Deborah R. Gordon - Insulet Corp. Patrick J. Sullivan - Insulet Corp. Michael L. Levitz - Insulet Corp. Shacey Petrovic - Insulet Corp..

Jeff D. Johnson - Robert W. Baird & Co., Inc. Scott S. Wang - Morgan Stanley & Co. LLC Robbie J. Marcus - JPMorgan Securities LLC Tao L. Levy - Wedbush Securities, Inc. Ryan Blicker - Cowen & Co. LLC Dominick Leali - Raymond James Financial, Inc. Danielle J. Antalffy - Leerink Partners LLC Raj Denhoy - Jefferies LLC Kyle William Rose - Canaccord Genuity, Inc.

Suraj Kalia - Northland Securities, Inc..

Good afternoon, ladies and gentlemen, and welcome to the Insulet Corporation First Quarter 2017 Earnings 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..

Thank you, Andrew. Good afternoon and thank you for joining us for our first quarter 2017 earnings call. Joining me today are Patrick Sullivan, Chairman and Chief Executive Officer; Shacey Petrovic, President and Chief Operating Officer; and Michael Levitz, Senior Vice President and Chief Financial Officer.

The replay of this call will be archived on our website. Our press release discussing our first quarter 2017 results and second quarter and full year 2017 guidance is 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 involves 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 first quarter earnings release and in the company's filings with the SEC. With that, I'll turn the call over to Pat..

Thank you, Deb. Good afternoon, and thank you for joining us on the call today. I'll begin with a brief review of our first quarter performance and share recent business highlights and accomplishments. Mike will then discuss our first quarter financial results in more detail and provide our second quarter and updated full-year 2017 guidance.

Shacey will then give an update on our exciting commercial and R&D progress and then we'll open the call up for questions. I'm once again thrilled with Insulet's performance. We exited 2016 with strong momentum exceeding expectations in each quarter and we are continuing this positive trend in 2017.

We're executing on all of our commercial and operational strategies and making significant progress on all of our initiatives. We finished Q1 2017 with revenue of $102 million representing year-over-year growth of 25% and $4 million above the midpoint of our guidance range.

Our gross margin for Q1 improved to over 58% from just one year ago and we are on track to achieve our long-term target of 65% Every area of our business delivered outstanding performance. U.S. Omnipod revenue was $60 million, a strong growth of 18% over the prior year.

Our International Omnipod revenue was $25 million, a significant growth of over 60% versus the prior year. We achieved strong growth in our installed base in both the U.S. and internationally positioning us for our continued near- and long-term growth.

Our Drug Delivery revenue was $17 million, in line with our expectations and representing growth of 12% over the prior year. This performance was primarily due to sales to Amgen and according to Amgen's most recent public commentary, sales of its Neulasta Onpro kit represented over 50% of the U.S.

Neulasta doses at the end of the first quarter of 2017. This impressive growth trajectory was achieved in just over two years. Turning to some of the other highlights for the quarter. We continued to make significant progress on our manufacturing and supply chain initiatives.

In 2016, these improvements resulted in dramatic gains in gross margin and allowed us to achieve an approximate 15% savings per pod. Our 2016 productivity, our line efficiency and reduction in scrap plus our ongoing improvement efforts continue to drive sustainable cost savings.

At the end of 2016, we completed the beta launch of our product shipments from China to the United States via ocean freight. During the first quarter, we increased ocean shipments to approximately 30% of our first quarter manufactured volume for the United States. And we plan to increase this rate during the course of this year.

As a reminder, we expect our move from air to ocean freight will have a positive partial-year impact to gross margin in 2017 of approximately half a point and on an annual basis, a positive impact to our gross margin of a full point.

We are also incredibly excited about the progress we are making with our new state-of-the-art manufacturing facility in Massachusetts where we will install highly automated manufacturing lines, the first of which we expect to be operational in 2019.

Turing to our innovation efforts, we're making significant progress on and are extraordinarily excited about introducing our Omnipod Dash product at the American Diabetes Association Trade Show in June.

This will also be the technology platform for our artificial pancreas development program, which is progressing extremely well with very promising results to date. These development efforts will allow Insulet to maintain its competitive edge with truly innovative and differentiated products.

Our significant product differentiation and the strength of our business model continue to insulate us from much of the distractions that exist in the diabetes market today. Our installed base is growing at a very strong rate and we remain fully on track to achieve our five-year target of $1 billion in revenue. Turning to Drug Delivery.

In addition to our existing relationship with Amgen, we continue to work closely with many pharmaceutical partners for the delivery of a number of drugs using our Omnipod technology.

We have a unique value proposition within this area of our business, and we are excited about the long-term potential and value-creation opportunity this business provides. And as I review the team's significant accomplishments, I'm very proud of their dedication, their hard work, strategic vision and extraordinarily high-quality execution.

