Brian K. Roberts – Chief Financial Officer.

Allison Dorval – Vice President and Controller.

Danielle Antalffy – Leerink Partners Raj Denhoy – Jefferies Ben Andrew – William Blair William J. Plovanic – Canaccord Genuity, Inc Mike Rich – Raymond James Jan Wald – Benchmark Company.

Good day, ladies and gentlemen, and welcome to the Insulet Corporation Q3 2014 |Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. (Operator Instructions) As a reminder, this conference call is being recorded.

I would now like to introduce your host for today’s call Brian Roberts, CFO. Sir, please begin..

Thank you. Good afternoon, everyone. Thank you for joining us for our third quarter 2014 conference call. I’m Brian Roberts, Chief Financial Officer of Insulet, and joining me on the call today is Patrick Sullivan, our President and Chief Executive Officer and Allison Dorval our Vice President and Controller.

Before we get started, I’d like to remind everyone that our discussion today may include forward-looking statements as defined under the securities laws.

We intend these forward-looking statements to be covered by the Safe Harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and are making this statement for purposes of complying with those Safe Harbor provisions.

These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies, and prospects, which are based on the information currently available to us and on assumptions we have made.

There are risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements.

Information concerning the company’s potential risks and uncertainties is highlighted in the company’s press release issued earlier today and in the Risk Factors section of the company’s SEC filings, including the company’s Annual Report on Form 10-K for the year ended December 31, 2013. These risk factors apply to our oral and written comments.

We assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise. I’d also like to remind you that the guidance we’re offering today represents a point-in-time estimate of our future performance.

You’ll find a link to the webcast of this call, as well as to today’s press release, at myomnipod.com in the Investors section. And now, let me take a minute to introduce you to Patrick Sullivan.

As you know Pat joined Insulet on September 17 as President and CEO and brings to Insulet over 30 years of Executive leadership experience including a 13 year period as Chairman, President and CEO of Cytyc Corporation.

Pat led Cytyc to exceptional growth as revenues increased from $4 million to more than $750 million through a combination of organic growth and strategic acquisitions culminating in its acquisition by Hologic in 2007. His leadership and experience is a great addition to Insulet as the company enters its next phase of growth. Welcome aboard Pat..

Thanks, Brian and good afternoon everyone and thank you for joining us on the call today. I’m very excited and honored to have the opportunity to work with such an innovative and progressive company. Over the last 50 days I’ve had the opportunity to gain a much deeper understanding of our company, the industry and the opportunities that lie ahead.

As I learn more, my enthusiasm for this business and its future continues to grow. I’m looking forward to finishing out 2014 and driving our strategic initiatives in 2015 and beyond. As we look towards 2015, its clear that we are building off a very solid foundation as the existing business continues to perform.

We delivered $70 million of topline revenue in the third quarter representing a 23% increase year-over-year. In my short time here, I’ve been impressed with the passion of our commercial team as they continued to build our presence with both the existing and new healthcare practices to drive adoption of the OmniPod.

Our product helps people improve control over their diabetes providing them the freedom to enjoy life. In fact, about 70% of our initial patient starts are new to insulin pumping.

These customers report that the easy to use water proof and tubeless design is appealing as they gained the benefits of insulin pumping without the hassle of conventional pumps. This is especially true in the age 18 and under group. Approximately 40% of our new patient starts in the third quarter or in this important age group.

While our annualized attrition continues at a rate of about 9% we know that the rate of attrition in those 18 and under is only about 5%. Once kids and their parents experience the freedom of the OmniPod they do not change.

Critical to our ability to convert multiple daily injectors to the OmniPod is for us to deepen our relationship with endocrinologist and clinical diabetes educators.

In addition to discreet size the pod, healthcare professionals continue to cite the updated insulin on board calculator, the simplicity of a low assembly system and life style convenience as the key reasons why they prescribe the product.

They clearly expect our sales professionals to be readily available to assist them as required in adopting the OmniPod. To that end over this year we added approximately 20 new commercial team members to increase our presence and ability to serve healthcare professionals.

We’ve added a new role that we refer to as Key Account Manager or KAMS who are permanently passed with ensuring a high level of customer service to critical existing accounts, which will allow our territory sales reps to spend more time with new prescribers. The early returns for these new resources are positive.

Territories with Cams have experienced a 15% average increase from referrals since we added them in Q2. As these resources continue to gain experience, we believe overall productivity will increase further and expect we will add additional commercial resources early next year.

Last quarter, you will recall that we discussed an issue with a significant payor who made changes to the Insulin pump coverage guidelines which were not eliminating reimbursement for the OmniPod did cause a lot of confusion across the country.

Over the past few months, we have worked diligently with this payer and our distributor partner to serve this payer to rectify the problem. We are pleased to report that we believe the issue is behind us and will not impact new patient starts in 2015.

The payors revised its process in a manner that we believe will both eliminate the confusion surrounding OmniPod reimbursement eligibility and keep OmniPod consistent with traditional insulin pumps in terms of required documentation.

The payor is currently rolling out to revise process and forms and given the timing of the roll out we expect new patient starts to be impacted through Q4 but declining with a declining impact each month. On the international side our business our business continues to grow as well as we remain on track to double for calendar year 2014.

