Earnings Labs

Insulet Corporation (PODD)

Q3 2016 Earnings Call· Thu, Nov 3, 2016

$182.95

-2.85%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

+14.64%

1 Week

+17.83%

1 Month

+17.34%

vs S&P

+11.16%

Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Insulet Corporation Third Quarter 2016 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will 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 - Insulet Corp.

Management

Thank you and good afternoon and thank you for joining us for our third quarter 2016 earnings call. Joining me today are Patrick Sullivan, Chairman and Chief Executive Officer; Shacey Petrovic, President and Chief Operating Officer; Michael Levitz, Senior Vice President and Chief Financial Officer; and Daniel Levangie, President, Drug Delivery. The replay of this call will be archived on our website. Our press release discussing our third quarter 2016 results and fourth quarter and full year 2016 guidance is also available in the IR section of our website. Before we begin, we 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 third 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 - Insulet Corp.

Management

Thank you, Deb, and good afternoon, everyone, and thank you for joining us today. I'll begin with a brief review of our third quarter performance and recent business highlights and then Mike will discuss our financial results and provide our fourth quarter and full year guidance. Shacey will provide an update on our exciting commercial and R&D progress. Dan will then give us an update on our Drug Delivery business. We'll then turn the call over for questions. Before we get started, I'd like to first recognize November as National Diabetes Awareness Month. We're very proud of what we do every day to simplify life for people with diabetes by providing them with an easy-to-use and convenient technology to control their diabetes. We took part in the Closing Bell Ringing Ceremony at NASDAQ on November the 1 to continue to raise diabetes awareness. I'm once again thrilled with Insulet's continued strong performance in all aspects of our business. Our momentum this year remains very strong. And our team is making significant progress on all of our key initiatives in every facet of our business. As a result of this strong performance and our confidence in the future, we are raising our full year revenue guidance $13 million to $363 million at the midpoint, up from our previous midpoint guidance of $350 million, a growth of 38% year-over-year. Our gross margin continues to improve to 58.6%. We're reporting strong and impressive financial results in all product lines for the third quarter. Total revenue grew 30% year-over-year with total revenue of $95 million and $5.5 million higher than the midpoint of our guidance range. Third quarter U.S. Omnipod revenue was nearly $60 million, representing a strong 18% year-over-year growth. International Omnipod revenue of $19 million was stronger than we expected, primarily due…

Michael L. Levitz - Insulet Corp.

Management

Thank you, Pat. I will review the third quarter 2016 results and then introduce our fourth quarter and updated full year guidance. Our prior year results for comparative purposes exclude Neighborhood Diabetes which we divested in February of this year. As I review our results, unless otherwise stated, all commentary regarding changes will be on a year-over-year basis. We're very pleased to report third quarter revenue growth of 33%, with revenue of $94.9 million compared to $71.4 million. All three of our product lines contributed meaningfully to this increase. Our results this past quarter once again demonstrated significant growth, driven by the success of the ongoing commercial initiatives within our U.S. diabetes business, rapid volume growth internationally and strong growth in Drug Delivery. We exceeded the midpoint of our stated guidance by over $5 million, primarily due to strong demand for Omnipod from a growing installed base in the United States and existing markets in Europe, as well as higher-than-expected penetration in new markets such as France, with the remainder driven by continued strong adoption of the Neulasta Onpro system. Our gross margin increased to 58.6%, up over 14 points from 44.2% and higher than our expectation as our investments in improving manufacturing and supply chain efficiency and effectiveness, as well as improving the overall product quality are paying off. The improvement compared to last year reflect $7.7 million of costs in the third quarter of last year associated with products that did not meet our quality expectation, which negatively impacted prior year third quarter gross margin by nine points. The remainder of the year-over-year improvement was due to the supply chain operations improvements that we've made in 2016. We expect our gross margin for the remainder of this year to be in line with the third quarter. And, therefore,…

Shacey Petrovic - Insulet Corp.

