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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

Operator

Good afternoon. My name is Sue and I will be your conference operator today. At this time, I would like to welcome everyone to the First Quarter 2013 Insulet Corporation Earnings Conference Call. All lines have been placed on-mute to private any background noise. After the speakers’ remarks, there will be a question-and-answer session. (Operator Instructions) Thank you.

Mr. Brian Roberts, Chief Financial Officer, you may begin your conference.

Brian Roberts

Thank you. Good afternoon everyone and thank you for joining us for our first quarter 2013 conference call. I am Brian Roberts, Chief Financial Officer of Insulet and joining me on the call today is Duane DeSisto our Chief Executive Officer.

Before we get started, I would like to remind everyone that our discussion today may include forward-looking statements as defined under the Securities Laws. We intend these forward-looking statements to be covered by the Safe Harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making these statement for purposes of complying with the Safe Harbor provisions.

These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies, prospects which are based on the information currently available to us and on assumptions we have made. There are risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements.

Information concerning the company’s potential risks and uncertainties is highlighted in the company’s press release issued earlier today and in the Risk Factors section of the company’s SEC filings including the company’s annual report on Form 10-K for the year ended December 31, 2012. These risk factors apply to our oral and written comments. We assume no obligation to update publicly any forward-looking statements whether as a result of new information, future events or otherwise. I would also like to remind you that the guidance we are offering today represents a point-in-time estimate of our future performance. You will find a link to the webcast of this call as well as to today’s press release at myomnipod.com in the investors section.

And now, I'll turn the call over to Duane.

Duane DeSisto

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.

For example, a significant practice in the Northeast region that averaged just one new patient addition per month in 2012 has added over 20 patients in just the last 60 days. In the Mid-Atlantic, one of the most recent patient additions is a clinical diabetes educator at a large practice, while previously intrigued by the OmniPod’s tubeless design, she was turned off by the insulin on board calculation methodology and by the size of the old OmniPod.

Once she tried the new OmniPod, she was hooked. With the CGM board the practice has dramatically ramped up its referrals and OmniPod is becoming the pump of choice across the practice. And yet another example a pediatric center in the South would not typically recommend the old OmniPod as they believe it to be too big and bulky for kids.

Now, with the new 34% smaller OmniPod, the practice is starting kids on the [sailing] [ph] trial using the new OmniPod. The feedback of this trial program has been exceptional as kids and parents love the size and the automatic insertion feature of the new product. The result is that the number of referrals in just last month was more than double from what we usually would receive in a quarter.

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.

We are seeing demand grow in Europe as well; Ypsomed continues to accelerate their rate of patient addition. As they indicated in a recent press release they continue to focus their business and dedicate incremental resources to the support of the mylife brand including the mylife OmniPod, which is how they brand the product overseas. We continue to work closely with Ypsomed with a goal of launching OmniPod in several additional countries in 2013.

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.

Insulet was initially founded to develop a better more patient friendly solution for insulin delivery. At our core, we are innovators focused on technology that will help make the lives of people living with diabetes easier. This mission led us to the creation of the OmniPod which has changed the lives of tens of thousands of Type 1 diabetes patients across the U.S., Europe and Canada.

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

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.

Operating expenses for the first quarter were 31.4 million, effectively flat from last quarter and from the first quarter of 2012. Operating expenses are expected to be in the range of 32 million to 34 million per quarter for the remainder of the year, as we invest in our sales and marketing function to support our growth and as we continue our development effort with both our CGM partners and with Eli Lilly. Our operating loss for the quarter declined by more than 40% to 6.2 million as compared to 10.9 million in the first quarter of 2012. Excluding non-cash expenses such as amortization, depreciation, and stock-based compensation, we were operating cash profitable for the second quarter.

Net interest expense was 4.3 million in the first quarter of 2013 compared to 3.8 million in the first quarter of 2012. Of the 4.3 million in interest expense approximately 2.9 million was non-cash. Finally, we reported a net loss for the first quarter of 2013 at 10.7 million or $0.20 per share compared to a net loss of 14.8 million or $0.31 per share for the first quarter of last year.

We sold 4.7 million shares of common stock in January at a price of $20.75 per share. These offering resulted in net proceeds to us of approximately 92.8 million after underwriter fees and issuance cost. As of March 31, 2013, cash and cash equivalents totalled 148.1 million. Adjusting for the proceeds received from the offering our net cash burn was just over 2 million in the first quarter.

