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Insulet (NASDAQ:PODD)
Q4 2018 Earnings Conference Call
Feb. 25, 2019 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good afternoon, ladies and gentlemen, and welcome to the Insulet Corporation fourth-quarter and full-year 2018 earnings call. [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.

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'll assume the CFO role on March 1st.

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'd like to inform you that certain statements made by Insulet during the course of this call may be forward-looking and involve known and unknown risks and uncertainties that may cause actual results to be materially different from any future results implied by such statements. Such factors include those referenced in our safe harbor statement, in our fourth-quarter earnings release and in the company's filings with the SEC. Also, unless otherwise stated, all financial commentary regarding dollar and percentage changes will be on a year-over-year basis.And with that, I'll turn the call over to Shacey.

Shacey Petrovic -- President and Chief Executive Officer

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'm so proud of all 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 to profitability, expanding globally and creating new pathways for how we can improve the lives of those with diabetes.

I'd like to review the highlights of our financial results in the fourth quarter and present some color on progress we've continued to make in executing our strategic initiatives. I'll turn the call over to Mike to walk through our results in more detail, and I'll 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 midteens operating margin. In the fourth quarter, we delivered revenue of $165 million, representing year-over-year growth of 26%. We drove gross margin to 67%, a 600-basis-point improvement from a year ago, and we achieved over $16 million of operating income. This strong quarter resulted in both positive operating income and net income for the full year for the first time in Insulet's history.

I continue to be incredibly pleased with our team's focus, drive and deep commitment to our customers. We are in a great position to create value for our shareholders in the near and long term. I'll now provide additional color on the progress we made throughout 2018, which was a year of tremendous execution and foundation building for long-term sustainable and profitable growth. We began 2018 with the much anticipated guidance from CMS, that Omnipod can now be covered through the Medicare Part D or pharmacy channel.

Securing this coverage has provided us with a direct pathway to the pharmacy, as well as to state Medicaid coverage. And by the end of the year, we successfully secured Omnipod coverage for about a third of all Medicare lives and almost half of all Medicaid lives. Together with the in-network coverage for Omnipod through UnitedHealthcare that we secured in early 2018, we have expanded our access to the additional 40% of the U.S. diabetes market we didn't have access to previously.

We have already started to see the impact of this significant increase in access, which helped drive our record Q4 U.S. revenue and new patient growth. This expanded access establishes a strong foundation to fuel growth over the long term. In June, we received FDA clearance for our next-generation mobile platform, Omnipod DASH.

DASH is designed to be the simplest and most preferred Insulet delivery system on the market, as well as the foundation for our future innovation. We are wrapping up our limited market release, and we look forward to kicking off our full commercial release in a matter of weeks. In a short period of time, we have already secured impressive coverage for DASH. We will leverage this coverage position and launch DASH in the U.S.

through the pharmacy channel, providing several competitive, and strategic advantages for us. In the pharmacy, by eliminating the upfront cost of the Personal Diabetes Manager, we are providing a better customer experience for the patient, coupled with lower out-of-pocket costs. For the physician, Omnipod DASH can be prescribed with a simple e-script and less burdensome paperwork. And for payers, we have established a true pay-as-you-go model, which offers them less risk as they don't have to pay the thousands of dollars upfront for our product they would otherwise would for a traditional tube pump.

While we expect this shift in business model away from an upfront charge to be a significant win for Omnipod, we anticipate it will result in a temporary headwind in our year-over-year U.S. revenue growth comparison. However, this impact should be limited to the initial months of the DASH launch, and we anticipate very healthy U.S. Omnipod demand and revenue growth for 2019.

And longer term, DASH has the potential to dramatically reduce barriers to pump therapy adoption. Beyond our DASH system, we have already announced that with our Omnipod Horizon automated insulin delivery system, which we expect to launch in the second half of next year, we will make both hybrid closed-loop and personal smartphone control of the Pod a reality. We are incredibly excited about our progress on Horizon development and proud that Insulet will be the first to deliver this experience to the diabetes community. According to recent independent market research from Seagrove Partners, Omnipod Horizon is the single biggest winner as a stand-alone AP product, and respondents felt that our patch pump design with phone control is the best embodiment of an AP pump.

