Q1 2024 Insulet Corp Earnings Call
Operator: Good afternoon, ladies and gentlemen, and welcome to the Insulet Corporation first quarter 2024 earnings call. At this time, all participants are in a listen-only mode.
Good afternoon, ladies and gentlemen, and welcome to the Insulet Corporation first quarter 'twenty 'twenty four earnings call. At this time, all participants are in a listen only mode.
Operator: 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.
Deborah R. Gordon: 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.
Deborah R. Gordon: As a reminder, this conference call is being recorded.
Operator: I would now like to turn the conference over to your host Deborah Gordon Vice President Investor Relations.
Deborah R. Gordon: Good afternoon, and thank you for joining us for Insulet's first quarter 2024 earnings call. With me today are Jim Hollingshead, President and Chief Executive Officer, and Ana Maria Chadwick, Chief Financial Officer and Treasurer. Both the replay of this call and the press release discussing our first quarter results and 2024 guidance will be available on the investor relations section of our website. Also on our website is our supplemental earnings presentation. We encourage you to refer to that document for a summary of key metrics and business updates.
Deborah R. Gordon: Thank you good afternoon, and thank you for joining us for infill. Its first quarter 2024 earnings call with me today are Jim Hollingshead, President and Chief Executive Officer, and Anna Maria Chadwick, Chief Financial Officer, and Treasurer, both the replay of this call and the press release discussing our first quarter results in <unk>.
Deborah R. Gordon: 24 guidance will be available on the Investor Relations section of our website also on our website as our supplemental earnings presentation. We encourage you to reference that document for a summary of key metrics and business updates.
Deborah R. Gordon: Before we begin, we remind 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.
Deborah R. Gordon: Before we begin we remind 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 will also discuss non-GAAP financial.
Deborah R. Gordon: We'll also discuss non-GAAP financial measures with respect to our performance, namely adjusted growth in operating margins, adjusted EBITDA, and constant currency revenue, which is revenue growth excluding the effect of foreign exchange. These measures align with what management uses as supplemental measures in assessing our operating performance from period to period, and we believe they are helpful for others as well. Additionally, unless otherwise stated, all financial commentary regarding dollar and percentage changes will be on a year-over-year 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 Jim. Thanks, Deb.
Deborah R. Gordon: [noise] measures with respect to our performance, namely adjusted gross and operating margin 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 from period to period and we believe they are helpful.
Deborah R. Gordon: For others as well 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 rate, which will be on a year over year constant currency basis with that I'll turn the call over to Jim.
Jim: Thanks, Deb and good afternoon, and thank you for joining us.
James Hollingshead: Good afternoon, and thank you for joining us. Coming out of 2023 that saw Insulet emerge as the clear industry leader, we entered 2024 with significant momentum. We are off to a great start in Q1, fueled by continuing strong demand for Omnipot 5. Our global Insulet team continues to execute at a high level, bolstering our confidence in another year of robust revenue growth and margin expansion. Our first quarter revenue results exceeded our expectations for every product.
Jim: Now to the 2023 that Insulet emerged as the clear industry leader, we entered 2024 with significant momentum.
James Hollingshead: We are off to a great start in Q1 fueled by continuing strong demand for Omnipod five.
James Hollingshead: Our global Insulet team continues to execute at a high level bolstering our confidence in another year of robust revenue growth and margin expansion.
James Hollingshead: Our first quarter revenue results exceeded our expectations for every product line.
James Hollingshead: Given those results and the cascade of innovations that we plan to deliver this year, we have increased our guidance for both top line and operating margin growth. On today's call, I want to do three things: provide a high-level review of our Q1 results and the continuing strength of our competitive position in the market. I will give an update on our broad innovation agenda for 2024, including our efforts to expand the Omnipot5 platform and our progress in the Type 2 market, and discuss our ongoing efforts to capture the value of scale across our business. Starting with financial performance, our first quarter revenue and margins exceeded our expectations.
James Hollingshead: Given those results in the Cascade of innovations that we plan to deliver this year, we have increased our guidance for both top line and operating margin growth.
James Hollingshead: On today's call I want to do three things provide a high level review of our Q1 results and the continuing strength of our competitive position in the market give an update on our broad innovation agenda for 2024, including our efforts to expand the Omnipod five platform and our progress in the type two market and discuss our ongoing efforts to <unk>.
James Hollingshead: Capture the value of scale across our business.
James Hollingshead: Starting with financial performance, our first quarter revenue and margins exceeded our expectations. We achieved a total omnipod revenue growth of 21%, including U S growth of 23% and international growth of 15%.
James Hollingshead: We achieved total Omnipod revenue growth of 21%, including U.S. growth of 23% and international growth of 15%. In the U.S., we continue to build on our clear leadership in the market, and our Omnipod 5 automated insulin delivery system was number one in new customer starts by a wide margin. Demand for Omnipot 5 remains very high, and U.S. new customer starts were robust and in line with our expectations. Omnipot 5 is designed to expand the market through its ease of use and easy access, and we continue to succeed in driving market growth.
James Hollingshead: In the U S. We continued to build on our clear leadership in the market and our Omnipod five automated insulin delivery system was number one in new customer starts by a wide margin.
James Hollingshead: Demand for Omnipod, five remains very high and U S. New customer starts were robust and in line with our expectations.
James Hollingshead: Omnipod five is designed to expand the market through its ease of use and easy access and we continue to succeed in driving market growth.
James Hollingshead: During the quarter, roughly 85% of our new starts came from people previously using multiple daily injections; this is our target market, and our competitive conversions remain very strong. The Omnipod platform also remains the top choice for people with either type 1 or type 2 diabetes. Type 2 patients represented roughly 25% of our new starts in the quarter.
James Hollingshead: During the quarter roughly 85% of our new starts came from people previously using multiple daily injections for our target market and our competitive conversions remained very strong.
James Hollingshead: The Omnipod platform also remains the top choice for people with either type one or type two diabetes type two patients represented roughly 25% of our new starts in the quarter.
James Hollingshead: Yes.
James Hollingshead: OmniPot 5 continues to be the game-changing offer we thought it would be when we first brought it to market. This is true in the U.S. and also internationally, where it is dramatically accelerating our growth. Last year's successful launches in the UK and Germany continue to exceed our expectations as our teams generate strong new customer starts. In fact, in Q1, more than half of our total international new customer starts were Omnipod 5.
