Courtesy of SeekingAlpha.com
Executives
- Brian Roberts - CFO
- Duane DeSisto - President & CEO
Analysts
- Danielle Antalffy - Leerink Swann
- Kim Gailun - JPMorgan
- William Plovanic - Canaccord Adams
- Ben Andrew - William Blair & Company
- Tom Gunderson - Piper Jaffray & Co.
- Robert Goldman - CL King & Associates
- Suraj Kalia - SMH Capital
Insulet Corporation (PODD) Q1 2013 Earnings Call May 6, 2013 5:00 PM ET
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Duane DeSisto - President & CEO
Thanks, Brian. Good afternoon everyone and thank you for joining us today. 2013 is off to a great start as we continue to make significant progress across all aspects of the business highlighted by the launch of our new OmniPod; our second consecutive quarter of operating cash profitability and our announcement just last Thursday of our plans to develop a new version of the OmniPod, specifically designed to work with Eli Lilly’s Humulin U-500 insulin.First quarter revenue grew by 20% year-over-year to $57.4 million. In late February, we transitioned to all new customer starts for the new OmniPod and the initial feedback has been excellent. Customers and healthcare professionals have commented not only on the reduced size of the smaller and lighter pod, but also the ease-of-use and the changes made to the insulin onboard calculation.
The results have been impressive. Since March 1st, new referrals and shipments have increased by more than 40% as compared to the prior year and in April these metrics were up by more than 50% over April of 2012. As anticipated, the launch of the new OmniPod provides our commercial team with an opportunity to engage healthcare professionals, who for a variety of reasons have not been significant prescribers in the past. While the launch is in its early days, we are thrilled by the number of doors that seem to be opening at endocrinologist practices across the country.
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These are just a few examples of stories we are hearing across the country. Our territory reps are telling us stories of new practices and educators prescribing the OmniPod. In fact over 10% of our new shipments since launch have come for practices that did not have a shipment in 2012.
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With this significant uptick in demand we did make the decision to delay the transition of existing customers for approximately 90 days in order to build additional OmniPod supply. While the manufacturing process continues to improve, we had an unexpected component issue that resulted in a lower than planned production in the latter part of Q1. While this component issue was quickly identified and remedied in conjunction with both Flextronics and the supplier, we determined it most prudent to build inventory (inaudible) both manufacturing lines while operating efficiently before we commenced the transition of over 45,000 customers to the new OmniPod. At this point, we expect that conversion will start in the next few weeks and we remain confident that nearly all customers will be transitioned by the end of the third quarter.
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With the launch of the new OmniPod in the first quarter, we have raised the bar even higher. Most recently, we were pleased to announce in partnership with Eli Lilly & Company, a version of the OmniPod which will be specifically designed to delver Humulin U-500 insulin; a concentrated form of insulin used primarily by people with highly insulin resistant Type 2 diabetes. As we all know Type 2 Diabetes is reaching epidemic proportions in the U.S. In March, the American Diabetes Association released sobering news with its announcements that in 2012 more than 20 million people are living with Type 2 diabetics, nearly double the number from a decade prior.
We estimate that up to 10% of this population or approximately 2 million people could benefit from highly insulin – or highly insulin resisting - could potentially benefit by an insulin pump designed for Humulin U-500 insulin. The number of people with highly insulin resistant diabetes will continue to grow in the coming years as more people are diagnosed with Type 2.
Once approved our target markets will potentially more than double as compared to the approximately 1.5 million people living with Type 1 diabetes in the US today. We have held our initial meetings with the Eli Lilly team and are putting together our developmental time lines. Critical to our partnership is a planned clinical program to evaluate the safety and efficacy of the combined delivery system. It is our expectation that this clinical program will allow both companies to appropriately update our labeling and will demonstrate to healthcare professionals and reimbursement providers the benefits of an insulin pump specifically designed for the Type 2 patients.
As timelines become clearer, we will update you as to when these programs will commence.
Our pipeline remains robust and as we discussed on our last earnings call, we have signed a development agreement with a continuous glucose monitoring partner for the development of a CGM sensor to be included in the OmniPod. By integrating directly into the pod itself, we are able to leverage the commonality of components across both our products and the typical CGM sensor.
