Q2 2021 Insulet Corp Earnings Call
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Good afternoon, ladies and gentlemen, and welcome to the Insulet Corporation's second quarter 2021 earnings Conference call. At this time all participants are in a listen only mode later.
We will conduct the question and answer session and instructions will follow at that time she.
Should anyone require assistance at any time during the conference. Please press Star then zero on the of Touchstone telephone.
As a reminder of this conference call is being recorded.
I would now like to turn the conference over to your host Deborah Gordon Vice President and Investor Relations.
Thank you Joanne and good afternoon, and thank you for joining us for Insulet second quarter 2021 earnings call with me today, and our CP Petrovich, President and Chief Executive Officer, and Wade Mcmillan Executive Vice President and Chief Financial Officer, both of the replay of this call and the press release discussing our second quarter 2021.
And full year 2021 guidance will be available on the Investor Relations section of our website before we begin I would like to inform you that certain statements made by Insulet. During this call may be forward looking and could materially differ from current expectations. Please refer to the cautionary statements and our SEC filing.
For a detailed explanation of the inherent limitations of such statements.
We will also discuss non-GAAP financial measures with respect to our performance, namely adjusted EBITDA and constant currency revenue, which is revenue growth. Excluding the effect of foreign exchange. These measures aligned with what management uses as supplemental measures and assessing our operating performance and we believe that our <unk>.
Full to investors analysts and other interested parties as measures of our operating performance from period to period and.
Additionally, unless otherwise stated all financial commentary regarding dollar and percentage changes will be on a year over year reported basis with the exception of revenue growth rates, which will be on a year over year constant currency basis with that I will turn the call over to Stacey. Thank.
Thank you Deb and good afternoon, everyone and thank you for joining US we have reached the midpoint of the year and continue to deliver solid financial and operational performance and the underlying fundamentals of our business are strong.
We maintain sharp focus on executing our strategy and driving growth and have sustained momentum across our business. Our outlook is also strong and we are on track to deliver another year of double digit revenue growth, including meaningful acceleration during the second half.
During the second quarter, we achieved 13% revenue growth, including total omnipod growth of 16% or.
Our results met our expectations, despite a headwind from higher than anticipated rebate adjustments and the U S pharmacy channel.
And these we drove revenue results both in terms of volume growth and mixed benefit that exceeded our expectations. We also achieved another quarterly record of U S and global Omnipod, new customer starts, which gives us great confidence and enthusiasm for <unk> future.
While our team remains squarely focused on Omnipod 5 clearance efforts, we made terrific progress across each of our strategic imperatives.
We expanded coverage and volume growth of Omnipod dash and the pharmacy drove continued adoption in the type 2 market, where we are uniquely positioned once again drove strong MDI conversions and presented compelling clinical data at the ATT D and a day conferences.
These accomplishments demonstrate both the success, we're having unlocking the type 2 market with our innovative product and business model and the acceleration, we expect and the type 1 market with the launch of Omnipod 5.
We have delivered consistently strong performance and these critical areas without and automated insulin delivery system in the market, which speaks to the power of Omnipod and the unique advantages of our pay as you go of business model and the differentiated customer experience we provide.
Regarding our Omnipod 5 AIG system, we are in the final stages of the FDA review process and are incredibly appreciative of the agency's diligence and collaboration particularly given the pandemic workload.
While we continue to expect FDA clearance and limited market release, and the second half of 2021, we believe Q3 clearances unlikely and now estimate that both will happen later in the fourth quarter. We remain incredibly excited about what omnipod 5 will offer the diabetes community.
Our market position, which is already strong will be greatly enhanced by the introduction of Omnipod fives, we are well prepared have invested and our sales teams and expanded our manufacturing capacity and made great progress securing payer support our efforts in these areas will continue as we work through the.
Final stages of the clearance process, we are confidence and a successful launch of Omnipod, 5 and I will share more on that and a few minutes.
I'll now speak to each of our strategic imperatives, including expanding access and awareness.
Delivering consumer focused innovation growing our global addressable market and driving operational excellence.
Getting with access and awareness of the global diabetes market is growing rapidly with millions of people expect it to be newly diagnosed this year alone and rapid adoption of CGM among people living with type 1 diabetes and more recently type 2 diabetes.
Despite such a large and fast growing market. It remains critically underserved and awareness of and access to technology remained far too low.
We continue to expand access and utilization through the pharmacy, which provides a better customer experience a more efficient channel for physicians and for Insulet.
And the second quarter, we grew Omnipod dash us covered lives to approximately 80% a sizable sequential increase this drove a notable increase of us volume through the pharmacy and Q2.
Omnipod Dash continues to be our primary growth driver with the majority of our new customers across the globe starting on the system.
Approximately 80% of our U S. New customer starts are consistently driven by MDI conversions and the percentage of our U S. New customers that were type 2 during the second quarter remained strong at 35% to 40%, even with the record setting growth and new customer starts.
And the type 1 segment historically large numbers of MDI users are adopting technology, which gives us continued confidence that AIG will drive a doubling of the pump market in the coming years.
We are pleased with our current growth and type 1 which is a testament to omnipod the differentiation and as we look ahead to Omnipod 5 we expect to be extremely well positioned to accelerate growth in this segment.
We are also successfully driving adoption among type 2 users a large market segment that has tremendous long term growth potential, particularly of CGI and becomes more widely adopted we are learning that omnipod is uniquely well suited for type 2 users.
Because of awareness of Omnipod remains low we are investing to raise awareness across the globe. We are advancing our direct to consumer advertising advertising campaign and the U S as well as our pilot program in Europe, primarily in the United Kingdom.
While our DTC efforts remain in early stages. The response has been encouraging and all markets, where we've tested it and we believe DTC is a contributing factor that helped to drive record U S and global new customer starts this past quarter.
Our growth is also supported by our superior technology robust innovation pipeline and expanding clinical evidence that shows how life changing omnipod can be for people living with diabetes. The.
Tube free Omnipod experience is unique and we know from our clinical trial participants that omnipod 5 will be a transformative product for insulet and for the diabetes community, we cannot wait to bring it to market.
We're making good progress in this regard and our recent interactions with the FDA continue to give us confidence and a second half limited market release, a third quarter FDA clearances unlikely. So we now estimate clearance will be later in the fourth quarter.
Through our ongoing collaborations as part of the breakthrough devices program. Among other things. The FDA has provided clarity on open questions related to full of smart phone control.
Based on their feedback we are updating our smartphone app to add a product feature and we are working through the final steps towards clearance. This work is well underway and gives us confidence and our expected clearance timing.
Insulet is a pioneer in this space with full phone control and we're grateful for the agency's support and guidance and delighted to be close to clearance achieving full of smartphone control is a complex and novel innovation that we know will be enthusiastically welcomed by our customers. We are committed to providing the best path.
<unk> user experience and getting omnipod 5 to market as quickly as possible.
While we work through to clearance of our teams are successfully securing pharmacy coverage for Omnipod 5 testing all elements of our customer experience and preparing for a successful limited market release.
No other product on the market delivers the value technology and functionality of Omnipod 5 we believe it will significantly change the lives of people with diabetes and their caregivers through unparalleled ease of use better quality of life and improved outcomes.
From a commercial perspective, we previously communicated the core components of our pricing and access strategies.
And the U S. Omnipod 5 will be available only through the pharmacy and it will be priced at parity with Omnipod dash.
We will continue to provide no upfront costs and no long term lock in period. In addition, any customer whether and MDI or tube pump user will be able to try omnipod 5 for free at any time through our 30 days of the freedom program, which has already helped to fuel increased omnipod adoption.
Given this approach we expect the low monthly out of pocket costs for Omnipod, 5 will be comparable to Omnipod dash and MDI, which we believe has a tremendous value given the improved outcomes and quality of life Omnipod 5 delivers the.
And the majority of our Omnipod dash customers in the US have a monthly pharmacy co pay of under $50 and we are thrilled to offer the same benefit to our omnipod 5 customers.
We have already contracted more coverage for Omnipod..5 then what Omnipod dash had after commercial launch setting us up for a successful limited market release.
The value Omnipod <unk> can deliver to people with diabetes is clear as demonstrated by the compelling clinical data. We recently shared at major diabetes conferences, including Omnipod 5 preschool pivotal and pivotal extension results and our non AIB system data.
While we are proud of all of the impressive omnipod data our omnipod 5 preschool pivotal data certainly stands out our study represented the largest dataset of primary outcomes for any AI system down to <unk>.
The results were compelling and included a statistically significant overall <unk> reduction a significant increase and time and range and no severe adverse events, 100% of the preschool participants moved into the extension phase, which shows these families did not want to give up their system.
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This clearly speaks to the tremendous value children and their parents experienced on Omnipod 5.
The results mirrored Omnipod fives strong performance across other age groups, including up to age 70, and this is quite an accomplishment as many experts agree the pediatric age group as the most challenging for clinical care the.
The results also demonstrated a significant improvement and sleep for caregivers, it's a very common concern for concerned parents.
We are so pleased to see these young children greatly benefit from our technology. They are often unable to verbalize, how they're feeling and are too young to manage this complicated disease on their own. We believe omnipod 5 will greatly ease the burden of diabetes for these vulnerable children and their caregivers.
Another major highlight of our pivotal extension was the further reduction and <unk> levels, because they already were significantly reduced during the first pivotal phase to see a greater reduction speaks to the durable power of Omnipod 5 to transform diabetes management.
While we are proud of all of our clinical results. There is much more to do and we will continue to invest and our clinical roadmap, including expanding omnipod fives indication down to age 2 and for type 2.
Our preschool internal clinical efforts are advancing well yet our FDA submission is contingent upon the timing of Omnipod 5 clearance. We are now planning for this expanded indication in 2022.
Additionally, our type 2 feasibility study is advancing we recently concluded the 3 month study period and are now in the extension phase we expect to share the results of our type 2 study at an upcoming conference.
And finally, while the upcoming clearance and launch of Omnipod 5 remain our top priorities. Our pipeline is robust and we believe some of our best innovations are yet to come.
As such investing and our software development data science and other capabilities remain a critical priority.
Our development work is well underway, including iOS and Libre integrations and the international launch of Omnipod, 5 and database innovations aimed at providing insights for our customers.