Management

Thanks, Mike. Consistent with the first half of this year, we are converting market opportunity at record rate. And in Q3, we continued to deliver strong revenue and new patient growth. We're on track to grow our 2016 worldwide installed base by 20% and generate approximately 20% growth in our U.S. new patient starts, consistent with our previous guidance. The growth we've seen in new users and the significant loyalty in our existing customer base of Podders is driven by Omnipod's truly unique technology and its ability to simplify and improve the lives of people living with insulin-dependent diabetes. This quarter we achieved yet another record-setting number of new patient starts in both the U.S. and international markets. And I'm confident that this momentum will carry us through to a strong finish for the year. The four key drivers of Omnipod's growth have remained consistent throughout the year: first, targeted clinical messaging and a growing body of data demonstrating the benefits of Omnipod, particularly for multiple daily injection users; second, strong adoption of tools like Insulet Provided Glooko and our Omnipod customer mobile app, which improve training and support for our clinics and patients; third, our focus on a world-class customer experience; and fourth, continued strength in our international markets. First, our targeted clinical messaging. We continue to grow our body of clinical evidence supporting the many benefits of Omnipod in addition to the six presentations at the ADA scientific sessions in June of this year and two subsequent publications of compelling clinical studies demonstrating the benefits of Omnipod. Just this last month, Dr. William Polonsky's manuscript, Impact of Omnipod Insulin Management System on Quality of Life, was published in Diabetes Technology & Therapeutics. This study included more than 1,200 current adult Omnipod users with type 1 diabetes. They completed…

Daniel J. Levangie - Insulet Corp.

Management

Thanks, Shacey. As we reported earlier, we've had another very strong quarter performance in our Drug Delivery business. As reported by Amgen, the Onpro system continues to be adopted by oncologists and oncology clinics throughout the United States and the professional and consumer campaigns being conducted by Amgen are clearly being effective. Third quarter Drug Delivery revenue was $16 million and we believe we're on track for full year 2016 revenue of approximately $64 million. Our business development team in the field continues to make inroads in their discussions with additional Drug Delivery partners. And I'm very pleased with our progress in building a pipeline of projects that will generate growth for our business. As Pat announced earlier, I've made the decision to transition out of my position with Insulet at the end of this year. I've been involved with Insulet now for five years, having joined the company as a member of the Insulet board in late 2011 and transitioning into a full-time operating position two years ago. As I reflect on the last five years, I'm very proud of the progress we've made in establishing Insulet as a growth company serving so many patients with life-saving products. And I look forward to working with Shacey to complete a smooth transition. I'll also be available to Pat and the team in a consulting role as the need for my assistance dictates. I'd like to thank all of our employees, our customers and our investors for your support of our efforts during my tenure with the company. And, with that, I'll turn the call back to Pat.

Patrick J. Sullivan - Insulet Corp.

Management

Thanks, Dan. Operator, we'd like to now open the call up for questions.

Operator

Operator

Thank you. Our first question comes from the line of David Lewis with Morgan Stanley. Your line is open. Please go ahead. David Ryan Lewis - Morgan Stanley & Co. LLC: Good afternoon. Congrats on the quarter and, Dan, congrats on retirement. I feel like you're leaving as I arrived. So I'm trying not to take it personally. But two quick questions here. First, for Shacey maybe or Pat, the quarter guidance and the commentary suggest you're obviously seeing a little impact from this competitive channel dynamics that many are talking about. Are you seeing any impact, Shacey? And is there any reason to believe that your competitive insulation will change in anyway as you get closer to this competitor's launch? And then I had a quick follow-up on profitability.

Shacey Petrovic - Insulet Corp.

Management

Okay. So I would say we're really seeing very little impact. There's, of course, noise in the marketplace and customers are doing their research. But I think where we benefited that it's not the same target segment. 670 is very much focused on patients who are willing to wear a tubed pump, well controlled adults who are willing to put the work into get the incremental improvement with that system. And our target patient population, as we've talked about, I think, for many quarters now, is the multiple daily injection user and so we're targeted towards different segments. The other thing I would say is that, as you know, I'm sure, 670 is not approved for people 14 and younger. And it's actually black box in seven and younger. So the pediatric patient population, which is our fastest-growing segment, is not really eligible or appropriate for this technology. And as we get closer to this actually becoming available on the market, I actually would say that in that instance when people start to learn more about the technology, we're probably going to feel this a little bit less in the marketplace. But we are very confident in our growth and our opportunity and feeling good about the finish for this year and 2017. David Ryan Lewis - Morgan Stanley & Co. LLC: Okay. Very helpful. And then, Mike, I guess I should ask you how it feels to make some money, but I'll ask a serious question. Margins have been, obviously, the investor surprise this year and gross margins, obviously, have been heading higher (29:38). But you've been driving dramatic leverage, right. I think this is the fourth straight quarter where operating expenses continue to fall. So, it sounds like based on your commentary, looking forward I think at some point we have to expect that operating expense growth to tick back up. Is that sort of a same assumption from these depressed levels? And then in terms of gross margins, I'm expecting ratable improvements from here into 2017 and beyond, but obviously not the step function we saw here in 2016. Thanks so much.

Michael L. Levitz - Insulet Corp.