As many of you may have seen our European partner, Ypsomed released a six month results ended September 30, 2014 last week. Those results showed a 60% sales increase for the OmniPod system driving nearly all of the growth in the direct diabetes business.

And looking at the success we see continuous share gains across Europe with countries such as the Netherlands, Austria, the U.K. and Switzerland in the mid to upper teens.

And as we look forward, we believe the opportunity for growth remains high as Ypsomed continues to add share in other markets such as Germany, Sweden, Finland and opens new market such as Italy which we lost last quarter and France which we hope to launch early next year once reimbursement is secured.

Although we generate lower gross margins on our international partnerships this business continues to drive our operating margin improvement as increased revenues require only minimal incremental operating expenses.

In Q3, we manufactured more than 3 million pods for the first time in a quarter, and more importantly the quality of the product from Flextronics has never been higher as yields have improved to greater than 98%. This improved quality has translated to reduced cost through our customer support team and higher confidence in the field.

We are in the process of finishing line for Flextronics and expect to put it in service early next year. Additionally, our record production drove incremental gross margin improvement in the quarter as U.S. product margins are now in the low 60s and consolidated gross margins increased by more than a 100 basis points to 51%.

On a consolidated basis gross margins continued to be impacted slightly by product mix within our neighborhood subsidiary and increasing international market share. Overall, we have improved gross margins by more than 700 basis points since the new OmniPod was launched.

Gross margins will continue to improve in the fourth quarter as additional OmniPod cost savings further reduce the cost per pod. I’m very impressed with our manufacturing capabilities endured as one of our core competencies. And in our deed we need to continue to enhance our existing product or development, new products that meet the customer needs.

I’ve spend a significant amount of my time to date at Insulet gaining a full understanding of our research and development efforts. At the top of the priority list is our new PDM initiative.

The goal of this new PDM is to provide our users with more modern looking touch screen devices that with a cleaner user interface as well as incorporate blue tooth capabilities to allow us to solve some of the data management challenges facing the industry today.

We see the blue tooth capability as one of the most important enhancements as it will allow two way communications with other platforms such as Dexcom’s chair platform recently approved by the FDA. Once the PDM is approved we look forward to sharing data with Dexcom to allow our common users improve data viewing capabilities.

While the work on our PDM moves forward, we are also making progress in our activities to integrate a CGM sensor into the OmniPod. I’m particularly interested in this long term initiative as it is clear that a one item on the body and one hand held solution is very attractive for our customers, healthcare professionals and managed care payors alike.

We’re the only company with a capability to bring these two tremendous technologies into one easy to use platform. We’ve recently completed additional testing around proximity of sensing and dispensing that gives us increased confidence in our integrated CGM solution.

During the quarter, we also received feedback from the FDA regarding our planned approach in partnership with Eli Lilly for our OmniPod system specifically designed for use with U-500 insulin. Our initial approach with Lilly was for us to file our 510(k) gain approval and then complete our clinical trial with -- to update their labeling.

The FDA however has informed us that they now prefer the clinical trial to be completed prior to our F 510(k) submission. We are working closely with Lilly to revise the timeline for our clinical study and to file for clearance. We anticipate the clinical commuting mid next year.

There is a number of highly resistant people living with type-2 diabetes is increasing daily, the need for this product continues to grow and both companies remain committed and enthusiastic about this project. Finally, last week Amgen publicly discussed the first time the Neulasta on-body delivery system that leverages the OmniPod technology.

This one of a kind system will allow a patient to leave the doctors office with an activated delivery device programmed to deliver relapse of the following day. We are working closely with Amgen for their approval and subsequent launch of this product.

In addition to Amgen and our ongoing partnership with Ferring pharmaceuticals, our newest partner Capricor Therapeutics announced last month to start a clinical program for the drug and Cenderitide to treat post acute heart fail using our drug delivery system.

We will provide product development, product management and design control activities in partnership with Capricor in addition to providing clinical product for their clinical trial. We look forward to assisting in this exciting opportunity. With those comments let me turn the call back to Brian for additional details on our financial performance..

Thanks Pat. Consolidated revenue increased by 23% year-over-year to $75 million for the quarter ended September 30, 2014 from $61.1 million in the same period last year. For the nine months of 2014 consolidated revenue was $216.2 million compared to $178.6 million for the first nine months of 2013 a year-over-year increase of 21%.

Gross profit increased by 39% in the third quarter to $38 million as compared to a gross profit of $27.4 million in the third quarter of last year. Consolidated gross margins of 51% represent a 600 basis point improvement over the third quarter of 2013.

As we look towards the fourth quarter and early 2015, we expect further improvements in our consolidated gross margins through a combination of additional component price reductions and incremental overhead leverage with the start of the fourth manufacturing line.

Gross profit for the first nine months of 2014 was $106.6 million, an increase of $27.2 million or 34% as compared to $79.4 million in the first nine months of 2013. Operating expenses decreased by $3.8 million or 8% year-over-year to $40.9 million in the third quarter of 2014 from $44.7 million in the prior year.

This quarter’s operating expenses include approximately $7 million of compensation charges related to the CEO transition in September most of which is non cash. Excluding those charges operating expenses would have been about $34 million in Q3.

Last years third quarter operating expenses also included approximately $10 million of one time charges related to the settlement of the patent litigation of Medtronics.