James Hollingshead: I'm just talked five continues to be the game changing offer we thought it would be when we first brought it to market. This is true in the U S and also internationally, where it is dramatically accelerating our growth.
James Hollingshead: Last year's successful launches in the UK and Germany continued to exceed our expectations as our teams generate strong new customer starts.
James Hollingshead: In fact in Q1 more than half of our total international new customer starts where omnipod five.
James Hollingshead: Given Omnipod 5's early contribution in our European markets, we are raising our international revenue outlook by 500 basis points to a range of 12% to 15%. As a result, we now expect total Omnipot growth of 19% at the high end and 18% for the entire company, representing a milestone of $2 billion in total company revenue. Anna will provide more details on our increased guidance in a few moments. But our global results in Q1 make one thing very clear. Omnipod 5 is, without a doubt, highly differentiated and the best offer on the market.
James Hollingshead: Given omnipod five's early contribution in our European markets, we are raising our international revenue outlook by 500 basis points to a range of 12% to 15%.
James Hollingshead: As a result, we now expect total omnipod growth of 19% at the high end and 18% for total company, representing a milestone of $2 billion in total company revenue.
James Hollingshead: Andrew will provide more details on our increased guidance in a few moments.
James Hollingshead: Our global results in Q1 make one thing very clear.
James Hollingshead: Omnipod five is without a doubt highly differentiated and the best offer on the market. Its ease of use pay as you go economics affordability and widespread access make the obvious choice for insulin delivery for people with type one diabetes and soon for people with type two diabetes once we achieve label expansion.
James Hollingshead: Its ease of use, pay-as-you-go economics, affordability, and widespread access make it the obvious choice for insulin delivery for people with type 1 diabetes and soon for people with type 2 diabetes once we achieve label expansion. Omnipod 5 leads the market everywhere it goes. And we are not stopping there. During Q1, we made significant strides across our innovation portfolio. Because Omnipod 5 is the market leader, it's easy to forget that the current version remains our initial minimum viable product.
James Hollingshead: Omnipod five leads the market everywhere it goes.
James Hollingshead: And we are not stopping there.
James Hollingshead: During Q1, we made significant strides across our innovation portfolio.
James Hollingshead: Because omnipod five as the market leader, it's easy to forget that the current version remains our initial minimum viable product.
James Hollingshead: In 2024, we will expand on the Omnipod 5 platform by bringing new sensor integrations, launching the system in new geographies, and extending our phone control offering. In the U.S., during Q1, we entered a limited market release of our integration with Dexcom's G7 and are on track for full market release this summer, which will allow us to expand choice for customers and capture the opportunity created by the growth and adoption of Dexcom's latest sensor.
James Hollingshead: In 2024, we will expand on the Omnipod five platform by bringing new sensor integrations launching the system in new geographies and extending our phone control offering.
James Hollingshead: In the U S. During Q1, we entered limited market release of our integration with <unk> <unk> seven.
James Hollingshead: We're on track for full market release, this summer, which will allow us to expand choice for customers and capture the opportunity created by the growth and adoption of <unk> latest sensor.
James Hollingshead: In Europe, we successfully entered a limited market release of our integration with Abbott's Freestyle Libre 2 Plus sensor in both the UK and the Netherlands ahead of our mid-year launch plan. This release represents two firsts. Omnipod 5 is the first AID system to offer integration with the Libre2 sensor in Europe, which is Abbott's most widely adopted CGM. And Omnipod 5 in the Netherlands represents our first sensor of choice, PodOp. These pods are compatible with both Abbott's Libre II Plus and Dexcom's G6 sensors.
James Hollingshead: In Europe, we successfully entered limited market release of our integration with Abbott freestyle Libre, two plus sensor in both the UK and the Netherlands ahead of our midyear launch plans.
James Hollingshead: This release represents two first omnipod.
James Hollingshead: Slide five is the first AI system to offer integration with the Libre two sensor in Europe, which is abbott's most widely adopted CGM and Omnipod five in the Netherlands represents our first center of choice part offering. These pods are compatible with both Abbott's Libre, two plus <unk> <unk> sensor.
James Hollingshead: Early results from the UK and the Netherlands are extremely promising, and we look forward to providing future updates with regard to the timing of full market release. Staying in Europe, we are pleased to announce that we now plan to launch Omnipod 5 with G6 in France this summer.
James Hollingshead: Early results from the UK and the Netherlands are extremely promising and we look forward to providing future updates with regard to the timing of full market release.
James Hollingshead: Staying in Europe, we are pleased to announce that we now plan to launch omni five five with <unk> in France also this summer.
James Hollingshead: France has historically been one of our largest markets and one in which we know demand for our solutions is high. When we first launched Omnipot Dash in this market, it quickly became the insulin pump brand of choice. And we are confident in our ability to drive strong adoption with our advanced AID system. With the launch in France, we will achieve our stated goal of making Omnipod 5 accessible to the majority of our European customers and reach this milestone ahead of our internal end-of-year expectations.
James Hollingshead: France has historically been one of our largest markets and one in which we know demand for our solutions is high.
James Hollingshead: When we first launched Omnipod dash in this market. It quickly became the insulin pump Brandon choice and we are confident in our ability to drive strong adoption with our advanced AI system.
James Hollingshead: With the launch in France, we will achieve our stated goal of making Omnipod five accessible to the majority of our European customers and reached this milestone ahead of our internal end of your expectations.
James Hollingshead: We anticipate our recent Omnipot5 International launches will fuel accelerated new customer starts in the second half of this year and revenue growth next year and beyond. We also plan to enter the U.S. limited market release for our iOS app this summer. Extending Omnipod 5 onto the iPhone platform is one of our most frequently requested features, and we are excited to bring this offer to you.
James Hollingshead: We anticipate our recent Omnipod five international launches will fuel accelerated new customer starts in the second half of this year and revenue growth next year and beyond.
James Hollingshead: We also plan to enter our U S limited market release for our iOS App This summer.
James Hollingshead: Extending omnipod five onto the iPhone platform is one of our most frequently requested features and we are excited to bring this offer to market.
