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St. Jude Medical Inc. (NYSE:STJ)

Q3 2010 Earnings Call

October 20, 2010 8:00 AM ET

Executives

Dan Starks – Chairman, President and CEO

John Heinmiller – Executive Vice President and CFO

Mike Rousseau – Group President

Eric Fain – President, Cardiac Rhythm Management Division

Angie Craig – Vice President, Corporate Relations and Human Resources

Analysts

Bob Hopkins – Banc of America

Mike Weinstein – J.P. Morgan

Rick Wise – Leerink Swann

Kristen Stewart – Deutsche Bank

Derrick Sung – Sanford Bernstein

Joanne Wuensch – BMO Capital Markets

Vivian Cervantes – Maxim Group

David Roman – Goldman Sachs

Adam Feinstein – Barclays Capital

Operator

Welcome to St. Jude Medicals Third Quarter 2010 Earnings Conference Call. Hosting the call today is Dan Starks, Chairman, President and Chief Executive Officer of St. Jude Medical.

The remarks made during this conference call contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the company including potential clinical successes, anticipated regulatory approvals and future product launches and projected revenues, margins, earnings and market shares.

The statements made by the company are based upon managements current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions, risk related to the companys proposed acquisition of AGA Medical Holdings and other factors beyond the companys control and the risk factors and other cautionary statements described in the companys filings with the SEC including those described in the risk factors and cautionary statement sections of the companys quarterly report on Form 10-Q for the fiscal quarter ended April 3rd, 2010.

The company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance. (Operator Instructions)

It is now my pleasure to turn the floor over to Dan Starks.

Dan Starks

Thank you, Dennis. Welcome to the St. Jude Medical third quarter 2010 earnings conference call. With me on the call today are John Heinmiller, Executive Vice President and Chief Financial Officer, Mike Rousseau, Group President, Eric Fain, President of our Cardiac Rhythm Management Division and Angie Craig, Vice President of Corporate Relations and Human Resources.

Our third quarter results reinforce our conviction that our growth program is on track and that St. Jude Medical is well positioned to continue growing long-term at a superior rate. We now have raised our 2010 EPS guidance range for the third time in three quarters and beaten consensus expectations for EPS by a combined total of $0.17 earnings per share over the same period.

Before I discuss the factors underlying another successful quarter for St. Jude Medical, I want to talk briefly about our proposed acquisition of AGA Medical. As we announced on Monday, St. Jude Medical has entered into a definitive agreement to acquire AGA Medical for $20.80 per share in cash and stock in a total transaction valued at $1.3 billion.

For those of you who are unfamiliar with AGA Medical, the company generated total revenue in 2009 of $199 million, an increase of 21% over the prior year on a constant currency basis. AGA Medical has a leading share of the $250 million interventional cardiology market to repair congenital heart defects, as well as a full pipeline of products directed toward new growth drivers.

We are especially excited to enter the market for left atrial appendage closure in patients who suffer from atrial fibrillation. The AGA Medical left atrial appendage occluder already has a leading market share in Europe and has the potential to become a major new growth driver for St. Jude Medical over the next five years as part of our atrial fibrillation and our structural heart programs.

The AGA Medical acquisition also will add to St. Jude Medicals structural heart program, a leading share of the emerging market in Europe, to close a PFO or hole in the atrial septum in cryptogenic stroke patients.

The market for left atrial appendage closure and the market for PFO closure both have the opportunity to become new billion dollar markets following global market release of products and full development of relevant markets. The AGA acquisition also brings to St. Jude Medical a next generation vascular plug technology that we expect to replace embolic coils to occlude peripheral blood vessels in a variety of interventional radiology procedures.

This vascular plug technology will add both a new growth driver and critical mass to St. Jude Medicals vascular closure franchise in the interventional radiology cath lab. We expect a strong complement between all of these new growth drivers in St. Jude Medicals existing cardiovascular programs. The transaction is expected to be accretive to adjusted earnings per share in 2011.

Last but not least, John Barr, the President and CEO of AGA Medical has agreed to join St. Jude Medical to add to our leadership talent and to help ensure a smooth integration of the acquisition. We look forward to welcoming John Barr and AGAs 550 employees to St. Jude Medical just as soon as the transaction is closed.

I would now like to ask John Heinmiller to conduct his normal review of our third quarter results along with his typical update for the entire St. Jude Medical business. I will then address several topics about our overall program and open it up for your questions on the quarter and our acquisition of AGA Medical. Go ahead, John.

John Heinmiller

Thank you, Dan. Sales for the quarter totaled $1.240 billion up approximately 7% over the $1.160 billion reported in the third quarter of last year. On a constant currency basis, third quarter sales increased 8% versus last year. Unfavorable foreign currency translations versus last years third quarter reduced this quarters sales by about $10 million.

At the end of 2009, the federal research and development tax credit expired and congress has not yet extended the credit for 2010. In this circumstance, GAAP requires us to estimate our-- and record our effective income tax rate assuming that the R&D credit is not extended.

For purposes of this conference call and our calculation of adjusted net earnings, however, we are assuming that the tax credit will be extended retroactively for 2010, as in past years. As a result, comments referencing third quarter results and our guidance for 2010 including EPS amounts are presented based on an effective income tax rate that contemplates the extension of the tax credit retroactive to January 1st, 2010.

To the extent that the federal research and development tax credit is not enacted our effective income tax rate for 2010 would be higher than what is being presented during this call.

During the third quarter, we recorded after tax charges of $11 million related primarily to closing and other costs associated with the acquisition of LightLab imaging. And $12 million of in process research and development expenses related to the acquisition of certain predevelopment technology assets.

Any financial impact of the AGA Medical transaction including the impact on shares outstanding has been excluded from our guidance for the fourth quarter and full year 2010. We expect to complete the transaction during the fourth quarter.

Comments during this call referencing third quarter EPS amounts and our guidance for fourth quarter EPS and 2010 full year earnings per share therefore exclude any impact from the AGA Medical transaction.

