Good afternoon, ladies and gentlemen and welcome to the Insulet Corporation Fourth Quarter and Full Year 2018 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. [Operator Instructions] 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, Howard. Good afternoon and thank you for joining our fourth quarter 2018 earnings call. Joining me today are Shacey Petrovic, President and Chief Executive Officer and Michael Levitz, Chief Financial Officer. We are also pleased to have Wayde McMillan with us today who will assume the CFO role on March 1. The replay of this call will be archived on our website and our press release discussing our fourth quarter 2018 results and first quarter and full year 2019 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 maybe 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 and our fourth quarter earnings release and in the company’s filings with the SEC. Also, unless otherwise stated all financial commentary regarding dollar and percentage changes will be on a year-over-year basis. And with that, I will turn the call over to Shacey.

Thanks, Deb and good afternoon everyone. I am pleased to join you for my first earnings call as CEO of Insulet and to do so from our new company headquarters and U.S. manufacturing facility in Acton, Massachusetts. As most of you know, I assume the role at the start of this year after serving for the last few years as President and Chief Operating Officer. I am so proud of all of the company and our dedicated employees have achieved over this time. Insulet has made remarkable progress having just delivered our third consecutive year of over 20% revenue growth, improving gross margins from the mid 40s a few years ago to the mid 60s now and achieving net income for the first year in Insulet’s almost 20-year history. As Insulet begins a new chapter our team remains focused on achieving our long-term strategic, financial, and operational goals. We are at an important inflection point transitioning the profitability, expanding globally and creating new pathways for how we can improve the lives of those with diabetes. I would like to review the highlights of our financial results in the fourth quarter and present some color on progress we have continued to make in executing our strategic initiatives. I will turn the call over to Mike to walk through our results in more detail and I will then come back to discuss our outlook for 2019. Mike and I will then take questions. Our fourth quarter financial results once again demonstrate our strong commercial and operational execution. It was another record quarter and we made demonstrable progress toward achieving our 2021 financial targets of delivering $1 billion in revenue, 70% gross margin and a mid-teens operating margin. In the fourth quarter, we delivered revenue of $165 million, representing year-over-year growth of 26%.…

Thank you, Shacey. Insulet continues its tremendous momentum and as a result the company once again delivered exceptional growth in the fourth quarter and for the full year. Our fourth quarter revenue growth of 26% was above the high-end of our guidance range. U.S. Omnipod grew 22% reaching $93.2 million, which was $2 million above the high-end of our guidance on strong and growing demand. International Omnipod grew 54%, totaling $55 million at the high-end of our guidance, finishing at a $200 plus million annual run-rate just as we expected and drug delivery was $16.7 million, that’s down 8%, which was at the low end of our guidance range. Turning to gross margin for the quarter, we once again drove significant expansion reaching 67%, up 600 basis points in line with our expectations. This expansion was driven by the considerable productivity and cost improvements we have realized in our purchasing, manufacturing and supply chain operations as well as the benefit of approximately 400 basis points from our successful transition to direct operations in Europe earlier in 2018. Our operating expenses totaled $94.1 million, that’s up from $80.3 million, reflecting the transition to the direct operations in Europe and our investments in innovation and product development supporting our growth initiatives. We delivered a positive operating margin of close to 10% for the fourth quarter and approaching 5% for the full year. We also achieved positive net income in both the fourth quarter and full year representing a true milestone. The company is on a strong trajectory for growth and profitability in 2019 while continuing the investments in strategic initiatives to support our near and long-term growth objectives. We ended the quarter with $430 million in cash and investments compared to $566 million at the end of last year due primarily to…

Thank you, Mike. I would also like to take this opportunity to thank Mike on behalf of the Board of Directors and the entire company for his many contributions as CFO over the past 4 years. In that time Mike helped develop and execute our strategic imperatives, strengthen our infrastructure and capabilities in support of future growth and generate exceptional value for shareholders. I have been fortunate to know Mike for two decades and he has been a great colleague and a great friend. And I know I speak on behalf of everyone at Insulet when I wish him the very best. We have the right leadership team in place as we continue to execute on our stated objectives and drive toward our 2021 targets of $1 billion in revenue, 70% gross margins and mid teens operating margin. We are setup for an exciting year and I will now walk you through our 2019 outlook. For the full year, we expect total revenue in the range of $662 million to $687 million, representing growth of 17% to 22%. By product line, we expect U.S. Omnipod revenue in the range of $373 million to $383 million, representing growth of 15% to 18%. This reflects our confidence in the continued strong growth of our customer base, given this year’s market access wins and our commercial momentum overall. We expect International Omnipod revenue in the range of $235 million to $244 million, representing growth of 37% to 42%, reflecting the great position we are in to continue our strong growth in our existing markets. Given that our go direct strategy in Europe began in the second half of 2018. We will have a much higher revenue growth rate in the first half of 2019, as compared to the prior year. And a more…

Thank you, Shacey for such a warm welcome to the Insulet and thank you Mike for your partnership in the time we have had a working together over the last month and for the months ahead during this transition. In my first weeks, I had the opportunity to travel with our field teams and to meet employees across the company. It has been great to feel the passion insulin employees for improving the lives of people with diabetes. As a leader in innovation in the market, it is exciting to see the differentiation we have today and what our technology roadmap holds for the future. As Shacey discussed earlier, we have some compelling catalysts for growth both short and long term, including increased coverage in existing markets and for global expansion. As a finance leader, it is encouraging to join the company at this time, given the revenue growth and an inflection point we have, as we expand both gross margin and operating profit margin, a truly unique value creation opportunity. With an already strong leadership team in place, I’m honored to join the team to help advance Insulet’s mission and deliver on our commitment to customers and to create significant value for our shareholders. Thank you again to Mike and Shacey. And so those of you on the call today, I look forward to meeting you in person over the course of the year.