Management

Well, what I would say about profitability, yes, it was wonderful this quarter to be in positive EBIT territory. That's – as we've said before, we're almost familiar with being. (30:19) And we continue to expect to be positive in EBIT beginning in 2018. And as we've said before, it's within our control to move and be sustainably positive EBIT before then. But the opportunities in front of us with this product are significant. And when you think about the new product opportunities with the U200, U-500, our concentrated influence, which double our addressable market, in addition to the artificial pancreas and then the mobile Omnipod that precedes that, that we'll take more about at our Investor Day in the next couple weeks, these are very straightforward value creation opportunities from our perspective. And we want to make sure we make sufficient investments in the product development, in the clinical support and data, and in the commercial organization, operational organization, to drive that. So we will see an uptick in spending, but really mostly in those areas that I just described. As far as gross margin, we were pleased last quarter to say that we were at the new normal level and we've improved from, there really principally driven by improvements in yield, production effectiveness and efficiency with really driving down the amount of labor we've needed to use. We'll give more clarity around the gross margin improvements, but on the pathway to 65% and higher gross margins, we will be making regular improvements in that. And there are some different drivers along the way that we'll talk more about in a couple weeks at Investor Day, like the U.S. manufacturing and otherwise, but we're not waiting for that. We continue to expect regular improvements in gross margins.

Patrick J. Sullivan - Insulet Corp.

Management

Investing for growth. David Ryan Lewis - Morgan Stanley & Co. LLC: Thanks so much. Thanks, Pat.

Operator

Operator

Thank you. And our next question comes from the line of Brooks West with Piper Jaffray. Your line is open. Please go ahead. Brooks E. West - Piper Jaffray & Co.: Hi. Can you hear me?

Patrick J. Sullivan - Insulet Corp.

Management

We got you, Brooks. Brooks E. West - Piper Jaffray & Co.: Great. Thanks, Pat. Congratulations on a great quarter. I had kind of a follow-up question on the market influence of 670G, maybe looking at it from a different direction. I think there's a perception on the Street that maybe the Omnipod is sometimes looked at as a starter pump on a progression from a patient to a more complex technology. So I'm wondering, Shacey or Pat, if you'd comment on that. And then as you look at your attrition rate and where those patients go after Omnipod, I'm wondering, do you have a sense for are they progressing to a tubed pump? Are they dropping off pump therapy? That would be a helpful clarification. And then I've got a follow-up.

Shacey Petrovic - Insulet Corp.

Management

Sure. I would say – I think that's a great characterization of our technology. We are very much the pump that patients from MDI go to. And we're able to get people to transition from MDI therapy to pump therapy just because of Omnipod's form factor and its simplicity and ease-of-use. And so, I think, that's a great way to describe us. And, in fact, we've got a fairly strong retention rate and loyalty in our customer base. So, remember, in any given time period, we really only have 9% of patients falloff the product. And of those, I wouldn't say we see transition to tubed pumps. When people get used to relying on a system that isn't tethered and gives them that freedom of life and that ability to exercise and sleep and run busy lives with that freedom, they generally don't want to move to a tethered product. Brooks E. West - Piper Jaffray & Co.: Okay. That's helpful. And I was hoping you were going to say a lower attrition rate but you still said the 9%.

Patrick J. Sullivan - Insulet Corp.

Management

Well, half of that, Brooks, is due to the economics and product performance. And we're making improvements in all of those to really improve the attrition rate. So it's an area we're focused on by improved market access and in our manufacturing to continuously improve product quality. Brooks E. West - Piper Jaffray & Co.: Okay. That's helpful. And then my follow-up was on the Lilly. I thought I heard you say that Lilly finished the trial for the U-500. I wanted to make sure if that was correct. And then does that – we've been speculating on a product timeline to market; it maybe late 2017 or early 2018. Does that fit? I know that's not 100% in your control, but it feels like maybe the trial got done a little bit earlier than we thought.

Shacey Petrovic - Insulet Corp.

Management

Well, I should clarify. So thanks for giving me that opportunity. We finished enrollment. So the trial will go actually through the better part of next year. So we really are looking – projecting this to be late 2018, 2019 in terms of market entry. Brooks E. West - Piper Jaffray & Co.: Got it, okay. Thanks so much.

Shacey Petrovic - Insulet Corp.

Management

Sure.

Operator

Operator

Thank you. And our next question comes from the line of Mike Weinstein with JP Morgan. Your line is open. Please go ahead.

Michael Weinstein - JPMorgan Securities LLC

Analyst · JP Morgan. Your line is open. Please go ahead.

