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CryoLife, Inc. (NYSE:CRY)

Q3 2012 Earnings Call

October 30, 2012 10:00 a.m. ET

Executives

Steve Anderson – President and CEO

Ashley Lee – EVP, CFO and COO

Analysts

Jeffrey Cohen – Ladenburg Thalmann

Chris Lewis – Roth Capital Partners

Operator

Greetings. As a reminder this conference is being recorded. It is my pleasure to introduce your host Steve Anderson, President and CEO of CryoLife. Thank you, Mr. Anderson you may begin.

Steve Anderson

Good morning everyone, this is Steve Anderson, CryoLife’s President and CEO, and I would like to welcome you to the CryoLife’s third quarter conference call. With me today is Ashley Lee, the company’s Executive Vice President, COO and CFO.

This morning we announced all-time record revenues of $33.4 million for the third quarter, a 13% increase over the third quarter of last year. Revenues for the nine months ended September 30th were also our record $98.9 million and 11% increase over the same time frame in 2011. Earnings for the third quarter were $0.06 per share and for the nine months ended on September 30th were $0.21.

This excellent result was a result of the successful implementation of the corporate development strategy that was initiated two years ago. This strategy has successfully positioned the company into the higher growth and higher margin markets in the areas of cardiovascular surgery and end-stage renal disease.

With the acquisitions that we have made over these last two years, we have significantly broadened our addressable markets to include pediatrics adults and aging baby boomers. We have a more comprehensive set of medical device products and are leveraging our global sales force to reach cardiac and vascular surgeons and we continue to look for ways to augment our product offerings.

The agenda for today’s call is as follows, Ashley will review today’s press release and will comment on each product’s growth and our full year expectations for those products. He will update you on the status of the clinical trial valve exchanges conducting in Europe and the potential timetable for their achieving a CE Mark as well as an update on discussions that we have began regarding the potential distribution of their valve in the EU.

He will also update you on the launch of the HeRO Graft for end-stage renal disease and our plans for manufacturing that product in our new manufacturing facility on the Georgia Tech campus here in Atlanta.

I will comment on our expansion plans for the Asia-Pacific area and the growth opportunities that we see in those markets. I will also provide an update on the submission timing for our revised IDE for PerClot and the approximately approval cycle.

Finally, I will review our continued corporate growth initiatives and our effort to identify products and companies that we can acquire in the end-stage renal disease space to support our strong sales growth with the HeRO Graft.

After my comments are completed, Ashley will discuss our financial guidance for the full year of 2012. At this time, Ashley will comment on today’s press release and earnings report.

Ashley Lee

Thank you, Steve. To comply with the Safe Harbor requirements of the Private Securities Litigation Reform Act of 1995, I’d like make the following statement. Comments made in this call that look forward in time involve risk and uncertainties and are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

The forward-looking statements include the statements made as to the company’s or management’s intentions, hopes, beliefs, expectations or predictions of the future including the guidance for 2012 that I’ll provide in a moment.

Additional information concerning risks and uncertainties that may impact these forward-looking statements is contained from time to time in the company’s SEC filings including the Risk Factors section of our previously filed Form 10-K for the year ending December 31, 2011, and our subsequently filed Form 10-Qs for the quarters ended March 31 and June 30, 2012, and September 30, 2012 which we expect to file shortly and in the press release that went out this morning. A reconciliation of certain non-GAAP financial measures to the comparable GAAP measures are contained on our website.

This morning we reported our results for the third quarter and first nine months of 2012. We achieved an all-time quarterly revenue record of $33.4 million driven by year-over-year increases in most of our lines of business and by the recent acquisition of Hemosphere. The following factors influenced our revenue performance.

Total product revenues grew 15% to $16.9 million. Worldwide BioGlue revenues were up 5% for the third quarter. This was driven by volume increases in international markets, primarily Japan. PerClot Sales increased 18% to $734,000 for the third quarter compared to last year’s quarter, and increase 6% sequentially from the second quarter of 2012.

We believe our focus on markets in the EU where we sell directly is starting to pay off. As we expand our international selling efforts beyond cardiac and vascular surgery to other medical specialties and as we continue to open new markets for PerClot, we expect that we will continue to experience revenue growth for this product.