Thanks, Wayde. At this time, Mike and I would be happy to take your questions. So, operator, please open the call.

Thank you. [Operator Instructions] Our first question or comment comes from the line of Kyle Rose from Canaccord. Your line is open.

Great. Thank you very much for taking the question. Can you hear me alright?

Yes, we have you.

Great. So I kind of wanted to walk through a little bit of the commentary on DASH very exciting to hear about the transition into full market release over the next couple of weeks. So maybe you could just kind of help us understand what you really learned during the controlled market launch and how that’s going to give you the competence when you move into the full market launch? And then if you could just kind of help us also understand the puts and takes on any potential impact of gross margins when you think about your transition into the pharmacy channel. I think in the past you have talked about it a slightly higher ASP on the Pod, but maybe kind of offsetting some of the capital. So maybe just kind of help us understand the puts and takes there?

Great. Yes, I will start with what we have learned and then maybe Mike can comment on the margin puts and takes, but the limited market release for DASH, I think was terrific for us. We were looking to validate the product performance and get customer feedback from a variety of different segments on the performance of the product and then also really evaluate and strengthen our support ability. So I think most people know, we have been moving to this pay-as-you-go model and incrementally increasing our business in the pharmacy channel and so we’ve recognized that this changes in what we are doing today right, there is a difference in how we even evaluate, find benefits, and deliver benefits, how we distribute the product in terms of our dispensing pharmacies and our wholesalers and how we even train the patient and even product configuration. So we’ve been testing all of those systems and ensuring we’re in good shape from a support ability standpoint. And then from a product standpoint, the feedback has been terrific. The vast majority 95% to 97% of patients as bill that the system is easier more discreet, very simple to use, very positive reviews and actually from the segment of our limited market release that were multiple daily injection users, which is obviously our target segment 100% characterize it is easy to use – a 100% characterize that intuitive discrete and 95% prefer it over their previous therapy. So just really tremendous feedback from our targeted customer base and we are excited I think, we still have some work to do to kind of finalize everything around support ability. So you said a few weeks I said, a number of weeks and so I think we’re looking really towards the end of this quarter to be expanding into full market release. And Mike?

And from a margin perspective, actually, let me just speak to the impact of the move to the pay-as-you-go model in the pharmacy with DASH. This is because of our recurring revenue stream, we’re fortunate to build to make this make this transition and there we do expect that there will be a headwind in the initial months of launch, because we are foregoing the upfront revenue while it has not been a significant part of our overall revenue. It still has been a real part of our revenue and so we expect the headwind from the move to no PDM revenue on DASH to be at about $68 million in 2019. That said, as we’ve said before, we do expect the impact on revenues in the year to be neutral and the reason for that is we are charging a higher price per Pod you described moderately higher and we will be charging that for those people that the new patients where we are for going the PDM revenue and we also offer for those people who are already on the Omnipod who will be transitioning to DASH. And so the combination of the higher price for Pod on those combined population. We expect that will offset the loss PDM revenue. And so it is a bit of a headwind in the first few months, but it really is a tailwind going forward and we’re really excited about this because we think it really differentiates the product and the patient experience and it’s very beneficial for the company. In terms of the impact, the gross margin, which was your specific question, because it’s revenue neutral in the year, we don’t expect it to have a meaningful impact on gross margin. The low end of our guidance does reflect if we are not able to cover that the loss PDM revenue then we would be at the low end, but the underlying business growth supports a higher level and as I said, this is very good for us going forward.

Okay, great. Thank you very much for taking the question.

Thanks.

Thank you. Our next question or comment comes from the line of Doug Schenkel from Cowen. Your line is open.

Hi, good afternoon and thank you for taking our questions. Maybe just starting with a couple of installed base questions, historically you have provided updates annually. I don’t think you did this time in your prepared remarks. So I just wanted to see if you might provide us with how things went in 2018, specifically did you achieve your worldwide installed base growth target of 20% plus growth in 2018 and was there a meaningful difference in growth within the U.S. or internationally?

Sure, Doug. We did achieve our objectives in terms of customer base growth. However, we are no longer giving that color for a variety of reasons. It’s why we attempted to pointing towards kind of the revenue growth rates, which are in line with the customer base growth, the one exception and this is why we provided that cover is Europe, because we are pointing you to the second half which is our normalized growth rate. So we tried to provide you that color, ultimately because of our recurring revenue model, the customer base growth does line up with the revenue base growth and where it doesn’t we will provide that color just as we did this quarter to make sure that you guys have that transparency. So I appreciate the question.

Yes. And just to make sure, I am completely getting that it’s essentially with DASH being revenue neutral. And based on what you just described Shacey essentially installed base growth should be pretty similar to revenue growth this year is that at this at the right conclusion.

That’s exactly right that as we move to that pay-as-you-go model and kind of eliminate the upfront cost, they really line up perfectly. And we will definitely provide color if for some reason, those trends separate and, but we don’t expect them to.

