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Executives

Charles Randal Mills - Chief Executive Officer, President and Director

Philip R. Jacoby - Chief Financial Officer, Treasurer and Corporate Secretary

Analysts

Edward A. Tenthoff - Piper Jaffray Companies, Research Division

Osiris Therapeutics (OSIR) Q1 2013 Earnings Call May 7, 2013 9:00 AM ET

Operator

Good morning, everyone, and welcome to the Osiris Therapeutics First Quarter 2013 Earnings Conference Call.

Before we begin, I would like to remind you that -- I would like to remind everyone that this conference may include forward-looking statements that involve uncertainties and risks. Actual results could differ materially from those anticipated in forward-looking statements, for many reasons, including the factors described in the section entitled Risk Factors in our filings with the Securities and Exchange Commission.

As a reminder, today's conference is being recorded.

I would now like to turn the conference over to Dr. C. Randal Mills, President and CEO of Osiris Therapeutics. Please go ahead, sir.

Charles Randal Mills

Thank you, guys, very much for joining us for our First Quarter 2013 Earnings Call. We're going to continue with the format that we used last quarter, going through a little bit less of a script and then more of a presentation format. For the call today, I'll be making some initial remarks regarding our performance, and then I'm going to turn the call over to Phil who will talk a little bit on our financial performance. I'll go through some of our products after Phil's comments and then, obviously, close out with questions, like we always do. So with that said, let's get started with it.

For those of you who are new to the story -- we see in the call that we do have a fair number of people that are new to the story. Osiris is the clear leader in stem cell medicine. And we've gotten to that position not through anything other than a very hard and committed work to the space. So we were founded 20 years ago. We came out of Case Western University. And for 20 years, we've been doing nothing but working on the development of cell therapies and, specifically, mesenchymal cell therapies. We commercialized the world's first stem cell product, Osteocel, back in 2005. We have the world's first and only approved stem cell drug, Prochymal. We currently have 4 products on the market. We have a very strong intellectual property position, with 50 patents issued in the United States and the corollary to those, patents issued around the world.

Importantly, we have over 1,500 patients worth of data collected in clinical trials. And that includes over 2,000 years of patient follow-up. And the reason I say "importantly" around that is, because in cell therapy and cell medicine, those who control the data and who have the data to demonstrate the safety and efficacy of a drug have the ability to do more work with those drugs faster with the regulatory agencies. And so this is clearly a very important point for us.

Perhaps more important than that, though, is the validation we're seeing in the marketplace. So we now have over 100,000 patients that we've treated commercially with our products. We are continuously manufacturing and selling our products, and that has led us to a gross margin, not a theoretical gross margin but a real gross margin, that we're pleased to report this quarter of 72%, up 200 basis points from the last quarter.

Looking back at this last quarter, some recent highlights and developments, it was a very busy for -- quarter for us commercially, as we expect and hope will be going forward. So this quarter, we were able to launch Cartiform, our viable cell therapy cartilage product for acute cartilage injury. We established a direct sales force for Grafix. We were able to receive the Orphan Drug designation title back from the EMA. Very importantly, we were able to grow revenues this quarter 38% over last quarter to $4.1 million, representing a 257% growth rate over the quarter in the previous year. Again, as I mentioned, we're very pleased that, not only are we experiencing top line growth, but our manufacturing people are doing what's necessary in order for us to realize the increased gross margins, again 200 basis points increase to 72%. And finally, we ended the quarter with a very strong balance sheet, again no debt, and $34.9 million in cash, receivables and investments.

Let's look specifically at some of the product sales performance for the quarter. So for this quarter, product revenue was at $4.1 million, again up 38% from the previous quarter, up over 250% from the prior year. Below that, you can see the gross margin and how the gross margin is tracking along at an almost accelerated pace to that, from only $0.25 million dollars -- or $0.75 million of gross margin last year, $2.1 million of gross margin in the fourth quarter and $2.9 million of gross margin. And in fact, our gross margin, we generated off of product revenue was equal to our entire product revenue for the fourth quarter of 2012, and so we're pleased with that. And then along the bottom, you can see how we're still making very steady improvement in percent gross margins, so 66% to 70% to 72%. So all around, from a financial standpoint, from a sales standpoint, from a manufacturing and execution standpoint, a very solid quarter.

When we look at that quarter in historical perspective since we've launched this round of products, we're seeing the type of growth rates that we would have hoped to and we would have expected to see, particularly given our history with Osteocel. And so very nice, very strong sequential quarter-over-quarter growth since we launched the product in the second quarter of 2011.

