Q4 2019 Earnings Call

Time, all participants are in listen only mode. Later, we will conduct a question answer session and instructions will follow at that time, if anyone should require assistance. During the conference. Please press Star then zero on your Touchtone telephone.

A reminder, this conference call is being recorded I would now like to turn the conference.

Deborah Gordon Vice President Investor Relations and corporate communication.

Thank you Laurie good afternoon, everyone and thank you for joining us today for Insulates fourth quarter in full year 2019 earnings call. Joining me are shaky, Patrick President and Chief Executive Officer, and we'd be selling executive Vice President and Chief Financial Officer.

A replay of this call will be archived on our website in the press release discussing our fourth quarter in full year 2019 years old in first quarter in full year 2020 guidance is also available to 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 its calls me before.

Looking you could materially differ from current expectations. We ask that you. Please refer to the cautionary statements contained in our SEC filings for a detailed explanation of the inherent limitations that such forward looking statements.

We also will discuss the non-GAAP financial measure adjusted EBITDA with respect to our guidance, we have transition to adjusted EBITDA as it aligns with what management uses as a supplemental measure in assessing our operating performance and we believe that it's helpful to investors analysts and other interested parties I didn't.

Measure of our comparative operating performance from period to period also unless otherwise stated all financial commentary regarding dollar in percentage changes will be on a year over year basis.

With that I'll turn the call appreciate it thanks, Deb and good afternoon, everyone.

2019 was an exciting year, we celebrated the achievement of many milestones.

Our strong financial and operational performance reflected the culmination of several years of strategic discipline to create a strong foundation from which insulet can grow and evolve.

And we did so while staying true to our mission to improve the lives of people with diabetes.

Throughout 2019, it we made great progress advancing our strategic imperatives and in 2020, we remain focused on driving our initiatives forward, specifically wanted to deliver consumer focused innovation.

To ensure the best global customer experience three expand our global footprint and for drive operational excellence.

As we look ahead, we're confident that the execution of our strategy is driving sustainable long term growth and value creation.

The global type, one and type two diabetes markets represent approximately 10 million insulin requiring individuals in just the countries. We're in today.

This large underserved and growing global market opportunity represents a tremendous opportunity that is what is uniquely positioned to capture.

We are on track to achieve our 2021 financial targets and excited about our additional catalysts for growth over the long term.

During today's call I will share financial highlights and provide an overview of our recent strategic progress I will then turn the call over to Wade who will discuss our financial results in greater detail and share our 2020 outlook.

Our fourth quarter results marked another strong quarter of financial performance and closed out an exceptional 2019 for insulet.

We generated more than $209 million and revenue exceeding the high end of our guidance by $8 million and representing a 27% increase year over year.

This was driven by 30% revenue growth in our total Omnipod product line with both our U.S. and international operations, continuing to execute and drive strong operational performance.

We also achieved another record quarter of global New Omnipod users.

On a full year basis, we delivered consistent financial outperformance throughout 2019.

We generated $738 million in revenue, representing a 31% increase driven by 36% revenue growth in our total omnipod product line.

We also improved annual operating profitability, which weighed will speak to shortly.

It's what team continues to knock it out of the park with focus execution and an intense drives to deliver on our mission in order to provide the best value to all of our stakeholders.

I'll now share additional color on the progress we made executing our strategy starting with innovation.

We continue to advance our efforts to deliver products that are easy to use simple and improved quality of life and outcomes for our consumers.

In 2019, we completed the launch of Omnipod dash in the United States and in December we introduce dash to select European markets. As many of you know our Omnipod dash system utilizes a mobile app on a locked down phone to provide consumers intuitive simplicity and unparalleled ease of use.

With the launch of Dash, we are one step closer to consumers being able to control their pod with their own personal smartphones.

This is the top request, we get from the diabetes community and Omnipod horizon will make it a reality.

With dash, we are disrupting the market with our unique pay as you go business model I.

Omnipod Dash is the only insulin pump on the U.S. market that can be accessed with no upfront cost and no for your lock in period.

We are shifting the old market paradigm by eliminating restrictions so more people can easily access our technology without having to wait for their lock in period to end and without having to pay large upfront costs.

As a result, we are providing access to a much broader patient population.

This business model allows us to better serve the type two diabetes market, which omnipod dash is uniquely positioned to address.

Well doctors have historically been less willing to prescribed pump therapy for their type two patients. They now tell us they are increasingly recommending omnipod dash for this population as an alternative to multiple daily injections.

Our platform is easy to use and requires minimal training. So users of all ages and backgrounds are quickly up and running on the system.

As a result for the third consecutive quarter. We saw another notable increase in the percentage of our new omnipod users through the pharmacy being individuals living with type two diabetes.

To put this into perspective in Q4, almost 30% of our U.S., new Omnipod users were tied to.

We're confident that tied to users who try omnipod dash realize its many benefits. This trend is already evident in our results and we expected to continue to gain momentum.

Also encouraging is the momentum omnipod dash and growing market access have created as they continue to fuel the number of total new omnipod users.

In Q4, we saw an increase to over 80% of U.S., new Omnipod users coming from multiple daily injections, which is slightly greater than our historical average.

He pod with the benefit of the pay as you go business model in the pharmacy continues to lead the way as a category grower, helping more people get the benefits of pump therapy.

And growth of Omnipod Dash continues to be in line with pharmacy access.

The successful commercial launch of Omnipod dash, and resulting market access wins are paving the way for our innovation pipeline, we're making good progress on omnipod powered by horizon, the first ever to Bliss personal smartphone controlled automated insulin delivery system.

Many pot horizon has several key differentiators one it is designed for greater time in close loop.

Two it will provide unparalleled personalized therapy and three it can be controlled by a user's personal smartphone.

In December we completed pre pivotal testing and moved into our pivotal study, which will support our FDA submission.

Demand for trial participation has been incredible with people willing to fly across the country for the last remaining spots, which have now been filled.

In fact within weeks the majority of our sites completed enrollment and in total our pivotal includes approximately 240 individuals ages six to 70 years old.

