Artivion Inc (AORT) 2010 Q2 法說會逐字稿

Greetings and welcome to the CryoLife Second Quarter 2010 Financial Conference Call. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Steve Anderson, President and Chief Executive Officer for CryoLife. Thank you, Mr. Anderson, you may begin. Chief Operating Officer

Good morning, everyone, this is Steve Anderson, CryoLife's CEO, and I would like to welcome you to CryoLife's Q2 2010 conference call. With me today is Ashley Lee, the Company's Executive Vice President, COO and CFO.

We were very pleased to announce record revenues for the second quarter, as well as record revenues for the first six months of 2010. Revenues for Q2 were $29.3 million, up from $28.2 million a year ago and revenues for the first six months of 2010 were $59 million, up from $54.9 million in the first six months of 2009, an 8.0% increase.

Diluted earnings per share for Q2 2010 were $0.10, up from $0.09 for Q2 2009 and a penny above analyst estimates. Diluted earnings per share for the first six months of 2010 were $17, up from $0.16 in 2009. This is the fourteenth consecutive quarter of profitability for the Company and we continue to be very pleased with our operating results in this difficult economic situation.

The agenda for today's call is as follows. Ashley will discuss today's press release in detail and by line of business. He will also focus on the Company's successful buyback of our common stock. He will also discuss the Company's cash position. Ashley will complete his remarks with a discussion on the status of the Medafor litigation.

I will discuss the recent FDA clearance for the five-year shelf life for the CryoValve SG Human Pulmonary Heart Valve. I will discuss the significance of Medafor resuming its shipments of HemoStase to us that was announced on June 30th.

I will also discuss the continuing rollout of BioFoam sales in Europe and the beginning of the BioFoam clinical trial in the U.S. I will update you on the status of several SynerGraft tissue projects that are ongoing. At the end of my comments, Ashley will return to review our financial guidance for the rest of the year. At this time, Ashley will discuss this morning's press release.

Thank you, 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, which look forward in time, involve risks and uncertainties and are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements include statements made as to the Company's or management's intentions, hopes, beliefs, expectations, or predictions of the future.

Additional information concerning risk 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 Form 10-K for the year-ended December 31, 2009, our Form 10-Q for the quarter ended March 31, 2010 and our Form 10-Q for the quarter ended June 30,2010, which we expect to file by the end of this week, and in the press release that went out this morning, a copy of which is contained on the investor relations portion of our website.

This morning we reported our results for the second quarter and first half of 2010. We set all-time second quarter and first half revenue records of $29.3 million and $59 million for the periods ended June 30, 2010 and reported our fourteenth consecutive quarter of profitability. These revenue amounts represent increases of 4.0 and 8.0% compared to the corresponding periods in 2009.

As of June 30, 2010 we had $41.4 million in cash, cash equivalents and restricted securities, compared to $35.1 million at December 31, 2009. Of this $41.4 million, $2.4 million was received from the U.S. Department of Defense as advance funding for the development of BioFoam protein hydrogel technology and $5.3 million was designated as restricted, primarily due to a financial covenant requirement under our credit agreement.

Net income for the second quarter of 2010 was $2.9 million or $0.10 per basic and fully diluted common share, compared to $2.5 million or $0.09 per basic and fully diluted common share for the second quarter of '09.

We recorded pretax charges in the second quarter of 2010 of approximately $420,000 in costs associated with our litigation with Medafor and recorded a $385,000 gain on valuation of the derivative related to the investment in Medafor common stock.

Net income for the first half of 2010 was $4.9 million, or $0.17 per basic and fully diluted common share, compared to $4.5 million or $0.16 per basic and fully diluted common share for the first half of '09.

We recorded pretax charges in the first half of 2010 of $729,000 in connection with the write-off of capitalized legal expenses associated with our BioGlue intellectual property rights in Germany and approximately $834,000 in costs associated with our litigation with Medafor. Additionally, we recorded a $1.2 million gain on valuation of the derivative related to the investment in Medafor common stock.

Cardiac revenues for the second quarter and first half of 2010 increased 6.0 and 14% compared to the corresponding period in 2009. The increase in the second quarter and first half of 2010, compared to the prior year, was primarily due to the aggregate impact of favorable tissue mix due to increasing shipments of SynerGraft Heart Valves and cardiac patches.

