Q4 2021 Insulet Corp Earnings Call
Good afternoon, ladies and gentlemen, and welcome to the Insulet Corporation's fourth quarter and full year 2021 earnings conference call. At this time, all participants are in a listen only mode.
Later, we will conduct a question and answer session and instructions will follow at that time.
If anyone should require assistance during the conference. Please press Star then zero on your Touchtone telephone as a reminder, this conference call is being recorded I would now like to turn the conference over to your host Deborah Gordon Vice President Investor Relations.
Thank you John Good afternoon, and thank you for joining us for Insulet fourth quarter 2021 earnings call with me today are shaky Petrovich, <unk>, President and Chief Executive Officer, and Wade Mcmillan Executive Vice President and Chief Financial Officer, Brad Christiansen, Our executive Vice President and Chief Commercial Officer is also with.
Today for the Q&A portion of our call. Both the replay of this call and the press release discussing our 2021 and fourth quarter results and 2022 guidance will be available on the Investor Relations section of our website before.
Before we begin I would like to inform you that certain statements made by Insulet. During the course of this call may be forward looking and could materially differ from current expectations. Please refer to the cautionary statements in our SEC filings for a detailed explanation of the inherent limitations of such statements.
Well 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 in assessing our operating performance and we believe they are helpful to 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 constant currency basis with that.
I'll turn the call over to Stacy.
Thanks, Deb and good afternoon, everyone and thank you for joining us our fourth quarter results marked the end of another year of strong growth.
First of all execution across our strategic imperatives and advancement of our mission to improve the lives of people with diabetes around the world.
In 2020, why do we increased awareness and adoption of Omnipod in both the type one and type two market.
Continue to unlock access through the U S pharmacy channel.
Expanded internationally and strengthened our global manufacturing operations.
That momentum has continued into 2022 with the recent FDA clearance of Omnipod, five, which we could not be more excited about.
While 2021 was a strong year it certainly wasn't without its challenges, including the ongoing impact of the pandemic global supply chain shortages and growing a I D competition, particularly in our international markets.
It is.
Wonderful to see the global diabetes community embraced automated insulin delivery technology and it is a clear indicator of how well received we believe omnipod five we'll be we are making great progress with our commercial rollout in the U S and advancing our efforts to bring omnipod five to our international markets.
The consistent strategic progress we have made is reflected in our financial results in 2021, we surpassed $1 billion in annual revenue in line with the goal we provided in 2016 as part of our long range plan two.
2021 also marked our sixth consecutive year of 20% or more revenue growth and we now serve approximately 300000 global customers using omnipod.
We are already off to a terrific start in 2022 with a critical milestones the FDA clearance and commercial launch of Omnipod five the first two blyth automated insulin delivery system that offers ball compatible smartphone control and an advanced algorithm residing on the pod.
It has taken incredible effort and commitment by the influx team to reach this ground breaking achievements.
Omnipod five marks the greatest and most complex innovation what has brought to market in our Companys 20 year history.
It offers on match innovation with a patient preferred form factor.
And it strengthens the value we provide customers today through our pay as you go business model in U S pharmacy access.
These distinctive benefits should provide us with unique competitive advantages in the market and will deliver life changing technology to our customers.
Taking a step back diabetes is a growing epidemic and the global markets remain critically underserved with low pump utilization. However.
However people with diabetes are adopting wearable technology at an increasing rate as CGM use and awareness accelerate.
Our efforts to improve access to and awareness of Omnipod, along with our customer centric approach to innovation are driving continued omnipod adoption.
The U S. We continued to capture over 80% of our new customers from multiple daily injections and.
And we remain a leader in the type two market based on our form factor the simplicity of our technology.
Emmons traded outcomes and broad affordable access through the pharmacy.
Type two continues to represent between 35 and 40% are new customers in the U S.
These trends offer significant growth opportunities for insulet over the long term given omnipod differentiated benefits as well as our relentless focus on delivering a great customer experience. We expect to continue to drive omnipod penetration expand our total addressable market and grow our global market share.
I will now provide an update on our strategic imperatives, which include expanding access and awareness delivering consumer focused innovation growing our global addressable market and driving operational excellence.
Expanding access to and awareness of Omnipod is essential to our strategy.
Day for more people than ever Omnipod is available through our pay as you go model in the U S pharmacy channel.
The pharmacy provides easier access and lower cost for the majority of our customers.
<unk> and Omnipod users are not burdened with four year lock in period, New technologies like Omnipod five can be adopted without upgrade or upfront fees and supplies can be picked up conveniently from a nearby pharmacy for the payer. This means we assumed the risks through our pay as you go business model and for the Omnipod user.
It means easier access and affordability.
The enhanced experience in the pharmacy is great and it's exactly why we are investing to expand access here.
The primary driver of our growth over the last two years has been Omnipod dash and we have successfully secured broad access to this innovation globally.
Almost all of our new customers in 2021 started on Omnipod dash and in the U S. We've now secured almost 90% of covered lives for this product primarily in the pharmacy.
Essential to access is affordability the vast majority of our U S consumers paid less than $50 each month for Omnipod dash through the pharmacy.
And the average is far less with many customers paying nothing.
While the cost to users of Omnipod dash is on par with multiple daily injections Omnipod provides improved outcomes and quality of life. We continue to look for ways to reduce cost and the logistical and administrative hurdles for all customers. So they can access and afford omnipod.
Our efforts to raise awareness through our direct to consumer advertising campaign is also helping to drive adoption our programs across the U S and select international markets are ramping and continued to drive a positive response and contribute to our customer growth in.
In 2022, we plan to expand our DTC efforts to drive increased awareness of Omnipod Dash and now Omnipod five given our success to date, we are excited to see the impact our DTC campaign will have once the omnipod five is fully launched.