Thank you. And I'll add my congratulations. I apologize if I missed this. We have four earnings calls happening at the same time, so it's hard to catch everything. But I just wanted to come back to a couple of your comments. So, one, you said that – are you on track for 20% growth in U.S. new patient starts this year? Two, Shacey, I thought I heard you say that the bottom-line is that despite the recent noise, we believe, continue to grow at 20% year-over-year. And I just wanted to clarify, we're you talking about U.S. new patients starts next year or were you talking about revenues? Maybe just clarify that?

Shacey Petrovic - Insulet Corp.

Management

Sure.

Michael Weinstein - JPMorgan Securities LLC

Analyst · JP Morgan. Your line is open. Please go ahead.

And then just the third item is, could you just talk about the cash raise? Because now you have a lot more cash, obviously, more debt too than you had previously. How much of that is going to the facility investments you're making and is there anything else you're planning on doing with it? Thanks.

Shacey Petrovic - Insulet Corp.

Management

Yes. I'll take the first two and then I'll punt to Mike for the third one. So, we are very much on track for 20% growth in new patient starts in the United States. And when I was reefing to 20% growth, I just meant global new patients. I wasn't referring to revenue.

Michael L. Levitz - Insulet Corp.

Management

And with regards to the cash raise, so we ended up with a net cash raise of about $180 million, because we used the $345 million of new notes, which were at a wonderfully low coupon of 1.25%. We used a portion to buy back two-thirds of our existing 2% note. So, net-net we ended with $180 the million and we intend to use that for the U.S. manufacturing investment and there's still roughly $67 million of the 2% notes out there. So, there's also the opportunity to consider buying back some of those over time. And as we talked about, there are a number of opportunities across the business to make investments. And we want to make sure that we're not really thinking about the cash when we're doing that. So that's how we intend to use the cash.

Michael Weinstein - JPMorgan Securities LLC

Analyst · JP Morgan. Your line is open. Please go ahead.

Okay. Let me just clarify a couple items. So, Shacey, on the 20%, obviously, in light of the activity in all of the diabetes stocks over the last week and really last month or so, just want to clarify your view on the sustainability of new patient starts in the U.S. I don't think people are really worried about outside the U.S., particularly in the back what's happening in France for you guys. So can you just give us your view on the sustainability of the growth rates we're seeing in new patient starts in the U.S.? And then just maybe one last question for Mike and then I'll drop. Just the inventory levels continue to rise here to new levels that we weren't expecting. Could you just talk about where those are headed? I know you're trying to support this transition from air freight to ocean freight but could you set expectations? Thank you.

Shacey Petrovic - Insulet Corp.

Management

Sure, Mike. We believe that the growth is eminently sustainable. I don't know how else to say it. I think there is noise in the marketplace but that's our job to clarify and educate around the noise. And we believe we have a very unique value opposition that's targeted towards a different segment of the market, people that are relying on multiple daily injections today. And that is not an appropriate segment to transition to a product creating this competitive noise in the market.

Patrick J. Sullivan - Insulet Corp.

Management

Yes. And I would just add, Mike, that I think as evidence of our confidence in our diabetes business, we are raising guidance $13 million at the midpoint. And that's across all business lines, international, Drug Delivery and U.S. diabetes. So we're very confident of our ability to continue to grow the diabetes business in the U.S.

Michael L. Levitz - Insulet Corp.

Management

And this is Mike. With regards to your question on inventory levels, the growth in inventory is exactly as we planned and as we expected. This is entirely consistent with what we talked about making sure we have enough product for the transition to the lower cost mode of transportation with ocean freight as well as supporting the growth of the business. So in terms of expectations, I really don't – we don't expect it to grow a whole lot more as we get into year-end. But as we're making these transitions, this is what we believe is the level that we're comfortable at the support of the growing demand.

Operator

Operator

Thank you. And our next question comes from the line of Tao Levy with Wedbush. Your line is open. Please go ahead.

Tao L. Levy - Wedbush Securities, Inc.

Analyst · Wedbush. Your line is open. Please go ahead.

Great. Thanks. Congratulations on a great quarter. Just maybe I could ask about the Lilly program. Is it possible that we can see that data presented at next year's ADA? It seems like it has completed enrollment early. It's 27-week follow-up. Is that in the realm?

Shacey Petrovic - Insulet Corp.

Management

I think it's possible, but it is Lily's clinical trial. So we'll certainly support them in getting this clinical data out into the community as quickly as possible. But it really is their data to collect, analyze, and publish when they see fit.

Tao L. Levy - Wedbush Securities, Inc.

Analyst · Wedbush. Your line is open. Please go ahead.

Okay. And as a follow-up, you spoke very specifically about the OUS opportunity as being huge. Outside of Europe, is there a strategy in place? Is there a plan that you can go after?

Shacey Petrovic - Insulet Corp.