James Hollingshead: Turning to the opportunity in type 2 diabetes, where we remain the U.S. market leader in this large and underserved patient population, the commercial pilot with Omnipod Go, our FDA-cleared offering for the over 3 million people in the U.S. who need daily basal-only insulin, continues to offer significant learning. Because of our pilot efforts, we have developed a better understanding of this market, and we have expanded the definition of the targeted patient segment. We now also have even greater confidence that we will be able to bring our innovative technology to a broader range of HCP and physician practices.
James Hollingshead: Turning to the opportunity in type two diabetes, we remain the U S market leader in this large and underserved patient population the.
James Hollingshead: The commercial pilot with Omnipod go our FDA cleared offering for the over 3 million people in the U S who need daily basal only insulin continues to offer significant learnings.
James Hollingshead: Because of our pilot efforts, we have developed a better understanding of this market and we have expanded the definition of targeted patient segments.
James Hollingshead: We now also have even greater confidence that we will be able to bring our innovative technology to a broader range of HCP and physician practices.
James Hollingshead: We are refining our plans for extended commercial reach based on those learnings. We also know that there is significant current demand for solutions that support intensive insulin use for people with type 2 diabetes. In this market, Omnipod Dash continues to perform extremely well, driven by its ease of use and accessibility.
James Hollingshead: We are refining our plans for extended commercial reach based on those learnings.
James Hollingshead: We also know that there is significant demand for solutions that support intensive insulin used for people with type two diabetes and this market Omnipod dash continues to perform extremely well driven by its ease of use and accessibility.
James Hollingshead: In that context, we are very excited about the progress we are making towards achieving FDA clearance for OmniPy5 for type 2. During Q1, we reached a key milestone in our secure T2D pivotal trial with the last patient completing the protocol. We are well on track to meet our goal of submitting to the FDA for label expansion by the end of the year. Once cleared, we expect to meaningfully accelerate Omnipod 5 adoption among the approximate 2.5 million people with insulin-intensive type 2 diabetes.
James Hollingshead: In that context, we are very excited about the progress we are making towards achieving FDA clearance for omnipod five for type two <unk>.
James Hollingshead: During Q1, we reached a key milestone in our secure <unk> pivotal trial with the last patient completing the protocol.
James Hollingshead: We are well on track to meet our goal of submitting to the FDA for label expansion by the end of the year.
James Hollingshead: Once cleared we expect to meaningfully accelerate omnipod five adoption among the approximate $2 5 million people with insulin intensive type two diabetes.
James Hollingshead: And we will have the broadest offering of insulin delivery technology solutions on the market for this important patient population. Lastly, we continue to analyze the market impact of GLT-1 use. Analysis of actual claims data demonstrates that GLP-1 use accelerates the adoption of insulin among people living with type 2 diabetes.
James Hollingshead: And we will have the broadest offering of insulin delivery technology solutions on the market for this important patient population.
James Hollingshead: Lastly, we continue to analyze the market impact of <unk> one use.
James Hollingshead: Analysis of actual claims data demonstrates the GOP one year's accelerates the adoption of insulin among people living with type two diabetes.
James Hollingshead: The data are definitive and striking and strengthen our conviction in the size of the unmet need and the size of the business opportunity for our growing Type 2 portfolio. We are finalizing our analysis and look forward to providing a more detailed update soon. 2024 is shaping up, as we planned, to be a year filled with a cascade of innovations that will allow us to build on our position of market leadership, and we will take advantage of those innovations because of our expanding scale.
James Hollingshead: The data are definitive and striking and strengthen our conviction in the size of the unmet need and the size of the business opportunity for our growing type II portfolio.
James Hollingshead: We are finalizing our analysis and look forward to providing a more detailed update soon.
James Hollingshead: 2024 is shaping up as we planned to be a year filled with a cascade of innovations that will allow us to build on our position of market leadership, and we will take advantage of those innovations because of our expanding scale.
James Hollingshead: Our business continues to enjoy several advantages that we've achieved through commercial scope and operational scale. First, our products have very broad reimbursement, with more than 95% of covered lives in the U.S. for both Omnipod 5 and Omnipod Dash. And through our nationwide distribution reach, Omnipod is available at retail pharmacies that are within five miles of over 85% of the U.S. population.
James Hollingshead: Our business continues to enjoy several advantages that we've achieved through commercial scope and operational scale.
James Hollingshead: First our products have very broad reimbursement with more than 95% of covered lives in the U S for both Omnipod five Omnipod dash.
James Hollingshead: And through our nationwide distribution reach Omnipod is available at retail pharmacies that are within five miles of over 85% of the U S population.
James Hollingshead: Our strategy to increase awareness of Omnipod with endocrinologists and primary care physicians has resulted in an expanded base of health care providers writing scripts for our products, fueling our leadership position. In the U.S., in Q1, the number of U.S. Omnipod 5 prescribing HCPs grew to over 20,000, up from over 18,500 the prior quarter. These prescribers were endocrinologists, PCPs, and other ACPs, and the split was approximately a third each.
James Hollingshead: Our strategy to increase awareness of Omnipod with endocrinologists and primary care physicians as resulted in an expanded base of healthcare providers, writing scripts for our products fueling our leadership position.
James Hollingshead: In the U S. In Q1, the number of U S. Omnipod five prescribing Hcp's grew to over 20000 up from over 18500, the prior quarter. These.
James Hollingshead: These prescribers were endocrinologists pcp's and other Hcp's and the split was approximately a third each and the prescriber span both the type one and type two markets and both increased substantially year over year.
James Hollingshead: The prescribers spanned both the Type 1 and Type 2 markets, and both increased substantially year over year. In order to fuel our growth, we are further expanding our commercial reach. Internationally, we continue to prudently invest in our commercial expansion and in our market access capability. In the U.S., we are in the process of incrementally expanding our sales force, including the creation of new territories and expansion into targeted pediatric markets. Our broad sales, marketing, and channel capabilities allow us to reach a large and growing population of patients and represent a growing set of advantages over aspiring competitors.
James Hollingshead: In order to fuel our growth we are further expanding our commercial reach.