Delivering the best customer experience is at the heart of what we do.
For 15 years, we've been using our unique form factor to simplify diabetes management Omnipod.
<unk> takes our innovation to the next level. It is the world's first phone controlled pod based AI system and we are confident it will build on our history of improving diabetes management as we leapfrog all other AIG system on the market.
Full phone control is far beyond what others in the market had been working on with full phone control, there's no separate controller and there was no traditional pump.
Tire experiences on body and on phone no tubes, and no pulling out the pump to dismiss them alarm change pump settings or private infusion set.
Phone control is the next level of simplicity and sophistication and it is an experience that is only possible with a true wearable form factor of Omnipod, we've redefined the category of insulin delivery.
In addition to being the first to blessed fully smartphone controlled system Omnipod five includes customizable checkpoint or smart adjust algorithm on the pod and a novel bolus calculator this level of innovation required.
Required unusually complex regulatory submission, including three 500 10-K, three lead reviewers at the agency and thousands of pages of data.
Our limited market release has already begun and the early customers are over the Moon limited market releases are best practice with launches of major new innovations and ours is designed to test our customer training and support system build access and ensure the best possible customer experience upon full market release.
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In addition to product innovation, we have also transformed how users access omnipod through the pharmacy.
Customers can now enjoy a simple onboarding process and a modernized customer service platform we.
We can verify pharmacy benefits in seconds streamline complex paperwork request enable our field teams to manage their pipelines more efficiently and facilitate a 100% digital pathway to access our products.
During 2021, our market access teams contracted strong coverage for Omnipod five prior to FDA clearance and we are now able to move more swiftly to expand coverage further as many payers waited for clearance to establish coverage policies.
We expect to be in limited release for three to nine months and are excited to rollout our system more broadly as the year progresses.
We can't wait for everyone to experience with simplicity and improved outcomes enjoyed by our clinical study participants.
Omnipod five is the most anticipated innovation within the diabetes community and our team is laser focused on ensuring the system is available to everyone.
Shortly after clearance. We also delivered our FDA submission to expand Omnipod <unk> indication down to each to.
This is important as we know the tremendous benefits omnipod five can provide this vulnerable population and their caregivers and we continue to plan for an expanded indication in 2022.
We recently completed our tight to feasibility study and look forward to sharing results at the <unk> diabetes conference in April we will take the learnings from this study to design a pivotal study with the intent to deliver omnipod five to the type two diabetes community.
We have proven to be a pioneer in the type two space and expect continued strong adoption given the benefits of Omnipod dash, our U S pharmacy channel access and now Omnipod five.
Even as we launch Omnipod five we continued to strategically invest in a robust product pipeline.
<unk> five is a platform that youll see us advance in the coming years, our iOS App development is making terrific progress as is our integration work with both desktops G seven and Abbott freestyle Libre.
Beyond the Omnipod five we are focused in three areas. We are working on advancements that will grow our addressable market.
We are developing next generation AI technology, and we are creating digital innovations and data products to make diabetes management easier for our powders.
Over the last several years, we have built on and enriched our digital platform capabilities.
With Sim cards in every omnipod, five controller and by better aggregating and analyzing user level data. We can further enhance the customer experience for all stakeholders.
With these investments we can improve outcomes lessen the burden for both physicians and users by providing actionable insights and develop more advanced future product offerings.
These innovations will serve as another driver to secure omnipod as they use your preferred brand and strengthen our digital health capabilities.
We have a sharp focus on our growing intellectual property as we create innovative new technology and build on our strong existing patent portfolio. In 2021, we filed more new patent applications than in any previous year. This will help ensure we are well positioned to deliver on our mission and provide differentiation.
<unk> and industry, leading innovation to people with diabetes for decades to come.
This past year, we built upon our 2020 expansion efforts and the rollout of Omnipod dash across our international markets through targeted geographic expansion, we entered the Asia Pacific region through our entry into Australia, and also expanded into Turkey. These efforts broadened access to Omnipod and strengthened.
Our foundation for future growth, we expect additional market expansion in 2022 in the middle East.
Our efforts to deliver Omnipod five to our international markets are underway, we are making great progress and I'm happy to share that we submitted for CE, marking in Europe .
Any idea adoption is accelerating and while it presents a near term headwind.
Creasing market acceptance reimbursement pathways and awareness of these technologies bode well for Omnipod five once we launch in our international markets. We look forward to Omnipod five being the product of choice globally.
Many additional people around the world would benefit from Omnipod and we are focused on bringing it to them over time, we are building our international teams and advancing our regulatory reimbursement and market development effort diabetes is underserved everywhere in the world and entering new markets represents a critical.
Long term growth driver for Insulet.
Investing in our manufacturing operations also remains a strategic priority as we build upon our established global capabilities and scale.
We made great progress in 2021, including additional steps to strengthen our global manufacturing operation and to secure uninterrupted access to critical components, creating a more resilient supply chain. During these unprecedented times.
We can produce tens of millions of pounds, a year and are extremely well positioned despite the challenging supply chain environment.
Our team continues to execute remarkably well successfully mitigating the impact.
On our business and on our customers.
These efforts will support the full commercial release of Omnipod five the continued strong global demand, we expect for Omnipod dash and our growing innovation pipeline.
Our growth plans in 2022, and the years ahead will not be constrained by capacity.
In closing we finished another strong year and are extremely excited about 2022, we expect to fully launch Omnipod five this year in the U S. We are advancing our strategy to bring omnipod to our international markets and we have an exciting and robust innovation roadmap.
Our success is due to our talented team and their on wavering commitment to our mission.
We have built an amazing company and an award winning culture. This past year, we were named a great place to work in both the U S and the U K, while also separately being recognized as one of the best workplaces for women.
This past December Truckers Institute listed Insulet as one of the top managed companies of 2021 based on customer satisfaction employee engagement innovation, social responsibility and financial strength.
