to the Zomig transaction. This item as well as other items impacting the third quarter of 2012 results has been reflected in our reconciliation of non-GAAP income including any earnings release.

Our adjusted gross margin in the third quarter would have been 69% without these changes. Total reported operating expense increased approximately 11 million over the prior year, which is net 5 million for the reimbursement of legal fees related to the settlement of litigation. Therefore the total adjusted third quarter operating expenses increased approximately 16 million. This increase was due to higher selling and marketing costs associated with the US Zomig franchise including the addition of 20 sales reps in the second quarter of 2012.

Also contributing to the increase was the continued expansions of brand divisions infrastructure and market research activities and preparations for the potential launch of Rytary and higher legal activities related to several ANDA cases. Our effective tax rate was 32.5 was slightly lower than last year’s rate of 33%, and is also lower than the second quarter of 2012 rate of 38%, due to 2011 tax return items recognized last quarter.

During the quarter, we spent approximately $34 million on capital expenditures. For the first nine months of 2012, we’ve invested $58 million in CapEx primarily related to the construction our manufacturing facility in Taiwan. With our continue reinvestment in the business, we ended the third quarter with $340 million in cash and short term investments, we have no debt; a slight decline from $354 million at the end of last quarter.

Positive cash flows from operations in the third quarter were more than offset by payments of $56 million for product licensing rights related to the Zomig and TOLMAR transactions, $34 million on CapEx and $25 million in tax payments.

Looking ahead to cash flow activities for the fourth quarter, 2012, we will make the final payment $40 million to AstraZeneca for Zomig and invest approximately $22 million in CapEx. As previously communicated, our cash outflows on investing activities in the second half of 2012 would exceed the first half of the year due to the timing of CapEx and the stepped up quarterly payments to AstraZeneca.

We expect to see a boost to our cash flow levels with the first quarter 2013 payments of approximately $110 from Endo under our settlement agreement related to original Opana ER. This one-time payment will be recorded as other income, however for comparison purposes it will be excluded from our adjusted results.

Our healthy balance sheet provides significant resources enabling us to continue investing in our business both internally to facility expansion and improvements, and externally to our preferred approach of making selective investments in partnerships or M&A opportunities.

Thank you all for your participation and we will now turn the call over to Janis to open the line up for questions.

Question-and-Answer Session

Operator

(Operator Instructions) And your first question is from Ami Fadia of UBS.

Ami Fadia - UBS

I've got two, three questions. Firstly, regarding the amortization adjustment that you had in the gross margin line this quarter, what, how do you expect that to progress in fourth quarter and into 2013? It was slightly higher than what I had expected based on your last Q and that's why I'm asking. And just if you could elaborate a little bit on the products that are expected to be launched under the TOLMAR deal and give us a little bit of detail around the timeline that would be great. Thank you.

Bryan Reasons

I'll take the first question. The amortization and the acquisition related expenses is a little bit higher this quarter because it includes the TOLMAR transaction previous quarter included predominantly Zomig related costs. Q4, it should be in a similar range as Q3. Going forward next year, we are currently putting together our financial guidance and we will share more about that at the JPMorgan Conference in early January.

Carole Ben-Maimon

So with regard to the TOLMAR product, so this is a deal, we have nine approved products that are all topical solutions including (inaudible). We are actually in the process of launching all nine and by the end of November they will all be launched. You may recall that these were the products that had been marketed by Sandoz but when Sandoz bought [Fujairah] they turned them back to TOLMAR and we acquired them, actually licensed them from TOLMAR. Did that answer the question?

Operator

The next question is from Dewey Steadman of JPMorgan

Dewey Steadman - JPMorgan

So can you just give us some estimate on the progress on your ability to secure a quota for Opana ER for Oxymorphone beginning next year and then on Sinutabs, how aggressively do you think Mylan will be in that market and do you anticipate other competitors for the Sinutabs from Horizon. And what's the, have you seen orders decline in destocking for Sinutabs ahead of the branded launch?

Carole Ben-Maimon

So let me start with the quote on Opana, we are actually very excited about Opana and we aren't really give you a lot of color at this point on, at plans for launch for obvious competitive reasons but we obviously are doing everything we need to prepare for the launch of that product and we are excited and we think that its going to be a nice product add to our portfolio.

