Deborah R. Gordon - VP-Investor Relations & Corporate Communications Patrick J. Sullivan - President, Chief Executive Officer & Director Michael L. Levitz - Chief Financial Officer Shacey Petrovic - President-Insulet Diabetes Products Daniel J. Levangie - President-Drug Delivery Division.

Tao L. Levy - Wedbush Securities, Inc. Robbie J. Marcus - JPMorgan Securities LLC James Francescone - Morgan Stanley & Co. LLC Danielle J. Antalffy - Leerink Partners LLC Kyle Rose - Canaccord Genuity, Inc. Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker) Ryan Blicker - Cowen & Co. LLC Ben C. Andrew - William Blair & Co. LLC.

Good afternoon, ladies and gentlemen, and welcome to the Insulet Corporation's Fourth Quarter and Full-Year 2015 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host, Deborah Gordon, Vice President- Investor Relations and Corporate Communications..

Thank you, Liliana. Good afternoon, and thank you for joining us for our fourth quarter 2015 earnings call. Joining me today are Patrick Sullivan, our President and Chief Executive Officer; Shacey Petrovic, President of Insulet Diabetes Products; Michael Levitz, Chief Financial Officer; and Dan Levangie, President, Insulet Drug Delivery.

The replay of this call will be archived on our website. Our press release discussing our fourth quarter and full year 2015 results and first quarter and full year 2016 guidance are also available in the IR section of our website.

Before we begin, I would like to inform you that certain statements made by Insulet during the course of this call may be forward-looking and 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. With that, let me turn the call over to Pat..

Thank you, Deb. And good afternoon, everyone, and thank you for joining us today. I'll start off today's call with a brief review of our performance and our view of the business and our market opportunities today.

Following my remarks, Mike will review our financial results in more detail and discuss our outlook for 2016, and then Shacey will provide an update on our commercial progress before we turn the call over for questions.

2015 was a year of dramatically improved performance and significant accomplishments, specifically our fourth quarter revenue and full year 2015 revenue results, the recently announced sale of Neighborhood Diabetes business, the team's continued progress on our key commercial initiatives, our recently announced partnerships with Glooko and Eli Lilly, our Digital Insulet strategy on our path to the artificial pancreas product offering and the dramatic growth in our Drug Delivery business.

We've made significant strides in our key areas of focus during 2015 and as we enter 2016, our momentum is stronger than ever.

I remain tremendously excited about our business and the market opportunities and continue to be confident that we have the right products, a winning strategy and a really energized team that has positioned the company for long-term sustainable and profitable growth.

In the fourth quarter, all four of our product lines once again grew year-over-year revenue and our results exceeded expectations. Fourth quarter revenue was just over $100 million and grew 38% year-over-year, $9 million higher than the midpoint of our guidance range.

And for the year, we generated revenue of $324 million, a 12% increase compared to 2014. We again set a number of performance records within our U.S. OmniPod business. Our fourth quarter U.S. OmniPod revenue reached a record of $53 million, representing year-over-year growth of 21%. New patient starts in the U.S.

during the quarter were up just over 20% year-over-year, representing the highest number of patient starts in the company's history. In addition, new patient starts within the pediatric population in the United States were up approximately 30% year-over-year, also hitting another all-time high.

And as you know, these new patient starts are an early indicator of revenue growth in – the revenue growth in our recurring revenue model and these growth rates set us up for continuing strong revenue growth going into 2016.

Our International OmniPod business also delivered strong growth with revenue up 16% year-over-year to a record of over $15 million. The results from our Drug Delivery business are very strong with fourth quarter revenue of nearly $15 million.

As you know, a large portion of our Drug Delivery business includes sales to Amgen and last month, they reported that the sales of the Neulasta Onpro kit, which includes our OmniPod technology, continues to gain adoption and after only one year on the market achieved approximately 25% share of the Neulasta doses in the United States.

We are thrilled with our Drug Delivery results and our relationships we have with both of our existing commercial partners, as well as all of our other Drug Delivery partners. Finally our Neighborhood Diabetes business generated revenue of just over $17 million in the fourth quarter.

The recent sale of Neighborhood Diabetes to Liberty Medical enables us to focus our operational and financial resources on driving accelerated growth of our innovative OmniPod and Drug Delivery products. Liberty Medical is positioned to make investments in Neighborhood to further develop and scale their business.

Divesting Neighborhood Diabetes also improves our overall company revenue growth rate and gross margin profile. I'd like to thank the Neighborhood employees for their hard work and commitment to Insulet, and wish them continued success as part of Liberty. I'd like to now make a few organizational announcements that we're making here.

First, Shacey Petrovic will assume the role of President, Insulet Diabetes Products. Shacey joined us a year ago as Chief Commercial Officer and led the realignment of our commercial operations, including sales, marketing, managed care, customer care, international and strategic partnerships.

Under her leadership, Insulet achieved record-breaking commercial results, reset the product development roadmap and established and energized a collaborative culture. Second, I'd like to also welcome Chuck Alpuche who joined us earlier this month as Senior Vice President of Global Manufacturing and Operations.

Chuck is a senior PepsiCo veteran and comes to our organization with more than 30 years of global manufacturing operations and engineering experience. Chuck had responsibility for the international supply chain for PepsiCo, with responsibility for over 300 plants and has made over 120 trips to China.