These recognitions in part because they come directly from employee and customer feedback are wonderful reminders of the power of our people and our positive impact on one another in our communities and on our mission to improve the lives of people with diabetes.
I'll now turn the call over to Wade.
Thank you Stacey.
Our fourth quarter performance closed out another year of progress for Insulet on many fronts, our focused investments and consistent execution of our strategic imperatives continue to strengthen our financial profile, while driving meaningful value for all of our stakeholders.
In the fourth quarter, we generated 26% revenue growth, finishing above our guidance range with record U S and global Omnipod new customer starts.
On a reported basis for total revenue foreign currency was a 70 basis point headwind over the prior year.
We delivered U S. Omnipod revenue growth of 28% also exceeding our guidance range.
Trend of record U S. New customer starts continued through the fourth quarter. The primary reason for our strong U S revenue growth.
Also contributing was our success driving volume growth through the pharmacy channel due to continued omnipod dash adoption.
So let me first dash drove over 80% of our U S. New customer search and we increased pharmacy channel volume to almost 55% of our total U S volume.
In Q4 International Omnipod revenue grew 6%, which was below our guidance range. Our growth was impacted by an estimated $5 million channel inventory reduction due to our European distributor returning to more normalized levels from a higher balance secured throughout much of the pandemic.
Nick.
This occurred sooner than anticipated and was not fully factored into our guidance.
It negatively impacted our Q4 growth rate by approximately 600 basis points.
As a reminder, the majority of our revenue is sold through distributors in international regions and fluctuations in inventory levels can impact our results were.
We also continue to be affected by increasing competition and the compounding impact of the pandemic on our annuity model.
On a reported basis for international Omnipod foreign currency was a 180 basis point headwind over prior year.
Our estimated global attrition and pod utilization remained stable during Q4.
Drug delivery revenue increased 113% during the fourth quarter, finishing above our guidance range due to increased production volumes driven by higher than expected demand from our partner.
Gross margin was 69, 3% in the fourth quarter, representing a 380 basis point increase or 370 basis points on a constant currency basis.
The primary drivers were the mixed benefit of growing volume through the U S pharmacy channel product mix and our improved manufacturing operations.
These drivers were partially offset by an expected higher mix of costs as we further ramp U S manufacturing.
Our year end inventory balance includes higher component costs as a result of inflationary pressure in 2021 and this is expected to continue in 2022.
This will affect our gross margin in 2022, as we sell the product out of inventory I will touch on that more in a few minutes.
Operating expenses were in line with our expectations as we continue to strategically invest in.
In our innovation pipeline sales and marketing capabilities global manufacturing operations and international expansion. These investments are designed to fuel sustainable long term growth and expand our total addressable market, while we further advance our mission.
Operating margin was 16, 2% and adjusted EBITDA margin was 23, 7% both showed an increase over prior year and were in line with our expectations as we grow profitably while also investing across our business for long term growth.
Turning to full year results, we delivered total omnipod revenue growth of 19% and total company revenue growth of 20% achieving another record year at $1 1 billion, demonstrating the strength and durability of our annuity model.
On a reported basis foreign currency was favorable to 2021 total revenue by 180 basis points.
In 2021, we achieved gross margin of 68, 4% up 400 basis points and in line with our expectations were.
We are benefiting from our growing scale and global manufacturing efficiencies and mixed benefit from growing volume through the U S pharmacy channel, but we also had lower onetime costs associated with the pandemic.
These drivers were partially offset by expected higher costs as we further ramp U S manufacturing.
Operating margin was 11, 5% up 580 basis points and adjusted EBITDA margin was 19, 6% up 340 basis points.
Both were a significant step up from prior year and consistent with our expectations.
Turning to cash and liquidity, we ended the year with over $790 million in cash and the full $60 million available under our revolving credit facility.
We entered 2022 and a strong financial position with a strategic roadmap to invest in critical areas of our business that will drive our innovation and.
And growth for years to come.
This past year, we took a series of steps to strengthen our capital structure and reduce our overall cost of capital we are well positioned to finance our growth strategy.
More recently in the current quarter, we finalized the strategic vertical integration acquisition of one of our suppliers, which brings key intellectual property and expertise in house, allowing us to strengthen our competitive moat production capabilities and efficiency and drive <unk>.
Further operational excellence, while mitigating supply chain risks.
We have also taken additional steps to strengthen our global manufacturing capabilities, we have optimized operations in China by consolidating production in that region into one location.
We also plan to invest in a new international manufacturing location to further diversify globally and increase efficiency consistent with our goal to drive higher gross margins overtime.
Now turning to our outlook for 2022 for the full year, we expect total omnipod revenue growth of 15% to 20% and total company revenue growth of 12% to 16%.
By product line, we expect U S omnipod revenue growth of 18% to 23%.
Our growth within type one and type two markets will be driven primarily by Omnipod dash volume growth and our unique pay as you go model and pharmacy channel access we.
We will also benefit from the commercial release of Omnipod five and we anticipate this latest innovation will begin to contribute to growth this year and even more so over the long term.
We expect growth to be higher in the second half of the year versus the first half as we gained momentum from the launch of Omnipod five <unk>.
Begin to move past pandemic headwinds and realize the benefits of other commercial investments.
As a reminder, the launch of Omnipod five and its adoption ramp will take time due to the nature of our annuity model and given we were in limited market release for a period of time before transitioning to full market release.
For International Omnipod, we expect full year 2022 revenue growth in the range of 9% to 14% driven.
Driven by ongoing dash adoption, partially offset by the impact of competition and pandemic related headwinds.
We expect international to remain a long term strategic growth driver and we will continue investing with a focus to expand our global footprint and to bring omnipod five to our international markets.