Thus, we are uniquely positioned to be the only pump provider that can offer the customer combined system with one product on the body and one handheld device. Feasibility work has continued throughout the quarter. We set our detailed project plan and worked out deliverables with the goal of being into human trials by early 2014.
Finally, we are continuing to look for opportunities to use our products to deliver drugs other than insulin. We have partners in multiple areas including fertility, oncology and obesity and continue to add to the pipeline. While we cannot yet identify the partner for our oncology partnership, we have made tremendous progress in the clinical phase and anticipate a commercially available product in 2014. We are proud to note that with all these activities ongoing, we also continue to operate in a fiscally responsible manner. The first quarter of 2013 represents our second consecutive of operating cash profitability. In fact during the quarter operating expenses remained flat with Q4 2012 and our net cash burned decreased to just over $2 million in the quarter. We remain on track to be operating profitable by year end.
In summary we are extremely pleased with the launch of next generation OmniPod and initial feedback across the country has been exceptional and is resulting in a significant up tick in referrals as shipments as evidenced by more than 50% year-over-year increase in April. We remain confident that the new OmniPod will accelerate the top line of our business and our prescribing base of endocrinologists will continue to expand. We expect this transition to customer base commence shortly and nearly all customers should be converted by the end of September. We did experience some reorder disruption in the first quarter as many customers have delayed shipments removed from quarterly to monthly ordering. We expect this trend to continue throughout the second quarter and then begin to normalize in the back half of 2013.
Finally, we are excited about our future beyond the new OmniPod as we work towards an OmniPod integrated with CGM sensing towards an OmniPod pump specifically designed for type two patients and towards versions in the OmniPod designed to be used for delivery above the drugs outside of insulin. With that I will turn the call over to Brian to provide additional details about the first quarter and our expectations for the rest of 2013.
Brian Roberts - CFO
Thank you, Duane. Consolidated revenue increased by 20% to $57.4 million in the first quarter of 2013 compared to $47.8 million in the first quarter of 2012. Our core OmniPod revenue improved by approximately 25% over Q1 of last year. As Duane noted, the new OmniPod was launched in late February and since launch we've seen a significant uptick in referrals and shipments. New shipments and referrals have increased by more than 40% since launch as compared to the prior year. The increased revenue resulting from these higher shipments was offset in the quarter as expected by lower than planned re-order revenue as existing customers delayed shipments or lower quantities ordered in anticipation of converting to the new pod. We expect this disruption in reordering pattern to continue in the second quarter and then normalize in the back half of 2013 as the transition is completed.Gross profit for the quarter improved by 24% to 25.2 million compared to gross profit of 20.3 million in the first quarter of last year. Gross margins expanded by approximately 100 basis points to 44% as compared to Q1 of 2012 and remained relatively unchanged from Q4 of 2012. Gross margin should remain at this level in the second quarter as we provide in-warranty customers with a new PDM at the time of transition at no additional cost. With the base expected to be converted by the end of the third quarter, we remain confident that we’ll achieve 60% plus gross margins on our US OmniPod business by year-end and 50% plus gross margin on a consolidated basis.
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Duane DeSisto - President & CEO
Thanks Brian. In summary, 2013 is off to a strong start. We believe the momentum in new referrals and shipments that we’ve seen since launching the new OmniPod will continue and that the OmniPod will become the pump of choice for more and more endocrinologists, educators and patients. We are eager to transition our customer base and thank them for their patience as we work to ensure that their experiences with the new OmniPod are as positive as new customers trying the product for the first time. And we are excited about our pipeline as we continue development on other drug delivery opportunities and we continue with CGM and now the first Type 2 insulin pump for people living with highly insulin resistant diabetes....
Question-and-Answer Session
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Kim Gailun - JPMorgan
So first question is, just on your comments with regard to the component supply issue that you saw, how I guess most importantly how confident are you that that issue is fixed? And I'd actually be curious what impact this component disruption had on the construction of the 2Q revenue guidance?Duane DeSisto - President & CEO
So, Kim, I think we are confident enough that we are shutting down the old line. That will be done here probably at the end of month. So that's all going away. We feel good about it. I'll tell you that I think having been through this now a couple of times, it’s kind of -- it's kind of been in the normal course of business as you ramp this stuff up. The issue for us quite simply is, we want the consistency aligned to that, our vendors have promised us, the guys who make the individual components have promised us, and so that's what we are pushing for.So I think from our standpoint, I think the Q2 guidance, we are more worried about disruptions as we stated here. Some people now only take it, their reorder comes up in April. They only want one box hoping that we can convert them by the end of May. So it is reflected in the numbers that we gave you and that there will be some disruption because it's not just they only order one box and then you can ship him two when you are ready. I mean you got to go through the third-party reimbursement. You have to understand that whole piece, what their insurance plans willing to pay for. So it's reflected -- a little bit of that's reflected in the number, but I would tell you it's not -- for us it's, we're not surprised, we've built in enough timeframe.