We're thrilled to have Chuck onboard and we are confident that his extensive operational expertise will be extremely viable in helping us refine our global manufacturing footprint, and identify opportunities to significantly improve manufacturing operations and supply chain effectiveness.

This is one of the many steps we are taking across the organization to achieve operational excellence, and to ensure we achieve profitability in the near term.

Before I'd turn the call over to Mike, I like to speak briefly about what we believe is the tremendous market opportunity before us, and the importance of the OmniPod, elegant and differentiated insulin delivery system. Diabetes is a growing global epidemic. There are 20 million people worldwide living with type 1 diabetes.

Most are managing with multiple daily injections, with their lives depending on navigating the minefield of carb counting, skin pricks, injecting themselves or their children and challenging unpredictable blood glucose levels.

These patients, particularly if they are not well controlled, have alarming rates of comorbidities like blindness, heart disease and a higher rate of death.

We are convinced that the OmniPod is the best insulin delivery system available to help these patients improve their glycemic control and significantly improve their quality of life, live longer and healthier lives.

In addition to the large population of type 1 diabetes patients, the incidence of type 2 diabetes towards that of type 1 was a substantial subset of type 2 patients requiring administration of daily insulin to survive.

These people typically require more insulin than the average type 1 patient and many would benefit from the OmniPod if they could hold more units of insulin in their existing OmniPod reservoir.

We're partnered with Eli Lilly to complete development and clinical work to obtain regulatory approval for use of their concentrated insulins, U200 and U500 in our OmniPod, which would effectively increase the capacity of the OmniPod reservoir.

This will ensure that all people living with insulin-dependent diabetes, regardless of their daily insulin dose requirements, can experience the freedom and proved glycemic control the OmniPod provides.

As Mike and Shacey will discuss in detail, we look forward to a very exciting 2016 of key initiatives in full swing and revenue that we expect to grow by approximately 30% compared to 2015.

We are growing – we are highly focused on maximizing the future potential of our OmniPod technology, and our senior leadership team is executing our winning strategy. And our commercial team are developing – delivering very strong results.

I am very pleased with the momentum we see in our diabetes and drug delivery business opportunities and I'm confident we have the right foundation in place to enable the company to deliver long-term sustainable profitable growth. I'll now turn the call over to Mike..

Thank you, Pat. I'll first review our fourth quarter and full year 2015 results and then introduce our 2016 guidance. Please note that our 2015 results include Neighborhood Diabetes.

However, effective January 1, 2016, the Neighborhood results will no longer be included in our continuing operation, and our forward-looking guidance will reflect this change.

To assist you with your modeling and for clearer year-over-year comparisons, we've provided pro forma 2015 financial statements in our earnings release, which exclude the Neighborhood business as if they were divested on January 1 of last year.

In addition, we have posted to our website a schedule of the pro-forma revenue for each quarter of 2015 reflecting this divestiture. Please also note that as I review our results, unless otherwise stated, all of the commentary regarding changes will be on a year-over-year basis.

We are very pleased to report fourth-quarter revenue growth of 38%, with revenue reaching over $100 million in the quarter, compared to $72.5 million. We saw growth across all of our product lines and the primary growth drivers were the over 20% growth in U.S.

OmniPod sales and the significant growth of our Drug Delivery business, which delivered revenue approaching $14 million in the quarter from less than $1 million one year ago.

This brought our full year 2015 revenue to just over $324 million, an increase of 12%, even with the low shipments in the first half of 2015, as our OmniPod distributors significantly reduced their inventories to steady-state levels from their higher inventory levels in 2014. Our reported gross margin in the fourth quarter was 45%.

This is five points lower than the same period last year, and primarily reflects costs directly and indirectly attributable to the voluntary Field Safety Notification we discussed with you in detail last quarter. The decrease also reflects our increased investment in product quality and related policies and procedures that stand behind our products.

For the full year, our reported gross margin was 46%, that's approximately four points lower than 2014 due to the costs I just described related to the Field Safety Notification, as well as additional scrap costs we described to you in the first half of this year.

Excluding these items, our adjusted gross margin for the year was in line with our expectations of approximately 50%. Operating expenses in the fourth quarter were $69.4 million and just under $209 million for the full year.

The fourth quarter expenses included approximately $12 million non-recurring expenses, of which $9 million represented a non-cash impairment charge associated with the sale of Neighborhood. Excluding these items, operating expenses were directly in line with our expectations of $195 million to $200 million for the full year 2015.

And we ended the year with a cash balance of almost $122 million. Let me now walk you through our outlook for 2016. We are extremely pleased with our revenue growth in 2015 and our 2016 revenue guidance reflects our expectation of continued strong growth in the coming year.

For the full year of 2016, we anticipate revenues will be in the range of $330 million to $350 million, compared to pro forma 2015 revenue of $264 million. At the midpoint, this represents growth of approximately 30%. We expect the strong revenue growth will be driven by U.S.

OmniPod growth in the mid-teens on a percentage basis, International OmniPod growth of approximately 50% and Drug Delivery growth of approximately 75%.

The percentage growth in International is higher than historic and expected future trends due to a lower base for comparison resulting from reductions in distributor inventory in the first half of 2015.

