St Jude Medical Earnings Call NUGGETS: CRM Expectations, FX Fallout

On Wednesday, St Jude Medical, Inc. (NYSE:STJ) reported its second quarter earnings and discussed the following topics in its earnings conference call. Here’s what the C-suite revealed.

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CRM Expectations

Kristen Stewart – Deutsche Bank: I was wondering if you can kind of touch on the CRM expectations. I think your guidance assumes a more moderated view of the CRM market as a whole and then a little bit more of a reduction in your market share that you expect to take for the rest of the year. Can you maybe just give us an update on what you are seeing with kind of particularly the U.S. ICD business and what kind of has prompted your change in guidance?

A Closer Look: St. Jude Earnings Cheat sheet>>

Daniel J. Starks – Chairman, President and CEO: Kristen, this is Dan. During the second quarter, we saw really across the board a little bit softer utilization in our CRM business and our AF business and in our CVD business and this was largely driven by Europe, but it really was an across-the-board effect. That’s the first thing is that we’re being more reserved in our outlook for the second half of the year because during the second quarter we saw signs of softness in most of our major markets. So that’s that one. Secondly, we didn’t really know. A quarter ago, we indicated that we’re not changing the guidance for our CRM business for the year because we didn’t think we had enough information to do it, but that we fully expected to change our guidance for the year with another quarters of experience and we partly wanted to look at the other companies’ numbers and we also wanted to get more information about the impact, that issue surrounding our Riata high-voltage lead would have a customer use of St. Jude Medical ICD product. So we have another quarters of experience and that together with my prior comments has led us to reduce our outlook on the CRM side. So we previously were talking about low single-digit decline in the global CRM market and now we’ve tweaked that a little bit to say 3% to 4%, which is maybe low to mid single-digit decline in the CRM market and a quarter ago we were talking about gaining between a half a point to a point of global share of the CRM market and now this quarter we’re reducing that to say that we think that we’re on track to gain about a point and a half point of global share of the CRM market. So those are the factors together that – along with the negative trend in FX translations that caused us to reduce our outlook here on the CRM side, partly market growth, partly market share, neither factor a major change but both factors together cumulating to our revised guidance. On the high-voltage lead side of things and others here around the table can offer more insight than I, but you see from our comments and from our numbers on the U.S. ICD market that although we clearly lost some business during the quarter due to reduced use of our high-voltage lead in the U.S. ICD market. We also – we gained more new business than that, so it all nets out to what we think is about a point to a point and a half point gain in U.S. ICD market share for the quarter. So there is a lot of moving parts and crosscurrents in our number, but when you net it all out, our U.S. ICD business came out of the second quarter in a stronger competitive position based on the results than we showed going into the quarter. So we were under a lot of stress, but we also had lot of a new technology and lot of very strong service education and training to support the business and all of that has resulted in the – netted out to the results in the revised guidance we’re announcing this morning.

Kristen Stewart – Deutsche Bank: Just a follow-up on the European, I guess trends that you’re seeing. Are there’s more softness in terms of utilization trends? Or is there softness just in terms of greater pricing pressures?

Daniel J. Starks – Chairman, President and CEO: It’s really both, it’s both. So it seems that every day there is just new volatility in European, all the European dynamics. So our international organization, our European organization have reported us that we really haven’t experienced this kind of environment before that we’re experiencing in Europe today and it – the trends are all on the downside, number one, both (Us) and ASPs. There’s – when you add the economic issues, debt crisis issues, austerity issues and political volatility, it just all create some disruption in the market in the short-term. It isn’t something that we would want to overstate, but it is something that we’re very focused on and that we are taking into account in revising our guidance downward slightly for the second half of this year.

Kristen Stewart – Deutsche Bank: Just a quick one for John, just on the gross margin guidance. I was surprised that you guys kept that equal in light of the FX reduction. Is that just are you seeing greater cost efficiencies with manufacturing and maybe some of the savings from some of these restructuring programs being pulled forward into 2012?

John C. Heinmiller – EVP and CFO: I think that I am not sure I get the last part of your comment, Kristen, on how that plays into it, but I think with respect to our guidance, we’re really holding to the guidance that our gross profit margin for the full year would be in that range of 73.5% to 74.0%. We’ve taken into account the currency changes that we expect here in the second half. We typically see a little bit of seasonality in the business, which again is factored into our expectations for the second half. We are really right on track with what we’ve seen so far in the year. We’re comfortable with that guidance range for gross profit.

