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Artivion, Inc. (AORT)

Q2 2012 Earnings Call· Tue, Jul 31, 2012

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Transcript

Operator

Operator

Greetings and welcome to the CryoLife Second Quarter 2012 Financial 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, Mr. Steve Anderson, President and CEO for CryoLife. Thank you. You may begin.

Steven Anderson

Analyst

Good morning everyone and welcome to welcome you to CryoLife’s second quarter conference call. This is Steve Anderson, CryoLife’s CEO, and with me today is Ashley Lee, the company’s Executive Vice President, COO and CFO. During the second quarter we continued to execute on our growth strategy and delivered solid top and bottom line financial results. We achieved quarterly revenues of $33.2 million, an increase of 13% over the same quarter last year and up 3% quarter-to-quarter. Our revenue growth was driven by continuing excellent sales of BioGlue in Japan, a strong quarter for Allographenes and valves, a full-quarter of Cardiogenesis sales compared to the previous year's partial quarter and the addition of $635,000 of HeRO Graft sales due to our recent acquisition of Hemosphere. On the bottom line, we delivered net income of $0.12 per share compared to $0.06 per share in 2011. In addition to the solid quarter, we further enhanced our long-term market opportunity and growth potential with the acquisition of the HeRO Graft for end-stage in dialysis patients which will allow us to further leverage our sales force and core competencies. During the quarter we also eliminated the ongoing legal exposure in costs related to some very material lawsuits. We will provide updates on each of these items on today’s call. The agenda is as follows. Ashley will discuss today’s earnings press release in detail. He will discuss our performance by tissue and product line and he will discuss the recent settlement of the Medafor and CardioFocus lawsuits and the positive effect these settlements will have on our earnings going forward. At the end of the call he will return and provide updated financial guidance for the remainder of the year. I will discuss the recent acquisition of Hemosphere and then HeRO Graft for end-stage renal disease vascular access. I will also discuss the timetable for the beginning of the PerClot human clinical trial here in the United States.

David Lee

Analyst

Thanks Steve. To comply with the Safe Harbor requirements of the Private Securities Litigation Reform Act of 1995, I would like to 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 ended December 31, 2011, and our subsequently filed Form 10-Qs for the quarters ended March 31, 2012 and June 30, 2012, which we expect to file shortly and in the press release that went out this morning. This morning we reported our results for the second quarter and first 6 months of 2012. We achieved strong financial results for the second quarter and further positioned the company for long-term revenue and earnings growth. Here are some of the highlights. We achieved an all-time quarterly revenue record of $33.2 million driven by year-over-year increases in all lines of business and by the recent acquisition of Hemosphere. We settled 3 outstanding lawsuits with Medafor, CardioFocus and Tenaxis which eliminated our ongoing legal exposure and expenses related to these lawsuits. And we completed the acquisition of Hemosphere, a company that has the only currently approved fully subcutaneous product to bypass central venous stenosis in end-stage renal disease patients undergoing hemodialysis. As I previously mentioned, we set an all-time quarterly revenue record of $33.2 million, up 13% year-over-year.…

Steven Anderson

Analyst

In May we completed the acquisition of Hemosphere and our HeRO Graft which provides a long-term hemodialysis access solution for access challenged and catheter dependent patients. Hemosphere is located in the Twin Cities and was doing about $5 million a year in revenues. This will prove to be a complementary business to our Allograft vascular graft business which should be an approximately $34 million annual business for us in 2012. Hemosphere had 7 sales representatives that were focused on developing their business, predominantly east of the Mississippi. We are in the process of integrating their business into ours and their sales force into our distribution network. In the third quarter, we plan to begin selling the HeRO Graft throughout the U.S. with our combined 35% vascular sales force. We estimate this device will address about a $250 million and growing global market opportunity due to the aging population and the increasing number of people undergoing hemodialysis. The HeRO Graft has margins in the mid-60 range which could possibly move into the low 70% range in future years. Sales since we acquired Hemosphere and had the HeRO Graft for sale were $635,000. We have a team of people working with the Hemosphere staff for the purpose of relocating in our manufacturing from Eden Prairie, Minnesota to our corporate headquarters in Georgia. We expect this project to be completed during the first quarter of 2013. We expect the HeRO Graft to be a significant growth area for the company going forward. We are currently focused on executing on the acquisitions that we’ve closed over the last several months and we are not aggressively pursuing other targets at this time. However, we continue to be made aware of interesting opportunities on the business development front and we’ll continue to evaluate them as appropriate.…