Management

There is a strategy in place in terms of geographic expansion over the long-term with the business. But our focus in the more near-term is on U.S., Canada and Europe. But I would say even within Europe, we are not by any means fully penetrated or even half the way penetrated into the countries with opportunity in Europe. So, we see a tremendous opportunity just in terms of expansion in Europe. And then beyond that, of course, there are attractive markets across the globe that would benefit from Omnipod. So that's a longer-term plan I would say. But in the near-term, we really see great opportunity for continued growth within the MDI segment here and abroad. And also with our partner, with Ypsomed in Europe and across those markets, both in our existing markets to continue to grow, but also in terms of market expansion across Europe.

Tao L. Levy - Wedbush Securities, Inc.

Analyst · Wedbush. Your line is open. Please go ahead.

And do you help Ypsomed on that market expansion in Europe or is that really on their responsibilities?

Shacey Petrovic - Insulet Corp.

Management

It's their responsibility from a commercial standpoint. We do the development work to be able to enter into new markets and the regulatory work to be able to enter into new markets. And, of course, we do market research with key opinion leaders to get input into our product development and clinical plans. But in terms of entering into a market and the commercial activities, that's primarily Ypsomed.

Tao L. Levy - Wedbush Securities, Inc.

Analyst · Wedbush. Your line is open. Please go ahead.

Okay. Great. Thanks a lot.

Shacey Petrovic - Insulet Corp.

Management

Sure.

Operator

Operator

Thank you. And our next question comes from the line of Danielle Antalffy with Leerink Partners. Your line is open. Please go ahead.

Danielle J. Antalffy - Leerink Partners LLC

Analyst · Leerink Partners. Your line is open. Please go ahead.

Hey. Good afternoon, guys. Thanks so much for taking the question and congratulations on an excellent quarter. Guys, I just wanted to ask you pretty high level. Sorry, if I missed this. I'm also on a few earnings calls at once. But just the diabetes market as a whole, I mean a few tough quarters for some of the competitive diabetes companies. J&J called out a difficult quarter in their – actually specifically in their pump business, but, of course, the strip business, Tandem, also, Dexcom called out some noise around the competition. What are you guys seeing in the market? I mean clearly you guys put up really great numbers. So is this something that you, Insulet, are just immune to or perhaps there are other factors that we're not considering that the market's actually still growing but maybe there are issues with those specific companies.

Shacey Petrovic - Insulet Corp.

Management

Danielle, I would say that we are somewhat immune to it just based on which market segment we're focused on, the fact that again we're focused on that MDI segment. Second of all, the pediatric patient population is such an important fast-growing component of our patient population. And that is not a population that will be eligible for or appropriate for competing products that we're talking about. And I think also the fact that we have geographically diverse revenue streams. And this is very much, I think, U.S. noise that's happening at this point. So I think we really have just been impacted less than some of the other companies out there.

Michael L. Levitz - Insulet Corp.

Management

And Danielle, this is – I would just add that we have a recurring revenue model. And that is different from some of those other parties that you described. So it provides us a greater degree of stability.

Danielle J. Antalffy - Leerink Partners LLC

Analyst · Leerink Partners. Your line is open. Please go ahead.

Understood. That's really helpful. So just a follow up on that. I mean do you see the pump market – is the insulin pump market growing and you guys are growing significantly faster than that or do you think the pump market has decelerated at all?

Shacey Petrovic - Insulet Corp.

Management

I would say that we're growing fast and we're helping the pump market to grow. We don't really consider ourselves as taking share within the pump market. We're looking at the entire type 1 diabetes patient population. But we are definitely growing faster than the pump market but at least all market estimates are that the pump market is growing between 5% and 10% CAGR, annual CAGR at least in the United States.

Danielle J. Antalffy - Leerink Partners LLC

Analyst · Leerink Partners. Your line is open. Please go ahead.

Great. Thanks so much.

Operator

Operator

Thank you. And our next question comes from the line of Jayson Bedford with Raymond James. Your line is open. Please go ahead. Jayson T. Bedford - Raymond James & Associates, Inc.: Good afternoon and thanks for taking the questions. Apologize if I missed this. But gross margins continue to be strong here. You signed the new manufacturing agreement with Flextronics during the quarter. Just wondering – are the economics more favorable to Insulet versus the old contract? And I'm wondering if that had an impact on gross margins over the last couple quarters.

Michael L. Levitz - Insulet Corp.