Revenues from the Cardiogenesis product line were $2.1 million for the third quarter essentially flat with last year. Revenues from the sales of disposable handsets increased 18% in the third quarter as compared to the second quarter of 2012. We believe these results were driven by the programs recently implemented to drive procedure volumes.

Revenues from the sales of the HeRO Graft are $1.4 million inline with our expectations. We launched the HeRO Graft with our broader 36% sales force last month. We expect to see the results of our expanded selling effort over the next couple of quarters.

Total tissue processing revenues grew 12% to $16.4 million, driven by a 22% increase in cardiac tissue revenues resulting from an 18% increase in unit shipments, and a 3% increase in vascular revenues resulting from a 3% increase in unit shipments.

Total gross margins were 64% for the third quarters of 2012 and 2011, gross margins for the first nine months of 2012 were 64% versus 63% in the prior years first nine months. Margins for the nine month period were favorably affected by an increase and preservation services gross margins. Gross margin also benefited from an increased mix of our higher margin products, including surgical sealants and hemostats, the HeRO Graft in the Cardiogenesis product line.

General administrative and marketing expenses for the third quarter of 2012 were $16.5 million, up 12% from the third quarter of 2011. G&A increased primarily due to an increase in marketing expenses, including costs of our expanded sales force and increases and spending on advertising partially offset by a decrease and litigation expense.

R&D expenses were $1.8 million for the third quarter of 2012 compared to $1.7 million in the prior year. R&D spending in 2012 was focused on PerClot, the HeRO Graft, SynerGraft tissues and products, BioFoam and revascularization technologies.

Net income for the third quarter of 2012 was $1.5 million or $0.06 per basic and fully diluted common share. Net income for the third quarter of 2012 included $796,000 in business development and integration charges primarily related to the acquisition of Hemosphere, and $130,000 in litigation expenses.

Excluding these charges on a pro forma non-GAAP basis, earnings per share would have been $0.08 in the third quarter of 2012. Pro forma non-GAAP earnings per share in the third quarter of 2011 would have been $0.09.

As of September 30, 2012 we had $13.1 million in cash, cash equivalents and restricted cash and securities. This includes $740,000 received from the Department Of Defense for the development of BioFoam and $5 million in restricted cash and securities. Our balance sheet remains very strong. We continue to carry almost no debt and continue to generate cash. Based on the strength and predictability of cash flow, during the quarter we initiated a quarterly dividend of $0.025 per share with the first payment made to shareholders on September 21st.

We are pleased to be able to return a portion of our profits to shareholders, while continuing to build shareholder value through our share buyback program and our investments in organic and acquisition growth opportunities.

I have a few more updates on various subjects. Regarding to Hemosphere acquisition, we continue with our efforts to consolidate the manufacturing operations to Atlanta. We recently leased a small footprint at Georgia Tech that will serve as our primary manufacturing site for the HeRO Graft and certain portions of PerClot manufacturing, as well as serve as back up manufacturing space.

We remain on track to relocate the HeRO Graft manufacturing to Atlanta around the end of 2012. In September, we launched the HeRO Graft through our 36% sales force focused on vascular sergeants and nephrologists. We expect that later this year into early next year, we will begin seeing the expanded selling effort pay off in higher HeRO Graft revenues.

For our TMR business, we have initiatives underway designed to accelerate growth. We have initiated more robust training and education programs for positions interested in the technology. We’re also establishing a clinical registry that we believe will track important data about the clinical utility of TMR and potentially place more opinion leading sergeants on the podium talking about the procedure.

Lastly, we expect to launch a new handpiece the Pro 8 in 2013. Pro 8 is specifically designed for a less invasive standalone TMR procedure via a thoracoscopic approach.

In regards to valve exchange, we’re pleased to report that they initiated their EU clinical study in September which could potentially lead to a CE mark during the second half of 2013. We recently began initial discussions with valve exchange on EU distribution for which we own the rights. For more information about their progress, we encourage you to visit their website or contact them directly.