For the first quarter of 2016, we expect revenue in the range of $77 million to $80 million, compared to pro forma first quarter 2015 revenue of $48 million. That represents growth of approximately 65% at the midpoint. We expect strong U.S. OmniPod revenue growth of approximately 25% for the quarter.

We expect our International revenue to be in the range of $13 million to $15 million, which represents strong year-over-year growth even excluding the favorable comparable.

On the Drug Delivery side, we expect revenue of approximately $15 million, up significantly from last year, due largely to the strong adoption of our Pod for Amgen's Neulasta drug for cancer treatment. We expect our 2016 gross margin to improve to the low-to-mid-50% range.

We expect 2016 to be a year of significant commercial success in revenue growth, gross margin improvement and continued investment in building our foundation for long-term growth and profitability. With the sale of Neighborhood Diabetes earlier this month, we will record additional charges in the first quarter related to the divestiture.

My comments regarding profitability exclude any such non-recurring items. In 2016, we plan to continue our ramped up R&D investments in the areas that Shacey will share with you shortly. Even with these strategic investments in our future, we expect to improve our operating leverage in 2016.

Looking beyond 2016, we continue to target gross margins to 60% or higher over the next few years and expect improving operating leverage, based on the timing of our development initiatives, our expanded field sales force reaching their full productivity, and as we begin to leverage the strong foundation that we've been building in support of our continued growth objectives.

As such, we plan to deliver positive EBIT in 2018 and significant improved profitability over the longer term. In summary, we are very pleased with our successes in 2015.

We believe strongly in the long-term growth and profitability of our business and we are excited about the opportunities to leverage our unique offerings with OmniPod and Drug Delivery to drive significant value for our shareholders, and make a real difference in quality of life for patients that use our products.

I will now turn the call over to Shacey..

Thanks, Mike. 2015 has been a year of tremendous progress here at Insulet. We have an enormous market opportunity that we have been successfully converting through improved commercial execution, our laser-beam – and our laser-beam focus on new patient retention with terrific results.

Also, we've defined and launched an exciting product development roadmap internally claimed Digital Insulet. This is paving the way for innovative mobile capabilities and putting Insulet in the vanguard of research, development and commercialization of an artificial pancreas.

These efforts have resulted in a quarter – another quarter and ultimately a year of record revenue and new patients starts, early progress toward improved patient retention, along with exciting tangible headway on the longer-term strategic roadmap.

First, I'll touch on our market opportunity, and how we're converting the market through first-rate commercial execution, robust clinical differentiation and improved market access. OmniPod has many advantages over tube pumps.

The improved freedom and quality of life, the glycemic control that users get, because they don't need to disconnect from their insulin and its ease of use over other delivery methods. And given these significant advantages, we are convinced that OmniPod should command a larger share of the pump market.

But our true opportunity is much larger than the pump market; in fact it's three times as large. It represents the population of patients today that rely on multiple daily injections. This is more than 2 million people living with type 1 diabetes and insulin-dependent type 2 diabetes in the U.S. alone.

It's a $6 billion domestic market opportunity and likely more than double that internationally. Today, this is the population of patients from which more than 70% of our new users come. And more than half of these users tell us that they would not convert to pump therapy if they had to be tethered to a conventional pump. That is extraordinary.

The majority of our new users tell us that they would not have converted to a pump if it hadn't been for OmniPod. Our investment in increasing the footprint of our sales force has driven an expansion in our prescriber base and also improved utilization among our targeted accounts.

Our sales reps and field clinicians are doing a great job, building awareness and advocacy of OmniPod unique advantages, through a focus on improved clinical outcomes and quality of life associated with OmniPod. We also made impressive progress on our goal to clearly differentiate OmniPod through robust clinical data.

As of the start of this year, we had submitted six abstracts or conference presentations and three manuscripts for publication. These clinicals demonstrate OmniPod's positive impact on glycemic control, quality of life and other key benefits and we're not stopping here.

In 2016, we will deliver these publications and continue to grow the body of evidence that demonstrates that OmniPod is the best delivery system for people living with insulin-dependent diabetes and that OmniPod is the best platform for future innovations. In Q4, we also expanded our market access team, with a focus on improving access for our U.S.

patients. We believe it is important to demonstrate OmniPod's value proposition for payers and our new market access team is doing just that, using compelling data and the healthcare economic model that we developed last quarter.

The early efforts of this team paid off in 2015 with expanded Medicaid coverage in New Jersey, in Texas and in managed Medicaid access in Florida. Great execution across sales, market access, marketing and customer care drove the record new patient starts and record revenue that we reported for Q4 and the full year.

We've also remained laser-focused on patient retention for our new users, by providing new and significantly improved programs, resources and support. And now with the recent launch of Insulet Provided Glooko, we provide them with a best-in-class data management system.

Our customer demand for Insulet-provided Glooko has exceeded our expectations and this new solution is really opening the door for many accounts that were previously reluctant to proactively offer OmniPod. It's also providing a vehicle for accounts to identify more patients who could benefit from OmniPod.

These retention efforts have paid off and by the end of the year, we significantly improved our new patient retention rates. We're not resting here, our active OmniPod users are precious to us and we want to ensure that we give all users, not just our new users, a best-in-class experience.

In 2016, we will take our learnings from our new patient retention program and expand our efforts to positively impact our entire OmniPod customer base. One of the primary drivers for existing user retention is product quality or reliability. And in 2015, we made great progress.