Okay. And then I guess maybe just as a quick follow-up and I’ll get back in the queue with everything we just talked about and keeping in mind your U.S. guidance is for 15% to 17% revenue growth this year. I’m just wondering why growth would decelerate this year. There is a lot of catalyst including expanded market access and the DASH launch. So, I am just wondering why things might wouldn’t be as good as last year if not a little bit ahead of last year, is this just earlier in the year conservatism or are there other factors we should be considering?

Hi, Doug, it’s Mike. I will speak to the guidance piece and then I’m sure Shacey color as appropriate on the business. So, the guidance that we gave was 15% to 18% for the U.S. and as I mentioned previously, the low end of the guidance really isn’t about the growth of the business, it’s really around the change in the business model to the pharmacy with the PDM revenue since we are foregoing that if we don’t cover that with the transition of existing users into the pharmacy, then that could lead you to the lower end of the range. So we are growing at a larger number dollar amount. We are off of a higher base. But we are accelerating the growth of the business, off of a higher dollar number. The other point I would just make is and I mentioned this briefly in my remarks as well as the fourth quarter was very strong and finished above our guidance because we actually saw some of those market access wins that we had expected in 2019 already materialized, which is great news and which is why we feel even more confident as we go into this year and so that does impact the growth rates a little bit, but it’s already built into our strong finish and positions us well for 2019.

All right. That’s great. Mike. The only thing I would add is, I would point to what you just said, here we are In February, and there’s a lot of work to be done frankly to successfully launched DASH and successfully transition into the pharmacy, I think you know this team executes well and we’re counting on that, but we also recognize where we are and how much is to happen between now and the end of the year to get to where we want to get too.

Okay. Thank you for all that. Very helpful.

Thank you. Our next question or comment comes from the line of David Lewis from Morgan Stanley. Your line is open.

Good afternoon. This is Jay Chadha in for David. Thanks for taking the questions. Shacey just on the ex-U.S. growth outlook, your comments said the implied growth in the mid-teens to low ‘20s in the back half of ‘19. I was wondering if you could give us some additional color on how that growth compares to what you saw over the past six months foresee it’s in a transition maybe on an underlying basis, and how that compares to your growth expectations on an underlying basis in the first half of the year?

Sure, so Jay, it’s fairly consistent with what we’ve seen, since we’ve got our team established in moving forward, the big difference there from historic performance of Europe is France. So, as we’ve said for actually almost a year and a half now and we were seeing extraordinary growth and penetration into France, we fully expected that that would moderate to kind of the underlying growth levels of Europe and we have seen that happen just as we expected it too. So, when we look at our existing markets, what we’re guiding to is mid-teens high teens to low ‘20s in terms of growth rates. That’s the underlying growth rate of these markets. We still believe that there’s still a lot of growth we had there and our teams are focused this year on our existing markets.

Thank you. And then just switching to the U.S. momentum stepped up pretty material into the fourth quarter, but guidance into 1Q implies momentum, was more in line with the first three quarters of ‘18. Is there anything one time that drove the 4Q beat in the U.S. or can you know in the fourth quarter momentum really continue into ‘19 given that the DASH impact you’d feel would be more so beginning in 2Q given the sort of rollout?

Yes, I think it’s a great question. I think one thing to keep in mind Jay, is just that the fourth quarter is always our strongest quarter seasonally. So, we would not expect for example for that momentum to be continued into Q1, which seasonally is always our lightest quarter. So, we’re just taking that into consideration. I think, Q4 is a great indication of the power of Market Access because we started to see that already in our baseline and we saw that tick up in Q4.

Thank you.

Thank you. Our next question comes from the line of Danielle Antalffy from SVB Leerink. Your line is open.

Hi, good afternoon guys. Thanks so much for taking the question. And Mike, just wanted to say I’m sad to see you go, and it’s been a pleasure working with you and we’d excited to you. So quick question on the access point, so Shacey, you mentioned that you now have access to 40% of the market that you didn’t have previously, but I think you said in your prepared remarks, you’ve only got actual coverage for at this point for the third of Medicare and half of Medicaid, so hoping you could give a little bit more color on A how much incremental access are covered lives, I should say you have entering 2019 versus 2018 and B when we should expect for you to have complete coverage of the remainder of Medicare and Medicaid patients?

Sure. So, Danielle, when we think about Medicare, we made a strategic choice to essentially in 2018. We were negotiating with all of the providers and we recognized two things, one we, having a lot of success, helping people through the Medicare exception process we’ve actually help thousands of patients through that process, and then we also recognize that we could help steer patients to plans that covered Omnipod. And so, we really made the strategic decision to get coverage established with fewer providers in order to maintain our price integrity in the market, because we are seeing these other avenues for people to be able to access Medicare. So, we actually feel great about where we landed. And I don’t know that a third of Medicare covered lives necessarily reflect how many Medicare patients have access to Omnipod through those channels. And the other thing to remember is that this process happens every year. And so, we’re going to be back at the table with all of these payers, starting again kind of August, September timeframe so that we’ll be able to have another bite at the apple event. And then the final thing that I would say is that Medicaid is the bigger opportunity for us versus Medicare. So, Medicare one thing that was strategically important to us is that it was a pathway to Medicaid, where there is obviously a large pediatric population and so very exciting to see that, that is something that’s translating into real progress, we continue to grow our Medicaid coverage we’re at 50% a covered-lives there or thereabouts. And we expect that to continue to grow as we look towards the end of this towards through ‘19.

