Artivion Inc (AORT) 2006 Q1 法說會逐字稿

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  • Operator

  • Greetings, ladies and gentlemen. Welcome to the first quarter earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the 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 of CryoLife Corporation. Sir, you may begin.

  • - President, CEO

  • Thank you. Good morning, everybody, and welcome to CryoLife's first quarter conference call. This is Steve Anderson, CryoLife's President and CEO. With me today is Ashley Lee, the Company's Executive Vice President, Chief Operating Officer, and Chief Financial Officer.

  • This morning we announced the highest quarterly revenue total we have had since the second quarter of 2002. Revenues for the first quarter of 2006 were 19.4 million, an increase of 10% over the same period a year ago, and an increase of 8% over the fourth quarter of 2005. The recovery of CryoLife's business is continuing, and as we predicted during our year end conference call we have succeeded in having significant quarter to quarter growth.

  • The agenda for today's call is as follows: Ashley will discuss the results of the first quarter by service and product. He will comment on the progress we have made on the project of researching the Company's strategic alternatives.

  • I will discuss some developments in the regulatory process regarding SynerGraft processed human pulmonary heart valves. The tenth patient in our clinical pilot study is scheduled to be implanted with our BioDisc nucleus pulposus replacement product in mid-May, and I will discuss the timetable for the follow up and timing for our application for a CE Mark approval.

  • We are in discussions with the Cleveland Clinic regarding a license to techniques they have developed for the transplantation of a combination aortic mitral allograft heart valve. I will discuss the timetable for the FDA submission and approval of our decellularized surgical patch, that will be used for soft tissue repair of shoulder injuries.

  • The last subject I will discuss are the various meetings and interactions that CryoLife management has had with the House Armed Services Committee, and certain high ranking officials from all of services, regarding the use of BioGlue in the field in Iraq. After my comments are completed, Ashley will return to give some financial guidance for the rest of the year. After Ashley's guidance comments, we will open up the call to questions.

  • At this time Ashley is going to comment on today's press release.

  • - EVP, COO, CFO

  • 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 in our 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. All statements made during this conference call that do not reflect historical results or information, should be deemed to be forward-looking statements.

  • It is important to note that the Company's actual results could differ materially from those projected in such forward-looking statements. Additional information concerning risks and uncertainties 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, 2005.

  • This morning CryoLife reported financial results for the three months ended March 31, 2006. Revenues for the first quarter of 2006 increased 10% to 19.4 million compared to 17.7 million in the first quarter of 2005. The net loss in the first quarter of 2006 was 1.8 million, or $0.08 per basic and fully diluted common share, compared to a net loss of 1.4 million, or $0.06 per basic and fully diluted common share in the first quarter of 2005. Excluding a $244,000, or $0.01 per share, non-cash charge related to stock based compensation expense, and a $248,000, or $0.01 per share, charge related to an adjustment to the valuation allowances on foreign deferred tax liabilities, the adjusted net loss in the first quarter of 2006 was 1.3 million, or $0.06 per fully diluted common share.

  • The first quarter 2005 results also include a $337,000 benefit, related to a reduction in litigation accruals, whereas the first quarter of 2006 includes a charge of approximately $160,000, related to product liability reserves, and a $150,000 charge, related to post-employment benefits. All of these amounts are included in general and administrative expenses for the relevant timeframe.

  • BioGlue sales in the first quarter of 2006 decreased 1% to 9.8 million, compared to 9.9 million in the same period in 2005. The decrease was primarily attributable to a decrease in BioGlue sales volume, which decreased revenues by 4%, partially offset by an increase in average selling prices which increased revenues by 3%.

  • U.S. BioGlue sales were 7.4 million and 7.7 million in the first quarter of 2006 and 2005 respectively. International BioGlue sales were 2.4 million, and 2.2 million, in the first quarter of 2006 and 2005 respectively. With the restaffing of our salesforce in March of this year and the recent approval of the BioGlue 10 ml syringe, and the BioGlue spreader tip, we are optimistic that we will see growth in BioGlue revenues during 2006.