Omnipod Horizon will be game changing for people with diabetes, taking glycemic control, ease of use and discretion to a whole new level. In addition to substantial progress on our new product innovation last year marks significant progress on our global footprint with our successful midyear transition to a direct model in Europe. We have more than 120 talented team members with extensive diabetes experience up and running across Europe. We are now better able to support our large and growing European customer base and to gain market insights to help inform our innovation pathway and global expansion opportunities.

Add to this, the significant top-line and gross margin benefits, and we have established a robust business with incredible growth potential. I spent time with our team in Europe a couple of weeks ago, and it is clear we are strengthening our relationships with clinicians and payers, adding new patients bacross the continent and improving on the legacy European customer experience. The most recent independent survey data from the Q&A shows that in the last six months, our European team has made an incredible impact. And just as we see in the United States, our net promoter score in Europe is No.

1 compared to all other insulin pumps. Finally, I want to touch on our new highly automated state-of-the-art U.S. manufacturing facility. As you know, over the past two years, we've made a significant investment in sophisticated, custom-designed automation that will enable us to reduce costs, continue to raise the bar on product quality and increase capacity.

In fact, even after all of the improvements we've made in China over the last couple of years, one line in the United States will provide up to 50% of the capacity of our total China operations with up to 90% less headcount. It is great to see our manufacturing automation in the clean room and undergoing validation. We're looking forward to being up and running shortly. This is truly an investment in the future, one that strengthens our supply chain and creates important redundancy and scalable capacity.

We had a terrific 2018, which is reflected in our record results and our achievement of profitability. Our team continues to execute successfully on our strategic initiatives, driving financial and operational improvements while improving our customers -- while ensuring our customers remain at the core of everything we do. With that, I'll turn the call over to Mike.

Mike Levitz -- Chief Financial Officer

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've realized in our purchasing, manufacturing and supply chain operation, 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 planned capital expenditures as the company invest in U.S.

manufacturing and supply chain operation. In summary, 2018 was a tremendous and a very successful year, demonstrated by strong sales growth, significant gross margin expansion and the pivot to profitability. Since this is my last call as Insulet's CFO, I'd like to say a few words before I turn the call over to Shacey. I am extremely proud of the time I have served as a member of this leadership team and all that the collective Insulet team has achieved together, setting aggressive goals, consistently meeting or exceeding those goals and delivering on our mission to improve the lives of people with diabetes.

We have established a strong foundation for Insulet's near and long-term success and has positioned the company to fulfill its mission and continue to deliver significant value for shareholders. Insulet has very strong fundamentals and catalysts for growth globally, and I believe in this company and its management team's ability to realize Insulet's tremendous potential. I have so appreciated working closely with Shacey these last four years, and it has been wonderful to get to know Wayde McMillan over the last month. Led by Shacey, Insulet's leadership team has tremendous character, passion, and wisdom as are the extraordinary people across the company.

And I know that I'm living Insulet in very capable hands. I truly look forward to seeing all this team will accomplish. With that, I will turn the call over to Shacey.

Shacey Petrovic -- President and Chief Executive Officer

Thank you, Mike. I 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 four 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 midteens operating margin. We are set up 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 normalized second-half growth of midteens to low 20s percent in our existing markets. Lastly, for Drug Delivery, we expect revenue of $54 million to $60 million, representing a decline of 12% to 21%. For the first quarter of 2019, we expect total revenue of $152 million to $156 million, representing growth of 23% to 27%. This includes U.S.

Omnipod revenue of $82 million to $84 million, representing growth of 17% to 19%; international Omnipod revenues of $56 million to $57 million, representing growth of 46% to 50%; and Drug Delivery of $14 million to $15 million, fairly consistent with last year. As we previously communicated, we expect our 2019 full-year gross margins to be consistent with last year, as the benefit of continued operating and supply chain improvements will be offset by the temporary headwinds from the normal ramp-up of our U.S. manufacturing, which is proceeding on schedule. Once we are through this initial ramp-up phase, we expect gross margin expansion in 2020, and we remain confident in achieving our gross margin objectives of 70% in 2021.