Got it. Okay. That’s helpful. And one quick point of clarification on the headwind from DASH. Mike, I think you said, entirely if I heard this correctly $68 million in total in the excuse me, headwind in the shift in business model from not selling the PDM, but I understand you expect to offset that on higher Pod prices throughout the year, but that is going to drive some volatility in the quarters that it sounds like you said, the majority of the impact is going to be in the first few months, so, is it safe to assume that a lot of that is going to happen in Q2 because it sounds like you go into full launch mode here in the coming weeks. It will be mostly in Q2. Can you help us understand, I understand commentary, a little bit or Mike, probably confuse that’s also possible?

No, you’re spot on Danielle. So, the $68 million as a full-year number so if you just spread that evenly through the year as an example, you’re basically talking about roughly $1 million to $2 million a quarter. And so, with the timeline that Shacey described DASH, moving into full release here in the coming weeks. It’s then yes, the Q2 would be when you would expect to see more of that impact, because where it gets offset is as you add people into the pharmacy channel both new DASH users as well as existing Omnipod users, who move into the pharmacy both with DASH or otherwise. And we’ve been seeing great momentum and move to the pharmacy channel, even to date. And so that will also help offset it. But again, I think the timeline you described is reasonable.

Perfect. Thanks, so much guys.

Thank you, Danielle.

Thank you. Our next question or comment comes from the line of Robbie Marcus from JPMorgan. Your line is open.

Hi, thanks for the question and congrats on the good quarter. Shacey maybe for you to start off, since you’re new in the CEO role mantra Insulet in the CEO role and in transition at the CFO role. You could give us some thoughts on how you set guidance for 2019, maybe relative to 2018 and how we should think about some of the considerations that are in the guidance here?

Sure. I think ultimately, we took a similar path to setting guidance for 2019, as we did for 2018. I will say both Wayde and Mike were very involved in that process. And so, we feel good about where we landed. I think, if you look at the range 17% to 22% anyway you cut it, really attractive, but it also recognizes that here we are in February and we just want to be thoughtful, as I mentioned to talk about what needs to play out over the next 12 months. We are really excited about the growth opportunities ahead of us that’s reflected in the range, but we just also acknowledge there’s a lot to do, where seven months into our European business. So, we are learning, a great deal there. We’re launching a new product. We’re driving a significant business through the pharmacy channel and we’re implementing U.S. manufacturing. So, these are all really important things for the business that drive long-term growth and long-term profitability and sustainability. And, but there’s a lot of execution that is being asked of and counted on by the steam. So, we’re just recognizing that, that’s what we do well, is executing if it goes well will be at 17% growth, and if it goes very well, it will be a 22% growth.

Okay, great. And just as a follow-up. First, I’ll, Danielle sentiment, Mike. It was great working with you’d look forward to it, but maybe Mike, you can give us a little bit on the cadence through the year, because I look at first quarter guidance and the U.S. growth number looks pretty healthy, international looks on trend and Drug Delivery is flat year-over-year. So maybe just help us think about the cadence through the year, any gross margin considerations, that’s different quarter to quarter and then just if you could touch on the, reasons for the slowdown, I’m assuming in the back part of the year? Thanks.

Sure. Thank you, Robbie. So, in terms of the cadence of the year and the impact to gross margin, we’ve got a few different dynamics playing out obviously. We’ve got the move to the pay-as-you-go model, which we just discussed in the couple of questions. I won’t repeat what I’ve already said there, which is a bit of a headwind initially but becomes a very, very healthy tailwind, that we really believe is good for patients, payors and also very good for us. In terms of the cadence on the international side, we are absolutely thrilled with what’s going on in Europe and you have secured a 50% uplift in ASPs and without an impact to the end customer, and having that materialize in our revenue growth is just tremendous. And so that is a difference in the first half, then, it was at the same time last year. And as Shacey described more normalized growth in our existing markets in Europe in the second half and so there’s the cadence there. In terms of the Drug Delivery we expect this is going to be roughly consistent throughout the year is what we what we’ve tried to do historically. We are not always successful, but we do have a longer-term forecast from Amgen that informs the vast majority of our Drug Delivery. So, we try and even out as much as we can with working with Amgen just reduced volatility. In terms of the gross margin, as I said earlier, we do expect gross margin to be flat for the year at this tremendous result that we had about 65% in 2018. So, we’re thrilled about that. But the cadence is different. So, the first quarter, assuming that we launched U.S. manufacturing as we are on schedule to do in shortly, you really going to see that impact the numbers more in the second quarter and through the remainder of the year than you would in the first quarter. So, I would expect the margin trajectory in the first quarter to be essentially consistent with where we’ve been for the last couple of quarters. But then there as I’ve said in prior comments, we are going to take the accounting charges for period costs as you ramp in a new manufacturing and you ramp it up and as Shacey described we are thrilled to talk about the fact that we are now going to have two lines here Acton. And so, we are going to have a pullback of probably two points to three points in gross margin from this move to U.S. manufacturing. However, as I said earlier, that’s offset in part by just the tremendous work that the operations team is doing both in China and other were otherwise that offsets that. So, all in all, that I think helps illustrate, some of the cadence here for the year on gross margin.

Thanks so much.