Our customer experience and the quality and reliability of OmniPod have never been better. But we know that here our work is never done and in 2016, we will continue to raise the bar for our customers. Our customer care team drove meaningful improvements in 2015. This meant that we answered our customer's calls more quickly.

We significantly reduced the turnaround time from patient referral to product shipment. We delivered an enquiring patients benefit investigation much more rapidly. And ultimately, we improved our conversion rate from qualified leads to new patients.

We spent the last year analyzing our customer base, particularly in the United States, in an effort to provide a more accurate assessment of our OmniPod installed base, and for us to gain insight into customer behaviors and opportunities for us to provide the best possible support.

As you know or many of you know, this can be challenging, because about 40% of our U.S. users obtained their OmniPod through a third-party distributor. And throughout the year, patients will change distributors based on insurance plans or other factors.

Taking all of this into consideration, we estimate our worldwide installed base was approximately 85,000 users at the end of 2015, with just over two-thirds being U.S. customers. This is an increase of approximately 15,000 customers over the installed base at the end of 2014.

Please note that our installed base estimate for 2014 has been revised and at the end of 2014, we now believe we had 70,000 users with approximately 70% being in the United States. As always, this is directional in nature, primarily because we have a little less insight into the distributor component of our customer base.

We are very pleased with the 20% plus growth in our worldwide installed base in 2015 and we expect this trend to continue on an annual basis for 2016. Rather than provide specific growth metrics on a quarterly basis, we'll give you quarterly updates and color on how we're progressing towards this annual view.

Finally, I am thrilled with how our team is refining and executing on our product development roadmap. With the recently announced expansion of our concentrated insulin development program with Lilly, we will effectively double the reservoir capacity of the pod, with no changes to the form factor that everyone loves.

And with concentrated insulins in our pod, we double the size of our addressable market. U200 and U500 enable OmniPod to help more people living with insulin-dependent diabetes with a three-day pod change. Our U500 program is on track with approximately a third of patients enrolled in the study plan to wrap this year and U200 is off to the races.

Our current plan has both of these hitting the market in the next two years to three years. We've also made great progress on our artificial pancreas program. Insulet will lead a transition to digital and we will launch the most differentiated, innovative artificial pancreas system to the market.

OmniPod's tubeless platform, automated cannula insertion and the potential to migrate the functionality of our handheld PDM through a phone are our really true differentiators that will position Insulet to deliver the most unique AP product on the market.

We have completed comprehensive market research that clearly and enthusiastically showed us that our customers want fewer devices to carry around. They want more capability on their mobile phone and they are frustrated by the obsolescence of CGM integration that they've seen with other pump companies in our space.

As a result, over the last several months, we built internal capabilities and we've worked closely with partners such as Dexcom, Glooko and others to rethink our next-gen PDM program and to prioritize our mobile digital strategy. Thanks to these efforts, we will be launching our first patient app in the first half of this year.

This app will enable patients to order products, access training resources and is really designed to continue to enhance our OmniPod user experience.

In addition, later this year we will submit a 510(k) for our Bluetooth PDM and mobile app that will display key real-time data on a customer's mobile device, including CGM integration with Dexcom's G5 sensor.

In fact, this will enable CGM integration in a manner that ensures that our users will always have the latest and greatest CGM sensor with the latest and greatest OmniPod.

In 2015 and particularly in Q4, we took significant steps in the development of our artificial pancreas device and program, including a pre-submission meeting with the FDA, the completion of our clinical and product development roadmap and the selection of our algorithm partner.

We are thrilled to announce that we've entered into an agreement with Mode AGC to license what we feel is the most robust artificial pancreas algorithm available. The algorithm is based on over two decades of clinical research conducted at the University of California, Santa Barbara.

Frank Doyle, one of the algorithm's inventors, recently appointed Dean of Harvard's School of Engineering and Applied Sciences will continue to serve as advisor to Insulet as we collaborate to commercialize our system.

We've spent the better part of last year incorporating the algorithm into our unique platform and we expect to be in clinical trials later on this year. We are working diligently to bring a truly differentiated, artificial pancreas system to the market that will help us make good on our mission to make diabetes a smaller part of patients' lives.

While our team is pleased with the Q4 revenue performance and our success growing our installed base with record new patient starts, we really are just getting started.

The progress we made this year on our strategic roadmap will ensure that we continue to deliver our best-in-class customer experience, that we drive significant conversion of this enormous market opportunity, and that Insulet leads our market with an exciting digital strategy, paving the way for innovative mobile capabilities and a groundbreaking artificial pancreas system.

2015 was a great year here at Insulet and 2016 is on pace to be even more exciting. I'll now turn the call back to Pat..

Thank you, Shacey. With that operator, let's open the call up for questions..

Thank you. Our first question is from the line of Brooks West of Piper Jaffray. Your line is now open..

Hey, guys this is Tom (28:12) on for Brooks. Congrats on a great quarter..

Thanks..

So, two quick questions if I may. And the first one, I was hoping you could maybe talk about utilization just in the U.S. diabetes business. And maybe how the impact is being felt in patients just from the focus on quality control and the manufacturing process.

And if you're seeing any kind of difference in reorder rates or maybe a little bit higher utilization from that..

