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CryoLife, Inc. (NYSE:CRY)

Acquisition of Hemosphere, Inc by CryoLife, Inc. Call

May 15, 2012 11:00 am ET

Executives

Steven G. Anderson – Chairman, President and Chief Executive Officer

D. Ashley Lee – Executive Vice President, Chief Operating Officer, Chief Financial Officer and Treasurer

Analysts

Jeffrey S. Cohen – Ladenburg Thalmann & Co.

Matt Dolan – Roth Capital Partners

Raymond Myers – The Benchmark Company, LLC

Operator

Greetings and welcome to the CryoLife Update Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Steve Anderson, President and CEO for CryoLife. Thank you, Mr. Anderson, you may begin.

Steven G. Anderson

Good morning, everyone, and welcome to CryoLife’s Hemosphere acquisition conference call. This is Steven Anderson, CryoLife’s President and CEO. I’m joined today by Ashley Lee, CryoLife’s Executive Vice President, COO and CFO. We’d like to thank you for joining us on this call to discuss the acquisition of Hemosphere that we announced earlier this morning.

Before going farther, I want to remind everyone that we posted a slide presentation to accompany this conference call in the Investor Relations section of our corporate website at www.cryolife.com. If you have not done so already, I encourage you to download these slides now.

The agenda for today’s call is as follows. I will open the call with some comments about the acquisition of Hemosphere and its strategic fit with CryoLife and the acquisition strategy that we have been working on for some time. Ashley will follow these comments with a detailed overview of the HeRO Graft business, the incremental opportunity it opens for CryoLife and the financial details of the transaction. After Ashley’s comments, we will open the call for questions.

So turning to slide two, this conference call and presentation contains forward-looking statements and we encourage you to review this slide, the related slide discussing applicable risk factors and the risk factor discussions contained in our most recent Form 10-K and our other filings with the Securities and Exchange Commission.

As outlined on slide three, over the last two years or so, we have been focused on accelerating CryoLife’s growth by expanding into new geographies with our existing products and by acquiring innovative new products and technologies.

On the acquisition front, we believe there is a tremendous opportunity to leverage our expertise in cardiac and vascular surgery, our 70-rep global direct sales organization, including managers and distribution network and our strong commercial and clinical infrastructure. To accelerate the growth of complementary medical device products, we have been implementing this acquisition strategy for about the last 18 months to two years.

We have focused on products utilized by our main call points of cardiac and vascular surgeons, targeting deals that provide the opportunity to drive revenue growth, expand our gross margins, increase our profitability and ultimately create shareholder value. We believe the acquisition of Hemosphere meets all of these criteria and opportunities with strong potential growth for the HeRO Graft once it is integrated into our business.

Slide four covers the key highlights of the acquisition. Hemosphere’s FDA cleared and marketed product is the HeRO Graft, a proprietary graft-based solution for end-stage renal disease, hemodialysis patients with venous outflow obstruction. It provides a number of key advantages compared to alternatives, including reduced infection rates and improved dialysis treatments. It is the only long-term fully implantable AV access solution for hemodialysis patients with central venous stenosis.

Hemosphere has a strong intellectual property portfolio on the HeRO Graft technology and the product has high gross margins. In 2011, Hemosphere drove HeRO Graft sales of $5.3 million with a limited U.S. sales force. We estimate the market opportunity for the HeRO Graft in the United States is approximately $150 million and growing annually with another $100 million market opportunity internationally.

Our initial focus will be driving broader adoption in the United States through our 28-rep cardiovascular sales force, which has the advantage of already selling our preserved tissues to vascular surgeon customers for use in AV access. Longer term, our global sales infrastructure will provide an incremental growth driver for this business.

Slide five gives a more detailed view of strong sales force leverage we expect from this transaction, both in terms of accelerating HeRO Graft sales in the CryoLife customer base, but also to cross-sell our surgical sealants, hemostats and tissues into the HeRO Graft customer base and our other medical device customer bases.

You can clearly see how our growth strategy has focused on leveraging our sales force with higher growth products and large market opportunities. We think the addition of the HeRO Graft will further advance the strategy and position CryoLife for long-term success.