Thank you. Our next question or comment comes from the line of J.P. McKim from Piper Jaffray. Your line is open.

Hi, good afternoon. Thanks for taking the question. I wanted to ask first on just getting your take on the ace of the Ipump? And what’s the Omnipod strategy towards obtaining that? As well as just ask about phone control? Can you move to straight to phone control quicker or do you need to wait for Horizon and I guess why?

Sure, J.P. And so, in terms of the pump, I think it’s great to see the agency just making these moves to support interoperability. I think we’ve been talking about interoperability as the vision for DASH and certainly pool and horizon for quite some time and we have been in discussions with the agency as they work to establish special controls etcetera. We don’t see any issues with special controls and so we do expect to take advantage of that pathway, but it really doesn’t change our innovation plans it’s really only helpful, but I think just a great example of how the agency is helping to find more pathways to bring innovation to the market. So great news for the community, great news for us, I think we’re very positive about that. In terms of phone-control we could move to phone control more quickly than horizon. But we, it’s a lot of work and it just made sense as we’re going through human factors testing and all of the clinical and development work to include that as part of our horizon program. So that’s not the end of the story with Horizon, we will launch with Samsung Galaxy phone control, but we fully expect to move to other platforms and that work is starting to be underway as well. So very exciting and we should just remember horizon is the second half of next year. So, it’s right around the corner and we’re gearing up for a great product launch.

Okay. That’s helpful. And this maybe one more, just kind of strategically Shacey, I mean you kind of walked into the 2021 targets, but when you take your comments today on flat gross margins carrying OpEx 20% you really, you’ve kind of back half loaded a lot of these growth of 70% margins and then mid-teens operating margin. So, how comfortable are you selling those targets and then just what about anything change, you got 300 million in cash for about M&A for the company or getting into CGM or smart pens are there anything that you as CEO looking at it differently?

Yes. So, it’s the main comment that I’ll make tied to those 2021 targets is the biggest lever is gross margin. And, I don’t really view it as back half loaded as you said, because here we are finishing this year above 65%, I think finishing the quarter somewhere close to 67% and so we are making great progress on that front. We always planned to take a step back so to speak in order to implement our manufacturing strategy that would then unlock the ability to further expand our gross margin. So, this is completely part of the plan, and I don’t really view it as back and loaded – I was as exactly where we expected to be heading into this year, so…

And J.P. this is Mike. I would just add an on Shacey comments for the 2021 targets, we are exactly where we had planned to be. This was always the idea of this ramp of U.S. manufacturing and how this is going to play out in gross margins in terms of the operating margin. Look, as we’ve said in previous periods like we could go and get the double-digit operating margin outlook, you saw this Q4, we were at 10% Q3 we were strong. I mean, so if we, if we were not investing for what we believe to be a very strong robust future of significant growth. Then yes, we can get to that tomorrow. So, I think the broader point, we’ve now demonstrated what this business can do from our revenue growth, gross margin and profitability standpoint and we’re positioned exactly where we want it to be making investments in the pharmacy channel, which really differentiates the product. And really honestly, we’re already driving operator operating leverage across the rest of the business. We just had very targeted investments, innovation and these things like the pharmacy channel, which we believe really drive shareholder value.

And maybe at last two comments are I was really arm-in-arm with Pat in establishing these targets and laying out the strategy, so there is just as much my as anybody else’s and we are not going to short change our top line growth opportunities and that’s what you see this year, but we fully believe that we can unlock the top line growth and deliver on those targets that we shared.

Thank you. Our next question or comment comes from the line of Jayson Bedford from Raymond James. Your line is open.

Thanks and good evening. Just a couple of questions for me. You mentioned that you are pleased with the coverage for DASH, can you comment on the number of lives under coverage and what percent of those are have access through the pharmacy?

Sure. Yes, we have about $120 million covered lives for DASH now. So that right, actually a little bit ahead of where we expected to be on full market release. I don’t think we’re going to report on that on an ongoing basis. But just to give you some visibility to we feel like we’re in a strong position to launch and about 10% of our business today is already in the pharmacy channel and so we expect that to grow. If you look at where we are from covered lives about a third of all Omnipod covered lives and so that’s right now kind of the access position and we expect that to grow through the year.

Is there a situation though when you launch a full launch of DASH that new people Omnipod today that won’t have access to DASH that because of reimbursement?

Yes, that’s right, because we are leveraging DASH to move into the pharmacy channel. And so there will be some limitations in terms of reimbursement for DASH. I mean part of the benefit of the pay-as-you-go business model is that there really isn’t a reason why as soon as the patient gets access to DASH because we’ve been able to establish pharmacy coverage they can convert to DASH if they so choose to do that. So, we don’t see people kind of waiting for it being a problem, etcetera. And they can’t really convert very quickly once they have access and that is the primary focus of our market access team today is to expand access through the pharmacy channel for DASH.

Thank you. Our next question or comment comes from the line of Joanne Wuensch from BMO. Your line is open.

Can you hear me okay?

Yes.

Terrific. Thank you so much for taking the question. It feels like we’ve really focused on sort of the four key things which is the U.S. Pharmacy, the OUS Direct, Horizon and gross margins. Is there something that we’re missing or is there something that you’re like, I just wish where you had the opportunity to talk about X or we just – we really understand it [indiscernible] around these sort of four factors?