And I'm even more excited about what the future holds. We have put in place and are fully executing on a strong and robust strategy that has positioned Insulet for near and long-term growth and value creation. With that, I'll turn the call over to Mike.

Michael?.

Thank you, Pat. I will review our first quarter results and then discuss our second quarter and full-year 2017 guidance. As I review our results, unless otherwise stated, all commentary regarding changes will be on a year-over-year basis.

We are very pleased to report first quarter revenue growth of 25%, with revenue of $101.7 million compared to $81.2 million. All three of our product lines contributed meaningfully to this growth. We exceeded the midpoint of our stated guidance by $4 million with approximately two-thirds of the beat coming from U.S.

Omnipod and one-third from International Omnipod, with both due to strong demand from our growing installed base. Our first quarter gross margin increased 420 basis points to 58.4% primarily from improvements we have made over the last year to our manufacturing and supply chain operations as well as improvements in product quality.

Our operating expenses increased to $64.7 million compared to $51.8 million, and were consistent year-over-year as a percentage of revenues.

The increase in spending reflects head count added over the last year to support the growth in our business, including increased investment in development and clinical work on our innovation projects, as well as the expansion of our commercial and operational infrastructure consistent with our stated plans and objectives.

We ended the quarter with $254 million in cash and investment, compared to approximately $300 million at the end of 2016. The decrease is a result of capital expenditures primarily associated with our U.S. manufacturing project which is on plan and to a lesser extent working capital timing.

We are very pleased with our strong financial position as we continue to make strategic investments in support of our near and longer term organic growth opportunities. I will now update you on our 2017 outlook.

For the full year, we are raising the low end of our previously stated revenue range by $5 million, largely associated with International Omnipod sales. And we now expect revenue in a range of $425 million to $440 million, compared to revenue of $367 million, representing growth of 18% at the midpoint.

This guidance reflects our expectation of continued strong growth across all of our business lines. First, we expect full year U.S. Omnipod in the range of $258 million to $265 million, representing growth of 14% at the midpoint.

Second, we expect International Omnipod in the range of $97 million to $101 million, now representing growth of 38% at the midpoint. And third, we expect Drug Delivery in the range of $70 million to $74 million representing growth of 10% at the midpoint.

For the second quarter of 2017, we expect revenue in the range of $104 million to $108 million, compared to $87.3 million and representing growth of 21% at the midpoint. This will be driven by continued strong growth across all of our business lines. First, we expect second quarter U.S.

Omnipod in the range of $62.5 million to $64.5 million, representing growth of 13% at the midpoint. As we shared on our last earnings call, our U.S. Omnipod year-over-year growth is net of a two-point impact from the contractual expiration near the start of this year of a historic royalty rearrangement.

Second, we expect International Omnipod in the range of $25 million to $26 million, representing growth of 54% at the midpoint. And third, we expect Drug Delivery in the range of $16.5 million to $17.5 million, representing growth of 18% at the midpoint.

On gross margin, we are reaffirming our expectation that full year gross margin will increase significantly, approaching 60% for 2017 compared to 57.5% for 2016. This reflects the significant operational improvements we've made over the last year.

We are extremely pleased with the tremendous progress to-date in margin expansion despite the unfavorable mix impact of better than expected international distributor revenue, which pressures overall gross margin. Our performance continues to support our multiyear gross margin target of 65%.

To achieve our goals, we will continue to invest in our business to drive long-term growth and profitability, including commercial, research and development, and infrastructure investments.

While our level of spend for the upcoming year may change, we are reaffirming our expectation of an approximate 20% to 25% increase in full year 2017 operating expenses from 2016. This will be driven largely by the increased spend we described to you last quarter to support our exciting product development and innovation pipeline.

Expansion of our commercial team to meet our growing demand and investments in our manufacturing, supply chain operations and overall operational infrastructure. We continue to expect EBIT in 2017 to be roughly in line with 2016 and are on track with our goal of becoming sustainably EBIT positive beginning 2018.

We also remain confident about reaching our longer term targets of $1 billion in revenue in five years with gross margin of 65% or higher, delivering above market profitability. I will now turn the call over to Shacey..

Thanks, Mike. 2017 is off to a terrific start with this successful first quarter. Our commercial strategies are driving robust revenue growth and a strong increase in our installed base. We also made substantial progress on innovation for both our diabetes and Drug Delivery businesses with great momentum headed into the remainder of this year.

As I mentioned on our last call, our recurring revenue model makes installed base growth the best predictor of future revenue growth. We are affirming our full-year guidance of 20% growth in our installed base with 15% in the United States.

In Q1, our installed base grew 15% year-over-year as we expected and our international installed base grew over 60% exceeding our expectation. Combined, this represents year-over-year growth in our global installed base of approximately 30% as of the end of the first quarter which drove our strong company revenue growth of 25%.