Now I'm going to let Phil talk in more detail about some of the financial aspects of our business. And following that, I will be back to take you briefly through the products that we have on the market now. Phil?

Philip R. Jacoby

Thanks, Randy.

We had a good quarter from a financial perspective. As Randy mentioned, our revenue from Biosurgery products was a total of $4.1 million in the first quarter, which continued that steady growth rate that we've been experiencing throughout the product launch. Our total revenue for the quarter was $4.2 million, and it will all convert into cash. In 2012, our total revenues were $4.6 million, but that included $3.3 million amortization of deferred revenue related to a collaboration agreement. Only $1.2 million of our first quarter 2012 revenue converted to cash, when you are all said and done.

The growth in the Biosurgery revenue occurred in both Grafix and Ovation. We did introduce Cartiform during the quarter, but that had a pretty minor impact on the first quarter revenue.

We did establish a direct sales force in the quarter but that hasn't really gain traction yet. It takes a while to bring these people up to speed, to train them in the products and then get them to make their contacts in the hospitals. So we expect to see that pay off in future quarters. As Randy mentioned, the products continue to be very profitable. The gross margin of 72% reflects better utilization of our facilities primarily, but there's also some process improvement that improved the gross margin, and that's a continuing process here.

In the first quarter, we operated on a single shift in our manufacturing facility, and we have plenty of room to increase our activities. In our Osteocel days, we ended up operating 3 shifts on a 24/7 basis. For the first quarter of 2013, we are going to report operating income for Biosurgery, about $0.5 million. This compares to an operating loss of about $800,000 in the first quarter of last year.

The balance sheet continues to look very strong. We've had no debt since 2008. Our cash burn for the quarter was $4.5 million, which was higher than what we've experienced recently, but $2.6 million of that was invested in our Biosurgery accounts receivable and inventory. Our inventory and accounts receivable at the end of the first quarter was $7 million. This compares to $1.4 million at the end of the first quarter in 2012. Our bad debts remained negligible. Our aging of the receivables sits in pretty good shape.

Total R&D spending for the quarter was $3 million this year compared to $4 million in the prior year. The Biosurgery R&D was about $700,000 compared to $1.2 million in 2012. We're devoting more of our efforts to commercialization lately. The majority of the it -- of the R&D in the Biosurgery area was for the DFU trial. The Prochymal R&D was $2.3 million in the first quarter of this year, and that compares to about $2.7 million in the prior year. And that primarily reflects the costs of the cardiac, Crohn's and the expanded access GvHD trial.

We relabeled what we used to call G&A expense into SG&A expense, and we're experiencing increases there as we increase our commercial activities. In the first quarter, our total SG&A was $2.9 million. That compares to about $1.8 million in the prior year. The Biosurgery SG&A was $1.7 million in the first quarter, and that compares to $400,000 in 2012. And again, that reflects the increased costs of the commissions and marketing efforts in our end-user sales, as well as the costs of the direct sales force which is just getting up to speed present time [ph].

We ended the quarter showing a loss of about $0.08 a share, which was pretty much on track with what we expected.

Randy?

Charles Randal Mills

Excellent. Thanks, Phil. So now I'd like to go through some of the products for you and give you some update. I promised in the last call that I would not drag this part out as long as I did last time, and I will attempt to stick to that while giving you still sufficient insight and visibility to what we're doing in the products.

So we have, as I mentioned, 4 commercial products on the market right now. Prochymal, which is our intravenous stem cell therapy for the treatment of graft-versus-host disease. We have Grafix, which we use for acute and chronic wounds; Ovation, for tissue repair; and Cartiform, for acute cartilage injury.

Specifically looking at Prochymal. So again, Prochymal is approved in a couple of territories for the treatment of refractory graft-versus-host disease. To date, with Prochymal, so we've attained a couple of approvals. Importantly, we have made the asset whole by getting the rights back from Sanofi. So now we have the world's first approved and approvable stem cell drug, which we have all of the rights do. The other thing that's important to know is we've also made it by far, by far, the most widely used stem cell drug in the world. So we regularly and constantly treat patients now in 4 different continents and -- are literally treating a patient on Prochymal anywhere around the world at any given time of the day.