During the quarter, we also made the decision to discontinue our U.S. BioFoam, IDE and pilot study. Even with the protocol amendments that the study design it was extremely difficult to recruit patients to the restricted, due to the restrictive inclusion exclusion criteria. To be good stewards of public funds, we made the decision to terminate the study and we will be returning the unspent funds to the DOD. This decision will not have any impact on our revenue guidance in this net neutral to our bottom line.

Please refer to our SEC filings for detailed discussions of factors affecting our results of operations including our Form 10-Q that we planned to file shortly.

And now I’ll turn it back over to Steve.

Steve Anderson

With the approval, BioGlue in Japan, and subsequent launch in May of 2011, our revenues in the Asia-Pacific region had been steadily rising over the past two years. Our business in the region has increased 93% from 2011 to 2012 with the majority of the growth and expansion in Japan. We have been pleased with these results and believe there is an excellent opportunity for continued growth in the region. We are in discussions with the potential partner in the People’s Republic regarding a distribution agreement for BioGlue in China.

To better support our existing business and marketing and sales initiatives in Asia, we have made the decision to expand our physical presence in the Asia-Pacific region by relocating a CryoLife Sales and Marketing Executive to Singapore after the first of the next year. This executive will be responsible for developing new distributors throughout Southeast Asia as well as being a liaison with our current distributors in the region. This person will also be responsible for our efforts to establish distribution in China.

We are also adding a contract Sales and Marketing Executive in Thailand. The distribution network will address Asia-Pacific markets we estimate to be between $110 million and $140 million per year.

Turning to our U.S. business, we continued to make progress in our IDE submission to FDA for PerClot’s clinical trial. We now expect the IDE to be filed with FDA in November with the clinical trial to begin in quarter one of 2013. We expect enrollment of the 400 patients to take about eight months with a follow-up period of 30 days. So we would expect to file our PMA application towards the end of 2013 with FDA approval some time in 2014.

We are also planning a regulatory strategy for PerClot in Japan in conjunction with an approval in the United States. The manufacturing facility for PerClot has been completed at our corporate headquarters and will be ready for our IDE clinical trial, which we expect to begin in the first part of next year. We have completed three manufacturing lots of PerClot that will be used in our U.S. clinical trials. These manufacturing lots have been packaged and have been sent to the sterilizer.

When they return from the sterilizer, they will be tested, and if they pass, they will be placed in finished goods inventory and will be ready to be shipped to our investigative sites upon the approval of the IDE.

As we face in the regulatory approvals over the next few years in other countries, such as Canada and Brazil, this manufacturing facility has the capacity to serve those additional markets. We are continuing our corporate development activities and are focusing on leveraging our recent acquisition of the HeRO Graft by adding complementary products that have the same cull points as the HeRO Graft business. This includes products in the AV access and end-stage renal disease areas.

We have recently met with several companies on these product areas and are in continuing discussions with them regarding potential business development opportunities. In conjunction with certain vascular surgery consultants, our physician training department has been developing the curriculum and selecting a faculty for our first end-stage renal disease summit that will be held here at our corporate headquarters next spring. We expect the faculty will be international in scope and will attract experts in the treatment of end-stage renal disease from around the world.

Our physician training department has also been working on a curriculum and a faculty for our Cardiovascular Surgery Fellows Program that will be held here at CryoLife in the fall of 2013. The fellows program will replace our Annual Ross Procedure Summit which will now be held in alternate years. This initiative should help us develop professional relationships with future cardiovascular surgeons as they work their way through their resident and fellows programs at the various medical schools throughout the U.S.

That concludes my comments, and now I’d like to turn the call back over to Ashley, so that he can give you some financial guidance going forward.

Ashley Lee

We are increasing our financial guidance for the full year of 2012. We expect revenues for the full-year of 2012 to be between $131 million and $133 million, which includes revenues of approximately $500,000 related to the user funds received from the U.S. Department of Defense in connections with the development of BioFoam.