As a reminder, our installed base is an estimate due to the fact that close to half of our U.S. sales and most of our international sales are through third-party distributors. The installed base estimate is net of attrition which remained consistent with previous quarters. The U.S.

double-digit revenue growth was fueled by our investments to increase the field sales footprint, raise product awareness and improve market access for Omnipod.

In Q1, we completed our sales force expansion and armed them with compelling data demonstrating the positive impact Omnipod has on a user's quality of life and reduction of burden for people living with diabetes.

This expansion is driving increased penetration into existing endocrinology accounts and also growth into new accounts which had not previously prescribed Omnipod.

Based on prior experience, we do not expect the new team to be at full productivity until Q4 but the increased field presence is already helping us to identify and train more new patients and clinicians on the value of Omnipod.

And our supplemental efforts with Insulet Provided Glooko and direct-to-consumer advertising are attracting more potential patients into the funnel. In fact, the early results of our direct-to-consumer digital advertising campaign are encouraging. We're clearly increasing awareness among our targeted segment, the multiple daily injection user.

This campaign is helping to educate MDI users on how Omnipod can give them better control, freedom and quality of life compared to other insulin delivery methods. In the last three months, we also made tangible progress on access and reimbursement for Omnipod.

Our expanded market access team has developed a greater presence with insurance companies and state Medicaid programs. Our messaging of improved outcomes and quality of life for patients who migrate to Omnipod is being received very well.

In particular, managed Medicaid programs, which tend to have high population turnover also find Omnipod's low upfront cost and pay-as-you-go business model compelling.

As a result of our efforts, in Q1, we added access to 1.7 million lives for Omnipod, bringing our total to approximately 178 million covered lives or approximately 60% of all covered lives in the United States. Our international business continues to grow at an exciting pace, thanks to new markets like France and our direct market in Canada.

We remain encouraged by the huge market opportunity for Omnipod in Europe. In addition to significant Omnipod growth in France, we continue to see strength within our core European markets namely the United Kingdom, Germany, and the Netherlands.

Together, these countries represent the majority of our installed base in Europe, yet we are still underpenetrated in this region. There is tremendous untapped opportunity in markets outside of the United States, and this will be an attractive avenue for long-term growth for Omnipod.

We continue to make great progress on our innovation road map, particularly our Dash Bluetooth connected platform, which we will be showcasing at ADA next month in San Diego. We have now tested Dash's modern, intuitive user interface with more than 100 consumers and clinicians. And the feedback has been incredibly enthusiastic.

This system is designed to make insulin delivery even easier, and to serve as a platform for additional innovation like CGM integration with Dexcom, and our Omnipod Horizon automated glucose control system. We know that one of the barriers to adopting insulin delivery technology is the perceived complexity of these systems.

Our new users tell us that one of the reasons they opt for Omnipod is that it is easy to use and Dash will strengthen this differentiation even further. Bluetooth in the pod and PDM will enable features like connectivity and secondary display on a user's mobile phone, and share/follow functionality for loved ones.

User interface testing for the Dash system indicates that we have greatly reduced the time that it takes to perform common tasks on the handheld PDM, making the next-generation system even easier to use. On this same platform, we are developing Omnipod Horizon, our connected, automated glucose control system, in parallel with Dash.

And this past quarter, we completed our second IDE study, which evaluated the system performance in increasingly challenging cases, including vigorous exercise, and high fat meals. We now have data on the performance of the algorithm from more than 80 patients across all age ranges, and the user feedback and clinical results have been terrific.

Horizon data in pediatrics and adolescents will be presented at ADA next month. Again, this year, we will have a robust clinical presence at the meeting, with a total of four presentations, including new Omnipod data in research partnerships with centers of excellence across the United States and Europe.

As a reminder, we're also innovating with Eli Lilly to use U200 and U500 concentrated insulins out of Omnipod. These advancements will enable us to better serve people with higher daily insulin requirements, including people living with insulin dependent type 2 diabetes.

Our programs remain on track with the final U500 patient follow-up and clinical data compilation completing by the end of next year. We are in discussions with the FDA regarding U200 trial design and expect to start this clinical trial by early next year.

We remain on target for 2019 and 2020 launches of these products, which will double our addressable market and be exciting growth catalysts for Omnipod. And lastly, our Drug Delivery team has made great progress with continued growth of our existing combination products and development of new ones.

As Amgen mentioned on their last earnings call, its Neulasta Onpro kit now accounts for more than half of all U.S. Neulasta doses. The expertise that we've developed in innovating, improving and manufacturing the pod platform for our current customers has proven to be valuable to our pipeline partnership.

The team continues to work with other pharmaceutical partners to leverage our precision Omnipod platform to provide an improved drug delivery experience for other medicines and we remain bullish on this exciting opportunity. Before I turn the call back over to Pat, let me just summarize by saying that Insulet is off to a great start for 2017.