Fourth quarter operating expenses are expected to be in a range of $36 million to $39 million including approximately $3 million of remaining stock compensation charges associated with the CEO transition. Operating expense were $116.7 million for the first nine months of 2014 compared to $108.7 million for the first nine months of 2013.

Operating loss was $2.9 million compared to $17.3 million in the prior year, an improvement of over 80%. Excluding the one-time compensation charges, we would have reported an operating profit of approximately $4 million in the third quarter of 2014. Interest and other expense was $7.9 million in the third quarter compared to $4 million last year.

In June, we issued approximately $201 million of 2% convertible senior notes maturing in June 2019, and used approximately $160 million of the net proceeds to repurchase the $115 million of the outstanding 3.75% notes that were due in June of 2016.

In July, we retired the remaining outstanding 3.75% notes in exchange for $28.8 million in cash and approximately 350,000 shares of common stock. We recorded a loss on the extinguishment of debt of approximately $4.3 million in the third quarter relating to that transaction.

Net interest and other expense was $35.9 million for the first nine months of 2014 including a total of approximately $23 million of expense related to the early extinguishment of the 3.75% convertible senior notes. That compares to $12.9 million for the first nine months of 2013.

Going forward, we expect to record interest expense related to the 2% notes of approximately $3 million per quarter comprised of $1 million in cash interest expense and $2 million in non-cash interest expense.

Excluding the impact of the extinguishment of debt and the one-time compensation charges they reached breakeven results of the net income line and on an earnings per share basis in the third quarter of 2014.

Including these items our net loss for the third quarter was $10.8 million or $0.19 per share as compared to net loss of $21.3 million or $0.39 per share for the third quarter of last year. Net loss for the first nine months of 2014 was $46.1 million or $0.83 per share compared to $42.5 million or $0.79 per share for the first nine months of 2013.

Our cash and cash equivalents balance was $146.4 million at September 30 compared to $149.7 million at December 31. As of September 30, we had approximately 56 million common shares outstanding.

Turning to guidance, we have further refined our 2014 revenue expectations to $292 million to $297 million translating to a range of expected revenue of $76 million to $81 million for the fourth quarter. That takes into consideration the impact of the payer issue we’ve discussed.

Lastly, after six rewarding years, I’ve made the difficult decision to resign my position at Insulet.

I’m very proud of all that has been accomplished over my time here including a 10x increase revenue from approximately $30 million in 2008 and only $300 million this year, and even larger increase in market cap to over $2.2 billion and achieving operating profitability.

More importantly, I’ve had the privilege to speak with many of our customers and see the impact we’re making their life each and every day and to work with an incredibly talented team of people. It’s with even greater pride that I turn the CFO range over the Allison Dorval, who has been my right hand since by first day.

Many of you have the opportunity to meet Allison in various investor conferences over the past couple of years and I’m more than confident that she would do a tremendous job for you, our shareholders, our customers and our colleagues. I’ll stay as an employee of Insulet through the end of the year to ensure smooth transition.

And with that, operator, please open the call for questions.

(Operator Instructions) Our first question comes from the line of Danielle Antalffy from Leerink Partners. Please with our question..

Thanks so much. Good afternoon, guys and let me start by saying Brian, you will very much be missed, but Allison congratulations, I’m not sure if you’re there, but looking forward to working with you more closely and also welcome aboard Pat, looking forward to getting to know you better.

Maybe I start with sort of how was your first 50 days has been, any thing surprising? What’s your initial read of the company and the potential long-term growth trajectory here?.

Well, as I – when I joined the company back in September, I was working excited about the technology and the opportunity that this product can make a better mix in the lives of patients that use it. And I guess what I’ve learned over the last 50 years that it is more exciting than when I joined.

I’m very existed about the product, the technology and really focus on market adoption of this technology for anyone with Type 1 diabetes.

This organization is tremendously focused on capitalizing on this opportunity and I’m very excited to be here and also congratulate Allison on her promotion to CFO and spending some time on the road with her meeting all of you..

Great. Thanks for that. And then Pat, I was hoping, or Brian I was hoping to get a little bit more granularity on the [UNA] issue and revolution there.

Guys, can you talk about number one, what that equates you in annual sales in your view? If I remember correctly I think you characterize it previously in the $10 million to $50 million range, so if you could confirm that? And then also sort of what gives you the confidence that the issue at rest and no longer an issues..

Yes. Danielle, it’s Brian, so thank for that, thank you for your warm words. Initial I can tell over the last few months, the team has worked extremely hard and there’s been a lot of conversations have happened between the payer, the distributor and internally we try to ultimately figure what was the best way to resolve it.

I think in the end we come through with a couple of changes specifically around this, form that we had talked about previously that will allow for a brand name of the product to be included on the form which should allow to be able to eliminate I think all of the confusion that existed in the marketplace. So, we’re pleased with that.

As you can imagine with any change that needs to go through large organization that’s take a little for it to go through, and so, that’s why we continue to expect that we’ve seen for example, in October -- still some impact on the new patients starts front.

But it seem like that will dwindle now over the course of the coming weeks and we think it will be a non-issue as we turn the calendar year into 2015.

As we talk about last quarter, we have built in to the change in the revenue guidance, the full impact to this for the full year and I think as we given the guidance for this quarter of $76 million to $81 million, that’s including all of the impacts that we expect to have in Q4 as well.