Sure. Tom (28:54), this is Shacey. I haven't seen differences in utilization rates that are material this year in 2015. We have seen in new patients as I mentioned a higher reorder or retention rate. But in our total patient data, the utilization rates remain pretty steady..

Okay, great. And then just one quick follow up.

There was an announcement from one of your major partners in the Drug Delivery business, that they announced an agreement with another manufacturer of on-body devices for drug delivery (29:19)?.

Dan, would you like to take that one?.

Yeah. Sure. I'm not sure I heard the end of the question. Could you repeat the question? My line broke up..

I think we may have lost Tom (29:47)..

Okay. Well, I mean – I think the question was related to the announcement by Amgen with respect to Unilife. And here's what I'd say about that. And – in my mind – in our mind, Amgen is doing what it needs to do for its business, it's evaluating technology.

It's a technology leader as a company, and the interesting thing is the overwhelming majority of drugs that are manufactured by Amgen are delivered by devices. And so, I think this is just an example of Amgen being Amgen and evaluating technology that's out there.

As it relates to our agreement with Amgen on the Onpro kit for Neulasta, it really has no impact on that relationship, and in fact, our relationship with Amgen continues to strengthen.

This – just this quarter, we launched a new engagement team model, where we've got teams from both companies that work together very closely – on a monthly basis they're in contact. And every quarter, we have a multi-day business review meeting that really ties the two teams together and develops our strategy for going forward.

So, I think the announcement by Amgen this week was Amgen being Amgen..

Thanks, Dan. Next question, operator..

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

Yeah. Hi, good afternoon..

Hi Tao..

Hi. So I guess, there are two questions.

The first one, in your guidance, are you including the recent reimbursement decision out of France in that outlook?.

Yes..

Yes..

Okay. And we started talking about your next generation PDM, the Bluetooth-enabled, how small can that PDM become? If all the display functionality gets transferred onto the smartphone – on the patient's phone.

Do you need much – or does that PDM need to be as big as it currently is?.

Yeah. Well, I think Tao, you're asking the same question we're asking and some of that will depend on our conversations with the FDA and how much capability they will enable us to put on the mobile platform, but you're thinking the way that we're thinking about it.

That we can make the mobile environment more and more rich and sort of feature-up the app and then be able to feature-down the PDM. We know that patients interact with their phones every minute and that they don't want to take their pump off their waist or go searching for their PDM.

So, our goal is to make them less – or I guess enable them to be less and less reliant on that PDM, but we don't have a sense today exactly of all of the capabilities that we'll be able to put on the mobile app. We are having those discussions with the FDA today..

Okay. Great. Thanks a lot and congrats on a good quarter..

Thank you..

And our next question is from the line of Michael Weinstein from JPMorgan. Your line is now open..

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

Thanks..

I wanted to maybe touch on the Drug Delivery business, because that number came in well above not only the Street's number, but also your guidance and what IMS scripts are pointing to if you do the math off of what on-body sales are and how much you get per pod.

So, can you help us fill in the gap? Are you maybe getting a different ASP than the 70% to 75% – $70 to $75 per pod you talked about in the past.

And is that changing next year at all?.

Danny, do you hear that question?.

Yeah. I got that. First of all, I don't know that we've confirmed any price on the – to our partner Amgen and would not want to do that, number one. Number two, I just think, the revenue is a reflection of the increased uptake of the product at the – in the month of December, I think the conversion rate was roughly 27%.

So, we're feeling really good about the adoption rate of the product in the marketplace, and I think the revenues are a reflection of that..

Okay.

So, you would say, there is not a lot of stocking in that number, that it's a true reflection of commercial sales?.

No, I didn't say that – as we've said in the past, we build product and ship product to a forecast that's provided to us by our partner. We don't have a specific visibility into end-user used versus what's stocking. Some of it is obviously stocking. But I think, if you need more information on that, I'd direct you to Amgen..

Okay. And then, maybe turning to your comments about EBIT positive in 2018, that was great to get a timeline.

I want to see, one, is that EBIT positive in the insulin business as well or for the company as a whole? And what level of sales do you need to get to for your insulin business to be EBIT positive? And is, can you get there with what you have now in the Insulet framework or do you need to add on to that as well?.

Robbie. This is Mike. First of all, we only run our business as one business. So, any comments we make about EBIT or profitability are purely related to that. We share resources across our business and make strategic decisions in that fashion. So, what we talked about in terms of the EBIT guidance, I talked about improved gross margins.

We've made significant investments in our product, performance and our team. We've seen the commercial success that we've talked about and where Shacey talked about the strong growth, that we're seeing across the business, (36:17).

So, all of those things together, the revenue growth, the improvement in gross margins and the ability to leverage our operating foundation that we've been building. I mean, we've been talking about the fact that we've been building it now because, we believe in the future of the company. And the improved operating performance purely reflects that..

Okay. Appreciate it. Thanks again..

Sure..

And our next question is from the line of James Francescone with Morgan Stanley. Your line is now open..

Hey, thanks for taking the question guys. I wanted to touch on gross margin first. If you look at the gross margin in the quarter 45%, obviously down from last year and down from where you've been early in the year. I understand there are some issues, in terms of the product field action and the investments that you're continuing to make in quality.

But we maybe would have expected a little bit stronger gross margin number given the upside in Drug Delivery, which you've described as meaningfully higher than the corporate average.