  • We indicated in our previous conference call, that procurement trends were favorable and that we expected that to be reflected in our top line. We are continuing to see the results of favorable procurement in the first quarter of 2006. Tissue processing revenues in the first quarter of 2006 increased 24% to 9.3 million, compared to 7.5 million in the first quarter of 2005.

  • Tissue processing revenues increased, primarily due to an increase in tissue procurement and an improvement in processing yields, which resulted in an increased number of allografts available for distribution, and price increases. Procurement trends continue to be favorable, and we continue to experience strong growth in tissue processing revenues during April. You may refer to our 10-Q which we plan to file by the end of the week for more information about procurement trends.

  • I would like to talk a little bit about specific tissue processing product lines right now. Cardiac revenues were 3.6 million for the first quarter of 2006, compared to 3.8 million in the first quarter of 2005, a decrease of 5%. Although we saw an increase of 1% in cardiac units shipped in 2006, we experienced a product mix shift in 2006, which resulted in more lower-priced cardiac patches being shipped, and fewer higher-priced valves being shipped, which overall resulted in a 5% decrease in revenues. We believe the decrease in shipments of heart valves is largely the results of experienced salesperson turnover in 2005.

  • Vascular revenues were 4 million for the first quarter of 2006, compared to 2.7 million in the first quarter of 2005, an increase of 49%. The increase in vascular revenues was driven by price increases, and a 33% increase in vascular unit shipments, which increased vascular revenues by 42% in the first quarter of 2006, as compared to the same period in 2005. The increase in unit shipments is a result of the strengthening procurement trends we saw in the latter half of 2005, and an increase in yields.

  • Orthopedic revenues were 1.7 million for the first quarter of 2006, compared to 1.1 million in the first quarter of 2005, an increase of 61%. Unit shipments of orthopedic tissue increased 33%, which increased revenues by 55% in the first quarter of 2006, compared to the first quarter of 2005. Again, the increase in unit shipments reflects improving procurement trends and improving tissue yields. For a more detailed discussion of the factors driving revenues, please refer to our Form 10-Q for the quarter ended March 31, 2006, which we expect to file by the end of the week.

  • Total product and tissue processing gross margins in the first quarter of 2006 were 55%, compared to the same number in the first quarter of 2005. Tissue processing gross margins in the first quarter of 2006 were 28% compared to 22% in the first quarter of 2005. Tissue processing gross margins improved in 2006 compared to 2005, primarily as a result of price increases, and improvements in the Company's tissue processing yields.

  • We expect continued improvement in gross margins on tissue processing services during 2006. We implemented some changes to our processes at the beginning of 2006. We are optimistic that these changes will have a measurable, positive effect on tissue processing gross margins in the future.

  • General, administrative and marketing expenses in the first quarter of 2006 were 11.3 million, compared to 10.1 million in the first quarter of 2005. General, administrative, and marketing expenses for the first quarter of 2006 include a $244,000 charge, related to stock based compensation expense. Additionally, the first quarter of 2005 G&A expenses include a $337,000 benefit, related to a reduction in litigation accruals, whereas the first quarter of 2006 includes a charge of approximately $160,000, related to product liability reserves, and a $150,000 charge related to post-employment benefits. You should refer to our SEC filings for detailed discussions of factors effecting our results of operations.

  • During the first quarter, our cash balance decreased from 12.2 million at December 31, 2005, to 11.3 million at March 31, 2006. In early January, we announced that we had engaged Piper Jaffray to assist the Board and management, in identifying and evaluating potential strategies available to the Company. This is a comprehensive process that is ongoing, and we cannot talk about any specifics about the process. When the Board of Directors has determined an appropriate course of action, we will communicate that information to you.

  • Now I will turn it back over to Steve.