Our Omnipod and Drug Delivery businesses contributed terrific growth in Q1; and at the same time, we're making significant progress on our innovation programs to drive continued growth over the medium to long term.

We are very well positioned to deliver attractive returns to our shareholders and deliver meaningful differentiated technology to the market.

This is an exciting time at Insulet, and we're moving as fast as we can to make a difference for people living with diabetes and other conditions where the pod can improve outcomes and quality of life for our users..

Thanks, Shacey. Operator, we'll now open the call up for questions..

Thank you. And our first question comes from the line of Jeff Johnson with Robert Baird. Your line is now open..

Thank you, guys. Good afternoon.

Can you hear me okay?.

Got you..

Okay, great. Hey, Pat, just wondering on the guidance, if you could flesh out maybe your installed base guidance 30% growth this quarter, calling for 20% for the year.

I don't think any of us think 60% is sustainable necessarily in the international markets but is that kind of the reason why the full year guidance may be a little bit below what you were able to put up in the first quarter? Does that international slow down a little bit? Or maybe you can flesh out also how you're thinking about U.S.

installed base growth this year. Thank you..

Sure. I can actually take that one, Jeff. This is Shacey. The installed base for the U.S., we're guiding to be consistent with what we guided at the beginning of the year.

It's international where we're a little bit softer than the performance that we had this quarter and that's simply because it's early in the year and we're also in discussions with Ypsomed and so, that's reflected in that guidance..

Yeah. That makes sense. And then, Shacey, maybe any insight you could provide on that 30% or so of your patients that you get from non-MDI every year, any change in mix of what pump companies those are coming from, your market share gains, how is it trending relative to Medtronic and then maybe some of the others, that would be helpful? Thanks..

Sure. It's actually closer to 80% of our new users come to us from the multiple daily injection users as opposed to other pumps. That percentage hasn't changed materially. We remain focused on the MDI user.

In terms of the mix of pumps that those come from, the vast majority are of Medtronic and I think that just reflects the market share in the market and that has not changed materially either.

Next question?.

Our next question comes from the line of David Lewis with Morgan Stanley. Your line is now open..

Hi, guys. This is actually Scott Wang filling in for David. Just two quick questions for me. I guess, Shacey, starting with market dynamics, implied new patient starts were below expectations last quarter and could have been flattish.

Can you give us any sense on how they've rebounded this quarter, either qualitatively or quantitatively? And how has the competitive impact trended from last year into this year?.

Sure. New patient starts grew nicely this quarter in line with our expectations. And in terms of competitive dynamics, I would say our pipeline is stronger than it has ever been. So, clearly, we're attracting new patients into the pipeline.

And some of the delay in conversion has lightened in Q1 and continues to do so as we are even a month into this quarter. So, we're feeling very good about maintaining our guidance at the beginning of the year with a really strong pipeline and kind of reduced conversion rate time..

Got it. And then just one follow-up for me. Focusing on kind of ex-U.S. markets, performance was very strong again this quarter. Can you comment on what performance was like in new markets that you've entered such as France and Italy and how should we be thinking about the overall U.S. versus ex-U.S. mix for the year? Thank you..

France is one of the newer markets that we've entered into. Very strong, really outsized expectations – or it's kind of out-achieved expectations for both I think Ypsomed as well as Insulet. And so that remains a great driver of the growth that we see internationally.

But really, we see strength across all of our major markets internationally including the ones that I mentioned in Europe and Canada. And so, we continue to see that business outpace our U.S. business. And at the end of the year, I think I don't know where that lands us. I don't know, Mike, if you know off the top of your head.

But we'll continue to see international grow nicely..

Yeah, we described the installed base for the year growing 20% globally, 15% in the U.S. So, that would imply a higher growth rate for international, which is great in both our distributor markets and our direct markets internationally..

And our next question comes from the line of Mike Weinstein with JPMorgan. Your line is now open..

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

Thank you..

Maybe I can just ask I think what everyone's trying to get at a bit differently. So, I appreciate the color on the installed base, that's very helpful. But, as you guys have said many times, the installed base is more reflective of the longer term health of the business.

But I think what most investors are focused on is the short-term considering the significant deceleration in U.S. new patient starts. And what's implied here in the first quarter internationally like something like a 40% increase in new patients quarter-over-quarter from fourth quarter.

So, maybe considering 15% new patient growth, that could be anywhere from slightly down new patient growth to double-digit U.S. new patient growth.

Can you help clarify especially given the slowdown in the fourth quarter?.

Just to clarify, Robbie, we said 15% installed base growth, not patient start growth, right?.

Right. I'm asking if you can help clarify what happened in this quarter because the installed base is really just a reflection of multiple quarters..

No, actually, the installed base growth is new patient starts minus attrition. And as I said, attrition remained relatively flat. So, we didn't have a deceleration of new patient starts. In fact, new patient starts grew nicely in line with our expectations in Q1 so I'm not sure if I'm missing something in your question..