All participants will complete a three month outpatient study.

It is important to note that our participants include pediatrics and also individuals coming from both M.D. I am pump therapy, not just to be better controlled adult population or well controlled patients include already using pump therapy.

This is another differentiator compared to other E I'd systems.

We are incredibly excited that study participants are wearing our system at home as part of this final stage of testing and feedback has been terrific.

Investigators and participants have shared many amazing stories of how Omnipod horizon will be a game changer and transform the diabetes landscape for automated insulin delivery.

Mothers, who can finally sleep through the night, while their child as well controlled children, who are maintaining tight glucose control through Dan first titles and pizza parties and adults who are experiencing quality of life improvements as a result of their ability to more easily manage their diabetes.

We will share clinical results of our Omnipod Horizon study at the American Diabetes Association Conference in June and one of our principal investigators was invited by E.D.A. to present, our pre pivotal data in a special session.

We also expect the data for our pivotal testing to be completed later this summer and we will share it either in publication or at a conference later this year.

Another key aspect of Omnipod huh.

Horizons innovative power is its design incorporating the algorithm on the pod. This should allow the user to remain in close loop for a longer period of time as compared to other systems.

The user does not need a device to keep the on body pod and CGM sensor in direct communication.

In order to accomplish this we have worked in close collaboration with Dexcom a longstanding partner. We are really excited to have recently announced an agreement that builds on our integration efforts formalizes, our commercial launch plans and includes access to integrate Dexcoms next generation G seven CGM into omni.

Pot horizon.

Our horizon effort with Dexcom isn't illustration of just one of several partnerships. We have established to deliver an innovative aggie platform that will bring freedom and simplicity to people living with insulin dependent diabetes.

We also recently announced a collaboration with Abbott another long standing partner to bring together the power of our Omnipod horizon platform and Abbott's next generation Libra sensor.

This on body system will provide patients with choice of CGM sensor in an intuitive automated insulin delivery system.

Library has had a remarkable adoption trajectory recently celebrating more than 2 million users across the globe. It's very exciting to think about the broad impact our technologies together can have on people living with diabetes.

We believe a simple design sensor choice and personalization will provide outcomes with out complexity. The differentiators of our Omnipod platform position us to further penetrate the global diabetes market, including those living with type two.

Due to this incredibly large opportunity we have prioritized. These development efforts over our concentrated insulin development programs in order to shift resources toward maximizing our AG development efforts with our sensor partners.

Our rationale for this change is a matter of priority based on market opportunity. We believe the benefits of our technology platform together with our expanded collaborations with Abbott and Dexcom provide a pathway to move more rapidly and effectively into a much larger addressable type two diabetes market.

We are excited to partner with Dexcom and Abbott to deliver consumer focused innovation that will provide benefits to a larger population and build off our current strategy that has already proving to be a winning approach to driving omnipod adoption.

Innovation as a top priority here at Insulet, we will continue to invest in growth opportunities to accelerate our pipeline and help us bring greater advancements to more people with diabetes around the world.

Now turning to our global expansion, we made tremendous progress in 2019, strengthening our global footprint and securing our leadership position in geographies with large addressable markets.

By the end of 2019, we introduced Omnipod dash in select European markets, and we expect to further roll it out across Europe in Canada. This year.

Additionally, last month, we announced that we expect to enter five new markets. This year, specifically in Europe, and the Middle East, where we see significant demand and long term value creation potential.

He pod dash is the preferred platform for our new markets and we are encouraged by the positive feedback we've received from our European early adopters.

Well, we don't expect our European our international expansion to add meaningful revenue in 2020, we're confident that we're taking the right stops to drive significant and sustainable revenue growth over the long term [noise].

Finally, I'd turning to our manufacturing innovation and global operational excellence.

First I would like to acknowledge that as we all deal with the global challenges of the Corona virus and its impact on families employees and the operations of many global organizations. It highlights the importance of our investment in manufacturing and supply chain redundancy.

In May of last year, we began production on our first highly automated state of the art manufacturing line in the United States.

In doing so we not only developed valuable internal manufacturing expertise. We also added redundancy expanded capacity and strengthened our supply chain.

Assessing the ability and internal expertise to manufacture our own products at scale and manage the complexity of our supply chain are critical to support our rapid growth and long term capacity needs. We are in the middle of ramping up our first U.S. manufacturing line and starting line too with production of Sellable.

Product on the second line expected by mid year. We also remain on track to install our third manufacturing line in the United States later this year with Sellable product next year.

But our focus on driving efficiency and effectiveness. We have created significant competitive advantages that we expect will drive long term cost reductions across our manufacturing and supply chain operations.

It does take time to ramp the lines given the complexity and scope of this effort and while this ramp is a headwind to margins in the near term our manufacturing innovation is a key driver of our 2021, 70% gross margin target, which we remain on track to deliver.

As we look ahead, we remain focused on continuing to execute our initiatives and strategy to invest in our long term growth opportunities I'll now turn the call over to Wade into Shacey as Shacey noted, we had a terrific 2019 and consistently outperformed during the year, our fourth quarter finance.

From an operational performance was no exception, we're confident that continued execution of our strategic imperatives with a focus on investing for growth will create additional value for our stakeholders and further our mission to improve the lives of people with diabetes.

In the fourth quarter of 2019, we delivered revenue of 209.4 million representing growth of 27%, which was 8 million above our quarterly guidance range.

But product line you assume you thought revenue grew 36% to 126 point Sevenmillion almost 7 million above the high end of our guidance range and marked our fifth consecutive quarter of accelerating growth in the United States.

Mainly driven by increased volume from our growing customer base and increased adoption of our new product innovation with Omnipod dash, primarily through the pharmacy chain also contributing was the mix benefit on the premium for Omnipod dash.

Volume growth of Omnipod gas drove approximately 55% of our U.S., new omnipod users in the fourth quarter.

We grew our U.S. volume through the pharmacy channel to over 25% of our total.

Also driving the growth of are you asking omnipod users is our strategic focus on that type two diabetes market.