  • - President, CEO

  • Thank you, Ashley. On March 22nd, CryoLife representatives met with senior staff members of the device branch of the FDA, that's the office of CDRH, on the status of the 5 10-K submission for our SynerGraft treated human heart valves. The meeting allowed both parties to review and discuss the issues surrounding the approval process.

  • Based on the outcome of the meeting, CryoLife has developed a plan to meet the new data requirements requested by the FDA, which includes additional follow-up data on 300 patients who have SynerGraft processed heart valves. 150 of these patients will be Ross procedure patients, and 150 will be patients who have undergone right ventricular outflow track reconstruction. We expect to submit this additional information to the FDA during the fourth quarter of 2006.

  • The control group that will be used for establishing substantial equivalents will be published literature of standard processed cryo-preserved allograft heart valves. Assuming a favorable review of the new data by the FDA, it is our expectation that market clearance of the SynerGraft processed pulmonary heart valve, could occur as soon as the first quarter of 2007. For those of you who are new to our conference call, or do not understand the significance of the SynerGraft processing technology, I will give you a brief description of the technology and an indication of its significance.

  • The SynerGraft tissue processing technology consists of a hypotonic cell lysis, and a series of enzymatic washing steps, that removes cells from the tissues. Management believes that the reintroduction of SynerGraft processed pulmonary heart valves, which will be used primarily for right heart reconstruction in infants and children, will strengthen CryoLife's leadership position in the surgical specialty of cardiac reconstruction. I want to emphasize that we consider the Company's SynerGraft intellectual property position to be very strong.

  • CryoLife is not aware of any other allograft heart valve processor that has technology like the SynerGraft. SynerGraft processed human heart valves have been the subject of a number of medical papers, from some of the best medical schools and clinics throughout the United States. If we receive FDA clearance in early 2007, all pulmonary allograft valves processed by CryoLife will be SynerGraft processed valves. Management believes that market clearance and subsequent availability of SynerGraft processed pulmonary heart valves, would have a favorable impact on revenues and margins in 2007.

  • Now I would like to bring you up to date on the BioDisc nucleus pulposus replacement product clinical study, that is being conducted in Aberdeen, Scotland. A tenth patient was implanted with the BioDisc on April 19th. Since one of the initial ten patients has not returned for follow-up, an 11th patient has been planned for this study. This patient is scheduled for surgery later this month.

  • The implant data from all of these patients will be collected during the next six months, and that data will be analyzed and included in the Company's application for a CE Mark, which we expect to send to our notified body for their review during the fourth quarter of 2006. We anticipate that the approval process for our CE Mark application will take about 90 days, and therefore we expect that BioDisc will be approved for general distribution in Europe during early 2007.

  • At that time, we will begin additional controlled studies with three or four more clinics from the European market, that specialize in spinal disc reconstruction. This technology places the Company squarely in the center of the spinal implant business, one of the fastest growing segments of the orthopedic implant business. We expect the market introduction of BioDisc in Europe during 2007, to have a positive impact on sales and margins in our European subsidiary.

  • As we have said before, we anticipate announcing a European partner for the distribution of BioDisc within that same timeframe. I would encourage you to access our website, and to click on the new BioDisc DVD. This DVD shows the surgical procedure for the implantation of BioDisc, interviews the physician who is managing the clinical investigation, and also interviews one patient who had intractable lower back pain prior to her surgery using BioDisc. The first clinical poster that discusses the implantation of BioDisc was given by Mr. Wardlaw, the investigating surgeon at the Britspine meeting that was held on April 26 and 28th in Cardiff, Wales.

  • Mr. Wardlaw also reported on the satisfactory patient outcomes of these patients. He will be presenting the first clinical paper on these initial BioDisc implants, which will include additional data on these patients at the Spine Arthroplasty Meeting that will be held in Montreal, Canada on May 10th. The Company will also be participating in the Annual Spine Technology Summit Conference on May 9th in Montreal. This conference precedes the Spine Arthroplasty Society Meeting.

