Abbott Laboratories Q2 2007 Earnings Call Transcript

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2007-07-18 11:39:00.0

Tags: Abbott Laboratories Inc.

Question-and-Answer Session


Operator

(Operator Instructions) Our first question today is from Mike Weinstein. And please state your company name.

Mike Weinstein - J.P. Morgan

Thank you. It's J.P. Morgan. Excuse me, a couple questions if we could start-off. There was during this quarter, there was that Barron's article and there was noise on TriCor in particular, its uses with statins and the company never really came out and made a response to that.

But there's obviously a lot of research that's been done on TriCor with statins including the Sapphire -- excuse me, the SAFARI trial and there's work that's obviously ongoing with 335 in combination with various statins.

So in particular what would be helpful is if you could talk about the 335 studies that are ongoing combination with various statins? And what you know from that data so far and when you think that data might be published? Thanks.

John Thomas

Sure. Hi, Mike. This is John.

Mike Weinstein - J.P. Morgan

Hi, John.

John Thomas

Hi. So on the Barron's TriCor article that came out unfortunately, that article was fairly skewed in the facts. We did feel like we responded through our media folks to that article, as best that we could. I will tell you though that that's one of those things that's unfortunate when those things happen.

I'm sure; it's a very fine reporter at Barron's but for fact based for our investors, I think it's important to understand that this particular reporter did not -- is not a health care reporter, did not know about Abbott and did not know about the lipid market.

We tried to educate her but sometimes these things turn out the way they do. The facts are though that TriCor's safety is very well understood. There is no data or nothing new here with TriCor to substantiate any of the implications that were made in that article.

Fibrates, as you probably know have been around for more than 30 years and TriCor specifically has been used by 2 million patients or more than 2 million patients and has been available in the U.S. for 10 years.

So we are not seeing any concerns from physicians or prescribers. In fact hopefully we put that to rest with the 21% growth in the quarter and the very robust prescription growth that we are seeing with TriCor, its safety profile is very well understood by clinicians and prescribing physicians and we have checked with our commercial team. And as you can see from the results there's really been no impact to prescribing patterns.

With regard to 335, we are obviously very encouraged by the development of that program. We have completed the trials. We expect to show that data early next year publicly. We are working with AstraZeneca to determine next steps. As I mentioned in my remarks about do we pick TriCor, existing TriCor or do we pick the next generation product 335?

So because of that partnership, we have seen data but I don't want to discuss it at this point. I will tell you that we are encouraged with the general situation with 335. We will file that product, I think as I mentioned as a mono-therapy later this year irregardless of what decision we make with AstraZeneca. But we are getting closer to a decision with them and I can't give you a specific time line but I would expect in the coming months that you'll hear from us on 335, and where we go with AstraZeneca.

Mike Weinstein - J.P. Morgan

Okay. Let me follow-up with a couple different questions. At that first, I think probably everybody would like to hear a little bit more of a thought on this strategy of the diagnostics business going forward. I don't know, if Tom wants to take that or if Rick's on the line.

But maybe what we'd like to dive into is to what degrees you'll be digging up this businesses as a long-term piece of Abbott while the GE deal fell apart. Obviously, there might be other interested parties and have you heard from the other parties and are you willing to entertain any of those discussions?

And then the last item is just on the guidance for the back half of the year. HUMIRA obviously was well above consensus expectations. A number of other products are strong, XIENCE is doing well, you raised your guidance on Niaspan. So a lot of things are obviously moving in the right direction and then you left your EPS guidance for the year unchanged, even though you lowered your tax rate a little bit.

So maybe just talk about the upside we're seeing from some of the key drivers of the company, why leave the EPS guidance intact and where are you going to spend that money? Thanks.

Tom Freyman

Mike, let me take the second question first on the tax rate because this does require a little explanation. And I think your impression is not and I understand it because it's a little confusing it's not the right one. So let me walk through it.

The lower tax rate we're forecasting for the full year is pure optics. It's a function of now having diagnostics in the mix versus our assumptions back in April that we would sell the business and re-deploy the proceeds.

Now let me give you a couple ways to think about that. If back in April, when our forecast of tax rate turned positive and we lowered the rate in our guidance if at that time we had known that ATD (ph) would be part of the mix, instead of reducing the rate to 20%, we would have reduced the rate to 19.5%, which is what our rate is now. So that's one way to think about it.