For the full year, we realized a pdm headwind of $3 million compared to our guidance of 4 million to $6 million, resulting from the continued strength of showing pdm into our DSD indirect channels.

A reminder, our new innovative business model eliminates the upfront cost for the dash Pdm and rimage hurdles for adopting pod therapy.

International Omnipod revenue in the fourth quarter grew 20% to 65.8 million achieving the high end of our guidance range, primarily driven by increased volume in Europe. As we continued to drive demand in our existing markets as well is less of a negative headwind from foreign exchange assumed.

In guidance.

Excluding the 2% negative FX impact in the quarter.

Actual omnipod revenue grew 22% on a constant currency basis.

Drug delivery revenue was 16.9 million an increase of 1% exceeding the high end of our guidance range by 2 million as a result were partners updated forecast.

Turning to gross margin, we delivered 64% in Q4 down 290 basis points year over year, and 10 basis points sequentially.

Q4 gross margin ended slightly below Q3, as U.S. manufacturing costs were higher in Q4 than plan.

Partially offsetting these headwinds was favorable Mitch from increased volume of Omnipod gosh in the U.S., primarily through the pharmacy channel.

We expect the headwinds of U.S. manufacturing ramp could continue in 2020.

As she noted despite the short term headwinds we are confident that our investment in manufacturing innovation will contribute to meaningful gross margin expansion over the long term.

For the full year 2019 gross margin of 65.1% was 60 basis points below prior year inline with our expectations for your gross margin was impacted by the ramp of our first U.S. manufacturing line during the year, partially offset by the mix.

Benefit in the U.S. from the premium for Omnipod dashing pharmacy as was the benefit in the first half of the year from direct operations in Europe.

Operating expenses in the fourth quarter were 55% of revenue compared to 57% in the prior year inline with our expectations.

Operating income for the fourth quarter was 18.2 million, representing 8.7% of revenue on a full year basis operating income was 50 million or 6.8% of revenue slightly exceeding the high end of our guidance range.

Net income for the fourth quarter was 5 million and included a onetime noncash charge of 2.3 million relating to the extinguishment of the remaining 35% of the 2021 convertible notes. This charge was slightly better than our original estimate of 3 million due to the.

Timing of the extinguishment.

We ended the year with 435 million in cash and investments compared to 637 million at the end of the third quarter and 430 million at the end of last year. This sequential decrease from Q3 was primarily due to the 210 million we used to repurchase the room.

Meaning 2021 notch.

We ended 2019 accelerated revenue growth improved profitability and a solid global commercial and operational foundation positioning us for continued growth over the long term.

I will now walk you through our 2020 expectations, beginning with full year guidance.

For the full year, we expect reported revenue growth for total omnipod in the range of 17% to 21% and reported revenue growth for total company in the range of 14% to 18% with both including an approximate 1% negative foreign currency impact.

By product line, we expect U.S. omnipod revenue of 18% to 22%. This reflects continued volume growth of Omnipod dash, primarily in pharmacy channel.

And continued omnipod adoption in the type one and type two markets as well as expanding market access.

We will also continue to benefit from the dash pod premium in the pharmacy.

Part of the pay as you go strategy to provide pdm for no charge.

As a reminder, we launched Omnipod gosh at the end of the first quarter of last year and began generating revenue for dash at the start of the second quarter.

Therefore, our first half 2020 growth rate will benefit from Annualizing. The first full year of Omnipod gosh and move into the pharmacy.

As a result, we expect our great trades to be stronger in the first half than in the second half of 2020 as we anniversary the dash launch.

We expect full year 2020 international Omnipod revenue in the range of 16% to 20%, reflecting continued strength in our existing markets. This growth rate includes an approximate 2% negative foreign currency impact.

As previously mentioned, we plan to expand into new countries within Europe, and the Middle East and although we don't expect these new markets to contribute materially in 2020 revenue. We are laying a strong foundation for revenue expansion over the long term.

Lastly for drug delivery, we expect a decline of 15% to 20% based on our partners current forecast.

For the first quarter of 2020, we expect total omnipod growth of 23% to 26% and total company revenue growth of 17% to 20% with both including and approximately 1% negative foreign currency impact.

This growth is primarily driven by increased omnipod volume globally.

This includes U.S. omnipod revenue growth of 27% to 29% versus prior year Q1, which did not include Omnipod dash. Our first quarter reflects growing omnipod volume as we continue to expand market access and drive growth within both the type one and type two day.

Bds markets.

We expect international Omnipod revenue growth of 17% to 20%, including an approximate 3% negative foreign currency impact.

This growth is primarily driven by increased volume growth as we continue to drive penetration in our existing markets.

And lastly, we expected decline in drug delivery revenue of 28% to 34% based upon our partners current forecast.

Now turning to the rest of the 2020 piano on a full year basis.

We expect full year gross margin to be relatively consistent with the prior year as we previously communicated we expect to continue to experience short term gross margin headwinds in 2020, as we ramp to additional highly automated manufacturing lines in our move toward operational efficiency.

As a reminder, it typically takes up to two years to reach full capacity on each line. We installed our first line in May of last year, and we're making progress every day. We continue to expect to begin production of sold product on our second manufacturing line by mid year also.

Contributing to the short term headwind.

As we continue to ramp us manufacturing and gain efficiencies, we expect second half of 2020 gross margin to improve over the first half.

Despite the short term headwinds, we're confident that as we optimize and grow volumes, we will achieve our 2021 gross margin target of 70%.

Overall in 2020 or financial strategy entails.

Continued investment in our innovation pipeline, including our Omnipod horizon clinical trial and anticipated launch.

Expansion of our commercial initiatives globally.

And investment in the ramp over us manufacturing lines for capacity expansion redundancy in cost efficiencies.

We therefore expect to deliver full year 2020, adjusted EBITDA in the mid teens percentage range.

Finally, we expect capital expenditures to be relatively consistent with 2019 as we continue to expand capacity in our us operations build our global infrastructure and invest in innovation to support our growth and profitability objectives.