James Hollingshead: Internationally, we continue to prudently invest in our commercial expansion and in our market access capabilities.
James Hollingshead: In the U S. We are in the process of incrementally expanding our sales force, including the creation of new territories and expansion into targeted pediatric centers.
James Hollingshead: Our broad sales marketing and channel capabilities allow us to reach a large and growing population of patients and represent a growing set of advantages over aspiring competitors.
James Hollingshead: Lastly, we also enjoy significant financial benefits from our scaled manufacturing. Insulet has been on a 20-year journey of capability building and continuous improvement, which has allowed us to build world-class capabilities that drive ongoing quality and productivity. Manufacturing scale and scope have been big drivers of our gross margin expansion over that time, and we expect our new Malaysia facility will fuel continued efficiency gains. We are in the final stages of validating our manufacturing lines in Malaysia and expect to begin producing saleable products in Q3.
James Hollingshead: Lastly, we also enjoy significant financial benefits from our scale manufacturing.
James Hollingshead: Insulet has been on a 20 year journey of capability building and continuous improvement, which has allowed us to build world class capabilities that drive ongoing quality and productivity.
James Hollingshead: Manufacturing scale and scope have been big drivers of our gross margin expansion over that time, and we expect our new Malaysia facility will fuel continued efficiency gains.
James Hollingshead: We are in the final stages of validating our manufacturing lines in Malaysia, and expect to begin producing salable product in Q3.
James Hollingshead: The facility represents a sizable investment of approximately $200 million over the course of four years through 2026, provides approximately 400,000 square feet of manufacturing space, and is expected to house more than 1,000 full-time employees at full capacity. Our regional sourcing strategy includes using local suppliers for components, contributing to resiliency and improved cost.
James Hollingshead: The facility represents a sizable investment of approximately $200 million over.
James Hollingshead: Over the course of four years through 2026 provides approximately 400000 square feet of manufacturing space and is expected to house more than 1000 full time employees at full capacity.
James Hollingshead: Our regional sourcing strategy includes using local suppliers for components contributing to resiliency and improved costs.
James Hollingshead: This facility will also strengthen our global operational capabilities, drive increased capacity to meet our robust demand, and support future international market expansion. We expect our Malaysian site to be accretive to gross margin in its first full year of production, with the rate of growth increasing over time. It represents one of the many opportunities we have to lower total landed product costs and expand margins over the near and long term. Our advantages in scope and scale put Insulet in a strong position to continue to invest in the growth of our business and to expand our margins.
James Hollingshead: This facility will also strengthen our global operational capabilities driving increased capacity to meet our robust demand and support future international market expansion.
James Hollingshead: We expect our Malaysia site to be accretive to gross margin in its first full year of production ramping over time.
James Hollingshead: It represents one of the many opportunities we have to lower total landed product costs and expand margins over the near and long term.
James Hollingshead: Our advantages in scope and scale with Insulet in a strong position to continue to invest in the growth of our business and to expand our margins. This.
James Hollingshead: This is yet another way in which our business is unique among our direct competitors. With that, I'll introduce Anna, who is joining us for her first meeting as our CFO. As you will have seen in our announcement, Anna is a highly accomplished and proven leader. We are thrilled to have her join the Insulet team, and I'm personally looking forward to benefiting from her partnership as we execute our strategy to drive rapid growth and strengthen our financial profile. It's over to you, Anna.
James Hollingshead: This is yet another way in which our business is unique among our direct competitors.
James Hollingshead: With that ill introduce Anna who is joining us for her first call as our CFO as you will have seen in our announcement and is a highly accomplished improvement leader. We are thrilled to have joined the insulet team and Im personally looking forward to benefiting from her partnership as we execute our strategy to drive rapid growth and strengthen our financial profile.
Anna: Over to you Anna.
Anna: Thank you, Jim, and good afternoon, everyone. Before I dive into the first quarter financial results, I want to say how excited I am to be part of this outstanding company. Insulet is transforming diabetes management and improving the lives of hundreds of thousands of people while driving strong financial performance. I am confident that we're just getting started, especially with the exciting developments in our pipeline. I look forward to partnering with Jim, our skilled leadership, and the rest of Insulet's talented global team to advance our mission for our customers while also delivering robust revenue growth, margin expansion, and shareholder value. And, above all else, I look forward to helping make a positive impact on people around the world with diabetes. Now, on to our first quarter.
Anna: Thank you Jim and good afternoon, everyone before I dive into the first quarter financial results I want to say how excited I am to be part of this outstanding company.
Anna: Insulet is transforming diabetes management and improving the lives of hundreds of thousands of people, while driving strong financial performance I am confident that we're just getting started especially with the exciting developments in our pipeline.
Anna: Look forward to partnering with Jim.
Anna: Our skilled leadership and the rest of influence talented global team to advance our mission for our customers. While also delivering robust revenue growth margin expansion and shareholder value.
Anna: All else I look forward to helping make a positive impact on people around the world with diabetes.
Anna: Now onto our first quarter results.
Anna: First quarter exceeded our expectations, and we generated strong global new customer starts. As a result of our growing customer base, we delivered 23% revenue growth, driven by global omnipotent growth of 21%. Additionally, our estimated global retention and utilization trends remain stable. Foreign currency was a 50 basis point tailwind for our total revenue on a reported basis compared to first quarter last year.
Anna: First quarter exceeded our expectations and we generated strong global new customer starts.
Anna: As a result of our growing customer base, we delivered 23% revenue growth.
Anna: Driven by global Omnipod growth of 21% and our.
Anna: Estimated global retention and utilization trends remained stable.
Anna: Foreign currency was a 50 basis point tailwind for our total revenue on a reported basis compared to first quarter last year.
Anna: U.S. Omnipot revenue growth was 23%, driven by robust growth in both the type one and type two diabetes customer base, as well as expanding volume through the pharmacy channel. Adoption of Omnipod 5 integrated with G6 continues to be the driving force. And we are excited to have launched our limited US market release with G7, which we expect will accelerate new customer starts in the second half of this year following our planned full market release this summer.
Anna: U S. Omnipod revenue growth was 23% driven by robust growth on both type one and type two diabetes customer basis, as well as expanding volume through the pharmacy channel.