I think you do – the one thing that you didn’t mention, which is just a really important long-term value driver for the company is U.S. manufacturing. So, we talked a little bit about it, but I think the fact that where we are now establishing our second line and creating this much capacity, we fully expect in the U.S. that, that has the ability to drive down costs to increase quality and also to obviously give us much needed capacity and redundancy. And so that is a massive value driver and kind of strengthening of the position that we’re in as a company. So, I could not be more thrilled about that investment and what is the promise that it’s going to deliver on for the company.

And second question, can we just spend a moment on Drug Delivery, I know we don’t really think about at all too much, but it looks like it’s a little bit heavier in 2019 than it was in 2018, when I mean heavier, it’s just declining a little bit faster, any thoughts on that one?

Yes, I mean, I think our guidance for Drug Delivery is always based primarily on Amgen’s forecast and then our production planning, so that’s what’s factored really into the range and into the guidance. We still view Drug Delivery as an exciting long-term growth opportunity. I think Amgen and our partnership is very strong and it’s a great example of what can be done, but this is also just the reality as the competitive market changes that’s reflected obviously in the forecast from Amgen.

And I would just add it’s – we are obviously not thrilled when the forecast come down, but Drug Delivery is now less than 10% of our revenue. And so it really didn’t have all that meaningful of an impact on us, because it is so much a smaller part of our business and the other parts of our business are growing so rapidly.

Thank you. Our next question or comment comes from the line of Margaret Kaczor from William Blair. Your line is open.

Everyone, thanks for taking the question. This is Brandon in for Margaret. I just wanted to start off and as we’re talking more about the pharmacy channel, in your early experiences, are you guys seeing any notable differences in utilization between DME patients and pharmacy, and I guess, by that, I mean, since the pharmacy passes presumably easier – much easier for patients, are they reordering more often, is it better compliance and resulting in better utilization? And then kind of a follow-up to that is, are you seeing similar benefits through physicians who are saying well now this is such an easy process going through scripts, I’m going to recommend more Omnipod than I am going to other competitive pumps?

Brandon, I think those are great questions. And outside of utilization, I think you really described our vision for the pharmacy channel. I don’t know that we necessarily think utilization is going to increase substantively, but we definitely believe that this channel will provide a better customer experience for both the patient and the physician. And so I don’t have specific feedback to give you yet because I think it’s a little bit early days, but we will be looking for that type of patient feedback in the channel and physician feedback and early feedback from the limited market release has been very positive in terms of the patient experience in the pharmacy.

Yes, the only other thing I would add is just that we are seeing acceleration with our existing product in the pharmacy, so it’s – it definitely is being well received.

Got it. Thanks. And a quick follow-up on the international side. Could you remind me outside of or remind all of us outside of Europe, how many other international markets you’re in, I guess, just trying to understand if there is a blended ASP of Omnipod increase that we should think about in the international market? And then if there are any plans in 2019 to expand into new markets as well? Thank you.

I’ll start and I’m sure Mike can add some color. So today we are in a handful of markets in Europe really I think 9 or 10 countries in total, 5 of any substance. We are in Canada and we are in the United States and Israel. So, it’s a pretty limited really geographic footprint. It’s one of the reasons why we’re so excited about the investment that we made in our decision to terminate this legacy distributorship, because it unlocks now our ability to expand to new global markets. And so we’re in the process now in 2019 of really doing the research and prioritizing and categorizing the most attractive markets that we may want to move into. In 2019, our guidance really contemplates our existing markets and growing further in – you mentioned ASPs, the only thing I’ll mention is that the guidance range in international does contemplate pricing pressures on the lower end, so that’s – that is factored into the guidance.

And I would just add that I’m glad you brought up the question because sometimes you’ll get confused. So, Europe represents roughly 85% of our international revenues and so that 50% uplift on the ASP by us going direct in replacing one layer there in Europe, that 50% uplift applies to Europe, it doesn’t apply to the rest of the international business and sometimes that’s confusing. So, thank you for the question.

Okay.

Thank you. We have time for one more question. Our final question for this evening comes from the line of Jeff Johnson from Baird. Your line is open.

Hey guys, good afternoon. Can you hear me okay?

Yes, Jeff.

Great. Shacey, I don’t want to over-read your comments, but you’ve mentioned now Horizon launch in the second half of 2020 a couple of times and I’ve heard it kind of second half 2020, I’ve heard it late 2020? Have you had any kind of increased visibility from FDA on the pathway there, any change in confidence levels, just anything that’s developed over the last few months since we last talked about that?

I think we – this is the great thing about the breakthrough devices program, frankly, it’s just that we have a lot of collaboration with the agency. And so we’ve been talking a lot through the clinical development plan and making sure that we have the most efficient and effective pathway to market, so a bit more clarity around that. And so, but no, nothing’s really changed in our guidance, so our timeline [indiscernible] that it will be earlier. I just – I feel very good about the progress that we’re making both on the development front and on the clinical plan.

Alright, that’s helpful. And then just follow-up question, just on the international market. When might we see DASH in the international market, and do we need to think about a similar kind of headwind initially on the conversion and then – an uplift on higher priced pods or will it still work the same way outside the U.S.? Thank you.