We also mentioned on previous calls that -- as part of our strategy going forward, that we are in talks with multiple partners for the further development and distribution of Prochymal. Our goals here are to seek a partner with the commitment and the resources necessary to capture the full value of this product as they take it forward; two, to strengthen our own financial position during the transaction; and three, maintain future upside with regards to the product. In the meantime, we continue working on additional approvals, which we believe we're having progress in, and obviously pushing forward the Crohn's and cardiac trials, which we think are valuable to the future of this product moving forward.

The next product I'll talk about is Ovation. Our -- Ovation is our, essentially, follow-on product to Osteocel. It's a combination of rich extracellular matrix growth factors and mesenchymal stem cells that's used to create an osteogenic environment in patients who need to grow bone. Our primary market that we use Ovation in is the spinal fusion market. And so those not familiar, there's between 400,000 to 450,000 spinal fusions performed each year in the United States. There's over $1.9 billion spent on bone grafting products alone. Stem cell products, which before, Osteocel made up none of that, now actually are making up about 150 million of that number and growing rapidly. One of the reasons that having such success and we're having such success in this area is because of the continued negative findings centered around recombinant BMP-2, specifically safety concerns around recombinant BMP-2, which is giving us the opportunity to displace what was at the time the 800-pound gorilla in the market.

Ovation, we like it from a product standpoint. It is a very flexible product. Our surgeons like it because they have the opportunity to combine it with other products that they choose, other bone growth carriers that they choose, whether it be ceramics or sponges or cages. In this product, it's important from a distribution standpoint to understand that we're using the distributor model here. And the reason we went with the distributor model was that we -- in order to sell Ovation into a spinal case, you not only need the Ovation but you need the other spinal hardware that goes along with the spinal procedure, so the plates and the hooks and the rods and the screws, the other thing that the -- the other things that the surgeons are going to use in order to complete that surgery. And so what we've done is create a network of distributors that are able to deliver the product plus the ancillary devices that go along with that product.

So for us -- because the product is very flexible, because it's been received very favorably in the marketplace and because stem cells are accepted pretty well in spinal fusion, for us, the key point here is continued training of the surgeons, continued training of the reps, really blocking and tackling to continue the growth of this product. From a reimbursement standpoint, this product is reasonably well covered under the VRG system, so we don't really have challenges there.

So that's Ovation. The next product we'll talk about is Grafix. Grafix is our wound care product, essentially a membrane that contains an extracellular matrix and mesenchymal stem cells. We use it for the treatment -- we actually developed it for the treatment of second- and third-degree burns in highly contoured areas such as the face and hands. We have come to discover, actually, largely, our physicians have come to discover, that it is -- also makes an excellent product for the treatment of diabetic foot ulcers, the significance there being the diabetic foot ulcer market is enormous compared to the burn market. And this represents probably our largest single-market potential out of any of the products today that we have on the market.

From our experience in the marketplace, we have very high confidence on how Grafix is performing. That confidence was supported recently by the publication of a 62 patient pilot study we did in refractory wounds, that is, wounds that would not close despite treatment with other standards of care. And out of that difficult-to-treat population, we experienced a 72% closure rate, which is impressive. But more importantly, that closure rate wasn't just complete, it was prompt. And so our median time to closure was 5.5 weeks. And so we were getting patients closed quickly and we're getting them closed completely. The significance of the 5.5-week duration to closure represents a significant opportunity for payers to decrease their expense in controlling and closing serious wounds in diabetic patients. Typically, a patient would need up to 8 applications of a skin substitute in order to get closure rates, which actually aren't even as high as 72%. Here, we're able to get closure in about 5.5 weeks. And if you only need treatment for 5.5 weeks, then you only pay for 5.5 weeks. And so as we said on other calls and in other presentations, a consistent theme about Osiris is our desire, our drive and, actually, our insistence that our products remove costs overall from the health care system. And we think, because of Grafix excellent performance and prompt closure rates, we're going to be able to do that.

As we've reported, we have received CMS C- and Q-codes for Grafix. Last quarter, we have established a proprietary sales force. We have about 15 professionals now that detail the product. And you want to point out -- because I've received some questions about this, I do want to point out that hiring a sales rep to detail a product such as Grafix, there's a little bit of cycle time associated with it. And so these reps come in and they have to learn about the complexities of the product. One of the things at Osiris that we're very insistent on is that the people that represent our product do it in a completely professional way in that, when a surgeon has a question and they're asking the sales professional that question, they get an answer that's on par with what they would get if they were asking one of our scientists. And so it does take time to train new reps. They go into new territories, they have to enter new house -- hospitals. There is a significant cycle time associated with taking a rep from the hiring stage and into where they're generating the types of revenue that we believe they're going to be generating in the future. But with that said, we're very pleased with this core team that we have.