With regard to feno, Mylan is in the market and is behaving like any other generic marketplace would behave. As far as in his earlier remarks, he clearly anticipated that sooner or later that there would be competition on these products and so although we don’t have any visibility as to whether there will be a third competitor, there may very well. This is not a force, so we won't be aware of any litigation and we won't be aware of anybody launching unless somebody actually tells us (inaudible) to marketplace but we do anticipate that sooner or later that there will be additional competitors in that market.

Dewey Steadman - JPMorgan

And is pricing materially declined post launch?

Carole Ben-Maimon

We really didn’t still comment on that stuff and we really just are out there competing and trying to maintain as much as market share as we possibly can, but with any generic marketplace, there is going to be competition and we're dealing with it and working it and being aggressive and competitive and hopefully we will maintain as much market share as we can.

Mark Donohue

Thanks, next question please.

Operator

Our next question from Louise Chen of Guggenheim.

Louise Chen - Guggenheim

I’ve a couple of questions. First one is on business development, just curious if you could give us a little bit more color on where you stated in your press release, maybe the timing and then also you were more interested bolt-on type business development or acquisitions or something that's more transformation like the (inaudible) acquisition?

Larry Hsu

Well, I guess, as I mentioned in my part and we’ll continue to make a lot of effort around the (inaudible) activity and you know, on the [bund] side, we're not only looking at the product, like a Zomig but also looking at the company opportunities. We're looking at even the pipeline opportunity on the generic side and the focus had been on the outer form, the company will give us a new technology on that. So we continue working on that. At this point, obviously it’s difficult for me to give a timing on that. Other hand, we are looking at I would say we have kept a pretty wide now at this point and hopefully we will commence something pretty quickly.

Louise Chen - Guggenheim

And then the other two questions were with respect to Taiwan manufacturing, have you started to see any margin benefit or tax rate benefit from that yet? And then secondly, on the Rytary complete response letter with respect to the excipient is that an excipient that’s been used in other drugs before and if so how many other drugs are, may be just gives us some color that will be helpful. Thank you.

Bryan Reasons

On the margin benefit yes, Taiwan is certainly has lower cost structure and so product that is there compared to Hayward are at a lower cost so therefore we would see better margin out of there. On the tax, it’s too early at this point to really see significant impact on our effective tax rate. I guess made some color. We are aggressively looking at taxes, putting it in an international tax structure that will be by the end of the year. So taxes are something we certainly are [lucky]. And then, on the international tax stuff it will certainly we will see much more benefit as we launch Rytary and then certainly ex-US sales of that product will be at a significant lower tax rate as well.

Michael Nestor

And as to the excipient question, so obviously utilized in our product is also used in other products, however given the fact that, we are in active discussion with the FDA, we prefer not to give any specific details on that at this point.

Operator

Your next question is from Ken Cacciatore of Cowen & Company.

Ken Cacciatore - Cowen & Company

I think you were indicating that you re-inspected or tested the batches, can you just talk about, you have to refilled something or when do you think best guess understanding that there is a wide range among the FDA will accomplish re-inspections but can you give us sense of when you believe Hayward will be re-inspected. And then also Carole, I am just kind of fascinated by your commentary, can you help us to understand a little bit how are you going to try to impact this market, I know there is probably some trade secrets you want to keep to yourself but can you expand the little bit on what you are thinking on Opana ER and then also can you discuss any interactions you had on CONCERTA® at this point in time with the regulators, thank you.

Larry Hsu

Okay, I will try to answer the first question and then have Carole to answer the other two, generic specific questions. Related to the Hayward we inspected it as I have pointed out in my talks. FDA has notified have to have re-inspection so they can (inaudible) out of one letter. But and again, we do not talk about anything specific at this point. I do promise that as soon as we have significant items they are worthwhile to report, we will report right away at this point, Carole.

Carole Ben-Maimon

So with regard to Opana ER as of now clearly, we old Opana is not (inaudible) to the new Opana, and so it will be a challenging marketplace to launch into. But if you look at the 7.5 and 15 that are actually currently marketed by Actavis, they have actually done quite well. And there are strategies that we can employ and as you acknowledge it’s a little difficult for me to discuss them for competitive reasons in detail. But we have explored ways that there our products that are out there that don't necessarily have a reference for the drugs that are still prescribed and still substituted.

So we are optimistic that we will be gain some market share; again, we don't know how much, but we will be aggressive in that marketplace and we are hopeful that the agency will allow us to launching with our products for safety reasons which is really the other caveat. But so far, there hasn't been any indication that that will occur and clearly the 7.5 and 15 are out there and that hasn't been an issue.

