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Insulet Corporation (PODD)

Q4 2015 Earnings Call· Thu, Feb 25, 2016

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Transcript

Operator

Operator

Good afternoon, ladies and gentlemen, and welcome to the Insulet Corporation's Fourth Quarter and Full-Year 2015 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Deborah Gordon, Vice President- Investor Relations and Corporate Communications. Deborah R. Gordon - VP-Investor Relations & Corporate Communications: Thank you, Liliana. Good afternoon, and thank you for joining us for our fourth quarter 2015 earnings call. Joining me today are Patrick Sullivan, our President and Chief Executive Officer; Shacey Petrovic, President of Insulet Diabetes Products; Michael Levitz, Chief Financial Officer; and Dan Levangie, President, Insulet Drug Delivery. The replay of this call will be archived on our website. Our press release discussing our fourth quarter and full year 2015 results and first quarter and full year 2016 guidance are also available in the IR section of our website. Before we begin, I would like to inform you that certain statements made by Insulet during the course of this call may be forward-looking and involve known and unknown risks and uncertainties that may cause actual results to be materially different from any future results implied by such statements. Such factors include those referenced in our Safe Harbor Statement in our fourth quarter earnings release, and in the company's filings with the SEC. With that, let me turn the call over to Pat. Patrick J. Sullivan - President, Chief Executive Officer & Director: Thank you, Deb. And good afternoon, everyone, and thank you for joining us today. I'll start off today's call with a brief review of our performance and our view of the business and our market opportunities…

Michael L. Levitz - Chief Financial Officer

Management

Thank you, Pat. I'll first review our fourth quarter and full year 2015 results and then introduce our 2016 guidance. Please note that our 2015 results include Neighborhood Diabetes. However, effective January 1, 2016, the Neighborhood results will no longer be included in our continuing operation, and our forward-looking guidance will reflect this change. To assist you with your modeling and for clearer year-over-year comparisons, we've provided pro forma 2015 financial statements in our earnings release, which exclude the Neighborhood business as if they were divested on January 1 of last year. In addition, we have posted to our website a schedule of the pro-forma revenue for each quarter of 2015 reflecting this divestiture. Please also note that as I review our results, unless otherwise stated, all of the commentary regarding changes will be on a year-over-year basis. We are very pleased to report fourth-quarter revenue growth of 38%, with revenue reaching over $100 million in the quarter, compared to $72.5 million. We saw growth across all of our product lines and the primary growth drivers were the over 20% growth in U.S. OmniPod sales and the significant growth of our Drug Delivery business, which delivered revenue approaching $14 million in the quarter from less than $1 million one year ago. This brought our full year 2015 revenue to just over $324 million, an increase of 12%, even with the low shipments in the first half of 2015, as our OmniPod distributors significantly reduced their inventories to steady-state levels from their higher inventory levels in 2014. Our reported gross margin in the fourth quarter was 45%. This is five points lower than the same period last year, and primarily reflects costs directly and indirectly attributable to the voluntary Field Safety Notification we discussed with you in detail last quarter. The…

Shacey Petrovic - President-Insulet Diabetes Products

Management

Thanks, Mike. 2015 has been a year of tremendous progress here at Insulet. We have an enormous market opportunity that we have been successfully converting through improved commercial execution, our laser-beam – and our laser-beam focus on new patient retention with terrific results. Also, we've defined and launched an exciting product development roadmap internally claimed Digital Insulet. This is paving the way for innovative mobile capabilities and putting Insulet in the vanguard of research, development and commercialization of an artificial pancreas. These efforts have resulted in a quarter – another quarter and ultimately a year of record revenue and new patients starts, early progress toward improved patient retention, along with exciting tangible headway on the longer-term strategic roadmap. First, I'll touch on our market opportunity, and how we're converting the market through first-rate commercial execution, robust clinical differentiation and improved market access. OmniPod has many advantages over tube pumps. The improved freedom and quality of life, the glycemic control that users get, because they don't need to disconnect from their insulin and its ease of use over other delivery methods. And given these significant advantages, we are convinced that OmniPod should command a larger share of the pump market. But our true opportunity is much larger than the pump market; in fact it's three times as large. It represents the population of patients today that rely on multiple daily injections. This is more than 2 million people living with type 1 diabetes and insulin-dependent type 2 diabetes in the U.S. alone. It's a $6 billion domestic market opportunity and likely more than double that internationally. Today, this is the population of patients from which more than 70% of our new users come. And more than half of these users tell us that they would not convert to pump therapy if…