We also think there's a very significant upside to Grafix, and that primarily comes out of a larger Grafix trial we have running right now, a 266-patient DFU trial. It's a randomized, controlled study, randomized 1 to 1 versus standard of care that's running out at 20 centers. The trial is currently enrolling. And the endpoint in this trial is closure of the wound by 12 weeks. And this is done not by the closing physician but actually by an independent laboratory that analysis the closure and the rate of closure using advanced imaging technology. This is a very sophisticated, essentially pharmaceutical study. The study is not being run for regulatory purposes, I'll point out. The study is being run for reimbursement purposes.

And so it is our intention to get the data from this trial, we hope, by the end of the year, and use that to cement to not only CMS but also the private payers around the country and get full reimbursement for Grafix both in the inpatient and the outpatient setting.

So that's what we're doing with Grafix, it's a very exciting product. We're very pleased with the way it's going. I'll turn to the last product, Cartiform.

Cartiform is our brand-new viable cartilage mesh that we use for acute cartilage injury. This is -- from a revolutionary standpoint, I think this is probably, next to Prochymal, one of the most revolutionary products we have. Acute cartilage injury today is a very significant problem. So there's over 500,000 acute cartilage injury surgeries performed each year, and the vast majority of those surgeries fail. So there's a very significant market that is, in essence, not served. Cartiform, we think, answers that question by providing a viable cellular cartilage mesh with living chondrocytes in a matrix that is able to capture the patient's own mesenchymal stem cells from their own body and really hybridize these 2 concepts of allograft and autograft into 1. We think this product, based on the feedback we've gotten from the initial users, is a very user-friendly product, it's a very easy and intuitive product to use, and we're very excited about its potential.

Here were are also establishing a direct sales team. We currently have about 5 people that detail this product. We think -- going forward, I will say that we think that this is going to be very significant product to Osiris. And so we are going to be taking our time with the launch of this. There is technique involved in using Cartiform, so this isn't a product we can ship out to a surgeon that has never used it before and hope he gets it right. So every time we want to introduce a new surgeon to the product, we insist that for at least the first few times that we have an Osiris sales professional or scientist with them to show them the nuances about handling the product and how to use it, and to make sure that they use the product possibly -- as well as they possibly can. So we're not looking to rush into driving sales here as much as we are as making sure that the surgeon's first experiences with the product are positive ones so that they'll come back and be repeat users of this.

We are also -- because we have -- we are investing in a direct sales force here, we are also in the product -- process of developing additional products for this sports medicine sales force, and you'll see more about that coming up in the future calls.

One last thing I want to say about our commercial operations, which makes us unique, is our manufacturing is done in-house. And so we have a facility here in Columbia, Maryland, that is both registered with the Food and Drug Administration and accredited by the American Association of Tissue Banks. We have our own manufacturing technologists that perform this work. There's a tremendous amount of know-how involved in creating cellular therapy products in mass production that are used in the commercial marketplace. And we're very proud of the team that we have here. We developed that expertise during the initial launch of Osteocel, the teams have improved upon it. And as seen by the increase, the steady increase, in gross margin, their efficiencies keep rising as they continue to manufacture more and more product. And so we're very pleased with the asset that we have with regards to our own in-house manufacturing capabilities.

Okay, getting to the end here. So I'll just remind everyone a little bit about our development rationale. While we believe stem cells and cell therapies are very, very useful tools, we do not think that everything that can be done with a stem cell should be done with a stem cell. And that's a lesson that we have come to learn through having done this exercise now for 20 years. And so we put in place some very strict development criteria for the products that we develop. The first is they have to offer a very real value proposition to our patients. The -- if steroids can do the same thing as the products that we're proposing that's made out of stem cells, we won't do that because steroids, frankly, are mass produced and quite cheap and we don't think we would be offering a value proposition. So the -- we need to be able to fix a problem, a medical problem or a health care problem, a payer problem, that otherwise can't be fixed with current technology.

The second thing is we need to make sure we have a practical development pathway in order to get there. There are some diseases, there are some indications, that although they theoretically might be well served by stem cells, the development regulatory pathway would be prohibitively long. And so we look for, not necessarily expedited pathways, but at least ones where the risk and time are balanced with the return that we are likely to see.