Beyond the Omnipod 5 we are developing technologies that we believe will simplify and improve the lives of people living with both type 1 and type 2 diabetes.
Turning to global expansion, we have spent the last few years working to expand awareness and access to omnipod across our key international markets. Our latest efforts have been in Australia, where we continue to plan for and Omnipod Dash launch this year.
This builds upon our expansion into Turkey earlier, this year and across Europe, and the middle East last year.
We expect our international expansion efforts will drive access to a huge global addressable market far beyond the estimated 11% to 12 million people living with insulin dependent diabetes across our current global footprint.
As we look ahead, we know there are additional opportunities to further expand our addressable market and to help improve the lives of people living with diabetes around the world. We continue to drive strong growth and our international markets with the recent full launch of Omnipod Dash and we fully expect to bring Omnipod 5 to these markets and the few.
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Lastly, we continue to invest significantly to further strengthen and scale our global manufacturing operations. We are in a strong position to meet growing global demand for Omnipod dash supports the upcoming U S release of Omnipod, 5 and scale our operations to support our future innovation pipe.
Line and geographic expansion initiatives, we've made terrific strides on our path to build on our operational excellence, which we believe to be a critical enabler of sustainable revenue growth and margin expansion in the years ahead.
In closing we are on track to deliver another strong year of financial results and strategic progress and we are gearing up for the upcoming launch of Omnipod 5 our mission to improve the lives of people with diabetes has never been more important and our innovative solutions have never been more needed I'll now turn the call over to Wade.
Thanks Rich.
We achieved another solid quarter of financial results with building momentum from record global New customer starts and are on track to drive accelerated revenue growth and the second half of the year.
The support our accelerating growth, we continue to invest and our strategic imperatives through innovation and clinical commercial manufacturing and other supporting functions the position us for sustainable long term global growth, we generated 13% revenue growth and the second quarter, finishing with whom our guy.
And this range driven by total omnipod growth of 16%.
As expected the Pandemics effect on 2020 global new customer starts impacted results again in Q2, given the annuity nature of our revenue model, although the impact of the pandemic headwind continues to linger and the United States and it's still more challenged and some of our international markets. We expect the main.
The impact is largely behind us.
In Q2, we delivered us omnipod revenue growth of 17%, which was at the low end of our expectations due to the higher than expected rebase from 1 of our largest pharmacy partners of approximately $4 million Approx.
Approximately half of the adjustment related to of rebates catch up from prior to Q2.
As a reminder, Q2 also had a tough comparison with approximately $4 million to $5 million of channel build and the prior year.
During the second quarter, we continued to build our customer base with record U S. New customer starts ongoing omnipod dash adoption with both type 1 and type 2 customers and the mix benefit we realized as we drive increased volume through the pharmacy channel.
These growth drivers continued to trend upward and Q2 as Omnipod dash drove almost 80% of our U S. New customer starts and we grew pharmacy channel volume to over 45% of our total U S volume.
And Q2 International Omnipod revenue grew 13%, which which finished slightly ahead of our expectations.
Our growth and the quarter was driven by our success with Omnipod dash and expanding our customer base throughout our markets as well as the team's ability to successfully execute through continued COVID-19 challenges.
Our global attrition and utilization remained stable during Q2.
The drug delivery revenue declined 13% during the second quarter, finishing slightly ahead of our expectations. As a reminder, order volumes were elevated and the prior year as a result of the pandemic and are normalizing this year as expected.
Gross margin was 69, 4% and the second quarter, representing a 640 basis point increase or a 510 basis point increase on a constant currency basis. This expansion was in line with our expectations and marks our highest gross margin reported to date.
Overall, our gross margin expansion continues to be driven by our improved manufacturing operations and supply chain efficiencies lower COVID-19 related costs and.
And the mix benefit of increasing volumes and the U S pharmacy channel.
These benefits were partially offset by the expected higher mix of costs as we continue to ramp us manufacturing and.
Including our third highly automated U S loan, which is now producing salable product.
Operating expenses were in line with expectations as we continue to invest and our robust innovation and clinical pipelines the ups.
The coming launch of Omnipod, 5 and other commercial investments, including our global direct to consumer advertising initiatives and our international expansion plans operating margin was 10% debt.
220 basis points and adjusted EBITDA margin was 19, 9% up 40 basis points.
Our operating income was in line with our expectations as we continue to invest throughout our global business to fuel our long term growth trajectory.
Turning to cash and liquidity, we remain and a strong position with no near term maturities and further runway for continued to invest and our business. We ended the quarter with $872 million and cash and short term investments. We have also taken a number of steps to strengthen our capital structure, including successfully execute.
And a $500 million term loan b financing, we used the proceeds to repurchase 92% of our convertible notes due 2024, which resulted in a $40 million loss on extinguishment debt is excluded from adjusted EBITDA.
Additional notes for since converted and now approximately 3% of the original issuance remains outstanding.
Following these transactions on an annual basis, we expect our net cash interest expense will be approximately $30 million and noncash interest expense will be significantly reduced to approximately $25 million to $30 million now.
Now turning to our outlook for the remainder of the year, we are maintaining our full year revenue guidance of 16% to 20%, including total omnipod revenue growth of 18% to 21%.
We continue to expect a full year U S. Omnipod revenue growth range of 22% to 25%, we expect our growth to be driven primarily by expanding omnipod dash volume increase access and awareness of our differentiated pay as you go model and the mixed benefit and the pharmacy Channel and addition.
We expect further penetration and customer adoption and both the type 1 and type 2 markets.
Offsetting these tail winds are less omnipod 5 incremental revenue than we had previously anticipated and the Q2 rebate adjustment.
For International Omnipod, we continue to expect full year 2021 revenue growth and a range of 11% to 15%.
Dash adoption rates continue to grow following its launch near the end of last year the.
Despite the lingering impact of Covid across several of our markets. During the first half of 2021 and our team has successfully driven additional market penetration and strong new customer growth the runway to expand omnipod adoption across our international markets is large and we see clear pathways for future growth.
As a reminder, we had a tough comp due to the $8 million to $9 million of pandemic related inventory, we experienced in the prior year as well as from our initial launch of Omnipod dash.
Lastly, we are maintaining our expectations for drug delivery revenue and a range of 11% decrease to a 4% increase.
Turning to gross margin, we now expect full year gross margin to be and the range of 68% to 69%.
The core drivers of our gross margin expansion have not changed as we build scale and create efficiencies throughout our global manufacturing and operations as well as the ongoing benefits of volume shift into the U S pharmacy channel and.
In addition, we expect to benefit from lower Covid related costs.
We continue to expect operating expenses will largely rise in line with revenue growth. This year, we view the investments and consumer focused innovation and our sales and marketing teams and our international expansion efforts is critical to our long term growth profile.
We are reaffirming full year operating margin and the low double digits range, our operating margin expansion will be driven by our strong topline growth and gross margin improvements as well as our expectation that the onetime costs that occurred in the fourth quarter of last year will not recur this year on a sequential basis we.
<unk> operating margin improvements throughout the second half of this year, primarily due to our expected accelerated revenue growth.
We continue to expect capital expenditures to increase this year with the investments throughout our global manufacturing and operations as well as our strategic initiatives.
Turning to our third quarter 2021 guidance, we expect total company revenue growth of 11% to 18%. This includes total omnipod revenue growth of 17% to 23%. We expect Q3 U S. Omnipod revenue growth of 23% to 20.
8% as a reminder, Q3 growth also benefits from the net impact of estimated distributor channel Destocking last year the.
The significant step up and our sequential growth rate is primarily due to the impact of channel stocking and destocking and the prior year volume ramp from our accumulating record setting new customer start quarters.
Annualized and the most impactful COVID-19 related quarters from 2020 and to a lesser degree the mixed benefit from volume through the pharmacy channel we.
We expect Q3 international Omnipod revenue growth of 8% to 14%.
We continue to expect our growth rate to be partially offset by the trailing pandemic related headwinds that existed in the second half of 2020 and the first half of this year and many of our international markets also as a reminder, Q3 growth is impacted by the estimated $4 million to $5 million.
<unk> channel stocking, we experienced in the third quarter of last year ahead of the international full market release of Omnipod Dash.
We expect drug delivery revenue declined 40% to 28% due to the normalization of order volumes as compared to elevated levels and the prior year, resulting from the pandemic.
In conclusion, we of sustained momentum throughout the business and are on track to deliver another year of strong revenue growth and margin expansion, while advancing our strategic imperatives, our financial position is sound and provides us the flexibility to invest and our leading innovation pipeline access.
And awareness initiatives global sales force international expansion and manufacturing efficiencies.
All of these efforts are designed to drive significant shareholder value over the long term and strengthen our ability to improve the lives of people with diabetes across the globe.
With that I will turn the call over to the operator for questions.
Thank you Sir.
And if you have a question at this time. Please press the star key Dan the 1 key on your Touchtone telephone and for your question has been answered of your wisdom of yourself from the queue. Please press the pound key.
The limited each participants questions to 1 however, please feel free to go back into the queue and if time permits we'll be more than happy to take your follow up questions at that time.
Our first question comes from the line of Travis Steed from Barclays. Please go ahead.
Hi.
And thanks for the questions and I missed.
Out of the prepared remarks, I apologies, but and then wanted to get more color on the Omnipod pod, Bob delay and just to make sure I understand the all the moving parts, there and what exactly happened and.
And what gives you confidence that youre going for half the approval by Q4.
Sure of Travis and I. Appreciate the question I think may be helpful to take a step back to where we were in may.
<unk> received the the agency's feedback on our submission and there were no surprises, which had put us on track for our anticipated timeline.
We are very fortunate to be of part of the breakthrough devices program and that allows us frequent and collaboration with the agency. So we took the opportunity to discuss in more detail for mobile phone control and get extreme clarity on the Fda's response.
Their feedback was really helpful for us and valuable and it prompted us to update our app with a feature that we believe will improve the the customer experience. So that is basically what's happened since may and the work is well underway and <unk>.
<unk> all of our verification and validation testing and then our assessment of that final work and the Fda's review.
And then of course from buffer because of time times are not normal given the COVID-19 workload that all puts us.