As of March 31, we had approximately 53.3 million common shares outstanding. As Duane noted the initial feedback to the launch of the new OmniPod has been excellent and we are seeing the results in significant increases to both referrals and new shipments. These increases will be tampered slightly in the second quarter as reorder pattern remain choppy in advance of the customer base conversion. As a result we are projecting second quarter 2013 revenue of 59 million to 62 million and for the full year, our revenue range remains unchanged at 240 million to 255 million. With that let me turn the call back over to Duane.

Duane DeSisto

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.

And with that operator, please open the call for questions.

Question-and-Answer Session

Operator

(Operator Instructions) Your first question comes from the line of Danielle Antalffy

Danielle Antalffy - Leerink Swann

Brian, I was hoping I could dig a little bit more into the gross margin expansion as you transition the existing patient base. Does the outlook for the cadence of gross margin expansion for the year change at all if you could talk a little bit about that given the PDM automatic upgrade, and then ultimately where in 2014 and beyond I appreciate that you can’t guidance per se. Can you talk directly about gross margins potentially getting beyond that 60% range?

Brian Roberts

In the short term depending on the rate that we are able to convert folks starting here in a few weeks will factor a little bit in to where the Q3 gross margin comes out. You’ll recall from the last earnings call that we believe Q1 and Q2 will remain flat with Q4; Q1 followed that. And then we would see probably somewhere 200 to 300 basis points of improvement in both Q3 and Q4. We need to lose 100 basis point of that in Q3 just depending on exactly how many people are converted in May, June versus converted in July, August, September timeline. So that piece will certainly have a little bit color on as we get to our next earnings call and figure exactly what percentage of the base has been moved.

Longer term I can tell you certainly that you know Charlie and the team have been doing a fantastic job working with Flex and all of our suppliers to really not only continue to move the manufacturing process here in the short term but find additional efficiencies to be able to continue to drive the price down.

So as we look out longer term, again using a US OmniPod $28 average selling price, we certainly still believe 65% plus margins here are very doable for the business once we've fully transitioned everybody and eliminated some of the inefficiencies that would remain with the old line that needs to be eliminated. We are not ready to go beyond that at this point, but I can tell you that the team is certainly working on a bunch of different projects that we hope will get an even further, but we will have to wait and see how those go.

Danielle Antalffy - Leerink Swann

And then, Duane, I am wondering if you can talk a little bit about neighborhood diabetes, any update there on your thoughts strategically as it relates to that business in the upcoming July 1st competitive bidding that will go into effect?

Duane DeSisto

This is Duane. So I think with regard to the whole competitive bidding, obviously we are following that closely and there's significant amount of activity down in Washington. The guidance we gave you assumes that we are not going forward with that Medicare piece of the business. But there's a whole kind of, if you read all the stuff going on in DC there's a whole movement of foot to try to push that to December. How that all turns out? I guess only time will tell here. We've dialed in assuming it's all gone come July 1st.

With regard to the neighborhood, in general, I think all the reasons we want it all makes sense, I mean obviously the Medicare business came along with the Medicare, it came along with neighborhood, but it's a small piece of the business and we are cognizant that we've got to continue to wring efficiencies out of that. We are going to make each individual sales worth more money and we continue to work with that. And so we feel pretty good about it long term. Obviously the price that came out competitive bidding us as a side player, we are kind of surprised how low it was going, but when you look at all the guys that have billions of dollars at stake here, they were surprised also. So stay tuned, I mean, like I said, all the guidance we gave you assumes that business is going away, but we are paying attention to it as we continue to go forward.

Operator

Your next question comes from the line of Kim Gailun [JPMorgan].

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

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

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.

Operator

Your next question comes from the line of WiIl Plovanic [Canaccord Adams].

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

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

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

Perfect. And then Brian just on NDI, 13, 25 million is my math, is that correct?

Brian Roberts

Well, obviously, we are basically not surprised in the Q1, we’ve had seasonality in these types of businesses. We’ve seen in the past, so the level of revenue in Q1 for neighborhood was similar to Q4.

William Plovanic - Canaccord Adams

Okay. And then I think we saw the announcement where they talked about their mylife pump, then they came out and talked about bring out their own tube pump next year. Is that just supply the market with every type of pump there is? I am just trying to figure out why they would out with another pump?

Duane DeSisto

So Bill this is Duane, so from day one they have talked to us, I mean since we signed the deal with Ypsomed, they've talked about coming up with a very cheap traditional insulin pump and they believe there is a subset of this market that cannot afford you know our price point a typical insulin pump price point. So what they are trying to do is really kind of a down and dirty and not for me to speak for them, but to give some clarity on it; its kind of a down and dirty pump for the person that probably you know could do a little bit better than shops, but probably couldn’t afford the higher care that comes with our product, so they are trying to come up with the down and dirty way to do that and that's what (inaudible).