We will continue to invest in our business this year, including in the ramp-up of our U.S. manufacturing, our exciting innovation pipeline led by Horizon as we gear up for pivotal and to accelerate Omnipod adoption through the pharmacy channel in the United States. We therefore expect full-year 2019 operating expenses to increase approximately 20% from 2018 but to remain relatively consistent as a percentage of revenue as we drive efficiencies to fund our strategic initiatives. We expect CAPEX to be consistent with 2018 as we continue to expand capacity in our U.S.

operations and support of our growth and profitability objectives. This is an exciting time for Insulet as we are now on track to implement two automated lines in the United States, which when fully ramped up will equal approximately 100% of our capacity in China. This is important because it creates scalable capacity and redundancy, provides us with the flexibility to respond to global market dynamics and over the long term, enables us to better serve our global customer base in a sustainable way. Finally, we expect to deliver full-year operating margin in the mid-single-digit percentage range.

In summary, we see a long and exciting runway of continued market penetration and global expansion. Our team is motivated and committed to strong and sustainable growth. We have multiple value-creation catalysts ahead, tied to ongoing innovation, further global expansion and continued margin improvement. We really are just getting started, and I look forward to an even more successful future.

Now briefly before we turn to Q&A, as you know, Wayde McMillan joined Insulet earlier this month and will succeed Mike as CFO. Wayde joins us from Medtronic, where he most recently served as CFO of the $8 billion Minimally Invasive Therapies Group. He brings significant experience, scaling large organizations and a thorough understanding of the strategies we are pursuing globally to accelerate growth. We're thrilled to have Wayde join our leadership team, and I'd like to introduce him now to say a few words.

Wayde McMillan -- Incoming Chief Financial Officer

Thank you, Shacey, for such a warm welcome to Insulet, and thank you, Mike, for your partnership and the time we've had working together over the last month and for the months ahead during this transition. In my first weeks, I've had the opportunity to travel with our field teams and to meet employees across the company. It has been great to feel the passion Insulet employees have 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 road map 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 to those of you on the call today, I look forward to meeting you in person over the course of the year.

Shacey Petrovic -- President and Chief Executive Officer

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

Questions and Answers:

Operator 

[Operator instructions] Our first question or comment comes from the line of Kyle Rose from Canaccord.

Kyle Rose -- Canaccord Genuity -- Analyst

Can you hear me all right?

Shacey Petrovic -- President and Chief Executive Officer

Yes. We hear you.

Kyle Rose -- Canaccord Genuity -- Analyst

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 couple of weeks. So maybe if 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 confidence 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 transitioning to the pharmacy channel. I think in the past, you've talked about seeing a slightly higher ASP on the Pod, so maybe kind of offsetting some of the capital. So maybe just kind of help us understand the puts and takes there.

Shacey Petrovic -- President and Chief Executive Officer

Great. Yes. I'll start with what we've 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 supportability. 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 takes changes in what we're doing today, right? There's a difference in how we even evaluate, find benefits and deliver benefits, how we distribute the products 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 supportability standpoint.

And then from a product standpoint, the feedback has been terrific. The vast majority, 95% to 97% of patients feel that the system is easier, more discrete, very simple to use, very positive reviews. And actually, from the segment of our limited market release that were multiple daily injections users, which is obviously our target segment, 100% characterized it as easy to use, 100% characterized it as intuitive, discreet, and 95% prefer it over their previous therapy. So just really tremendous feedback from our targeted customer base, and we're excited.

I think we still have some work to do to kind of finalize everything around supportability. So you said a few weeks. I said a number of weeks. And so I think we're looking really toward the end of this quarter to be expanding into full market release.

And Mike?

Mike Levitz -- Chief Financial Officer

And from a margin perspective -- or actually, let me just speak to the impact of the move to the payas-you-go model in the pharmacy with DASH. This is -- because of our recurring revenue stream, we're fortunate to be able to make this transition. And we do expect there will be a headwind in the initial months of launch because we are forgoing 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 $6 million to $8 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, as you described, moderately higher. And we will be charging that for those people that the new patients where we are foregoing the PDM revenue and also for those people who are already on the Omnipod who will be transitioning to DASH.