We expect international revenue growth to also be higher in the second half of the year versus the first half, resulting from a slightly easier comparison as well as the expected improving conditions related to COVID-19 .
For drug delivery, we expect revenue to decline, 30% to 35% as levels were elevated during the pandemic.
Turning to gross margin for full year 2022, we expect to achieve gross margin of 67% to 68% and expect it to be higher in the first half of the year as compared to the second half.
The expected decline from prior year is driven by product mix, including ramping Omnipod five volume.
Costs associated with our U S manufacturing ramp and higher component and manufacturing costs associated with inflation.
We expect this to be partially offset by the benefits of our strengthened global manufacturing operations and capabilities and increasing volume in the U S pharmacy channel.
Looking beyond 2022, we fully expect to continue to expand gross margin over the long term as we begin to see the full benefit of our scale and manufacturing efficiencies.
We still see 70% gross margin as a near to midterm goal and we are driving toward it.
During 2022, we expect operating expenses to rise slightly below our revenue growth as we further invest in key areas of our business well progressing our financial profitability.
This includes investments in our robust innovation and clinical pipelines increased direct to consumer marketing and further scaling other commercial related activities.
We are also experiencing inflationary pressure within operating expenses.
2022 will be a pivotal year as we launch omnipod five and strengthen our position in a large and rapidly expanding market that remains underpenetrated.
We continue to invest heavily in innovation is our team advances omnipod five internationally, our I O S development effort integration with Libre and G seven and much more.
This year to make the most of our Omnipod five launch we expect the majority of operating expense growth will be within SG&A.
Even with our increased investments and pressure from inflation, we continue to target operating margin expansion of approximately 100 basis points each year, which is our goal over the short and midterm as we invest in long term strategic growth drivers.
At the start of 2022, we adopted new accounting guidance that reduces most of the noncash interest expense associated with our convertible notes to an insignificant amount.
Cash interest expense remains unchanged at approximately $30 million per year.
Finally, we expect capital expenditures in 2022 will grow slightly from 2021 with continued investment throughout our business.
Turning now to our first quarter 2022 revenue guidance, we expect both total company growth and total omnipod growth of 13% to 16%.
For U S. Omnipod, we expect growth of 17% to 20%.
We expect the core drivers will be the benefits of our recurring revenue model following consistent record setting new customer starts in 2021 and additional Omnipod dash volume through the U S pharmacy channel.
We expect Q1 international Omnipod growth of 6% to 10% driven by continued Omnipod dash adoption, partially offset by a D competition.
And the compounding impact from lower new customer starts in 2021, largely due to the pandemic.
Finally, we expect Q1 drug delivery revenue growth of 20% to 25% Q1 is expected to be higher than each of the subsequent quarters in the year due to production timing.
In conclusion, we completed another solid year of growth and strategic progress.
U S. Omnipod five has launched the preschool expanded indication filing is under active review at the FDA. We are advancing our type two initiatives and our efforts to bring omnipod five to our international markets are progressing.
We expect 2022 to be a transformative year as we advance our strategy and build upon our existing competitive advantages to position insulet for sustainable growth for years to come.
With that we will turn the call over to Don to open the call for questions.
Thank you.
If you have a question at this time. Please press Star then the one key on your Touchtone telephone.
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We ask that you keep your questions to no more than one but 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 Jayson Bedford from Raymond James. Please go ahead.
Hi, good afternoon, and congrats on an a on the approval.
I wanted to start on the international side, if I add back.
The $5 million for the fourth quarter in terms of the inventory drawdown.
National was still down quarter on quarter and is it just a function way too.
The inventory build in <unk> and <unk> that just got unwound in the fourth quarter and I guess, just more specifically would be installed base on a net basis.
Increase over the past few quarters, and then has there been any kind of pricing changes in international markets.
All kind of related to the same question.
Sure Hi, Jason Thanks for the question and.
We certainly are experiencing a more tailwind and our momentum in the U S business and the international.
International business as you call out we had this channel impact.
We had been monitoring actually throughout 2020, we had seen a distributor caring.
Higher inventory balances throughout the pandemic.
And we were unexpectedly hit with it at the end of the quarter because you know in conversations with them. We didn't think they were gonna be taken it down but they did so we didn't include in guidance. As you said it takes our growth rate. If you normalize for that up to about 12% so pretty consistent with the growth that we've had throughout the year, 13%, 14% and.
And so no there's nothing really irregular to call out other than just normal order patterns with our distributors you know most of our business internationally is through distributors and so it will ebb and flow between the quarters.
So overall our growth for the year ended up quarter by quarter over the four quarters between 12, and 14% so pretty consistent and as you know we target low twenty's percent growth to high teens growth and we've been off that over the last year for a couple of main reasons.
Obviously, the pandemic has persisted longer and been an impact on our new customer starts as well as the idea of competition that we've called out.
As C. G M has got.
We got approval in certain countries E. I D systems are starting to take off and as we've said in our prepared remarks, you know chassis highlighted that we can't wait to get Omnipod five Internet international markets and participate in the segment of the market that's growing with the IV.
So that's the run down on our international business is still strong growth you know the base of business is growing.
You know were still double digits to mid to low teens growth there and we can't wait to bring more innovation with omnipod five and get back into that targeted range, where we think we can sustain that high teens low twenty's type of group.
Thank you.
Our next question comes from the line of Josh Jennings from Cowen. Please go ahead.
Thank you this is Eric on for Josh.
With your announcement today that you've submitted for CE Mark about it about five could you help us understand any milestones or timelines for Ohio to receive an approval decision there.
Is it safe to assume that an approval could be delivered in the second half of this year.
And then I'll ask a follow up to that now.
Sure that the U S limited launch will be three to five months should we expect a similar timeline in the EU. Once you have CE mark in hand.