I think what we told everybody was by the end of the third quarter we've the installed base converted. We still think by the end of third quarter we will have the installed base converted. It's taken us probably a little bit longer than we had hoped to get going, but it is pretty much, pretty much, you want to start machine up and you want to make 400,000 of these a month. We feel real good at the 200,000 level, that's line one and the second machine we're going to squeeze it out. I guess the best analogy I can give you is if you are going to change a tire on the car to get it run better, you want to do while the car stops. You’d probably don’t want to be doing while it's going down the road at 30 miles an hour. So we had the window, we took advantage of it to squeeze this efficiency out of it and we feel pretty good about it.
Kim Gailun - JPMorgan
That’s really helpful. So it sounds like a little hiccup but a manageable hiccup and maybe it's fair to say that some of the initial demand here with the kind of 40% numbers that you guys threw out, might be if anything outpacing some of your expectations because my next question would be just on the annual guide. No change to the annual guidance despite maybe just a little more conservatism on the second quarter, and just kind of what gives you confidence to kind of maintain the high end of that annual guidance range.Brian Roberts - CFO
Kim, it's Brian. I mean overall and I think we're extremely encouraged and we had -- as you can imagine, we had a very, very slow January and first half of February, right, because everybody in the new shipment side as well was anticipating moving to the new Pod. Since the launch, I think it's fair to say that’s exceeded our initial expectations, April was up 50% referrals and shipments year-over-year.I think when we look at the volume that we processed in April, I think it's fair to say that it's the largest first month of a quarter that we’ve had as a business. So I think we are all very, very encouraged by the level that we seen, but as Duane is pointing out, I mean a lot of these kind of component issues and all, in all honesty, it happens normal course, it's happened throughout the course for the last few years.
It's just that as we have inventory on hand, and as we have got the production kind of ramped and run, a lot of it just happens kind of behind the scenes and seamless; in this case here given that it was right at the start of this conversion, we just wanted to make sure, I would say be doubly cautious that we’re taking the right approach to make sure we had enough inventory and we’re going to be able to once we convert the people over. As we have talked about, we never want to be able to go back.
So I think that feels very jazzed up about what we are seeing so far. Duane gave you a couple of different stories. We are getting tons of these different examples back about practices, letting us come in, I mean again if you think about a launch that’s effectively only 60 days old to have over 10% of our shipments coming from doctors who did not prescribe the product in 2012, in that shorter period of time, to me is pretty telling, it means doctors have taken these visit, they are looking at the products, they are excited about it, and they putting a few people on, and we think that trend is going to continue. So that gives us a lot of confidence as you look at that revenue range throughout 2013.
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William Plovanic - Canaccord Adams
Couple of questions for you. Just first on the component issue, I just want to make completely sure. So you are fully resolved and you’re building inventory. Do you have inventory levels today that will support that transition or do you think you have that by the end of the month?Duane DeSisto - President & CEO
Bill, I think where we are, we will have inventory levels here in the next few weeks that we will start converting people in the quarter we will feel comfortable, but today -- as of today no we are still doing.William Plovanic - Canaccord Adams
And the component issue is fully resolved the shipping, you are getting the components and so that you can build the inventory, so it’s just a capacity issues?Duane DeSisto - President & CEO
Yeah, we see -- so just a kind of give me some slight indications probably more detail than you really need. What we are talking about a component that was to 10,000 basically off the spec which just give me some indication of how precise in order to be as successful as we been today, how precise in this design. So what we receive now since that component issue few hundred thousand of these components surround and then manufacturing. So the answer to you long way to answer but the answer to your question is yes....