David Lee

Analyst

We are updating our guidance for the full year of 2012 to reflect the actual results from the first half of 2012, the acquisition of Hemosphere and the settlement of all the company’s outstanding litigation during the quarter. We expect total revenues for the full year of 2012 to be between $129 million and $133 million, which includes revenues of approximately $500,000 related to the use of funds received from the U.S. DOD in connection with the development of BioFoam. This represents annual total revenue growth between 8% to 11% up from our previous guidance of 5% to 8% revenue growth. We expect tissue processing revenues to increase from low to mid-single digits on a percentage basis for the full year of 2012 compared to 2011, up from our previous guidance of flat revenues. 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 $2.5 million and $3 million. We expect revenues from revascularization technologies to be between $9 million and $10 million in 2012. We expect HeRO Graft revenues to be between $2.5 million and $3.5 million in 2012. Turning to expenses, we expect general administrative and marketing expenses for the full year of 2012 to be between $64 million and $66 million, which includes approximately $2.7 million of integration cost resulting from the acquisition of Hemosphere in May 2012. Research and development expenses are expected to be between $9 million and $10 million in 2012 as a result of our investments in our U.S. clinical trials for PerClot and BioFoam. We expect earnings per…

Steven Anderson

Analyst

At this time, we will open up the conference call for questions.

Operator

Operator

[Operator Instructions] Our first question is from Brooks West with Piper Jaffray.

Brooks West

Analyst

Hey, very thorough commentary, thank you for that. Just a couple of small things. Steve, you mentioned on the HeRO Graft, that product was only being sold east of the Mississippi?

Steven Anderson

Analyst

Yes.

Brooks West

Analyst

And you’re going to fully expand distribution to the west in Q3. What do you think like, what do you think that product looks like with kind of a mature U.S. distribution behind it?

Steven Anderson

Analyst

I think that that product would move pretty quickly into the $20 million range. To wit, when we acquire the company they had a 150 lead forms that had been filled out at conventions from - or by physicians west to the Mississippi, so they had never been called on. And those leads have been distributed to our sales force and beginning in September as we expand the sales efforts across the United States those 150 physicians will be called on immediately. So I think this is a big growth engine for the company.

Brooks West

Analyst

That’s great. Then on the PerClot, what did you - what was the anticipated trial size again that you were describing?

Steven Anderson

Analyst

300, 150 in the control group and 150 PerClot patients.

Brooks West

Analyst

And then what’s the follow-up?

Steven Anderson

Analyst

We don’t know that yet. We’re still in the process of negotiating that with the FDA when we send our response in, towards the end of this quarter that will be one of the items that we will have to negotiate with them.

Brooks West

Analyst

Okay. And then last for me, Ashley on the SG&A. I missed your commentary there, that was significantly less than we were looking for in our model. Is that the go forward number or how should we think about SG&A from here?

David Lee

Analyst

Yes I mean I think if you look at our - well first of all, Brooks the second quarter benefited from a couple of things, one was the reimbursements from the insurance companies for legal expenses and the settlement with Metaphor. So there was a lot noise in the G&A number in the second quarter. Going forward, if you look at our guidance for the second half of the year, we’re guiding towards I think roughly $16 million per quarter, maybe a little bit more than that. And so actually maybe $16 million to $17 million which includes some integration expenses from Hemosphere. So I think going forward, you’re probably looking between $16 million and $17 million on a go forward basis.

Operator

Operator

Our next question comes from the line of Matt Dolan with Roth Capital Partners. Please proceed with your question.

Matthew Dolan

Analyst · Roth Capital Partners. Please proceed with your question.