So, can you help us maybe quantify a bit some of the puts and takes that were – that were working against you on the gross margin line in the quarter?.

Sure. This is Mike. As I said a few moments ago, the principal thing was related to the Field Safety Notification, and there were – the direct costs and there were indirect costs of that. We scrapped a significant amount of inventory at a time when we had – and we're seeing in the future dramatic demand.

And so, ramping up our supply chain manufacturing from a standstill there, created some additional inefficiencies in the quarter.

And those continue a bit into the beginning of 2016, but we're really pleased with the progress that we've made, and now we feel very confident of where we are, and you can see that reflected in our gross margin expectations for this year of low-to-mid 50s. So, yeah, there were some challenges in the fourth quarter.

They were principally related to the Field Safety Notification that we – that we did and we talked about in the past.

But I think we have a – we have a very bright future ahead of us and we're making, we talked about the introduction of a new leader in manufacturing operations, where we're placing a lot of resources there, because we really believe in this product and we want to strengthen our not only product quality, but our ability to leverage the cost of that product..

Okay. Got it. And then second, just on international guidance. The guidance implies, you're doing kind of $13 million, $14 million, $15 million a quarter in the back half of the year – sorry, back half of 2015.

The guidance seems to imply that – that run rate of $14 million, $15 million a quarter is going to be about the same run rate that you're looking for in 2016 as well.

So, I mean how do we think about that in light of the new territories that are coming online, and the underlying growth of that business? I mean, is that a conservative outlook, or is there something else that's kind of working against growth there where sequential trends would be kind of more flattish is you're guiding?.

This is Mike again. I guess, I see us providing some pretty strong growth, we're talking about growing that business at approximately 50% year-over-year. So, there is a significant amount of growth built into this plan. So, we'll continue to give guidance as we go through the year.

I would not say that our guidance is overly conservative or overly aggressive. We want to give you a plan that we believe in, and that we stand behind. But, is there upside to this plan? Absolutely.

But, negative things can happen too, and that's why we give guidance with the best information we have available, but there aren't any major headwinds or roadblocks that we're concerned about, in fact, we're very excited, I mean being able to deliver 50% growth in that business, I think is tremendous, and reflect our excitement about that space..

And James, it may be helpful to know that any new country within the scope of – Insulet's (40:25) business for example, is going to be relatively small contributing to the whole. So these new countries while they're just getting started over the course of 2016 are going to be relatively smaller contributors..

Great. Well, thanks for taking the questions. And congrats on some great numbers..

Thanks..

Thank you..

And our next question is from the line of Jayson Bedford with Raymond James. Your line is now open..

Hello, good afternoon. This is Mike (40:51) calling in for Jayson. Thank you for taking the questions. First thing I wanted to ask about was the artificial pancreas development.

Just logistically, the new algorithm, where does that sit within the product? Is it within the smartphone app, is it within the pod, is it in the PDM? So, where is that captured? And then, I know you're conducting first-in-man trials this year, but when do you begin a pivotal? And then lastly, based on your conversations with the FDA, do you think you can start with a basal management product or do you need to start with predictive low-glucose suspend before you can get into basal management..

So, those are all great questions, Mike (41:32). So let me see if I can take them one at a time. I think, the first one was about where the algorithm resides. And the algorithm will reside partially in the pod and partially in the cloud. That's the way that this system is designed today and were intended to be designed today.

The second question I think was about when we'll be in pivotal. So, we will be in on-body trials later today and – or, I mean, later this year and we intend to be in a pivotal in sometime in 2017, probably towards the end of that year.

And then, I think the last question was regarding how much capability the FDA will support incorporating into our first system as opposed to that step-wise approach.

And – again, we're – we've had one pre-step meeting with the FDA, which will probably be one of many, but our intention is to offer more than predictive low-glucose suspend and they supported that proposal..

Okay. Very helpful. And then, just a quickie.

Any new commercial agreements for the Drug Delivery business signed in the fourth quarter and any other revenue streams that might be new that are assumed in the 2016 guidance?.

Yeah. We continue to have the sixth ongoing development agreement we've talked about in the past. We didn't add any new ones in the quarter. And there is no new commercial revenue generating arrangements in place in the guidance for 2016..

And our next question is from the line of Danielle Antalffy, Junior, with Leerrink Partners. Your line is now open..

Hi. Good afternoon, guys. Thanks for taking the question. And I didn't know I had a senior, so that's interesting. But, congrats on a great quarter.

I was wondering Shacey, if you could follow up on some of the commentary around the Glooko partnership and what would it take for FDA to get comfortable with allowing only the iPhone for insulin data? How far off are we – do you think we'll ever get there? And what gets us there?.

Okay. Danielle, thanks. I think – so, the first question regarding Glooko, as I mentioned, we're really excited with the early launch of that product. We were in a sort of limited market release with it, sometime in December.

And we knew that customers were going to really appreciate the improved data management, the retrospective analysis and some of the better tools and insight that it gives to both patients and secure teams to enable them to make better decisions regarding their diabetes care.

But in fact, we were kind of blown away by the demand as we got out into full market release, and we are rolling this out much faster than we anticipated.

And what we see, our kind of two big advantages, our previous data management system was probably not as – it was not very competitive, in terms of features and it's provided some technical challenges to our accounts.

