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Valeant Pharmaceuticals International (NYSE:VRX)

Q3 2009 Earnings Call

November 2, 2009 10:00 am ET

Executives

Laurie W. Little – Vice President of Investor Relations

J. Michael Pearson – Chairman and Chief Executive Officer

Peter J. Blott – Executive Vice President and Chief Financial Officer

Rajiv De Silva – Chief Operating Officer of Specialty Pharmaceuticals

Bhaskar Chaudhuri – President of Valeant

Analysts

Gary Nachman – Leerink Swann

David Amsellem – Piper Jaffray

Michael Tong – Wells Fargo Securities

[Greg Fraser] – Bank of America Merrill Lynch

Juan Sanchez – Ladenburg Thalmann & Co.

Operator

At this time I would like to welcome everyone to the third quarter earnings conference call. (Operator Instructions). Ms. Laurie Little you may begin your conference.

Laurie Little

Good morning everyone and welcome to Valeant's 2009 Third Quarter Financial Results conference call. Joining us on the call today are Mike Pearson, chairman and chief executive officer. Peter Blott, chief financial officer. Bhaskar Chaudhuri, president of Valeant and Rajiv De Silva, chief operating officer of Specialty Pharmaceuticals.

In addition to a live webcast, a copy of today's slide presentation can be found on our website under the Investor Relations section. Certain statements made in this presentation and other statements made during this call and the Q&A session afterwards may constitute forward-looking statements. Please refer to the current slide for our cautionary statement regarding these forward-looking statements.

In addition to supplement the consolidated financial results prepared in accordance with generally accepted accounting principles, the company uses non-GAAP financial measures. These non-GAAP financial measures include measures such as, cash EPS, organic product sales growth and adjusted cash flow from operations.

Reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the table to our third quarter earnings press release, which was issued earlier today and can be found in the investor relations section of our website at www.valeant.com and with that I'd like to turn the call over to Mr. Pearson.

Michael Pearson

Good morning everyone and thank you for joining us. Valeant's third quarter results again delivered solid growth in cash flows across all of our operating units. Total revenue in the third quarter of 2009 is $220 million as compared to $168 million in the same period last year, an increase of 31%. Our cash EPS is $0.58 per share and adjusted cash flow from operations is $65 million for the quarter.

The solid business performance that we have achieved so far this year provides a platform for us to again raise our earnings guidance for 2009 from our previous range of $1.90 to $2.10 cash EPS to our new guidance range from $2.10 to $2.20 cash EPS.

Our confidence and the continuing strength of our base business and our management team here at Valeant is reflected in our guidance. Additionally, I am very pleased to report that on October 30, we and our colleagues at GSK submitted both the NDA and MAA registration packages for retigabine.

This is a major achievement and I would like to publicly thank both the GSK and Valeant members of the joint development team for their hard work and dedication to getting this file completed. And I would like to note that while the submission took longer than we expected, what matters is when a drug gets approved, not when it is submitted.

And we believe that with GSK's assistance a very high quality file has been put together and we are hopeful that this potentially important medication for epilepsy patients will be available sooner rather than later.

Today, I would like to spend some time on the following three areas. First, the performance of our core business and continued improvement in our cash generation, second a review of how we have deployed our cash, first by reviewing the performance of our acquisitions and second, by reviewing our securities repurchase program.

And third, our new strategic objectives for 2010, including an early outlook on our expected grow and revenues and earnings. I will then turn the call over to Peter to discuss our third quarter financial results in more detail.

One of our core operating principles of Valeant is to achieve double-digit top and bottom line growth. Similar to our first and second quarter results, our third quarter product sales, net of currency and acquisitions, delivered strong double-digit organic growth of 18%. While Specialty Pharma in Europe had high double-digit organic growth, our organic growth in Mexico did not.

This is largely due to the fact that we chose not to extend credit terms to our Mexican distributors who are unfortunately experienced delayed payments from their customers, the retailers. We are committed to continuing our very conservative fiscal policy in Latin America given the problems we had there before I joined Valeant. If this translates into slower growth in Latin America [per] quarter, we will live with it.