William Plovanic - Canaccord Adams
Okay, got you. And then last question I'll jump off, just as you look at this transition, does this impact your attrition rate or maybe is it too early to tell on the new OmniPod, the Gen-II kind of what those attrition rates look like?Brian Roberts - CFO
If you look at what's happening in Europe, you know attrition rates in Europe have been lower than what they have been here in the United States. So that's probably the best indication; you know purely to say anything in the US except for our overall attrition you know the first quarter was down slightly from where we were in Q4. So you although everybody wants to get their hands on the new pod and we certainly understand that you know we are not seeing people leave....
Ben Andrew - William Blair & Company
So where did you find the manufacturing and the component issue; in the field or internally in QA?Duane DeSisto - President & CEO
So Ben here's how we found it; we found it within QA. So line one was running pretty well. Line two we automated a couple of the stations from line one to help continue drive the costs out and in that automation process is we are kind of popped out. So the product never left the building and it was pretty, obvious pretty quickly that something was different and we immediately went to a couple of these stations that we automated as the ones being different from the original line that was running and we noticed like I said you know we noticed basically an eyelash of tolerance difference in the particular product, the components going for that line and that's how we put it.Ben Andrew - William Blair & Company
Okay, so internally, that's the key.Duane DeSisto - President & CEO
Yeah, it never saw the light of day.Ben Andrew - William Blair & Company
And then Brian that 50% growth in shipments and referrals in April, I mean can you key it out at all how much of that is pent-up demand versus more durable or something we should anchor off of?Brian Roberts - CFO
You know, I mean again hard for me to say, but I keep coming back to I guess is the fact that you know again over 10% of the shipments over the last 60 days have been you know have come from brand new practices. You know doctors -- you know defined as doctors who haven't prescribed the product in at least the last, excuse me, 15 or 16 months, you know before 2012. So when we look at that metric and you've seen over 10% come, that can be is not pent up demand; that is the expansion of the prescribing base which I would say is what we are most excited about.Ben Andrew - William Blair & Company
And then my third one to cheat is on CGM, you talked about in the past, the human trials or at least human trials in ’14. Can you give us any update on what sort of data you have in human so far and where that path takes you in ’14? Thanks.Duane DeSisto - President & CEO
Yeah, look I think it’s too early, I think it’s too early to go there. I would tell you obviously the single biggest issue for us with integrating and if you talk to any other guys that are in the CGM business, the single biggest thing that we are wrestling to the ground as we speak is we've done the testing on CGM, we kind of like what we see, but the next big step before we invest any kind of money in this whole process here is really to wrestle down the whole sterilization cycle for the fluid path as well as for the sensor and that’s kind of where we are at the moment.So we will keep you updated, but I think it's too early to tell in terms of accuracy versus all the other products that are out there that need that now. I think the real test for us is we really want to clear this sterilization cycle issue and once we get there, then I think, then I think we have a couple of really good ideas on the joint board, but I would reemphasize their ideas on the joint board and how to go about it, but we really want to get back things down before the end of the year.
Ben Andrew - William Blair & Company
And you say anymore about what human data there is just for sensor itself though, what either is published or what you guys saw as far as your diligence?Duane DeSisto - President & CEO
Well, again, when we look at the sensor data that we had, we’re based off of the animal studies we've done, and then as well as some of the sensor data that they had done; a combination of human and animal. You know, again, we came away from it, because we thought that the accuracy of the sensor was comparable to what we're seeing out in the marketplace today. So that’s probably specific as we can be at this point, but again, I mean certainly we feel like it's the sensor that’s going to have a level of accuracy and that it’s going to be compete in the marketplace for us to be able to decide to move forward with it....
Tom Gunderson - Piper Jaffray & Co.