  • Giving the presentation on the progress of the Company's clinical study on our BioDisc product will be Gerald B. Seery, the Company's Senior Vice President of Sales and Marketing.

  • Another orthopedic product that the Company has been developing over the past year is the decellularized surgical patch, that will be intended for the reinforcement of soft tissues, repaired by sutures or suture anchors, during tendon repair surgery. We will be submitting an abbreviated 5 10-K for ProPatch our decellularized surgical patch to the FDA in June of this year. This type of submission may take as little as 40 days to get market clearance.

  • We anticipate a controlled launch of the ProPatch product to a few of our distributors around October 1st. We will collect post-marketing data for use to reinforce the rotator cuff indication during this controlled launch, and then plan to release the product for general distribution at the American Association of Orthopedic Surgeons Meeting in February of '07.

  • This product would be sold through our sports medicine distribution network. Hospital pricing would be in the $2000 to $2100 range, which is competitive with similar products that are presently on the market.

  • The Company is presently in negotiations with the Cleveland Clinic Foundation for a technique for the transplantation of a combination aortic mitral allograft heart valve, developed by Dr. Jose Navia, a cardiovascular surgeon on the staff of the clinic. This combination valve will be used to treat cases of endocarditis, that involve both the aortic and mitral valves. The mortality for patients having endocarditis of both of these valves is about 40%. The development of this combination valve and surgical implant technique is a life saving procedure.

  • CryoLife's interest in this technology is a result of the Company's continuing focus on methods of cardiac reconstruction, where the Company's expertise in allograft valve preservation, in combination with BioGlue surgical adhesive, provides cardiac surgeons with unique solutions to complex cardiac reconstruction problems.

  • The Company attended the Annual Meeting of the American Association of Thorasic Surgery from April 30th to May 2nd in Philadelphia. Over 100 physicians visited CryoLife's booth. The primary subjects of the discussions we had with the surgeons were the timetables for the FDA approval of the SynerGraft processed human heart valves, that we discussed in detail earlier in the conference call, and the new mitral aortic combo allograft heart valve, developed by Dr. Jose Navia of the Cleveland Clinic. Senior members of CryoLife's management team attended the Annual ROSS Society Meeting and dinner, that is held annually in honor of Donald N Ross, FRCS, a pioneer cardiac surgeon from England.

  • On April 7th, CryoLife management attended a meeting in Washington, D.C. of high ranking Department of Defense officials, that was called by the Chairman of the House of Representatives Armed Services Committee, Representative Duncan Hunter of California. The purpose of the meeting was to demonstrate and discuss the use of BioGlue in battlefield trauma.

  • Giving the presentation on behalf of the company was Dr. Albert Heacox, the Senior VP, Research & Development. Approximately 22 people from all service branches attended the meeting along with Georgia Representative, Dr. Phillip Gingrey, who is a retired physician. After the meeting there were numerous additional contacts between DoD officials and military medical personnel from Iraq.

  • That concludes my comments, and at this time Ashley will give some financial guidance for the rest of the year.

  • - EVP, COO, CFO

  • Thanks, Steve. We are reaffirming the guidance that we provided to you in early April of 2006. The Company expects tissue processing and product revenues, to increase to between 76 and $80 million for the full year 2006. The Company expects BioGlue revenues to be between 39 and $41 million, and tissue processing revenues to be between 36 and $38 million for the full year 2006. Bioprosthetic, cardiovascular and vascular device revenues are expected to be approximately $1 million in 2006.

  • We expect an increase in tissue processing gross margins during 2006, as compared to the first quarter of 2006, as a result of tissue processing improvement initiatives implemented in 2005, and early this year. We expect general and administrative expenses to be between 44 and $48 million for the full year of 2006, and R&D expenses to be between 5 and $6 million for 2006. With the anticipated improvement in BioGlue revenues, and if the favorable trends in the tissue processing area continue, we expect to be profitable in the first or second quarter of 2007.