First question is on the EPS. Let me start with the revenue guidance. If we look at the second half of the year and kind of back into it and obviously considering you now have HeRO for the full 6 months. It seems that the core business would be sequentially down in the second half versus the first half. Is that the nature of the business seasonally speaking, or conservatism? Or maybe you can help us understand that a little better.

David Lee

Analyst · Roth Capital Partners. Please proceed with your question.

As it relates to the third quarter that’s always been a little bit weaker for us, we have a pretty significant international business in all of Europe goes on vacation for the month of August. So that’s one factor that has gone into it and then we’ve got the holiday season coming up towards the end of the year. So if the - we see seasonable weakness and we could end up towards the lower end of our range but if we see some improvement in our PerClot and TMR businesses which were already exceeding in the third quarter of this year and we do a little bit better than we expect to then we could be towards the upper end of the range.

Matthew Dolan

Analyst · Roth Capital Partners. Please proceed with your question.

Okay. And then on the EPS side of things, you have a number of moving parts and adjustments. Is there any way you could provide some type of apples-to-apples comparison you gave us the pro forma $0.10 for the second quarter. Can you do that on an annual basis both with your prior guidance and current so that we can kind of understand where the underlying EPS guidance is going?

David Lee

Analyst · Roth Capital Partners. Please proceed with your question.

I think the best thing that you can refer to, Matt, is there is a schedule included in our press release. It’s on the very last page of our press release that pro forma is a reconciliation of our reported GAAP numbers and our non-GAAP numbers. There is a lot of information in there that backs out all the noise that we’ve had related to business development and litigation. And that I think that gives you a pretty clear indication of where we should be heading in the second half of the year and going forward.

Matthew Dolan

Analyst · Roth Capital Partners. Please proceed with your question.

Sure, but what’s your guidance doing then? If we strip all that out, I mean are you seeing the underlying guidance go up purely because the legal spend is out of the equation or is the underlying business, I know your R&D spend is down for example. So maybe just some type of clarity on the direction, it’s clearly a big increase in guidance we’re just trying to make sure we’re comparing the right numbers to each other.

David Lee

Analyst · Roth Capital Partners. Please proceed with your question.

Yes, well, obviously we’re stripping out the litigation expenses related to the second half of the year. We hope that we’re going to end up towards the upper end of the range of revenue guidance which would obviously be beneficial for the bottom line. The second half of the year, we’re expecting increases in R&D spending as compared to the first 2 quarters of this year. So we certainly expect that to be a driver of our performance in the second half. And then the other thing is, we’ve got integration related cost related to the ongoing integration of Hemosphere and I believe that we said that that number, we expect it to be $1.6 million, $1.7 million for the balance of this year. So I think if you look at that again point to that reconciliation of earnings as being par for the second quarter I think those are the factors that I’ve just mentioned that could expect to impact the second half of the year as compared to the second quarter.

Matthew Dolan

Analyst · Roth Capital Partners. Please proceed with your question.

Okay. So it seems that R&D relative to prior expectations, R&D is down so that’s helping and the legal is coming out and those are the 2 main underlying factors, fair?

David Lee

Analyst · Roth Capital Partners. Please proceed with your question.

Yes, and then you got obviously again the integration related cost related to Hemosphere and if we continue to execute on the top line we think that that could hopefully we’re going to end up towards the upper end of the range that’s our hope. And that would also be beneficial too.

Matthew Dolan

Analyst · Roth Capital Partners. Please proceed with your question.

Okay. And the last topic is on your sales force that you eluted to expanding it on little bit on today’s call as well as the prior call. So anything you can quantify there and what we’re trying to understand is the cross selling capability as HeRO comes in. Maybe talk about how you’ve been able to cross sell with the prior acquisition like cardio genesis and how that plays into the sales force plans going forward? Thank you guys.

David Lee

Analyst · Roth Capital Partners. Please proceed with your question.

I think the sales force expansion that we mentioned a little bit earlier was primarily related to the additional people that we brought on with cardio genesis and the additional people that we brought on with the Hemosphere acquisition. There currently are no plans going forward to add significantly to our headcount as relates to sales staff. As it relates to cross selling opportunities for the Hemosphere acquisition our existing sales force is currently being trained on the product and we expect to launch fully later this quarter, sometime in September and we’re already starting to see just anecdotally because some doctors are calling us and wanting to do procedures. So we haven’t launched fully but we’ve done somewhat of soft launch. And the feedback that we’ve gotten is very positive, as it relates to potential cross selling particularly. So there could be some beneficial effect and we expect there to be some beneficial effect on the cross selling opportunities especially in our vascular allograft business.