Additionally, in the first half of 2010, there was a 10% increase in shipments of cardiac valves and patches. We believe that this is, in large part, due to the efforts of our cardiac specialists. Additionally, we are seeing growing interest in the international markets for our preserved cardiac tissues.

The vascular business continues to do very well, driven by strong unit growth. Vascular revenues for the second quarter and first half of 2010 increased 7.0 and 9.0% compared to the corresponding periods in 2009. These increases primarily resulted from a 6.0 and 7.0% increase in unit shipments for the second quarter and first half of 2010 compared to the corresponding periods in 2009.

Product revenues, which consist primarily of BioGlue and HemoStase, increased 2.0 and 5.0% in the second quarter and first half of 2010, compared to the corresponding periods in 2009. The increases year-over-year primarily reflect the growing usage of HemoStase in cardiac and vascular surgical indications in the U.S. and cardiac, vascular and general surgery indications in many markets outside of the U.S.

Total preservation services and product gross margins were 61% for the second quarter of 2010, compared to 63% for the second quarter of 2009 and 60% in the first half of 2010, compared to 64% in the first half of 2009. Preservation services gross margins for the second quarter of 2010 were 40%, compared to 43% in the second quarter of 2009 and 40% in the first half of 2010, compared to 44% in the first half of 2009.

Product gross margins for the second quarter of 2010 were 82%, compared to 84% in the corresponding period in 2009 and 82% in the first half of 2010, compared to 84% in the first half of 2009.

General, administrative and marketing expenses for the second quarter of 2010 were $11.7 million, compared to $12.3 million for the second quarter of 2009. These expenses for the second quarter of 2010 included approximately $420,000 in costs related to our litigation with Medafor. General, administrative and marketing expenses for the first half of 2010 were $25.5 million, compared to $25.1 million for the first half of 2009.

The first half of 2010 included a charge of $729,000 related to the write off of capitalized legal expenses associated with our BioGlue intellectual property rights in Germany and approximately $834,000 in costs related to our litigation with Medafor.

R&D expenses were $1.2 million and $1.4 million for the second quarters of 2010 and 2009 and $2.5 million and $2.4 million for the first halves of 2010 and 2009. R&D spending in 2010 primarily focused on BioGlue, BioFoam, and SynerGraft tissues and products. Refer to our SEC filings for detailed discussions of factor affecting our results of operations, including our Form 10-Q that we plan to file by the end of the week.

I'd like to comment on our recently announced stock buyback. During the second quarter of 2010 we purchased 274,000 share of common stock in the open market at an average price of $5.52 per share, for a total cost of $1.5 million. Our buyback has continued into the third quarter and as of yesterday, we have purchased 217,000 shares in July 2010 at an average price of $5.48 per share, for a total cost of $1.2 million. We will continue to purchase shares strategically, going forward, as conditions warrant.

We continue our efforts on the business development from to find complimentary products or companies that we can acquire to leverage our existing infrastructure and sales force. We have carefully evaluated a number of alternatives and belief that select business development efforts, along with our ongoing stock buyback, our prudent uses of our cash reserves and will create value for our shareholders.

Now I'll turn it back over to Steve.

On June 8th, we announced that the FDA had cleared our 510(k) submission to extend the shelf life on our CryoValve SG Pulmonary Valve from one year to five years. These valves are commonly used in infants and pediatric patients in cardiac reconstruction procedures. The extension of the shelf life to five years simplifies the purchasing decisions and tissue inventory management issues presented to hospitals by the previous one-year shelf life.

The increased shelf life also gives us more flexibility in planning our manufacturing cycle. Since the change in the shelf life was announced, our shipments of SynerGraft-processed pulmonary valves have more than doubled from the average monthly shipments through May of 2010.

In late June, Medafor filled most of an approximately $2.5 million order for HemoStase, the hemostatic agent that we distribute for them. We were surprised that this order was filled, since they had refused to sell three previous orders totalling approximately $1.8 million that we had placed in March and April of this year.

As a result of Medafor not shipping the March and April orders, we were unable to fill some requests for the 1.0 gram sized product. We believe this adversely affected our Q2 HemoStase revenues over what we believed they would have been, along with the confusion in the marketplace caused by Medafor's announcement that it was terminating the agreement and what we believe are continued sales by Medafor into our exclusive field. We expect to pursue reimbursement of our damages from those lost sales in our lawsuit against Medafor.