Ken Cacciatore - Cowen & Company

And some of those are the products that you were talking about, what's kind of share have they gotten to maybe give us a frame of reference?

Carole Ben-Maimon

I don't actually know the answer to that question, but what I can tell you is that it would be hard to compare because of the closure issue here. I mean because if there's a controlled substance comparing it to products that are not controlled substances that might be difficult. But I think the one thing you do have to recognize is that we do have six months exclusivity for all of the strengths with the exception of 7.5 and 15 and so whatever market share the generics do get, we will be the ones to benefit from that.

I think the other thing to keep in mind is also that the package inserts on both of those products are identical, so the brand is actually not allowed to claim any advantage over these other products and there have also been some anecdotal, not actually anecdotal, but there have actually been some reports of adverse events for drug abusers of what we think is the new OPANA and so how this whole market is actually going to play out, I'm not really sure, but we are very excited about that we think this is a really good opportunity and obviously we will be aggressive within the market.

As related to Concerta, obviously we don't comment on discussions we have with the agency; what I can tell you is that we are optimistic, obviously we have to resolve the warning letter issues first, that's the first hurdle, but we fully anticipate that that will occur. And then as we go into the first half of next year, we will be preparing for launch and we will be, we are obviously in discussions with the agency to make sure that our application is complete and approvable and will get approved as we head towards July and we can launch the product.

Operator

The next question is from Jason Gerberry of Leerink Swann.

Jason Gerberry - Leerink Swann

Just had a question on the 4Q revenue guidance, it seems like a pretty steep sequential decline. So just wanted to get a better sense of your guys’ assumptions for that number; does it assume any additional competitors, are there any transient factors in that such as stocking for the quarter or should we be looking at the 4Q number for fenofibrate and Adderall XR as sort of a go forward run rate going into 2013?

Bryan Reasons

So, I'm not going to give specific assumptions that we use; clearly the drivers in our business going into Q4, fenofibrate in the additional competition and obviously when you get additional competition in the generic market there is always market share pressures as well as pricing pressure. And then Adderall continues to be highly competitive dynamic market. So that kind of at this point all the color we're going to give, and then like I said, we're still looking at our plans for 2013.

Carole Ben-Maimon

Yeah and I can, just with regard to products that Bryan mentioned, clearly we're being as aggressive as we can in the Adderall market and we’ll continue to be aggressive, but it's still a very dynamic market, active as still trying to get market share and as you see lagging indicator with the script data, clearly they have picked up market share and so we're being as aggressive we can, as we’ve said in their prepared comments, we do have supply at this point and we will continue to be aggressive. And obviously some of that is going to play out with 2013 with the code and how DEA perform, what kind of code DEA actually grabs in the early first quarter. With regard to feno, I think that’s more of a typical generic market, the kind of market we’re all used to and you’re all used to and you should use the kinds of models that you use to covering and utilizing as an additional player comes into any generic marketplace.

Jason Gerberry - Leerink Swann

Okay, and then I guess as a follow-up on Adderall XR, I noticed that the final adjusted quota for Amphetamine was I think a proven increase for like a 33% step-up. Are you factoring in sort of an increase in the overall tie; and as you guys think about the next quarter and then going in to next year?

Carole Ben-Maimon

Well, as you know, we're aware of that, but as you know, we don’t promote products, so the whole increase or decrease as doctors see fit or depend on whether Shire continues or decides to promote the product or not, it really doesn’t and we don’t promote products. But we obviously anticipate that we will get out there, share that quota and we will continue to be aggressive throughout the contract to make sure we compete and keep our customers and maintain our market share.

Operator

Your next question is from Shibani Malhotra of RBC Capital.

Shibani Malhotra - RBC Capital

So first on fenofibrate; we will assuming annual sales of 145-ish for the year of which the capsules are on 60% of revenues, could you confirm that just so we have some idea of what is actually at risk with Mylan coming into the market and then does your guidance assume an additional competitor or is it just based on Mylan?

And then second, on the Adderall situation just following Ken’s question, do you expect additional, did you expect Actavis to have a step-up in share and inventory once Watson takes over the company? And then finally, on the excipient, if you are willing to comment on this; is this something that is the driver of your kind of differentiated formulation or is this just one excipient which is not already meaningful to the way like (inaudible)? Thank you.