Anna: Adoption of Omnipod five integrated with <unk> six continues to be the driving force and we are excited to have launched our U S limited market release with G. Seven, which we expect will accelerate new customer starts in the second half of this year.
Anna: Boeing are planned full market release this summer.
Anna: Our U.S. business and related revenue growth are very strong, fueled by Omnibus 5's success and Robust Demand. With many catalysts ahead of us this year, we're laying the foundation for sustained revenue growth in 2024 and beyond. International Omnipug revenue increased 15%, which was well above our expectations. While Omnipod Dash remains the largest percentage of our overall international volume, last year's Omnipod 5 launches in both the UK and Germany continued to drive notable increases in new customer starts and were the primary drivers of our accelerated growth.
Anna: Our U S business and related revenue growth are very strong.
Anna: Fueled by Omnipod slides success and robust demand.
Anna: With many catalysts ahead of us this year, we're laying the foundation for sustained revenue growth for 2024 and beyond.
Anna: International Omnipod revenue increased 15%, which was well above our expectations.
Anna: Omnipod dash remains the largest percentage of our overall international volume last year's op was.
Anna: Five launches in both the UK and Germany continued to drive notable increases in new customer starts and were the primary drivers of our accelerated growth.
Anna: Yeah.
Anna: On a reported basis, foreign currency was 210 basis points of a tailwind over the prior year, which was approximately 110 points favorable versus our guide. Drug delivery revenue was almost $9 million, which was above our guidance range due to timing. Gross margin was 69.5%, up 230 basis points on a reported basis and up 460 basis points compared to prior year adjusted gross margin.
Anna: On a reported basis foreign currency was 210 basis point tailwind over the prior year, which was approximately $110 favorable versus our guide.
Anna: Drug delivery revenue was almost $9 million, which was above our guidance range due to timing.
Anna: Gross margin was 69, 5% up 230 basis points on a reported basis.
Anna: 460 basis points compared to prior year adjusted gross margin.
Anna: The increase in gross margin, which exceeded our internal expectations, was primarily due to volume growth in the U.S. Pharmacy Channel, with a premium on the pods, as well as our international Omnipot revenue performance and improved manufacturing efficiency. While operating expenses increased in the quarter as we invest in our business, including multiple product launches globally, the timing of some expected spend shifted into the remainder of the year.
Anna: The increase in gross margin, which exceeded our internal expectations was primarily due to volume growth in the U S pharmacy channel.
Anna: With a premium on the pod as well as our international Omnipod revenue performance and improved manufacturing efficiencies.
Anna: While operating expenses increased in the quarter as we invest in our business.
Anna: Adding multiple product launches globally.
Anna: Timing of some expected spend shifted into the remainder of the year.
Anna: We will continue to invest to drive above-market growth while remaining committed to expanding operating margin through improvements in gross margin as well as efficiencies throughout our global business. Operating margin was 12.9% and adjusted EBITDA was 20.2% of revenue, both exceeding our expectations primarily due to higher than expected revenue and gross margin as well as timing of spend. Turning to cash and liquidity, we ended the quarter with approximately $750 million in cash and the full $300 million available under our credit facility.
Anna: We will continue to invest to drive above market growth, while remaining committed to expanding operating margins through improvements in gross margin as well as efficiencies throughout our global business.
Anna: Operating margin was 12, 9% and adjusted EBITDA was 22% of revenue.
Anna: Both exceeding our expectations, primarily due to higher than expected revenue and gross margin as well as timing of spend.
Anna: Turning to cash and liquidity, we ended the quarter with approximately $750 million in cash and the.
Anna: For $300 million.
Anna: Available under our credit facility.
Anna: As anticipated, our increased efforts to drive profitable growth are translating into expanding margins and a stronger overall financial profile. Now turning to our 2024 outlook, for the full year, we're raising expectations for total Omnipod revenue growth to a range of 15% to 19% and total company revenue growth to a range of 14% to 18%. For U.S. Omnipot, we are racing the low end of our guidance and now expect a range of 17 to 21% revenue growth.
Anna: As anticipated our increased efforts to drive profitable growth are translating into expanding margins and a stronger overall financial profile.
Anna: Now turning to our 2020 for outlook for.
Anna: For the full year, we're raising expectations for total omnipod revenue growth to a range of 15% to 19% and total company revenue growth to a range of 14% to 18%.
Anna: For U S. Omnipod, we are raising the low end of our guidance and now expect a range of 17% to 21% revenue growth, we expect growth to be driven by strong omnipod five adoption, which provides the benefit of reoccurring revenue stream due to.
Anna: We expect growth to be driven by strong Omnipot 5 adoption, which provides the benefits of a reoccurring revenue stream due to our annuity model. We continue to anticipate both revenue dollars and new customer starts in the second half of 2024 to be higher than levels in the first half of 2024, consistent with the normal historical seasonality trend. Additionally, our planned U.S. full market release of Omnibus 5 with G7 this summer is expected to contribute to the acceleration of new customer starts in the back half of the U.S. We are well-positioned to accelerate new customer starts this year, which we expect will drive further revenue growth next year and beyond.
Anna: Our annuity model.
Anna: We continue to anticipate both revenue and.
Anna: New customer starts in the second half of 2024 to be higher than levels in the first half of 2024, consistent with normal historical seasonality trends.
Anna: Additionally, our planned U S full market release of Omnipod files with G. Seven this summer.
Anna: Expect it to contribute to the acceleration of new customer starts in the back half of the year.
Anna: We are well positioned to accelerate new customer starts this year.
Anna: Which we expect will drive further revenue growth next year and beyond.
Anna: We have massive market opportunities, not only from further type 1 MDI penetration but also as we continue to penetrate the Type 2 market. We are building a Type 2 product portfolio and are excited to have this be one of our accelerated growth drivers over the near and long term. For International Omnipod, we are raising our revenue growth expectations by 500 basis points to a range of 12 to 15 percent. On a reported basis, we now assume an unfavorable foreign currency impact of 100 basis points.
Anna: We have massive market opportunities.
Anna: Not only from further type one MDI penetration.
Anna: But also as we continue to penetrate the type two market.
Anna: We are building a type two product portfolio and are excited to have this be one of our accelerated growth drivers over the near and long term.