Another thing that we found disturbing about Medafor's order filling process is that we believe a portion of the product they delivered to us in late June did not meet our incoming acceptance standard. We do not believe this portion of their shipment had the proper instructions for use in the package or the correct information on the printed boxes. These discrepancies affected the 5.0 gram product. This is the second instance of this type of issue.

We placed another order for approximately $1.3 million of HemoStase with Medafor on July 9th. They have begun to fill this order but have informed us that they will not fill all of it on a timely basis. They have also informed us that they will not fill all of our June purchase order on a timely basis.

These issues with Medafor make working with them increasingly difficult and working with these folks is increasingly becoming similar to trying to work with Larry, Moe and Curly. Despite the difficulty of dealing with Medafor's management, however, we continue to have faith in the HemoStase product.

During the second quarter, our European prospective multi-center, single arm study for BioFoam was completed. A total of 55 patients from three countries were enrolled in this study. There were 15 enrolled in the UK, 15 in France, and 25 in Germany. The focus of the study was to determine the effectiveness of BioFoam in sealing liver resections.

Data analysis of the primary end point shows achievement of hemostasis within three minutes in 92% of the application sites. BioFoam's mean hemostatic time compares favorably to those reported for comparative products. The final report should be completed in the third quarter and will be used to supplement an application for approval in Canada. Since product launch, there have been approximately 130 cases of BioFoam in the clinical setting.

We continue to move forward on our approval IDE for BioFoam use in the sealing of liver parenchyma. Upon receipt of final approval from the United States Department of Defense, we expect to start patient enrollment into this study mid-third-quarter of this year. The approved IDE is for a prospective multi-center, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent.

The feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group. Upon successful completion of the feasibility study, a follow-on, prospective, multi-center, randomized, controlled pivotal study will be conducted. It is currently projected that the pivotal investigation will enroll a total of 164 eligible subjects - 82 subjects in each treatment group, across a maximum of 10 investigational sites.

We continue to make progress on our CryoValve SG Human Aortic Valve Humane Device Exemption submission. We are in the process of completing bench test and efficacy animal study and the collection of recent follow-up data on a series of clinical implants. We expect this process to be completed in approximately 12 months.

The patented SynerGraft technology platform serves as the foundation for the next generation of implantable biological tissues and is designed to remove allogenic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix.

We are currently evaluating potential partners for continued development and distribution of ProPatch Soft Tissue Repair Matrix. ProPatch is a surgical mesh derived from decellularized bovine pericardium and is indicated for implantation to reinforce soft tissue where weakness exists, including but not limited to, defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, construction of the pelvic floor, hernias, suture line reinforcement in reconstructive procedures. ProPatch is FDA 510-cleared.

In addition to seeking a partner, we are currently organizing a pilot study for hernia repair with clinical implants planned for the fourth quarter of this year.

That concludes my comments and now I'll turn the call back to Ashley so he can give you some financial guidance for the rest of the year.

Subject to the assumptions and qualifications I'll discuss in a moment, we expect total revenues for the full year of 2010 to be between $118 and $122 million, which includes between $1.0 and $2.0 million related to funding received from the Department of Defense in connection with the development of BioFoam.

We expect tissue processing revenues to increase between mid-single and low double-digits, on a percentage basis, in 2010 compared to 2009, BioGlue revenues to increase by low single-digits on a percentage basis and HemoStase revenues to increase more than tissue or BioGlue revenues on a percentage basis.

R&D spending should increase for the remainder of the year as we anticipate beginning enrollment in our BioFoam IDE in the third quarter and expect increased costs associated with the SynerGraft aortic and pulmonary valve studies. We expect our effective income tax rate for the remainder of this year to be approximately 42%. We expect EPS to be between $0.34 and $0.38 for 2010.

The assumptions upon which this guidance is based include HemoStase revenues of between $4.0 and $4.5 million in the second half of the year, levels of Medafor-related litigation expenses in the second half of the year consistent with the first half of the year, and that the EDA with Medafor will not be terminated. Additionally, our guidance includes general expenses associated with business development opportunities but does not include significant expenses associated with specific targets.