Earnings per share were $0.72 for the third quarter of 2010, a 22% increase over EPS of $0.59 in the third quarter of 2009 and above our guidance range of $0.67 to $0.69. Before we discuss our third quarter 2000 and sales results by product category with guidance for the fourth quarter of 2010, let me comment on foreign currency.

As discussed on prior calls, the two main currencies influencing St. Jude Medicals operations are the euro and the Yen. Given the fact that we established our exchange rates at the beginning of each month, the recent weakening of the U.S. dollar which has primarily occurred since mid-September did not significantly impact our sales results in the third quarter. Currency translations for the third quarter were calculated at average exchange rates that fell within our assumed ranges used in July when we last provided guidance.

In preparing our sales and earnings guidance for the fourth quarter of 2010, we are now assuming that each euro will translate into about $1.34 to $1.39 and for the yen, each 80 to 85 yen will translate into $1.

Now, for the sales by project category discussion. Total cardiac rhythm management sales, which includes revenue from both our ICD and pacemaker product lines were $738 million, up 7% from last years third quarter, including $9 million of unfavorable currency translations.

On a constant currency basis third quarter CRM sales increased 8% versus last year. For the third quarter, ICD sales were $439 million, up 13% from last years third quarter. On a constant currency basis, third quarter ICD sales increased 14% versus last year. U.S. ICD sales were $284 million, up 15% from last years third quarter.

International ICD sales were $155 million, representing a 10% increase over the third quarter of 2009, including $6 million of unfavorable foreign currency translations. On a constant currency basis, ICD sales in our international business grew 14% in the third quarter.

For low voltage devices, sales for the third quarter totaled $299 million, about the same as last years third quarter, including $3 million of unfavorable foreign currency translations. In the United States, pacemaker sales were $134 million, down slightly compared to last years third quarter.

In our international markets, pacemaker sales were approximately $165 million, equal to the third quarter of 2009. On a currency neutral basis, international pacemaker sales grew approximately 2% in the third quarter.

For the fourth quarter of 2010, we expect total CRM product sales to be in the range of $730 million to $760 million. Atrial fibrillation or AF product sales for the third quarter totaled $169 million up 8% over the third quarter of last year.

On a constant currency basis, AF sales grew approximately 9% in the third quarter. For the fourth quarter of 2010, we expect AF product sales to be in the range of $165 million to $180 million.

Total sales of cardiovascular products for the third quarter of 2010 were $240 million, up 4% over the third quarter of 2009 on both a reported and constant currency basis. Within this category of products, sales of vascular closure products in the third quarter of 2010 were $86 million and sales of heart valve products in the third quarter of 2010 were $78 million.

For the fourth quarter of 2010, we expect cardiovascular product sales to be in the range of $240 million to $255 million. Total sales of neuromodulation products in the third quarter of 2010 were $93 million, up 11% from the third quarter of 2009. For the fourth quarter of 2010, we expect sales of neuromodulation products to be in the range of $95 million to $105 million.

Looking to revenue by geography, in total 53% of St. Jude Medicals sales in the third quarter of 2010 came from the United States, while 47% came from our international markets. As with prior quarters, the specific geographic breakdown of St. Jude Medicals sales for the third quarter of 2010 is available in our press release.

The gross profit margin this quarter was 72.7%, representing a decline as expected compared with the third quarter of 2009, due to the impact of absorbing costs associated with remote monitoring and wireless telemetry capabilities in our pacemaker product line. For the full year 2010, we continue to expect gross profit margins to be in the range of 73.2% to 73.8%.

Our third quarter SG&A expenses were 34.3% of net sales, a 250 basis point improvement over the third quarter of 2009. For the full year 2010, we now forecast SG&A as a percentage of net sales in the range of 34.3% to 34.8%.

R&D expenses in the third quarter of 2010 were 12.1% of net sales. For the full year 2010, we continue to expect R&D expense to be in the range of 12.0% to 12.6% of net sales, as we continue to balance delivering short-term results with the right investments in long-term growth drivers.

Net other expense was $11 million in the third quarter and we anticipate the other expense category to be in the range of $12 million to $16 million in the fourth quarter.

For the third quarter, the companys effective income tax rate was 24.5%. For 2010, we continue to expect the tax rate to be in the range of 24.3% to 24.8%. As mentioned previously, these effective income tax rates contemplate the extension of the federal research and development tax credit in 2010, retroactive to the beginning of the year. We have also assumed the extension of the federal research and development tax credit in our EPS guidance for the fourth quarter and full year 2010.

Moving on to the balance sheet. At the end of the third quarter of 2010, we had $852 million in cash and cash equivalents and $1,988, billion in total debt and $1 billion available under a revolving credit facility with a group of banks. The debt on our balance sheet includes $1,661 billion of senior notes with maturities in 2013, 2014 and 2019, and $327 million in yen-based borrowings with maturities in 2017 and 2020.

Next, I want to offer some comments regarding our earnings per share outlook for the fourth quarter and full year 2010. In preparing our EPS guidance, we have assumed that in the fourth quarter of 2010 the share count used in our fully diluted EPS calculation will be 331 to 333 million shares with the weighted average outstanding shares for the full year 2010 at 329 to 331 million.

Again, this assumption does not include any impact on shares outstanding resulting from the acquisition of AGA Medical. The Company expects consolidated earnings per share for the fourth quarter to be in the range of $0.72 to $0.74.

For the full year 2010, we now expect consolidated EPS to be in the range of $2.98 to $3, a $0.09 increase on the top end of the guidance from the full year 2010 guidance, we gave during our July 2010 conference call. This updated expectation represents EPS growth of approximately 13 -- Im sorry, 23% over the 2009 adjusted EPS of $2.43.

I would now like to turn it back to Dan.

Dan Starks

Thank you, John. Turning to our quarterly results and our confidence that we are well positioned for long-term growth at a superior rate, I would like to review several key factors underlying the success of our Cardiac Rhythm Management or CRM business.

First, we are the only company which has gained major ICD market share over the last six years. The significance of this is that we hold approximately a 29% share of the ICD market for de novo implants and only a 19% share of the ICD market for replacement devices. This implies a likely 4 point gain in total ICD market share for St. Jude Medical over the next few years as we move through the natural replacement cycle for our products.