Operator

Operator

Thank you. Our first question is from the line of Brooks West of Piper Jaffray. Your line is now open.

Unknown Speaker

Analyst · Brooks West of Piper Jaffray. Your line is now open

Hey, guys this is Tom (28:12) on for Brooks. Congrats on a great quarter.

Shacey Petrovic - President-Insulet Diabetes Products

Management

Thanks.

Unknown Speaker

Analyst · Brooks West of Piper Jaffray. Your line is now open

So, two quick questions if I may. And the first one, I was hoping you could maybe talk about utilization just in the U.S. diabetes business. And maybe how the impact is being felt in patients just from the focus on quality control and the manufacturing process. And if you're seeing any kind of difference in reorder rates or maybe a little bit higher utilization from that.

Shacey Petrovic - President-Insulet Diabetes Products

Management

Sure. Tom (28:54), this is Shacey. I haven't seen differences in utilization rates that are material this year in 2015. We have seen in new patients as I mentioned a higher reorder or retention rate. But in our total patient data, the utilization rates remain pretty steady.

Unknown Speaker

Analyst · Brooks West of Piper Jaffray. Your line is now open

Okay, great. And then just one quick follow up. There was an announcement from one of your major partners in the Drug Delivery business, that they announced an agreement with another manufacturer of on-body devices for drug delivery (29:19)? Patrick J. Sullivan - President, Chief Executive Officer & Director: Dan, would you like to take that one?

Daniel J. Levangie - President-Drug Delivery Division

Analyst · Brooks West of Piper Jaffray. Your line is now open

Yeah. Sure. I'm not sure I heard the end of the question. Could you repeat the question? My line broke up.

Shacey Petrovic - President-Insulet Diabetes Products

Management

I think we may have lost Tom (29:47).

Daniel J. Levangie - President-Drug Delivery Division

Analyst · Brooks West of Piper Jaffray. Your line is now open

Okay. Well, I mean – I think the question was related to the announcement by Amgen with respect to Unilife. And here's what I'd say about that. And – in my mind – in our mind, Amgen is doing what it needs to do for its business, it's evaluating technology. It's a technology leader as a company, and the interesting thing is the overwhelming majority of drugs that are manufactured by Amgen are delivered by devices. And so, I think this is just an example of Amgen being Amgen and evaluating technology that's out there. As it relates to our agreement with Amgen on the Onpro kit for Neulasta, it really has no impact on that relationship, and in fact, our relationship with Amgen continues to strengthen. This – just this quarter, we launched a new engagement team model, where we've got teams from both companies that work together very closely – on a monthly basis they're in contact. And every quarter, we have a multi-day business review meeting that really ties the two teams together and develops our strategy for going forward. So, I think the announcement by Amgen this week was Amgen being Amgen. Patrick J. Sullivan - President, Chief Executive Officer & Director: Thanks, Dan. Next question, operator.

Operator

Operator

And our next question is from the line of Tao Levy with Wedbush. Your line is now open.

Tao L. Levy - Wedbush Securities, Inc.

Analyst · Tao Levy with Wedbush. Your line is now open

Yeah. Hi, good afternoon. Patrick J. Sullivan - President, Chief Executive Officer & Director: Hi Tao.

Tao L. Levy - Wedbush Securities, Inc.

Analyst · Tao Levy with Wedbush. Your line is now open

Hi. So I guess, there are two questions. The first one, in your guidance, are you including the recent reimbursement decision out of France in that outlook?