Great, and that’s a really good question, Jeff. So, we’re in the process of kind of doing all of the evaluation work to understand the right go-to-market strategy. It’s not clear to me that we will launch with a similar model, so, I don’t think I would include that headwind as it relates to our international markets. We know there’s a lot of demand, in fact, just last week at ATTD, we demoed DASH for European physicians and none of them wanted to give the system back to us. So, we are working very hard to make sure that we can launch that product across Europe, I would expect that to be more of a late ‘19, early 2020 launch in Europe.

Thank you. So, we can extend our Q&A session. So, our next question or comment comes from the line of Ravi Misra from Berenberg. Your line is open.

Hi, thank you for taking the question. I just wanted to get a couple of clarity – and Mike congratulations and good luck in the future. Just wanted to get a little bit clarity on those 2021 targets, I think you said above market profitability in the long-term. Can you just help us peg down what you mean by what market profitability actually is? And then secondly just on the OpEx commentary, Shacey, how should we think about that as it kind of pertains to the S&M and G&A, I apologize if you went over that already, just been switching between calls? Thanks.

Great.

Well, I’m happy to start and Shacey please obviously fill in. So, in terms of the ‘21 targets of above market profitability, as Shacey said, we’re really viewing that as mid-teens. Now when we set that target in 2016 for 2021, what’s market – the diabetes market, nobody was delivering that kind of profitability. And so what we really try to do is target something that reflected our view that you really could – you could make decent and appropriate profit in this business. That as I said before is not the end of the story for this company. We just felt like setting a target that we thought was reasonable and appropriate given that the company had been in a loss position. This is the first year now, we’ve now delivered as we said we would positive EBIT for the full-year and we delivered positive net income. And that really – that net income is ahead of schedule and positions us very well for the 2021 targets of mid-teens. In terms of the OpEx guidance and Shacey could speak to, but I’ll just reiterate my earlier comment, which is the largest piece of the increase there is really on innovation and we’re a year away now from Horizon in the second – as Shacey said in the second half of ‘20 and there’s just a good amount of development work that we’re working on. Apart from that and the move to the pharmacy, which over time will really benefit us, we’re driving leverage across the business, and so that would include G&A, that would include sales and marketing in across the business.

Yes, since you just specifically mentioned sales and marketing, there is an investment this year to be able to improve our capabilities in the pharmacy channel and to really to be able to effectively move patients from the DME channel to the pharmacy channel. So, that is an investment that we believe is a complete worthy investment because as we look out then over the Horizon, it’s a more attractive channel for us for a number of reasons. And that’s not – it’s – some of that investment is one-time investment captured in OpEx.

And just if I can may just seek a follow-up there, that, that should – should that lead to higher ROI per patient just because, I mean, is it the case that the pharmacy channel is less expensive to service the patient on a kind of profit per patient dynamic there, so that should lead to leverage in the out-years?

I’ll comment and then Shacey can jump in. I think Shacey made the comment in the past that we don’t expect the pricing to be different the value to be different on the customer revenue side, there is a lower cost to being in the pharmacy channel over time. There’s just – and one of the reasons we’ve said it’s beneficial is, it’s just less work, and so that’s only less work for the physicians and less work for the users, it’s less work for us and work really constitutes cost. And so that doesn’t materialize right away, but it is very real.

Yes, no, that’s right, you captured.

Thank you. Our next question or comment comes from the line of Steven Lichtman from Oppenheimer and Company. Your line is open.

Thank you for squeezing me in. I’ll just stick with one, guys within your U.S. guidance, I was wondering if you could share what mix of your installed base, you’re assuming will be going through the pharmacy channel as we exit 2019? I think Shacey you mentioned, it’s about 10% today or if you – you can’t provide that specifically. Any commentary you can provide on how we should be thinking about that ramp of the pharmacy mix over the next 12 months to 24 months?

Yes, I think it’s a great question. So today, I said it’s somewhere around 10%. If we were – if you just think about where we are from a coverage position, so I think I mentioned about 30%, a third – 120 million covered lives, it’s about a third of covered lives have access to DASH. So, if we were able to track them all down and convert them all, we would move from 10% to 30%. We don’t expect to have 100% batting average on that, but that’s kind of the guardrails as you think about how that might ramp this year.

Okay, great. Thanks, Shacey.

Sure.

Thank you. Our next question or comment comes from the line of Chris Pasquale from Guggenheim. Your line is open.

Thanks. One follow-up on DASH, does the $6 million to $8 million [ph] headwind you talked about, it’s about a quarter to a third of what we estimate your U.S. PDM revenue was in 2018. Just to set a baseline, I know you guys don’t usually give explicit numbers there, but is that in the right ballpark?

Hi, Chris, it’s Mike. Yes. We really don’t – we don’t break that out. What I would say though is, what we’ve talked about in foregone PDM revenue is related to the launch of DASH and the pay-as-you-go model. We’re still going to be selling our existing Omnipod globally. And so it’s not like we’re going to zero in PDM revenue in a year. And, in fact, we even started a little bit of the move to the pay-as-you-go model here in 2018. So, we’re not – we don’t break that out on a total number, but I just wanted to give a rough number so that people could get a sense of the impact.

Okay. And then Mike, just one follow-up for you, the mix of operating expenses during the fourth quarter was little different than we had expected big jump in R&D spending in particular. Any color on how you would expect the growth rates of those two lines to maybe compare to the overall 20% OpEx growth in 2019?