Four points of market share translates into approximately 15% growth for St. Jude Medicals base business in ICDs, before we factor in the benefit of additional gains in the de novo segment of the ICD market where the impact of any growth in the ICD market as a whole.

With respect to the de novo segment of the ICD market, we expect to continue gaining share on the strength of our Unify and Fortify lines of ICDs, our core view pulmonary edema monitoring technology, our Promote Quadra with Quartet Quadripolar Lead CRT-system. Our DF4 simplified connector system, our seven French high voltage lead line, our ST segment monitoring technology and our QuickFlex micro 4 French bipolar left heart leads to name just a few of our many advantages in CRM technology and products.

The ICD business may not be a growth driver for our competitors as they lose market share but we expect it to continue to be a growth driver for St. Jude Medical. This expectation is validated by our delivering 14% constant currency growth in global ICD revenue during the third quarter in the face of challenging market dynamics.

With respect to long-term growth of the global CRM market, last quarter I reported that we expected the global CRM market to grow between 4% and 6% on a constant currency basis, taking into account differences in global geographies, the impact of new technologies, changes in model mix, pressure on ASPs, the impact of device replacement cycles and all other appropriate factors.

The global CRM market grew slower than expected during the third quarter. We now expect the global CRM market to grow closer to 3% on a constant currency basis for full year 2010. To be conservative, we will assume that the global CRM market will continue to grow approximately 3% annually, due the impact of macroeconomic factors until we see evidence of market recovery.

Keep in mind that with a 25% share of the global CRM market, St. Jude Medical is four times more sensitive to 1 point gain in market share than it is to a 1 point change in rate of market growth. We are comfortable with the current rate of growth in the global CRM market in the context of our ability to continue gaining market share.

We expect this market growth rate to recover longer term due to the impact of new technology and the impact of faster growth in under penetrated international markets, but such market recovery will represent upside to our minimum growth goals.

Moving beyond CRM, our entire growth program remains robust at the level needed to meet or exceed the superior long-term growth expectations we announced at the beginning of this year. With respect to initiatives designed to optimize our cost structure, we opened our new manufacturing facility in Costa Rica ahead of schedule and already are shipping finished goods from this facility to our customers. Our new manufacturing facility in Malaysia is on track to come online towards the end of this year. We expect these two components of our cost optimization program alone to benefit our income statement by well over $100 million annually, within the next few years.

With respect to our top line growth, we start by reminding investors that St. Jude Medical has a solid leadership position in two of the best growth opportunities in medical device technology, the broad electrophysiology space addressed by our Atrial Fibrillation or AF division and the chronic pain space addressed by the spinal cord stimulation technology of our Neuromodulation division.

Each of these growth drivers has an elective component and a capital equipment component that are affected by macroeconomic pressures in the short-term, but we continue to expect both of these markets to grow long-term at a double-digit rate due to their current level of under-penetration in the ongoing accumulation of data that confirms both the clinical benefit and cost effectiveness of AF and Neuromodulation device therapies.

In spite of the strength of our AF and Neuromodulation growth drivers, we indicated during our Investor Conference in February of this year that our 2010 growth program includes significant focus and investment to accelerate sales growth longer-term.

I would hike to summarize 14 initiatives that either have been completed or are under way to accelerate our sales growth. First and foremost, we have restored competitive effectiveness through our U.S. CRM sales organization. This is testament to the leadership effectiveness of Mike Rousseau in the reorganized leadership team he put in place, we have now returned to gaining CRM share in our U.S. business in the same way we continue to gain CRM share in our international business.

Second, we are now entering for the first time the $500 million market for pericardial stented tissue valves. We are rolling out full commercial launch of our Trifecta line of pericardial stented tissue valves in Europe beginning this quarter.

Early clinical response is favorable and consistent with our expectation that our Trifecta line of stented tissue valves can become a major new growth driver for our CVD business. We expect full launch of the Trifecta line in the United States to begin by the middle of 2011.

Third, we are now entering the $500 million market for deep brain stimulation or DBS for patients suffering from Parkinsons disease. Beginning this quarter, we are rolling out full of our commercial launch in Europe of our real rechargeable deep brain stimulator, DBA ATHENA programmer, DBS and a clinician programmer and a complete line of proprietary leads and accessories.

Its a rechargeable and constant currency system and is the smallest, lightest and longest lasting system on the market. We expect to support this launch with publication of favorable data from our U.S. pivotal clinical trial during the first half of 2011. We have only the one key competitor in this market share and expect to gain meaningful market share in this new growing market.

Fourth, we have the leading position in the market for fractional flow reserve or FFR guided therapy for stenting patients of multi-vessel disease. Although this market is still small today at less than $200 million in size, we expect FFR measurement to become the standard of care in the future on the strength of data from the FAME landmark clinical trial, the potential for positive data from the FAME II trial just getting underway, ongoing improvements to ease of use and our market development programs.

Fifth, we have just begun to compete in the $500 million market for intravascular imaging technology through our acquisition of LightLab imaging and our launch of the first and only optical coherence tomography or OCT product line and the market. We are in the process of integrating our OCT technology into our FFR hardware platform to facilitate growth of the FFR market. At the same time we strengthen both the clinical and the economic benefit of our competitive position in intravascular imaging.

We envision strong synergy between our programs to develop the market for OCT technology and our programs to develop the market for FFR technology. We expect both technologies to become meaningful new growth drivers for St. Jude Medical in the near to mid-term.

Sixth, we are making good progress continuing to advance our transcatheter aortic valve implant or T-A-V-I, TAVI development program.

During the third quarter, we announced that Dr. Gregory Fontana and Dr. Raj Makkar from Cedars-Sinai will serve as core principal investigators to the pivotal trials, covering both our transfemoral and our transapical TAVI systems.

At the recent TCT meeting, Dr. Fontana presented data about these systems which supports our conviction that our TAVI program consists of next generation technology that will be fully competitive at the time of market release. We continue to expect to launch both our transfemoral 33:33 and transapical TAVI systems in Europe by the first half of 2013.