And so the combination of the higher price per Pod on those combined population, we expect that will offset the lost 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 to 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 the lost 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.

Operator

Our next question or comment comes from the line of Doug Schenkel from Cowen.

Doug Schenkel -- Cowen and Company -- Analyst

Maybe just starting with a couple of installed base questions. Historically, you 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?

Shacey Petrovic -- President and Chief Executive Officer

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 point you toward 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're pointing you to the second half, which is our normalized growth rate. So we try 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.

Doug Schenkel -- Cowen and Company -- Analyst

Yes. And just to make sure I'm 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 the right conclusion?

Shacey Petrovic -- President and Chief Executive Officer

That's exactly right, Doug. 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, but we don't expect them to.

Doug Schenkel -- Cowen and Company -- Analyst

OK. And then I guess, maybe just as a quick follow-up, and then 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's a lot of catalyst, including the expanded market access and the DASH launch. So I'm just wondering why things wouldn't be as good as last year if not a little bit ahead of last year. Is this just early in the year conservatism? Or are there other factors we should be considering?

Mike Levitz -- Chief Financial Officer

Doug, it's Mike. I'll speak to the guidance piece, and then I'm sure Shacey can add 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 is, the fourth quarter was very strong and finished above our guidance because we actually felt some of those market access wins that we had expected in 2019 already materialize, 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.

Shacey Petrovic -- President and Chief Executive Officer

That's great, Mike. And the only thing I would add is I would point to what you just said, Doug. Here we are in February, and there's a lot of work to be done, frankly, to successfully launch DASH and successfully transition into the pharmacy. I think this team executes well, and we're counting on that.

But we also recognize where we are and how much needs to happen between now and the end of the year to get to where we want to get to.

Operator

Our next question or comment comes from the line of David Lewis from Morgan Stanley.

Jay Chadha -- Morgan Stanley -- Analyst

This is Jay Chadha in for David. Shacey, just on the ex-U.S. growth outlook, your comments said the implied growth, in the midteens 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 past six months, post the Ypsomed transition maybe on an underlying basis and how that compares to your growth expectations on an underlying in the first half of the year.

Shacey Petrovic -- President and Chief Executive Officer

Sure. So Jay, it's fairly consistent with what we've seen since we've gotten our team established and 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, 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 expect it to. So when we look at our existing markets, what we're guiding to is mid -- high teens to low 20s in terms of growth rates. That's the underlying growth rate of these markets. We still believe that there are still a lot of growth to be had there, and our teams are focused this year on our existing markets.

Jay Chadha -- Morgan Stanley -- Analyst

OK. And then just switching to the U.S. U.S. momentum stepped up pretty materially into the fourth quarter but guidance into 1Q implies momentum is 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 the fourth-quarter momentum really continue into '19 given that the DASH impact you feel would be more so beginning in 2Q given the quarter rollout?

Shacey Petrovic -- President and Chief Executive Officer

Well, I think it's -- 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.

Operator

Our next question or comment comes from the line of Danielle Antalffy from SVB Leerink.

Danielle Antalffy -- SVB Leerink -- Analyst

And Mike, just wanted to say, I'm sad to see you go. It's been a pleasure working with you, and Wayde excited to meet 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 an actual coverage for, at this point, for a third of Medicare and half of Medicaid. So I was hoping you could give a little bit more color on, a, how much incremental access or 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?

Shacey Petrovic -- President and Chief Executive Officer

Sure. So Danielle, when we think about Medicare, we made a strategic choice essentially in 2018. We were negotiating with all of the providers, and we recognized two things. One, we were having a lot of success helping people through the Medicare exception process.

We've actually helped 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 this 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 reflects 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 in kind of August, September time frame. So we'll be able to have another bite at the apple then.

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% of covered lives there or thereabouts, and we expect that to continue to grow as we look toward the end of the -- through 2019.

Danielle Antalffy -- SVB Leerink -- Analyst

Got it. OK. That's helpful. And one quick point of clarification on the headwind from DASH.

Mike, I think you said, and tell me if I heard this correctly, $6 million to $8 million in total 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. But It sounds like you said the majority of the impact is going 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'll be mostly in Q2. Can you help us understand, though, the commentary a little bit? Or Mike, I'm just really confused. That's also possible.