Anna: For International Omnipod, we are raising our revenue growth expectations by 500 basis points to a range of 12% to 15%.
Anna: On a reported basis, we now assume an unfavorable foreign currency impact of 100 basis points.
Anna: We expect growth to be driven by last year's Omnipod 5 launches in the UK and Germany, partially offset by headwinds in the countries where we do not yet have Omnipod 5. The substantial raise in our international revenue outlook reflects the outperformance of new customer starts and revenue since we launched Omnipod 5 in the UK and Germany and, to a lesser extent, additional launches in 2024. We originally expected revenue growth in the first half of the year to be in the high single digits. With our revised outlook, we now expect first half growth of 13% to 15% and a similar second half year-over-year growth profile, also up from prior expectations.
Anna: We expect growth to be driven by last year's Omnipod five launches in the UK and Germany, partially offset by headwinds in the countries, where we do not yet have omnipod five.
Anna: The substantial rate in our international revenue outlook reflects the outperformance of new customer starts and revenue since we launched omnipod five in the UK and Germany and to a lesser extent the additional launches in 2024.
Anna: We originally expected revenue growth in the first half of the year to be in the high single digits.
Anna: With our revised outlook, we now expect first half growth of 13% to 15% and similar second half year over year growth profile.
Anna: Also up from prior expectations.
Anna: We expect our recent Omnipot 5 launches in 1Q to contribute to new customer starts in the second half of the year, and given the nature of our annuity model, to meaningfully contribute to our revenue growth in 2025. We have strong momentum internationally, and we are confident that Omnipod 5 will drive growth and share gain in every market in which we launch. For both the U.S. and international Omnipod, we expect quarterly revenue fluctuations resulting from the many product launches we have planned in 2024. This includes ramping inventory in the channels for new launches and reducing levels for the prior Omnipod generation. We do not expect this to materially impact our full year out.
Anna: We expect our recent Omnipod five launches in one Q2 contribute to new customer starts in the second half of the year and given the nature of our annuity model to more meaningfully contribute to our revenue growth in 2025.
Anna: Hi.
Anna: We have strong momentum internationally and we are confident that omnipod five will drive growth and share gains in every market in which we launch.
Anna: For both the U S and international Omnipod, we expect quarterly revenue fluctuations, resulting from the many product launches we have in 2024.
Anna: This includes ramping inventory in the channels for new launches.
Anna: And reducing levels for prior Omnipod generations we.
Anna: We do not expect this to materially impact our full year outlook.
Anna: Lastly, for drug delivery, we are reaffirming our expectations of a 50 to 60 percent decline. Turning to 2024 Gross Margin, We are reaffirming a range of 68 to 69%, closer to the midpoint of the ring. While we have a number of opportunities that could result in further gross margin expansion this year, we want to be prudent with our expectations given the risks that come with significant product launches and standing up a new manufacturing facility.
Anna: Lastly for drug delivery, we are reaffirming our expectations of a 50% to 60% decline.
Anna: Turning to 2020 for gross margin, we are reaffirming our range of 68% to 69% closer to the midpoint of the range.
Anna: While we have a number of opportunities that could result in further gross margin expansion. This year, we want to be prudent with our expectations given risks that come with significant product launches and standing up a new manufacturing facility.
Anna: We are in a fantastic position to continue driving further gross margin expansion over the near and long term, and we remain committed to doing so. We also have an increased commitment to drive operating margin expansion. While we continue to expect operating expenses to increase as we invest in R&D, clinical, and our commercial launches, we now expect to drive some operating leverage as we capitalize on our efficiencies and economies of scale. As a result, we are raising our operating margin expectations to approximately 13.5 percent, up 50 basis points from our original expectations.
Anna: We are in a fantastic position to continue driving further gross margin expansion over the near and long term and we remain committed to doing so.
Anna: We also have an increased commitment to drive operating margin expansion.
Anna: While we continue to expect operating expenses to increase as we invest in R&D clinical and our commercial launches.
Anna: We now expect to drive some operating leverage as we capitalize on our efficiencies and economies of scale.
Anna: As a result, we are raising our operating margin expectations to approximately 13, 5% up 50 basis points from our original expectation.
Anna: Although we don't guide to our effective tax rate, I will provide color since our income continues to grow. Our first quarter effective tax rate almost doubled to approximately 6% due to changes in income distribution among our jurisdictions.
Anna: Although we don't guide to our effective tax rate I will provide color since our income continues to grow.
Anna: Our first quarter effective tax rate almost doubled to approximately 6% due to changes in income distribution among our jurisdictions.
Anna: Given the positive trend in our earnings, we may reach a point this year where we conclude that the valuation allowance we have against our net deferred tax assets is no longer needed. We estimate this would result in a $200 million non-cash reduction of income tax expense in the period the release is recorded, which we would adjust out for non-GAAP purposes.
Anna: Given the positive trend in our earnings we may reach a point this year, where we conclude that the valuation allowance we have against our net deferred tax assets is no longer needed.
Anna: We estimate this would result in a $200 million noncash.
Anna: Noncash reduction of income tax expense in the period the releases recorded.
Anna: Which we would adjust out for non-GAAP purposes.
Anna: Subsequently, our effective tax rate may increase to an estimated annualized operational run rate of approximately 20% for the near term. Turning to our second quarter 2024 guide, we expect total Omnipod growth of 18 to 21% and total company growth of 15 to 18%. For U.S. Omnipod, we expect growth of 21 to 24%.
Anna: Subsequently, our effective tax rate may increase to an estimated annualized operational run rate of approximately 20% for the near term.
Anna: Turning to our second quarter 2024 guidance, we expect total omnipod growth of 18% to 21% and total company growth of 15% to 18%.
Anna: For U S. Omnipod, we expect growth of 21% to 24% growth drivers include the ongoing adoption of Omnipod five bringing with it the advantages of U S pharmacy channel.
Anna: Gross drivers include the ongoing adoption of Omnipod 5, bringing with it the advantages of the U.S. Pharmacy Channel, continued strong new customer starts, and the benefits of our anointing model. With our new customer start momentum, we expect sequential growth in the second quarter, partially offset by wholesalers taking down G6 pot inventory as we begin to ramp G7 pots. And we expect to see some meaningful second half sequential dollar growth due to the many catalysts we discussed.