In summary, 2019 was a terrific year in 2020 will benefit from the momentum as we further execute our strategy.

We will continue to invest for growth.

Both in innovation and commercial.

Expand into new countries launch Omnipod dash across Europe in Canada.

And we look forward to the US launch of Omnipod Horizon, we continue to execute on our strategic objectives and make a positive impact on the lives of our customers. We remain solidly on track to deliver our 2021 targets of 1 billion in revenue gross margin of 70% and operating.

Income in the mid teens.

That I'll turn the call back to Shacey for concluding remarks makes weighed 2019 was a tremendous year for inflect as we made significant progress on our strategic initiatives. We are now beginning to realize the positive impact from these efforts. It is clear that we have a sound strategy and thanks to the hard work and debt.

Location of the entire Insulet team, we entered 2020 in a position of strength.

And now I'll turn the call back to add Lauren for Tonight. Thank you.

Thank you if you have a question at this time. Please press the star number one on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the Q. Please press the pound.

Keep your questions to no more than one plus a follow up but please feel free to go back into queue. If time permits we will be more than happy to take your follow up questions at that time. Our first question is from Matthew O'brien with Piper Sandler Your line is open.

Afternoon. Thanks for taking my questions just I guess for starters here the.

The Q1 and guide as far as the U.S. number goes is a bigger sequential drop than we've seen.

Over the last couple of years and I get your revenue base is bigger but can you just talk a little bit about your thought process on that Q1 guide is there anything of note that's going in there and maybe some more attrition through the pharmacy et cetera that.

As surprised me a little bit or is that just a bit a conservative ism.

Hi, that's weighted.

So first of all thanks for the call for the question.

For our U.S. guidance, we feel that 18% to 22% as a strong guide.

For the year end for Q1 that you referenced 27% to 29% also a strong guide.

As a couple key drivers that give us confidence here I mentioned that the first half benefits from dash and the pharmacy.

It does create a tougher comp first and second half. So we have the Q1 guide here above the full year.

We have a larger percentage, 30% of our new patient starts in Q4 are coming from time to.

And we're positioned very well there so a lot of reasons that we're confident in the 27 to 29.

We are aware of one now in a potential second new competitive DLT there in the marketplace.

In 2020, so we do think it will create some noise in the marketplace. We havent seen that in Q1 and so that's why we're confident in this guide so yes, I think to the second part of your question. Matt. This is just a standard guidance practice for us.

We feel comfortable and that a 27% to 29% guide in the US is is a strong guide.

Okay. That's fair and then flipping over to horizon for a second one of those.

One of those companies mentioned yesterday on their call that they have a delay in one of their products because of the linked to the phone.

Specifically, so I don't think I heard you say, yes, we're on track for the horizon and to your timeframe. Specifically can you talk a little bit about that and then when exactly did you finish enrollment and the pivotal. Thank you yes, Matt. Thanks for the question we remain on track for launch at the end of this year, we've got all too high.

Third 40 trial participants on the system. So right now were about 35% of the way through the trial and learning a ton as you might imagine so I just to give a little bit more color. There we're seeing started.

Typical things you would see when you send users home with a new system like this for the first time, but obviously, that's why you do trials like this and the team is doing a great job collecting and addressing these learnings and kind of supporting our sites across the country. So making good progress there and when did we exactly finish enrollment it was within.

Weeks of opening enrollments I don't know the exact date, but very early on demand was pretty incredible and feedback from the trial participants has been frankly emotional and gratifying.

No doubt that consumer demand is really high and we're working very hard to collect address learnings from the trial and I get the system to market as quickly as possible, but nothing's changed our timeline.

Thank you. Our next question comes from Robbie Marcus with Jpmorgan. Your line is now open.

Thanks wanted to just follow up on the guidance Wade because you have such a strong first quarter guidance and it's a recurring revenue business and I do realize theres. Some mix benefit that will go away as more and more patients are in the pharmacy with you know some price pre.

To me I'm, you're getting as the installed base upgrades, but it seems like such a sharp decline in the second half the year for the recurring revenue business. After such strong growth in 2019, you know how should we really be thinking about the drivers of maybe price mix and volume what's assumed in your guidance there.

For the U.S. growth number thanks.

Yes, hi, Robby so yeah, I can try to add little more perspective to the guidance particular to the US here with your question.

One way to think about it is that we have similar close to the same year over year gross dollars that we had in 2019, which was a very strong growth year for us with dash in the pharmacy in earnest ramping in the second half and so we do see the benefit in 2020 of the second couple.

Two quarters of Annualizing.

The strategic moves for launching dash in for moving into the pharmacy.

Horizon does not have a material impact to revenue in 2020 until it ramps in 2021.

So we feel that dollar growth similar to the strong year, we had in 2019 with momentum coming here into the first half from 2020 is the right level and we're going to start the year, there and we're going to monitor as many dynamics in the marketplace that we're monitoring and we'll keep close tabs on them and see how.

We progress here throughout the year.

Okay, and I'm, sorry, if you touched on this in the prepared remarks I'm jumping across a couple of different calls Tonight.

But can you touch on your supply chain in China, and any impact from Corona virus, how manufacturing in China is how much safety stock you have and if you foresee any a potential supply disruptions here. Thanks.

Yes, Robbie and it's a great question and I want to first just commend our team because they're managing through this incredibly capably and we do not anticipate any product supply issues due to the chronic virus at this time.

Our as we mentioned earlier, our automated facility in the U.S. is starting to provide manufacturing redundancy and risk mitigation and additional capacity as line one ramps and then we bring line to on and we got.

Our best people frankly on this here and on the ground in Shenzhen, we have a comprehensive plan in place to add to.

To make sure that we've got a risk mitigation. So plenty of inventory on hand at and then act and continues to produce more and more everyday and then our facility in Shenzhen is also up and producing again.

So I think we right now feel as if we are in a solid position and the team is managing this incredibly closely monitoring it every day and making sure that we're proactively putting on mitigation plans in place.