Towards a Q4, we believe late in Q4, our clearance and limited market release. So that's kind of where we are I would just emphasize that in the meantime, we are not standing still the teams are doing great work preparing for a limited market release and us.
And I think making really good use of the time that we have while we get the final clearance.
Thank you I show our.
The next question comes from the line of allow us to Larry <unk> from Wells Fargo. Please go ahead.
Good afternoon, and thanks for taking the question I guess, if I'm going to use my 1 question on the <unk>.
Omnipod, Bob I'll ask what is the final feature.
And and I guess.
When do you plan to submit that.
The FDA and just given the delays there what gives you confidence and what's the buffer that you're incorporating it and to get to that late Q4 clearance and thanks for taking the question sure. Yes. Thanks, Larry the feature is related to full of smartphone control. So it's the way that the app interact with the system. It has nothing to do with our.
1 on the pharmacy rebate I was hoping you could just go into a little more detail of exactly what that was and how it works was that did you over earn from this.
From this payer and now your Rebating it back us at 1 time, how do we think about that any further impacts you expect on forward.
And then the second on the US the results are obviously better when you put the rebate back in but it would be great to hear what you're seeing out and the field do you think people are holding back on starting Omnipod is there waiting from the pipe 5 I am sure they hear it and the news.
Just thinking about how it's impacting the field if at all thanks.
Sure before and I can start zone Siouxsie on the rebate of question and go ahead and run it up royally because it gives us an opportunity to share a little bit more color around it. It is due to and updated rebate information from 1 of our largest pharmacy partners. So as we mentioned and the prepared remarks, the partially related to.
Stark quarter, so and that's important to US we think about you know are people holding off of it certainly would not be evident and our numbers based on a new paid for new customer starts in this past quarter and that said you're right that there is growing consumer awareness of Omnipod 5 of the company and I personally get daily.
E mails from customers that are anxiously awaiting so I don't I don't believe customers are holding off based on the new customer starts numbers, but there is growing awareness of of the technology that's coming.
Thank you I show. Our next question comes from the line of Daniel and tough for Us.
Paul for you from a fib.
SBB Leerink. Please go ahead.
Hey, good afternoon, everyone. Thanks for much for for taking the question and I don't know if this is for weight or change the or maybe both of you, but I guess with the with the approval for Omnipod 5 now coming later this year you know contented pre today was looking at like 20% growth and <unk>.
And in 'twenty, 2 so slight acceleration of if youre looking at the midpoint of the range I mean, you're talking about still a limited market release for Omnipod 5 I'd just be curious what you can say about how the change and the timeline for Omnipod 5 might impact the outlook for 2020.2 if at all and how that you know accelerating growth.
Via the consensus numbers again pre today and how achievable that might be thanks, so much.
Thanks, Daniel I'll, maybe I'll kick us off and then Wade can give some comments on any color you want us to give regarding 2022 with omnipod 5 and I think ultimately we know that the of the market is waiting for Omnipod volume. So we're going to do whatever we can to make our limited market releases efficient as possible yeah. It's important to do a limited market.
Please if you think about what's going to happen with the Omnipod 5 we know that people today, who use dash or classic omnipod or multiple daily injections or tube pumps and.
They're they're all going to have a different customer journey coming onto the omnipod 5 they're each different pathways and we will have different requirements. For example, all of our dash customers already know the benefits of pharmacy and low out of pocket costs.
And we're gonna have to get to the pump users or potentially MDI users comfortable with the benefits of the pharmacy and then each of those different patient segments have different training and onboarding needs and so those are the types of customer experiences that we're testing today to make sure that we've got everything in and of great position for the launch and then the other governor and.
Access and it's 1 of the reasons why we gave some color that the team is making great progress establishing access. So we are doing everything we can to make as efficient and the LMR as possible, but we do want to do 1 and hopefully we will not hopefully today for sure we are and a better position.
And today than we were a quarter ago and a quarter from now we're gonna be and an even stronger position. So I think we're going to head into 2022.
And a really strong position and hopefully keep the LMR as efficient as possible.
Yeah, and just picking up on the guidance part of the question there Danielle we arent guiding for 2022, you can see.
And we appreciate the question and we can provide some color on how we're thinking about the U S guidance for 'twenty 2 at this point and time.
And a half and that momentum will carry into 2022 further dash penetration of the type 1 and type 2 customer adoption really being aided by CGM. So we're riding that wave as well and we're continuing to expand and the pharmacy with our pay as you go model or a direct to consumer programs. So a lot of momentum and the business.
Quite a few tailwinds a couple of headwinds that we're monitoring and.
And that some color for you will get into the 2022 guidance on our on our queue 1 call.
Thank you I show and next question comes from the the line of Jeff Johnson from the Bad. Please go ahead.
Well. Thank you good afternoon, and guys Alright, let me just wait or Cynthia I got the new 1 follow up on it and Daniels question, there and ask it and maybe a slightly differently. When we thought omnipod 5 was coming maybe mid year or sell it was kind of a 6 month limited market release, but Shane fee to your point of lot of that I think was getting commercial coverage in place and it's the it sounds like you're making.
Good progress there is it fair to think about that LMR then could be.
Cut in half think about it is 1 quarter and then moving by second quarter into.
And to that bull market release, and and wait I know respect that you're not giving 22 guidance but.
It feels like there should be some shortly and of that LMR scheduled given the the commercial coverage of already established thanks.
Yeah, Thanks, Jeff and we are going to do everything that we can to drive as efficient and and limited market released as possible I think just something to keep in mind is.
Limited market releases are designed to uncover of things that weren't contemplated and all of the testing and launch preparation. So yeah. I think that's the caution of course, we are in a stronger position, where securing coverage I think all of the set us up for success and and trying to add.
Shorten the limited market relief, but and caution everybody by saying, if we bump into something we're going to address that that's the whole purpose of doing a limited market released I think the teams are doing great work and certainly.
Ameliorating the potential of running into something with all of the work that we're doing and we are certainly establishing access which is 1 of the main governors and so those are great signs and.
But of course, we're gonna take our learning from the limited market release, it and we're going to make sure that we're providing the best possible customer experience.
Thank you I show of next question comes from the line of Matthew O'brien from Piper Sandler. Please go ahead and.
Afternoon, and thanks for taking the question I know everybody's focused on the 5 slippage here, but I'm I'm curious about the core business and for your point JC that.
The the growth of new patients was the record that you saw can you talk a little bit more about some of the the the dynamics there that are driving new.
Patient edition, so much higher if it's type twos, if it's pediatrics.
Just talk about some of those dynamics and then how those might maybe augmented once you do get the 5 on the market. The Marceau next year. Thank you.
Yes, ma'am. Thanks for the question and actually I think it's really exciting to see what's happening with the for business right now and what's driving our growth I would point it too well 3 dynamics and the first is DTC. So this investment that we're making in raising awareness is definitely working and we think with 1 of the drivers for our record.
By quite a bit and the U S and new patient starts and that's coming out broadly across and.
Type 1 primarily among multiple daily injection users and then also take 2 and to take 2 would be the second dynamic that I would point too we are and a pretty rarefied position here and nobody else is having the success that we're having unlocking the market opportunity and it's because we have a product that is uniquely well suited to the <unk>.
Right to user and.
And its simplicity and in its cost and profile and so that's the third piece is the pharmacy and pay as you go and that's helping us certainly to make our technology more accessible and more affordable to the people that are becoming increasingly aware of it and the reason why we like these dynamics.
These underlying dynamics is because when we launched omnipod 5 it will be additive to these things. We are we fully intend to maintain our advantage and type 2.
We fully intend to maintain our advantage and the pharmacy and are pay as you go model and we're going to then deliver what we think will be a game changing technology and omnipod 5 to the market and so the team could not be more excited because we've got this underlying momentum.
That's and that's being or the.
It's helping to deliver record setting new patient stark and and of course, we're all gearing up every aspect of the company right now is gearing up for and Omnipod 5 launch and just incredibly excited about what it will bring to patients. So and so I think it is and exciting additive technology to what is already a really strong momentum.
And our business, particularly in the us.
Thank you.
Sure. The next question comes from the the line of Margaret Kesar from William Blair. Please go ahead.
Andrew and thanks for taking the questions and.
And I wanted to focus and the pharmacy channel and kind of that increase and adoption of quarter and it does seem like it did pop up certainly for new patient Stark and perhaps for active users as well. So was there something different and that you guys were doing to drive that uptake is the D. T C and and I guess since we look of year from now where she.
Should we see that active base or is it just going to be a little bit more pre determined that and on the launch and timing of both of them.
Yeah, a great question Margaret So there's a few things happening 1 we continue to kick up access and that increased notably and as we increase access then more people in our base have at the opportunity to move into the pharmacy. So that's 1 piece of it and the second is at DTC is definitely driving demand and if you think about now.
Our Wade mentioned it cumulative record setting quarters for 3 quarters, where we've got in our new customer starts I think on each of those quarters between 70, and 80% of customer's going directly into the pharmacy or directly onto dash. The vast majority of that and the pharmacy. So that trend is just helping to drive more and more people and to the pharmacy.
The really strong position and a really nice trajectory as we get closer to launch.
Every quarter, we establish more access for Omnipod 5 so as we get closer to launch we're certainly not standing still that the teams are making great and use of this time and I think to your point that sets us up for a successful and what we certainly hope is a very efficient limited market release, because we knew that there are 2 primary governors to limited.
Margaret release, 1 is access and as you note. The team is making great progress there the other us customer experience and that's the 1 where we can't really sort of say how quick that's going to be until we get into the throes of it and then the team is doing a really nice job testing all of the different pathways testing the training and Onboarding.
Processes testing the benefits investigation all of that stuff, but that's the type of thing that you really need ly patients going through the process to test effectively but that will be I think the primary governor us we look to move from limited market released into full market released given how well we're doing with the access.
Thank you for sure.
And the next question comes from the line of Carl Rose from Kenacort. Please go ahead and.
Great. Thank you for taking the question.
Just the maybe a bit of a bigger picture of question of images. The this is and the second and third time on these calls you talked about investiture, making the software.
I think and traditionally we've become more accustomed to.