Mike Levitz -- Chief Financial Officer

No, you're spot on, Danielle. So the $6 million to $8 million is 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 time line that Shacey described with DASH moving into full release here and in the coming weeks.

Then yes, Q2 would be when you 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. We've seen great momentum in the move to the pharmacy channel even to date. And so that will also help offset it.

But again, I think the time line you described is reasonable.

Operator

Our next question or comment comes from the line of Robbie Marcus from JP Morgan.

Robbie Marcus -- J.P. Morgan -- Analyst

Shacey, maybe for you to start off, since you're new in the CEO role, not at Insulet but in the CEO role and in transition at the CFO role, can you 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?

Shacey Petrovic -- President and Chief Executive Officer

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%, any way 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 Doug, 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.

We're seven months into our European business. So we are learning a great deal there. We're launching a new product. We're driving significant businesses through the pharmacy channel, and we're implementing U.S.

manufacturing. So these are all really important things for the business that drives long-term growth and long-term profitability and sustainability. But there's a lot of execution that is being asked of and counted on by this team. So we're just recognizing that.

That's what we do well, is execute. If it goes well, it will a 17% growth. And if it goes very well, it will be a 22% growth.

Robbie Marcus -- J.P. Morgan -- Analyst

OK. Great. And just as a follow-up, first, I'll echo Danielle's sentiment, Mike, it was great working with you and Wayde, 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.

Mike Levitz -- Chief Financial Officer

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've discussed in a 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, payers and also very good for us.

And in terms of the cadence on the international side, we are absolutely thrilled with what's going on in Europe and to have secured a 50% uplift in ASPs 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 than it was the same time last year. And I'd say, if you described, more normalized in our existing markets in Europe in the second half. And so there is the cadence there.

In terms of the -- in Drug Delivery, we expect it's going to be roughly consistent throughout the year. It's what we've tried to do historically, though we're not always successful, but we do have a longerterm forecast from Amgen that informs the vast majority of our Drug Delivery. So we try and even that out as much as we can with working with the Amgen just through this volatility. In terms of the gross margin, as I've said earlier, we do expect gross margin to be flat for the year at this tremendous result that we had, above 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're really going to see that impact the numbers more in the second quarter and through the remainder of the year that you would in the first quarter.

So I would expect the margin trajectory in the first quarter to be potentially consistent with where we've been for the last couple of quarters. But then, as I've said in prior comments, we are going to take the accounting charges per period cost as you ramp in new manufacturing and you ramp it up. And as Shacey described, we are thrilled to talk about the fact that we're now going to have two lines here in Acton. And so we are going to have a pullback of probably two 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 otherwhere -otherwise that offsets that. So all in all, that, I think, helps in illustrate some of the cadence here for the year on gross margin.

Operator

Our next question or comment comes from the line of J.P. McKim from Piper Jaffray.

J.P. McKim -- Piper Jaffray -- Analyst

I wanted to ask, first, on just getting your take on the AACE or the Ipump? And what's the Omnipod strategy toward obtaining that? As well as just ask about phone control, can you move straight to phone control quicker? Or do you need to wait for Horizon? And I guess, why?

Shacey Petrovic -- President and Chief Executive Officer

Sure, J.P. So in terms of the AACE 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, Tidepool and Horizon for quite some time. And we have been in discussions with agency as they work to establish special controls, etc.

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 it's 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 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'll launch with Samsung Galaxy phone control. But we fully expect to move to other platforms, and that work is starting to be under way 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.

J.P. McKim -- Piper Jaffray -- Analyst

OK. That's helpful. And just maybe one more just kind of strategically, Shacey, I mean, you kind of walked into these 2021 targets when you take your comments on flat gross margins, recurring OPEX, 20%. You really -- you've kind of back-half loaded a lot of these growth -- 17% margins and then midteens operating margins.

So how comfortable are you still in those targets? And then just, what about anything changed? You've got $300 million in cash? What M&A for the company? Or getting into CGMs or smart pens? Is there anything that you as CEO are looking at it differently on that front?