Obviously, as you think forward to 2015 there will be reorder impact because those people won’t have started yet or they have just started, but I think we’ll be able mitigate most of it..

All right. Thanks so much..

And our next question comes from the line of Raj Denhoy from Jefferies. Please proceed with your question..

Hi, good afternoon. Maybe I was talking little bit on Danielle’s question, but with so much change in the senior management over such a short period of time variable it will raise questions and people will ask whether there is something perhaps more to this than simply Brian you moving on and the Board wanted to make a change at the CO levels.

So I don’t know if there’s anything else you can maybe offer those Pat or Brian about share amount of change at the senior level in such a short period of time?.

I can tell you from my side Raj, for me and I’ve obviously been here in Insulet for about six years. It’s been a great ride. I’d loved every minute of this company and I remained very passionate about what we do and what we do and how we help folks.

You see it every single day I can give you an example of running into a kid on my son’s 10-year old basketball team this pass weekend. And that doesn’t change for me.

For me personally it was – I started to have some conversations earlier this year, thinking about what was next and what was the right time for me to potentially take on additional opportunities and see if they’re either here at Insulet or elsewhere.

And this just seems like the appropriate time for me to kind of make that next step of transition and move on. I think Pat, I can tell you for being here the last 50 days and watching Pat in action.

He spend inordinate amount of time getting to know people, getting to know this company, not jump in the conclusions, really trying to understand what’s going on here and I think his track records speak for himself and he’s going to make a very, very positive impact in this business.

And so, I look forward to still being here for the next couple of months and helping the company through and then watching it from the side lines, but obviously have some very vested interest and how the business continues to do with this lot of relationships from me both internally and externally and I wanted to exceed..

Yes. And I guess, I would say that I’ve been very impress with the organization since I joint 50 days ago and for me it was an opportunity as I’d say to some of my friends, I just went to retirement and decided to get back into the saddle and really enjoy running – I enjoyed running slide deck and I’m enjoying doing what I’m doing here.

And I think the opportunities are similar, that there are challenges in every organization, but there are certain things that we can do better, and I’m focused on converting this market to Standard of Care with the OmiPad product. I think it’s an exciting technology.

There are obviously obstacles and you have knocked down one at a time, but we’re focused on making that happen..

Great. Maybe I can ask two specific follow-up questions. First to you Pat.

You’ve talked about – you’ve talk about diabetes but less about perhaps drug delivery and that seems to have been perhaps an involving part of the story that could potentially get larger, much larger over time and I’m curious if you any thoughts around that? Might be the timeline that sounds or perhaps lengthen a little bit in terms of Amgen deal and also the Type 2 products, so I don’t know if there anything you comment around that?.

I would say, as I’ve gotten into the company and understand the technology and particular the Amgen deal, I think the opportunity to leverage the existing technology in the drug delivery business is quite frankly huge, and Amgen is the first really significant opportunity I think to capitalize on that opportunity.

And I – we’re looking at making additional investments in the whole drug delivery side, because I think from a revenue perspective it can be potentially a very large number..

And Raj, it’s Brian. I do have a couple of things. One, I don’t think there’s anything that we said so far that you should takeaway thing, the timeline for the Amgen product has changed. If anything the fact that on their earnings call last week they presented this new product, talk about it first time publicly, showed the picture of the product.

If anything I think shows that they’re feeling extremely confident that we’re going to get to the finish line and our timeline on that has always been thinking that they were going to have a Q4 approval and Q4 has done yet.

In the Lilly case, we’ve originally been working towards a plan where we would be able to file the 10-K and get clearance and Lilly wanted to use cleared product to drive the clinical.

The FDA provide us some feedback as we are working through them kind of collaboratively around human factor testing that they wanted us to just reverse that and kind of do in the different order.

So, it is different and that we won’t have to file 10-K file which would have allowed us to potentially sell a little bit on the side, while Lilly was going through their process that said, from the overall timeline of the product that’s really not changed, it just reordered..

Okay. And then, sorry, just last one, just on gross margins, you mentioned low 60% for the U.S.

How much more is left there? I think you have talked about kind of getting into the low 60s with the Gen2 where the current generation pod, how much left do you think there is in driving that gross margin higher?.

Personally I think there’s a lot of that. I mean, I think that there is – I’m sure at some point there’s a theoretical feeling, but I said to different people at different times. I certainly I’m not willing to – you put us feeling on our ability to gain leverage in the business.

I mean, we should be able to continue to drive as the business gets bigger and bigger and we add more lines, more and more efficiencies that should be able to drive the cost of different components done and be able to spread out the overhead even more. And so, I think as we looked at this quarter, we gained a couple hundred basis points on the U.S.

OmniPod basis. We lost a little bit on our consolidated margin when you look at international share in the neighborhood mix. I think when we look at Q4 to gain a couple of hundred points more of margin, it’s absolutely achievable.

And hopefully all of that close to the consolidated, but again, that will just depend a little bit upon mix of the different components of the business..

That’s helpful, and you will be miss, Brian. Thanks..

Thanks, Raj..

Our next question comes from the line of Ben Andrew from William Blair. Your line is now open..