Products and Medtech being more focused on tangible things like like like widgets of insulin pumps and you can touch maybe help us understand how you think about maybe not necessarily with the <unk>, but maybe the next generation of products that are going to be made me more software focused and saw that might change the patient and the and the physician experience of the technology and the value of your provider.
Hi, and thank you for the question and I think and great.
The opportunity to just talk about the.
The position that we see ourselves and and as it relates to patient data.
And very few companies have access to the volume of data that and set will have with Omnipod 5.
And had mentioned earlier on a previous call that we're putting sim cards into our omnipod 5 and can.
Controllers, and then of course, we will be offering full phone control, which means that we will have a stream of real time data coming off of the user that helps us understand how their continuous blue closest doing helps us understand how they're interacting with the system helps us understand how much insulin is being delivered when it's the.
Suspended and when they're eating and so that provides us with incredible potential to generate insights that can be valuable to our customers to their clinicians and potentially to payers as well and population analytics and so we see ourselves and just really well positioned.
Because it's essentially a wearable technology, that's providing real time data.
That we believe can can help us help people achieve better outcomes through a variety of of mechanism. So I think you'll you'll hear us talk more about that as we get omnipod 5 to market and how we see that and our role in that for our customers and including our consumers are clinicians and our payers.
But we do believe we're very well positioned.
To provide value here.
Thank you.
Sure. Our next question comes from the line of Joanne and West from City. Please go ahead.
Oh, good afternoon, and thank you for taking the question I think 1 of the things that I'm hearing and the pattern of the questions Tonight is is there a positive thing and that comes out of this delay doesn't mean you need to have a shorter limited launch does it maybe accelerate your type 2 label or your product with the Abyss free break and is there any way to address.
That are is just everything is pushed back call at 6 months.
Yeah, and I think the positive thing that comes out of this is that the day has given us really valuable helpful. Feedback that we think will ultimately enable us to deliver a product that is even better and.
But and I also believe that the limited Margaret release will be shorter as a result of this time that we've had to establish coverage. So that is good how much shorter and that will rely on us really testing the customer experience and understanding of we've got learnings there that needs to be incorporated or adjusted too but.
The value that we've.
Been able to have during this time is just the the the opportunity to establish coverage and continue to test the customer experience both of those things should help us to deliver a more efficient limited market release.
Thank you.
So our next question comes from the line of Anthony Patrol and from Jeffries. Please go ahead.
Thanks Hope everyone's doing well a question on just collaboration behind the scenes on on Omnipod 5 with the <unk> com.
I had some bullish language on the earnings call and.
And the past couple of days. So just wondering what level of collaboration is going on behind the scenes ahead of launch later this year that would be the first question and then the follow up question would just be maybe a longer term sort of opinion and view on the automated insulin delivery space, how you see and evolving next 2 to 3.
Years, when you consider that we now have multiple offerings are there on market are coming to market eminently. Thanks.
Thanks, Anthony and <unk> has been and outstanding Parker and it has been remarkable to see what they have done in the market and the value that they provided consumers and we really believe that they are helping to drive adoption and so we could not be more excited for our combination.
Offering the have helped us across the number of fronts and collaboration has been incredibly strong and obviously they have and incredible technology and so that combined with Omnipod and Omnipod..5 we think is going to be a game changer in the market it will be of game changer and.
Terms of patient experience and patient outcomes and it will be of game changer in the market in terms of our.
Our position so we.
We're strong collaborators strong partners today, and then of course working on G 7 and future integration and so that would be really exciting part of our pipeline as well in terms of the AIG market and.
And I think it's very exciting to see what's occurring out there and.
And we see the trend in terms of CGM adoption among type ones and what's happening now with AI D gives us great confidence that among type 1 users the pump market will double and a big part of that will be automated insulin delivery of course, we believe we're going to deliver the best market and or the.
Best product to market and I think the thing that gives us excitement is that we have been competing so effectively with our non AI system and so people are choosing omnipod, even though there is no CGM integration and despite the fact that we've seen such dramatic uptake and CGM. So we think that we're going to see the.
Real power of the form factor now that we've got CGM integration and automated insulin delivery with Omnipod 5 because people will no longer really have a reason to choose and alternative device, which we know many people if they they prefer the pot form factor, but choose another system because of Dexcom integration.
And so we're really excited to.
Even the play and ground, there and really frankly leapfrog the.
The field there and then the other thing I would point US just type to all of these trends are more mature and type 1 and I talk sometimes about the competitive field, but I would say that among this large patient population and no 1 really needs to lose for us to win there. If you look at the field, even and type 1 where there is more maturity here still today.
Because we're increasing patient awareness to technology, but what we saw before we invested in and DTC was that patient.
Patients awareness even of type 2 consumers awareness of their options unaided awareness was somewhere around 15%. So even a person with type 1 and you know could only named a pump manufacturer of <unk> 15 per cent of the time. So there is a massive opportunity here to just help people understand and get.
And more awareness to the treatment options that are available to them and then we mean, we need to make them cost effective and simple to access and to us.
Yeah.
Thank you.
I saw the next question comes from the line of Steve Lichtman from Oppenheimer. Please go ahead.
Yeah.
Thank you.
I was wondering if you could talk about international what are the biggest.
The biggest incremental drivers we should be focused on for you guys internationally over the next day 6 to 12 months of it.
It's in terms of new countries or.
Particular countries, where the dash and recently launched and and anything you can talk about relative to potential timing of omnipod 5 outside of the U S. GAAP.
Yep, Thanks, Steve and.
When we think about our international and the drivers there dash and continued expansion internationally will be drivers and particularly the adoption of Omnipod dash, which we know is doing really well across our international markets, but our room to continue to grow there and.
And new market additions and so now in the last year or so we've added a handful of markets that will contribute over time, but any new market edition for US internationally. It takes time to accumulate and you lose new users. It's just the way that our business model works. So we view international as a long term growth driver and we will.
And to invest in expanding into new markets that will drive growth over time and we of course also are really excited to bring omnipod 5 to our international markets, which we view as the next growth driver and we arent going to give a timeline on that yet we really want to get omnipod 5 to market first and the US and then we'll update our.
Timelines are on things that everybody is asking about iOS integration Libre integration G 7 and international but all of that work every program I. Just mentioned is underway and certainly we're going to aim to follow as quickly as we can once we get omnipod and 5 to market and the U S, which we could not be more excited to do.
Yes.
Thank you.
I'm showing no further questions at this time I would now like to turn the conference back over to the shaky Petkovic for closing remarks. Please go ahead.
Great. Thank you everyone for joining us today as you can see we continue to drive our strategy forward and we have great momentum throughout the business and real confidence and our outlook, we're halfway through the year and what we expect will be another successful year for Insulet and the clinical evidence we share it speaks to the tremendous value.
Our technology offers to those living with type 1 and type 2 diabetes and we could just not be more excited for the launch of Omnipod 5 because we are confident it will mark an important new chapter for Insulet and more importantly for those living with diabetes worldwide. Thank so much of a great evening.
Ladies and gentlemen. This concludes today's conference. Thank you for participating and have a wonderful day and you may all disconnect.
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Good afternoon, ladies and gentlemen, and welcome to the Insulet Corporation's second quarter 2021 earnings Conference call. At this time all participants are in a listen only mode. Later, we will conduct the question and answer session and instructions will follow at that time she.
Should anyone require assistance at any time during the conference. Please press Star then zero on the I touched on the telephone.
As a reminder of this conference call is being recorded and I'd like to turn the conference over to your host Deborah Gordon Vice President and Investor Relations.
Thank you Duane and good afternoon, and thank you for joining us for Insulet second quarter, 2020.1 earnings call with me today are safety Petrovich, the President and Chief Executive Officer, and weighted Mcmillan Executive Vice President and Chief Financial Officer, both of the replay of this call and the press release discussing our second quarter 2021.
Results and full year 2021 guidance will be available on the Investor Relations section of our website before we begin I would like to inform you that certain statements made by Insulet. During this call may be forward looking and could materially differ from current expectations. Please refer to the cautionary statements and our SEC filing.
And for a detailed explanation of the inherent limitations of such statements.
We'll also discuss non-GAAP financial measures with respect to our performance, namely adjusted EBITDA and constant currency revenue, which is revenue growth. Excluding the effect of foreign exchange. These measures aligned with what management uses as supplemental measures and assessing our operating performance and we believe that our health.
For 2 investors analysts and other interested parties as measures of our operating performance from period to period. Additionally, unless otherwise stated all financial commentary regarding dollar and percentage changes will be on a year over year reported basis with the exception of revenue growth rates, which will be on a year over year.
Year constant currency basis with that I will turn the call over to Stacy.
Thank you Deb and good afternoon, everyone and thank you for joining US we have reached the midpoint of the year and continued to deliver solid financial and operational performance and the underlying fundamentals of our business are strong.
And we've maintained sharp focus on executing our strategy and driving growth and have sustained momentum across our business and our outlook is also strong and we are on track to deliver another year of double digit revenue growth, including meaningful acceleration during the second half.
During the second quarter, we achieved 13% revenue growth, including total omnipod growth of 16%.
Our results met our expectations, despite a headwind from higher than anticipated rebate adjustments and the U S pharmacy channel.
Absent. These we drove revenue results both in terms of volume growth and mixed benefit that exceeded our expectations.
We also achieved another quarterly record of U S and global Omnipod, new customer starts, which gives us great confidence and enthusiasm for insulet as future.
While our team remains squarely focused on Omnipod 5 clearance efforts, we made terrific progress across each of our strategic imperatives.
And we expanded coverage and volume growth of Omnipod dash and the pharmacy drove continued adoption and the type 2 market, where we are uniquely positioned.
Once again drove strong MDI conversions and presented compelling clinical data at the HGTV and conferences.
These accomplishments demonstrate both the success, we're having unlocking the type 2 market with our innovative product and business model.
And the acceleration, we expect and the type 1 market with the launch of Omnipod 5.
We have delivered consistently strong performance and these critical areas without and automated insulin delivery system in the market, which speaks to the power of Omnipod. The unique advantages of our pay as you go business model and the differentiated customer experience we provide.