Shacey Petrovic -- President and Chief Executive Officer

Yes. So the main comment that I'll make tied to those '21 -- or 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 gross margin. So this is completely part of the plan. And I don't really view it as back-end loaded. I view us as exactly where we expected to be heading into this year, so.

Mike Levitz -- Chief Financial Officer

And J.P., this is Mike. I would add, in echo of Shacey's comments, for the 2021 targets, we are exactly where we have planned to be. This is always the idea, this ramp of U.S. manufacturing and how this is going to play on gross margins.

In terms of the operating margin, look, as we've said in previous periods, we could go and get the double-digit operating margin now. Look, you saw this Q4 we were at 10%. Q3, we were strong. I think, so 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 yes, I think, the broader point is we've now demonstrated what this business can do from a revenue growth or gross margin profitability standpoint, and we're positioned exactly where we wanted to be, making investments in the pharmacy channel, which really differentiates the product. And really, honestly, we're already driving operating leverage across the rest of the business. We just have very targeted investments, innovations and these things like the pharmacy channel, which we believe really drives shareholder value.

Shacey Petrovic -- President and Chief Executive Officer

And my last two comments are I was really arm in arm with Pat in establishing these targets and laying out this strategy. So they are just as much mine as anybody else's. And we are not going to shortchange 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 delivery on those targets that we share.

Operator

Our next question or comment comes from the line of Jayson Bedford from Raymond James.

Jayson Bedford -- Raymond James -- Analyst

Just a couple of quickies for me. You mentioned that you're pleased with the coverage for DASH. Can you just comment on the number of lives under coverage? And what percent of those have access through the pharmacy?

Shacey Petrovic -- President and Chief Executive Officer

Sure. Yes, we have about 120 million covered lives for DASH now. So that's right -- actually a little bit ahead of where we expect it 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 our covered lives, that's 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.

Jayson Bedford -- Raymond James -- Analyst

Is there a situation, though, when you launch a full of DASH that there is people on Omnipod today that won't have access to the DASH because of reimbursement?

Shacey Petrovic -- President and Chief Executive Officer

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, etc. They can really convert very quickly once they have access. And that's the primary focus of our market access team today, is to expand access through the pharmacy channel for DASH.

Operator

Our next question or comment comes from the line of Joanne Wuensch from BMO.

Joanne Wuensch -- BMO Capital Markets -- Analyst

Can you hear me OK?

Shacey Petrovic -- President and Chief Executive Officer

Yes.

Joanne Wuensch -- BMO Capital Markets -- Analyst

Oh, terrific. 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, "Ooh, I just wish we had the opportunity to talk about x?" Or are we just -- we really understand it and got arms around these sort of four factors?

Shacey Petrovic -- President and Chief Executive Officer

I think you do, though 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 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 a muchneeded capacity and redundancy. And so that is a massive value driver in 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.

Joanne Wuensch -- BMO Capital Markets -- Analyst

And as a second question. Can we just spend a moment on Drug Delivery? I know we don't really think about it 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 that it's declining a little bit faster.

Any thoughts on that one?

Shacey Petrovic -- President and Chief Executive Officer

Yes. I mean, I think our work -- our guidance for Drug Delivery is always based primarily on Amgen's forecast and then our production planning. So that's what factored, really, into that 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.

Mike Levitz -- Chief Financial Officer

And I would just add. We're obviously not thrilled when 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.

Operator

Our next question or comment comes from the line of Margaret Kaczor from William Blair.

Brandon Vazquez -- William Blair -- Analyst

This 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 pass is presumably easier, much easier for patients, are they reordering more often? Is it better compliance and resulting in better utilization? And then kind of the 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?"

Shacey Petrovic -- President and Chief Executive Officer

Brandon, I think you those are great questions. And outside of utilization, I think you've 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.

Mike Levitz -- Chief Financial Officer

Yes. The only other thing I would add is just that we are seeing acceleration with our existing product in the pharmacy. So it definitely is being well-received.

Brandon Vazquez -- William Blair -- Analyst

Got it. 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 2019 to expand into new markets as well.

Shacey Petrovic -- President and Chief Executive Officer

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, nine or 10 countries in total, five 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 investments that we've 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 them. And 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 is factored into the guidance.