The third point, I think, is fairly unique to Osiris, but it's something that we've come to see and is very real, and that is it is our goal, it is our absolute aim, to develop products that actually reduce the overall burden on the health care system. And so as we go through these trials and these evaluations, and we have -- for patients, we have a number of -- in addition to just trials, we have patient databases set up, so we're collecting registry data. We look to collect the appropriate pharmacoeconomic data so that we can go to not only the physicians and the patients and say, "Hey, this is a great product," but that we can go to the payers and say, "And this is a product which is going to reduce your overall spend." That's a very important point for us.

The last 2 are fairly obvious. We're looking to go with meaningfully sized markets because we're looking to have good top line revenue and we want good economics come out of the bottom. Meaning very simply, we want to be able to make money on this product, as well as the insurance companies.

So that's our rationale development, in a nutshell. It's pretty practical, it's pretty straightforward, but it has some -- imposed a fair amount of discipline on the number of projects that we say yes to and the types of projects that we say no to.

So just in summary to our -- on our 4 products that we have commercially available right now. Prochymal, we're in the process, as I mentioned, of partnering that product. Ovation, we're going with the distribution model. We have those distributors in place, and we're very pleased with how they're performing. With Grafix and Cartiform, we are going direct. We have about 20 -- or 15 reps in Grafix, about 5 in Cartiform. And as far as new product development goes along, because this is where we have the direct sales force, this is where we're focusing our new product development efforts. So don't be surprised to see additional products come out in these 2 areas of wound care and sports medicine orthopedics because we want to make sure we fully leverage the sales assets as well as the technology.

Okay, so just finishing up on our long-term -- or our near-term strategic goals for success. No surprise, we're going to continue to drive our revenue growth. We've done a very good job of this sequentially every quarter since we've launched the products, and we're going to continue to that. We're going to continue to control costs because, at the end of the day, we're looking to create a company that has solid positive cash flow, not just good top line revenue.

Product development but product development in a very focused way that we'll develop products that not only patients and physicians will be happy about but that payers will be happy about as well too. We're clearly in the process of gaining some very important reimbursement data and hope to have that out by the end of the year.

And then lastly, improving gross margin, again so we can affect our bottom line, is something that we're very keen on.

We'd like you to come see us at upcoming events. We're going to be at Jefferies, coming up here in June. And from a commercial standpoint, we are going to be at AOSSM, which is the big sports medicine meeting in Chicago on July 11 through 14; and the American Podiatric Medical Association meeting, which does a lot of the wound care interests in Las Vegas on July 21 to 25.

And so that said, I will stop talking and turn the call back over Huey to see if anyone has any questions.

Question-and-Answer Session

Operator

[Operator Instructions] And it looks like our first question will come from the line of Ted Tenthoff with Piper Jaffray.

Edward A. Tenthoff - Piper Jaffray Companies, Research Division

I have 2 quick questions, if I may. So firstly, just on this decision by the tissue reference board, is there anything that changes the launch decision, the reimbursement, everything with -- that has to do with Grafix? And secondly, tell us a little bit more about the sales force buildout and kind of -- I know it's still early days around Cartiform, but this is a really exciting program. Tell us a little bit more about how you're going to distribute or market that product.

Charles Randal Mills

Okay. So I got the Cartiform question. Ted, can you clarify for me your first question, though?

Edward A. Tenthoff - Piper Jaffray Companies, Research Division

Yes. Just with respect to Grafix. Was there a decision around 361 from the tissue reference board? And does that have any impact on how you're selling Grafix?