Seventh, during the third quarter we made an equity investment in CardioMEMS with an exclusive option to purchase the company at a later time. This investment positions us to leverage our CRM business and creates a major new growth driver within our heart failure franchise. Data presented at the TCT meeting from the CardioMEMS champion trial showed a 38% reduction in heart failure hospitalizations during an average follow-up duration of 15 months for patients implanted with a CardioMEMS device. This technology has the potential to support a new billion dollar growth opportunity following global market release and full development of the market. The product line is scheduled for limited launch in Europe in 2011 and in the United States in 2012. St. Jude Medical now is positioned to become the clear leader in this new market.

Eighth, we recently announced approval of our Eon mini line of spinal cord stimulators in Japan. We will begin launching our Eon mini product line in Japan during the fourth quarter to create the conditions for meaningful sales contribution with this new growth driver in 2011 and beyond. The success of our mini product line in the United States and in Europe gives us confidence we can gain leadership in the spinal cord stimulation market in Japan.

Ninth, we are in the process of completing our assessment of data from our US pivotal trial for patients suffering from certain forms of migraine. We plan to announce the results of this clinical trial during the first half of 2011. We are not yet prepared to predict whether our results will meet FDA requirements for approval in the United States, but we expect to receive CE Mark for migraine indication in Europe during 2011. This puts us on track for our migraine business in Europe to become a meaningful new growth driver for St. Jude Medical in 2012 and beyond.

10th, we are continuing to integrate our MediGuide technology with existing technologies in our AF business, our CRM business and our CVD business. Our first MediGuide enabled cath lab already is online in Europe. We are optimistic that over time our MediGuide technology will be a key differentiator for multiple St. Jude Medical growth programs, based on its ability to improve both the clinical effectiveness and the cost effectiveness of minimally innovative procedures in a wide variety of clinical settings.

Additionally, once we close the acquisition of AGA Medical we announced earlier this week, we will add to St. Jude Medicals growth program, a leading position in four new markets. The market for left atrial appendage closure, the market for PFO closure in cryptogenic stroke patients, the market to modify abnormal peripheral vessels with vascular plugs instead of embolic coils and the market to repair (inaudible) heart defects with an international cardiology procedure.

At this point, I have identified 14 areas of investment at St. Jude Medical. All of which are designed to accelerate our rate of sales growth. Many investors ask me routinely why I feel so confident about our business. The comments I just outlined are exactly why. Many of these investments will benefit our sales growth in 2011, all of these investments should benefit our sales growth in 2012 and beyond. All of these new sales growth programs are surrounded by our initiatives to optimize our cost structure and leverage the middle of our income statement. We look forward to providing additional information about these and other new growth drivers during our next annual investor conference in February 2011.

With that, we have concluded our prepared remarks. John Heinmiller, Mike Rousseau, Eric Fain and I now all are ready to take your questions. Dennis, would you please moderate the questions?

Question-and-Answer Session

Operator

Thank you, sir. (Operator Instructions) And our first question is coming from the line of Bob Hopkins with Banc of America.

Bob Hopkins – Banc of America

Hi. Can you hear me okay?

Dan Starks

Yeah.

Bob Hopkins – Banc of America

Great. Good morning. First question, Dan, I just wanted to see if you would talk a little bit about your long-term growth objectives in light of everything that you just spoke about today, including the fact that you now think the CRM market is more of a 3% grower at least in the near term. Does that lower growth outlook for CRM alter at all your long-term growth objectives that you laid out in February of last -- in February of this year?

Dan Starks

No, it doesnt, Bob. We have added enough new growth drivers to more than offset this modest lowering of our expectations for growth in the CRM market. So that doesnt change our long-term objectives at all.

Bob Hopkins – Banc of America

Okay. Great. Thank you. Just wanted to clarify that. And then also regarding AGA from earlier this week, should we read into that announcement that you guys have a sense as to what the PFO trial is showing or is that trial still ongoing and you dont yet know and have or have the results?

Dan Starks

I cant clarify it for you, Bob. What I would say is that our entire due diligence effort was done under complete confidentiality. That confidentiality continues to apply to our conference call today, so we are not in anyway at liberty to talk about nonpublic aspects of our due diligence. What I can tell you is that we did exhaustive due diligence into every significant issue and were very comfortable with the results of our due diligence to enter into the definitive agreement. Im sorry I cant be more specific.

Bob Hopkins – Banc of America

Thats all right. Just real quickly, could you just talk about the AF growth rate in terms of what was U.S. or U.S. constant currency growth and it was a little slower than last quarter. Just talk about the dynamics there and thats all from me. Thanks.

Dan Starks

Sure. The numbers that I have in mind, Im going to ask for some slacks on whether Im giving you constant currency or as reported but as I recall, we had the breakout and everybody can do their own math. But I recall the breakout was about 15% growth in the AF business in international markets and about 1% growth of the AF business in the U.S. The growth rate was really impacted. I alluded to it in my prepared remarks that the AF business during the third quarter and here in 2010 is impacted to the extent that procedures are somewhat elective and to the extent that the revenue includes a capital component.

And with respect to the impact of the capital component of the revenue, the capital component itself is pretty small, but capital component ends up impacting the associated sale of disposable devices as well that kind of the razor and razor blades, we sell fewer razor blades when we sell fewer razors. Macroeconomic factors did impact market growth rate for the AF business in the third quarter. But we expect that impact to be transient and we expect to continue long-term. We expect to see the AF market on a global basis continue to grow at a double-digit rate.

Bob Hopkins – Banc of America

Great. Thank you very much.

Dan Starks

Youre welcome.

Operator

Our next question comes from the line of Mike Weinstein with J.P. Morgan.

Mike Weinstein – J.P. Morgan

Thanks. Good morning. Just a couple of follow-ups to start with -- on the income statement. The gross margin down tick this quarter you highlighted impacted the wireless pacemaker roll-out. Is the expectation that you will have that largely behind you in 2011?

Dan Starks

Im not sure that were able to offer specific guidance to you yet, Mike. We prefer to offer gross margin guidance for -- along with all of our guidance for 2011. But – Im so sorry, I dont want to select out any two pieces and comment on them now. But keep in mind that the drop in gross margin thats reflected in the third quarter was exactly as contemplated and as baked into our guidance for full year gross margin at the beginning of this year, so all of this was as expected.