Mike Levitz -- Chief Financial Officer

And I would just add that -- I'm glad that you brought up the question because sometimes people get confused. So Europe represents roughly 85% of our international revenues. And so that 50% uplift on the ASP by us going direct and 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.

Operator

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

Jeff Johnson -- Robert W. Baird -- Analyst

Can you hear me OK?

Shacey Petrovic -- President and Chief Executive Officer

Yes, Jeff.

Jeff Johnson -- Robert W. Baird -- Analyst

Great. Shacey, I don't want to overread your comments, but you've mentioned now Horizon launched in the second half of 2020 a couple of times. And I've heard it kind of second half of 2020. I've heard it late 2020.

Have you had any kind of any 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.

Shacey Petrovic -- President and Chief Executive Officer

I think 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 or our time line. I didn't mean to insinuate 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.

Jeff Johnson -- Robert W. Baird -- Analyst

Right. That's helpful. And then just a 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? Will it still work the same way outside the U.S.?

Shacey Petrovic -- President and Chief Executive Officer

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.

Operator

So we can extend our Q&A session. So our next question or comment comes from the line of Ravi Misra from Berenberg.

Ravi Misra -- Berenberg Capital Markets -- Analyst

I just wanted to get a couple of clarity -- and Mike, congratulations and good luck in the future. I just wanted to get a little bit of clarity on those 2021 targets. I think you've said above market profitability in the long term. Can you help us peg down what you mean by -- what market profitability actually is? And then secondly, just on the OPEX comment -- 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.

I've just been switching between calls.

Mike Levitz -- Chief Financial Officer

Well, I'm happy to start. And Shacey, please, obviously, fill in. So in terms of the '21 target 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 tried to do is target something that reflected our view that you really could -- you could make decent and appropriate profit in this business. That is, I've 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 -and 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 about it, I'll just reiterate my earlier comments, which is the largest piece of the increase there is really on innovation. And we're a year way 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 are 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 across the business.

Shacey Petrovic -- President and Chief Executive Officer

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 be -- really to 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 and over the Horizon, it's a more attractive channel for us for a number of reasons. And that's not -- some of that investment is one-time investment captured in OPEX.

Ravi Misra -- Berenberg Capital Markets -- Analyst

And just if I may just sneak a follow-up there. 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 a profit-per-patient dynamic there so that should lead to leverage in the outyears?

Mike Levitz -- Chief Financial Officer

I'll comment, and then Shacey can jump in. I think Shacey's 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 just -- and one of the reasons we've said it's beneficial is it's just less work.

And so that's not only less work for the physician and less work for the users, it's less work for us, and work really constitutes costs. And so that doesn't materialize right away, but it's very real.

Shacey Petrovic -- President and Chief Executive Officer

Yes. No, that's right. I'm sure.

Operator

Our next question or comment comes from the line of Steven Lichtman from Oppenheimer & Co.

Steven Lichtman -- Oppenheimer and Company -- Analyst

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 mentioned it's about 10% today.

Or if 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 to 24 months?

Shacey Petrovic -- President and Chief Executive Officer

Sure. 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%, one-third.

120 million of covered lives, that's about one-third of covered lives, have access for 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 a 100% batting average on that, but that's kind of the guard rails as you think about how that ramp this year.

Operator

Our next question or comment comes from the line of Chris Pasquale from Guggenheim.

Chris Pasquale -- Guggenheim Securities -- Analyst

One follow-up on DASH. The $6 million to $8 million headwind you talked about, it's about one-fourth to one-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, is that in the right ballpark?

Mike Levitz -- Chief Financial Officer

Chris, this is Mike. Yes, we really 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. But we're still going to be selling of 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 while 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.

Chris Pasquale -- Guggenheim Securities -- Analyst

OK. And then, Mike, just one follow-up for you. The mix of operating expenses here in the fourth quarter is a little different than we expected, a 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?

Mike Levitz -- Chief Financial Officer

Absolutely. And in fact, this is a little bit of what I spoke to when we were 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, 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 is going to be working 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 No.

1 driver of the growth in spending. And it really is because of the value that we see from this innovation globally. 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 to 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.

Operator

Our next question or comment comes from the line of Matt Taylor from UBS.