Now, I’d like to turn the call over to Ashley for his in-depth review of the HeRO Graft business.

D. Ashley Lee

Thank you, Steve. Turning to slide six, I’ll begin with an overview of the HeRO Graft. The product was initially cleared by the FDA in 2008 and received CE Mark approval in the second half of 2011. Since its U.S. commercial launch, more than 5,000 grafts have been implanted. The procedure and product are reimbursed and Hemosphere has strong clinical data and intellectual property around the product. The HeRO Graft is utilized in patients that have developed central venous stenosis that inhibits conventional hemodialysis access through grafts or fistulas.

Prior to the HeRO Graft, most of these patients achieved access with tunneled dialysis catheters, which are associated with higher rates of infection and less productive treatments. The HeRO Graft provides these patients with a new option that reduces infections compared to Tunneled Dialysis Catheters, improves the adequacy of the dialysis and enhances patient quality of life since the system is fully subcutaneous.

As you would imagine, these benefits are highly aligned with healthcare reform goals of improving clinical outcomes and reducing cost. We think the HeRO Graft is one of very few medical devices that is so highly aligned with this focus of CMS in hospitals. We believe the HeRO Graft due to its excellent clinical data is positioned for strong adoption as more healthcare providers are educated on its benefits.

Slide seven provides a view of the HeRO Graft system after it has been implanted. The procedure requires three small incisions to implant and connect the arterial graft and venous outflow components and bypass the diseased venous anatomy.

Slide eight shows that the HeRO Graft system provides benefits for patients, dialysis providers and payors, making it an attractive addition to the CryoLife product portfolio. For patients, the HeRO Graft was shown in clinical testing to reduce the occurrence of bloodstream infections by 69%. In addition, it has documented improved flow rates and patency versus Tunneled Dialysis Catheters.

As a result, there are fewer interventions and readmissions, which strives the benefits for payors of lower-cost and improved outcomes. For dialysis providers, HeRO Graft patients have been shown to miss fewer dialysis sessions as compared to patients with catheters, resulting in more revenue for the provider.

For CryoLife, in addition to providing access to a significant market opportunity, the HeRO Graft is a commercially active, high margin product that can be plugged into our U.S. sales infrastructure. It has potential for incremental growth in international markets and through product enhancements that could broaden physician adoption of the products.

On slide nine, we have outlined the HeRO Graft’s adoption and commercial progress. As I mentioned, more than 5,000 procedures have been performed to date, including by many key opinion leaders at leading vascular access centers. Hemosphere has developed robust sales and marketing support programs for its reps, including training programs. This contributed to $5.3 million in HeRO Graft revenue in 2011 with a limited direct sales force and a strategic initiative to transition away from a distributor sales model in the U.S.

We intend to leverage Hemosphere’s established sales and marketing program to train our 28-rep cardiovascular team during the second quarter in anticipation of launching the product through CryoLife’s sales force beginning in the third quarter. The added coverage from our team will allow us to call on the major medical centers in the U.S. with an initial focus on existing CryoLife customers.

One of the key sales tools that we will utilize is the strong clinical data supporting the use of the HeRO Graft versus Tunneled Dialysis Catheters. On slide 10, we have summarized this data, which demonstrates clear benefits in terms of infection, adequacy of dialysis, intervention rates and secondary patency rates. As you can see, the data is very compelling.

Slide 11 summarizes where HeRO Graft fits in the dialysis treatment cascade, providing a new option for patients that are not able to use arteriovenous fistulas or arteriovenous grafts. As we’ve discussed, tunneled dialysis catheters have several drawbacks that are addressed by the HeRO Graft.

Shifting to reimbursement, there are several tailwinds in favor of HeRO Graft adoption outlined on slide 12. First, CMS is shifting the cost and risk of infections to dialysis providers by bundling the payment for dialysis treatment and potential infection related diagnostics and treatment.

They also are making providers responsible for readmissions within 30 days of treatment. Together, this gives dialysis providers a strong economic incentive to reduce infection rates of their dialysis patients.