Regarding our Omnipod 5 Aig's systems, we are in the final stages of the FDA review process and are incredibly appreciative of the agency's diligence and collaboration particularly given the pandemic workload.
While we continue to expect FDA clearance and limited market release, and the second half of 2021, we believe Q3 clearances unlikely and now estimate that both will happen later in the fourth quarter. We remain incredibly excited about what omnipod 5 will offer the diabetes community.
Our market position, which is already strong will be greatly enhanced by the introduction of Omnipod..5 we are well prepared and have invested in our sales teams and expanded our manufacturing capacity and made great progress securing payer support our efforts in these areas will continue as we work through the.
The final stages of the clearance process, we are confident and a successful launch of Omnipod, 5 and I will share more on that and a few minutes.
And now speak to each of our strategic imperatives, including expanding access and awareness delivering consumer focused innovation growing our global addressable market and driving operational excellence.
Beginning with access and awareness of the global diabetes market is growing rapidly with millions of people expect it to be newly diagnosed this year alone and rapid adoption of CGM among people living with type 1 diabetes and more recently type 2 diabetes.
Despite such a large and fast growing market. It remains critically underserved and awareness of and access to technology remained far too low.
We continue to expand access and utilization through the pharmacy, which provides a better customer experience a more efficient channel for physicians and for Insulet.
And the second quarter, we grew Omnipod Dash U S covered lives to approximately 80% a sizable sequential increase this drove a notable increase of U S volume through the pharmacy and Q2.
Omnipod Dash continues to be our primary growth driver with the majority of our new customers across the globe starting on the system.
Approximately 80% of our U S. New customer starts are consistently driven by MDI conversions and the percentage of our U S. New customers that were type 2 during the second quarter remained strong at 35% to 40%, even with the record setting growth and new customer starts.
And the type 1 segment historically large numbers of MDI users are adopting technology, which gives us continued confidence that AIG will drive a doubling of the pump market and the coming years. We are pleased with our current growth and type 1 which is a testament to omnipod differentiation and as we look ahead.
And the 2 Omnipod 5 we expect to be extremely well positioned to accelerate growth and this segment.
We are also successfully driving adoption among type 2 users a large market segment that has tremendous long term growth potential, particularly of CGI and becomes more widely adopted we are learning that omnipod is uniquely well suited for type 2 users.
Because the awareness of Omnipod remains low we are investing to raise awareness across the globe. We are advancing our direct to consumer advertising advertising campaign and the U S as well as our pilot program in Europe, primarily in the United Kingdom.
All of our DTC efforts remain in early stages. The response has been encouraging and all markets, where we've tested it and we believe DTC is a contributing factor that helped to drive record U S and global new customer starts this past quarter.
Our growth is also supported by our superior technology robust innovation pipeline and expanding clinical evidence that shows how life changing omnipod can be for people living with diabetes.
The tube free Omnipod experience is unique and we know from our clinical trial participants that omnipod 5 will be a transformative product for insulet and for the diabetes community, we cannot wait to bring it to market we.
We are making good progress in this regard and our recent interactions with the FDA and continue to give us confidence and a second half limited market release, a third quarter FDA clearances unlikely. So we now estimate clearance will be later in the fourth quarter.
Through our ongoing collaborations as part of the breakthrough devices program. Among other things. The FDA has provided clarity on open questions related to full of smart phone control.
Based on their feedback we are updating our smartphone app to add a product feature and we are working through the final steps towards clearance. This work is well underway and gives us confidence and our expected clearance timing.
Insulet is a pioneer in this space with full phone control and we're grateful for the agency's support and guidance and delighted to be close to clearance achieving full smartphone control is a complex and novel innovation that we know will be enthusiastically welcomed by our customers. We are committed to providing the best path.
<unk> user experience and getting omnipod 5 to market as quickly as possible.
While we work through to clearance. Our teams are successfully securing pharmacy coverage for Omnipod 5 testing all elements of our customer experience and preparing for a successful limited market release.
No other product on the market delivers the value technology and functionality of Omnipod 5 we believe it will significantly change the lives of people with diabetes and their caregivers through unparalleled ease of use better quality of life and improved outcomes.
From a commercial perspective, we previously communicated the core components of our pricing and access strategies and.
And the U S. Omnipod 5 will be available only through the pharmacy and it will be priced at parity with Omnipod dash.
We will continue to provide no upfront costs and no long term market and period. In addition, any customer whether and MDI or tooth pump user will be able to try omnipod 5 for free at any time through our 30 days of Freedom program, which has already helped to fuel increased omnipod adoption.
Given this approach we expect the lower monthly out of pocket costs for Omnipod, 5 will be comparable to Omnipod dash and MDI, which we believe has a tremendous value given the improved outcomes and quality of life Omnipod 5 delivers the.
The majority of our Omnipod dash customers in the US have a monthly pharmacy co pay of under $50 and we are thrilled to offer the same benefit to our omnipod 5 customers.
We have already contracted more coverage for Omnipod..5 then what Omnipod dash had after commercial launch and setting us up for a successful limited market release.
The value Omnipod <unk> can deliver to people with diabetes is clear as demonstrated by the compelling clinical data. We recently shared at major diabetes conferences, including Omnipod 5 preschool pivotal and pivotal extension results and our non AIB system data.
We are proud of all of the impressive omnipod data our omnipod 5 preschool pivotal data certainly stands out our study represented the largest dataset of primary outcomes for any AIB system down to <unk>.
The results were compelling and included a statistically significant overall <unk> reduction a significant increase and time and range and no severe adverse events, 100% of the preschool participants moved into the extension phase, which shows these families did not want to give up their systems.
And there's clearly speaks to the tremendous value children and their parents experience on Omnipod 5.
The results mirrored omnipod 5 strong performance across other age groups, including up to age 70, and this is quite an accomplishment as many experts agree the pediatric age group as the most challenging for clinical care.
The results also demonstrated a significant improvement and sleep for caregivers of very common concern for concerned parents.
We are so pleased to see these young children greatly benefit from our technology. They are often unable to verbalize, how they're feeling and are too young to manage this complicated disease on their own. We believe omnipod 5 will greatly ease the burden of diabetes for these vulnerable children and their caregivers.
Another major highlight of our pivotal extension was the further reduction in <unk> levels, because they already were significantly reduced during the first pivotal phase to see a greater reduction speaks to the durable power of Omnipod 5 to transform diabetes management.
While we are proud of all of our clinical results. There is much more to do and we will continue to invest and our clinical roadmap, including expanding omnipod fives indication down to HQ and for type 2.
Our preschool internal clinical efforts are advancing well yet our FDA submission is contingent upon the timing of Omnipod 5 clearance. We are now planning for this expanded indication in 2022.
Additionally, our type 2 feasibility study is advancing we recently concluded the 3 month study period and are now in the extension phase we expect to share the results of our type 2 study at an upcoming conference.
Finally, while the upcoming clearance and launch of Omnipod 5 remain our top priorities. Our pipeline is robust and we believe some of our best innovations are yet to come.
As such investing and our software development data science and other capabilities remain a critical priority.
Our development work is well underway, including iOS and Libre integrations and the international launch of Omnipod, 5 and database innovations aimed at providing insights for our customers.
Beyond Omnipod 5 we are developing technologies that we believe will simplify and improve the lives of people living with both type 1 and type 2 diabetes.
Turning to global expansion, we have spent the last few years working to expand awareness and access to omnipod across our key international markets. Our latest efforts have been in Australia, where we continue to plan for and Omnipod Dash launched this year.
This builds upon our expansion into Turkey earlier, this year and across Europe, and the middle East last year.
We expect our international expansion efforts will drive access to a huge global addressable market far beyond the estimated 11 to 12 million people living with insulin dependent diabetes across our current global footprint.
As we look ahead, we know there are additional opportunities to further expand our addressable market and to help improve the lives of people living with diabetes around the world. We continue to drive strong growth and our international markets with the recent full launch of Omnipod Dash and we fully expect to bring Omnipod 5 to these markets and the few.
<unk>.
Lastly, we continue to invest significantly to further strengthen and scale our global manufacturing operations. We are in a strong position to meet growing global demand for Omnipod dash supports the upcoming U S release of Omnipod, 5 and scale our operations to support our future innovation pipe.
Blind and geographic expansion initiatives, we've made terrific strides on our path to build on our operational excellence, which we believe to be a critical enabler of sustainable revenue growth and margin expansion in the years ahead.
In closing we are on track to deliver another strong year of financial results and strategic progress and we are gearing up for the upcoming launch of Omnipod 5 our mission to improve the lives of people with diabetes has never been more important and our innovative solutions have never been more needed I'll now turn the call over to Wade.
Thanks Rich.
We achieved another solid quarter of financial results with building momentum from record global New customer starts and are on track to drive accelerated revenue growth and the second half of the year.
To support our accelerated growth, we continue to invest and our strategic imperatives through innovation clinical and commercial manufacturing and other supporting functions the position us for sustainable long term global growth, we generated 13% revenue growth and the second quarter, finishing within our <unk>.
<unk> range, driven by total omnipod growth of 16%.
As expected the pandemic the effect on 2020 global new customer starts impacted results again in Q2, given the annuity nature of our revenue model, although the impact of the pandemic headwind continues to linger and the United States and it's still more challenged and some of our international markets. We expect the major <unk>.
Impact is largely behind us.
In Q2, we delivered us omnipod revenue growth of 17%, which was at the low end of our expectations due to the higher than expected rebates from 1 of our largest pharmacy partners of approximately $4 million.
Approximately half of the adjustment related to a rebate catch up from prior to Q2.
As a reminder, Q2 also had a tough comparison with approximately $4 million to $5 million of channel build and the prior year.
During the second quarter, we continued to build our customer base with record U S. New customer starts ongoing omnipod dash adoption with both type 1 and type 2 customers.
And the mix benefit we realize as we drive increased volume through the pharmacy channel.
These growth drivers continued to trend upward and Q2 as Omnipod dash drove almost 80% of our U S. New customer starts and we grew pharmacy channel volume to over 45% of our total U S volume.
And Q2 International Omnipod revenue grew 13%, which which finished slightly ahead of our expectations.
Our growth and the quarter was driven by our success with Omnipod dash and expanding our customer base throughout our markets as well as the team's ability to successfully execute through continued COVID-19 challenges.