In addition to our healthy sales growth, our businesses continued to deliver strong earnings in cash generation. Our Specialty Pharmaceutical segment had non-GAAP operating margins well in excess of our 40% operating margin target, due in part to the inclusion of generic BenzaClin and the total contributed $34 million this quarter to our adjusted cash flow number.

Our two branded generic businesses delivered operating margins above the 30% level and generated $27 million of adjusted cash flow. We expect our branded generic margins to improve in 2010 as we integrate our past acquisitions and become more efficient.

After three quarters we have generated over $170 million in adjusted cash flow and we are well on our way to beating our objective of generating over $200 million in adjusted cash flow from operations in 2009 and more important we are building a business that will continue to grow this number in the years to come.

Let me now turn to our capital deployment. As important as generating cash is, it is equally important what we do with it. Since joining Valeant 20 months ago our primary uses of cash have been bolt on acquisitions and our security repurchase programs. First, let me review our acquisitions.

Starting this November we will undertake an annual formal evaluation for our board of how we are doing on our acquisitions. We will review each acquisition on two dimensions, growth and cash generation relative to the models we used at the time of the deal.

I am pleased to report that on the six acquisitions we evaluated this year, we are ahead in revenues for five of the six and ahead on cash generation for all six. In the U.S., Coria was acquired a year ago and our dermatology products acquired with that transaction are performing well.

Atralin has grown almost 30% year-to-date and CeraVe our OTC moisturizing line has grown over 40% over the same time period. This month we reached an agreement with Wal-Mart to introduce our three SKUs of CeraVe in over 3,000 Walmarts in 2010.

Overall Coria, excluding Acanya which came to us through the Dow acquisition has grown 22% over the prior year. Our acquisitions in Australia have also provided strong growth with Dermafine growing almost 30% and UV Reef at 6% since they were acquired. Lastly, EMO-FARM our dermatology acquisition in Poland has grown over 30% since the deal closed in May.

In addition to sales growth all these acquisitions continue to generate positive cash flows well ahead of our initial projections. To conclude our acquisition evaluation we are pleased with the progress we have made with the integration of Dow.

Our team at Dow has moved three products out of Phase II. We had several positive FDA meetings this past summer on these compounds and we are in the process of initiating Phase III clinical trials.

We have seen a decline in the Dow services business this year primarily due to economic factors that have affected our client this year.

We believe this affect will lesson as the economy improves. However, the service business continues to be profitable and we utilized the leveraged R&D model to offset our R&D expenses, a prime strategic reason for acquiring Dow.

Our royalties generated from Dow including generic BenzaClin are $22 million for the first nine months of 2009, well ahead of our original forecast. Our three most recent acquisitions, Tecnofarma in Mexico, PFI in Australia and the Polish dermatology acquisition we announced last Friday are all to recent to comment on other than to say that we are pleased with both the underlying economics and the results we have seen to date.

Now let me turn to our second major use of cash. Over the last three years we have been executing an aggressive campaign to repurchase our securities. Our board of directors initially approved a $200 million share repurchase program that eventually expanded to $800 million and included the option of repurchasing our convertible debt.

Through these programs we have purchased over 20 million shares of our common stock at an average stock price of $17.93 and acquired over $200 million principal amount of our convertibles at an average rate of $0.97 to $0.98. In total we have spent $574 million on our repurchase programs and based on our current stock price we believe this has been a tremendous value creating event for our shareholders.

We feel very good about the progress we have made on completing our six initiatives for 2009. With the exception of partnering to ribavirin, all of our 2009 objectives are now essentially complete. Let me look to the future, our plans for 2010. We have recently established six new strategic initiatives for 2010. First our stretch target for 2010 is to grow our global dermatology from approximately $300 million in 2009 to $500 million in 2010.

Second, now that we have submitted our retigabine immediate release formulation to the FDA and the EMEA, we are putting significant resources behind the modified release program. The current ongoing Phase I study is evaluating multiple MR options. Our goal is to have a lead MR candidate identified for progression next year.