Great. Thanks, Eric for the question, Yes, we are excited to be under active review for CE, Mark and we don't really have a timeline to share beyond that.
As you May know this is a new regulatory pathway of the medical device regulation pathway and obviously a complex submission we know the data looks great and we're very confident in the quality of the submission, but it could take some time for us to secure this approval. So we haven't given guidance for timing.
Just wanted to let everybody know that we are under active review and and looking forward to getting that out onto the market in terms of what the limited market release will look like.
We are.
Are still finalizing that strategy, it's very likely that we would enter into select markets as part of the limited market release, and then expand from there very similar to how we rolled out dash in our our international markets, where we started with a handful of markets and as part of the limited market release, and then expanding from there.
Thanks for the question.
Thank you. Our next question comes from the line of Robbie Marcus from JP Morgan. Please go ahead.
Oh, great. Thanks for taking my questions. So I was wondering if you could just elaborate on the limited launch and the impact it's having on us.
User buying patterns in new patient starts.
U S had a good fourth quarter, but I would say first quarter is looking a little below where the street was thinking for the U S and for the full year as well so would love to just get a sense of.
What youre seeing in those buying patterns and if patients who are waiting.
Sure Robert maybe I'll start and then Wade can speak to what's factored into the guidance for Q1, but and it's just been a few weeks and the limited market release is progressing exactly as planned I think you know feedback from those participating in it has been terrific and were getting the early insights that were law.
Looking for.
As we had said what we're looking for is sort of.
Testing our training pathways are onboarding, our product experience all while the team continues to build access and so so far so good although it is early days, but we are encouraged.
And as it relates to buying patterns I think you would look at the fourth quarter in the U S, which was very strong and ahead of our expectations.
And it doesn't it wouldn't indicate that people are waiting for Omnipod five just given how strong the quarter was I'm sure. There are people out there that are waiting for omnipod five to get onto Omnipod, but certainly the performance in the fourth quarter wouldn't indicate that.
Okay, Great and then regarding guidance Ravi.
One thing we have to keep in mind, when we compare Q4 s to Q1 s is the seasonality.
Particularly in the U S and you know a couple of years ago, we thought that that may wane somewhat with move volume into the pharmacy channel, but similar to what we experienced last year in from 2020 into 'twenty one and.
Is that that there are just inherent.
You know built in behaviors in and people start stocking up.
With more pods in Q4 and driving seasonality higher in Q4, and then as a result lower in Q1. So we're following those similar trends in our guidance and we'll wait and see if in fact, it does Wayne this year or not but our expectation is given the strength of the utilization in Q4.
And and what we learned last year of just what's built into the marketplace and people's buying behavior that we'll still see pretty strong behavior are pretty strong buying behavior in Q4.
Even though we've moved a good percentage over half of our volume into the pharmacy channel.
Okay.
Thank you.
I show. Our next question comes from the line of Laurence Eagleson from Wells Fargo. Please go ahead.
Hi, good afternoon. Thanks for taking the question Stacy did I hear you say the limited launch would be three to nine months or three to five months.
The nine it says we haven't changed our estimate on that that's what we've been saying all along.
And so my question is kind of what gets you to kind of the why why such a wide range what would get you to the low end of that versus the high end of that if you will the nine months and you know what.
What what is the goal for them.
For covered lives.
Exiting 2002, thanks for taking the question yeah, Yeah. Thanks, Larry So.
And moving through to a full market release is really dependent on just getting the number of days of use across our different customer journeys. So we have MDI users getting onboard traditional tube pump users getting onboard people coming from Omnipod and people, who are coming from CGM or <unk>.
G M naive so we look across each of those and want to confirm the training pathways, we want to confirm the onboarding pathways.
And of course, the product experience. So if all of that goes flawlessly then we'll be at three months. If we learn some things in that that we wanted to address then that may push us closer to six or nine months and.
While we're doing that we're also working to build access and so once we've got the customer experience, where we want it and then we've got access where we want it which we don't expect really to be a governing factor. That's when we'll move into full market release, we just know there's going to be enthusiastic demand out there and we want to make sure we've got the best.
Possible customer experience the best possible access position and so you know.
I guess three months really would assume that we recruit everybody at the pace that we want to and that the experience is flawless in nine months, we would assume that you know we're learning some things that we want to address.
Yeah, Larry it's Brent I'll just add.
One of the reasons why it's important is we want to move quickly at the full market release and so some of the systems that were testing during the LMR or the ordering process. The onboarding process, both of which provide tremendous amount of self service for our users remember we don't have a four year lock in period with our user base and so there's going to be a.
Tremendous amount of demand from existing potters two moved Omnipod five we want them to be able to self serve and into self start on the product and so the reason why those systems need to move.
Go flawlessly as she put it so we can move really quickly and continue to focus on new starts during the FMR and so we're testing those two parts of the system along with access as you mentioned, but access is going to be probably.
Probably not the limiting factor to get to full market release, because we got a head start we said that we were ahead of well ahead of where we were at with Dash before we launched that product. So access will probably be an acceptable level and once we get comfortable with those two systems, the ordering and onboarding process that will enable us to move really quickly doing that anymore.
Yeah.
Thank you.
Your next question comes from the line of Margaret Counselor from William Blair. Please go ahead.
Hi, This is Brandon on for Margaret Thanks for taking the question.
I wanted to focus on the 2022 guidance Theres a lot of moving pieces a lot of good and exciting things going on through the year. So I was wondering if you could just talk about what is and what is not factored into that guidance and I guess, the three things that I would focus on are one what what are what's factored in for the global or I'd say.
Cadence of global launch of Omnipod five.
What are you considering for mix of type two as a percent of new users and then maybe DTC investments when are those factored into guidance is kind of ramping up so any color around those dynamics and what's what is and what is not factored in your guidance would be helpful.