Shacey Petrovic - President-Insulet Diabetes Products

Management

Yes. Patrick J. Sullivan - President, Chief Executive Officer & Director: Yes.

Tao L. Levy - Wedbush Securities, Inc.

Analyst · Tao Levy with Wedbush. Your line is now open

Okay. And we started talking about your next generation PDM, the Bluetooth-enabled, how small can that PDM become? If all the display functionality gets transferred onto the smartphone – on the patient's phone. Do you need much – or does that PDM need to be as big as it currently is?

Shacey Petrovic - President-Insulet Diabetes Products

Management

Yeah. Well, I think Tao, you're asking the same question we're asking and some of that will depend on our conversations with the FDA and how much capability they will enable us to put on the mobile platform, but you're thinking the way that we're thinking about it. That we can make the mobile environment more and more rich and sort of feature-up the app and then be able to feature-down the PDM. We know that patients interact with their phones every minute and that they don't want to take their pump off their waist or go searching for their PDM. So, our goal is to make them less – or I guess enable them to be less and less reliant on that PDM, but we don't have a sense today exactly of all of the capabilities that we'll be able to put on the mobile app. We are having those discussions with the FDA today.

Tao L. Levy - Wedbush Securities, Inc.

Analyst · Tao Levy with Wedbush. Your line is now open

Okay. Great. Thanks a lot and congrats on a good quarter.

Shacey Petrovic - President-Insulet Diabetes Products

Management

Thank you.

Operator

Operator

And our next question is from the line of Michael Weinstein from JPMorgan. Your line is now open.

Robbie J. Marcus - JPMorgan Securities LLC

Analyst · Michael Weinstein from JPMorgan. Your line is now open

Hi. This is Robbie in for Mike. Congrats on the good quarter.

Unknown Speaker

Analyst · Michael Weinstein from JPMorgan. Your line is now open

Thanks.

Robbie J. Marcus - JPMorgan Securities LLC

Analyst · Michael Weinstein from JPMorgan. Your line is now open

I wanted to maybe touch on the Drug Delivery business, because that number came in well above not only the Street's number, but also your guidance and what IMS scripts are pointing to if you do the math off of what on-body sales are and how much you get per pod. So, can you help us fill in the gap? Are you maybe getting a different ASP than the 70% to 75% – $70 to $75 per pod you talked about in the past. And is that changing next year at all? Patrick J. Sullivan - President, Chief Executive Officer & Director: Danny, do you hear that question?

Daniel J. Levangie - President-Drug Delivery Division

Analyst · Michael Weinstein from JPMorgan. Your line is now open

Yeah. I got that. First of all, I don't know that we've confirmed any price on the – to our partner Amgen and would not want to do that, number one. Number two, I just think, the revenue is a reflection of the increased uptake of the product at the – in the month of December, I think the conversion rate was roughly 27%. So, we're feeling really good about the adoption rate of the product in the marketplace, and I think the revenues are a reflection of that.

Robbie J. Marcus - JPMorgan Securities LLC

Analyst · Michael Weinstein from JPMorgan. Your line is now open

Okay. So, you would say, there is not a lot of stocking in that number, that it's a true reflection of commercial sales? Patrick J. Sullivan - President, Chief Executive Officer & Director: No, I didn't say that – as we've said in the past, we build product and ship product to a forecast that's provided to us by our partner. We don't have a specific visibility into end-user used versus what's stocking. Some of it is obviously stocking. But I think, if you need more information on that, I'd direct you to Amgen.

Robbie J. Marcus - JPMorgan Securities LLC

Analyst · Michael Weinstein from JPMorgan. Your line is now open

Okay. And then, maybe turning to your comments about EBIT positive in 2018, that was great to get a timeline. I want to see, one, is that EBIT positive in the insulin business as well or for the company as a whole? And what level of sales do you need to get to for your insulin business to be EBIT positive? And is, can you get there with what you have now in the Insulet framework or do you need to add on to that as well?