And so, this certainly has addressed all of those concerns and then offered improved reporting, improved ease of use and improved insights. And what that means is that there were accounts that were not proactively offering OmniPod, because of the challenges associated with our previous data management system.

And now they are proactively offering OmniPod. And then in accounts where they were offering OmniPod and Glooko is giving them some tools to identify patients who could benefit from better glycemic control with OmniPod. And so, it's really doing both things, helping us go deeper and helping us go into more accounts, which is really exciting.

And then the other comment or the other question regarding iPhone or a phone control of insulin delivery, and when the FDA will be comfortable with that.

I think, it's the million dollar question, I don't really have the answer to that, except to say that in our early discussions regarding the artificial pancreas and our desire to sort of move more and more capability to the phone, it struck me that they were much more comfortable with the plan to have a backup PDM.

So, I think, I think that they are understanding, as we are, what our patients want, in terms of more and more functionality on their phone. But of course there are safety and security concerns, and a backup PDM really helps resolve some of those concerns..

Right. That does makes sense. And then, just a quick question on Neighborhood, what happens to the OmniPod business that was running through Neighborhood now.

Do you guys just bring that back in-house or how does that work?.

Danielle, this is Mike. So, we will continue to sell Neighborhood Diabetes was purchased as you know by Liberty and we know Liberty very well, and we'll continue to sell to those patients through Liberty.

What we did to make it easier from a modeling standpoint is we put on our website a breakout of revenue, historically this past year – as reported and then just so you can compare year-over-year, what it would have been, had we divested Neighborhood at the beginning of the year.

And so, you can see the breakout of the OmniPod revenue that went through Neighborhood that will be – we expect to be part of our continuing business, and that will now be reflected in the U.S. OmniPod line, now it's about $2.8 million in 2015..

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

Great. Thanks for taking the question.

Can you hear me, all right?.

Got it..

Fantastic. So, I just wanted to see, if we can dig into – and get a little more color on some of the comments made about improving retention rates and attrition. It sounds like you're making big strides on the new patient retention rates, and you're going to focus in 2016 on transitioning that to some of the existing patients.

Just wanted to see, if you could give us a little more color around the improvement that we saw over 2015? What's the breakdown in attrition from a new patient versus an underlying existing patient? I mean, I think that we've used a 9% blend in the past.

How should we think about that, and then what were the improvements like over 2015, and how should we think about that improving in 2016?.

Sure. So, the new patient improvement or the new patient retention rate is actually approximately the same as the whole. We don't really break it out. But we – it enables us to do sort of a retrospective analysis. So, when we ship a patient products for the first time, we ship them a starter kit, which is 90 days' worth of pods and the PDM.

And so, what we started to track with the implementation of our new strategies was the – how many of these patients placed their second reorder. So, we could start to evaluate that four months after a new patient came on board.

And what we saw with the implementation of some of these new strategies and support and programs was that we virtually halved our attrition rate with new patients. So, we really saw a dramatic impact there, but remember that new patients is only ever 10% of our total patient volume in any given time period.

So, relative to the whole it's not a huge impact. As we look to 2016, our goal will be to take some of those really effective strategies and then also use our new patient app to really help drive ongoing improved performance, and a lot of that comes from as I said product quality and reliability, which we're doing really great with.

And then also just with training, support, ongoing support for those patients and just a better customer experience, and we're working very hard at that also..

Okay, great. I appreciate the color there. And then just a follow up on the new patient additions in 2015, just wanted to make sure my math is correct, but you get the two-thirds of the underlying patients – the global patient base in 2015, and 70% of the underlying patients are based in 2014.

I guess – my math kind of says that implies 8,000 net additions in the U.S. year-over-year in 2015.

So, I guess – one, am I on track with that math? But then two, on the OUS side when you think about 2016 guidance, how much of that 50% growth year-over-year comes from going direct in Canada, and how much of that comes from improved pricing that you'll see from a direct business versus distributor?.

This is Mike. I'll answer that last question first. And maybe turn it over to Shacey for the installed base piece. With regards to Canada, I think we've said in the past and it remains true that of our international revenues, our European distributor represents about 75% of that.

And of the remaining 25%, Canada is the most meaningful part of that in – most of that remaining 25%. So that said, when you look at – just do the math with that – Canada, we're excited out being direct there.

It's a great business, but it really is a very small part of things and really doesn't move the needle a whole lot frankly relative to our overall trends and guidance..

And I think in terms of the installed base, you're, I think, directionally correct. We're a little bit over two-thirds in the U.S. today. You're pretty close.

Next question?.

And our next question is from the line of Jeff Johnson with Robert W. Baird. Your line is now open..

Thank you. Good afternoon, guys. Michael, I wanted to ask a question on gross margins, just so I understand and I'm on the road, so I haven't pulled the restated ex-Neighborhood filings yet. But, I think you were talking about a gross margin in 2016 in the low-to-mid 50% range.

Ex-Neighborhood, what was it in 2015? And could you adjust that for us with some of the costs you had that you excluded in 2015, kind of what's the baseline we should be building off of 2015 going into 2016 on the gross margin line ex-Neighborhood?.