Steven Anderson

Analyst · Roth Capital Partners. Please proceed with your question.

I’d like to expand on that a little bit. Our sales force that handles the vascular grafts of course was calling on dialysis type physicians and those grafts were being used for infected prosthetic grafts and also for early stage, renal dialysis patients. So we’re now covering the full spectrum early to mid-stage hemodialysis patients and with the addition of HeRO, the late stage and chronic hemodialysis patients. Our sales force has been able to see physicians, vascular surgeons with the HeRO Graft that they never were able to see before. And they have been quite successful in talking into those physicians about our complete line of vascular grafts at this time. So we’re very positive about the cross-selling opportunities in that part of our business and in the early stages of it, it’s having a really great impact.

Operator

Operator

Our next question comes from the line of Jeffrey Cohen with Ladenburg Thalmann.

Jeffrey Cohen

Analyst · Ladenburg Thalmann.

Could you review and discuss a little bit about BioGlue and I guess the rate of international markets growing or not growing and particularly what countries that are being sold into as well as Japan?

David Lee

Analyst · Ladenburg Thalmann.

The - we’ll talk specifically about Japan first. Right now, we’re currently on about a $4.5 million to $5 million run rate for Japan and it’s a very narrow indication which is aortic dissection. When we launched the product there, we indicated that the potential market opportunity for aortic dissection in Japan could approach $10 million or so. Going forward, we do expect to see some continued growth in the Japanese market as we move forward. We think if there is a larger opportunity there if we’re able to expand the indications for use in Japan, which we’re currently working with our partner on doing right now. Some of the other areas where we’re seeing particular growth that relates to BioGlue is in the Middle East. We’re also seeing a lot of strength through the Asia-Pacific rim, those markets are all doing very well for us and there are some of the South American markets that are doing very well too. The European business for BioGlue has been relatively flat. Of course we’ve been selling in that particular market for 10 or 12 years now. So again, so we’ve been in that market for a while, but all of the other international markets are growing very well for us and particular in Japan.

Jeffrey Cohen

Analyst · Ladenburg Thalmann.

Okay. What’s the specific on label expansion that you’re hoping to get?

David Lee

Analyst · Ladenburg Thalmann.

We’re hoping to get a label in Japan that mirrors the U.S. label which is for all practical purposes, cardiac and vascular surgery. Now we’ve started that process. We think there is a possibility that we could get that expanded label indication sometime late next year.

Jeffrey Cohen

Analyst · Ladenburg Thalmann.

Got it. And on PerClot revenue, you were talking about UK, Ireland, Australia and Germany being was it 308,000?

David Lee

Analyst · Ladenburg Thalmann.

Now let me look.

Jeffrey Cohen

Analyst · Ladenburg Thalmann.

For the quarter, and could you provide any general commentary as well in PerClot per country OUS?

David Lee

Analyst · Ladenburg Thalmann.

I don’t have the statistics in front of me, Jeff. By country for PerClot, we’re predominantly selling in the EU right now. There might be 1 or 2 countries outside of the EU that we’re selling into that we’re predominantly selling PerClot in the EU. We have recently refocused our efforts in our direct markets. Those are markets that we’re doing particularly well in and we’re refocusing our efforts there. Going forward and based on some of these new sales programs that we put in place and so forth and because of that strategy we’ve seen an improvement in the business there. July has started out very well as it relates to PerClot, so we expect some of the changes that we’ve made to really have a positive effect on the PerClot business going forward. If you look beyond that, next year, we think that’s - there are some opportunities to bring some additional international markets on board. In particular, there is a possibility that we could be in Brazil next year and maybe Canada and then beyond that hopefully in about late 2014 we could get the U.S. approval. So we think that there’re going to be continued opportunities to grow that business going forward.