Michael L. Levitz - Chief Financial Officer

Management

Robbie. This is Mike. First of all, we only run our business as one business. So, any comments we make about EBIT or profitability are purely related to that. We share resources across our business and make strategic decisions in that fashion. So, what we talked about in terms of the EBIT guidance, I talked about improved gross margins. We've made significant investments in our product, performance and our team. We've seen the commercial success that we've talked about and where Shacey talked about the strong growth, that we're seeing across the business, (36:17). So, all of those things together, the revenue growth, the improvement in gross margins and the ability to leverage our operating foundation that we've been building. I mean, we've been talking about the fact that we've been building it now because, we believe in the future of the company. And the improved operating performance purely reflects that.

Robbie J. Marcus - JPMorgan Securities LLC

Analyst · Michael Weinstein from JPMorgan. Your line is now open

Okay. Appreciate it. Thanks again.

Michael L. Levitz - Chief Financial Officer

Management

Sure.

Operator

Operator

And our next question is from the line of James Francescone with Morgan Stanley. Your line is now open. James Francescone - Morgan Stanley & Co. LLC: Hey, thanks for taking the question guys. I wanted to touch on gross margin first. If you look at the gross margin in the quarter 45%, obviously down from last year and down from where you've been early in the year. I understand there are some issues, in terms of the product field action and the investments that you're continuing to make in quality. But we maybe would have expected a little bit stronger gross margin number given the upside in Drug Delivery, which you've described as meaningfully higher than the corporate average. So, can you help us maybe quantify a bit some of the puts and takes that were – that were working against you on the gross margin line in the quarter?

Michael L. Levitz - Chief Financial Officer

Management

Sure. This is Mike. As I said a few moments ago, the principal thing was related to the Field Safety Notification, and there were – the direct costs and there were indirect costs of that. We scrapped a significant amount of inventory at a time when we had – and we're seeing in the future dramatic demand. And so, ramping up our supply chain manufacturing from a standstill there, created some additional inefficiencies in the quarter. And those continue a bit into the beginning of 2016, but we're really pleased with the progress that we've made, and now we feel very confident of where we are, and you can see that reflected in our gross margin expectations for this year of low-to-mid 50s. So, yeah, there were some challenges in the fourth quarter. They were principally related to the Field Safety Notification that we – that we did and we talked about in the past. But I think we have a – we have a very bright future ahead of us and we're making, we talked about the introduction of a new leader in manufacturing operations, where we're placing a lot of resources there, because we really believe in this product and we want to strengthen our not only product quality, but our ability to leverage the cost of that product. James Francescone - Morgan Stanley & Co. LLC: Okay. Got it. And then second, just on international guidance. The guidance implies, you're doing kind of $13 million, $14 million, $15 million a quarter in the back half of the year – sorry, back half of 2015. The guidance seems to imply that – that run rate of $14 million, $15 million a quarter is going to be about the same run rate that you're looking for in 2016 as well. So, I mean how do we think about that in light of the new territories that are coming online, and the underlying growth of that business? I mean, is that a conservative outlook, or is there something else that's kind of working against growth there where sequential trends would be kind of more flattish is you're guiding?

Michael L. Levitz - Chief Financial Officer

Management

This is Mike again. I guess, I see us providing some pretty strong growth, we're talking about growing that business at approximately 50% year-over-year. So, there is a significant amount of growth built into this plan. So, we'll continue to give guidance as we go through the year. I would not say that our guidance is overly conservative or overly aggressive. We want to give you a plan that we believe in, and that we stand behind. But, is there upside to this plan? Absolutely. But, negative things can happen too, and that's why we give guidance with the best information we have available, but there aren't any major headwinds or roadblocks that we're concerned about, in fact, we're very excited, I mean being able to deliver 50% growth in that business, I think is tremendous, and reflect our excitement about that space.