Good afternoon. And I’ll add my congratulations and also to everybody that’s staying with the company, and Brian, we will miss you. Two questions I guess from me, first, can you talk a little bit about the new patient add trajectory in Q3 and what’s implied in Q4, was it plus minus 20% or whatever detail you can give us there.

And then, what’s the neighborhood diabetes revenue number for the quarter or maybe a percentage there if we can? Thanks..

Yes, sure, Ben, it’s Brian. So a couple of things in new patients starts, I think as Pat mentioned in his remarks I think we’re seeing some nice productivity uptick for the new territories where we’ve added the provable third man in form of kind of this KAM or territory associate kind of role.

Overall, we saw probably somewhere about 5% to 10% sequential increase in new patient starts from Q2 to Q3. Still on the trajectory I would tell you a kind of somewhere in the 15% to 20% range overall, new patients starts year-over-year and the trajectory still seems very solid here as where month and few days into the fourth quarter.

So I think everybody is feeling good about that and obviously the payer issue kind of being put to bed. I think allows everybody to feel that much more confident as we end this year and look forward into 2015.

On the neighborhood side, neighborhood, obviously we lapse competitive bidding this year in the third quarter that was July 1 of 2013 when CMS kind of really significantly reduced the pricing of blood glucose testing supplies. The neighborhood business was up slightly in Q3 on year-over-year basis, probably a couple percentage points.

Again, absolutely kind of filling their role and doing a good job, only difference as we have seen in settling a gross margin basis has come down a little bit as the mix of the business has changed and obviously the lower pricing overall from blood glucose testing strips..

Okay. And then Pat maybe a question for you that I think we’ve all kind of looked at over the years, why is – given that only 30% of people are using insulin pumps there is obviously reasons for that.

What do you think is the bottlenecks to adoption that Insulet can address them here that perhaps it wasn’t addressing effectively before and what are the real levers that you guys can bring operationally to try to accelerate that?.

I think there is a number of atleast my initial read on the whole insulin market are Type 1 diabetes market. You have certainly those that are in the multiple daily injections and mostly patients start out in that therapy and then move over to being considered for pump and pump therapy.

And I think as we’ve done market research into the market, it appears that there is a large number of MDI patients that would never consider a pump if they had to use the current conventional pumps, but when provided with the opportunity to use OmniPod the uptake or the interest level is exceedingly high.

So I would say what we need to do is focus on the marketing message through the endocrinologists and getting more MDI patients converted to the OmniPod technology. So I think from my perspective, it’s really leveraging the -- sales force presence in the field and focusing on those high prescribers.

And as I said earlier if you look at the number of patients below 18 this is where the product really I think is very good for the kids and their parents to manage these patients with type-1 diabetes. So focusing on that market segment I think will pay great dividends..

Were the things the company wasn’t doing effectively before from that marketing message to end those or is this just simply going to require a fair bit more of spending whether at times sales people or marketing dollars to accomplish..

Well I think its fair to say that in order to grow we’re going to have to add sales and marketing resources to get the message out and to have adequate coverage in the market place.

When I compare sort of what we spent at Cytyc at the same level of $300 million in revenue versus where we are today, at Cytyc we spend more in sales and marketing and I think we need to make some investments in sales and marketing to really to ramp the sales number..

I’m not prepared to give you exactly what that looks like today because I’m still more struggling to do that process, but I think it’s fair to say that we’re going to add additional sales from marketing resources..

Great. Thank you..

Our next question comes from the line of Bill Plovanic from Canaccord. Please proceed with your question..

Thanks, good evening. Can you hear me okay..

Hey Bill, how are you?.

Good. So I’m on the airport side there’s some background noise. You know saying welcome Pat, congrats to Allison and Brian definitely missed. Most of my questions have been asked but this time I’m going to ask more pointed questions.

Just it sounds you are kind of still viewing things that sounds like but as we think about 2015 and the current revenue expectations and even profitability expectations out there, I mean should we – can we [casually] say you are comfortable with that, it sounds like maybe from an operating standpoint maybe some more investments in sales and marketing, I know you are still 50 days in getting in there, but how should we start thinking about as you put your stamp on the business from 2015 and beyond?.

Hey Bill, it’s Brian. Let me take a first crack at some of it and I think we’re prepared certainly the company as we get into the first quarter will ultimately provide appropriate guidance for ’15 but I think there is a couple of takeaways.

One is, we’ve been adding sales resources as we know and kind of these 20 person or so kind of chunks, because it works well from a historically from a manufacturing side for not over taxing the sales management and the infrastructure of the business the reimbursement pieces and the like.

And that has worked really well and so again I think one of the things to take away is this kind of again third man in or so that we have put into some of these territories, assuming that although early days keep in mind these folks have only been in the field now for one full quarter.

They seem to have some good momentum and productivity behind them that I think is something that the team it works through strategic planning and budgeting here in Q4.

It’s really trying to figure out how that model works and do we add more – there are certain territory level where it doesn’t isn’t as effective and really kind of what that planning is.

And a lot of the marketing type things you will recall six months ago or so we talked about we hired for the first time an agency of record and digitized to able to come in here and help drive the branding and help I think really push messaging into the healthcare professional community, that talks about pumps make sense for multiple daily injectors, we need to move them on the pumps and this is how you do it.