Thank you Sir our next question comes from David Lewis of Morgan Stanley. Your line is open.

Good afternoon. Thank you, where I guess just to be very clear about you U.S. guidance, because I guess I'm surprised by a few of the questions here.

That's very simply your growth rate in the fourth quarter 2019 is about 20 points fast in the growth rate in the first quarter. So really what you're saying is your guidance reflects stable momentum in the business you just going to anniversary harder comps in the back half the year.

That's correct.

Okay very straight clear. Thank you and then just ex us.

Actually this business momentum, which slowed a little bit into the back half for the year. Your guidance for 2020, it's actually very consistent with what you said over the last couple of months could just sort of walk us through back half 19 dynamics and your confidence in the.

2020, ex us guidance and then I had a quick question for Shacey.

Hi, David exactly as you said you know our.

Long stated guidance here for international has been high teens low twentys, we feel that that's the.

Range that we can continue to grow in outside the U.S. and so our all U.S. guidance is 18% to 22% FX is right in that guidance range and right, where we expect the region to be we also have a strong Q1 guide in international we typically have better focus or better insight into.

To the pipeline for the shorter quarters, and so we've taken up that range on an ex FX basis to 20, 23% that's above the high teens low twentys to start the year, but overall now that weve annualized going direct in Europe, we have a good here.

And on our business by region.

We still sell through distributors for most regions and therefore, we have to account for some uncertainty there as well as potential for some attrition, but overall I think.

Guiding for this business in the high teens low twentys as we should expect us to be we think we're going to start you're a little stronger just by insights the pipeline.

Okay and then she should just one of the things that happened last couple of quarters has been this T. Two momentum it's has gone from basically 15% to 20% to 30% over the last six months I guess the question is that's pretty remarkable inflection where we're can that go this year or long term. Thanks, so much.

Sure David It's a great question you know I think it's still early days and there's a lot of wood to chop in type two I think about pharmacy, I think about only being a year into our business and launching a new product in Europe. So I, just want to caution where I and I guess put that into context, where I think it can go but take two's incredibly exciting opportunity for us.

We have good access there, it's an incredibly large opportunity we and we believe it's twice at least the size of the type one opportunity in the United States and I were seeing great results, both anecdotally from clinicians and our users and just obviously, we've got data around.

A reduction of total daily dose of insulin and other specific outcomes in that patient population. So we think that we're just scratching the surface and just getting started and that we've got a.

A long runway frankly of providing this technology to people who are underserved in this market in a patient population, where clinicians don't have a lot of great tools and dash is a great tool in this patient segments I think it's going to hang with us for a while we're really excited about the potential and we're going to continue to invest to unlock the opportunity.

Thank you Sir our next question comes from Jeff Johnson with Baird. Your line is open.

Thank you good afternoon, guys Shacey ownership, maybe just to follow up questions one.

On the decision to maybe sidelined the concentrated insulins here you know you've kind of turned down some of the drug delivery efforts. It seems like an now on the concentrated insulin.

You know that would imply there's a lot of other stuff going on I would assume over the next couple of years and really beyond horizon. What is coming next what is taking up so much of that bandwidth I just want to make sure on the concentrated insulin side. There is not an issue with the data itself or are the product itself, it's more of a bandwidth issue.

Right, Jeff that's true this is not an issue with the data itself or the product a itself. It is about essentially having to make the tough choices as the leadership team that we have to make I think a great thing about insulet is that we're in a position to have multiple growth opportunities and programs and potential.

Steps that we can take in front of us and our job is to make those tough decisions and prioritize the ones that we think are going to drive the most value for the organization and right now with the addition of both Abbott.

Libra and Dexcoms next generation sensor out we believe that those combined have the potential to be more attractive opportunities in terms of the market size and how quickly we can use them to to drive into those market opportunities. It doesn't really diminish our enthusiasm we look at concentrated insulin.

As an attractive opportunity. It just means we have more attractive opportunities and in terms of the pipeline, we haven't been public with our entire pipeline. There's a lot going on here, but one thing. We have said is that we believe that omnipod powered by horizon is a platform that can continue to evolve and grow and bring value to.

I, both people living with type one and type two diabetes and so we've got really exciting plans on that front to continue to bring iterations of that platform into the marketplace and so this is I think the right decision you know, it's all driven by a number of analyses that we do to kind of evaluate a one program versus the other I think the team.

A rigorous evaluation and and that this prioritization level is the right prioritization.

Oh I understood and then maybe just a question on the horizon pivotal fit if it closed or it was fully enrolled a few weeks. After a it started so let's say at least by the end of January. It's a three month study I mean, just to push you a little bit is there any chance we could see some of that pivotal data.

At 80, a it sounded like.

I wasn't sure from your comments, if we're going to see pivotal data I know you said pre pivotal but also checking on the pivotal data and then a wouldn't seem crazy to me at the study you don't completes a at least primary completion by May ish, a three months at the FDA month to kind of get the data together I mean could we be see an approval sometime late this summer or do we really think deeper.

We're into the second half of this year. Thank you.

Yeah, Jeff you sound like me with the team [laughter], but you know I'll say, so when we say completely enrolled at then takes a while for people to actually get on the product right. There are enrolled as trial participants and the need to be seen and put on the product to be able to participate in the trial and that takes some time. So it doesn't happen overnight we.

I expect from this trial, the how about 21000 patient wearing days collected over the course of the pivotal and we've got about 8000 patient wearing days under our belts. We've still got some time to go and and so I think a lot to learn in that process I'm hesitant to kind of provide a more aggressive timeline I think later this year as what we've said and.

And that feels right to me based on all the work that still needs to happen, but I think we we are excited about the program just learning everyday and I want to be cautious about how we guide about that because I think I do think it's going to take some time for us to collect that data react to the data determine any learnings that we want to incorporate before we move.

But the commercial final product all that stuff still has to happen. So teams are committed we've got great people on it and it's going to be I think a terrific product.

Thank you Sir our next question comes from Ryan.

Your line is open.

Hi, Thank you for taking my questions.