The other way to think about it is under the previous scenario back in April, when we were assuming sale of the business, we were also assuming redeployment of proceeds in the second half primarily to pay down debt. As we have said all along on this deal, the 2007 impact of the deal was EPS neutral. Under the scenario the baseline scenario of running the business, we had a relatively lower tax rate on the business.

Under the scenario of selling the business, interest is subject to a relatively high tax rate. So when the assumption of reduced interest goes out of our forecast, the optics are that our average rate for the year goes down slightly. And so it really, in total, we are really assuming nothing different. It's a function of the way the neutral EPS was balanced between running the business or disposing of the business and paying down debt.

Mike Weinstein - J.P. Morgan

Got you. That makes sense.

Tom Freyman

So hopefully that explains it. On diagnostics itself from a strategic point of view, I think, John, at this point really did a nice job of re-grounding people on what the position of this business is. As you all know, it is a global leader, the global leader in Vitro. Got a huge footprint of instruments globally with the Architect and the Prism systems being state-of-the-art and leading systems.

Clearly, in blood banking we are in the best position. Point of Care is a smaller business, but more rapidly growing and that is a concept that continues to catch on at hospitals, and something we think can really add to the growth rate. It was a $2.7 billion business last year. We think it's going to approach $3 billion this year. So there's decent growth in it.

And as John indicated, the international business is performing extremely well, which is about 80% of the business. And from a GPO or a group purchasing organization point of view, ADD has been successful in securing two major contracts that will really help them over the next several years of the long range planning forecast cycle.

So, the base business is solid, is performing well, and there's a lot to build on here. Now, senior management is going to be spending more time looking at the strategies going forward.

We're working on that as we speak, we're spending a lot of time with the senior management at the division. And I think we'll have more to say about that in the coming quarters as we move forward.

Mike Weinstein - J.P. Morgan

Okay, great. I'll let someone else jump in here.

Tom Freyman

All right, thank you.

Operator

Thank you. Our next question is from Glenn Reicin and please state your company name.

Glenn Reicin - Morgan Stanley

Glenn Reicin, Morgan Stanley, thank you.

Tom Freyman

How you're doing.

Glenn Reicin - Morgan Stanley

Two quick questions. Actually one not very quick question, but the quick question is without GE now are there any assets at this point that you are considering to sell? Were there any sort of strategic areas you need to focus in on?

So sort of what are the implications of not having the extra cash from the GE deal? So that's question number one. And then, Tom, I think it would make life a lot easier if you can reconcile your old guidance in terms of the various line items with the new guidance.

And just sort of quantify what the impact of the diagnostics business is, because I think that's really just confusing everyone. So I'll leave it at that.

Tom Freyman

Okay. From a portfolio perspective, I mean as we said even before the GE deal and before the diagnostic business came back into the fold here, we're very happy with the portfolio between the Guidant, Kos and Knoll acquisitions, the Sarasense acquisition, and the spin-off of Hospira a few years ago.

When we look at this portfolio, we're very happy with the growth prospects and the market positions of these products, and the technology-driven nature of them, and our ability to innovate and grow them over the long-term.

So, we are very happy with this portfolio, all aspects of it and you can see in the quarter good things happening in all of those businesses. As always, every business could benefit from technology augmentation or niche type additions.

And as you know, we have a very active M&A group that continually look at those types of opportunities. I don't think there's anything critical, though that we need to execute on our strategic plan and to be successful in our financial forecast as we put them together.

There's really no crying need for a deal. And if we were to think about it, the odds are at this point in time given how happy we are with the overall portfolio, that it would tend to be a smaller niche type of thing if we pursued anything.

Glenn Reicin - Morgan Stanley

Could I just interrupt? Just to answer Michael's question about diagnostics, would you say now it's a very low likelihood that anything will be done in the future with that business? And also what is the status of TAP?

Tom Freyman

Yes, we have no, and we are committed to the diagnostics business for the long-term. There are no plans to reconsider a sale of the business. So we're moving forward with this as part of the portfolio, and we're going to manage it for the long-term.

TAP, we talked about this a number of times publicly, both companies have expressed interest in running that business on their own in different ways over the years. We've never been able to come to a conclusion on that.