Sure Brendan that's wait I can start that one and then I'm sure, but I would like to jump in on a couple of the business drivers that you mentioned so.
So our 2022 guide for the U S 18% to 23%.
Strong guide in fact at the high end.
Over to the growth we had in 2021 off a much higher base and.
Across all of our high end goods product lines U S International.
We achieved the high end they will be record setting our revenue.
Revenue basis for us again, and so even though the percentages.
Are slightly lower than last year.
The dollar growth rates are really what we need to keep an eye on given the size of our.
Existing base from year to year, and so specific things that are in the guidance, obviously in the U S, including the launch of Omnipod five what we have scenarios running on and have to watch is just as she's seen Bret talked about.
Whether we're at the low end three three months in where the full market release or if it takes us to nine months and given the annuity model that we sell through in the pharmacy channel with our pay as you go model. It is a pretty significant difference through the year, whether we get it at the at the three months or at the nine months end of the range and so that's something we'll be monitoring very close.
Throughout the year the mix of type two is interesting again it will be on me bought five dependent we've been pretty consistent at 35% to 40% of our new customer starts.
I've been type two over the last few quarters and through out 2021, and so that's what we would expect it to be however, as army bought five ramps and Omnipod five has type one indication as Tracey said in our prepared remarks, we're working on type two so we do think that the type two mix could be lower as omnipod.
Ive rents given that it's indicated for type one only at this point in time and then from a DTC standpoint, we have had really good success in driving an increasing awareness for our product.
Brett maybe you could talk to where the market stands today on a lack of awareness and why we think D. T. C is still a strong driver for us.
Yes, Thanks Wade.
So.
I think once we get to Omnipod five will we really will have the most complete offering and we pointed to the lack of an AI system has been a headwind for us not just internationally, but in the U S. But we've had these tailwind.
Pharmacy type two in DTC and in my mind, when we add AIB now to the best form factor in the marketplace and Omnipod awareness becomes the next frontier for US. So we've already made tremendous strides in DTC television commercials, our learnings in converting those leads that come in to new starts.
Have been tremendous and I look forward to the improved messaging and the addition of AIG to Omnipod that should be an enhancement to DTC and a better message and should drive even in a even better conversion rates. So some people will continue to do we look forward to doing it throughout the year and you'll see our message evolve as we.
We approach the full market release of Omnipod to include that AIB message in the in those TV commercials.
And Brendan just one note and although we are really excited to have them. Both under active review the preschool expansion and international Omnipod five are not factored into our guidance.
Okay.
Thank you.
I show. Our next question comes from the line of Jeff Johnson from Baird. Please go ahead.
Hey, good afternoon, guys shaped the are you just kind of took my last question there on whether or not Omnipod five was in international markets, but let me ask kind of I guess, maybe a more detailed international question. So I know that MTR pathway. It is tough to predict you know do we think it is six to 12 months a conservative window any way to put any kind of guide rails on that.
All number one but more importantly, once you do get CE Mark in let's just let's say, it's July 1st or something like that if that were to happen is there. Another six month window. We have to think about 12 month window to think about whats the window that didn't get on reimbursement and some of your largest countries, whether that's France, or Germany, or I think UK something like that.
How long would it take to actually get reimbursed for all five so that it typically they start contributing more meaningfully to your international revenue. Thanks, Yeah. Jeff is such a good question because there is a lot of work in terms of market development, and we talk about Europe or international as if it's one thing, but we all know Europe is 'twenty for US 20, plus different countries.
As different business models different market registrations in different reimbursement pathways and the good news is we have that work under way. So we have teams who are doing the market development work today.
But there will be work depending on the market. Some will go faster and some will go slower in terms of establishing coverage and access for Omnipod five.
I can't really put a window on M D or you know are we are.
You know, it's still early days for M. D iron to the pathway is just not that established we're very confident in the submission and.
And we are under review, but it's one of the reasons why it's not built into guidance. This year is just it's it's an unpredictable pathway at this point, we will let you know obviously as we make progress there and I would say it will move into a market release that looks our limited market release that looks fairly similar to what we have in the U S and just base.
Just on the need to do that remaining market development work in terms of establishing access and.
And and market registrations et cetera, once we have our CE mark.
Thank you.
I show. Our next question comes from the line of Joanne Wuensch from Citi. Please go ahead.
Good evening and thank you for taking the question.
You certainly have a lot going on but I do want to ask about.
Libre three.
And G seven and it's a two part question how long do you think it takes to integrate it with Omnipod five and is that something that needs to be submitted by you by them or what's the regulatory pathway.
Great Joanne Yeah, it's a very exciting pipeline you know we've talked now today about preschoolers and the international launch them and of course, CGM integrations type two and iOS. So there's a lot going on very exciting.
And I think everything is progressing well and the work to integrate with with G. Seven and with Libre has been under way for quite some time.
And so that is making good progress there.
Based on IC G M pathway and clearance for our <unk> com and <unk>.
<unk> seven there should not be actually a regulatory submission. That's one of the beautiful things about the interoperable pathway and so that should go relatively straightforward in the long pole in the tent. There really is the technical work and Ah right. Now Libre me require is likely to require a submission.
And that work is underway as well we own those submission. So it's our responsibility to work with our partners to do the development work and get the regulatory clinical and technical support that we need and then those submissions would be ours to manage.
Thank you.
I show. Our next question comes from the line of Danielle <unk> from SVP Leerink. Please go ahead.
Hey, good afternoon, everyone. Thanks, so much for taking the question and I haven't had a chance to congratulate you on Omnipod type approval very exciting I have a two part question. So first internationally.
Curious if you could talk a little bit more about why a ids are so much more competitive internationally versus the U S. I mean, you guys have still had very strong growth in the U S. I. Appreciate you know with any idea you'll be more competitive but it feels like the pressures greater internationally and then the second part of the question is on limited market release and sort of how what what.