Carole Ben-Maimon

So Shibani, I guess I’ll…

Bryan Reasons

Let me first, you know……

Carole Ben-Maimon

But I started and then you can…..

Bryan Reasons

Go ahead.

Carole Ben-Maimon

We’ll negotiate, sorry.

Shibani Malhotra - RBC Capital

No fighting over who answer the question, you can all answer.

Carole Ben-Maimon

So with regard to feno obviously, we have not talked about specific towers and how much we actually sell and I don’t think we can actually comment on that. I think we can't and have said is that the capital was slightly more than half of the market and that, we have anticipated to behave as a traditional generic markets. We have Mylan obviously out there with us, again this product has no patent protections and so we won't know if somebody is going to actually launch or not and so we really can't comment at this point whether there is another player out there. But we have always factored in our projections especially our annual projections, additional competition and we will anticipate that through the product as well.

With regard to, I think second question was on Opana.

Shibani Malhotra - RBC Capital

Adderall?

Carole Ben-Maimon

Adderall, you know as we said, we had to supply; this as a very dynamic and very aggressive market. I don't think Watson will have some impact, but I don't any of us are, any better than any others of us are getting [quota]. Clearly as we market the authorized generic, Shire or whoever they go with is actually the one who obtains the quota in concert with us. So I don't think that they have any advantage over us in getting quota.

But I do think that given the drug shortage issue and the fact that this product was highlighted months ago as a product that had some drug shortages, and [DEA] present in some way about to be part of the problem, although we obviously thought that supply was the problem from Shire, but some in the industry thought that the DEA had a component, I think that we will get quota, I think after this we will have quota and it will continue to be a competitive market place.

Shibani Malhotra - RBC Capital

Okay, and then on Rytary?

Bryan Reasons

That Shibani was your question is the [incipient] critical to the functioning of the affect of Rytary. I won't comment on that only because its, our formulation is very important to us and I'll just leave it at that.

Operator

Our next question is from Greg Waterman of Goldman Sachs.

Greg Waterman - Goldman Sachs

On SG&A expense guidance implies pretty significant fourth quarter step up, even though the Rytary approval has been delayed. I was wondering if you could drive us, walk us through a drive that's spending and then also is there anything that's one-time there or is it suggestive of a longer term SG&A run rate.

Bryan Reasons

I think we've been saying all along that SG&A was going to ratchet up sequentially quarter-to-quarter, and I guess I would pull the G&A out of that and its predominantly sales and marketing. We've added 20 reps that are currently promoting Zomig that we continue to ratchet up the sales and marketing activity in anticipation of the Rytary launch, including building infrastructure market research. The typical type of things you do in front of a branded launch. Though the PDUFA date moved, we are still planning a Q1 launch. So when we looked at what we needed to do to prepare for that Q1 launch, we didn't slow down that activity. But we are still aggressively planning for that launch.

Greg Waterman - Goldman Sachs

Is that fourth quarter number, that fourth quarter estimate a reasonable run rate to think about going forward, or is there anything we should consider in that.

Bryan Reasons

Well, we are going to, as we launch Rytary we are going to add more sales reps. So, its probably not a reasonable run rate, and we will be giving more guidance on that at JPMorgan in early January.

Operator

The next question is from Sumant Kulkarni of Bank of America/Merrill Lynch

Sumant Kulkarni - Bank of America/Merrill Lynch

On Rytary what confidence level do you have that you do not need additional trial, is that just something that you learn from the FDA letter or is it from the nature of interactions with the agency.

Michael Nestor

Sumant, at this point we have absolutely no indication from the FDA that any additional trials will be required. So that's where we sit today. You know the PDUFA date is January 21, but we still have some time to go. But at this point we’ve heard nothing from the FDA relative to any additional trials.

Sumant Kulkarni - Bank of America/Merrill Lynch

And this might be a bit premature, but if there is something that you could point us to in terms of the, assumed pricing on Rytary what would be a good level given that's still was generic.

Bryan Reasons

I think you are (inaudible) in and out, did you ask about pricing of Rytary?

Sumant Kulkarni - Bank of America/Merrill Lynch

Yes.

Michael Nestor

Okay. I think you could probably use (Sulivo) as a pretty good guide.

Bryan Reasons

For generic?

Michael Nestor

Generic, yeah.