This represents annual total revenue growth of 10% to 11%, up from our previous guidance of 8% to 11%. We expect tissue processing revenues to increase in mid single-digits on a percentage basis for the full year of 2012 compared to 2011, up from our previous guidance of low to mid single digit percentage increases. Revenues from our higher margin product segment are expected to grow between 12% and 15% for the full-year of 2012.

The updated product revenue guidance includes expectations for BioGlue and BioFoam revenues to increase in the mid single-digits on a percentage basis in 2012 compared to 2011 and PerClot revenues to be between $2.7 million and $3 million. We expect revenues from revascularization technologies to be between $8 million and $8.5 million in 2012. We expect HeRO Graft revenues to be between $3.2 million and $3.6 million in 2012.

Turning to expenses, we expect general, administrative and marketing expenses for the full-year of 2012 to be between $65 million and $66 million, which includes approximately $2.5 million of integration cost resulting from the acquisition of Hemosphere in May 2012. Research and development expenses are expected to be between $7 million and $8 million as a result of our investments in our U.S. clinical trials for PerClot and continuing investment in the HeRO product line in SynerGraft.

We expect earnings per share for the full-year of 2012 to be between $0.25 and $0.27 which includes transaction and integration charges of approximately $2.5 million. This compares with prior year 2012 GAAP earnings per share guidance of $0.20 to $0.23. We expect the effective income tax rate for the full year of 2012 to be on the upper 30% to 40% range.

Now, I’d like to make a couple of comments about medical device tax for 2013. Based on our current understanding domestic sales of our medical devices will be subject to the device tax beginning in 2013. We believe the device tax for the third quarter and the first nine months of 2012 would have been approximately $250,000 and $700,000 respectively. Of course since the regulations implementing the medical device excise tax are not final, all of this information is subject to the final regulations and further interpretation.

Finally, we believe we are continuing to successfully execute on our strategy of positioning the company for accelerated revenue and earnings growth by expanding our addressable market opportunities through internal R&D, expanding and leveraging our sales and marketing, and executing on business development opportunities.

Looking forward we have several opportunities to expand the company’s market opportunity with higher growth, higher margin products. These include, one, to drive revenue growth in the HeRO Graft through our recent launch and our broader US direct sales force. Two, initiate enrollment in our PerClot IDE clinical trial in the first quarter of 2013 and gain additional marketing approvals in new international markets.

Three, expand our European sales and marketing coverage for PerClot to include other surgical specialties in addition to cardiac and vascular surgery. Four, potentially gain expanded indications for BioGlue in Japan. Five, building on our commitment to the Asia-Pacific region by gaining distribution partners for other products in new markets such as China and Southeast Asia. Six, drive our TMR business through our physician training and education programs. Our clinical registry, increased system placements as well as launching the [inaudible].

Seven, continuing our planning discussions with ValveXchange on the European distribution of their exchangeable valve product with the potential for initial European product launch as early as the second half of the 2013.

If we execute on the initiatives we will be in a good position to drive top line growth on our higher margin medical products and further leverage our operating infrastructure to improve profitability. That concludes our comments. I’ll now turn it back over to Steve.

Steve Anderson

At this time I will open up the call for questions.

Question-and-Answer Session

Operator

Thank you. We will now be conducting a question and answer session. [Operator Instructions]. Thank you, our first question comes from Mr. Jeffrey Cohen with Ladenburg Thalmann. Please go ahead.

Jeffrey Cohen – Ladenburg Thalmann

Hi, thanks for taking my questions. How are you doing?

Ashley Lee

Hey Jeff, how are you?

Steve Anderson

Good morning.

Jeffrey Cohen – Ladenburg Thalmann

Good morning. So no guidance for 2013 at all yet at this point?

Ashley Lee

No, you know, our normal convention is to release that guidance as part of our year end conference call.

Jeffrey Cohen – Ladenburg Thalmann

Got it. Regarding the litigation expenses, do you expect any for Q4?

Ashley Lee

Nothing significant at this point. All of our major litigation has been resolved and we are not expecting anything significant at this point.

Jeffrey Cohen – Ladenburg Thalmann

Go it. And could you review for us the stock repurchase plan that’s in effect as far as what the total is or the balance, and when that goes [inaudible] I see that there was – you purchased a few shares during the third quarter?