So, I think, my opinion really putting this project in your hands is a nice endorsement. So congratulations on that, and Duane I have a sense, I don't fully appreciate, but I have a sense of the regulatory reimbursement marketing pathways that we will have to be traversed. But I don't know much about Humulin U-500 is it a different consistency or they are different properties, is there a major technical change that has to be made to the pump.Duane DeSisto - President & CEO
So I think from a pump side, obviously so just kind of typically type on diabetes patient usage U-100, U-500 as a name basically depicts is five times the strength. It's also the typical U-100 is fast acting, U-500 is not [naissance] formulation. So U-500 is been used in the market place today and what we are going for in terms of from a drug side is obviously a labelling change. So could be used in a pump, but from the pump side we are basically trying to build device that accurate reflex dosing and the other criteria they are needed for a type 2 patient and then the other question obviously as part of the study is there way, this is type 2 patient need all the things that type 1 patient needs in terms of the very screenshot.So that’s kind of what we are going through. The thing that we are most excited about is what we are talking about doing is basically in combination with the drug doing a clinical study with some hopefully very positive clinical outcomes. So when you get this all approved, not only you are going to the market with a product and a drug specifically designed for one another, but also clinical outcomes that should reflect hopefully an improvement in patient’s life.
Tom Gunderson - Piper Jaffray & Co.
My second and last question is on the new start and the strong response that you’ve had so far, I realize that it’s early but you are kind of eyeballing it right now is the mix changing significantly between brand new to pump customers as oppose to people switching pumps?Duane DeSisto - President & CEO
I haven't seen the change in the mix what we are seeing now which is in my opinion and my opinion only at the moment is that there seems to be more pediatric type centers that really starting to pay attention to this because of the size. Prior to this new product we had the smallest pod period in the mark place. This size reduction for a lot of these pediatric centers is meaningful and the insulin onboard calculation, the methodology for that they are much, much more comfortable with, and so I would tell you, it will be interesting it’s still too early to tell obviously, but we are seeing an uptick across a bunch of these pediatric endocrinology centers....
Unidentified Analyst
We saw on the [blog] some users were upgraded to new pods in April, were those patients using specific distributors plus the direct shift. It seems like some other of your current users were hearing about whether those single folks are getting upgrade and getting pretty more nervous and upset.
Duane DeSisto - President & CEO
Yeah, so I guess when all this blocks I think so specifically we want planning on upgrading anyone, so I don't know if a distributor may have shift that around, I don't know Brian.Brian Roberts - CFO
Yeah, just to be clear we have not commenced the version yet of the existing customer base to the new OmniPod. If someone wound up receiving new pods it was probably somebody who is out of warranty, who maybe was ultimately went through a distributor partner or so and was able to obtain it that way, looking more like a new shipment. But I would expect that if any of those, those are onezies and twozies but not something that we've really seen at this point.Unidentified Analyst
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And then last question just regarding your type two pump with Lilly, do you think its generally a three day wear device, one day wear basal bullets combined and will it have a controller just sort of those three general categories of the product (inaudible).
Duane DeSisto - President & CEO
So to make it clear it’s our device using Eli Lilly’s U500. So we are the device they are the drug and it will have a handheld we believe for these highly insulin resistant type two patients with U500. One of the unique features of this is it should be a three day, it should be for a lot of them a three day device, but it will be, there will be a handheld, it will be basal and (inaudible) because there have to be meals, there have to be - you know it looks a lot like a type one device but without some of the bells and whistles that are unique to type one patients.Brian Roberts - CFO
And it will leverage the new OmniPods, continue to leverage the new pod that we are putting into the market now.Unidentified Analyst
Okay, so actually you might, I mean it won't be a cyclically separate manufacturing line down the road then.
Duane DeSisto - President & CEO
Oh, no, no.Brian Roberts - CFO
No, no new manufacturing line....
Robert Goldman - CL King & Associates
I had a question, a brief one on international sales and then question on the efforts for Lilly. But Brian could you give us some sense of international sales growth in the quarter either year-on-year or relative to the fourth quarter of ’12.Brian Roberts - CFO
Yeah, I mean compared to Q1 of 2012 which was probably much lighter in volume it was probably more than triple. What that number was back then and it was an uptick over Q4 of 2012, you know [Insulet] has done a great job of accelerating demand I mean you know like here in the US the first quarter is historically kind of the weakest of quarters and I think they were very pleased with their results as well especially in markets like the Netherlands and Switzerland where they continue to take significant share. So all systems kind of continue to go there and I think we are on paces, as we've talked about that our international revenue should be probably somewhere between 2X and 3X what it was in 2012.Robert Goldman - CL King & Associates
And then on the efforts with Lilly, what is the filing for this device by Insulet, and then also when the device is ready for market, to what extent will Lilly be engaged in the marketing and what can you say relative to the economics between Insulet and Lilly relative to the device?Duane DeSisto - President & CEO
I think it's pretty simple. It's dual path filing. Lilly’s filing for a labeling change on the drug and we're going to file a 10-K for a use of the product. So in terms of right now the only agreement we have with Eli Lilly is the development of this. So our plan is we will be selling the pump and the pods and they would be selling the drug.Robert Goldman - CL King & Associates
Okay, and on the economics, there is just some sort of transfer price of some sort of from Lilly to Insulet is there (inaudible)?Duane DeSisto - President & CEO
No. During the development phase, there is some certain cost around the clinic and other things that both companies will share. So that’s a little bit of expense for us over the course of the next couple of years while this is ongoing, not material. And then going forward, we will sell pods and we will sell the systems and they will sell the drug. So there is no cost share if you will for a patient once they are on product.......