Similar to the reimbursement pressure, hospitals are now required to report bloodstream infections. Catheters, including Tunneled Dialysis Catheters are the number one cause of these infections. A hospital’s ranking will be partially based on their ability to limit bloodstream infections, thus providing another incentive to implement technology that will lower infection rates.

On the procedure side, the HeRO Graft procedure is fully reimbursed with coding endorsed by the Society for Vascular Surgery and the American Medical Association. Slide 13 outlines Hemosphere’s intellectual property for the HeRO Graft. This includes comprehensive coverage of the existing version and potential product enhancements with six patents and 12 pending patent applications.

On slide 14, we have outlined the size and growth trends of the dialysis patient population. Patient growth is being driven by the aging population, rising rates of obesity, diabetes and high blood pressure, all of which can lead to end-stage renal disease and the need for dialysis.

Slide 15 translates the dialysis population into the HeRO Graft patient and market opportunity. The chart on the left shows the estimated size of the HeRO Graft market from 2011 to 2015 broken out by the U.S. and European markets. The chart on the right shows the HeRO Graft patient population growth calculated as 12% of the total hemodialysis population in the U.S. and Europe.

HeRO Graft is currently marketed only in the U.S., while we do plan on leveraging our global sales channels to sell the product, our initial efforts during year one will be focused on the U.S. segment of the market.

On slide 16, we have framed the $250 million plus market opportunity for the HeRO Graft against the backdrop of the market opportunity for all of our currently approved products. CryoLife’s current market opportunity, including the HeRO Graft is $1.4 billion and this is expected to grow to $1.8 billion by 2015.

When you include the potential FDA and other international market approvals of PerClot, the PHOENIX biologics hand piece for CardioGenesis, the European and international launch of the HeRO Graft and FDA approval of BioFoam in the U.S., our addressable market opportunity in 2015 nearly doubles. We are very excited about our growth potential and believe that we are poised to capture market share in each of these key product areas.

Now, let me turn to a quick summary of the financial terms of the acquisition. On slide 17, we have outlined the deal, which includes a $17 million upfront payment that will be financed with cash on hand. We also have $4.5 million in potential sales-based milestone payments, $2.5 million when we reach $10 million in trailing 12-month sales of the HeRO Graft and $2 million when we reach $15 million in trailing 12-month sales.

Regarding guidance, based on the May closing date, we anticipate Hemosphere will contribute between $2.5 million and $3.5 million to our 2012 revenue. The transaction is anticipated to be $0.09 to $0.10 dilutive to 2012 EPS, which includes non-recurring transaction and integration cost of approximately $0.06 to $0.08.

Approximately $0.04 to $0.05 per share of those estimated transaction and integration charges are anticipated to occur during the second quarter. The transaction is expected to be slightly dilutive to breakeven in 2013. The above per share charges assume a 35% income tax rate.

However, due to the non-deductibility of certain transaction expenses, the company expects its income tax rate in the second quarter of 2012 to be higher than 35%. In conclusion, we believe that the HeRO Graft system is poised for strong growth. Hemosphere has done an excellent job laying the groundwork and there are several factors that we believe will drive product adoption. This includes a growing population of catheter dependent dialysis patients, clinical initiatives to reduce catheter related infections and financial incentives to reduce infections with dialysis patients.

We believe this puts our team of 28 U.S. cardiovascular sales reps, strengthened by Hemosphere’s eight-person team in an excellent position to leverage HeRO Graft’s strong clinical data to drive product adoption and cross-sell our BioGlue products and vascular tissues. In the intermediate and longer term, we believe this is an incremental opportunity to leverage our global sales channels and product innovation capabilities to further expand the HeRO Graft to market opportunity.

We now like to open the call for questions.

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] Our first question is coming from Jeffrey Cohen from Ladenburg Thalmann. Please proceed with your question.

Jeffrey S. Cohen – Ladenburg Thalmann & Co.

Hello, Ashley and Steve. Thanks for taking my questions.