Shacey Petrovic - President-Insulet Diabetes Products

Management

And James, it may be helpful to know that any new country within the scope of – Insulet's (40:25) business for example, is going to be relatively small contributing to the whole. So these new countries while they're just getting started over the course of 2016 are going to be relatively smaller contributors. James Francescone - Morgan Stanley & Co. LLC: Great. Well, thanks for taking the questions. And congrats on some great numbers.

Shacey Petrovic - President-Insulet Diabetes Products

Management

Thanks.

Michael L. Levitz - Chief Financial Officer

Management

Thank you.

Operator

Operator

And our next question is from the line of Jayson Bedford with Raymond James. Your line is now open.

Unknown Speaker

Analyst · Jayson Bedford with Raymond James. Your line is now open

Hello, good afternoon. This is Mike (40:51) calling in for Jayson. Thank you for taking the questions. First thing I wanted to ask about was the artificial pancreas development. Just logistically, the new algorithm, where does that sit within the product? Is it within the smartphone app, is it within the pod, is it in the PDM? So, where is that captured? And then, I know you're conducting first-in-man trials this year, but when do you begin a pivotal? And then lastly, based on your conversations with the FDA, do you think you can start with a basal management product or do you need to start with predictive low-glucose suspend before you can get into basal management.

Shacey Petrovic - President-Insulet Diabetes Products

Management

So, those are all great questions, Mike (41:32). So let me see if I can take them one at a time. I think, the first one was about where the algorithm resides. And the algorithm will reside partially in the pod and partially in the cloud. That's the way that this system is designed today and were intended to be designed today. The second question I think was about when we'll be in pivotal. So, we will be in on-body trials later today and – or, I mean, later this year and we intend to be in a pivotal in sometime in 2017, probably towards the end of that year. And then, I think the last question was regarding how much capability the FDA will support incorporating into our first system as opposed to that step-wise approach. And – again, we're – we've had one pre-step meeting with the FDA, which will probably be one of many, but our intention is to offer more than predictive low-glucose suspend and they supported that proposal.

Unknown Speaker

Analyst · Jayson Bedford with Raymond James. Your line is now open

Okay. Very helpful. And then, just a quickie. Any new commercial agreements for the Drug Delivery business signed in the fourth quarter and any other revenue streams that might be new that are assumed in the 2016 guidance?

Daniel J. Levangie - President-Drug Delivery Division

Analyst · Jayson Bedford with Raymond James. Your line is now open

Yeah. We continue to have the sixth ongoing development agreement we've talked about in the past. We didn't add any new ones in the quarter. And there is no new commercial revenue generating arrangements in place in the guidance for 2016.

Operator

Operator

And our next question is from the line of Danielle Antalffy, Junior, with Leerrink Partners. Your line is now open.

Danielle J. Antalffy - Leerink Partners LLC

Analyst · Danielle Antalffy, Junior, with Leerrink Partners. Your line is now open

Hi. Good afternoon, guys. Thanks for taking the question. And I didn't know I had a senior, so that's interesting. But, congrats on a great quarter. I was wondering Shacey, if you could follow up on some of the commentary around the Glooko partnership and what would it take for FDA to get comfortable with allowing only the iPhone for insulin data? How far off are we – do you think we'll ever get there? And what gets us there?

Shacey Petrovic - President-Insulet Diabetes Products

Management

Okay. Danielle, thanks. I think – so, the first question regarding Glooko, as I mentioned, we're really excited with the early launch of that product. We were in a sort of limited market release with it, sometime in December. And we knew that customers were going to really appreciate the improved data management, the retrospective analysis and some of the better tools and insight that it gives to both patients and secure teams to enable them to make better decisions regarding their diabetes care. But in fact, we were kind of blown away by the demand as we got out into full market release, and we are rolling this out much faster than we anticipated. And what we see, our kind of two big advantages, our previous data management system was probably not as – it was not very competitive, in terms of features and it's provided some technical challenges to our accounts. And so, this certainly has addressed all of those concerns and then offered improved reporting, improved ease of use and improved insights. And what that means is that there were accounts that were not proactively offering OmniPod, because of the challenges associated with our previous data management system. And now they are proactively offering OmniPod. And then in accounts where they were offering OmniPod and Glooko is giving them some tools to identify patients who could benefit from better glycemic control with OmniPod. And so, it's really doing both things, helping us go deeper and helping us go into more accounts, which is really exciting. And then the other comment or the other question regarding iPhone or a phone control of insulin delivery, and when the FDA will be comfortable with that. I think, it's the million dollar question, I don't really have the answer to that, except to say that in our early discussions regarding the artificial pancreas and our desire to sort of move more and more capability to the phone, it struck me that they were much more comfortable with the plan to have a backup PDM. So, I think, I think that they are understanding, as we are, what our patients want, in terms of more and more functionality on their phone. But of course there are safety and security concerns, and a backup PDM really helps resolve some of those concerns.