Suraj Kalia - SMH Capital
And last question again Duane, obviously close loop systems, everyone is talking about it, it is the fact that you are not paid with DexCom, it is too obvious to miss right now. We also know the DexCom with its Bluetooth connectivity, remote monitoring for children, so on and so forth, they are incorporating all these CGM systems and that look ultimately being better than close loop systems whether for animals or other pumps.And I guess the question I have Duane again to the extent that you can share, you all have made a strategic bet with this so far unknown player with a certain technology, help us understand accuracy is one factor, I mean I get it, but isn't it true that CGM rather than point estimates we have been pretty much everyone starts looking at as the trend line monitor that is more important and what all features does your CGM partner have that can counter other things that (inaudible)?
Duane DeSisto - President & CEO
Well, let me and anyone that's seen any of these presentations that I go through, look I think despite what everyone’s telling you I think the idea of a close loop system in which the patient is not involved, no one on this phone call will live long enough to see that, that's my humble opinion.Having said that, I think the tool for patients as I described to you is the best tool for patients when they are going to use and what we know is 90% plus of people with type 1 diabetes are willing to live with one thing on their body that they need insulin. So our theory behind this is to integrate a continuous sensor in it. We have basically an option to license a couple of different software algorithms that are out there. And what we really would like to have our version of the right product isn't CGM to replace a fingerstick, it’s CGM to talk to a predictive algorithm as you describe taking all these data points to keep the patient out of trouble to only basically buzz, wake, kick, jump, whatever you have to make the handheld do in order to keep the patient out of trouble.
And so it could be in its simplest form, it could be turn on the handhelds and the screen’s screen, then everything’s fine. If the screen is yellow, let's say that says three to five hours based on the parameters you put in and based on what we are seeing here with the continuous sensing you are going to have, you are going to run into a problem and then if it’s as simple as it’s a red screen, it says based on the parameters you put in here you are now bumping up against the guard rails.
So look I think we are not going into the CGM business to sell CGM. What we believe is the combination of CGM with one thing easy to use on the body is going to result in better clinical outcomes, reduced hospital space and a much, much better like for people with type 1 diabetes and that's how we are going about it.
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Unidentified Analyst
Hi, guys, this is [Mike] calling in for Jayson. I don't want to harp on this just wanted to confirm are both Gen2 lines up and running again? And then on top of that, what's the new timeline or what is the timeline for getting the third line up and running.
Brian Roberts - CFO
Yes, both lines are up and running and third line is we talked about in the last call we are still targeting towards some time this summer.Unidentified Analyst
And then looking at the plan to transition to the LifeScan PDM, what's the timeline on that and is there any chance you can get that into the mix during the conversion process?
Brian Roberts - CFO
No, they won't be during the conversion process. They are making a lot of progress with LifeScan on it. At the moment we are waiting for some information back from them. Although it does not impact our meter, our product with them they do have a recall that they are dealing with that has probably distracted them slightly. So we are working with them to be able to just get the rest of the information needed to be able to file with the agency.Unidentified Analyst
Okay. Is that potentially so a 2013 development or could that get pushed a little bit?
Brian Roberts - CFO
We are hoping it could be the end of the year that we will have it.Unidentified Analyst
And then lastly just housekeeping, Brian did you say 25% core OmniPod business growth year-over-year?
Brian Roberts - CFO
Yes....
Duane DeSisto - President & CEO
Thank you everyone for joining us and we look forward to keeping you updated throughout the rest of this year. Take care....