Third, while we have been successful identifying and executing against a series of bolt-on acquisitions across most of our market units, business units, there are two notable exceptions, Canada and Brazil. In 2010, we are committed to completing at least one strategic transaction for each of these geographies.

Fourth, our 2009 revenues for the combined Latin American and European branded generics business are expected to be slightly north of $300 million. We have set a stretch target for 2010 for these combined businesses of $500 million.

Fifth, again we will continue to maintain a scorecard and remain committed to over-delivery on all of our acquisitions.

And finally, sixth, while we have made significant improvement to our cash flow generation in 2009, I believe we can become much more efficient and get much more out of our businesses, by improving our businesses in areas such as accounts receivable, inventory and other elements of working capital, which will be reflected in improved cash flow from operations next year.

Finally, in terms of operational performance, we expect to grow organically in double digits next year and also show double digit growth in both cash EPS and in cash generation from operations. We will provide more specific guidance on our next earnings call.

With this, I will turn the call over to Peter to discuss our third quarter financials.

Peter J. Blott

Thank you, Mike. Mike has already highlighted our top line growth over last year. We are also pleased to see continued strong sequential growth over the first two quarters of 2009, $220 million in the third quarter versus $192 million in the second quarter and $178 million in the first quarter.

As in earlier quarters, out P&L clearly shows the benefits of the structural changes made last year, as we implemented our business strategy changes. Adjusted operating income excluding currency impact was 40% of revenue in the third quarter, up from 18% in the same last year.

This benefited from additional alliance revenue, notably $8.5 million profit share related to the 1% clindamycin and 5% benzoyl peroxide products launched by Mylan in August. Our cost of goods sold percentage for the quarter was 29% as compared to 28% in the third quarter of 2008. This increase primarily relates to the impact of acquisitions such as Dow, Tecnofarma and EMO-FARM.

We mentioned earlier that the Tecnofarma business in Mexico, which is mostly generics sold into the government sector, has a high cost of goods sold percentage – has a higher cost of goods sold percentage than our existing business in Mexico. We expect this to improve over time, as we transition out of older plants into the new plant outside of Mexico City.

Also cost of goods sold in Specialty Pharma was higher than usual this quarter because of a number of small reserve and expense items totaling approximately $2.5 million taken in the quarter. We are maintaining a tight rein on our expenses and continue to see a downward trend in SG&A expenses. SG&A expenses were 47% of revenue in the third quarter 2008 versus 36% in this most recent quarter.

R&D expenses began to increase in the third quarter from previous quarters. But we're still down 51% from the third quarter last year. As Mike mentioned, we are ramping up our efforts for our dermatology pipeline compounds to enter Phase III before the end of the year and we will be incurring increased R&D expense related to those efforts.

We also expect to pay out an $8 million milestone payment to [Meta] in the fourth quarter due upon acceptance by the FDA of our retigabine filing.

We're also pleased to report this quarter was another strong quarter of cash generation. Our adjusted cash flow from operations record was $65 million coming off the back of $55 million adjusted cash flow from operations in the second quarter. We are clearly on track to exceed our goal of $200 million cash flow from operations in 2009.

As I've mentioned before, currency movement continues to have a negative impact on our business in the third quarter. We expect that in the fourth quarter the foreign exchange impact to be broadly neutral to us assuming exchange rates stay where they are today. We now estimate that foreign exchange will negatively affect our top line by approximately $80 million for the full year 2009 and our bottom line by approximately $0.20.

The next chart shows the key components for our cash sources and uses in the quarter. At June 30, 2009 we had an opening cash balance of $453 million. During the quarter, you can see the cash inflows of $65 million generated from operations.

We used $56 million for purchases of our convertible notes in the quarter, $36 million for share repurchases and $33 million for our acquisition of Tecnofarma in Mexico. Our ending cash balance for the third quarter was $386 million.

The cash movement of $115 million for the Dow buyout and $69 million for the acquisition of Private Formula in Australia took place in the first weeks of October. After these two items our cash balance was about $200 million.

We announced today that we have once again decided to raise our cash EPS guidance for 2009 up to a range of $2.10 to $2.20 for the year. Having already delivered $1.54 cash EPS for the first nine months of 2009, and with expectations for growth, the new range is a better reflection of our current expectations.