Would that make sense? Yes, it might if the appropriate arrangement could come in, but there's nothing, no immediate prospect of that happening, we'll see. We'll see if anything would change in that.

And to answer Mike' questions, we have no plans on any other businesses for dispositions.

Glenn Reicin - Morgan Stanley

Okay. The question about GE and the P&L, for example the gross margin guidance today versus what it was a quarter ago, and try to help us walk through the various line items and how GE impacted that.

Tom Freyman

Yes, the main and there are really two main areas where collapsing GE back or I'm sorry, diagnostics back into the business affected anything really in the quarter, while the business had a very nice growth rate of low double-digits as we talked about in the release and on the call today, it was somewhat below the corporate average.

So, from a sales growth perspective, there was about half a point impact of bringing GE into the results. The one area, and I mentioned it in my remarks, is gross margin. And as we said from the very beginning, there's about a 300 basis point impact when we thought it would be sold, and there's about a 300 basis point negative impact coming back in, which gets us to the 58% gross margin that I forecasted for the full year.

The other line items are fairly modest, a couple ticks on R&D, because the R&D spending on this business was a little bit less than our corporate average, and a little bit on the SG&A ratio, but given that it's 10%, 12% of the business, even though the profiles are slightly different in those other areas, it really doesn't have much impact.

So, the key areas are slight impact on growth rate on the top line in the quarter, and really the gross margin going forward.

Glenn Reicin - Morgan Stanley

Okay. Thank you very much.

Tom Freyman

Thanks.

Operator

Thank you. Our next question is from Rick Wise and please state your company name.

Rick Wise - Bear Stearns

Good morning. It's Rick Wise, Bear Stearns.

Tom Freyman

Good morning.

Rick Wise - Bear Stearns

Hi, Tom. Couple questions. First, since we're talking about diagnostics, maybe you could expand on the timing of FDA resolution, where are we now and how quickly does this get resolved?

Tom Freyman

Yeah, I mean, the situation in ADD is for most of our plants with the exception of Dallas, we've come through a pretty good inspection record here, very significantly in Lake County, we very recently completed an inspection there.

And as many of you know, our Lake County facility is our most significant one, it's our largest one, which is where the assays are manufactured, which is where the products that generate the sales really are produced.

That particular inspection had zero observations, so we're in very good shape there. The Dallas facility is under a warning letter. We did respond back in March to the observations the FDA had on that plant, and we are moving forward with our remediation activities, and I think are making very, very good progress in that regard.

Really can't speculate on timing on these things and we're not prepared to do that today. But we're making good progress.

Rick Wise - Bear Stearns

Trust it doesn't really affect the business or the outlook?

Tom Freyman

No, I mean, this doesn't affect our ability to ship product. And again, the key thing for us is to address the observations, put the remediation plans in, which we have done already and it's just a matter of validating that they're operating and then working through the final clearance process with the FDA.

So we're working through that, but it doesn't affect the business.

Rick Wise - Bear Stearns

Okay. Turning back to Xience, can you just remind us of the next milestone or milestones we expect, you reiterated your belief that I think you said first half '08 approval. Do you expect a panel this year or early next year? Just again, anything you can share with us?

John Thomas

Yes, hi, Rick. With XIENCE, obviously we're very early into the PMA submission process, it's only six weeks into that. We, as a company, have ongoing dialogue with the FDA, can't speak for other companies, but we have ongoing dialogue with the FDA.

Obviously, can't talk about that specifically, but I think the next couple of events that investors are interested in are obviously, will there be a panel to review XIENCE and or another product.

And we have not been notified by the FDA yet whether we're going to be scheduled for a panel, if we are, that's fine, we'd more than welcome the opportunity to talk about our data side by side with the competitive data that's under review. If we don't go to a panel, that's fine too.

Either way, it doesn't change our forecast, which has been, and continues to be that we expect to receive approval and launch in the U.S. in the first half of next year.

So, the other things that are of interest, obviously, would be new data. And at TCT we're going to have some new data on XIENCE where we'll talk about SPIRIT II and SPIRIT III one year, I believe that's a pooled analysis.