And I think all of that stuff is resonating and as for me one of the things that I shared with Pat when he started was a call -- this in my mind is a really great time for him to kind and join because in a lot of ways it’s the first chance that this business has had in a long time to play off and its versus [Indiscernible] as you guys know from following this company for a long time we were worried about how running made its action capacity with the old part and now I’m going to try to work at getting then new part approved and then the transition of the customer base which took up a big chunk of last year and then this year now we are putting in those building blocks into place.

And I think if anything some of the momentum of what’s been invested here over the last six to nine months is starting to show some of those dividends. And so I think that’s a really exciting thing to be. You know that said, and Bill I think Pat as he kind of keeps that in kind of starts to allude to it, there are absolutely things we can do better.

And I think his leadership and his commercial experience and what he’s been through along with Pete [Douglin] and his team and the planning effort they are will drive a lot of what makes some of those new investments look like next year..

Yes I think what Brian just discussed and I would also say that I’ve spend the majority of my time over the last 50 days being mostly internally focused inside the understanding, manufacturing R&D and then our commercial efforts, but now I’m turning my attention to spending more time in the field with the field force and over the next couple of months getting a good flavor of how we execute the sales strategy in the field and would come back here early next year with my assessments and plans for 2015..

Fair enough thank you.

And then some -- questions, just on the I was wondering with the Amgen can you quantify what you believe that market opportunity is and when do we actually start seeing that show up in the business?.

Well Neulasta for Amgen is about $4 billion product in the United States. There are I think as I’ve done the research about 900,000 patients are used at right every year and it currently in its current form is approved by the FDA. This filing is for use of that product and our OmniPod.

I would say it we will assuming it gets approved in the fourth quarter or early next year we expect to receive revenue from it, but its hard to really put a number on the table because it all depends upon how that launch goes for Amgen but I know that they are extremely excited about and we are working very hard with them for a very successful launch..

Okay. And then secondly just you mentioned the new PDM that you are looking to come out with what do you expect the timing for that product..

We expect to show that PDM at the ADA Meeting in the next summer in Boston, so we are going to have a coming out party in our home town with that product and would expect to file that in early 2016..

But you will show that ADA but you will file the PMA – I’m sorry the 510(k) in early 2016?.

Correct..

Okay, great. I think that’s all I have. Thank you very much..

Safe travel, Bill..

Thanks..

Our next question comes from the line of Mark [indiscernible] from JPMorgan. Please proceed with your question..

Hi, this is actually Robbie [Marcus] in for Mike.

You know maybe just turning towards the model, Brian do you mind quantifying exactly what the impact for UNH was this quarter and what you have for next quarter? You spoke for 3 million in 3Q and 4 to 5 million in 4Q is that still the assumption baked into the guidance?.

Yes, that’s correct. Because again each passing quarter you have to include the reorders or the last reorders if you will for the patients that didn’t start the quarter before.

So yes my assumption really hasn’t changed from what we talked about back last quarter whether which was those about a million and a half of it impacting Q2 probably somewhere in the 3 to 3.5 million range in Q3 and then probably 4 5 or so in Q4 is we start to see the new patient start kind of pipeline ramp up again..

Great. And then just coming back to the new patient growth you had mentioned 5% to 10% sequential growth.

You’d said 20% last quarter so is that so implied 25% to 30% this quarter?.

No different metrics, right. So 5% to 10% sequential growth Q2 to Q3 when we talked about 20% we are talking year-over-year, right. And the year-over-year we talked about that full kind of nine month period, so on a year-to-date basis which is that so, just to make sure we don’t mix and add there..

All right, since last quarter and much of the numbers are way off we had about 6000 for 100 patients, so would that imply about 6,500 this quarter, is that the right ball park?.

I mean I don’t want to comment about actual patient count numbers, I’ll just leave it to say that we’re about 5% to 10% higher sequentially in Q3 than we were in Q2. I don’t have all the models in front of me..

And then maybe just one more.

Looking at the drug delivery opportunity how should we think about that unfolding over the next few years are you targeting more existing products that could get into commercialization fairly quickly or is this something that you are looking more to mix of commercialization and generic drugs plus also drugs in trials, so how should we think about this impacting revenues over the next lets say three plus years?.

I think conceptually we are looking at the market place and basically looking at the drugs that are currently on the market and the opportunity for using the OmniPod as a special drug delivery device for those products whether they are currently on the market or in development, in stack ranking those in terms of opportunity and near term sales growth that we could expect from those type of applications and then putting resources against those opportunities to really capitalize on this use of the OmniPod.

I mean, I think from – you can leverage two things. You can leverage the technology which this obviously does and focusing on new sales and marketing to leverage the sales force. So we’re going to definitely making plans to leverage this technology. .

Its interesting when you think about like one of the benefits of the product when you think about existing drugs is looking at when certain compounds or things come off a patent for example could be an interesting way, the interesting reason why adding in a delivery device like the OmniPod makes sense.

And we keep in mind that, that with a lot of these and even with the Amgen product we’ve seen it, it takes a few years once from when you sign a deal its ultimately be able to get it to market, because of the process of either maybe a little bit of development, maybe not but then ultimately going through the obviously the FDA process.

So Capricor is on the other side that which is – there is the phase 2 product and we are helping them through their clinical trials. Now the reality of when that becomes a commercial product years down the line, but its exciting to be part of that one too and really affect to be part of their filing.