Now, I will turn the call back to Mike for closing remarks.

J. Michael Pearson

In conclusion, I believe the results of the first nine months of 2009 demonstrate the strength of our base business and our ability to deliver growth, earnings and cash flows. The acquisitions we have made so far have added depth to our core business and will provide product growth drivers for each of our businesses. As we look to the next few years, I believe we are well positioned to achieve both our financial and strategic goals of becoming a leading specialty pharmaceutical company.

With that, we'll now open it up for question. Operator, may we have the first question, please.

Question-and-Answer Session

Operator

Your first question comes from Gary Nachman – Leerink Swann.

Gary Nachman – Leerink Swann

First question, I guess, to Peter, how were you able to recognize so much profit sharing from generic BenzaClin? That deal closed at the end of September. And is that profit sharing reflective of a full quarter or could that number actually go higher going forward?

Peter J. Blott

Mylan launched the products, I think, at the beginning of September. They did include to some extent a fill of the pipeline as you would normally do. So to the extent to which it was – represents a full quarter, but there was only actually one month of sales, and we recorded that $8.5 million was – of alliance revenue that we recorded – was the profit share on those sales through the 30th of September.

Gary Nachman – Leerink Swann

But I guess the fact that you did the deal at the end of the quarter you were able to retroactively record that because you own that asset at this point?

Peter J. Blott

Essentially because of the way the deal was structured, we bought Dow Pharmaceuticals, the legal entity last year, but there were just remaining contractual considerations with the previous owners of Dow. And the Dow buyout arrangement that we did in September essentially just gave us the full rights to those unencumbered and, therefore, we were able to recognize all of the profit share in the quarter and will do in all previous quarters.

The other piece about the accounting was because of the Dow buyout, the original acquisition we had negative goodwill because there were some deferred consideration treatment from the U.S. GAAP. So this actual deal didn't create any intangibles and, therefore, there's no amortization associated with it. And therefore the profit share essentially drops straight to operating income.

Gary Nachman – Leerink Swann

And what is the profit share? Could you give us sort of a range on that?

Peter J. Blott

We've disclosed it as being significant, as in greater than 50%, but we've not given details of the exact profit share arrangements.

Gary Nachman – Leerink Swann

And this for Mike, on your 2010 guidance, your double digit growth goal, is that for both top and bottom line? I just want to clarify that. And then the two stretch goals for the derm business and also for the generic business. Is that organic or are you assuming that you're going to have to do deals to get there to that goal?

J. Michael Pearson

So the guidance in terms of the financials is double digit organic top line growth and then double digit cash EPS and cash flow from operations. So double digits on both. But it's organic growth on the top line, which hopefully will, since we do have some acquisitions that we've made that it'll be above that.

In terms of the two stretch goals, if we – let me take the second one first which is the two branded generic businesses. We have built a significant pipeline over the last year in both those regions which we've talked about. And we've also made some acquisitions over the last year. It's going to be a stretch to get to $500 million. It's a bit of an aspirational target.

And with just the parts we have, I'm not sure we'll make it. But we'll certainly try. But it's always possible that we'll be looking for again, similar tuck-in acquisitions. We're not looking to make any major acquisitions next year in those two areas.

On the derm side, again, it's going to be a stretch in terms of making that $500 million just with the parts we have. But again, if you don't shoot high you don't go high. And again, we will be looking for tuck-in acquisitions. But again, it's not predicated on any significant acquisition.

Gary Nachman – Leerink Swann

Okay. And then last question, just on those derm products that are entering Phase III, it sounds like you plan on doing those yourself at this point. But are you actually in partnership discussions with that possibility that you might have partners to help you fund that going forward? Thanks.

J. Michael Pearson

Sure, Gary. Actually, it's likely we'll have partners. One of our core principles is we like to partner our products in the pipeline. That does a couple things for us. One, it provides an ability to sell these products in geographies that we're not in, that we don't plan to enter. It also is a great litmus test in terms of whether someone else believes these products are worth funding.