D. Ashley Lee

Hello, Jeff.

Steven G. Anderson

Good morning.

Jeffrey S. Cohen – Ladenburg Thalmann & Co.

How are you? So the cardiovascular sales force goes from eight are added onto 28, correct?

Steven G. Anderson

Yes.

Jeffrey S. Cohen – Ladenburg Thalmann & Co.

Okay, got it. And as far as the international process, not year one, but that’s something you would potentially take up in the year?

Steven G. Anderson

I’d say so, yes.

Jeffrey S. Cohen – Ladenburg Thalmann & Co.

Okay. And I assume that you will not be breaking out number of units sold on a quarterly basis?

D. Ashley Lee

We will certainly be breaking out revenues on a quarterly basis and we’ll probably be talking about unit growth also.

Jeffrey S. Cohen – Ladenburg Thalmann & Co.

Okay. So you will break that out, as far as revenues at least, okay.

D. Ashley Lee

Yes.

Steven G. Anderson

One thing that was not apparent in our comments that we should have made a point of is that currently there are no sales representatives handling the Hemosphere product west of the Mississippi. So, the eight sales reps they have come down the central part of the state and are focused more on eastern markets. So, I think that opening up the western part of the country to our sales reps should give us an immediate shot in the arm.

Jeffrey S. Cohen – Ladenburg Thalmann & Co.

Yes, I would concur. Is manufacturing moving to Atlanta?

Steven G. Anderson

Eventually it will. We’re going to keep it there in Minneapolis through this year. And I would think during the first quarter of next year that we will move that here. We have plenty of space to do that and we have plenty of clean room space that is underutilized.

Jeffrey S. Cohen – Ladenburg Thalmann & Co.

Okay. And outside of the eight sales folks added, what’s the headcount on HeRO now and what do you expect that goes to when you transition manufacturing to your facility?

Steven G. Anderson

Hemosphere currently has about 20 people right now. Longer-term, we plan on keeping all of their sales function within CryoLife. When we move the manufacturing process down here, which is our current plan, we think we would probably add anywhere from maybe four to six people at the most in the manufacturing and assembly process.

Jeffrey S. Cohen – Ladenburg Thalmann & Co.

Got it. And so essentially, you’re telling us to take $0.09 or $0.10 off of your previous guidance on EPS for 2012?

D. Ashley Lee

That’s correct, of which a lot of that was going to be non-recurring related to the transaction.

Jeffrey S. Cohen – Ladenburg Thalmann & Co.

I got it. That does it for me. Thanks a lot and congrats.

D. Ashley Lee

Thanks, Jeff.

Operator

Thank you. Our next question is coming from Matt Dolan from ROTH Capital Markets. Please proceed with your question.

Matt Dolan – Roth Capital Partners

Hey guys, good morning. Can you hear me?

D. Ashley Lee

Yes.

Steven G. Anderson

Yes, good morning.

Matt Dolan – Roth Capital Partners

Great, thanks. Congrats on the deal. First question is on the sales, geographically speaking for the target, it looks like your field structure and the milestones you’re expecting that obviously more than doubling of revenue base for this product, is something that you’re hoping to reach. Maybe can you tell us what the overlap was with your existing geographic spread of your sales group? Meaning, what percent of the country were they covering relative to your national footprint?

D. Ashley Lee

I think that we probably estimate that, Matt, at around 30% to 35% is the part of the country that where there is overlap at this point.

Matt Dolan – Roth Capital Partners

Okay.

D. Ashley Lee

As Steve mentioned, they don’t have much of a presence at all west of the Mississippi nor in the Northeast. So, we think that those are definitely going to be near-term opportunities for us.

Matt Dolan – Roth Capital Partners

And that should be in your sales rep’s hands by what, early Q3, is that fair?

D. Ashley Lee

Probably mid Q3, we’re going to start training our reps immediately, but we’re looking at, let’s call it mid Q3.

Matt Dolan – Roth Capital Partners

Okay. And was Hemosphere growing at a rate worth noting?