Well, this is Mike. So, if – when you get an opportunity, if you look at the press release, when you're not on the road, the pro forma figures that we've shown here for 2015 would equate to a 50.5% gross margin on a pro forma, that's an unaudited obviously number. But, we wanted to give that indicative of, as you start to look year-over-year.

So, I think it's fair to say with our expectations in the low-to-mid 50s that we expect the margins to be definitely better than they were last year, because last year included a number of different manufacturing challenges and write-offs of product.

We talked about the Field Safety Notification and some of those other items, and we said they were non-recurring in nature. And so, we believe that to be the case, and so our guidance reflects having a much cleaner view this year and not having some of those same issues.

I would love to say there's upside and we are driving to improve our gross margins. And I think that – and you can tell by our guidance that we expect over the coming years or next few years to be 60%-plus gross margin, that we believe there are some definitely real opportunities there.

The challenge if you want to call it that is they don't happen overnight and that's what our guidance reflects for 2016. But, we're really excited about our opportunities for gross margin improvement over the next few years..

Fair enough. And I did see that 50.5% number.

I guess my question was does that include the costs – that 50.5% includes the costs on the Field Safety recall and what have you?.

Yes. The numbers in that table there basically take our reported numbers and the adjustments that are made are to pull out the effect of Neighborhood as if it had been divested. So there were no other adjustments to those figures..

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

Hi. This is Ryan Blicker in for Doug. Thanks for taking my questions. So starting with the U.S. OmniPod business. You obviously had some great patient starts in 2015, as well as some one-time headwinds I would say during the year.

Considering how you expect to start out the year in that business and all of the positive qualitative commentary you provided, is there any reason why that business doesn't grow a bit faster than mid-teens in 2016?.

Well, this is Mike. Since I gave the guidance, I'll refer to that. I think that growing mid-teens, we've – Shacey gave guidance on a number of different commercial areas, including I think 20% growth in – 20%-plus growth in new patient starts again. So, that's to say that we expect continued success commercially, and that's reflected in our guidance.

But, the reason we talked about new patient starts more as an indicator of future opportunity and in any one period, they don't represent a significant amount of the revenue impact. And so, mid-teens revenue growth, I think we believe is pretty strong. Are there opportunities to beat those numbers? Sure. There are definitely opportunities to beat that.

I mean, I know that our entire team is very excited coming out of last year, and with what we expect for this year, and we believe that's reflected in our guidance. But, there's always challenges that can crop up. And so, when we give guidance, we wanted to be something that we believe reasonable, and would love to do better than that..

It's early in the year..

Yes..

Okay. That's helpful. And then, just one on Drug Delivery. The full-year guidance seems to imply that you stay around this Q4 run rate for all of 2016.

Can you just give us a sense of how much visibility you have into that throughout the year? And you gave us some sub-commentary on your evolving relationship with Amgen, but any additional color would be helpful, and what gives you confidence there? Thank you..

Well, I'll speak to the financial impact aspect and Dan can speak to the relationship. From a financial standpoint, we've talked in the past about – we take orders from Amgen, and they give us a view into the future.

And as you can see, by the significant growth we're talking about for the year, it's a very strong future and we're really excited about it. But, what we try and do is to levels that, you know, manufacturing and other things, is so that we can get manufacturing efficiencies and consistency of supply.

And so, what you see reflected in the guidance is that level set. Again, as I've said before, is there upside to that – absolutely. As a continued adoption and everything else that would be great. But we – it's early in the year, as Pat said, so..

Ladies and gentlemen we have....

(57:02) Go ahead..

Ladies and gentlemen, we have time for one question. And our next question is from the line of Ben Andrew with William Blair. Your line is now open..

Good afternoon. Thanks for squeezing me in at the end here.

Pat or Shacey, can you talk about the manufacturing of the OmniPod going forward? Do you need to change any physical features of the product to support kind of where you're going with AP or with Bluetooth over the next two to three years that would entail kind of redoing manufacturing lines or things of that sort?.

We got a shoe horn that puts you in here at the end. But as it relates to manufacturing, we just brought Chuck Alpuche on board, a very experienced manufacturing operations executive from PepsiCo and we are going through the process of developing the long-term manufacturing strategy.

Right now, we have as you know lines in – four lines in China that are up and operational, I would say, they're going to be continuing for a very long period of time as we get into the product development and the artificial pancreas we are going to have to have different modifications or maybe modified some, one or several of the lines as that product ramps up.

We're taking all of that into account as we continue to develop the long-term manufacturing and footprint of our manufacturing operations around the globe..

And that is all the time we have for questions. I would now like to turn the conference back to Pat Sullivan..

Great. Thank you, operator. Look at overall, I am – I continue to be very pleased with where the company stands today and I'm very excited about where we're headed.

2015 was a year in which we reenergized and refocused the organization, strengthening – strengthening our talent, realigning our sales team and executing a winning strategy to position Insulet for long-term, sustainable, profitable growth.

I feel great about all that we've accomplished in 2015, and look forward to maximizing the potential of our innovative and differentiated technology. We entered 2016 with strong momentum and our entire team is looking forward with enthusiasm and confidence to the continued innovation and long-term sustainable growth for the company that lies ahead.

Thank you for listening again today and we will see you at the end of the second quarter. Thank you..

Ladies and gentlemen, thank you for your participation in today's conference. This concludes today's program. You may now disconnect. Everyone have a great day..