  • We will attempt to keep you updated on significant corporate developments that are likely to affect the outlook for the Company, but can make no guarantee that we will in fact be able to identify and communicate such factors to you on a timely basis. That concludes my comments, now I'll turn it back over to Steve.

  • - President, CEO

  • At this time, we'll open up the conference call for questions.

  • Operator

  • Thank you gentlemen. [OPERATOR INSTRUCTIONS] Our first question is from Raj Denhoy of Piper Jaffray.

  • - Analyst

  • Good morning. A couple questions. The tissue margins in the quarter, were surprising how good they were. I know you're indicating they could continue to improve over the course of the year. I don't imagine you're going to give us much detail on that. 20%, do you think you can maybe push close to the mid-30s here? How good can that get over the course of the year?

  • - EVP, COO, CFO

  • I think that's unreasonable, Raj, we're not going to give specific items, but I don't think that is unreasonable to think that we could get there. With the comment that we made regarding profitability, you know, in the first or second quarter of next year, I think that you could probably figure out where we think that we can take margins, and I will just leave it at that. We do expect improvement during 2006.

  • - Analyst

  • Fair enough. Also on the procurement trends you're seeing in tissue, are those coming from existing tissue banks, or are you out now getting more tissue banks into the fold, or what are the general trends there?

  • - President, CEO

  • Both I would say.

  • - EVP, COO, CFO

  • We don't have a specific break down on the mix. It is a combination of both.

  • - President, CEO

  • To be specific, the increase Q1 '05 to Q1 '06 is that procurement for all donors is up 23%.

  • - Analyst

  • On the BioGlue side I guess you launched the new cartridge spreader tip I believe on the 1st of March, I think it was.

  • - President, CEO

  • Yes.

  • - Analyst

  • Are you seeing that making a difference, start to go get taken up by the market?

  • - President, CEO

  • Yes. In the first quarter of '06, the syringes, all syringes accounted for 42% of the sales. There is a beginning of a rapid conversion of the 10 ml cartridge, and the 10 ml syringes.

  • If you remember, the 10 ml syringe was introduced on March 1st, so we have a limited time where that's been out in the marketplace, but in that time there has been an excellent reception to both that and the spreader tip.

  • - Analyst

  • I guess what I am trying to get at, is sounds like you're fairly confident in that business accelerating over the back half of the year.

  • - President, CEO

  • Yes. Simply because we were impaired because of the loss of some sales representatives, and the territories are now filled. The sales reps have been trained. They've been in here in the Company two or three times since the first of the year, and we now have a full contingent of them, and they're well trained, and I think you will see that rebound. Certainly the BioGlue sales have stabilized.

  • - Analyst

  • Great. I have a couple other ones, and is I will get back in line. The SynerGraft, the movement on SynerGraft by the FDA is pretty encouraging. How are they going to assess that? Sounds like you are looking at 300 patients I think you said, and comparing it to a control group. What sort of data are they actually going to be looking at in deciding whether they were actually getting some sort of remodeling with SynerGraft, that you're not getting on the other side.

  • - President, CEO

  • We're not making that claim. All we have to do is prove substantial equivalence. They will be asking for echo and physical examinations of the additional 300 patients that have been implanted.

  • In other words, getting a current realtime look at the function of those valves in the 300 patients. We're very encouraged by their approach. We think that it will be quite easy for us to get this information from the surgeons, and as you probably know, there is great interest in this product from the cardiac reconstruction specialists throughout the United States.

  • - Analyst

  • This really is just a strategy honestly to get it back on to the market, and as far as claims about --

  • - President, CEO

  • 5 10-K so really all we have to do is show equivalency to the standard processed pulmonary cryopreserved heart valves.