<unk>, you're looking to learn is that you know how to best train the patients and the clinicians is it are you looking for patient feedback has been about patient selection would just love a little bit more color about the learnings that come from the limited market release. Thank you. So much yeah. Thanks, Danielle and maybe I'll start with a limited market release question and then Brian can give some insight into the.
National market dynamics around E I D.
For the limited market release, what we're really looking to understand is bred side remember, we don't lock or our users into four year agreements and so that means that everybody who has a market access and coverage and has access to omnipod five so that's could be tens of thousands if not more than 100.
Users in the United States, and so we certainly want them to be able to get onto product.
But we want them to be able to self serve so there are training pathways that are purely virtual for these different patient segments. So if you are an omnipod today and decks com you should not even need to meet with a clinician or a physician to be able to get onto the product you need a prescription and to go through our training pathway. So that's.
An example of something that we want to test that pathway to make sure that everybody is satisfied and I'm, having a good experience and good success with the product. After the training and then there are a myriad of other patient pathways. The MDI user will have a different training pathway that doesn't involve for example meeting with a physician.
And most of this is really focused on the user as opposed to the clinician. The product itself is incredibly simple it's been designed to be his hands off as possible for the physician's office and to be very simple to use for the patient. So those are the types of things that were testing and we just need to make sure that we get a good amount of.
Patients across each of those patient pathways and that and then we have a good feedback and and confidence in the experience across each of those pathways and then of course, we're building access in the background, but those are the types of things that we're looking to test and then I'll ask Brett to take the second part of your question, Yes, Hi, Danielle spread.
Board AIB competition internationally I know it does appear that that it's stronger than it was in the U S. But a couple of things one we've had competition in the U S for about six years now. So it's just been something we've been living with and there are <unk> in the U S that have helped us that just don't exist to the same extent international Mark.
And those are really three things one is type two and remember with 35% to 40% of all of our new starts coming from type two that that doesn't exist internationally. So if you were to take that out of the U S number you would see.
Significantly lower results with new starts.
One the second is really the pharmacy.
Lift so both the pharmacy experience as well as the premium we get pricing on pods in the pharmacy channel has helped our revenues in the U S and the third really is DTC, that's been really significant for us over the last few years, it's been a significant spend it's not really available to all of our.
Markets outside the U S. So not something that although it's something we've tried in markets like Germany, Canada, It's not something we can do everywhere.
And then yes, just the pay as you go models that really is the benefit of pharmacy in the U S is something we're working on in our international markets, but just not to the extent that we have it today. So the idea is new in our international markets. So it's a it's a change in something that we're feeling today and we just got to work on those tailwind so that we have that lift.
Between now and when we launched Omnipod five to compete better in internationally.
Thank you.
I show. Our next question comes from the line of Matt Taylor from UBS. Please go ahead.
Okay.
Thank you for taking the question.
Excuse me I saw that you had said in the prepared remarks that you're making progress on that.
The iOS development Apple development.
Could you just give us an update there and talk about next steps and any any color on timing that you can give for that.
Sure Matt Yeah. Thanks for the question, we do and we have had be iOS work underway for a while and there's no timeline update there, but I can tell you that the work is going well and.
We certainly are excited about it our plan has always been to take the learnings from our limited market release with a phone control on Android and factor those into the submission and the launch plan for iOS and so we do want to wait to get through that before we would end up submitting but right now that's not the law.
Pull in the tent, it's likely to be the completion of the technical work. This does require a five 10-K submission. So we are going to wrap up our technical work and then factor in any learnings from our limited market release with Android full phone control and then submit that for a five 10-K clearance to the FDA.
Thank you.
I show. Our next question comes from the line of Steve Lichtman from Oppenheimer. Please go ahead.
Thank you hi, everyone.
Wondering how we should think about the potential for omnipod five to positively impact new patient Hello, even before the full launch.
Thanks, Jason you've talked in the past about given no capital upfront.
The people who are on Omnipod can switch to two five once available it does it does.
Does that provide an opportunity for you even if youre not explicitly building it into 2022 guidance.
Yeah. Thanks for the question, Steve I, and I guess I would point to Q4 as an example are an illustration of the fact that I think people get the business model right. What we're trying to avoid there is a slowdown before a new innovation launches and and and just helping educate clinicians at.
And our customers that they can get on the product and there'll be able to convert over time. He put aside once their insurer covers the product and I think the main focus there is to ensure that we don't see a step back as we bring new innovation to market them and I think Q4 is illustrative of the fact that people get it and others.
They're not delaying their choice to get on product as we get closer and closer to the launch of Omnipod five so I wouldn't necessarily look at it as an upside, but I think it's a great indication of the power of the business model that we don't slow down as we bring new innovation to market and that's very exciting. It's a great thing for patients and it's a great thing for Insulet.
Yes, Steve This is Brett part of our message to both.
Health care providers and to patients is that.
Quickest pathway to <unk> hundred five is to be on dash today, because there's this self service training component for anybody that's on dash. So.
So that training doesn't become a bottleneck for anybody that wants to start on Omnipod five right away. The best thing. They really can do is start on dash today go through the training. So that we're not only bought five comes out in a full market release fashion. They are able to self serve on that training and more quickly onboard with 75. So that's a message that's resonating.
Does she at this point I agree it's not really a.
Driving additional new starts but it is true it is preventing people from waiting which is what we're trying to do.
Okay, and then Steve if I can just pick up on the guidance part of that question.
The way to think about it is you know if we're at the shorter three to six month end of the limited market release period that that that helps push us to the higher end of the guide if we end up more in that six to nine months timeframe then that's.
That's one of the reasons that could push us to the lower end of the guide and then obviously depending on how successful we are with army bought five throughout the year. It starts to build into our annuity model and can help US you know at the end of the year or as we build momentum into 2023.