D. Ashley Lee

They were, they did have a shift in their sales strategy moving from a somewhat of a national coverage. And they were using a lot of distributors and they really focused on the geography that Steve spoke about. So, despite that change in their strategy moving from distributor base to direct in their top 50 accounts in 2011 compared to 2010, there was a 36% unit growth.

Matt Dolan – Roth Capital Partners

Okay. And then a follow-up on that earlier question regarding manufacturing, what would your target be or do you have one at this stage for gross margin on this business post the integration of manufacturing?

D. Ashley Lee

Well, currently their gross margins are right at about 66%, which is close to where we are right now. I think in the near-term, we’re probably looking at something in that neighborhood, we are looking at some product modifications and enhancements that we believe could possibly drive the gross margins into low to mid 70% range. If we’re successful in doing that, we don’t expect that we would be able to see that until the – probably the 2014 timeframe.

Matt Dolan – Roth Capital Partners

Okay. And then just on the transaction itself, walk us through how you got to the valuation that you’re announcing today and maybe why the asset was for sale?

D. Ashley Lee

Well, the Hemosphere was predominately was a VC-backed company and we believe that their board, management felt that the product could be more successful and have more update in the hands of a larger organization. So that was one of the reasons why they look to sell the company. In regards to – what was the first question, Matt, again?

Matt Dolan – Roth Capital Partners

How you arrived at the valuation?

D. Ashley Lee

They actually ran a competitive process. So we actually internally developed several models looking at comparable transactions and so forth, and we arrived at a value that we felt could still drive a very meaningful IRR on the transaction for the CryoLife shareholders.

Matt Dolan – Roth Capital Partners

Okay. But if I could speak just one more (Inaudible) you should have a little less than $10 million in cash on the balance sheet post this deal?

D. Ashley Lee

Yes, it should be a little less than $10 million.

Matt Dolan – Roth Capital Partners

So what are you looking at in terms of the other acquisitions? Is this it for this year or do you continue to have a pretty healthy pipeline?

Steven G. Anderson

We don’t have anything else on the table at this time, but we’re going to continue to evaluate opportunities as they became apparent to us.

Matt Dolan – Roth Capital Partners

Thank you.

Operator

Thank you. Our next question is coming Brooks West from Piper Jaffray. Please proceed with your question.

Unidentified Analyst

Hi, this is actually (Mitchell) for Brooks. Are there any other competitors versus I guess tunneled dialysis catheters and is there any potential over this to compete with CryoVein or CryoArtery in terms of cannibalization or is this more of a lateral-line type of therapy?

Steven G. Anderson

I think it’s more late stage disease related and our preserved tissues are primarily used for people that are just beginning AV access or that have infected AV access site.

D. Ashley Lee

The other thing from a competitive standpoint too (Mitchell), is that, what surgeons could do is try PTA with stents to allow for a more conventional placement of a fistula or a graft, but those approaches have higher intervention rates. The other thing that they could possibly do is go to the (Inaudible) and do an access there. But again those are prone to a higher risk of infection and really a low quality of life for a patient.

Unidentified Analyst

Okay, that’s helpful. And then just one last question, you mentioned potential product enhancements in the press release and I was just wondering if you could comment on those.

D. Ashley Lee

We’ll have more comments about product developments in future conference calls.

Unidentified Analyst

Okay, thank you.

D. Ashley Lee

Okay.

Operator

Thank you. Our next question is coming from Raymond Myers from Benchmark. Please proceed with your question.

Raymond Myers – The Benchmark Company, LLC

Thank you.

D. Ashley Lee

Hello, Ray.

Raymond Myers – The Benchmark Company, LLC

Hi, Ashley. Hi, Steve.

Steven G. Anderson

Hi.

Raymond Myers – The Benchmark Company, LLC

I want to ask first, is there a risk in transitioning from the former distributor sales model to direct sales by CryoLife. It wasn’t clear to me, how much of the sales were by distributors recently.

D. Ashley Lee

Recent sales, there had been essentially none from distributors, that was a process that really began in 2010 and 2011. And by late 2011, it was more or less none.