And without yet offering gross margin guidance for 2011, Ill tell you that we have a number of initiatives and kind of calculations and programs and birds in the hand that would give us the optimism that our gross margin will rebuild. Im not going to yet predict exactly what the gross margin rate will be in 2011, but what you see in the gross margin in -- in the third quarter here is not a source of concern to us at all. Its exactly what we contemplated, exactly what weve been planning for and you will see it offset here in future periods.

Mike Weinstein – J.P. Morgan

Okay. Thats helpful. Dan, I want to touch on something that was probably obscured to most people in the call and that was your comments on the migraine program. Your commentary was new, the first time youve actually made comments talking about potentially bringing the product to market for migraine. And you commented about potential CD Mark approval and you sound like you still dont know whether or not you have enough data to generate an FDA approval. But at this point, have you analyzed some of the data where youre at a point where you feel like you do have something there in migraine?

Dan Starks

Well, the short answer is yeah. And to your point of my saying something new on the conference call, thats always our goal is to say something new here. So Im in a little bit tongue in cheek. But our goal is to provide an update so youre right, I mean, my comments were actually full of new points that are significant to our -- to the rate of sales growth here going forward in 2011, 2012 and beyond. And migraine was certainly one of them.

And so I clearly had a well-supported basis supplied by our Neuromodulation team to make the comments I did that were very optimistic that we will receive CE Mark for migraine in Europe in 2011. And that this will become a new growth driver for us in 2012. So absolutely, that was a good database comment.

With respect to the U.S. opportunity for an indication for migraine, I would urge you and everyone else to continue to model nothing for St. Jude Medical revenue for a U.S. migraine indication. We will -- were not yet completed with our analysis of data. Were not yet prepared to describe the current state of the analysis.

We will do so once the analysis has been finalized. And well then do so in a peer reviewed setting and well look forward to publishing that data. And well all be sworn to secrecy until such time. But start to expect migraine related revenue in Europe in 2012. We will start to expect a launch of migraine in Europe before the end of 2011 and plan on nothing for migraine in the United States for the time being. Leave it for potential upside.

Mike Weinstein – J.P. Morgan

Congratulations. Thats very exciting.

Dan Starks

Thank you.

Operator

Our next question comes from the line of Rick Wise with Leerink Swann.

Rick Wise – Leerink Swann

Good morning, Dan. Hey, John. Let me go back to AGA, just some more thoughts, a couple questions. Can you tell us just any thoughts about how you might take AGAs core technology, the braid nitinol. Are there other ways to leverage that technology in other parts of St. Jude and on the structural heart side, which obviously youre a larger player in now. And you have a promising internal valve program, do you feel like you need to add to that internal TAVI program externally with some of the many smaller private companies that are out there?

Dan Starks

First, Rick, with respect to the potential to leverage the Best-in-Class nitinol technology that AGA has created over a significant period of time. Absolutely, there is opportunity for us to leverage this elsewhere in our business. So its truly a platform technology. Those of you who are followers of the AGA story see what AGA already has done with that platform technology in this variety of applications and there are other applications that AGA has invested in and is in the process of leveraging from that -- out of that nitinol technology platform and that would include stent grafts, AAA stent grafts, iliac artery stent grafts and other technologies as well. So there is a lot thatn can be done, if it is truly applied from technology. And with respect to -- I think you asked me a three-part question, Rick, and Im clear on two parts.

Rick Wise – Leerink Swann

Back on the structural heart side, just maybe focus, youve got a great internal program off and running. Do you feel like thats going to be sufficient to get you where you want to go in this emerging market or do you feel like you are going to look for external technology adds as well?

Dan Starks

The answer is both. We do think that it is sufficient to get us where we want to go. And so our strategy is with each program that is a major strategic initiative for us. Our strategy is to control it first. So that means our strategy is to fully fund an appropriate internal program where we really -- where were in control of our own destiny.

So thats option A. We have a good internal program. It is sufficient. And were very encouraged by all of the feedback we get from the KOLs that weve been working with on the -- on validating our sense that we have a Best-in-Class next generation technology that can help us gain significant market share at the point where we launch it into the markets.

Having said that, with each one of our internal growth programs, we always are alert for the possibility of either accelerating, strengthening or even replacing our internal growth program with an acquisition. So we always are looking for evaluating whether an acquisition can help us with a key strategic initiative. That puts us into perfect position where we dont have to do an acquisition. We can be very objective and rigorous in evaluating potential acquisitions.

It makes it less likely that were going to make a bad acquisition and knowing that we dont have to do anything. But if all the parts fall in place, we certainly have the balance sheet capability to take advantage of all of the parts falling in place if thats whats happened.

So we will go forward full steam and the timeline, it starts out being years out but the timeline is starting to come to near term now for getting to clinical phase and getting pivotal trials under way and we really can see our launch into the European market with two systems in the first half of 2013 and so were good to go. If somebody has something better thats cost effective, we wouldnt hesitate to take advantage of it.

Rick Wise – Leerink Swann

Follow-up on AF. You made a couple comments but particularly in the U.S., the business seems to be growing low single digits kind of range in the last three or four quarters. J&J is growing strong double digits. I appreciate they have a new product cycle but just can you give us a little more perspective on what turns that around? Should we expect AF to get back to double digits in the next year or so and the drivers, your thoughts there, Dan. Thank you.

Dan Starks

Sure. Yeah. Expect it to get back to double-digit. No question – I mean, now -- but with respect to exactly the timeline of it, Im not going to offer guidance for 2011 today. We will offer guidance for 2011 one quarter from today. So that will be really the definitive answer, Rick, on how much were guiding to, expect double-digit in 2011. Im just going to be completely non-committal on it on this call. But without a timeline, absolutely expect the AF to return to double-digit.

I think that here in the third quarter, besides macroeconomics that, again, timeline is debatable but the extent of macro factors on market growth in elective procedures and the capital equipment component are clearly real and also transient. Besides that, I think youre right that weve got a product cycle disadvantage which sometimes around the winning side of the product cycle, sometimes were not. I think we have a product cycle disadvantage here temporarily.