Sumant Kulkarni - Bank of America/Merrill Lynch

Okay. And on the generic side Larry you mentioned some of the well known generic launches that could be coming up in the next few years, but are there some potentially undisclosed launches that in reference could be missing and specifically could you comment on what is happening with your generic TriCor application?

Larry Hsu

Talking about those undisclosed products.

Unidentified Company Representative

In generic TRICOR which you know, we did disclose --.

Carole Ben-Maimon

Okay, so the answer to your question, we do have additional launches that are undisclosed. We actually have quite a few. We’ve said, greater than a dozen or so. So most of those are quite small, but in their totality they actually mean something. Obviously, that’s also a difficult challenge to launch that many products as quickly. So we will obviously be focusing on some of the bigger ones like Opana and CONCERTA. But clearly there are additional ones that are not being disclosed, and like I said, in their totality they amount to a lot.

The other ones, I think, that has been disclosed, that we haven't really focused on is [Solaray], and we don’t have the timing for that but the court case in that particular product has been dropped. We're the only (inaudible) that we know about that’s been sued. It's a $130 million for getting it from TOLMAR. So clearly the approval is not dependent on us getting resolution or the warning letter. And the issue there really is FDA approval at this point and that could come pretty much anytime in 2013 or later. But we are hopeful that it would be sooner rather than later. So that’s the answer to that question and then the TriCor as Mark just sort of alluded to, I think we've announced that we have to reformulate. So that’s not a near-term opportunity.

Operator

The next question from Ami Fadia of UBS.

Ami Fadia - UBS

Since I look at your earnings and revenue run rate, how should I think about the progression as we go into 2013 and 2014? I understand if not given guidance, but for us to see growth off of the 2012 base, what needs to happen in both your generic and branded business? Thanks.

Michael Nestor

Well I think Carole talked about some of the generic pipeline opportunities in the near term and medium term. Obviously two big drivers are the market around Adderall and fenofibrate, which I think we talked a lot about. And then obviously we have on the brand side, we continue to have Zomig and then the first quarter launch of Rytary will be very important. We are not going to give guidance on 2013, but I think those are the kind of the key top line drivers for 2013.

Larry Hsu

Well I do want to add obviously another important factor here is that comes out of (inaudible) here. Unless what comes out (inaudible) we may not get to a lot of product approval. But at this point it is unfair pointing out the confidence that we will get out of here, although the timing unfortunately is not in our control, as we are waiting for FDA’s reaction on that, but we think we are well prepared for this.

Ami Fadia - UBS

If I look at some of the factor and then some of the details that’s given us on the pipeline, do you see the business growing as we look at 2013?

Larry Hsu

Well, let me start to answer that question. I think at this point, we are very optimistic, okay. Why we cannot give you a lot of details but we always told you some of the generic launch we are talking about, the Rytary launched in the first quarter and then more than a dozen of (inaudible) the product, once we get the warning letter resolved, we will be able to get those product on the market and I think given more important here is that, we continue to look at the opportunity from product to companies to beginners and certainly to hope for sometime in the near future, we will help with activity or quick finish the report to the investor on the M&A side.

Carole Ben-Maimon

You know that earnings to the generic side, brand side also quite probably less frequently but the generic side is clearly an industry of new products. And so the warning letter is obviously hindered us and we have competition on Adderall and Feno but we do have some products that we can launch even without resolution of the warning letter, in particular sales rates in Opana ER and then we have some pretty big launches in Concerta or launching Concerta once we do have the resolution of the warning letter.

So I think as Larry said, we are optimistic and then of course we have Rytary which is an important product to fill itself. And so I think we are optimistic and hopefully we will also be aggressive on (inaudible) since we have so much….

Larry Hsu

And I have to emphasize we are fortunate we have all the cash out in the bank. And processing additional cash comes in generally from (inaudible). I think that will be something where we definitely to be very cautious on the beginning development side, that’s something we will achieve soon.

Mark Donohue

Thank you. Next question please.

Operator

The next question is from Michael Tong with Wells Fargo Securities.

Michael Tong - Wells Fargo Securities

Thanks. I hopped on the call a little bit late so I apologize if some of these questions have been answered, but two questions number one for Rytary, do you expect Rytary to be a profitable product in 2013 not just a top line contributor and then secondly, as you think about the Opana ER situation at this point what kind of confidence do you have that your version of Opana ER is bio equivalent or freely substitutable with the current Opana ER that is on the market?