And then SPIRIT III one-year data including subset analysis. Also we should have by then, I think the timing will work out that we'll have 12 month clinical data on ABSORB, the fully ABSORB bioabsorbable program.

So, those are some things to look out for. We're very likely to have another analyst meeting at TCT like we did last year, and we'll give you information on that. And if there's anything new between now and then or shortly thereafter to talk about in terms of FDA response, we'll let you know on that, as well.

Rick Wise - Bear Stearns

Okay. Let me just jump in with two quick last ones here. During the call, there was a press release that said that Merck KGA had transferred Niaspan rights OUS to Abbott. Is this new news?

And is this significant upside? And one last question for Tom. Obviously, the diagnostics sale was going to accelerate debt pay down. Maybe just review your thoughts about cash flow and debt pay down with diagnostics back in? Thanks.

John Thomas

Let me answer your question on the Merck KGA first and then I'll let Tom take the debt question. Yes, this release just went out this morning. And we got this question from investors when we did the Kos Pharmaceutical acquisitions last year.

And at that time, if you recall, what we told people was any international opportunity would be in addition to what our base modeling assumptions were for Kos. We didn't include that to be conservative. So we are pleased that we've gotten these rights back, and we're evaluating that opportunity internationally right now. And we'll keep you posted on that. But that is a new item, yes.

Tom Freyman

Rick, to answer your question on debt, as you know, we've been generating extremely strong operating cash flow for the last few years, and that's continuing to this year, well over $5 billion before dividends last year. We would expect that to continue probably another record this year.

That's what we forecast. And we expect a nice improvement in our net debt position as we progress through the year. I'm a little hesitant to give a forecast on that because that's somewhat dependent on our decisions and what we do with share repurchase.

But plenty of cash flow. And I think if you look at our net debt position, you're going to see a significant reduction when you look at it compared to 2006. Over the longer term, we've said this many times, with that strong operating cash flow, we see a mix of uses.

Certainly some debt reduction is something we want to continue to do, but also share repurchases continue to be active. We have $1.7 billion remaining on our current program. So that's something we would expect to continue to do.

And I think there's plenty of cash flow and capacity in the event we did have some smaller niche augmentations to the business from an M&A perspective. So feel very good about our cash position, our credit rating is very strong. No change from S&P and Moody's when the announcement of our retention of ADD was made. So I think we're in pretty good shape.

Rick Wise - Bear Stearns

Thank you so much.

Tom Freyman

Thanks.

Operator

Thank you. Our next question is from Glenn Novarro. Please state your company name.

Glenn Novarro - Banc of America

Thanks guys. Banc of America. Couple questions. First on the pharma side, Humira, Depakote, TriCor, all handily exceeded our expectations. I just want to get a sense of the organic growth.

Was there any stocking in the quarter? Were there any pricing, was there any price increases on these drugs? I just want to get a sense of how sustainable the growth is. That's question one.

John Thomas

Okay.

Glenn Novarro - Banc of America

Second is the bare metal stent leader. Can you give us a sense of where you think DES penetration is in the U.S. right now and what your sense of PCI volume? And then a quick one, Simcor, you haven't talked about OUS. Does there any plans for OUS? Do you have the rights to Simcor OUS? Thanks.

John Thomas

Okay, Glenn. Let me try to address those questions. As far as inventory, et cetera, we feel very comfortable with our inventory position. We did not see any major swings in inventory, and we obviously look at that very carefully.

And like to keep our inventory levels in a very comfortable position. So that was not an impact. There was very modest impact on price year-over-year on pharma sales in this second quarter. So we did see some modest year-over-year price increases, but there were no price increases taken on any of the major pharmaceuticals in the quarter. So I hope that answers your question there.

Glenn Novarro - Banc of America

Yes.

John Thomas

DES penetration, our information shows that it's in the mid to upper 60% range, which I think is fairly consistent with what we've heard from our competitors. And it looks like it's stabilizing in the U.S. X-U.S., it's actually ticking up a little bit depending on the market, Europe and Japan.

And the forecast is that that will continue to tick upward. So we're pleased with that. And of course, having the latest new technology in the marketplace with XIENCE will hopefully help with that when we get the product launch in the U.S. to launch into an accelerating, reaccelerating marketplace.