A couple on U.S. revenue, what was the U.S. installed base growth versus 30% US revenue growth you posted in 2019, and what did you ask guidance assume for install base growth in 2020, and then I mean Q3 call you talked about expecting some stocking associated with the move to the pharmacy channel in the future that any stocking occur in the us in Q4 I've a follow up.

Hi, Ryan it's weighted so we're not providing quantifying install base at this time, but what we said in chases prepared remarks that it was another record new patients third quarter for us. So we added.

More customers to our install base in Q4 than we had in any quarter before that.

So that's about all we can say on that at this point.

And then regarding Q3 stocking we did not see stocking again in Q4, so what we're learning about our pharmacy channel is that it's very efficient and we did see some net channel builds on the pharmacy side, but it was offset by reductions on the DMC side of the bid.

Snus, which is a different channel so on a net basis for Q4 in the U.S., we did not see any channel build however, we did see some build in the pharmacy offset by the DMV and.

The more wholesalers and distributors that we add to our.

Distribution channel here, we're learning, it's a very efficient channel, we do think that overtime that we will start to see a channel build.

Once we settle out on the DMC side of the business and we continue to add channel partners on the pharmacy side and then eventually when we start to add more inventory into the retail end of the channel. We would expect some channel build there having said that we're not reflecting in our guidance at this point because we do not.

We can't time, when we think thats going to happen. So we see immaterial amount of channel inventory build I will certainly photo for it.

Got it Okay and then two type two questions have you seen any notable difference in utilization or attrition amongst your type two years versus the overall installed base and you can find the U.S. type two total addressable market as two and a half to 3 million patients, which is a bit above what other companies have talked about can you talk a bit about your confidence not asked when and how you got to it.

Okay.

Sure I'll start with the first question, which was just change in utilization habits, and and we haven't noted a change in utilization or attrition with the type two but when I say, there's still a lot of wood to chop, it's kind of what I'm, referring to its early days with the type two at user population, we've seen a notable tick up but.

It's a little early to conclusively say attrition isn't different or utilization isn't different. So we're certainly monitoring those trends I carefully and to date, we haven't seen a notable difference and then the question regarding the estimates and so that comes we triangulate on that number from a.

Bunch of external a market research report.

The idea Atlas and internal data and one difference might be sometimes other organizations will hair cut based on access and remember I mean pod has a pretty solid access and the type two population and so we don't necessarily uptick same haircut that other companies might.

Thank you Sir our next question comes from Jason Bedford with Raymond James Your line is now open.

Hi, good afternoon.

Just a couple semi follow up questions.

I appreciate the comments around type two as a percent of your new users in the fourth quarter <unk>. What is the current tied to mix in the context of your installed base.

Sorry, I didn't catch that Jason when did the type to the mix.

Oh I see overnight.

We haven't.

Hey, good number there the last number that we gave was that it was 15% to 20% of the total base.

Okay. Okay.

Okay.

Maybe for weighted on the U.S. Guide you mentioned the new system has impacted your business today.

You did mention the device in reference to your U.S. business I guess the question is the guidance contemplates a more competitive impact in quarters two through four.

[noise], so maybe it Jason.

To start with.

We do see and monitor things in our marketplace and we recognize that Theres one out there now and in potential for a second so that was really my comment that just how we get to our guidance is.

Looking at the market factors out there, having said that given 80% of our new omnipod customers come from India.

We don't rely on to pump renewal cycles for the most part and so we do think it will create some noise in the U.S. market and you're going to monitor that that piece of it closely.

Yeah.

But having said that we haven't factored into a major impact to our guidance range.

Our next question comes from Danielle Antalffy SVB Leerink Your line is open.

Good afternoon, guys. Thanks, so much for taking the question congrats on a really strong 2019, I'm sorry to harp on that the guidance, but just wanted to peel back the onion, a little bit more if we could because even on a top but just to basis I mean really every quarter in 2019 in the U.S. you accelerated revenue growth and I know.

I appreciate the comps get tougher, but it feels like the momentum is actually going the other direction I eat your just continuing to accelerate so I just wanted to make sure I'm not missing something or is this sort of more just prudent conservatism on your part as it relates to the to the guidance.

Yes so.

Hey, Danielle twins, so from from a guidance standpoint, it sounds like this is a popular topic. This quarter you know again, we do take a thoughtful approach you know we include internal factors external factors, we build our bottoms up assumptions and there's nothing out of the ordinary here, we're not gonna do.

His factor in record new patient starts growth every quarter to quarter on quarter for four quarters, we're going to take a thoughtful approach here.

Yes, I did give the context that our dollar growth is close to the dollar growth. We had in 2019 and that brings us to for the US an 18% to 22% growth rate. So we feel that as a strong guide for the year, we see some strength in the first quarter shore Q1 guide is above that.

And we feel very comfortable where were up and we'll continue to assess it as the year goes along okay totally fair and then as we think about horizon I mean first of all I assume nothing's really in the <unk> I don't want to put words in your mouth I assume nothing's really in the 2020 guide is that is that a product launch that you see as as accelerating.

New patient adds are more just like the sustaining the current growth momentum you half.

Yes, so we're not going to guide to horizon, yet we're planning to habit in the second half of the year. We do not think it'll have a material impact on a 2020 revenue having said that we're very excited about this product in the value proposition proposition that brings for the business and our ability to deliver technology to more.

Patients.

In broader ways because of the the advantages of the system, but we're not going to provide any guidance on what that will do to 2021 at this point once we launch horizon.

They will give an update at that time.

Thank you. Our next question comes from market Costar with William Blair. Your line is open.

Hi, Thanks for taking my question. This is actually up Brandon and for Margaret I wanted to kind of focus again on the type two patient population just because you've had.

Oppressive adoption within that market and its relatively underpenetrated, rather than focusing on kind of where it can go kind of focus on how we got to where we are now I'm just interested in.

I.

Kind of marketing type two patient population.

It's been more of a type twos coming in to Insulet finding out on their own.