Danielle J. Antalffy - Leerink Partners LLC

Analyst · Danielle Antalffy, Junior, with Leerrink Partners. Your line is now open

Right. That does makes sense. And then, just a quick question on Neighborhood, what happens to the OmniPod business that was running through Neighborhood now. Do you guys just bring that back in-house or how does that work?

Michael L. Levitz - Chief Financial Officer

Management

Danielle, this is Mike. So, we will continue to sell Neighborhood Diabetes was purchased as you know by Liberty and we know Liberty very well, and we'll continue to sell to those patients through Liberty. What we did to make it easier from a modeling standpoint is we put on our website a breakout of revenue, historically this past year – as reported and then just so you can compare year-over-year, what it would have been, had we divested Neighborhood at the beginning of the year. And so, you can see the breakout of the OmniPod revenue that went through Neighborhood that will be – we expect to be part of our continuing business, and that will now be reflected in the U.S. OmniPod line, now it's about $2.8 million in 2015.

Operator

Operator

And our next question is from the line of Kyle Rose of Canaccord. Your line is now open.

Kyle Rose - Canaccord Genuity, Inc.

Analyst · Kyle Rose of Canaccord. Your line is now open

Great. Thanks for taking the question. Can you hear me, all right? Patrick J. Sullivan - President, Chief Executive Officer & Director: Got it.

Kyle Rose - Canaccord Genuity, Inc.

Analyst · Kyle Rose of Canaccord. Your line is now open

Fantastic. So, I just wanted to see, if we can dig into – and get a little more color on some of the comments made about improving retention rates and attrition. It sounds like you're making big strides on the new patient retention rates, and you're going to focus in 2016 on transitioning that to some of the existing patients. Just wanted to see, if you could give us a little more color around the improvement that we saw over 2015? What's the breakdown in attrition from a new patient versus an underlying existing patient? I mean, I think that we've used a 9% blend in the past. How should we think about that, and then what were the improvements like over 2015, and how should we think about that improving in 2016?

Shacey Petrovic - President-Insulet Diabetes Products

Management

Sure. So, the new patient improvement or the new patient retention rate is actually approximately the same as the whole. We don't really break it out. But we – it enables us to do sort of a retrospective analysis. So, when we ship a patient products for the first time, we ship them a starter kit, which is 90 days' worth of pods and the PDM. And so, what we started to track with the implementation of our new strategies was the – how many of these patients placed their second reorder. So, we could start to evaluate that four months after a new patient came on board. And what we saw with the implementation of some of these new strategies and support and programs was that we virtually halved our attrition rate with new patients. So, we really saw a dramatic impact there, but remember that new patients is only ever 10% of our total patient volume in any given time period. So, relative to the whole it's not a huge impact. As we look to 2016, our goal will be to take some of those really effective strategies and then also use our new patient app to really help drive ongoing improved performance, and a lot of that comes from as I said product quality and reliability, which we're doing really great with. And then also just with training, support, ongoing support for those patients and just a better customer experience, and we're working very hard at that also.

Kyle Rose - Canaccord Genuity, Inc.