Anna: <unk> strong new customer starts and the benefit of our annuity model.
Anna: With our new customer starts momentum, we expect sequential growth in second quarter.
Anna: Actually offset by wholesalers, taking down <unk> six spot inventory as we begin to ramp <unk> seven part and we expect to see some meaningful second half sequential dollar growth for the many catalyst we discussed.
Anna: For international Omnibud, we expect growth of 12 to 15%, driven by the ongoing adoption of Omnipod 5 in our initial market, partially offset by headwinds in countries where we do not have Omnipod 5. On a reported basis, we expect an unfavorable foreign currency impact of 200 basis points.
Anna: For International Omnipod, we expect growth of 12% to 15% driven by the ongoing adoption of Omnipod five in our initial market, partially offset by headwinds in countries, where we do not have omnipod five.
Anna: On a reported basis, we expect an unfavorable foreign currency impact of 200 basis points.
Anna: Finally, we expect Q2 drug delivery revenue to be approximately $4 million to $5 million. In conclusion, our strong first quarter results reflect continued successful execution of our strategy, as well as robust new customer starts in both our U.S. and international markets. In my first few weeks at Insulet, I have been incredibly impressed with what the company continues to accomplish, and I am even more energized by the incredible opportunities that lie ahead, which are greater than I had envisioned before joining.
Anna: Finally, we expect Q2 drug delivery revenue to be approximately 4 million to $5 million.
Anna: In conclusion, our strong first quarter results reflect continued successful execution of our strategy as well as robust new customer starts in both our U S and international markets.
Anna: In my first few weeks at Insulet I have been incredibly impressed with what the company continues to accomplish.
Anna: I'm, even more energized by the incredible opportunities that lie ahead.
Anna: Which are greater than I had ambition before joining.
Anna: We are well positioned and remain committed to delivering sustained revenue growth and margin expansion for the balance of this year and well beyond. With that, operator, please open the call for questions. Thank you. If you have a question at this time, please press the star and then one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key.
Anna: We are well positioned and remain committed to delivering sustained revenue growth and margin expansion for the balance of this year and well beyond with that operator. Please open the call for questions.
Speaker Change: Thank you. Thank you have a question at this time. Please press the Star then one key on your Touchtone telephone.
Anna: Question.
Anna: Third or you wish to remove yourself from the queue. Please press the pound key.
Anna: We are limiting each participants question till one however, please feel free to go back into queue and if time permits we will be more than happy to take your follow up questions at that time.
Operator: We are limiting each participant's question to one. However, please feel free to go back into queue. And if time permits, we will be more than happy to take your follow-up questions at that time. Our first question is from Margaret Caxor Andrew with William Blair. Margaret, your line is open.
Anna: Our first question is from Margaret <unk>, Andrew with William Blair.
Speaker Change: Your line is open.
Malgorzata Maria Kaczor Andrew: Hey, good afternoon, guys. Thanks for taking the question. Maybe just to start with kind of a big picture question, 2024 certainly seems like a year, probably as active as you guys have been with new launches, with an eye maybe towards 2025 acceleration in revenues as the new patient starts increasing in the back half of this year. So one, I guess, is that how you guys are thinking about it?
Speaker Change: Hey, good afternoon, guys. Thanks for taking my question.
Malgorzata Maria Kaczor Andrew: Maybe just to start a.
Malgorzata Maria Kaczor Andrew: Start with kind of a big picture question on 2024, certainly seems like a year probably as active as you guys have been with new launches.
Malgorzata Maria Kaczor Andrew: With an I may be towards 2025 acceleration in revenues.
Malgorzata Maria Kaczor Andrew: The new patient starts accelerated back half of this year. So one I guess is that how you guys are thinking about it and then two is it Q4 to think that as new patient starts accelerating back half those can add a step change in new start growth.
James Hollingshead: And then two, is it too forward to think that as new patients start accelerating the back half, those can add a step change and new start growth? Or is it going to be more of a steady acceleration as you launch all of these different initiatives in the back half of this year? Thanks. Thanks, Margaret. Great question.
James Hollingshead: Or is it going to be more of a steady acceleration as you launch all of these different initiatives in the back half of this year.
James Hollingshead: Yes.
James Hollingshead: We think that the timing of the product launches is really critical to ramping over the course of the year in 2024, and so that's why we're really excited to be in LMR and be able to say that we anticipate the full release of G7 in the U.S. over the summer and to already be in LMR doing really well with our sensor of choice offering, including the Libre 2 Plus in Europe. And we do think that both new customer starts and revenue continue to accelerate over the course of the year, and we'll see revenue results more strongly in the second half of the year. Great, thank you. Your next question comes from the line of Robbie Marcus with JPMorgan. Robby, your line is open.
James Hollingshead: Thanks, Margaret Great question.
Robert Justin Marcus: We think that the timing of the product launches is really critical to ramping over the course of the year in 'twenty four and so that's why we're really excited too.
Robert Justin Marcus: B in LMR and be able to say that we anticipate for release of <unk> seven in the U S over the summer and to already be in LMR going really well with our sensor choice offering with including the Libre two plus in Europe, and we do think that both new customer starts.
Robert Justin Marcus: <unk> to accelerate over the course of the year and revenue continues to accelerate and we will see the revenue results more strongly in the second half.
James Hollingshead: Okay.
James Hollingshead: Great. Thank you. Your next question comes from the line of Robbie Marcus with Jpmorgan.
Robert Justin Marcus: Ravi Your line is open.
Operator: Oh, great. Thanks for taking the question and congrats on a really nice quarter. I wanted to ask, yeah, what you're seeing competitively in the market, both in Type 1 and Type 2. Type 2 starts were particularly strong. It sounded like new patient growth wasn't a record, but it was still very robust.
Robert Justin Marcus: Oh, great. Thanks for taking my question.
Operator: That's on a really nice quarter.
Speaker Change: Thanks Al.
Speaker Change: Yes, I wanted to ask on <unk>.
Operator: What youre seeing competitively in the market both in type one and type two type two starts were particularly strong it sounded like new patient growth wasn't a record but was still very robust.