And then the product cycle impact, I think, is exacerbated by the fact that were still operating under a warning letter from FDA and that has an impact on new product approvals. And we really dont have the same product line here in the United States currently that we have on the market in Europe.

So I think when you see the European growth rate continuing right where we would like to see it at about 15%, that product line is coming to the U.S. in just a matter of time to get it here.

Rick Wise – Leerink Swann

Thanks so much.

Dan Starks

Youre welcome.

Operator

Our next question comes from the line of Kristen Stewart with Deutsche Bank.

Kristen Stewart – Deutsche Bank

Hi. Thanks for taking the question. I was just wondering if you could just go back, maybe to the gross margins again, not to beat a dead horse but just trying to get a sense for maybe some of the year-over-year changes and just movements to try to tease out what this effect was? Any way to quantify that or FX on a year-to-year basis.

Dan Starks

John, is there any additional color commentary that you might offer or does that go beyond the level of disclosure you want to provide?

John Heinmiller

I think, Kristen, you know, earlier in the year when we first laid out our guidance, as Dan mentioned earlier, we anticipated that this was exactly the position we were going to be in. And we really went into the detail a little bit more in those earlier calls this year, I think back in the first quarter when we first offered guidance we explained the impact of the wireless technology and our pacemakers and the at-home transmitter that is part of that system and then the different components that provide that functionality in those devices and so thats really what its about.

And its just a matter of -- we do, as Dan mentioned, we do have programs where we can see that those components are going to become more cost efficient in our systems and that overall we can absorb this. And its just the early introduction of this technology that we planned for and that were seeing in our gross profit margin right now.

Kristen Stewart – Deutsche Bank

Okay. Thanks. And then just the change you raised guidance by clearly another $0.09 on the top end. Could you just help us understand what the impact was from the fourth quarter change in currency? Since it doesnt sound like the third quarter was really all that different relative to your guidance.

Dan Starks

John, is there – do you want to say something about FX impact on the $0.09 increase in the range?

John Heinmiller

I think we looked through that currency impact pretty thoroughly. We saw some of the comments coming out and everybody focusing on it. And when we looked at it, we saw an increase in our guidance range in the neighborhood of $20 million for our sales in the fourth quarter attributed to the shift or the improvement in currency.

And so if you make the assumption that half of that or so drops down to the operating profit line, that would translate into maybe $0.02 of EPS that you might attribute to the improvement in the currency fluctuation. But it wouldnt be more than that.

Kristen Stewart – Deutsche Bank

Okay. And then just last question, I dont know if this is something that you have just yet, but how should we think about the AGA deal just in terms of the incremental intangible amortization, how will that be treated? And is that included in the commentary about accretion in 2011?

John Heinmiller

It definitely is included in our workup of accretion. And we wouldnt give any more specific numbers right now, Kristen, on what were assuming. Weve obviously worked through these kinds of transactions before. And we work with the people that provide those types of appraisals and then make assumptions about over what lives were going to be amortizing them. And as we do that we tend to be a little bit conservative in coming up with what our model well use for amortization expense and thats all being factored into our thinking as we report the expectation that this will be accretive in 2011.

Kristen Stewart – Deutsche Bank

Okay. Thanks very much.

Operator

Our next question comes from the line of Derrick Sung with Sanford Bernstein.

Derrick Sung – Sanford Bernstein

Hi. Good morning. Thanks for taking my question. Dan, I wanted to start by going back to your revised outlook for the global CRM market. How much -- as you kind of analyze whats been happening, how much of that slowdown is related to just pricing versus how much of it is procedural slowdown? And also if you might be able to give any color into your thoughts on breakdown by geography, where the slowing might be coming from more? Is it outside the U.S. or in the U.S.?

Dan Starks

Okay. Well, so theres a lot to it. And Im going to struggle a little bit, Derek, to give you a crisp answer. But there is clearly an ASP element to our revised view of the CRM market growth but there clearly is on the one hand. On the other hand, I would not overstate that and a data point I would give you is that in our third quarter, our U.S. ICD sales system ASPs were actually a little bit stronger again in the third quarter of 2010 than they were in the third quarter one year ago.

So it would be very surprising to folks Im sure and counter intuitive but true. So if you took that as one data point and it would be -- that would add some balance to whats the impact of ASP pressures. So we are seeing increased pressure on ASPs. We are seeing competitors be more aggressive on price. We are seeing ASP drops in the market. Were seeing it -- were seeing more of it internationally. Weve seen more of it on the low voltage side, offset by our U.S. ICD sales in our own product line benefiting from new technology premiums and from our particular mix versus the mix of competitors but ASP pressure is an element of it.

Another big element of it is just that Medtronic came out with CRM number in their last reported quarter that was lower than any of us expected it to be. So when we factor that into whats that do to market growth, we just have to be realistic that based on everybodys reported numbers, the markets growing slower than we had had previously modeled. And we can imagine reasons for that in somebody elses business but the prudent thing for us to do is to say the numbers are as they are.

The total growth is a little bit slower than we estimated and expected one quarter ago and now what do we say going forward? And we think its prudent to say going forward, lets assume that the status quo remains as it is and that the market grows a little bit slower. We can make the case for why the market ought to grow up, ought to continue to grow longer term constant currency 4 to 6%. We especially would look to -- when we think about that, the kinds of things that Id especially point to that people can miss.

You know, the first would be were always talking constant currency. And others sometimes are talking as reported and depending on the currency trend, that does make a difference. So were always talking constant currency, number one.

The other thing is not everybody takes into account the impact on market growth of – about trying to concern. Some of the market models we see are only take into account the results of the big three. And those analyses are going to underestimate market growth when the other two companies between the two of them are taking share as they did in 2008, 2009 and in the first half of 2010.

So that would be another potential -- thats another component that can lead to different market models producing different results. Another very significant component here in our market model outlook is the impact of new technology and so others cannot adequately factor in the impact of our new technology without having complete insight into what our new product flow is over the next few years which we dont tell people.