Our global attrition and utilization remained stable during Q2.
The drug delivery revenue declined 13% during the second quarter, finishing slightly ahead of our expectations. As a reminder, order volumes were elevated and the prior year as a result of the pandemic and are normalizing this year as expected.
Gross margin was 69, 4% and the second quarter, representing a 640 basis point increase or a 510 basis point increase on a constant currency basis. This expansion was in line with our expectations and marks our highest gross margin reported to date.
Overall, our gross margin expansion continues to be driven by our improved manufacturing operations and supply chain efficiencies and lower COVID-19 related costs and.
And the mix benefit of increasing volumes and the U S pharmacy channel.
These benefits were partially offset by the expected higher mix of costs as we continue to ramp us manufacturing and.
Including our third highly automated U S loan, which is now producing sellable product.
Operating expenses were in line with expectations as we continue to invest and our robust innovation and clinical pipelines and the upcoming launch of only 5.5 and other commercial investments, including our global direct to consumer advertising initiatives and our international expansion plans and operating margin was 10 per.
<unk> down 220 basis points and adjusted EBITDA margin was 19, 9% up 40 basis points. Our operating income was in line with our expectations as we continue to invest throughout our global business to fuel our long term growth trajectory.
Turning to cash and liquidity, we remain and a strong position with no near term maturities and further runway to continue to invest and our business.
We ended the quarter with $872 million and cash and short term investments.
We have also taken a number of steps to strengthen our capital structure, including successfully executing a $500 million term loan b financing.
And we used the proceeds to repurchase 92% of our convertible notes due 2024, which resulted in a $40 million loss on extinguishment debt is excluded from adjusted EBITDA.
Additional notes for since converted and now approximately 3% of the original issuance remains outstanding.
Following these transactions on an annual basis, we expect our net cash interest expense will be approximately $30 million and noncash interest expense will be significantly reduced to approximately $25 million to $30 million.
Now turning to our outlook for the remainder of the year, we are maintaining our full year revenue guidance of 16% to 20%, including total omnipod revenue growth of 18% to 21%.
We continue to expect a full year U S. Omnipod revenue growth range of 22% to 25%, we expect our growth to be driven primarily by expanding omnipod dash volume increased access and awareness of our differentiated pay as you go model and the mixed benefit and the pharmacy channel and edition.
We expect further penetration and customer adoption and both the type 1 and type 2 markets.
Offsetting these tailwind or less omnipod 5 incremental revenue than we had previously anticipated and the Q2 rebate adjustment.
For International Omnipod, we continue to expect full year 2021 revenue growth and a range of 11% to 15%.
Omnipod dash adoption rates continue to grow following its launch near the end of last year.
Despite the lingering impact of COVID-19 across several of our markets. During the first half of 2021, our team of successfully driven additional market penetration and strong new customer growth the runway to expand omnipod adoption across our international markets is large and we see clear pathways for future growth.
As a reminder, we had a tough comp due to the $8 million to $9 million of pandemic related inventory, we experienced in the prior year as well as from our initial launch of Omnipod dash.
Lastly, we are maintaining our expectations for drug delivery revenue and a range of 11% decrease to a 4% increase.
Turning to gross margin, we now expect full year gross margin to be and the range of 68% to 69%. The core drivers of our gross margin expansion have not changed as we build scale and create efficiencies throughout our global manufacturing operations as well as the ongoing benefits of volume shift into the <unk>.
U S pharmacy channel.
In addition, we expect to benefit from lower Covid related costs.
We continue to expect operating expenses will largely rise in line with revenue growth. This year, we view the investments and consumer focused innovation and our sales and marketing teams and our international expansion efforts as critical to our long term growth profile, we are reaffirming full year operating margin and the low double digit free.
Our operating margin expansion will be driven by our strong topline growth and gross margin improvements as well as our expectation that the onetime costs that occurred in the fourth quarter of last year will not recur this year.
On a sequential basis, we expect operating margin improvements throughout the second half of this year, primarily due to our expected accelerated revenue growth.
We continue to expect capital expenditures to increase this year with the investments throughout our global manufacturing and operations as well as our strategic initiatives.
Turning to our third quarter 2021 guidance, we expect total company revenue growth of 11% to 18%. This includes total omnipod revenue growth of 17% to 23%.
And we expect Q3 U S omnipod revenue growth of 23% to 28% as a reminder, Q3 growth also benefits from the net impact of estimated distributor channel Destocking last year, the significant step up and our sequential growth rate is primarily due to the impact of channel.
Stocking and Destocking and the prior year volume ramp from our accumulating record setting new customer start quarters annualized and the most impactful of COVID-19 related quarters from 2020 and to a lesser degree the mix benefit from volume through the pharmacy channel.
We expect Q3 international Omnipod revenue growth of 8% to 14%.
We continue to expect our growth rate to be partially offset by the trailing pandemic related headwinds that existed in the second half of 2020 and the first half of this year and many of our international markets also as a reminder, Q3 growth is impacted by the estimated for 2.5 million distributor.
For channel stocking, we experienced in the third quarter of last year ahead of the international full market release of Omnipod Dash.
We expect drug delivery revenue declined 40% to 28% due to the normalization of order volumes as compared to elevated levels and the prior year, resulting from the pandemic.
In conclusion, we of sustained momentum throughout the business and are on track to deliver another year of strong revenue growth and margin expansion, while advancing our strategic imperatives, our financial position is sound and provides us the flexibility to invest and our leading innovation pipeline and.
Access and awareness initiatives global sales force international expansion and manufacturing efficiencies.
All of these efforts are designed to drive significant shareholder value over the long term and strengthen our ability to improve the lives of people with diabetes across the globe.
With that I will turn the call over to the operator for questions.
Thank you Sir.
And if you have a question and at this time. Please press the star key and the 1 key on your Touchtone telephone and.
And for your question has been answered of your wisdom of yourself from the queue. Please press the pound key.
We are limiting each participants questions to 1 however, please feel free to go back into the queue and as time permits we'll be more than happy to take your follow up questions at that time.
Our first question comes from the line of Travis Steed from Barclays. Please go ahead.
Hi.
Thanks for the questions.
And this part of the prepared remarks, I apologize, but I didn't want to get more color on the Omnipod pods, Bob delay and just to make sure I understand all of the moving parts, there and what exactly happened and what gives you confidence that youre going to have the approval by Q4.
Share of Travis.
Appreciate the question I think may be helpful to take a step back to where we were in May we had received the the agency's feedback on our submission and there were no surprises, which had put us on track for our anticipated timeline. We are very fortunate to be of part of the breakthrough devices program.
And that allows us frequent collaboration with the agency. So we took the opportunity to discuss in more detail for mobile phone control and get extreme clarity on the Fda's response.
And their feedback was really helpful for us and valuable and it prompted us to update our app with a feature that we believe will improve the the customer experience. So that is basically what's happened since may and the work is well underway, including all of our verification and validation testing and then our.
And of that final work and the Fda's review.
And then of course and buffer because time times are not normal given the COVID-19 workload that all puts us.
Towards a Q4, we believe late in Q4, our clearance and limited market release. So that's kind of where we are I would just emphasize that in the meantime, we are not standing still of the teams are doing great work preparing for a limited market release and.
And I think making really good use of the time that we have while we get to final clearance.
Thank you I'll share our next.
Next question comes from the line of Larry <unk> from Wells Fargo. Please go ahead.
Good afternoon. Thanks.
Taking the question I guess, if I'm going to use my 1 question on the auto.
The pipe Bob I'll ask what is the final feature.
<unk> and <unk> and I guess.
When do you plan to submit that.
The FDA and just given the delays there what gives you confidence and what's the buffer that you incorporate it to get to that late Q4 clearance and thanks for taking the question sure. Yes. Thanks, Larry the feature is related to full of smartphone control. So it's the way that the app interact with the system. It has nothing to do with our.
Our core system or our algorithm, which we know delivered outstanding clinical results.
Ross the broadest age range of any AIG pivotal study so nothing that will impact us system functionality, but it is something that we believe will deliver a better customer experience.
And I think ultimately the feedback was helpful for us what gives us confidence when we think about the limited market release in Q4 is our interactions with the agency we've factored in all of the work that we have underway.
Plus review time and plus the buffer.
And I don't think its helpful to provide exactly the amount of buffer, but what I will say is we've learned a lot because we've been under review for quite some time all out while the pandemic has been underway as well. So we do understand how long the back and forth has been taking how much longer that's been traditional timelines and that's what we factored in that points of.
As to Q4 and.
So I think it's really those those interactions that give us that confidence.
And.
We have cleared and enormous amount of hurdles.
Up until this time, we really believe we are and the final stages here and remain confident and a second half, but likely like we said end of Q4 limited market release and and.
Clarence.
Thank you I show. Our next question comes from the line of Robbie Marcus from Jpmorgan. Please go ahead.
Great. Thanks.
2 from me and I'll ask them both upfront.
1 on the pharmacy rebate I was hoping you could just go into a little more detail of exactly what that was and how it works was that did you over earn from this.
From this payer and now Youre rebating it back us at 1 time, how do we think about that any further impacts you expect going forward.
And then second on the US the results are obviously better when you put the rebate back in but it would be great to hear what you're seeing out in the field do you think people are holding back on starting omnipod as they're waiting for Omnipod 5 I'm sure they hear it and the news.
Just thinking about how it's impacting the field if at all thanks.
Sure. If you want I can start though on <unk> on the rebate question and glad you brought it up Ravi because it gives us an opportunity to share a little bit more color around it. It is due to an updated rebate information from 1 of our largest pharmacy partners. So as we mentioned in the prepared remarks that per.
Partially related to prior to Q2, and it's the year to date catch up and the result changed our rebased expectations as well so our pharmacy partners have several quarters and arrears to correct. The rebate submissions and we have a wide range of rebate percentage programs and as we.
The cute our strategy and ramp of our business and the pharmacy.
So we anticipate variability and the rebates. However, this 1 was much larger than expected.
It's really of growing pain for both of us.
It's new for us and it's new for our pharmacy partners. So as they've set up our agreements and process for rebates for US. This will settle down over time once we get a majority of our business and the pharmacy and get more established I don't think we will see this type of variability.