  • - Analyst

  • One question on the cash situation. Your down about 1 million in the quarter, to 11.3. I may have missed this. As far as your potential liability is pretty low at this point. Do you think you'll make it to profitability in the first half of the year, without having to raise additional cash at this point? It seems like you should, but I want to hear from you guys.

  • - EVP, COO, CFO

  • Well, evaluating our finances needs is all part of this strategy review that we're currently conducting right now, Raj, and that's really all we're going to say at this point. We certainly haven't made any commitments to finance at this point. It is something that we're going to evaluate as we go through this alternatives review.

  • - Analyst

  • Fair enough. Nice quarter.

  • Operator

  • Our next question is from Raymond Myers of Emerging Growth Equities.

  • - EVP, COO, CFO

  • Hi Ray, how are you?

  • - Analyst

  • Well, Ashley. Thanks. Congratulations to both of you, Steve and Ashley on the great quarter, and the impressive product development.

  • - President, CEO

  • Thank you.

  • - Analyst

  • One area that hasn't been addressed is did you mention the operating cash flow in the quarter?

  • - EVP, COO, CFO

  • We did not. Our 10-Q is in the process of being finalized right now, and I don't have an operating cash flow number per se at this point. We did report on what the total decrease in cash balances were, but we expect that our 10-Q might be filled as early as this afternoon, but certainly by the end of the week.

  • - Analyst

  • Okay. I will certainly take a look for that. Part of my reason in asking the question was, it would seem to me you've got a number of non-cash expenses in the first quarter if that continues, I would imagine you reaching cash flow breakeven faster than the earnings breakeven.

  • - EVP, COO, CFO

  • We won't give out any guidance on that, but that's a fair assumption.

  • - Analyst

  • That's very nice. Move over it the deferred preservation on the balance sheet increased by 1.8 million sequentially to 15.8 million, which is a multi-year record here. I assume that's a signal that tissue supplies are expanding?

  • - EVP, COO, CFO

  • They are. Tissue supplies are expanding. Procurement is good. The actual procurement is probably a little bit ahead of our revenue growth rate at this point, but it is probably expected as we continue to grow this business.

  • - Analyst

  • Right. That's good to see. Which tissues in particular, account primarily for the growth in supply?

  • - President, CEO

  • I can answer that. Saphenous vein donors are up 59% this year and quarter to quarter, and orthopedic donors are up exactly 100%. I think that's where that's coming from.

  • - Analyst

  • And in particular in prior quarters the OA grafts had not reached very high rates of sales because supplies were still low, and I understood you were building those supplies.

  • - EVP, COO, CFO

  • Yes.

  • - Analyst

  • Is this an indication that you have in fact built those supplies, and if so, approximately what were OA sales in the quarter?

  • - President, CEO

  • The OA sales in Q1 '06 were 456,000, and that compares to 50,000 in Q1 '05.

  • - Analyst

  • That's a very nice increase. I understand those are very high margin items, and may account for some of the improvement in gross margin there.

  • - EVP, COO, CFO

  • Yes. You're correct, Ray. One other thing about the OA program. We really introduced that program in the first quarter of 2005, and we reached an important milestone during the first quarter of 2006, and that was, we were beginning to see 1-year data on cryopreserved OA grafts, and the data looks good, and we think that as the data continues to mature, that we'll be able to use that to our advantage and hopefully drive this program even further, which is what we expect.

  • - Analyst

  • That's great. You have answered most of the questions here. Maybe I can just leave it off with a discussion of the SynerGraft, and reminding people of the sales that CryoLife once had in that product, and what you might anticipate for the future of SynerGraft heart valves.

  • - President, CEO

  • Well, we're going to convert all of our processing for pulmonary valves to SynerGraft as soon as it is approved. Simply because the response of the physicians has been so good, and the published papers that have been published by the Mayo Clinic and University of Michigan are two that come to mind, have been very favorable, and very optimistic about the future of that technology.