But you can start to get a glimpse of how real the impact of new technology is in our product line alone. And so if you think about the pulmonary wedge pressure technology, think about left atrial -- direct left atrial pressure technology, you look at our CardioMEMS transaction, you look at our LAP technology, look at our ST segment monitoring technology, you know, just to name a few. These are the kinds of things that can reset a premium ASP that is well justified by clinical effectiveness and cost effectiveness in the same way that a CRT systems reset the ASP for ICDs and in the same way that ICDs reset the premium ASPs for pacemakers as pacemakers came to have the additional technology of a high voltage shock in them.

So new technology is a particular component of long-term market model growth that has a big impact that different people will see different ways, depending on their level of insight into the flow of new leading technologies that we have in our pipelines. Another thing that I would add, point to, just here on the longer term market growth is the impact of markets like China and other significant emerging markets. So we mentioned this before and its -- I think its the -- others will validate our data, that in 2009 there are fewer than 2,000 ICDs implanted in all for the full year in all of China.

And if you kind of look at that as a disconnect between indications and disconnect between that and the state of the economy in China and the size of the growing middle class in China and a disconnect between that level of penetration in the market and the amount of investment that the Chinese government has committed to raising the bar on healthcare in China here over the next number of years, were going to get a lot of growth out of international markets. And those who are kind of U.S. centric are going to underestimate long-term CRM market growth if they arent close enough to these major new international markets.

So those are all the things. But more than anything its just Medtronic came out with a bad number. And we dont know what theyre going to come out with here in the next quarter and for the time being well just bring our expectations down.

Derrick Sung – Sanford Bernstein

Okay. Thank you, Dan. Thats helpful. One just quick one if I could sneak in on margins. We saw some nice SG&A leverage this quarter. Was there any one-time items in there or is it reasonable to think that what we saw there is going to be sustainable moving forward? Thank you.

Dan Starks

Yeah. There were no one-time items on my radar screen. So nothing material.

Derrick Sung – Sanford Bernstein

Great. Thank you very much.

Dan Starks

Youre welcome.

Operator

Our next question comes from the line of Joanne Wuensch with BMO Capital Markets.

Joanne Wuensch – BMO Capital Markets

Thank you very much for taking my questions. I have two of them. First one, of course, could you give us an update on how Unify and Fortify are doing in the market? In the last quarter call, you were kind enough to let us know it was 50% of your U.S. sales. And the second one is assuming AGA Medical is closed in time can you give us a high level picture of how you would think about integrating that into your business. Thanks.

Dan Starks

Sure. Sure. Now, Im going to provide the information and at the same time, Im going to provide it with a disclaimer that we are not adopting a new protocol of describing product line mix. So this is not a precedent where next quarter people might ask whats our mix on a particular product line and expect an answer. We generally dont describe product line mix inside the sales categories that we report.

However, this Unify and Fortify is extraordinary. In the third quarter, we exited the third quarter with more than -- in the United States with more than 90% of our mix of ICDs consisting of Unify and Fortify. So in the same way that I mentioned that after one month we had an absolutely unprecedented percent of sales in that new technology. After one quarter, we continue to -- we set a new standard for uptake of new technology. So its absolutely a winning product line and strong component of our ASP strength, strong component of our market share growth and its going to be a great platform for us going forward for the next couple of years.

With respect to AGA integration at a high level, at a high level it would be appropriate to think of AGA as a bolt-on to our Cardiovascular division. And you might find that implied by John Barr agreeing to continue to serve as President and CEO of the AGA business unit here within St. Jude Medical. We have tremendous respect for the momentum, the breadth, the quality systems, the R&D productiveness, the manufacturing operations, you know and to the extent that anybody from AGA is listening and I didnt mention their function, it was not intended to be a slight.

But my point is that we think very highly of the AGA team and of the condition of their operations. Were happy to stand behind those operations and have the St. Jude Medical name on them. And the first -- the highest priority for us in this integration strategy is to make sure that we do not ruin a good thing in any way at all.

So we will be deliberate in looking for synergies. We will -- we know we can capture some good revenue synergies with the global distribution capabilities and footprint and product lines that we have. We know we can capture great synergies with the left atrial appendage occlusion technology and our access with electrophysiologist. On the cost side, we think very highly of the gross margin that AGA has been able to support on a sustainable basis and theres a lot to like and so think of it as a bolt-on.

Joanne Wuensch – BMO Capital Markets

Terrific. Thank you.

Dan Starks

Youre welcome.

Operator

Our next question comes from the line of Vivian Cervantes with Maxim Group.

Vivian Cervantes – Maxim Group

Hi. Good morning. Thank you for sneaking me in. Just two follow-up questions on some of the points that were discussed. On the (inaudible) procedure volumes, appreciate your comments that we are seeing that. If you could compare this to the last cycle we saw maybe like in early 09, anything markedly different with the current elective procedure slowdown were seeing now versus the one that we were just recently in?

Dan Starks

Im going to say nothing markedly different, Vivian. And it may be my -- it may be that there are differences that I should be smarter about. But there are no differences that Im aware of that I could pass on to you. So I would say nothing markedly different.

Vivian Cervantes – Maxim Group

Thats helpful. As another follow-up, you had mentioned $100 million of cost benefits from the Costa Rica facility thats up and running ahead of schedule and with Malaysia kicking in shortly. How should we look at that $100 million benefit as we incrementally fill capacity within these two facilities? Is it going to be like $20 million in the first year, moving to 40 or if you could just help us frame that, that would be helpful.

Dan Starks

I cant offer to help you very much, Vivian, but your sense -- I suspect that your own sense of how to ramp it up is generally correct. Im not going to say more than that because we -- I want to stay away from giving guidance here for 2011 yet. And there are so many other factors that bear on it. But it will be – you cannot, from an operational perspective, our priority is not to capture the cost advantage as quickly as possible in these new facilities. Instead, our priority is to make sure that we ramp up gradually and in full control and adding to the -- in full control in the quality sense and with the idea that growth too fast carries risks with respect to quality. And so we are not going to err, make that mistake in any way.