I don't like more of a push our call and then our your patience type two patients are they also.

<unk> costs converts.

Hello.

Great Ryan good questions on so our <unk> I would describe it as a pull strategy really and it got set up in terms of a strong foundation with insulet, securing Medicare reimbursement, because remember that 40% of people living with type two are over the age of 60, and so Medicare reimbursed.

Spend is really important in order to be able to drive adoption. Among this population and then I think the business model of eliminating the upfront cost and reducing the risk for the patient pair and physician to just try omnipod for this population of users has helped to.

I encourage more people, who otherwise would not have tried it to actually give it to go and then we're seeing obviously that they like it and are sticking with it also reduces the cost burden and makes the cost more predictable for the patient and so all of those things are really helpful, particularly in this patient population.

And then I think dash in particular has some design features that also are very appealing prototype to segment and so we have a you know educated our sales teams and provided them with tools and resources to help educate clinicians and potential new omnipod users living with type two diabetes on these benefits.

And a and then obviously a lunch programs to help them be able to potentially try it before they and before they buy it so to speak to all of those things have been helping us drive that increase adoption those aren't going away and I think as a growing experience and user base, especially among clinicians who are seeing this as a tool that they can wheeled that's a success.

Full for these after these patients I think is really helpful and that's why we we have confidence that the trend will continue.

Got it okay. That's helpful. Thanks and loss.

Horizon coming at the end of the air and Interestingly we saw some.

Oh I saw was pretty good data from tied call on their ongoing pivotal study last week. So I. Appreciate you won't want to comment on when that might be approved.

Just a question is one or is there any kind of contemplation of that being approved in your guidance is that baked into numbers now a and then town.

Once it gets approved so lets say theoretically it was approved today, how long would it take for you to be on the market tied Paul enable omnipod system. Thanks.

Sure. So I can serve the guide if you'd like so for products and are not on the mark yet we're not including in our guidance. So that's a that's an easy answer on the type of front you know, it's really up to them when they're timeline is and when they watch the product and when it is we'll assess if it has any impact to our guidance or not.

And we've just started to have discussions with tied fool around what the commercial launch strategy might look like I think there's a lot of unanswered questions and so I don't want to speak for I type pool in terms of what their strategy is I will say that for horizon and I was highly highly encourage if not require for type pool that a limited market release is something that.

We will do because it's really important to ensure that we have fully tested the system. We fully tested our internal support capabilities. We know in particular for horizon that demand is going to be strong and so we want to make sure that we get that right in terms of performance support.

Training all of the surround sound of launching a product like that so we will go into a limited market release, and we'll see a very typical I think execution of that which means at all it won't be a kind of full market release for probably a month after clearance.

Thank you Sir our next question comes from.

With Jefferies. Your line is open.

Oh apologies I Anthony for US just a couple on horizon.

Just wondering you know we break to though you know what actually is the timing for that.

On the Abbott side, certainly that's been delayed a bit so I'm just wondering from the insulin viewpoint, what's the the timeline for integrating horizon with leeway to though.

Then a follow up would be just on the horizon Clinicals, maybe just too.

Benchmark the views on time and ringing and what do you think ft is looking for and how that target compares to what was put up in debt clinical trials. Thanks again.

Sure. So I'll start with LIBOR rate, which I, we just finalize these agreements and then once that happens that programs be did.

And that's when a significant resources start working on them. So those teams will work together than to define the program and then timelines for regulatory submissions and launches and so we'll we'll communicate that out as we come to alignment and all that guidance is finalized with our partners I don't and wouldn't.

Comment on IC gem clearance for Abbott Libra, we're very confident in our partner, but it's their strategy and their timeline, so and our Libra by Horizon program is dependent upon a an ice CGM regulatory clearance.

And then at the second question was on Horizon time and range I think we feel very excited about the data that we have published today and.

But we're not we're a blinded to the pivotal clinical data. So we don't have visibility to timing range coming out of our pivotal we won't have that until the investigators present, the data and or we publish it. So I don't have a lot of insight there.

Discussions with the FDA, they havent really focused on a particular time in range target really has been about how these systems safely and effectively managed glucose delivery or manage insulin delivery.

For the patient as opposed to setting out a particular time and range target and I guess I would validate that by just pointing to the special controls, which has now been published for CGM and for our IC GM for I pump and I controller that there really aren't time and range targets as part of those special controls.

Our next question comes from Matt Taylor.

Your line is open.

Hi, Thank you for taking the question.

I guess I was hoping you might extend on some of the broader assumptions that would impact your forecasters are.

Are you assuming for the market that we see similar.

Versions of patients, we are pretty strong conversions of Mds patients to pump therapy in that forecast and can you share anything on the ASP trends or other things that you imputed into that guidance to get to this number.

Hey, Matt we're not providing details can you go into finer level details on the forecast.

What we did share was that.

If we achieve the high end of the guidance range.

We will be near the growth dollars excuse me near the growth dollars that we had in 2019, obviously, if we end up lower in the guidance range will be lower than 2019.

But having said that I think a lot of the dynamics that we benefited from in 2019 are still in play talked to booked ash in the pharmacy and the benefits that those spring, but we've also made investments in our commercial teams both in the U.S. and outside the us.

We continue to gain experience and strengthen a on the commercial side of things.

So I think we've got a lot of momentum we've got a lot of reasons to believe why we can continue to drive a high teens low twentys type of a growth rate for this business and that's what we're guiding to for the year.

We're not going to get down into further details on that at this time.

Okay. Let me just on international you are going into some new market.

Previously you've talked about these is pretty high teens growth markets.

But your growth rate doesn't assume that you're doing any better than that you why don't you getting a lot of revenue out of this new markets.

Going into or you're being conservative with the baseline forecast.

Yes, so out or you were getting a lot other markets actually mad and high teens low twentys growth rate is a very strong growth rate, we had to make a significant investment in Europe in particular.

Build the infrastructure in order to support a business growing high teens low twentys and.

Taking over responsibility and establishing ourselves in multiple different countries across Europe. So we think that we're going at a strong pace at a high teens low twentys growth rate.