Well, I would also – Robbie, this is Mike. You had alluded to how installed base is indicative of longer term, but I think we would argue that installed base is is a driver of near term as well as long term.

And in fact, if you look at the growth that we talked about here, Shacey mentioned in the U.S., 15% installed base growth as of the first quarter.

And when you look at our revenue guidance for the United States, apart from the 2 point year-over-year comparative on royalty that went away earlier this year, well directly our growth is absolutely and directly in line with the installed base growth.

So we're really excited about the momentum we've got in the growth of the business in the quarter and that's reflected in our revenue guidance..

All right.

Just to clarify, installed base growth is cumulative of all new patients from the first quarter last year through to first quarter this year where new patient starts is simply a reflection of this year versus last year?.

Right. And I guess if you're looking for additional color, we're extremely pleased with the new patient growth in the U.S. It was in line with our expectations for the first quarter..

We're hitting on all cylinders, Robbie....

Just a quick follow-up, based on your first quarter performance internationally and your second quarter guidance, it implies somewhere around $47 million in international sales for the back half of the year, which would be 18% year-over-year growth versus 58% in the first half.

So I was just hoping you might be able to help clarify what's driving the deceleration in the back half of the year? Thanks..

Robbie, this is Mike. As a reminder, we entered into – we're entering the new markets we, over the last number of years and one of which that was mentioned by an earlier question was France. We entered into France. Principally, the growth in France started in the second half of last year.

And so, when you have the comparatives on a year-over-year basis, of course, the growth is going to go down because we didn't have France in the first half of the year principally. And so, that's the driver for which you're describing.

But we are thrilled with how things are going internationally in our existing markets, and in new markets like France, and that's reflected in the strong revenue guidance that we have for the year for international..

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

Great. Thank you. Good afternoon..

Hi, Tao..

Hi, Tao..

Two questions for me. First, just looking at Drug Delivery. So, if we annualize the first quarter, you're going to end up a tad below your guidance range.

So, curious to see what is going to accelerate that or what you think could accelerate that in the back half of the year? And I wasn't sure if maybe you're expecting contribution from the other product that you sell internationally with Ferring?.

Tao, this is Mike. So, we take orders from Amgen and that's what our guidance is based on. As we mentioned in the earlier comments, they've been describing very exciting growth and that's reflected in their orders to us.

So, we are very comfortable with the guidance for the year and differences by quarter, we try and work with them to even it out, so that we can optimize manufacturing, but there is sometimes differences in timing and that's all that's reflected in the numbers so far versus what we're describing for the rest, but we are comfortable with the guidance for the year..

Okay. And then secondly for Shacey, maybe, on the attrition front, you mentioned that attrition is pretty flattish versus what you've seen in the past.

Where is that attrition mainly coming from these days? Is it from new patients that may have tried the product three months ago and now decided it's not the right pump for them or are you seeing attrition from patients who'd been on it for a year or two years, more experienced users? Thanks..

Sure, Tao. Most of what drives attrition is market access and the price experience. So, patient who losses coverage for example which is one of the reasons why we made such an investment in growing that team and trying to expand and improve coverage for Omnipod and then the rest of the driver is the product experience and product quality.

I wouldn't say that attrition comes more from a new user versus an experienced user. It's just by a number of users who are impacted by those two factors. We have made a great effort focused on new patient, meaning attrition in the first 90 days of the user experience, and we've seen some positive momentum there.

But for now, we'd really don't see a change in the overall annual attrition of the user base, which has remained pretty steady..

And our next question comes from the line of Doug Schenkel with Cowen & Company. Your line is now open.

Hi, this is Ryan on for Doug. Thanks for taking my questions. Maybe just starting with the sales force expansion you guys have going, can you give an update on how that's going? And yeah, I'll stop there..

Sure. That expansion has gone really, really well. We were able to attract I think a super talented team and get them up and running more quickly than many of us thought we might be able to. So, that expansion is now complete. It was completed really in the first quarter.

And so, those folks have been trained and they're out there kind of developing their territories, et cetera. So, that, as I mentioned in my prepared remarks, that has enabled us to actually find many physicians who weren't previously prescribing Omnipod.

So, we're seeing some expansion of the endocrinology user base, as well as just continued penetration into our existing account. So, I'm excited about the value that will drive. But based on our last two expansions, we don't really expect this team to be at full productivity again until the end of the year.

So, we won't see the vast majority of that impact until late this year, early next..

Got it. And then on Drug Delivery, you said you continue to work with multiple other pharma partners outside of your currently commercial partners.

I know it's not in your control but do you think we could hear more information about what you're working on during 2017 or maybe 2018?.

This is Pat. I think in terms of communicating with the Street on our progress in Drug Delivery, 2018 is probably more likely. But I would like to just say that our outlook for Drug Delivery is extraordinarily bright.