Management

Jayson, it's Mike. What drove the improvements in gross margins was improvement in yield, the effectiveness for manufacturing, the quality with which we're doing it and efficiency with which we're doing it. Pat mentioned that we've been able to reduce head count while we've been growing daily volumes, while we've been reducing scrap and increasing yield. That's what's been driving the improvement. In terms of the arrangement with Flextronics, we're very pleased in September to renew that arrangement. The way that the arrangement works is we've really been working together to drive incentives together where both parties are really driven to improve the efficiency and effectiveness of the operation. And so I wouldn't say that it's economics built into specifics in the agreement as much as it is that we're well aligned together to really drive these types of improvements. And that's what we're seeing. Jayson T. Bedford - Raymond James & Associates, Inc.: Okay. That's fair. Pat, apologize again if I missed this. But any update on Medicare reimbursement?

Patrick J. Sullivan - Insulet Corp.

Management

I'd be disappointed if somebody didn't ask me that. Jayson T. Bedford - Raymond James & Associates, Inc.: Yeah.

Patrick J. Sullivan - Insulet Corp.

Management

Not any new updates other than we continued to work very closely with CMS. Washington has been busy as you might expect, but we are working very closely with them on the two initiatives we talked about. And I hope to get it before my 61st birthday, which is coming up pretty soon. Jayson T. Bedford - Raymond James & Associates, Inc.: Fair enough. And then maybe just to spread the questions here. Dan, you mentioned new partnerships. I think you may have just been referring to going after new partnerships. But just to be clear, did you sign any new ones during the quarter?

Daniel J. Levangie - Insulet Corp.

Management

Yeah, Jayson, what I said was I'm really pleased with the pipeline of projects that we have at hand. And didn't identify any new projects. We're not going to talk about individual projects because of the confidential nature of those agreements with our pharmaceutical partners. I'd just leave it at that. Really happy with the progress we've made in developing a pipeline of opportunities that I think will pay off handsomely down the road for the company. Jayson T. Bedford - Raymond James & Associates, Inc.: Fair enough. Thank you.

Operator

Operator

Thank you. And our next question comes from the line of Raj Denhoy with Jefferies. Your line is open. Please go ahead.

Raj Denhoy - Jefferies LLC

Analyst · Jefferies. Your line is open. Please go ahead.

Hi. Good afternoon. Lots been asked, but I just – I'm curious about. You mentioned pediatrics as a defense against 670G and some of the limitations with that product. Is there anything you're willing to sort of share in terms of how many of your patients, your new starts at this point are pediatric?

Shacey Petrovic - Insulet Corp.

Management

So, Raj, I wouldn't say defense. I just think it's a reason why it's a separate segment and a separate target and a separate value proposition. But I'm not sure how much we shared before, but pediatric patients are approximately 30% of our total patient population.

Raj Denhoy - Jefferies LLC

Analyst · Jefferies. Your line is open. Please go ahead.

And what about of the new patients that are coming in? Are pediatrics – I guess, I won't ask you for a full number, but is it a higher number than that 30% in the sense is your pediatric volume growing?

Shacey Petrovic - Insulet Corp.

Management

I think it's in that neighborhood. I don't really know it off the top of my head and I don't want to give you a wrong answer but it's in that neighborhood.

Raj Denhoy - Jefferies LLC

Analyst · Jefferies. Your line is open. Please go ahead.

Okay. That's fair. And then just in terms of things you're doing on the sales force side in terms of continuing to grow that effort. Clearly the numbers are good. So I imagine you're adding salespeople, but anything you can provide with that?

Shacey Petrovic - Insulet Corp.

Management

Sure. We're very pleased that sales force productivity is now at the pre-expansion level, just where we thought it would be from the previous sales force expansion. So we are evaluating and likely will expand the sales force as we look at the growth opportunities before us in 2017 and maybe even before then.

Raj Denhoy - Jefferies LLC

Analyst · Jefferies. Your line is open. Please go ahead.

Great. Thank you.

Shacey Petrovic - Insulet Corp.

Management

Sure.

Operator

Operator

Thank you. And our next question comes from the line of Ben Andrew with William Blair. Your line is open. Please go ahead. Ben C. Andrew - William Blair & Co. LLC: Good afternoon and maybe a question for Shacey first on the attrition. We've talked over time about trying to take some of the lessons learned in new patients and translate that to the installed base. Can you break down the sources of attrition for us as they're different somewhat in the installed base and then what initiatives you guys are looking at over what timeframe?

Shacey Petrovic - Insulet Corp.