PCI volume based on the data that we have, which is pretty good, that we triangulate on in terms of catheter sales and so forth, our PCI volume looks to be down in the high single-digit range.

And then in terms of Simcor, I would tell you at this point that we are evaluating that opportunity, X-U.S. However, the dynamic in the marketplace is that combination drugs outside the U.S. are not as well reimbursed as they are in the U.S.

So there could be some selected countries where there's opportunity. But we've always looked at it, and for modeling purposes internally considered the U.S. as the market that will drive the growth of this product when it's approved.

Glenn Novarro - Banc of America

One just last question for Tom. Tax rate for 2008, should we continue to assume about 20%?

Tom Freyman

Yeah, we, as I mentioned in my remarks, are forecasting 19.5% this year. And again, based upon the description of that before, that really should be what you consider as kind of a baseline going forward. And as we said back in April when we reduced our rate forecast, we think that's sustainable. So I think that's the way you should think about 2008.

Glenn Novarro - Banc of America

Okay so 19.5% should be in our models?

Tom Freyman

That would be...

Glenn Novarro - Banc of America

Okay. Good. Thank you.

Operator

Thank you, our next question is from Larry Biegelsen. And please state your company name.

Larry Biegelsen - Wachovia Securities

It's Wachovia. Good morning. First question, does your goal for accelerating EPS growth in 2008 assume that generic Depakote ER does not enter the market in '08? And if it does, how would that change your outlook? And then I have a cholesterol-related question.

Tom Freyman

Larry, we've been through a number of generic challenges over the last two years, and I think we've managed through them extremely well. I mean when you think about Synthroid, Biaxin, Sevoflurane and Omnicef, the strength of the business has allowed us to work through those

And each of those had an interesting set of legal challenges and fairly unpredictable outcomes in terms of if and when any one of them would go generic. And the way we like to approach that from a forecasting point of view is to be realistic and even conservative to the point where, we're not going to tell you exactly what our assumptions are because obviously we feel very good about our legal position.

But from a financial planning perspective, it's challenging to totally count on predictability from these processes. And so we have been very, very realistic about what will happen to that franchise, when the compound patent expires in the middle of 2008. And we feel very comfortable with the way we've built our '08 assumptions in light of the realities that we're dealing with.

John Thomas

And the only thing I'd add there, Larry, is, as you know, Depakote ER has patents that go out to 2018, not that that's factoring into the realistic assumptions, because we are being very conservative in taking that out of our planning assumptions, and still delivering what we believe will be accelerating EPS in '08.

Larry Biegelsen - Wachovia Securities

Great, and then on the cholesterol franchise, in the past you've given ranges for peak sales of pipeline products. I would love to hear your thoughts on how big you think Simcor could be in fixed combination of Crestor and one of your fibrates. Or maybe you can discuss where you think the cholesterol franchise sales can go in three to five years from the $1.9 billion or so in '07?

Tom Freyman

Yes.

Larry Biegelsen - Wachovia Securities

And just lastly, could you just remind us of the patent life of ABT-335? Thanks.

John Thomas

Okay. Well, we are going to be seeking some new intellectual property protection around that, and I don't have any specifics with me right now. But as we file that and hopefully it gets approved by the FDA, we'll be able to share more along the lines of what we expect for 335.

I think you're absolutely right in your general observation that our cholesterol franchise in totality could be a significant contributor to Abbott over the longer term. We're already looking at upwards of $2 billion between TriCor and Niaspan this year, and both have very good growth trajectories. And then there is significant opportunity, as I mentioned with the other programs, 335, Simcor, and then a fixed dose combination with Astra Zeneca, whether that's TriCor or 335.

And I think, I mentioned this in remarks we're going to have five unique cholesterol therapies if all goes well by 2010. Specifically on Simcor, this is a product that if things go well, certainly could be in excess of $0.5 billion, and perhaps moving towards that $1 billion mark over time.

335 is a similar type of product. We'll talk more about it once we have a clearer path there in terms of discussion around filing and approval and so forth and we can talk about the data, which as I said, will be early next year and then I think you'll get a better sense of our optimism around the product.

And, anything else from you Larry? I think we have time for one more question.

Larry Biegelsen - Wachovia Securities

Who's going to book the fixed combination with Astra Zeneca? Can you just tell us that? I mean, how that's going to be booked, the TriCor-Crestor fixed combination?