Were going to be slow, deliberate, ramp it up as the management team, as the infrastructure has -- gains the experience and has the credibility and has the track record to continue to grow more in the next year and more in the next year. And that also holds -- we start with one product line in each facility with the idea that there are additional product lines we can add to the facility in future years as we establish track record and as we broaden and strengthen the local management teams. So it will be a gradual benefit first year, second year, third year.

Vivian Cervantes – Maxim Group

Perfect. Thank you very much.

Dan Starks

Youre welcome. Why dont we take just two more questions.

Operator

Our next question comes from the line of David Roman with Goldman Sachs.

David Roman – Goldman Sachs

Hi. Good morning, everyone. Thank you for taking the question. Dan, if I could just ask one quick clarification on the stented tissue valve launch. I think you said the market was $500 million. I assume thats a worldwide number and could you remind us on the timing of the U.S. launch? And then I have one follow-up.

Dan Starks

Yeah. It is a worldwide number, yeah. And the timing was actually another new point that I slipped in here in my prepared comments. I indicated that we expect to begin to launch in the U.S. by the middle of 2011. Previously, we indicated that we expected to launch by the end of 2011. And so weve now indicated on this mornings call that were -- that we have pulled that release up and that we expect to launch by about the middle of 2011.

David Roman – Goldman Sachs

And should we view that as a full launch or a similar phased roll-out that we saw in Europe?

Dan Starks

Phased roll-out.

David Roman – Goldman Sachs

Okay. And then just on the CRM side, youve obviously done very well with Unify and Fortify. Certainly, there are mixed messages from your two competitors, both companies have talked a little bit about -- not necessarily a bundling story but a combined marketing effort across their Cardiovascular platforms between stents, ICDs and other products. But youve remained competitive to that. Could you maybe talk about whats happening in the marketplace and how youre competing with their efforts and over time how you see that playing out, as they potentially get more aggressive on a contracting strategy how you continue to maintain the trajectory that youve established so far?

Dan Starks

David, your question is completely reasonable. I dont want to answer it directly from a competitive perspective, from a purely competitive perspective. I dont really want to indicate to competitors that might be listening to the call or reading the transcript how were doing versus their initiatives and how is it that were beating them and what do we think is going to happen next.

I really dont want to offer that just from a purely competitive perspective. But what I could say is generally speaking, the starting point would be to the extent that competitors are bundling in a way thats different from what were doing. I think the starting point would be to say and hows it working for them.

So if the bundling and losing share in their reported results and were not and were gaining share in our reported results, thats a better answer for you than any kind of soft information that I could provide to you. And then -- so and then I would say that customers are awfully smart. And theyre not interested in less than their desired products. And so if were -- if we have -- if the competitors -- if all players in the space have commodity devices, then its going to be price thats going to carry the day.

But thats not the case and we dont expect to see that to be the case in our major markets. So technology differences have an impact, not only on the cost effectiveness but on the clinical effectiveness and there are clearly technology differences in all of our major programs. The quality and capabilities of the field organizations, the experience levels and stability of the field organizations are major factors.

And so Im not going to -- theres a lot that Im just going to bite my tongue and not say that I might say from -- with a full head of steam to contrast our excellence versus the presentation of competitors. So Im sorry, Im not going to be more precise for you.

David Roman – Goldman Sachs

Thats helpful. Thank you. Appreciate all the color.

Dan Starks

Okay. Last question.

Operator

Thank you. Our last question comes from the line of Adam Feinstein with Barclays Capital.

Adam Feinstein – Barclays Capital

All right. Thank you. I guess a question to follow up on the AGA deal. You guys have typically avoided doing some of the bigger deals and such as with the transcatheter heart valve youre doing a build it instead of buy it model. Just may be, just walk us through your thoughts in terms of why this deal, in terms of doing a bigger deal, in terms of doing it now and certainly youve talked about the merits of it throughout the call but just curious in terms of just, you know, in terms of wanting to do a bigger deal now and in thought process in terms of buying instead of building.

Dan Starks

Sure. We dont think of this in terms of size of deal, Adam. So our criteria have not been lets find -- lets create a bucket of potential acquisition targets with revenue of X amount or that would carry a purchase price of Y amount. Thats not been our approach. We start with the commitment that were not going to do dumb dilutive deals. So, now, that -- so I dont think in terms of a large deal. I think in terms of a dumb dilutive deal.

Lets not do that. Weve seen plenty of companies over the years do dumb diluted deals. And we take some pride in being able to say that we havent done one and you wont see one on our collective leadership and board watch. The AGA acquisition, in contrast, is an accretive deal. In the first year, without synergies, its accretive to net adjusted earnings, if you exclude the inventory write-up due to acquisition accounting of the inventory and so thats a baseline right there.

We like accretive deals and then the idea that we can find appropriate synergies, we like that. And then if you add to it that we have two -- that we have four new growth drivers already on the market in Europe, we like that. Were very interested in adding accelerating the rate of sales growth and doing it with business that we understand and these -- so all of the new growth drivers of AGA that are -- that we look forward to bringing into our own program, our technology and growth drivers and customer call points that were already involved in. So you start checking these boxes and this is just a compelling acquisition for us and -- but none of it was with an orientation of lets do a little deal, lets do a mid-sized deal, lets do a big deal.

Adam Feinstein – Barclays Capital

Okay. And just a quick follow-up, I appreciate the feedback there. Was this something you guys have been vetting for a while or did this happen pretty quick? Just curious.

Dan Starks

We will offer a complete disclosure on that in the registration statement. It will be filed. So Ive been wood shedded by the attorneys that those -- that all of the disclosures along that line are carefully controlled and documented. And so well give you full information here very soon.

Adam Feinstein – Barclays Capital

Sure. Okay. Thank you.

Dan Starks

Youre welcome. All right. So weve gone a little bit long but there was a lot to talk about today. Id like to thank everybody for joining us. And with this, we will conclude the call and Ill turn it back to the moderator for concluding comments.

Operator

Thank you, sir. Todays call is being recorded and will be available for replay beginning at 12 p.m. Eastern Time today. The dial-in numbers are 1-800-642-1687 for U.S. callers and for international callers, 706-645-9291 and enter pin number 95881163. Thank you. This does conclude todays teleconference. Please disconnect your lines at this time.

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