Daniel J. Starks – Chairman, President and CEO: What I’d add, Kristen, I’d add that you’re absolutely right that with the change in FX and with the stability of our gross margin expectations, we are really showing some surprising strength in gross margin. I would attribute that to our ASP discipline, and in part I would attribute it to the value of our new technology and what that does to ASP support and I would also attribute it to our discipline and willingness to walk away from especially low-priced business. So, for example, on the pacing side there is a segment of the pacemaker market that really when the business is transacted at a very low ASP level, it doesn’t make sense to us. You see that reflected in the softness of our pacing revenue trends on the one hand, but you see the price discipline reflected in the stability of our gross margin guidance on the other hand.

John C. Heinmiller – EVP and CFO: I would add – the other comment I would add to that regarding our initiatives for manufacturing in more tax-advantaged locations, we see the benefit of that starting to come through now with the adjustment to our tax rate; we really weighted until we can validate that we’re comfortable with that. So as we went into the year, we were a little more conservative with our tax rate expectations, but we’re now comfortable that that is a new point for us to take credit for in that tax rate.

FX Fallout

Michael Weinstein – JPMorgan: First question. John, just to clarify the $0.04 reduction in guidance for FX, is that the full FX impact or were you able to absorb part of it?

John C. Heinmiller – EVP and CFO: When we look at the impact of adjusting our currency rates for the second half and then we assume that about 50% of that revenue impact flows through the operating profit line and you make that calculation, that’s the $0.04 to $0.05 of negative earnings per share impact that we’re absorbing. There are a lot of factors going into the current earnings per share expectation, but we’re absorbing all of that in our current guidance for earnings per share.

Daniel J. Starks – Chairman, President and CEO: One way to think about it Michael is that the FX impact, you can see that the numbers equate, so that one could say that the negative impact of FX on the revenue side and on the EPS line is directly translated into the revision of our guidance. There is significant – there is material – other reduced sales guidance that we are absorbing in our – to reduce sales guidance that is not (timed) to change in FX that we are absorbing in our FX, in our EPS guidance. So you can see that we had quite a bit of strength in our prior EPS guidance range.

Michael Weinstein – JPMorgan: Let me ask you that if you look at the performance this quarter, everybody is spending 90% of their times talking about the U.S. ICD business. Obviously, that relatively (expectations) is fine. What probably surprises people is that some of the business lines slowed sequentially in the U.S., whether it’s cardiovascular or AF and you talk about capital equipment or neurmod, any thoughts on that why the U.S. businesses across the company ex-ICDs appear to slow sequentially?

Daniel J. Starks – Chairman, President and CEO: Yeah, we think it is just – the good news Michael is that we see the impact across the board, so we don’t think it’s about us and our business and our competitive position. We really think it’s a class effect, the fact that we see it across virtually all product lines, all of our major product lines and that we see it not only in the U.S. but we’re seeing it in Europe, in particular, as well as and we see it in some other markets. It just seems like that there was some slowing in our markets, at least in our – as reflected in our outlook here and you see it reflected in the second quarter numbers. So, typically, you’ll see us up at the (turn in) results that are at the high-end. Some of our results often will exceed the high-end of our guidance range. This quarter, all of our results were well within our guidance range. So you put the actual results together with the signals that our global organizations are sending back here to headquarters about softness and trends in all major markets, and it looks like that there just is some softening in (Us) and continued strong ASP pressures and just budget and macroeconomic concerns across the board that are finding a way to impact our results, and therefore also impacting our outlook. It may turn out that we’re being too conservative in our outlook for the second half of the year, but that would be fine with us if our results end up coming in stronger than the guidance we’ve offered this morning.

Michael Weinstein – JPMorgan: Last one can I get an update on two pipeline items? Dan, you mentioned that the PFO closure for stroke RESPECT trial, can you just update us on the filing that data in that PMA with the FDA? Then second one for the Portico program, the transapical version, when do you expect to start to see March trial? Have you done that or if not when do you expect to start?

Daniel J. Starks – Chairman, President and CEO: On the PFO closure, the submission to FDA is being prepared as we speak and there is a lot of data to analyze and prepare and organize. So, I would be confident that the PMA submission will be in during the fourth quarter and I suspect that we would be unlikely to get that submission in the before the end of the third quarter. So timing wise that’s our update. Within that though one can see that we have a number – since our organization is strongly focused on preparing that submission, obviously we’re no longer blinded to the data and that was the basis for the level of confidence we’ve expressed that when the full trial results are reported at the TCT, we are optimistic that these will be favorable results. On the topic of Portico transapical, you’ve caught me a little bit unprepared Michael. I know that that program is fully on track. There have been no slippage in our timeline, but – and I know I saw a briefing paper on exactly the status of that initiative and I unfortunately don’t recall it and I don’t have it in front of me. So I’ll tell you that it is on track, but I’m afraid you’ve caught me a little bit unprepared.

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