Analyst · Kyle Rose of Canaccord. Your line is now open

Okay, great. I appreciate the color there. And then just a follow up on the new patient additions in 2015, just wanted to make sure my math is correct, but you get the two-thirds of the underlying patients – the global patient base in 2015, and 70% of the underlying patients are based in 2014. I guess – my math kind of says that implies 8,000 net additions in the U.S. year-over-year in 2015. So, I guess – one, am I on track with that math? But then two, on the OUS side when you think about 2016 guidance, how much of that 50% growth year-over-year comes from going direct in Canada, and how much of that comes from improved pricing that you'll see from a direct business versus distributor?

Michael L. Levitz - Chief Financial Officer

Management

This is Mike. I'll answer that last question first. And maybe turn it over to Shacey for the installed base piece. With regards to Canada, I think we've said in the past and it remains true that of our international revenues, our European distributor represents about 75% of that. And of the remaining 25%, Canada is the most meaningful part of that in – most of that remaining 25%. So that said, when you look at – just do the math with that – Canada, we're excited out being direct there. It's a great business, but it really is a very small part of things and really doesn't move the needle a whole lot frankly relative to our overall trends and guidance.

Shacey Petrovic - President-Insulet Diabetes Products

Management

And I think in terms of the installed base, you're, I think, directionally correct. We're a little bit over two-thirds in the U.S. today. You're pretty close. Next question?

Operator

Operator

And our next question is from the line of Jeff Johnson with Robert W. Baird. Your line is now open. Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker): Thank you. Good afternoon, guys. Michael, I wanted to ask a question on gross margins, just so I understand and I'm on the road, so I haven't pulled the restated ex-Neighborhood filings yet. But, I think you were talking about a gross margin in 2016 in the low-to-mid 50% range. Ex-Neighborhood, what was it in 2015? And could you adjust that for us with some of the costs you had that you excluded in 2015, kind of what's the baseline we should be building off of 2015 going into 2016 on the gross margin line ex-Neighborhood?

Michael L. Levitz - Chief Financial Officer

Management

Well, this is Mike. So, if – when you get an opportunity, if you look at the press release, when you're not on the road, the pro forma figures that we've shown here for 2015 would equate to a 50.5% gross margin on a pro forma, that's an unaudited obviously number. But, we wanted to give that indicative of, as you start to look year-over-year. So, I think it's fair to say with our expectations in the low-to-mid 50s that we expect the margins to be definitely better than they were last year, because last year included a number of different manufacturing challenges and write-offs of product. We talked about the Field Safety Notification and some of those other items, and we said they were non-recurring in nature. And so, we believe that to be the case, and so our guidance reflects having a much cleaner view this year and not having some of those same issues. I would love to say there's upside and we are driving to improve our gross margins. And I think that – and you can tell by our guidance that we expect over the coming years or next few years to be 60%-plus gross margin, that we believe there are some definitely real opportunities there. The challenge if you want to call it that is they don't happen overnight and that's what our guidance reflects for 2016. But, we're really excited about our opportunities for gross margin improvement over the next few years. Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker): Fair enough. And I did see that 50.5% number. I guess my question was does that include the costs – that 50.5% includes the costs on the Field Safety recall and what have you?

Michael L. Levitz - Chief Financial Officer

Management

Yes. The numbers in that table there basically take our reported numbers and the adjustments that are made are to pull out the effect of Neighborhood as if it had been divested. So there were no other adjustments to those figures.

Operator

Operator

And our next question is from the line of Doug Schenkel with Cowen & Company. Your line is now open. Ryan Blicker - Cowen & Co. LLC: Hi. This is Ryan Blicker in for Doug. Thanks for taking my questions. So starting with the U.S. OmniPod business. You obviously had some great patient starts in 2015, as well as some one-time headwinds I would say during the year. Considering how you expect to start out the year in that business and all of the positive qualitative commentary you provided, is there any reason why that business doesn't grow a bit faster than mid-teens in 2016?