Ashley Lee

Yeah, you know, we typically purchase our shares under our 10D5 [ph] plan and we recently had one in place. We have a current authorization that extends up through the middle of December and we currently have the authorization to purchase, I think up to maybe a little over $10 million more under that repurchase plan. I significantly doubt that we will purchase $10 million in shares between now and the middle of December. At that time, that authorization will expire.

Jeffrey Cohen – Ladenburg Thalmann

Okay. So theoretically a new one will come into effect.

Ashley Lee

The board will probably consider that later this year.

Jeffrey Cohen – Ladenburg Thalmann

Okay. The $500,000 from the DOD for BioFoam, where does that exist? That’s on your balance sheet now?

Ashley Lee

No, that $500,000 is actually revenue. So that is actually moneys that we have spent to-date on that plan. We currently have a little over $700,000 in cash that we have received from the DOD and in all likelihood we will be returning that plus maybe a little bit more at some point when that study has been formally terminated.

Jeffrey Cohen – Ladenburg Thalmann

So, what might that look like for the fourth quarter as far as returning moneys?

Ashley Lee

There will be no P&L impact. If we return the funds to the DOD we would simply – again it would be probably a little over three-quarters of a million dollars and return that amount to the DOD.

Jeffrey Cohen – Ladenburg Thalmann

Okay, got it.

Ashley Lee

No P&L impact.

Jeffrey Cohen – Ladenburg Thalmann

Okay. So apart from the study, you are terminating, so don’t expect to hear anything more about BioFoam for the U.S?

Ashley Lee

For the U.S, now I will say that we continue to make progress on expanding the indications for BioFoam in international markets to remind you. We filed to expand the indications for cardiac in vascular surgery and we remain optimistic that we are going to be able to get an expanded indication for that product in international markets.

Jeffrey Cohen – Ladenburg Thalmann

Okay, got it. And do you expect to be present at an exhibit or any scientific conferences like Beeth [ph] or ISAC [ph] over the next couple of quarters?

Ashley Lee

We typically will attend the – there are a few conferences beginning early next year, for instance STS, AATS is typically sometimes in April, and we will certainly be at those. We are going to be increasing our presence at surgical conventions significantly in 2013 as a result of the acquisition of HemoSphere. I don’t have that list of congresses at my fingertips, but I believe they are on our website and you can look and see which ones we will be attending.

Jeffrey Cohen – Ladenburg Thalmann

Okay. Could you talk a little bit about the decision to have a facility at Georgia Tech as far as – is that for redundancy purposes or because you are at full capacity in the main facility or why was that made?

Steve Anderson

We are not at full capacity here. But the initial decision was made to have a redundant facility in case of the fact that we got hit by a tornado here and that I wanted to move some of our inventory, our preserved tissue inventory off-site here and have an alternative site. There was a company there, a good sized pharmaceutical type company that went out of business and their whole facility, which was probably – I would say 30,000, 40,000 sq. feet was available for lease and it’s a beautiful space, and pharmaceutical grade clean rooms, and we decided to take 10,000 sq. feet of that.

And then upon looking further last week, I made the decision to expand that by another 10K. So we are going to take to take 20,000 sq. feet there and manufacture the HeRO Graft there. A certain number of steps for PerClot will be manufactured in the clean rooms there and then we will setup a redundant allograft inventory in that facility as well. But it is beautiful space, the price was right and we just decided that it was time to give ourselves a little protection here because of the frequency of tornados in this area.

Jeffrey Cohen – Ladenburg Thalmann

Okay, got it. Just a couple more. The pre-manufacturing allowance for the U.S trial for PerClot, would that be counting as sales?

Steve Anderson

When we put them into the testing, we start our program; yes they will be registered as sales.

Jeffrey Cohen – Ladenburg Thalmann

Okay. And I see that – so you got a letter from Medafor on PerClot. What was the timing of that?

Steve Anderson

I don’t know, I don’t remember exactly the timing. It was, what, within the last six weeks.

Jeffrey Cohen – Ladenburg Thalmann

Okay. Would you say that was largely expected?