Steven Anderson

Analyst · Ladenburg Thalmann.

Sales of PerClot in the first 6 months of 2012 were up 43% from $398,000 to $571,000. I do want to say this about some of the things in Europe, which at the risk of stating the obvious, there are some headwinds for us in Greece and there have been some headwinds also in Turkey and Italy due to the financial situations that those countries have confronted or are confronting. And we are watching those things carefully. We are evaluating whether we should change representation in those countries. But as a result of the headwinds in the countries around the Mediterranean there, we have been focusing on the northern part of Europe and trying to expand our shares in both France and Germany and the UK. But we definitely are concerned about it and I’m sure that CryoLife isn’t the lone ranger. I’m sure that other medical companies are confronted with that same situation.

Jeffrey Cohen

Analyst · Ladenburg Thalmann.

Got it, okay. Two more quick ones, do you expect any onetime charges related to the movement of the HeRO facility from the Twin Cities to Atlanta?

David Lee

Analyst · Ladenburg Thalmann.

We think that the cost at the time of the move, are probably not going to be material. We have indicated in our guidance, in our press release that they are going to be ongoing integration related charges over the balance of this year and I think that we indicated that over the balance of this year there is going to be like $1.6 million to $1.7 million in ongoing integration cost. The cost to formally set down the facility, are going to occur probably in early 2013, but we don’t expect that it will be material.

Jeffrey Cohen

Analyst · Ladenburg Thalmann.

Okay and lastly one more for you. You are talking about device tax and you were saying that that would include domestic BioGlue, HeRO, would that include or not include the SynerGraft technology?

David Lee

Analyst · Ladenburg Thalmann.

It would include the SynerGraft technology and those numbers that we gave you for - what the device tax would have been it did include the SynerGraft related tissues.

Jeffrey Cohen

Analyst · Ladenburg Thalmann.

Okay, which you said would be about $519,000, would have been for the first half?

David Lee

Analyst · Ladenburg Thalmann.

For the most of the year, that is correct.

Jeffrey Cohen

Analyst · Ladenburg Thalmann.

So net-net about 0.8% of 1%?

David Lee

Analyst · Ladenburg Thalmann.

Roughly.

Jeffrey Cohen

Analyst · Ladenburg Thalmann.

Okay. Thank you very much.

Operator

Operator

Our next question comes from the line of Raymond Myers with Benchmark.

Raymond Myers

Analyst · Benchmark.

Yes Steve and Ashley, I was hoping you could discuss the PerClot clinical to the FDA clinical trial in a little bit more detail. Specifically what are the milestones to initiating that trial and discuss--has the guidance for the total cost of that trial from your previous guidance?

Steven Anderson

Analyst · Benchmark.

We have been back and forth with the FDA a couple of time answering their questions and that is a subject that is ongoing negotiations regarding the parameters of that trial and I think that we expressed what we feel comfortable expressing earlier in the call. But our response will go back to them sometime in the late third quarter. And then I’m assuming that there will be a couple of meetings after they’ve had a chance to review our responses to their questions.

David Lee

Analyst · Benchmark.

You know Ray, as it relates to the cost associated with the trial, that really hasn’t changed since our initial guidance. We think that from here on out to completion of the trial we’re going to be somewhere between $4 million and $5 million.

Raymond Myers

Analyst · Benchmark.

And that cost would be starting now in Q1 next year?

David Lee

Analyst · Benchmark.

Well, I mean there's going to be some ongoing cost that we’re going to be incurring over the balance of this year, but the significant costs are going to start when we begin the enrollment which is going to be hopefully no later than the first quarter of next year, it might even be a little bit earlier than that, but let’s assume it’s going to be the first quarter. And then, so the majority of the cost will incur probably during 2013 with some into 2014 as we wrap up the trial and hopefully get approval.

Operator

Operator

There are no further questions at this time. I’d now like to hand the floor back over to Mr. Anderson for closing comments.

Steven Anderson

Analyst

Thank you for joining us and we look forward to speaking with you again in the third quarter.

Operator

Operator

Ladies and gentleman this does concludes today’s teleconference. You may disconnect your lines at this time and thank you for your participation.