Absolutely. And, in fact, this is a little bit of what I spoke to when we are on the Q3 call, which was that we really did expect the operating expenses to ramp up in the fourth quarter and specifically in development and that’s exactly what happened. And it really is related to the work that’s going on now with DASH finishing that the international work and most specifically Horizon. There’s going to be work in 2019 on Horizon, which is now a year away and so it’s the development work and it’s the clinical work that’s built into R&D. So, I would expect R&D to grow faster than the rest of OpEx. That’s really the number one driver of the growth in spending and it really is because of the value that we see from this innovation globally. We will – there will be some growth in sales and marketing and that is specific to the move to the pharmacy channel and making sure we have the infrastructure to support that, over time, as I say, that will come down as a cost of the company. And we are driving operating leverage across the company, across OpEx, across operations to fund these things, because we really do believe these initiatives drive real value.

Thank you. Our next question or comment comes from the line of Matt Taylor from UBS. Your line is open.

Hi, thank you for taking the question. So, I wanted to ask two things. The first one was just on Drug Delivery I think we understand there is some pressure there this year. What I want to ask you about is, a couple of years ago at your Analyst Day, you’d talked about this potentially being a much bigger business over time with more opportunities. Is that still the case or you – have you just pivoted here with the bigger opportunities in the core insulin pump business?

I think both are true just depending on the time horizon that you look at it. When – so in terms of the 2021 targets, I think we always said, we don’t need another Amgen to hit those. And one of the big, I guess, challenges I call them champagne problems here at Insulet that we have is, we have so many different opportunities that we could pursue for growth, it’s just as important that we determine what are we going to do. And so when we look at the Drug Delivery, we had so much activity underway, some of that was with commercial asset but it’s much more reliable, some of that was really early stage stuff that was incredibly bandwidth-intensive and had a high failure rate. And so any of these programs even if you look at like a concentrated insulin or you look at Neulasta, these could be 7-year programs even for commercially available molecules. And so it’s just a longer-term development Horizon, the longer-term growth opportunity and frankly, right now we happily have our hands full growing the diabetes business. If you take out Drug Delivery, diabetes is growing 23% to 27% this year, and we haven’t even really delivered on some exciting growth catalysts as we look over the future. So, I do think that’s where our focus is. We still have activity going on in Drug Delivery, but we’re being a little bit more selective about the programs and we do view it as a longer-term opportunity.

Okay. And then just one follow-up so – and Mike, congrats on a great few years, it’s been great working with you. And I did want to go back to one of your comments, you said that you had some access wins that’s helped in the fourth quarter. And we all know sort of what big picture those are. I was wondering if you could give us just a little bit of color on which ones specifically helped in the fourth quarter or anything on the pacing of those or other ones and that could help during this year?

Well, first of all, thank you, Matt. And Shacey may be better able to answer that question, but I will say that on the access wins, one of the things that we’ve talked about before is that with Medicare, we were starting to see some real wins in the exception process and that started to kick in here early and was really beneficial. And so we’ve had wins, I can’t tell them, I can’t call out by name, but we’ve had some pretty significant wins and it – we’ve had wins in Medicaid, we’ve had wins in Medicare, we’ve had wins commercially. And some of the things as I say that we thought we’re going to kick in, in ‘19 on Medicare have actually come early. And so I mean the growth that we’re seeing in our customer base is just – in our new starts, it’s just fantastic. And it really reflects the fact that when people have access to this product, they do want this product.

Thank you. Our final question or comment comes from the line of Suraj Kalia from Northland Securities. Your line is open.

Hey, good afternoon, everyone. Thank you for squeezing me in. So first and foremost, Mike, it’s been a pleasure working with you, wish you the very best in your future endeavors. Shacey, let me – typical questions and forgive me if they have been asked by others. Can the Omnipod be configured with Libre 2.0 if they receive an high designation?

Yes, that’s a beautiful thing about this pathway that the FDA has created if they were able to reach special controls then certainly it could be a very easy clinical path to integration of their sensor in for example Horizon down the road.

Got it. And finally, Shacey, as you look at FY ‘21 and beyond, obviously, you guys are going to be running ahead on Horizon. If I look at one of the themes at ATT this time was you know, most of the closed-loop pumps are in the 70% to 80% time and range. How do you view? What differentiates one closed loop system from another? Thank you for taking my questions.

Sure, Suraj. And I think it’s a great question. I’ll just say two things. First of all, all the data on these systems is collected in varying ways, some data is looking at very well-controlled population, and other data is looking at more real world data. So, I think we have to be skeptical about just all of the variety of performance. I think when we look at the real differentiators on the system, it’s about how do all of these pieces of the system come together to work easily and elegantly for the user, because the better experience that they have in terms of the user interface and in terms of how the sensor and the pump work together, the more time and range, the more time that they’re going to spend in closed loop and that translates to more time in range. And so that’s why we have been so focused, I mean, just laser-focused on the customer experience, the user interface and on designing a simple system that could be used for MDI users, as well as children, because I think it’s going to come down to how the user experience translates for the system.

Thank you. I’m showing no further questions in the queue at this time. I would now like to turn the conference back to Shacey Petrovic.

Great. Thank you all for joining us today. Insulet had a remarkable 2018 and we’re set up for an even more remarkable future. I want to thank the Insulet team across the globe working to improve the lives of people with diabetes. 2019 will be another year of important milestones and exciting growth and we’re looking forward to speaking with all of you again next quarter on our continued progress. Thanks, and have a great evening.

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