Steve Anderson

Yes, we don’t think that we infringe on their patent. They evidently think that we do. But, we’ve had a thorough analysis made of our technology and chemically it’s considerably different, it works differently. PerClot absorbs four or five times more fluid upon contact than the Arista product does. We just don’t think that molecularly it is similar at all. They have a history of being very litigious and I am personally aware of about five situations where they have sued companies or individuals and right now they are batting all for five. So I am not taking it very seriously. I think that we do not infringe on their patent at all. I don’t think that there is going to be an issue there going forward. Having said that they can sue us, anybody can sue us for anything they want to.

Jeffrey Cohen – Ladenburg Thalmann

Got it. Okay, perfect. Thank you very much for taking the questions.

Operator

Our next question is from Mr. Matt Dolan with Roth Capital.

Chris Lewis – Roth Capital Partners

Hey guys, this is Chris Lewis on the line for Matt. Thanks for taking the questions.

Ashley Lee

Hey Chris.

Chris Lewis – Roth Capital Partners

First question is just on cardiac tissue, it looks like you had a nice quarter. You mentioned an increase in shipments. Could you talk a little bit more about what factors contributed to that increase during the quarter?

Steve Anderson

Yes I can. The STS and their physician guidelines came out with an endorsement of using human valves and human tissue replacements in cases of endocarditis. In fact they went so far as to say that a homograft or allograft valve was the product of choice for treating active endocarditis in patients. Some of our consultants feel that there is an epidemic of endocarditis developing in the United States. And so I would expect to see that type of tissue continue to grow and that business grow. Also, allograft valves last 15 to 20 years, and so a lot of the patients that were implanted with our tissues in the early days of the company will probably be having replacements, and so there is a huge new market developing for adult congenital patients that have to be reconstructed because the valves will wear out over 15 to 20 years.

Chris Lewis – Roth Capital Partners

Okay, thanks. And then just I guess as a follow-up to that, regarding this kind of new sustainability and growth there, the tissue guidance in place, a step-down in fourth quarter, we assume roughly 5% growth for the year. Can you talk about despite the new sustainability there why your guidance is pointing to a draft in the fourth quarter for tissue?

Ashley Lee

Well, I think it’s kind of hard for us to expect to see 22% growth continued in that space although we are certainly very optimistic. Coming into the year we thought that the allograft business as a whole was a flat to low growth business, low single digit grower. We now believe that it could be a mid-single digit grower going forward. So, hopefully we are just being a little bit cautious. But it’s kind of hard to guide to sustainable growth at that level.

Steve Anderson

Looking at the sales this quarter, this morning, I have noticed that the vascular allograft tissues are doing very well and there is no question about the fact that the acquisition of the HeRO Graft has helped us greatly, we are seeing physicians, vascular-reconstruction physicians that we had been unable to see in the past as a result of having the HeRO Graft and I think that that trend probably is going to continue into the future. And then the other thing that goes on in the fourth quarter for our tissue business is that a lot of that surgery is elective and then over the holidays people have elective surgery they usually delay it until the first quarter and I think that we have a history of having extremely strong first quarters, don’t we?

Ashley Lee

We do, yes.

Chris Lewis – Roth Capital Partners

Okay, thank you. And then last question, we have been expecting for R&D to tick up here with some of your projects. But haven’t quite seen it with another pretty flat quarter sequentially. It looks like the guidance implies R&D to pick up here in Q4. Can you discuss why we may have seen some delays in the spending tick up there to this point and how we should expect R&D to trend in the next…

Steve Anderson

Well PerClot, we had originally forecasted that we would be in clinical trials with PerClot at the end of this year, and as you will recollect, the FDA had a number of questions and we had been in the process of responding to those questions and we will be resubmitting our IDE application in November. And so the PerClot clinical test has been delayed for some time.

Chris Lewis – Roth Capital Partners

Okay, thank you.

Operator

Mr. Anderson, there are no further questions at this time. I would like to turn the floor back over to you for closing comments.

Steve Anderson

All right. We would like to thank everyone that joined us today and we look forward to speaking with you at our year-end conference call.

Operator

This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.

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