Going forward, although the net rebate this quarter ends up much higher than expected it doesn't change our strategy and the pharmacy. It is of significant differentiation for us and better for our customers. So as the pharmacy channel becomes a larger portion of our revenue rebates will be 1 of the metrics that could impact our results going forward and we do.
Given the rebate percentage difference there see some variability.
In relation to guidance and as a metric that we factor into both the high end and the low and great.
Great. Thanks, Duane, Yes, I think it's important to emphasize that pharmacy is of strategic pillar for us and for all of I think Wade mentioned the reason, obviously, it's a better customer experience, but it's also a more efficient channel for physicians and for Insulet and Thats really important as we are.
As we get ready to scale with the launch of Omnipod 5 and then your question Robby and what are we hearing and the field and the 1 thing I would say is behind the numbers, it's just too important and sometimes it gets losses because of the business model, but behind the numbers, we had a record new patient start quarter, so and that's important.
And as we think about are people holding off it certainly would not be evident and our numbers based on new and new customer starts in this past quarter and.
And that said Youre right that there is growing consumer awareness of Omnipod 5 of the company and I personally get daily emails from <unk>.
Customers that are anxiously awaiting so I don't I don't believe customers are holding off based on the new customer starts numbers, but there is growing awareness of the technology that's coming.
Thank you I show. Our next question comes from the line of Danielle and Tav and power.
Free from S F.
<unk> Leerink. Please go ahead.
Hey, good afternoon, everyone. Thanks, so much for taking the question and I don't know if this is for weighted or <unk> or maybe both of you, but I guess with the.
With the approval for Omnipod size now coming later this year.
And to pre today was looking at like 20% growth and 2022, so slight acceleration of Youre looking at the mid point of the range I mean, youre talking about still a limited market release for Omnipod 5 I'd just be curious what you can say about how the change and the timeline for Omnipod 5 might impact the outlook for 2022.
2 if at all.
And how that accelerating growth via the consensus numbers again pre today.
And how achievable that might be thanks, so much.
Yes, Thanks, Danielle I'll, maybe I'll kick us off and then Wayne can give some comments on any color you want us to give regarding 2022 with omnipod 5.
Ultimately, we know that the the market is waiting for Omnipod volume. So we're going to do whatever we can to make our limited market releases efficient as possible.
It's important to do a limited market release, if you think about what's going to happen with Omnipod 5 we know that and people today, who use dash or classic omnipod or multiple daily injections or tube pumps and.
And there they are all going to have a different customer journey coming onto the omnipod 5 they are each different pathways and we will have different requirements. For example, all of our dash customers already know the benefits of pharmacy and low out of pocket costs.
And we're going to have to get to the pump users are potentially MDI users comfortable with the benefits of the pharmacy and then each of those different patient segments have different <unk>.
And training and Onboarding needs and so those are the types of customer experiences that we're testing today to make sure that we've got everything in and of great position for the launch and then the other governor US access and it's 1 of the reasons why we gave some color that the team is making great progress establishing access so and we are doing everything that we can.
And to make as efficient and <unk>.
LMR as possible, but we do want to do 1.
And hopefully.
Well not hopefully today for sure we are and a better position today and then we were a quarter ago and a quarter from now we're going to be and an even stronger position. So I think we're going to head into 2022 and.
And a really strong position and hopefully keep the RMR as efficient as possible.
Yeah, and just picking up on the guidance part of the question there Danielle we aren't guiding to 2022 yet.
And certainly appreciate the question and we can provide some color on how we're thinking about the us guidance for 'twenty 2 at this point in time of <unk>.
'twenty 2 is going to be a strong year for us and we will include the ramp of Omnipod 5 in 2022, however, as you're asking about here and as Tracey said in our prepared remarks that with the LMR and now starting most likely at the end of Q4 that we would expect that some portion of the LMR will extend the.
The 2022 with full market release coming sometime later in 2022, and so we won't likely get a full year of full market release in 2022 at this point, but it is going to be of very strong year for us and so we're not going to comment specifically on guidance numbers of ranges at this point a couple of the things to think about.
The pandemic has always of consideration and given our annuity model and the persistence of the pandemic here into 2021, and it will be somewhat of a headwind for us and 2022, but we've got a ways to go here throughout the rest of the 'twenty, 1 and we'll see what the dealt the variance and how.
Warnings and some countries and some of the challenges that are coming out impact us, but I don't think were going to be free and clear of but yet and 2022, but let's see how things progress through the rest of 2021, and then as usual, we'll give our guidance and the Q1 call. We do have other tailwind and growth drivers that are <unk>.
Accelerating here into the second half and that momentum will carry into 2022 further dash penetration of the type 1.
And tied to customer adoption really being aided by CGM. So we're riding that wave as well, we're continuing to expand and the pharmacy with our pay as you go model our direct to consumer program. So lot of momentum and the business quite of few tailwind of couple of headwinds that we're monitoring and.
That's some color for you we will get into the 2022 guidance on our on our Q1 call.
Thank you.
Our next question comes from the line of Jeff Johnson from Baird. Please go ahead.
Hey, Thank you. Good afternoon, guys, let me just wait or safety I guess, either 1 follow up on and on Daniel's question, there and ask it and maybe a slightly different way when we thought omnipod <unk> was coming maybe mid year or so it was kind of a 6 month limited market release, but JC to your point of lot of that I think was getting commercial coverage in place and it sounds like Youre, making.
Good progress there is it fair to think about that LMR, then could be cut in half, but think about it as 1 quarter and then moving by second quarter into it.
And to the full market release, and and Wade I know respect that youre, not giving 'twenty 2 guidance, but.
Feels like there should be some shortening of that LMR schedules given the commercial coverage of already established thanks.
Thanks, Jeff we are going to do everything we can to drive as efficient and a limited market release as possible I think just something to keep in mind is <unk>.
<unk> market releases are designed to uncover things that weren't contemplated and all of the testing and launch preparation. So yes, I think that's the caution of course, we are in a stronger position. We're securing coverage I think all of this sets us up for success and in trying to add.
Shortened and the limited market release, but I would caution everybody by saying, if we bump into something we're going to address that thats. The whole purpose of doing a limited market release I think the teams are doing great work and certainly.
Meliorate and the potential of running interesting thing with all of the work that we're doing and we are certainly establishing access which is 1 of the main governors and so those are great signs.
But I don't of course, we're going to take our learnings from the limited market release, and we're going to make sure of that we're providing the best possible customer experience.
Thank you I saw the next question comes from the line of Matthew O'brien from Piper Sandler. Please go ahead.
Good afternoon, and thanks for taking the question.
And everybody is focused on the 5 flipped.
Olympics here, but I'm curious about the core business and to your point, So you see that.
The growth of new patients was the record that you saw can you talk a little bit more about some of that and the dynamics there that are driving new.
Patient additions so much higher of its type twos, if the pediatrics.
And just talk about some of those dynamics and how those might maybe augmented once you do get the 5 on the market Marcel and next year. Thank you.
Yes, Matt Thanks for the question and actually I think it's really exciting to see what's happening with the core business right now and.
What's driving our growth I would point to 2 well 3 dynamics and the first is DTC. So this investment that we're making in raising awareness is definitely working and we think was 1 of the drivers for our record by quite a bit in the us and new patient starts and thats coming broadly across.
The type 1 primarily among multiple daily injection users and then also type 2 and so it takes you would be the second dynamic that I would point to we are in a pretty rarified position here and nobody else is having the success that we're having unlocking this market opportunity and it's because we have of product that is uniquely well suited.
2 the type 2 user and.
And its simplicity and its cost profile and so that's the third piece is the pharmacy and pay as you go and Thats, helping us certainly to make our technology more accessible and more affordable to the people that are becoming increasingly aware of it and the reason why we like these dynamics.
The underlying dynamics is because when we launch omnipod 5 it will be additive to these things.
We fully intend to maintain our advantage and type 2.
We fully intend to maintain our advantage and the pharmacy and our pay as you go model and we're going to then deliver what we think will be of game changing technology and omnipod 5 to the market and so the team could not be more excited because we've got this underlying momentum.
And that's being.
That is helping to deliver record setting new patient starts and and of course, we're all gearing up every aspect of the company right now is gearing up for and Omnipod 5 launch and just incredibly excited about what it will bring to patients so and so I.
I think it's an exciting additive technology to what is already a really strong momentum and our business, particularly in the us.
Thank you.
Our next question comes from the line of Margaret category from William Blair. Please go ahead.
Hi, everyone. Thanks for taking my questions.
And I wanted to focus and the pharmacy channel and kind of that increase and adoption this quarter and it does seem like it did pop up certainly for new patient starts.
And perhaps for active users as well so was there something different that you get.
We are doing to drive that uptake is the DTC and.
As we look a year from now where should we see that active base or is it just going to be a little bit more pre determined on the launch and timing of both of us.
Yes, a great question Margaret So theres, a few things happening 1 we continue to kick up access and that increased notably and as we increase access and then more people in our base have the opportunity to move into the pharmacy. So that's 1 piece of it and the second is DTC is definitely driving demand and if you think about.
And our Wade mentioned at cumulative record setting quarter for 3 quarters, where we've got in our new customer starts I think on each of those quarters between 70, and 80% of customers going directly into the pharmacy are directly onto dash. The vast majority of that in the pharmacy. So that trend is just helping to drive more and more people into the farm.
And.
And I think in terms of where does this go we fully expect to have the majority or vast majority of our business in the pharmacy over the coming years, we do see omnipod 5 as the big driver of their Omnipod 5 will be only available in the pharmacy and we know that there is growing demand among our existing users and also among the market.
And so and that will help us to continue to accelerate that move into the pharmacy and I would also point to type 2 all of our Medicare business as 3 of the pharmacy, So as type 2 growth and.
That is growing and the pharmacy and that's a great thing and what pharmacy does by providing us.
Omnipod at the same out of pocket cost us multiple daily injection, it's really remarkable for dash today, and it's going to be even more remarkable for omnipod 5 tomorrow. So just really.
Really great cost effective therapy for our patients.
Thank you.
I share. Our next question comes from the line of Jayson Bedford from Raymond James. Please go ahead.