  • At the meeting of the AATS that we attended last weekend and the first part of this week, that was the first question that came out of most of the doctors mouths that I talked with, and certainly when I attend the dinner for Mr. Ross on Saturday night, the first three physicians that walked up to me, that was their first question, so there is a keen awareness of that product, and the impact on their specialty, and the clinical results that have resulted over the past years, and you see when it gets put back on the market, I believe we'll have somewhere between 4 and 5 years of implant data with 2,000 patients that we can point to, and show the efficacy of that product.

  • - Analyst

  • And maybe could you describe for people who don't know it what the efficacy is?

  • - President, CEO

  • Well, it appears in early data, over the four-year data, that the SynerGraft processed heart valves seem to last longer. They seem to have more durability, as shown by the clinical data, and the data that we're collecting at the request of the FDA, is focused on reinforcing what has come out in clinical papers from certain clinics, so it is a very good product, particularly for reconstruction, cardiac reconstruction in infants and children.

  • - Analyst

  • Yes, the remodeling aspects I understood are particularly good for children, and it is very gratifying that that product may be back on the market. Congratulations. Thank you.

  • - President, CEO

  • Thank you.

  • Operator

  • Our next question is coming from Keith Markey of Value Line.

  • - EVP, COO, CFO

  • Hello, Keith, how are you?

  • - Analyst

  • Fine, thank you, and thanks for taking my call. Two quick questions really. I was just wondering since doctors are anticipating [inaudible-microphone inaccessible] graft valves coming back on to the market next year, is it possible there might be a limited demand for some of them this year, limited demand for your existing valves this year, that is?

  • - President, CEO

  • No, I don't think so.

  • - Analyst

  • There isn't a chance --

  • - President, CEO

  • From the first week that I started the Company in '84, we have always been back ordered for cardiac valves.

  • The doctors seem to order as many as they can possibly get, and as you probably are aware, they come in different sizes, so that's one of the challenges, but through the years the doctors have learned how to downsize aortic roots, and increase the size of the orifice of the allograft valve, so they can make do with different size requirements. Basically the enthusiasm for human heart valve replacement, particularly in infants and children remain very high.

  • - Analyst

  • There is very little opportunity for delaying the surgery, then?

  • - President, CEO

  • No. A lot of times, the kids have to be staged, depending on what their cardiac issue is. They have to be staged with operations, so it is perfectly possible in certain cardiac anomalies, a child would have three separate surgeries before they were 15 or 16, just depends on what kind of issue the doctor is dealing with.

  • There really are no synthetic alternatives that work well in pediatric patients, simply because kids have such high metabolism, high calcium metabolism, that it is very difficult to put in a porcine type of heart valve, and you don't really want to anticoagulate a child. That's why they don't put mechanical valve in little kids either. Because then they have to be on blood thinners, and that has its own issues.

  • - Analyst

  • Thank you. I wasn't quite sure, we've been talking about different numbers for your data, and that sort of thing. I was wondering on the 300 patients you're going to submit the data to the FDA on, what is the average follow-up time, or up-time that the FDA is looking for?

  • - President, CEO

  • I don't have that right in front of me, but I think a good guesstimate would be between 1.5 and 2 years. Some of the early patients that had this type of valve are out between 4 to 4.5 years at this time. A few were put in early, and then the bulk of them, I think the average time would be a 1.5 to 2 years, let's say. I think that would be a good guess.

  • - Analyst

  • Great. Thank you very much.

  • Operator

  • Gentlemen, it appears we are out of time for questions today. Do you have any closing comments?

  • - President, CEO

  • No. We look forward to talking with you at the end of the second quarter, and have enjoyed being able to answer all of these questions, and the enthusiasm that you have, and the Company's recovery.

  • Operator

  • Thank you, ladies and gentlemen, for your participation in today's teleconference. You may disconnect your lines at this time, and have a wonderful day.