And we are very pleased with the progress to-date both with Amgen and with Ferring Pharmaceutical, our two commercial partners that we have at this moment.

This business is different than the Omnipod business that you really need to match the drug delivery technology and capabilities that we bring to the party with the market needs and technical requirements of the pharmaceutical companies. So, it really is matching our capabilities with the market set of opportunities out there.

We're very pleased with the progress we've made, with the pipeline that we have.

But just given the confidential nature of these relationships with our pharma partners, it's unlikely we're going to be able to give any more than we've already given you, but I would say that we're very confident in our Drug Delivery business providing meaningful revenue to achieve our goal of $1 billion in revenue in 2021..

Okay. That was helpful. And maybe if I could....

Second follow-up again. (35:52).

Thank you..

And our next question comes from the line of Dominick Leali with Raymond James. Your line is now open..

Hi, guys. This is Dominick in for Jayson. I just had a couple of quick ones here.

I want to make sure that the timeline for Dash, is that still on track for I think it was a 3Q filing a soft launch in 4Q and then a more broader launch early next year?.

Yeah. I would say we're pretty much on track and we will be showcasing at ADA and that we're on track to submit in the second half. So depending on FDA review, we'd be on the market late this year or early next.

But I guess just as a reminder because of our recurring revenue model, an acceleration of a couple of months or deceleration of a couple of months, doesn't materially impact the revenue picture in the short term. But that said, we're really excited about the next generation platform so we're working hard to get it out there as soon as possible.

But we continue to get feedback from all of our users in the development process and we're going to make sure that we launch the best possible products. So if that means we're a couple of weeks or a month delayed in the submission to the FDA then so be it, we're going to have the best product on the market possible..

And we're excited about showing it to you at the upcoming ADA Meeting in San Diego. I think you'd be really excited as well..

Yeah. You guys are all going to get your hands on it. It's pretty cool..

Okay. Great. Thanks.

And then I was wondering if there was any update on the commercial launch strategy of the Dash?.

That's an interesting question. We've been working hard on that as well. That's not something we've given a lot of color around. And I think for competitive reasons, we probably will refrain from doing that. But as we get closer to the midst of the launch, we'll certainly give you guys a little bit more color.

But we have been thinking about some new interesting models and ways to really I guess get patients access to the technology. So, good question but I guess I'd say stay tuned at this point..

And our next question comes from the line of Danielle Antalffy with Leerink Partners. Your line is now open..

Good afternoon, guys. Thanks so much for taking the question and congrats on a really good quarter. I was just wondering a few things, first of all, other pump companies had a tough quarter from what we could tell; Tandem, Animas.

Not asking you to necessarily comment on their performance specifically, Shacey, but clearly, it seems like Insulet's not really seeing the same impact.

Can you talk about any of the trends in the quarter for the pump market as a whole? What are you guys seeing from a share perspective and maybe comment on the early days of competitive launch? And what's happening in the market there?.

Sure, Danielle. I think the difference in the impact to some of our tube pump companies on the market versus Omnipod is reflective of three things. One is our continued focus on the multiple daily injection user, I mean that is our target segment. And I don't think that's necessarily the case for the other companies out there.

So, I think it speaks to the strength of that strategy.

And then – obviously we have a very differentiated platform and differentiated business model, and I think that's the other thing that you see in this, just with the recurring revenue model, you don't have any particular impact in a quarter that could be something that could be disastrous for the capital models that are out in the marketplace.

And then the third thing is, we have a very strong international business which isn't the case for some of our partners as well. And obviously the competitive dynamics in that market are a little bit different. So, I think all three of those things are contributing to the fact that we're not seeing the same impact that some of the other companies are.

In terms of the competitive dynamics, I mean certainly there's a lot of noise on the market about the limited market release that's currently underway with 670G.

But that noise has really lightened up in terms of our field feedback, again primarily because we're focused on a target segment that is different than the target segment that that product is focused toward. So, I think that that's what's driving our success and I guess the limited impact or negligible impact that we've seen..

Okay. That's helpful. And then just one quick follow up on the U200 and U500 programs. Shacey, wondering if you could give any color on the size and scope of those trials, when we could possibly see data from those and how to think about a launch into type 2 patients. From a strategic perspective, it seems likely a tougher patient population to crack..

Yeah. So just to clarify on that last piece of your question, so the type 2 population that we're targeting is the insulin dependent type 2 patient population. In some cases physicians say that they can't really even differentiate between a type 1 and a type 2.

You'll hear the term type 1.5 sometimes referred to patients who are difficult to diagnose as one or the other .And so, this is a patient population where the vast majority of them in fact our data says 83% of this patient population is in the endocrinology office.

So, we are not planning on entering into new physician channels or trying to go after the primary care type 2 market, which has different needs and a different access point.

This population of patients is very much similar to the type 1 patient population in terms of how frequently they're seeing an endocrinology office and also the type of flexibility that they need in their insulin delivery. So probably not as much of a departure as one might expect.