John Thomas

Well, you mean booked? We'll book sales.

Larry Biegelsen - Wachovia Securities

You guys will book sales, not Astra Zeneca? Or how will that be split?

John Thomas

You know, I'm going to check on that exactly how the accounting for that will work. Because I think, they're booking some as well. But, I'll get back to you on that piece of it.

Larry Biegelsen - Wachovia Securities

Thanks, John.

John Thomas

Okay. We have time for one more question, operator.

Operator

Thank you. Our final question today is from Sara Michelmore. And please state your company name.

Sara Michelmore - Cowen & Company

Yes, Cowen and Company. Good morning.

Tom Freyman

Hi.

Sara Michelmore - Cowen & Company

Hi. Could you give us a quick update on the operating margin trend in that core diagnostics business? I know the sales have picked up, and before you guys had announced the divestiture, the operating margin was looking a little bit better on that business. Can you just give us an update in terms of the profitability trends there?

Tom Freyman

Yeah. I think if you're modeling '07, approaching 10% is the way we see it, probably very high single-digit to approaching 10%. Just a slight word of caution in the GAAP-defined segment data we provided in the first quarter. That isn't exactly the way the internal tracking within the company is, which as you know, is what is used for segment reporting.

So, we'll be back to the normal segment reporting approach and I think for '07, that's the way to think about this business.

Sara Michelmore - Cowen & Company

Okay. And in terms of Niaspan and the Kos integration broadly, I assume with the sales ticking up there that you're on track with the integration there? But can you just give us an update in terms of where you are in terms of making that deal neutral to accretive, and if there's any potential upside from that based on the sales pickup?

Tom Freyman

Well, we've executed extremely well in that integration. Probably a little ahead of schedule in some areas, and the products are doing very nicely. I think certainly going into 2008 that's going to be ahead of our expectations in terms of what we put into our deal model.

From a 2007 perspective, I think it's all part of the mix here. But I tell you the team has done a tremendous job, very near completion on things. And you're going to see a lot of the synergistic benefits in SG&A in the fourth quarter.

And as we mentioned today, we've increased the forecast on Niaspan sales because you're starting to see the commercial execution take hold. You're starting to see the script rates move up. And that's going to bode well going into 2008.

Sara Michelmore - Cowen & Company

Okay, thanks. And in terms of Ultane, I guess that was a little bit below my forecast this quarter. Could you just give us some commentary in terms of the progression of Ultane and Sevoflurane internationally, and what we should expect in terms of a contraction for that product?

John Thomas

Okay. Sure, Sara. I'll answer that and then I want to follow-up on the previous question from Larry Biegelsen, because I found some more information on that. So, Sevoflurane actually has done fairly well compared to our expectations, at least. And I think most of the models that we look at, I think it's actually in line or slightly above of what people expected.

And as you know, we have modeled in a decline due to some new competition in the marketplace. But also mainly is due to some price actions that we took proactively, as you might recall last year, when there was another product launch in the market.

So, actually based on what we've been seeing and what we've been modeling, we've done fairly well and the share has been fairly stable. We continue to actively promote the product. We have a very strong promotional presence around that, and we have the vast majority of the major accounts, over 80% of the marketplace, that we've been able to retain.

So, what we've done in terms of price has really been the driver of the decline, which is fully expected. So, net, net, we've done fairly well.

Back to Larry Biegelsen's question on the fixed dose. When and if that product gets approved, which we hope it will be down the road, the way that our agreement works with Astra Zeneca, our portion of profits that we get from that partnership will be booked as revenues.

So, that unlike the former Beringer Ingleheim agreement should be a good one in terms of gross margin. And then Astra Zeneca, I believe they'll book sales, as well. But the profit that we receive from the split, we will book as revenue. So, I hope that's helpful.

So, that concludes our conference call today. A replay of this call will be available after 11 a.m. Central time on Abbott's investor relations website, at Abbottinvestor.com, and after 11 a.m. Central time via telephone at 402-220-6421, confirmation code 3144138.

The audio replay is available until 4 p.m. on Wednesday, July 25th. Thank you all for joining us this morning.

Operator

Thank you, and this concludes today's conference. You may disconnect at this time.

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