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

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.

Operator

Your next question comes from the line of Ben Andrew [William Blair & Company].

Ben Andrew - William Blair & Company

A couple of questions Duane, I guess three if I might, but if you want to cut me out feel free. Where does it, in the component…..

Duane DeSisto

You are done.

Ben Andrew - William Blair & Company

Okay then, I guess I am done. So where did you find the manufacturing and the component issue; in the field or internally in QA?

Duane DeSisto

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

Yeah, I never saw it let it there.

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

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

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

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.

Operator

Your next question comes from the line of Tom Gunderson [Piper Jaffray & Co].

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

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

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.

Operator

Your next is from the line of (inaudible)

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

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

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

And then at ADA are you having any special sessions for the OmniPod, new OmniPod just to address what you are talking about seeing a lot more centers that typically didn't give you an initial look with the first gen.

Brian Roberts

I don't think we are planning any special sessions. I mean certainly in the booth we will have a lot of information about the new OmniPod and we've historically and will continue to do what we think has worked well for us is to be able to gather key opinion leaders and different settings and be able to kind of talk through with them as compared to something that's real formal like. So I think that will be our approach with all of the conferences this summer. We had folks at the ace conference last week and I can tell you that we were thrilled by the amount of people that attended just kind of as an informal session we had where we were literally standing and we presented a couple of slides and we had people standing behind me, basically standing behind the screen because we couldn’t fit all of them in the room.

Unidentified Analyst

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

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

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

Oh, no, no.

Brian Roberts

No, no new manufacturing line.

Operator

Your next question comes from the line of Robert Goldman [CL King & Associates].

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

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

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

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.

Operator

Your next question is from the line of Suraj Kalia [SMH Capital].

Suraj Kalia - SMH Capital

So Duane, let me start and forgive me for harping on Lilly after so many questions and maybe you all mentioned this but in case you then, so Duane I heard you say about highly resistant type 2 patients, obviously that’s a qualitative characterization. Care to put some numbers on that in terms of patients in the U.S. that you see? And the reason I ask is, we are obviously seeing a recent push of insulin pens in type 2, and there is a lot of buzz about betaprofen also, although these are far out, but I am just trying to get a handle on the market size, eventually when this product comes online?

Duane DeSisto

So here let me take step back and define what we call highly resistant and this is our definitions, people in need over a 100 units of insulin in day, okay. So it's a pretty large dosage. And I think if you take a look at this and these are numbers, obviously we are not speaking for literally, but we have been looking at this for a while. We have talked to a lot of our physicians and the belief is this market is going to be its biggest type 1 market if not bigger over time.

And if you would look at what's going on in the type 2 space, there is more and more these oral medications that are having bigger and bigger problems. There is kind of FDAs and panel, a lot of different panels to look at these various oral medications as a potential type 2 and what the side effects are and there is more and more studies coming out and say the best way to treat especially, epilepsy young kids that I would define as large body mass index kids for a lack of a better term year here is to treat them early on with insulin and try to reform the diet and maybe give them a little exercise.

And so there is a trend that we believe that will make this market as big if not bigger than these couple of things going on like I said, but as big it's not bigger than the type 1 market in the US, now that is our opinion, but it is a substantial market.

Suraj Kalia - SMH Capital

Duane, to the extend that you can share, your internal market analysis must have indicated a certain price elasticity of demand, can you shed some -- obviously your comments are factoring in what you will see as a price elasticity of demand, can you give us some color on what your analysis is suggesting?

Duane DeSisto

So here is how we look that right, I think it is simpler than that, about if you go back and you look at the various studies that have been performed using You-500 all kind of off-label use by various stock there is over the last, I think you can back three, four years but there has been multiple studies. All of these are showing better outcomes in terms of improved day one [cease] for these patients.

And the single biggest issue from many of these patients is compliance which it is which is about any drug, but if you look at the outcome there we believe that the price points for our device and what’s going on, if you take and do a full blown study with clinical outcomes, we think we can easily justify the current pricing that we have in the marketplace for the type 1 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

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.

Operator

Your final question comes from the line of Jayson Bedford.

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

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

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

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

Yes.

Operator

And there are no further questions at this time.

Duane DeSisto

Thank you everyone for joining us and we look forward to keeping you updated throughout the rest of this year. Take care.

Operator

Thank you. This concludes today’s conference call. You may now disconnect.

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