In terms of the data and the programs, the data – the clinical trials are being managed by Lilly, so that really is in their hands in terms of when and if they'll make the data public. But we would expect U500 data to become available next year.

Whether or not they decide to present that at ADA or other conferences, I think remains to be seen and we'll work with Lilly to support them in any way we can to make that happen. But the data, the scope of the trials, similar to what you see in this space, so hundreds of patients not anything more than that.

And we're excited about the impact that these have for our business and also just for patients out there that we can better serve with higher daily insulin requirements..

And our next question comes from the line of Raj Denhoy with Jefferies. Your line is now open..

Great. Thanks. Good afternoon. I wonder if I could just follow up a couple of questions on the international performance. I almost hate to ask this but there was a time previous to the current management obviously when really strong international results sort of masked what was some stocking on the part of your international distributor.

And I'm curious, again, just given the lack of visibility into where they're actually selling through, what gives you the strong confidence that we're not seeing stocking again with these really strong results..

I think the first indicator is just the growth in the installed base which is very much in line with the growth of the revenue. And we get good data from our distributors in terms of number of patients and installed growth. So, we're pretty confident in that data. So, you have that visibility that there's really nice alignment there..

Okay..

And this is Mike, I would also just make the point. We watch this closely and are very clear to avoid any stocking in the channel. And so, I think you can see that from the installed base data, but that's also just an approach to how we run the business..

No, like I said I almost hated asking, but just on Ypsomed as well.

I guess the contract is coming up for renegotiation, and I know you probably won't give us much but what are the thoughts or plans there, at this point, as we're heading into that for the end of 2017?.

Well, we're in active discussions with Ypsomed about next steps with the agreement, whether we extend or pick some alternative path. And because we're in active discussions, we really can't comment much. But I will say that both Insulet and Ypsomed are entirely committed to making sure that patients have continuity of care regardless of the outcome.

And we just want to find the best way forward for both us..

I guess, well, do you have a preferred outcome, though? I mean is your desire ultimately go direct at some point in these international markets, or would you rather sort of limit them to Europe and you can take the rest of the international market? Or is there any sort of preferred path you're willing to share with us at this point?.

I would just reiterate what Shacey said. It really is having the best interest of the patients in the installed base in Europe as the number one consideration. And I think the second is understanding the economics for each of us. And it's the combination of those two that would drive us to make the decision.

But it's primarily going to be the continuity of care for our patients with the great installed base that Ypsomed has provided for in Europe..

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

Great. Thank you very much for taking the question.

Can you hear me all right?.

Got you..

So, Pat, so historically, you've talked about CMS being a market opportunity and I don't want to rehash all of the moving pieces there.

But I just wondered if maybe you could comment on – when you think about your underlying attrition and the amount of people that are current customers that are aging into Medicare, maybe just talk to us about how much of an impact that has on your underlying user base.

And then how we should think about the potential for CMS to come into the story over the course of 2017?.

Great. I thought I would get by maybe not have to answer this question, but I'm glad you asked it. If you come back to Shacey's metric in her prepared remarks, 178 million covered lives that represented about 60% of the market.

When you combine Medicare and Medicaid, it makes up another 30% or so of market potential that we currently do not have access to even though we've been reasonably successful with some of the state Medicaid plans.

Having said that, it is remarkable that patients when they age into Medicare lose access to the Omnipod technology even though they would be provided an alternative tube pump on a Medicare Part B. I was extremely hopeful to get a decision by the end of last year before the change in administration.

And I think what happened is as that change in administration occurred, many of the decisions related to coverage and sort of what I would call routine decisions of CMS were basically put on hold, although they did describe to us that they would like to get this resolved quickly.

I think where we are today with CMS, we have a very strong position with coverage of Omnipod under either Medicare Part B or Part D and I have every confidence we're going to get Medicare coverage, although I think it's just the description of our product probably fits a little more nicely into the Medicare Part D.

But we have – and I think Medicare has the authority under either one of those providers coverage and we're working very actively with CMS and hope to get this resolved quickly..

Great. No, I appreciate the additional color there. And then just wanted to ask another question on the underlying new patient growth in the U.S. Just obviously, strong growth particularly when you think about the rest of the players there, 80% coming from the MDI side.

Just wondering if you could talk about what the main drivers of that new patient growth is.

Obviously, you're investing in the sales channel and some DTC marketing but just what are the types of patients we're seeing? Is it more children versus adults, more adolescence? Just kind of help us think about what those new patients really look like?.

Sure. We did see growth across our age ranges and in fact, we're probably a little bit lighter this quarter. I mean it just shifts every quarter in pediatrics than typical. And I think that is a reflection of the volume that DTC is driving.

Although that's my anecdotal feedback, I don't have direct evidence of that but it does seem that our advertising is engaging patients a bit earlier in the pipeline and their awareness of their different choices, et cetera.