Yeah.
Thank you.
I show. Our next question comes from the line of Matthew O'brien from Piper Sandler. Please go ahead.
Afternoon, Thanks for taking the question.
So say, we say six months.
<unk> for the limited market release that gets us to kind of August early September .
It kind of dovetails off of what Steve was just asking you about the conversion factor. You know are you going to be able to kind of go full bore after new patients with O five right away or are your reps really going to be spending a lot of time figuring out how to convert existing patients to one five and so they're really not being able to get after selling.
Only five 5% kidney patient until probably more so in 2023.
Yes, Hi, this is Brad I can take that one.
Our sales reps are compensated on new starts in new Omnipod starts so theyre going to want to focus on really building, our customer base and starting brand new users that are coming from MDI or from a tube pump conversion that are new to omnipod. Those tools that we talked about the both the ordering process and the onboarding process should allow them to do.
That to focus solely on new starts that is our intent.
No.
Think about this pay as you go model, there's no upfront fee and the.
Patients will always be able to upgrade to the latest Omnipod technology. That's a good thing and it's one of the reasons why we've been spending years now building. These self service tools and anticipation for this launch of Omnipod five so that we can innovate in short cycles and people will always be able to self serve and upgrade to the latest version of Omnipod and so that is our intent is one of the reasons why we've.
Put this range on the LMR, it's because we've got a test those systems. So we've had people on product remember for over a year, we're pretty confident that omnipod five is a fantastic product that people love. It these systems, though of ordering and Onboarding, our new and we're testing this in yellow more because that is our intent we want the sales and marketing teams to focus on new starts.
We went to existing partners, who really quickly migrate telling me about five on their own.
Thank you.
I'm showing our last question in the queue comes from Kyle Rose from Canaccord. Please go ahead.
Great Good evening to everyone and thanks for fitting me in so I wanted to just ask more of a bigger picture I guess business model question.
Thank you.
Reiterated the comment about future years leverage being in the ballpark of 100 bps and I guess I'm just trying to understand if you could unpack that for us just a little bit when I think about the work you're doing on manufacturing I think about some of the investments youre, making.
Understand that they take investments upfront, but they do appear to be more scalable long term thinking things like the pharmacy channel patient led Onboarding DTC advertising I guess, maybe what additional investments from a fixed cost or an infrastructure perspective, you need to be put in place that would kind of maybe constrain that to only 100 bps year over year movie.
Forward, assuming the topline growth is there.
Yeah, Good afternoon co and.
This is key to our financial thesis.
The.
Summary level is that we see ourselves in a very differentiated position and a leadership position within a very large total available market here both the type one in the type two and in a leadership.
Position in it and so we want to be able to continue to invest to capitalize on that leadership position and so we're going to do that through major areas.
R&D being one of the largest one of the ones you didn't mention but significant investments and driving innovation for years to come you know as Tracey said in her prepared remarks.
We've talked publicly about a lot of the projects that we have that don't have clinical submission timelines, but of course behind that our pipeline is also being invested in four significant advancements.
And further generations of our current products or Tam expansion for.
For international expansion, so just a lot coming in the pipeline. So heavy investment in R&D to continue in this to continue penetrating in this large available market for US and then as you mentioned manufacturing we want to make sure our capacity stays ahead obviously.
You mentioned leveraging the pharmacy channel you're right. It is a more efficient channel for US we've got.
Over half of our volume flowing through the pharmacy now and so we are getting benefits from that but as Brett mentioned earlier, we're also making investments in direct to consumer we see a pretty heavy lift to drive awareness and.
The majority of the market for type two and almost all of them are pardon me for type one and almost all of the market for type two is still more people who are using multiple daily injections and so we've got a big job to do and in developing the marketing and DTC is one of the areas that we're going to do that but we're also continuing to invest in our sales force to.
To drive those initiatives in both the type one and type two space and then the other major area of investment is on the international expansion side, which is a pretty significant investment to ashish highlighted earlier around the regulatory and government affairs as well as all the capabilities needed to deliver our product in those regions and so are we.
We see ourselves continuing in this heavy investment cycle, but as you mentioned, we also want to continue to strengthen our financial profile, we had a nice step up in operating margins and EBITDA. This year and we did that intentionally to get ourselves to a place where we're much stronger financially and now we're going to build on that from year to year, and we're targeting 100 basis points.
Of improvement each year, and we're going to continue to step our way to that stronger financial profile. So that's the plan for us over time, continuing to take advantage of our leadership and differentiated position here, while also building a stronger financial profile for the company.
Thank you Sir.
I'm showing no further questions at this time I would now like to turn the conference back to chassis Petrofac for clothing.
Thank you Dylan I wanted to take a moment to share some of the unsolicited and wonderful feedback we've received from Omnipod five users. During what has been just a few weeks of limited market release.
Any mother of a one year old shared quote Omnipod five has allowed me to be more present for my son, because I'm not constantly thinking about my own diabetes and Kevin a father of a 16 year old is elated about how omnipod five has changed their lives. He shared quote today with the third morning in a row, my son woke up with perfect.
Sugar and no overnight lows Omnipod five is a dream come true and finally, John who has been on a pump for over two decades shared his lifetime of personal challenges in frustration managing has diabetes and his words quote diabetes has taken its toll on me mentally I bottled up.
And try to stay strong for my wife, My Kids and those who love me I'm tired with Omnipod five I've slept through the night uninterrupted for the first time in a very long time. Thank you for all your hard work to make this dream a reality.
So we cannot wait to bring omnipod five and its unmatched benefits to the broader diabetes community. So that it can help millions of more people just like its doing for Bethany, Kevin and John and their families. Thanks again for joining us today and have a great evening.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation and have a wonderful day you may all disconnect.
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