Cool.
Excuse me and good afternoon kind.
And then going in and out so hopefully the question isn't repetitive, but just.
On access you mentioned that you're progressing on your contracting efforts with Omnipod and.
Any way you can frame, where you are with contracting and does this make the launch less limited if you will.
Yes, Jason Great question and so.
So rather than giving details of it just kind of conceptually where we are with access we have more.
Access established more covered lives today with Omnipod 5 pre.
Preceding launch than we did following launch with Omnipod dash, so that puts us I think and a really strong position and a really nice trajectory as we get closer to launch and <unk>.
Every quarter, we establish more access for Omnipod 5 so as we get closer to launch and we're certainly not standing still that the teams are making great use of this time and I think to your point that sets us up for a successful and what we certainly hope is a very efficient limited market release, because we knew that there are 2 primary governors to limited mark.
Release, 1 us access and and as you note. The team is making great progress there the other us customer experience and Thats. The 1 where we can't really sort of say how quick that's going to be until we get into the throes of it and then the team is doing a really nice job testing all of the different pathways and testing the training and Onboarding.
The <unk> testing the benefits investigation all of that stuff, but that's the type of thing that you really need.
<unk> patients going through the process to test effectively but that will be I think the primary governor as we look to move from limited market release into full market release, given how well we're doing with access.
Thank you I show. Our next question comes from the line of Kyle Rose from Canaccord. Please go ahead.
Great. Thank you for taking the question I wanted to ask just maybe a bit of a bigger picture question and you see this is and the second and third time on these calls you talked about investments youre, making and software.
Traditionally we've become more accustomed to.
<unk> and med tech being more focused on tangible things like widgets and insulin pumps and you can touch maybe help us understand how you think about maybe not necessarily with the <unk>, but maybe the next generation of products that are going and maybe more software focused and just of how that might change the patient and the physician experience of the technology and the value of Youre, providing yes.
Yes, hi, and thank you for the question and I think and great.
Opportunity to just talk about.
The position that we see ourselves and as it relates to patient data.
And very few.
Companies have access to the volume of data that and set will have with Omnipod 5.
We had mentioned earlier on the previous call that we're putting Sim cards into our Omnipod 5.
Controllers, and then of course, we'll be offering full of phone control, which means that we will have a stream of real time data coming off of the user that helps us understand how their continuous glucose is doing helps us understand how theyre interacting with the system helps us understand how much insulin is being delivered when it's the.
And suspended and when they're eating and so that provides us with incredible potential to generate insights that can be valuable to our customers to their clinicians and potentially to payers as well in population of analytics and so we see ourselves of just really well positioned.
Because it's essentially of wearable technology, that's providing real time data.
That we believe can help us help people achieve better outcomes through a variety of mechanisms. So I think you'll you'll hear us talk more about that as we get omnipod 5 to market and how we see that and our role in that for our customers, including our consumers our clinicians and our payers.
But we do believe we're very well positioned.
To provide value here.
Thank you.
I show. Our next question comes from the line of Joanne Wuensch from Citi. Please go ahead.
Oh, good afternoon, and thank you for taking the question I think 1 of the things that I'm hearing and the pattern of the questions Tonight of is there a positive thing and that comes out of this delay does it mean you need to have a shorter limited launch does it maybe accelerate your type 2 label or your product with the Abbott Libre and is there any way to address.
Or is just everything is pushed back call it 6 months.
And so and I think the positive thing that comes out of this is that the FDA has given us really valuable helpful. Feedback that we think will ultimately enable us to deliver a product that is even better.
But and I also believe that the limited market release will be shorter as a result of this time that we've had to establish coverage. So that is good how much shorter and that will rely on us really testing the customer experience and understanding of we've got learnings there that needs to be incorporated or adjusted too but.
The value that we have.
Being able to have during this time is just the the the opportunity to establish coverage and continue to test the customer experience both of those things should help us to deliver a more efficient limited market release.
Thank you.
I show. Our next question comes from the line of Anthony Petrone from Jefferies. Please go ahead.
Thanks Hope everyone's doing well a question on just collaborations behind the scenes on.
Omnipod 5 with <unk> com.
Some bullish language on the earnings call and.
In the past couple of days. So I'm just wondering what level of collaboration is going on behind the scenes ahead of launch later this year that would be the first question and then the follow up question would just be maybe a longer term sort of opinion and view on the automated insulin delivery space, how you see and evolving next 2 to 3.
Years, when you consider that we now have multiple offerings, either on market or coming to market imminently.
Thanks, Anthony and the Exxon has been an outstanding partner and it has been remarkable to see what the.
And have done in the market and the value that they provided consumers and.
We really believe that they are helping to drive.
The adoption and so we could not be more excited for our combination offering they have helped us across a number of fronts and collaboration has been incredibly strong and obviously they have and incredible technology and so that combined with Omnipod and Omnipod..5 we think is going to be a game changer in the market it will be a game changer.
In terms of patient experience and patient outcomes and it will be a game changer in the market in terms of our.
Our position so we were.
Strong collaborator of strong partners today, and then of course working on G 7 and future integration and so that would be a really exciting part of our pipeline as well in terms of the AIG E market.
And I think it's very exciting to see what's occurring out there.
And we see the trend in terms of CGM adoption among type ones and what's happening now with AIG.
US great confidence that among type 1 users the pump market will double and a big part of that will be automated insulin delivery of course, we believe we're going to deliver the best market and are the best product to market and I think the thing that gives us excitement is that we have been competing so effectively with our non AI.
The system and so people are choosing omnipod, even though there is no CGM integration and despite the fact that we've seen such dramatic uptake in CGM. So we think that we're going to see the real power of the form factor now that we've got CGM integration and automated insulin delivery with Omnipod 5 and.
Because people will no longer really have a reason to choose and alternative device, which we know many people.
The preferred the pod form factor, but she was another system because of debt com integration and so we're really excited to.
Even the playing around there and really frankly leapfrog the.
And the field there and then the other thing I would point to US just type 2 all of these trends are more mature and type 1 and I talk sometimes about the competitive field, but I would say that among this large patient population and no 1 really needs to lose for us to win there. If you look at the field, even and type 1 where there is more maturity here still today.
Somewhere north of a third of patients are using pump therapy. So there's a great opportunity for all of us to impact patient outcomes and provide better technology better care for people living with type 1 diabetes. The same trends are just burgeoning among type 2 and so we're really excited about our position there and we expect that both.
CGM and <unk>.
Certainly omnipod 5 and integrated devices are going to grow among type 2 users to over the coming years.
Thank you.
Our next question comes from the line of Ravi Misra from Barrett and Berg and please go ahead.
Alright, thanks for taking the question that evening.
Just kind of maybe jumping on that last question a little bit more big picture, you said earlier potential doubling of the pump market and I'm just curious.
Theres a lot of things going on here with access and the new technologies and telemedicine debt that can kind of support that debt.
And kind of statement.
What do you think is out if.
If I can kind of put it philosophically just curious what do you think still needs work on in terms of getting us from that 35% to 40% today to maybe significant majority of insulin delivery through pumps.
Not in existence, right now, but something that these and your control. Thanks.
Ravi I think you highlighted quite a few of them when you talk about new technology and access.
I'd say and for both of those is just how simple can we make both of those how simple. It can we make the technology. So that it can be easily and enthusiastically adopted by the masses and how simple can we make access because still today.
Omnipod has changed the game with pay as you go and the pharmacy and we've made it simpler but still today theres too many hurdles for people to get onto these technologies and Thats something we are committed to continuing to work to eliminate.
I would point of simplicity and technology simplicity and access and the last thing I would point to us awareness and we're really seeing it with DTC, we're investing in.
And in awareness and trial.
We're probably making a big impact and the market and helping everybody.
At the end of the day, because we're increasing patient awareness to technology, but what we saw before we invested and DTC was that.
The patients awareness even of type 2 consumers awareness of their options unaided awareness was somewhere around 15%, so even a person with type 1.
Could only.
The name a pump manufacturer of 15% of the time. So there is a massive opportunity here to just help people understand and gain more awareness to the treatment options that are available to them and then we need to make them cost effective and simple to access and to us.
Thank you.
I saw the next question comes from the line of Steve Lichtman from Oppenheimer. Please go ahead.
Thank you.
I was wondering if you could talk about international what are the.
The biggest incremental drivers we should be focused on for you guys internationally over the next day 6 to 12 months of it.
Whether it's in terms of new countries or.
Particular countries, where cash has recently launched and and anything you can talk about relative to potential timing of omnipod 5 outside of the us.
Yep Thanks, Steve.
When we think about international and the drivers there dash and continued.
Expansion internationally will be drivers and particularly the adoption of Omnipod dash, which we know is doing really well across our international markets, but room to continue to grow there and.
And new market additions, so now and the last 1.
A year or so we've added a handful of markets that will contribute over time, but any new market addition for US internationally takes time to accumulate new users. It's just the way that our business model works. So we view international as a long term growth driver and we will continue to invest and expanding into new markets that will drive growth.
Over time and we of course also are really excited to bring omnipod 5 to our international markets, which we view as the next growth driver.
And we aren't going to give a timeline on that yet we really want to get omnipod 5 to market first and the US and then we'll update our timelines.
The things that everybody is asking about iOS integration Libre integration G 7 and international but all of that work every program I. Just mentioned is underway and certainly we're going to aim to follow as quickly as we can once we get omnipod 5 to market and the us, which we could not be more excited to do.
Yes.
Thank you.
I am showing no further questions at this time I would now like to turn the conference back over to the JC Penney of Vic for closing remarks. Please go ahead.
Great. Thank you everyone for joining us today as you can see we continue to drive our strategy forward and we have great momentum throughout the business and real confidence and our outlook, we're halfway through the year and what we expect will be another successful year for insulet. The clinical evidence we share speaks to the tremendous value.
Our technology offers to those living with type 1 and type 2 diabetes and we could just not be more excited for the launch of Omnipod 5 because we are confident it will mark an important new chapter for Insulet and more importantly for those living with diabetes worldwide. Thanks, So much of a great evening.
Ladies and gentlemen. This concludes today's conference. Thank you for participating and have a wonderful day you may all disconnect.