So one of the reasons we did the buyout of the remaining obligations to Dow was to free up those products so they could be partnered, and that, and so we, whereas when they were as part of the original Dow agreement there were milestones and other things associated with them. So it will be very likely that we will be partnering some or all of those products.

Operator

Your next question comes from David Amsellem – Piper Jaffray.

David Amsellem – Piper Jaffray

Thanks. On the neurology business in the U.S., it looks like you had another strong quarter of sequential growth. Since we haven't seen any major price increases on the key products there like Diastat or any noticeable uptick in script growth, I was wondering if you could talk to what's driving the strength here, and is there an OTC component where you're seeing particular strength? Thanks.

J. Michael Pearson

So in neurology, we have had some price increases. There's also been on a number of our products actually a good organic growth, not on some of the larger products, but on some of the smaller ones, which is actually quite helpful. It is neurology and other.

The one OTC product we have to that question in that basket of parts is Bedoyecta in the U.S., where we sell a lot of the heavily Hispanic markets in the U.S. And that has been growing. But it doesn't account for, it only accounts for a fraction of the growth.

David Amsellem – Piper Jaffray

And then second question on the MR formulation for retigabine. If you have a lead candidate that emerges next year, is it your expectation that you could move into a pivotal study at some point next year?

J. Michael Pearson

It's possible. That would be great if it happened.

David Amsellem – Piper Jaffray

And then lastly, are you planning to present any new retigabine data at the American Epilepsy Society in December?

J. Michael Pearson

I don't think we're planning to present anything new. I think we are planning to have a presence. We have been focused with our colleagues at Glaxo just getting this thing filed up until last week. We have not spent a lot of time actually talking beyond the MR in terms of what our plans are for the next year.

So we have another joint steering committee coming up and we will be sorting through which conventions we go to, what publications we're going to invest in, that type of thing. So it would probably be premature to give you a conclusive answer on precisely our plans for next year.

Operator

Your next question comes from Michael Tong – Wells Fargo Securities.

Michael Tong – Wells Fargo Securities

Just a quick question, maybe this is for Peter. In the alliance revenue line there is a $6 million license payment. Can you give us some color as to how that came about?

Peter J. Blott

Certainly thank you, Michael, it's actually found I think in one of the footnotes. It consists of I think four individual payments that we received in the quarter. One of them was relating to the Mylan generic. But also the other elements were over out licensing of derm products for Europe for derm Acanya, not for Acanya, for –

J. Michael Pearson

Atralin.

Peter J. Blott

Atralin.

J. Michael Pearson

Ziana.

Peter J. Blott

And Ziana, sorry, I apologize. So those are $6 million in the quarter and you would not expect those necessarily to repeat. Although as part of our strategy, there's always the possibility that we would sort of do further deals of this nature.

Michael Tong – Wells Fargo Securities

And with respect to retigabine for PHN, what's your latest thinking on that right now?

J. Michael Pearson

Again, we have not had reached a definitive agreement with Glaxo. And as soon as we do, we will pass that along to you.

Michael Tong – Wells Fargo Securities

And finally, as I look at the gross margin or gross profit margin for the respective geographies, it seems like in addition to Latin America, North America also had a drop sequentially in gross margin, anything special in there? Or should I think of the Q3 margin as being more sort of the run rate going forward?

Peter J. Blott

I think as I mentioned in the presentation there was about $2.5 million of charges in the third quarter of 2009 within essentially the U.S., the Specialty Pharma cost of goods sold. These were mostly at – so a series of small reserves that we took about inventory and royalty payments and a few expense items coming through there. We hope those will not repeat.

But to a certain extent, an individual quarter will always have some fluctuation in it. So probably if you're looking for something going forward, you can probably exclude a fair part of that additional $2.5 million that went through this quarter.

Operator

Your next question comes from [Greg Fraser] – Bank of America.

[Greg Fraser] – Bank of America Merrill Lynch

Can you give us an update on your discussions with potential partners for your ribavirin?

J. Michael Pearson

Sure, we actually presented our final data last weekend or this weekend, I suppose, and a press release will be coming out tomorrow. We continue to have partnership discussions. But again, we will – we hope to be able to find a partner. We are not committing to finding a partner at this point because we haven't found one yet.