Management

Sure. So we do track this very closely, by the way. And we have made progress on new patient attrition. It's just that I don't want to get too far ahead of ourselves and it is kind of a lagging indicator. But we do see encouraging signs that we are providing a better customer experience and that should lead, of course, to satisfaction and retention. There are two main drivers to patient attrition. The first is just the product quality and experience. So I think part of what's driving the improvements that we see in retention is just improving product quality in the field. And then the other main driver is market access reimbursement and coverage. So, for example, we have sadly Podders that age into Medicare and lose coverage for Omnipod. That's just one example. When we lose coverage that's obviously a driver and it's one of the reasons why we've invested in market access and why we continue to invest in clinical data on the outcomes and cost economics of Omnipod because that's what can help us secure and expand our market access position and address that side of retention. Ben C. Andrew - William Blair & Co. LLC: Okay. And then my follow-up is on the international side. And obviously you've got the partnership with Ypsomed that runs for a couple more years. What other direct or perhaps distributor-based international opportunities are there aside from where you're already working with Ypsomed that you're particularly excited about that could be incremental as we move into 2017 and 2018?

Shacey Petrovic - Insulet Corp.

Management

For example, we're not heavily penetrated into Central and Eastern Europe. So, most of our business today is in Western Europe, so there's opportunity there. But I would say that there's opportunity everywhere across Europe. I mean Ypsomed has done a nice job growing the business and they've been a great partner for us over the years. But still, as in the United States, there's relatively low penetration of pump utilization. So there's an opportunity to continue to grow that market and continue to penetrate into our existing markets as well as growing into some newer countries. Ben C. Andrew - William Blair & Co. LLC: Are there reimbursement challenges there or just you need to get feet on the street and kind of detail the product successfully?

Shacey Petrovic - Insulet Corp.

Management

It just really depends on the market. Obviously it's fragmented in Europe, so it just depends on the particular country. There's a mix of both. And ultimately I think anywhere you sell Omnipod, you're going to need to build an expertise in market access, just like we're doing in the United States. Ben C. Andrew - William Blair & Co. LLC: Great. Thank you.

Operator

Operator

Thank you. And our next question comes from the line of Doug Schenkel with Cowen & Company. Your line is open. Please go ahead. Ryan Blicker - Cowen & Co. LLC: Hi. This is Ryan Blicker on for Doug. Thanks for taking my questions. So, another really strong quarter across the entire diabetes business. I think even when assuming a pretty high reorder rate, it's pretty tough to get to these revenue numbers without assuming that you're tracking to higher than 20% installed base growth for the year. Any comment about that?

Patrick J. Sullivan - Insulet Corp.

Management

No. Ryan Blicker - Cowen & Co. LLC: Okay. Fair enough. Okay. Sorry, go ahead.

Michael L. Levitz - Insulet Corp.

Management

Well Mike, I think it's fair to say that what we've said before is what we expect for the year, the 20% growth in new patient starts in the United States and 20% global growth. Yeah.

Patrick J. Sullivan - Insulet Corp.

Management

Consistent with our previous comments on the installed base growth is the 20% number is the one we're very comfortable with. Ryan Blicker - Cowen & Co. LLC: Okay. That's helpful. And then, one of the pipeline; I apologize if I missed this. But did you begin on body trials of your artificial pancreas product late in the quarter or early this quarter? And is 2019 still the right way to think about the U.S. launch of that system?

Shacey Petrovic - Insulet Corp.

Management

Yes, and yes. In fact, we started on body trials, I guess – when was the first – it was September. So that was the first IDE. And then we've just gotten second phase IDE approved by the FDA to look at that on body system and the algorithm performance in pediatrics and adolescents. And I think 2019 is the right way to look at the system entry. Ryan Blicker - Cowen & Co. LLC: Okay. Thank you.

Shacey Petrovic - Insulet Corp.

Management

Sure.

Operator

Operator

Thank you. And our next question comes from the line of Suraj Kalia with Northland Securities. Your line is open. Please go ahead.

Suraj A. Kalia - Northland Securities, Inc.

Analyst · Northland Securities. Your line is open. Please go ahead.

Good afternoon, everyone. Thank you for taking my questions. So, first, Dan, let me just start out, congrats to you and the team. You guys have executed a phenomenal turnaround in the last seven quarters, eight quarters and kudos to the entire team. That having said, let me start out with the two questions for Shacey. Shacey, obviously a lot of questions have been asked on the 670G. And I thought I heard you say that you all are not being affected. It's a different target market, especially in pediatrics. At least I thought I heard that. I guess my question, Shacey, is why do you all feel you are not being affected? My understanding is the 670G is 14 years and older indication on label. Are you all seeing no impact? Is it simply because of Medtronic's current marketing efforts – they're trying to convert their existing users to the 670 or any – if you could help me reconcile why you all are not seeing the impact?

Shacey Petrovic - Insulet Corp.