Michael L. Levitz - Chief Financial Officer

Management

Well, this is Mike. Since I gave the guidance, I'll refer to that. I think that growing mid-teens, we've – Shacey gave guidance on a number of different commercial areas, including I think 20% growth in – 20%-plus growth in new patient starts again. So, that's to say that we expect continued success commercially, and that's reflected in our guidance. But, the reason we talked about new patient starts more as an indicator of future opportunity and in any one period, they don't represent a significant amount of the revenue impact. And so, mid-teens revenue growth, I think we believe is pretty strong. Are there opportunities to beat those numbers? Sure. There are definitely opportunities to beat that. I mean, I know that our entire team is very excited coming out of last year, and with what we expect for this year, and we believe that's reflected in our guidance. But, there's always challenges that can crop up. And so, when we give guidance, we wanted to be something that we believe reasonable, and would love to do better than that. Ryan Blicker - Cowen & Co. LLC: It's early in the year.

Shacey Petrovic - President-Insulet Diabetes Products

Management

Yes. Ryan Blicker - Cowen & Co. LLC: Okay. That's helpful. And then, just one on Drug Delivery. The full-year guidance seems to imply that you stay around this Q4 run rate for all of 2016. Can you just give us a sense of how much visibility you have into that throughout the year? And you gave us some sub-commentary on your evolving relationship with Amgen, but any additional color would be helpful, and what gives you confidence there? Thank you.

Michael L. Levitz - Chief Financial Officer

Management

Well, I'll speak to the financial impact aspect and Dan can speak to the relationship. From a financial standpoint, we've talked in the past about – we take orders from Amgen, and they give us a view into the future. And as you can see, by the significant growth we're talking about for the year, it's a very strong future and we're really excited about it. But, what we try and do is to levels that, you know, manufacturing and other things, is so that we can get manufacturing efficiencies and consistency of supply. And so, what you see reflected in the guidance is that level set. Again, as I've said before, is there upside to that – absolutely. As a continued adoption and everything else that would be great. But we – it's early in the year, as Pat said, so.

Operator

Operator

Ladies and gentlemen we have... Patrick J. Sullivan - President, Chief Executive Officer & Director: (57:02) Go ahead.

Operator

Operator

Ladies and gentlemen, we have time for one question. And our next question is from the line of Ben Andrew with William Blair. Your line is now open. Ben C. Andrew - William Blair & Co. LLC: Good afternoon. Thanks for squeezing me in at the end here. Pat or Shacey, can you talk about the manufacturing of the OmniPod going forward? Do you need to change any physical features of the product to support kind of where you're going with AP or with Bluetooth over the next two to three years that would entail kind of redoing manufacturing lines or things of that sort? Patrick J. Sullivan - President, Chief Executive Officer & Director: We got a shoe horn that puts you in here at the end. But as it relates to manufacturing, we just brought Chuck Alpuche on board, a very experienced manufacturing operations executive from PepsiCo and we are going through the process of developing the long-term manufacturing strategy. Right now, we have as you know lines in – four lines in China that are up and operational, I would say, they're going to be continuing for a very long period of time as we get into the product development and the artificial pancreas we are going to have to have different modifications or maybe modified some, one or several of the lines as that product ramps up. We're taking all of that into account as we continue to develop the long-term manufacturing and footprint of our manufacturing operations around the globe.

Operator

Operator

And that is all the time we have for questions. I would now like to turn the conference back to Pat Sullivan. Patrick J. Sullivan - President, Chief Executive Officer & Director: Great. Thank you, operator. Look at overall, I am – I continue to be very pleased with where the company stands today and I'm very excited about where we're headed. 2015 was a year in which we reenergized and refocused the organization, strengthening – strengthening our talent, realigning our sales team and executing a winning strategy to position Insulet for long-term, sustainable, profitable growth. I feel great about all that we've accomplished in 2015, and look forward to maximizing the potential of our innovative and differentiated technology. We entered 2016 with strong momentum and our entire team is looking forward with enthusiasm and confidence to the continued innovation and long-term sustainable growth for the company that lies ahead. Thank you for listening again today and we will see you at the end of the second quarter. Thank you.