We have withdrawn our proposal to acquire Medafor and we do not currently anticipate a transaction with them occurring during 2010. However, should we renew our proposal or take other actions to acquire Medafor, such as a proxy contest or tender offer, we could incur expenses or changes in the value of the Medafor derivative that could materially affect our guidance.

There are several motions and matters resulting from our litigation with Medafor before the courts. We are awaiting rulings on those matters and they are more fully discussed in our press release this morning, in our Form 10-Q, which we expect to file by the end of the week.

That concludes my comments and now I'll turn it back to Steve.

At this time I'll open up the call for questions.

(Operator Instructions) Our first question comes from Matt Dolan with Roth Capital Partners. Please state your question.

Hey guys, good morning, thanks for taking my call.

Hey Matt.

Maybe a couple of questions on the guidance and the changes we saw there, just to be clear. So on the revenue line, Ashley, can you just walk us through why the top end is coming down? Is that specifically related to HemoStase or something more in the base CryoLife book of business?

There a couple of things of note there. A good portion of the top line or at least the top end of the range coming down relates to grant revenue associated with the BioFoam IDE.

Yes.

We were a little delayed in getting that started and it looks like that we will, in fact, begin enrollment in that trial during the third quarter. So, again, as you recall too, that those revenues, any revenues that we record there, there are some corresponding expenses. So any reduction in revenue for BioFoam is really neutral to the bottom line, the guidance there.

The other thing is, as we mentioned a little bit earlier, the HemoStase revenues were adversely affected in the second quarter of this year due to the variety of the issues that we previously mentioned. As we move into the third quarter, it looks like things are starting to normalize again for the HemoStase revenues. So there's a little bit of an effect there.

And then BioGlue, we saw a trialing of a new product in the Northeast called ProGel. We don't think the product works as well as BioGlue. However, we did see some trialing there, so we're bringing it down a little bit for that.

Okay. That's very helpful. Thanks and then on the EPS side of things, it still looks like -- I mean, even with those pressures on revenue it still looks like revenue per quarter should be slightly up, at least in Q3 and Q4. So what factors -- same question on the EPS side of things. What factors are making that come down by $0.02? I know you talked about some operating spend, but maybe a little more detail there would help.

It's primarily the litigation. We certainly spent a little bit more than we had anticipated in the first half of the year and we've adjusted our budgets and assumed that we're going to be spending similar amounts in the second half of the year. So, hopefully, if the litigation proceeds as it has been, we've provided for that in the second half of the year in our guidance.

So you're talking about close to $1.0 million in litigation in the second half of the year?

Yes and that's roughly what we spent in the first half of the year.

Yes. Okay and then just two more. So, on the Medafor situation, I mean, what sort of timeframe do you feel like you can find some type of approximately substitute or replacement for HemoStase? At this point obviously the relationship doesn't sound like it's overly healthy.

We've stated in the past that we would prefer to remain in the agreement and continue to distribute HemoStase. We just want to move forward with the agreement. With that being said, we continue to look at business development opportunities in a wide variety of areas and we're not going to get specific on any of our business development activities. And when and if there is an announcement to make in that area, then we'll announce it.

Okay, fair enough and then finally, with that as kind of a backdrop, as you guys think longer-term about just sales growth in general. Can you maybe just give us an update on your strategy there? Is there anything you could do to kind of pick up the growth within the base business beyond these business development activities, adding reps or adding new geographies or what have you? Thanks.

Rather than adding reps or geographies, I think that the key thing to keep in mind is that the HDE, the Humane Device Exemption, that we're going to apply for, for the aortic SynerGraft, is a key strategy of the Company. And a SynerGraft-processed aortic valve, in our opinion, is a big deal and we're expecting that to be approved sometime next year when we get all of our data together.

The other thing that you should focus in on is that BioFoam is a very fine product and during the last conference call I mentioned that we had found that it was able to withstand cardiovascular pressures. That's really significant and I'm looking forward to BioFoam making a big contribution to the Company down the road, both in Europe where its getting started now and then as the IDE approval moves forward here in the States. So BioFoam has the potential to be a very, very significant product for this Company and a SynerGraft-processed aortic valve is also a very significant product.

Thank you.

Raymond Myers, The Benchmark Co.

Thank you and good morning.

Good morning.

Good morning, Ray.