And but we are committed to not spending more of our money on this unless we do find a partner. So we've been engaged in a lot of conversations. There's some interest but nothing definitive yet.

[Greg Fraser] – Bank of America Merrill Lynch

Okay. And the $8.5 million payment for Mylan and future payments, do you record that at 100% gross margin?

Peter J. Blott

Yes, because essentially it goes in as alliance revenue and that essentially drops straight to operating income because there's no cost associated with it.

Operator

Your next question comes from Juan Sanchez – Ladenburg Thalmann & Co.

Juan Sanchez – Ladenburg Thalmann & Co.

Question one, what are the attainable operating margins in Poland, Mexico and Australia, let's say, next year organically, right? And I have a follow-up question after this one.

J. Michael Pearson

So in terms of the operating margins as we said they were both in the low 30s this year. We will expect those to improve next year. I think historically, Latin America has been actually almost up to 40% in some quarters. So I think mid-30s is a reasonable assumption for where we would hope to get those.

Juan Sanchez – Ladenburg Thalmann & Co.

In Latin America, right, or in both?

J. Michael Pearson

Both, in both. I'm sorry, in both.

Juan Sanchez – Ladenburg Thalmann & Co.

And the second question is the profit sharing with Mylan, this $8.5 million is for the whole quarter or just for one? I just didn't understand clearly. It was for the whole quarter or just for part of the quarter?

J. Michael Pearson

Just for part of the quarter, but it did include an inventory build. So I think they actually launched mid-August –

Juan Sanchez – Ladenburg Thalmann & Co.

Yes.

J. Michael Pearson

So it represents probably six weeks as opposed to a full quarter. But there was an inventory build. But they do have, they've attained about 30% of the scripts at this point. So it'll be a funny quarter but in that because of the buy-in. But it should be significant going forward.

Juan Sanchez – Ladenburg Thalmann & Co.

Got it, I now see it. $235 million in milestone payments coming to Dow, those are coming in through in the how many years? I mean, what's the timing of those payments if they happen?

J. Michael Pearson

So one of the reasons we did this deal is there was a series of payments tied to the specific compounds that had been identified that were in Phase II when we originally bought Dow. There was milestones based on submission into Phase III, so some of them actually would have come in the third quarter as we have now started Phase III trials, upon approval, upon certain sales targets, etc. They would have also been triggered if we partnered these products.

So we partner these product and get an upfront payment. Part of that upfront payment would have gone to Dow. So one of the reasons we felt quite comfortable after our Phase II meetings that we have some pretty exciting products here. And we have gotten good indications from potential partners. And this allows us to structure deals that could include an upfront where we would be able to benefit fully from the upfront payments.

Juan Sanchez – Ladenburg Thalmann & Co.

So you think that if everything goes fine you could receive more than $100 million over the next year and half or so or how should we think about –

J. Michael Pearson

I think that would – I have no idea because some of those were based on sort of sales and these things aren't going to launch in the next year or year and a half. But I think where we do feel comfortable is that over the life of these compounds, that, coupled with the generic BenzaClin substantial increase that the cash we will receive from both the products and the generic BenzaClin, will far exceed the 115 that we had to pay to remove those obligations.

Juan Sanchez – Ladenburg Thalmann & Co.

And the last question is what's the current balance of the convertible, the 3% and 4% convertible debt?

Peter J. Blott

So there's 225 million of the 4% convertibles left. And about 50 million I think of the 3% convertibles left at the moment.

Juan Sanchez – Ladenburg Thalmann & Co.

And you have an intention of continuing buying back shares or this is it?

J. Michael Pearson

Again, we will, we have a board meeting actually tomorrow and we will continue to discuss that. But it certainly has, as you can see in Q3, we continued to buy back shares. And as long as we continue to believe that it's a good investment for shareholders, we will continue to do that.

Operator

(Operator Instructions).

J. Michael Pearson

Okay, well if there's no more questions, thank you very much for joining us on this call and we'll look forward to speaking to you soon. Thank you.

Operator

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

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