Charles Randal Mills

Okay. So no. There's been a lot of talk around it than ever has, but Grafix has not gone before nor has the Tissue Reference Group made any decision on Grafix. We are completely confident in the regulatory paradigm and standing of Grafix. And would welcome a conversation with the TRG if they so choose to. But whatever product is being referred to is not our product, I want to make that very clear. And very clearly, if you go to the Tissue Reference Group website, you will see they highly suggest that people not generalize TRG decisions into other products. They get very unique filings with very specific manufacturing parameters and other things, and so a decision on one product is not generalizable to a decision on other products. So with regards to Grafix, there is no Grafix TRG decision. The second thing around Cartiform: Yes, Cartiform is a very exciting product for us. And so we have a number of orthopedic surgeons across the countries that are using it. Like I said, we are being very careful, essentially almost pampering the launch of this product. And the reason for that is it's a surgical implantation. And so there is technique to it. We have to make sure that the product is [indiscernible] correctly; that the product is implanted with the correct side up; that the physician, as he's using the product for the first time, can answer or can ask any questions that he may need to with regards how to use the product. And so for that purpose, for a couple of the first few times a surgeon uses the product, we're actually going out with them. We think that's very important because all of the surgeons that have used the product so far have loved the product and are repeat users of the product, and that's because their experience with the product has been a very positive one. What we don't want to do is flood the market with the product and not have it well controlled or well managed and not have the physicians completely comfortable with how to use the product and, in that case, would create -- could create a situation where the physician would have a bad experience and not use the product again. So we're being very protective about the product. Once the surgeon has used it a couple of times and gets up and running, they have no problem, they use it again on their own. And so we're seeing lots of repeat use in the product. But it -- we are going to be very careful with the asset because, as you said, it is an absolutely remarkable product. We think it's a company changer. And we just want to make sure we protect it and treat it the way a product of that value deserves to be treated.

Operator

[Operator Instructions] Our next question will come from the line of Eun Yang with Jefferies.

Unknown Analyst

Randy and Phil, this is John Ron [ph], in behalf of Eun. Just a couple of questions. Last call, it was mentioned that near-term revenue opportunity for all 3 Biosurgery products combined will generate about $75 million to $130 million near term. Given the current run rate of around $4 million, when do you guys think you will achieve that level? And what are your time frame?

Charles Randal Mills

Right, so we don't give specific forward-looking guidance, John. Not a new thing here, we never have. We were putting brackets around there last time, actually, to manage expectations because, a lot of times when you launch a product, people will get in their heads that well this is really a great product and so it's going to do $100 million next year and that -- and so that was really to say, while the market opportunity for this product might be $500 million over the next couple of years with a normal sales cycle and sales call, we would think this is going to -- over a couple-of-year period, we think we can get $30 million to $50 million on this product or that product. That was really the purpose of that bracketing.

Unknown Analyst

And then just a couple of follow-up questions on Prochymal for graft-versus-host disease. It's been approved in Canada and New Zealand last year. What's the pricing? And when do we expect some revenue from there? And the confirmatory studies, have you guys started that? And if not, when? And then lastly, any kind of update on the U.S. regulatory filing?

Charles Randal Mills

Great. Okay, so with regards to reimbursement. So we have -- we have presented all of the information we needed to the patented medicines pricing review board, which is at the national level in Canada. We are now on to the provincial level in Canada, which is they have a sort of a 2-step reimbursement process. With respect to that, we have submitted all of the pharmacoeconomic and budget impact data to IMNEST [ph]. We are expecting -- actually, we have a meeting with them planned for May. From a pricing standpoint. We're looking at around $200,000 for a course of therapy in the pediatric setting. Course of therapy is typically about 10 infusions. With regards to the confirmatory trial: The confirmatory trial, just a couple of clarification to that. It's a confirmatory trial. A confirmatory trial is done with existing patients. And so as a patient signs up, they have 2 -- or as a physician enrolls the patient with Prochymal, they also have 2 additional options. And they're highly encouraged, in addition to treating to them, they are encouraged to join the registry, which we have open, which is a long-term registry designed to evaluate safety data on the patient. And they're also designed to go into what we refer to as the confirmatory the Phase IV trial. And that is also essentially a registry-type process where we collect more intense data for the first 6 months to 1 year on that patient. And we have a database of compete -- case-matched comparators that we put these -- that we match these patients against and then we evaluate their outcomes versus their likely predicted outcome based on a number of different variables. With regards to the FDA, we have submitted some additional information to the FDA. We continue to have dialogue. Right now, we think the strategy with the FDA is best served by going ahead and finishing some of our other approval work in other territories around the world and having the confirmatory trial underway. So with that...

Operator

Thank you. And presenters, at this time, I'm showing no additional questioners in the queue. I'd like to turn the program back over to Dr. Mills for any additional or closing remarks.

Charles Randal Mills

Yes. Thank you, guys, very much. I appreciate your time on the call. I appreciate you listening. And we look forward to either seeing or talking with you again at an upcoming conference. And hope you all have a good day. Bye.

Operator

Thank you, gentlemen. And again, ladies and gentlemen, this does conclude today's conference. Thank you for your participation, and have a wonderful day. Attendees, you may disconnect at this time.

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