So there’s a mix of them in the pipeline, Ferring is obviously an approved one in Europe and we have been generating revenue from it. Amgen will be next and then as we continue to add more and more of these projects and we have a couple more on going, we’ll see how those develop and above and be able to drive actual timelines for each one..

Okay, great. And if I could just sneak in one last one.

How many territory managers did you end the quarter with?.

Just we have about 135 people or so in the field. Right now I think we are still split at 53 territories, right. So that would basically – so 53 I guess is the answer to your question..

Okay, great. Best of luck Brian..

Thank you..

Our next question comes from the line of [Tow] Levi from Westbush. Your line is now open..

Hi, good afternoon..

Hey [Tow]..

So maybe we could start with the new patient additions. Again, your comments, they definitely seem a little bit different than kind of the comments last quarter where – expectations were around 20% mutation growth and it doesn’t sound like you gave sort of a new number.

Yes, the revenue guidance is coming down, I guess what I’m trying to get at is the – there was a backlog of patients related to UNH, there is an expectation that most of those start to flow in here in the fourth quarter and even though they may not be big on the revenue side, they are going to be noticeable on the new patient additions?.

Apologize, I’m not sure I completely follow that, but we’re – again, where we’re heading just and so we stay clear here is on a year-over-year basis we’ve talked that we’re looking effectively for 20% year-over-year patient growth, new patients starts and I think everything has been trending close to that number.

We’re probably little lower than that at the moment, but again if you look at specific issue around the payer that’s been one that’s been driving it. On a quarter-over-quarter basis, Q2 to Q3, I mentioned a couple of minutes ago that we’re basically driving between kind of 5% and 10% sequential growth. So those are the two pieces.

In regards to the payer issue specifically its an open question, right, because what you seeing with the patients are in some cases they may – if there a chronologist is been saying, look you need to give on pump and unfortunately we can’t get this when approved right now, but you got to get another pump, some of those patients may have gone elsewhere.

Some may delay their decision. Some wait for the next trip back to the doctor. So, there’s –our team has done a really good job I think in the commercial side of trying to keep the patients – the pipeline warm if you will and trying to be able to bring these folks openly across the goal line.

No one that were able to get this result, but ultimately we have to see how that plays itself out. So, from that perspective I don’t think there’s any difference. I think when you look at the revenue growth in the business, again, we’ve always been a midpoint company and when we updated guidance last quarter, the midpoint of that range is 295.

If you look at the midpoint of the range that we gave you today is 295. So I don’t think there’s any real change or difference there at all..

Okay.

So the backlog of patients that I know you guys talked about last quarter has been sort of like one of the biggest in company’s history, that hasn’t necessary changed or is this patients gone away, that’s kind of what I was trying to reconcile?.

I mean, that’s overall pipeline, right, so we’re not talking about just one pair here. We’re talking about the overall pipeline and that is absolutely not changed. I mean, the team is continues to do a good job of drive-in referrals and ultimately those referrals turning into new patients starts.

So, I think we’ve seen good momentum in that business overall. My only comment specifically to this one pair is its unclear for patient who is looking start on OmniPod back in May is going to still be there for us to be able to convert in January.

I mean, we’re certainly try, right, but it’s a little less clear to be to say everybody is willing to wait six, seven, eight months or whatever it is to be able to finally cross the goal line..

Great. Thanks. And just one final question, Welcome Patrick, and as you talk about investing more sort of sales and marketing. In this quarter you excluding the one-time charges you get to breakeven, Q4 generally the strongest quarter of the year to assume that’s going to be positive net income there, we saw on adjusted basis.

As you move into 2015, where does profitability on the bottom-line sort of fit in your next call it 12 to 18 month thinking as you try to maximize top-line growth while obviously spending appropriately?.

I think the last point is the key one spending appropriately. We’re going through that process as we speak to develop our 2015 budgeting in our sales plan. But I guess it’s premature at this point to try to peak into the future and give the results of what we’re just literally in the process of doing.

So, I have more information for that earlier next year..

Okay, great. Thank you..

Our next question comes from the line Jayson Bedford from Raymond James. Please proceed with your questions..

Hi. This is Mike Rich calling for Jayson.

Can you hear me, okay?.

How are you?.

Hey, guys. Thanks for taking the questions. Most of my questions have been answered. But I just wanted to circle back to a couple of things. First, good color on the partnership with Ypsomed outside of the U.S. I know you’re tracking for doubling growth this year, but can you comment on the sales growth outside the U.S.

in the quarter or perhaps what percent of sales, international sales were?.

Not at this point I guess, but as Ypsomed said last week, I mean, they’ve seen over their last six months about a 60% or so increase in their business. We’re absolutely on track when we look at our international partnerships which will also include GlaxoSmithKline for Canada, to double our international revenue in 2014 versus 2013.

And as Pat in his remarks, I think we’re really excited and hopeful that we’re going to see reimbursement in France very soon, and France is a really interesting market in Europe. I think it’s the second largest pump market in Europe, and today we sit with the zero there.

So, getting France over the goal line would allow really another really good growth opportunity Ypsomed as they turn the corner into calendar year 2015. But overall, I think the international business has been doing great again. One thing you can point a little – the revenue share is great.