And I think that – because we're focused on digital channels and social media, we're just naturally getting an older age range in that group. But yeah, no, I think not much has changed in terms of the type of customer. We continue to target MDI, and that continues to make up the vast majority of our new users.

I think we're just catching them at a different point in their awareness and decision-making process, thanks to the investment that we're making in the digital advertising campaign. We continue to evaluate how that's tracking on the different channels in which we're advertising.

And we'll continue to sort of optimize that investment based on the return that it's providing. But so far, we're encouraged and pretty optimistic about what it can provide for us over the longer term..

And our next question comes from the line of Suraj Kalia with Northland Securities. Your line is now open.

Good afternoon, everyone. Congrats on a nice quarter.

Can you hear me okay?.

Absolutely. Loud and clear. Thanks..

Perfect. So, Pat and Shacey, two questions. First, Omnipod right now does not have Medicare reimbursement. Can you give us some color on the reason Medicare payment delays for CGMs, and we started getting a lot of questions about how that could affect Omnipod? Any color from you all would be great.

And the second part of it, Shacey, specifically, have you reached an asymptotic level on Neulasta prescriptions? It seems like last quarter was a little greater than 50%, now we have a little greater than 50%. How do you see this playing out as the year progresses? Thank you for taking my questions..

Great.

You want to take Medicare?.

Yeah. Let me take Medicare first. The most important thing we have to get done first is to get a coverage decision from Medicare. And as I said, I'm very confident in our position with Medicare and we've been working with the career staffers, even though there was a change in the administration.

The career staffers are the ones that have done a remarkable job I think of managing the process with CMS. And in terms of payments, after a coverage decision is made, it will depend upon whether it is which Medicare it is whether it's Part B or Part D, there are different processes that are put in place for payment decisions at that point in time.

But I guess I'd just say, we'll cross that bridge when we come to it hopefully soon..

And in terms of the Neulasta Onpro kit, it's really probably a good question for Amgen. Certainly, we see that there's been terrific continued growth of this product and it continues to grow quarter-after-quarter, so I don't know that we think we're approaching some sort of steady state at this point there.

It's a terrific product and there's really no reason why we shouldn't continue to see the technology grow. But that's my perspective. Amgen's probably better prepared to comment on it..

And our next question comes from the line of Mike Weinstein with JPMorgan. Your line is now open..

Great. Thanks for taking the follow up. Just wanted to ask on the cash burn. It was $44 million this quarter. You said some of it was due to CapEx. But it's a big number I think more than people are expecting.

So wonder if you could just clarify a bit and then maybe give us your expectations for the full year for cash use?.

Robbie, this is Mike. So I will tell you that our spending is right in line with our expectations. When we talked about the expectations for the year, we said we were going to be spending money to establish our U.S. manufacturing.

When we did the capital raise in September of last year, that was one of the primary stated purpose of it and we're right in line with, as I said in my prepared remarks, we are right on plan and really excited about the direction that's going.

In the first quarter, there was some timing on working capital, nothing that changes anything about how we're viewing the numbers for the year, so everything that we've said in our guidance last quarter is still the same. And we're very pleased with our strong financial position..

Okay. And one last quick one. At the recent AAC meeting, there was a presentation by a doctor talking about a competitor pump from Medtronic that might be on the market potentially by the end of 2018 with corrective boluses. Just wanted to get the latest thoughts on when your product might be available in the U.S.

and how – if a product's on the market before you with corrective boluses, would you still come to market as is or would you look to change your product to catch up? Thanks..

Thanks, Robbie. I appreciate the question and the opportunity to talk a bit about our Horizon product. We're really excited about the progress that we're making. You'll see, I think, pretty impressive data at ADA, just in a few weeks now in San Diego.

And we should be entering a pre-pivotal later this year and entering into pivotal next year in our plan. And we're very much on track as to be in the market in 2019 in the U.S. And yes, we will still bring our product to market. We fully expect that it will be differentiated even from the technology that you're describing, the next-generation 690G.

We will have some significant differentiation from that product and we expect to be more appealing to certain segments of the market for certain. So, stay tuned and hopefully you'll be at ADA to see the presentations of the data..

And I'm showing no further questions at this time. I would now like to turn the conference back to Patrick Sullivan..

Thank you, operator. I will once again finish where I started on the conference call by saying that I'm extremely pleased with Insulet's performance so far in 2017, and I'm very confident this trend will continue.

Simply put, we have the right team in place to drive significant performance and success, and we have the right tools in place to win and to achieve our goal of $1 billion in revenue by 2021.

As always, I would like to close by thanking the Insulet employees for all of their hard work and dedication, to ease the burden and improve the lives of people living with diabetes and other diseases.

I'd also like to thank everyone for joining us on the call today, and we look forward to sharing with you our progress during what I know will be a very exciting 2017. Thank you very much..

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