Management

Right. Sure. So, right. One reason is the one that you alluded to, which is that the product is not appropriate or indicated for the pediatric segment. I think the other reason that you're alluding to is that the data for 670G included well controlled patients on existing pump therapy. So I don't know Medtronic's strategy but it would seem like a likely target that they will focus on tubed pump patients who are well controlled. And then the third reason is it's just not our segment. We are sales strategy, our commercial organization. Our messaging is focused on the multiple daily injection patients. That is not where 670G is focused. And so I guess that's part of what's protecting us. We do – I don't want to underestimate. There is a tremendous amount of noise in the market. And so we are spending time clarifying what this new technology is and what it is not. And I guess we're just resonating and getting through that noise. But that's going to be with us for a while and we're fully prepared to do that. We have a different market segment and what we think is a very unique value proposition with Omnipod.

Suraj A. Kalia - Northland Securities, Inc.

Analyst · Northland Securities. Your line is open. Please go ahead.

And for my follow-up question, Shacey, I know you all – you mentioned something about the FDA just approved the second IDE. Shacey, can you give us some additional color on your artificial pancreas program? I guess what I'm really trying to understand is, is it Hybrid or is it true closed loop? Are you all looking at hyperglycemic events? Are you'll looking at – there's so many variables as we all know and I think 2018, 2019 keeps coming up. That's a pretty fast ramp-up from trial to launch and any color on – what is this product eventually going to be looking at? Thank you for taking my questions.

Shacey Petrovic - Insulet Corp.

Management

Sure. You're welcome. So I would agree. Artificial pancreas means a lot of different things to a lot of different people. And in fact I'm getting a little unenamoured with the name itself. It's an artificial pancreas research program. Our first product is the Omnipod Horizon Automated Glucose Control System. This is a Hybrid Loop Control System. But I think what we've done is taken a step back and said, what do people living with type 1 diabetes really want in an Automated Glucose Control System. And so we're focused less on features and technology and more on the user experience and how do we provide better control and better user experience. So we are anticipating that our system will be fully closed loop system overnight with Hybrid Loop Control System during the day.

Operator

Operator

Thank you. We have time for one more question. And our last question will come from the line of Jeff Johnson with Robert Baird. Your line is open. Please go ahead. Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker): Thank you. Good afternoon, guys, and congratulations on the quarter. Shacey, let me just follow-up on that question. The Hybrid Closed Loop during the day on the Horizon System, I think I might have asked you this question before, but I'm going to ask it again. Would that have an auto bolus component as well maybe a high, medium, low carb choice or something like that, but a meal time auto-bolus, something like that, in it as well?

Shacey Petrovic - Insulet Corp.

Management

The patient will still be required to bolus. So we are looking at ways to reduce the burden of carb estimation as you just alluded to, but the patient will be required to bolus. Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker): Okay. That's helpful. Thank you. And then, Dan, just one question for you and congratulations on the retirement. But question for you on the Drug Delivery pipeline. And that is timelines change in a lot of these things. I know you guys say you're making a lot of progress there. I guess what I'm wondering is, as those timelines change, I think the last update you gave or commentary you've made in the past is the next Drug Delivery product could be a few years out, three years to four years out. Could you update that timeline? When might we see another Drug Delivery product outside of the Onpro system contributing to your revenues?

Daniel J. Levangie - Insulet Corp.

Management

Yes. I'd say we're kind of in the same zone here of four years to five years, would be my best estimate. Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker): Kind of four years to five years from where we are today, is that how you – just to clarify?

Daniel J. Levangie - Insulet Corp.

Management

Yes. Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker): Thank you.

Operator

Operator

I'm showing no further questions at this time. And I'd like to turn the conference back over to Pat Sullivan for his closing remarks.

Patrick J. Sullivan - Insulet Corp.

Management

Thank you, operator. Let me summarize by saying again how pleased I am with the progress and the performance of the company not just during the last two quarters of remarkable growth, but our employees' commitment and focus during a time of significant transition over the last couple of years. We still have tremendous opportunities for growth in front of us. And I am impressed every day by the team's passion and execution. Our line of sight to sustainable and profitable growth comes more into focus each and every day. We will continue to build on our foundation and execute on our strategy and we are more confident than ever we will deliver long-term sustainable and profitable growth for our investors. Our Q3 results simply speak for themselves. I'd like to close by thanking the Insulet employees for all your hard work and dedication in doing what you do every day to simplify life for people with diabetes. Terrific job, well done, and keep up the great work. We look forward sharing much more with you in a couple of weeks at our Investor Day in Boston on November the 16. Thank you for your participation today. And, Dan, good luck.

Daniel J. Levangie - Insulet Corp.

Management

Thanks, Pat.

Operator

Operator

Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day. You may all disconnect.