There are certainly helping us to drive to net breakeven at the operating level or an operating profit. Its lowers the gross margins slightly, but that’s a good trade off..

Got it. Okay.

And then is there timeline for OmniPod approval in China?.

Not anything at this point. I mean, I would tell you that we’ve continued to kind of work through the regulatory process over there in China. I don’t have an update on it. I know that we’re still need [Ethernet] but it’s probably some while the company’s feeling we get..

Okay.

And then lastly sorry, I missed this, but an update on the currently generation like PDM with LifeScan meter?.

Yes. We’re looking to hopefully have approval that. Very soon we’ve responded to all of the FDA’s questions.

Most of the questions that the agency came back with actually were more I would say a LifeScan driven and Insulet driven and we’ll see some questions around the various strip and those pieces which our partner has done a great job of responding to and providing the data for. So, we’re just in the waiting game at the moment.

But hopefully we’ll have an answer pretty soon..

Okay. Great. Thank you very much..

Our next question comes from the line Jan Wald from Benchmark Company. Please proceed with your question..

Thank you. And congratulations to Allison, Brian and Pat welcome and good luck. I guess most of my questions has been answered, but let me just ask a couple of more. Maybe taking also on [Dave] question a little bit more on profitability versus investment. Not looking for what’s you’re going to do, but how do say company moving forward.

You company at your stage looks towards profitability but it needs to make investments.

How do you see the priority of those two things occurring over the next year to two years?.

I think you have to strike a balance between the two. I mean, I think you have to really focus on yourselves, but you also obviously have to focus on bringing numbers at the bottom line. And we’re looking at plans to be able to meet those objectives..

One of the nice things Jan, we’ve able to find a good balance to both of those in the past, as you could see from the fact that we’ve been able to balance I think a very strong overall top line growth with getting now operating profitability, $4 million of operating profit excluding up the transition costs is are highest level of operating profit and obviously we continue to feel very bullish about pushing more gross margin to the business.

So, I think the business has positioned well to be able to find balance for both those going forward, which is a good spot for the company to be..

Okay. I guess my next question is in your prepared remarks you mentioned there are more efficiencies that you’re going to look for.

I think you probably meant to manufacturing? What kinds of things would you be looking to do in manufacturing with us, I guess elsewhere in the business can might improve those – might lead to more efficiencies?.

Specifically when we talked about, we have the fourth manufacturing line come up and one of the thing that been interesting in our manufacturing processes, with each line we’re obviously getting smarter of how to make an OmniPod with highest level of quality and most cost effectively possible.

And so I think I’ve shared in the past that when you look at Line 3 for example, right now its been our efficient line and we’ve been able to make some small adjustments for like Line 2 for example to make it look Line 3, so that one becomes the lot more efficient.

Line 1 for us is probably been – always been our most inefficient line where its highest level of people required and with the lowest capacity.

So when Line 4 comes on board for example, its going to mere image Line 3, so we’ll get that efficiency out of the gate and it starts to give us some flexibility to think about how we can better leverage Line 1 for example and therefore spread out overhead cost and look at the amount of direct labor required and those type of things hopefully further bring down the pod price.

That plus as we keep moving up the volume spectrum, we’re able to drive some additional cost components increases from our suppliers, which is also another positive and helping us generate more gross margin. So, those are couple of examples that where more efficiency can be gain..

Okay. And my last question, on the CGM center, it sounds as if you’re still going through some kind of design process, because you’re addressing the kinds of issues that would get addressed in design.

Any sense of when you’re going to be – when it will design for use or some like can you be able move into the clinical?.

I think we’ve said, that we said, we’ve been going to a process obviously the sterilization we’ve gone through this latest testing we did was earlier on this idea of distance between sensing and dispensing and we think – we got some – we believe some pretty favorable results out of that.

So you’re right, that is still kind of a design phase if you will. And we’ve talked about doing some inhuman trial work hopefully sometime early to mid 2015. Ultimately we’ll see where that timeline is driving towards in the second kind of all the [indiscernible] next real indicator to drive the overall timeline of the project.

So as we get closer to that point, that probably the next checking time..

Okay. Thank you very much and congratulations on the quarter..

Thank you..

Okay. This concludes today’s Q&A session. I’ll turn the call back over to Mr. Sullivan for closing remarks..

Thank you very much, operator. In summary, Insulet has achieved much in the first nine months of 2014 and I am very excited for the opportunities that line before us. With the payer issue basically behind us new commercial resources gaining valuable experience and continued international expansion; I believe we’re probably for tremendous success.

Our manufacturing partnership with Flextronics is world-class as we continuously produced 1 million OmniPod per month with our fourth manufacturing line coming online soon. We have the most unique user friendly product in the market with a continued pipeline of innovation that should continually raise the bar.

I’m delighted that Allison and Brad Thomas our new EVP of HR to the senior leadership team of the company. Our workforce with Brad has build the [Cytyc] organization for future growth prior to the acquisition by Hologic. And finally, I’d also like to thank Brian for his dedication and hard work over the past six years and wish him well.

Thanks again for joining us today. I look forward to meeting many of you at the various Investor conferences over the coming months and keeping you updated you on our progress. Thanks..

Ladies and gentlemen, thank you for attending today’s conference. This does conclude today’s program. You may all disconnect and have a wonderful evening..