Bryan Reasons

I'll answer the first one and Michael can jump in. So Rytary, we are not going to give specific guidance on 2013, yeah clearly we think its important to properly invest in a branded launch that's very important. So we are investing on the launch and we are continuing right now we are doing market research studies and looking at pricing and stuff like that. So we are excited about the opportunity but we are not going to give specific P&L guidance on 2013 right now.

Michael Nestor

That's correct, for us the important thing is to ensure that we get Rytary off to a good start and on to a trajectory that will be consistent with the guidance that we had given before which is the $200 million to $400 million peak sales range.

Carole Ben-Maimon

And with regard to Opana ER our products, the products that we currently have approved and plan to launch in January is not bio equivalent to the tamper resistant Opana ER that's currently on the market. And so it will not actually be substitutable to that product. It is bio equivalent to the old non-tamper resistant Opana ER which in our mind was not pulled for any kind of safety reasons and which holds identical labeling to the new product and so we are looking at ways to promote that product as I think you may have missed since you joined the call late we talked a little bit about the fact that Actavis 7.5 and 15 mg tablets on the market are the old product and is doing quite well with it. So we do believe there is an opportunity. It’s hard for us to quantify that opportunity at this point, but we do believe there is opportunity to launch that product into what would be a receptive market.

Operator

The next question is from Shibani Malhotra of RBC Capital.

Shibani Malhotra - RBC Capital

I just have a follow-up on the Opana ER question. Carole just based on your experience I mean the FDA has come out and said that they expect to be giving guidance on genericizing the tamper resistant versions of Opana and OxyContin and we kind of understood that they would give us some guidance by the end of the year and perhaps at the same time deal with the issue of whether the old versions removed for safety reasons. Have you had an update on that or heard anything about that and what is your expectation in terms of what you think the FDA will require for the tamper resistant products.

Carole Ben-Maimon

So it’s a good question Shibani, I think there are two somewhat separate issues although obviously linked, but the first is tamper resistant and ensuring that if you are A, B rated to the tamper resistant products that there is some tamper resistance testing to show comparability, I think the agency is going to struggle with that. I think that there is some proposals in the citizen’s petition from ANDA and from Purdue but quite honestly they are not terribly scientific and not terribly reflective of how tamper-resistant the product is. So I don't know what the agency is actually going to do with that.

Actually the other issue I think is that they have not allowed either of those products to claim tamper resistance in their labeling. So how significant it really is and how important it is to the agency I think, is yet to be seen. With regard to the safety issue, the 7.5 and 15 are still on the market and the agency did not respond, actually found in their response petition that they were not removed for safety and so I am hopeful, obviously it's the FDA's call and not ours and we will comply with whatever the agency determines but we're hopeful that they will allow us to launch in January.

Shibani Malhotra - RBC Capital

Would we see an update from the agency and would they kind of deal with the [CT] beforehand or is it no news, good news for Impax?

Carole Ben-Maimon

I think no news is good news. I think what you are likely to see is the guidance on tamper resistance and the agencies; they usually deal with things at the very last minute. So it could be December 31 before we know, but we actually have approval as well as the six months exclusivity.

Mark Donohue

Thank you, Shibani and we've time for one more question.

Operator

The next question from Jason Gerberry of Leerink Swann.

Jason Gerberry - Leerink Swann

Just a follow up on this FDA news of the serious blood disorder with Opana ER on October, was that with the do you know given the, is that with the old form 7.5 and 15 or was that with the new tamper resistant form, just curious if there is any potential upside factor for you guys in your launch?

Carole Ben-Maimon

We don’t know the answer to that. I do not think it was a 7.5 and 15 and what I think, again reason I think that, again I don’t necessarily have data but as a physician this tamper resistant product contain different kinds of components to make them tamper resistant and what these drug abusers do is they try and inject them. So in injecting some of these components and they have been adverse events that were unanticipated. I would not interpret that though to be any upside for us. It was a single or couple of events. I don’t really know what caused them for sure and clearly the agency will be evaluating and they will decide what to do with it, but we have a protocol and we hope that they will continue to allow us to launch as they have allowed the 7.5 to 15 to stay in the market.

.

Mark Donohue

Thanks Jason. And thanks everyone for joining us and again we are to express that we are thinking of you and hoping that you and your families are safe. We will talk to you soon.

Operator

This concludes today’s conference. You may now disconnect.

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