Raymond Myers – The Benchmark Company, LLC

Okay, great. And judging from the trajectory, I think you said in another question 36% unit growth in 2011, is that correct?

Steven G. Anderson

That was in the top 50 accounts.

D. Ashley Lee

Yes.

Raymond Myers – The Benchmark Company, LLC

In top 50, so can you be more specific about the overall unit growth for the product in 2011, we’re trying to get a sense of what the trajectory was before you acquired the product?

Steven G. Anderson

In 2011 versus 2010, the overall top line growth was a little less than 10%. Again, as part of this strategy to consolidate their efforts into the geography where they’re currently in right now. But they actually, I would say, walked away from business, but they really focused on the geography and that they are currently focusing on which is any of the area from the Great Lakes to the mid-Atlantic down to the south. And so because of that there was some business that they lost, but again their strategy was to focus on key centers, develop a model for success at those centers, which it appears that they are doing and then rollout and replicate that success in 2012 and going forward. And we think that with our larger platforms that's what we hope to do was replicated that success that they’ve had at the large centers that they’re focusing on now.

Raymond Myers – The Benchmark Company, LLC

Ashley was that 10% growth in units or in revenue, because I imagine there is a significant difference, as you change from a distributor model.

D. Ashley Lee

That was revenue and the units were flattish.

Raymond Myers – The Benchmark Company, LLC

Okay. And I imagine you're anticipating strong growth as implied in your milestones, correct?

D. Ashley Lee

Yeah, well, again, we’re going to be focusing on training our sales force this year, focused on additional surgeon training, we think that in 2012, just based on our guidance, we’re not expecting a lot of growth in 2012. But going into 2013, we expect to see some acceleration in our 2013 numbers and going forward.

Raymond Myers – The Benchmark Company, LLC

As you move the manufacturing from Minneapolis to Atlanta, what improvement margin do you anticipate from that transition?

D. Ashley Lee

We don’t know if the move per se is going to really affect margin that much, where we think the opportunity to drive margins higher is on some of the product enhancements that we are envisioning going forward. And again, if we are success in getting some of these product enhancements done, we think that could manifest itself in higher gross margins beginning in 2014. And we think that we got the opportunity to get those into the low to mid 70% range.

Raymond Myers – The Benchmark Company, LLC

All right, well that all sounds fairly positive, I’m having a little trouble understanding how in 2013, your guidance is for this to be essentially earnings break-even, with that type of margin, how could this not be accretive?

D. Ashley Lee

Well, again, we’re going to be taking on their sales force, okay, they were losing money; they did lose money in 2011. And then, we’re going to have deal amortization related to the transaction too, so…

Raymond Myers – The Benchmark Company, LLC

How much of the expense is associated, because eight sales people who sell over $5 million worth of product at that kind of margin are throwing off a lot of gross profit. What kind of expense are you allocating to that?

D. Ashley Lee

To the sales force?

Raymond Myers – The Benchmark Company, LLC

Well, you’ve got eight sale people throwing off a lot of gross profit and then you’ve got, I assume some other overhead, is there a lot of other overhead beyond gross margin because (Inaudible) cost of manufacturing, what else is (Inaudible) gross profit.

D. Ashley Lee

They've got a management team there, they've got a facility and so their cost was running in organization. We certainly expect to get some expense synergies there. Again, we think that this could be slightly dilutive to breakeven. If the uptake is faster than we think it is, do we have a chance to get to be slightly accretive next year, yes, we do, but we have to have a lot of things go right.

Raymond Myers – The Benchmark Company, LLC

Thanks. Well, glad to hear it, and congrats on the deal. Thank you.

D. Ashley Lee

Okay. Thanks.

Operator

Thank you. Ladies and gentlemen, this concludes the question-and-answer session. Let’s turn the floor back over to management for closing comments.

Steven G. Anderson

Thank you for joining us today. And we will give you an update on the acquisition during our second quarter conference call, which should take place at the end of July.

Operator

Thank you. This concludes today’s teleconference. You may disconnect your lines at this time, and have a wonderful day. Thank you for your participation today.

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