You mentioned, the new countries that we're going into we've talked about five new countries. This year.

Really speaks to the strength of our business model and the annuity when we don't get a lot of revenue from moving into these five new countries in the beginning because it takes oh period of time to accrue enough customers to get to a material level revenue so for us I think thinking.

About the annuity model the durability of the revenue stream once we acquire enough customers and so in Europe, it's a little bit more dispersed because some of these countries have less people in them. The total available market for us is smaller when you aggregate at all for Europe.

As a very large market, but it takes a period of time for us to get to.

To these markets and bring these people on so we're actually quite happy with a high teens low twentys growth rate and obviously, we're going to.

Continue to make the investments to keep that pace of growth happening in Europe.

Thank you. Our next question comes from Steven Steven Richmond with Oppenheimer. Your line is open.

Thanks, Hi, guys, maybe just a couple of financial questions Wade just to level set on the EBITDA guidance and I and I apologize if I missed this where you end up 2019 on EBITDA margin in and what noncash expenses or how much we should we should we be assuming in the 2020 EBITDA guide.

Sure.

Thanks, Steven just to clarify its adjusted EBITDA. So we finished in low teens, 13% in 2019 and so our guide for this year is a slight improvement over 2019.

Okay got it and it just overall guys I mean, how should we be thinking about.

Core operating expense growth in 2020, and and will you be making investments in sales force growth in 2020.

Yes, we are making continued investments in sales force growth both in the U.S. and outside the U.S. outside the U.S, particularly for the new countries that we'll be moving into.

We're not providing guidance at a specific line item levels for operating expenses, but what we've talked about in our strategy. Several times throughout the year is that number one you can expect us to continue to invest for growth and what that means is we'll be making them majority of our investments in R&D in our innovation pipeline.

And as well as we talked about commercial which is in selling and marketing and continuing to invest there. We are still investing in gionee, because we have to continue to build the support functions in order to support the business when it's growing at the pace that we are but I think you can assume more leverage off the June.

Hey line than off of R&D, and selling and marketing.

Thank you and we do have time for one last question. Our final question comes from Kyle Rose with Canaccord. Your line is open.

Great. Thank you very much for squeezing me in sight I wondered if we could just take a step back and ask a question just about the broader market because I think the fact that 80% of your new patient starts are coming from MD I Gibbs gives you guys a little bit of a different perspective. So I'm wondering if you could just maybe help us understand how big do you think or from.

Penetration perspective, you do you think the type one market is just from a pump standpoint.

And then how do you view that from a from a type two perspective as well as you know how do you think about your market share within that type one market.

Sure. We don't so the best data that we have in terms of pump penetration is from the U.S. and the estimate there is that approximately 35%.

People living with type one diabetes are using pump therapy has been growing so that's up from 30% just a couple of years ago.

And I'd take two is much smaller than that we estimate at this point, probably less than 5% of people living with insulin dependent type two diabetes are relying on pump therapy.

We don't really contemplate you know our percentage of the.

The pump market, we think more about our percentage of the total opportunity because as you note, 80%, usually 70% to 80%, but more recently, 80% of our users come from multiple daily injections. So am I don't really have a off the top my head estimate in terms of market share. Although I would say, we probably have the largest market share and type.

Too I, just given the way that though the growth has occurred.

Great and then just one follow up question on.

Some of the dynamics preferred for Dasha me I know it initially when you talked about launch a dash who is using that as a way as a lever to open up the pharmacy channel I mean, obviously that's happened, but when you talk about the penetration or the percentage of patients come into the pharmacy versus the percentage of patients on dash. It implies that you're also getting pretty healthy component of some DMD patients there.

So I just wondered why did you could comment on some of the contracting and conversations you're having with payers regarding dash ended the army channel and then barely on horizon, how you plan on using that as a lever tell you know maybe widen the availability in.

In the pharmacy channel.

Sure, there's a great questions and things we're talking about all all to all the time in terms of horizon and leveraging the pharmacy channel.

So today dashes, primarily available in the pharmacy channel at we do have one on DMV contract through the pharmacy channel, where they have agreed to the pay as you go model and that's really the distinction. So we actually our open to contracting in the any channel, but what we believe firmly in and what we.

Believe in 2019 helped grow adoption, particularly among the tight to segment is what we call. Our pays you go model and eliminating this large upfront cost and in exchange for a premium on the pod and that should be in attractive value proposition for our payer weather frankly, whether you're in the DMC side or the.

Pharmacy side, because it helps to offset the risk or absorbed the risk for member attrition and in this one case large Jimmy I'm payer.

That is the model, but they agreed to and that we do have any contracts that we may or may not see that I grow and frankly, one of the surprises in 2019 was that while we started to see such great progress in pharmacy and started to see that channel establish itself and grow. We also did not see the consequence.

So decline in the DMC channel the way that we might have expected at the beginning of the year. So it's great to see both channels a thriving and what we believe any what we want to see grow across a potentially both channels, but particularly well suited in the pharmacy is this pay as you go model and then the second question you had regarding pharmacy.

On the intention or regarding horizon, rather the intention is to leverage all of the work that we've done, particularly in the pharmacy with establishing these dash agreements, establishing the wholesaler partnerships, establishing all of the relationships with our pvms in our pharmacy payers is to leverage all.

That so that we can rapidly established access for horizon in the pharmacy, which is our preferred a channel to launch the technology in.

But I would point out we did pretty quickly with dash. So we established pretty rapid access in nine months with dash and 2019, we're hoping to do it faster with horizon, but it was really rapid.

Adoption in that channel, which I think just points to the strength the value proposition.

Thank you.

No further questions at this time I would now like to turn the conference back to Shacey Petrovic.

Great. Thank you a everyone for joining our call today I want to close by thanking our global Insulet team, who worked tirelessly to improve the lives of people with diabetes 2020 is going to be another exciting year for Insulet and we look forward to speaking with all of you throughout the year about our continued progress thanks and have a great anything.

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

[music].