Matt Taylor -- UBS -- Analyst

So I wanted to ask two things. The first one was just on Drug Delivery. We understand there's some pressure there this year. And I wanted to ask you about a couple of years ago, at your Analyst Day, you 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 bigger opportunities in the core insulin business?

Shacey Petrovic -- President and Chief Executive Officer

I think both are true just depending on the time horizon that you look at it. 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 can pursue for growth, it's just as important that we determine what aren't we going to do. And so when we look at the Drug Delivery, we had so much activity under way.

Some of that was with commercial, stuff that's much more reliable. Some of it was really early stage stuff that was incredibly bandwidth intensive and had a high failure rate. So any of these programs, even if you look at it like a concentrated insulin or you look at Neulasta, these could be seven-year programs even for commercially available molecules. And so it's just longer-term development horizon.

It's a 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 targets 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.

Matt Taylor -- UBS -- Analyst

OK. And then just one follow-up. And Mike, congrats on a great few years. It's been great working with you.

I did want to go back to one of your comments. You said you had some access wins that helped in the fourth quarter. And we all know sort of what, big picture, those are. I was wondering if you could give us a little bit of color on which ones specifically helped in the fourth quarter and anything on the pacing of those or other ones that could help during this year?

Mike Levitz -- Chief Financial Officer

Well, first of all, thank you, Matt. And Shacey may be better able to answer that question. But I will say that, Omni 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 it was really beneficial. And so we've had wins. I can't throw them. I can't call out by name.

But we've had some significant wins. And yes, 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 '19 on Medicare have actually come early. So I mean, the growth that we're seeing in our customer base is just, in our new start, is just fantastic. And it really reflects the fact that when people have access to this product, they do want this product.

Operator

Our final question or comment comes from the line of Suraj Kalia from Northland Securities.

Suraj Kalia -- Northland Securities -- Analyst

So first of all is, Mike, it's been a pleasure working with you. Wish you the very best in your future endeavors. Shacey, let me -- a couple of questions, and forgive me if they've been asked by others. Can the Omnipod with be configured that with Libre 2.0 if they receive an eye designation?

Shacey Petrovic -- President and Chief Executive Officer

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.

Suraj Kalia -- Northland Securities -- Analyst

Got it. And frankly, Shacey, as you look FY '21 and beyond, obviously, you guys are going to be running ahead on Horizon. If I look at -- one of the themes at ATTD this time was a most of the closed-loops pumps are in the 70% to 80% time in range. How do you view -- what differentiates one closed-loop system from another?

Shacey Petrovic -- President and Chief Executive Officer

Sure. So Raj, 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 populations, 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. And I think it's going to come down to how the user experience translates for the system.

Operator

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

Shacey Petrovic -- President and Chief Executive Officer

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 from to improve the lives of people with diabetes.

2019 will be another year of important milestones and exciting growth, and we look forward to speaking all of you again next quarter on our continued progress. Thanks, and have a great evening.

Operator

[Operator signoff]

Duration: 72 minutes

Call Participants:

Deborah Gordon -- Vice President, Investor Relations and Corporate Communications

Shacey Petrovic -- President and Chief Executive Officer

Mike Levitz -- Chief Financial Officer

Wayde McMillan -- Incoming Chief Financial Officer

Kyle Rose -- Canaccord Genuity -- Analyst

Doug Schenkel -- Cowen and Company -- Analyst

Jay Chadha -- Morgan Stanley -- Analyst

Danielle Antalffy -- SVB Leerink -- Analyst

Robbie Marcus -- J.P. Morgan -- Analyst

J.P. McKim -- Piper Jaffray -- Analyst

Jayson Bedford -- Raymond James -- Analyst

Joanne Wuensch -- BMO Capital Markets -- Analyst

Brandon Vazquez -- William Blair -- Analyst

Jeff Johnson -- Robert W. Baird -- Analyst

Ravi Misra -- Berenberg Capital Markets-- Analyst

Steven Lichtman -- Oppenheimer and Company -- Analyst

Chris Pasquale -- Guggenheim Securities -- Analyst

Matt Taylor -- UBS -- Analyst

Suraj Kalia -- Northland Securities -- Analyst

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