Steve, I had some questions, but you just intrigued me with what you just said; that the SynerGraft Aortic Valve would be "a big deal". Can you compare the opportunity for a SynerGraft Aortic Valve with the SynerGraft Pulmonary Valve, which you already have cleared?

Well, that addresses a much bigger market for adult aortic disease, because the pulmonary valve is really focused primarily on pediatric and children, neonates to maybe 20 years old. So the aortic valve opens up the whole adult reconstruction market for us.

I don't have any published data at the moment regarding that, but I do know, in the collection of the data for the HDE, that we have some outstanding results from SynerGraft valves that have been implanted for ten years or better and it's definitely a better valve. SynerGraft-processed valves in general are better valves and are more durable and long-lived than a standard-processed cryo preserved valve and the rival, the performance characteristics of any other valve out there. The data will probably be published sometime here in the next year, year-and-a-half, but it is included in what we are submitting to the FDA regarding that application for the aortic valve.

So, for instance, I was just told this week by one of the physicians that has a series of aortic valves that go out over ten years that there are no signs of deterioration, that they have normal hemodynamic and they're functioning perfectly. And so those things are really big considerations and of course you don't have to use anticoagulants with them and I'm looking forward to that product being approved by the FDA.

I'm very positive about the fact that the HDE will be granted for that. But, as I said earlier today, that submission - all of the data and everything - won't be submitted until sometime early next year.

Right and in the past we had seen supply constraints for appropriate valves. Do you still have those and if there were a large opportunity could you fill it with pulmonary valves, (inaudible - multiple speakers)?

The answer to that is yes. Over the last four or five years we have lost five competitors that have left the homograft valve business and we, ourselves, have modified the amount of tissue that we're bringing into the laboratory so that it corresponds more closely with what we think our quarterly revenues are going to be. So I'm optimistic about the possibility that we can double or triple our incoming tissues at the appropriate time.

As a result of losing the competitors, there just isn't the demand for the human valve tissues from the procurement groups that there used to be.

Okay, great and my next area of questions is regarding the HemoStase. Given, though, the lack of cooperation from Medafor that you received to date and particularly recently with them not sending the correct product and packaging, do you think that under the current circumstances you will be able to grow your HemoStase sales in the second half of this year? Or is it permanently impaired.

I don't think it's permanently impaired. I think it has a lot to do with their ability to get their product packaged on a routine basis. They do that with contracted packaging firms. They don't do it themselves and I think it's a matter of their coordinating those processes better in their company. I know that they have enough powder in storage to significantly increase their production, but from afar I guess it has to do more with getting that raw material to the people that package their product for them and get the throughput coming out on a more regular basis.

Do you have the supply, currently, to supply all the different sizes that you require?

We do.

Okay, so there's no impediment in that regard currently?

Currently there is not.

Okay, great. Let me go back to the ProPatch, because that's something we've been talking about on and off for several years. With a 510(k) product that potentially could go into the larger hernia repair and other markets, what are you doing with that? Where do you see that going over the next few years?

We're in negotiations with a couple of potential partners that address the general surgery markets and we are anticipating doing some type of a license agreement, manufacturing agreement perhaps, with a partner that will handle that product in the marketplace. And the reason that we're seeking a partner for that product is that our present distribution network doesn't focus on general surgery, it's focused on cardiac and vascular surgery.

Right. That's certainly understandable. You mentioned a fourth quarter pilot study beginning in hernia, which is the thought that the partner would be funding the pilot study, would you have a partnership?

Yes. We're going to fund that study and the reason that we mentioned it was the fact that it will provide further evidence to a potential partner of the efficacy of the product and its on a comparative basis with other products that are already out there.

Can you give us a sense of the magnitude of increased R&D expense that we should expect in the second half of the year?

A lot of that, Ray, is just due to timing of getting these studies completed and sometimes that's out of our control. But if everything goes according to plan, we could see some significant increases in R&D expenses in the second half of the year, a portion of which or a large portion of which would be offset by grant revenues associated with the BioFoam IDE program.

Okay. Thank you.

There are no further questions at this time. I'll turn the conference back over to management for closing remarks. Thank you.

If there are no further questions, thank you for joining us and we look forward to seeing you next quarter.

This concludes today's conference. All parties may now disconnect. Thank you.