Robert Justin Marcus: And, you know, I think it was expected to be below record given, you know, no G7 integration yet or Apple. But I would love to hear how you feel you're doing competitively in terms of new patient share and any competitive switching. And also, if I could just tack on, I heard there was de-stocking in the second quarter. Was there any stocking or de-stocking in the first quarter?
Operator: It was expected to be below record given.
Robert Justin Marcus: No G seven integration, yet or Apple, but would love to hear how you feel you're doing competitively in terms of new patient share in any competitive switching and also if I could just tack on.
Robert Justin Marcus: I heard there was destocking in second quarter was there any stocking or destocking in first quarter and how do we think about the dollar impact in second quarter in the U S. Thanks.
James Hollingshead: And how do we think about the dollar impact in the second quarter in the U.S.? Thanks. I think there are a bunch of things.
James Hollingshead: Let me start with the stocking question and then come back to the competitive question. Stocking, we're only ever going to call that out if there's something unusual. The stock in the channel is back to normal. We don't see anything unusual happening, and we're not going to talk about that unless we ever see something change that we think changes the trend or whatever. That dynamic is totally ordinary in the quarter.
Speaker Change: I think there is a bunch of things and then let me start with the stocking question then come back to the competitive question.
James Hollingshead: So.
James Hollingshead: Stocking and it were only ever going to call that out if there's something unusual and channel.
James Hollingshead: And the channel is.
James Hollingshead: Back to normal we don't see anything unusual happening and we're not going to talk about that unless we ever see something change that we think changes trend or whatever so that dynamic is totally ordinary in the quarter.
James Hollingshead: So on the competitive position, we feel really strong about our competitive position, we're very very confident in our competitive position new quarters, new customer starts in the first quarter in the U S came in right in line with our expectations.
James Hollingshead: On the competitive position front, we feel really strong about our competitive position. We're very, very confident in our competitive position. New customer starts in the first quarter in the U.S. came in right in line with our expectations, and obviously, in Europe, they did really, really well, which led us to raise our guide. I think competitively, it'll give me an opportunity to just say a little bit about how we see the dynamic, which I'll try to be concise with.
James Hollingshead: And obviously in Europe did really really well, which led us to raise our guide and I think competitively.
James Hollingshead: Give me an opportunity to just say a little bit about how we see the dynamic which I will try to be concise with.
James Hollingshead: You know, in the U.S., for Type 1, the bulk of the market is still MDI, as you all know. So we estimate that, as we've said before, 40% of Type 1 patients in the U.S. are using some sort of pump technology, and 60% are not.
James Hollingshead: In the U S. In type one the bulk of the market is still on MDI as you. All know so we estimate that as we've said before 40% of type one patients in the U S are using some sort of pump technology and 60% are not our offering omnipod five has been designed to convert people off of MDI onto.
James Hollingshead: Our offering, Omnipot 5, has been designed to convert people off of MDI onto our technology because it's so simple to use, simple to put on, simple to use, simple to stay on, easy to access, great economics, and great clinical outcomes. So that's why we always say MDI is our target market, and from a competitive positioning point of view, we win that battle very, very handily. We clearly lead the market in MDI, and it's really Omnipot 5 that's growing the market in Type 1 for technology because we have such a clear leadership position.
James Hollingshead: Our technology, because it's so simple to use simple to put on simple to use simple to stay on easy to access great economics, and great clinical outcomes and so that's why we always say MDI is our target market.
James Hollingshead: From a competitive positioning point of view, we win that battle very very handily, we clearly lead the market in MDI and it's really only about 5% thats growing the market in type one for technology, because we have such a clear leadership position there.
James Hollingshead: In the remaining 40% that's penetrated, you do see, you know, there's a portion of that market that does have some competitive switching. And what we see over and over again, and again, in this quarter, is that we are the net winners in the competitive switching game. That's a smaller part of the market to begin with, and then it's only a fraction of that market that's up for conversion at any given time because of the four-year lock-in on the two pumps.
James Hollingshead: And the remaining 40% Thats penetrated you do see there is a portion of that market, which does have some competitive switching and what we see over and over again and again in this quarter is that we are the net winners in the competitive switching it and Thats a smaller part of the market to begin with and then it's only a fraction of that market that's up for conversion at any given time because of the four year law.
James Hollingshead: In the two pumps, but we are clearly the net winners in any kind of competitive switching dynamic so.
James Hollingshead: But we are clearly the net winners in any kind of competitive switching dynamics. So, you know, in sum, we lead in Type 1 clearly, we lead in Type 2 clearly, we lead very clearly in MDI, and we win the competitive switching game in the installed base. And so we feel very confident Omnipod 5 wins everywhere it goes. And we see that over and over again.
James Hollingshead: We lead in type one clearly we lead in type two clearly we lead very clearly in MDI and we win the competitive switching game in the installed base and so we feel very confident omnipod five wins everywhere. It goes and we see that over and over again.
James Hollingshead: Great, thank you so much. Your next question comes from the line of Jeff Johnson with Baird. Jeff, your line is... Thank you, good evening, all.
James Hollingshead: Great. Thank you. So much. Your next question comes from the line of Jeff Johnson with Baird Jeff.
Jeffrey D. Johnson: Your line is open.
Operator: Jim, maybe we can stay on that type 2 point. So forgive me; you've already talked about this, and I think you put a good focus on it. But, you know, we've seen the ATTD data that suggests GLP-1s might bring heavy insulin users back down to that 60, 65 units a day range where you can put them on a pump. We know you guys have shown some strong real-world data on T2 time and range.
Jeffrey D. Johnson: Thank you good evening, all Jim maybe we can stay on that type two point. So forgive me you've already talked about this and I think pretty good focus on it but we've seen the <unk> data that suggest <unk> ones might bring heavy insulin users back down to that like $60 65 units a day range, where you could put them on a pump. We know you guys have shown some strong real world World data on <unk> time.
Operator: So some of your competitors, it sounds like the KOLs are starting to push more and more for getting these type 2 intensives on AIDs as well. And you guys especially have been investing in the primary care channel, where I think a lot of that T2 care is delivered. So, you know, how close are we getting to the precipice of kind of this, you know, inflection and type 2 uptake?
Operator: <unk> <unk> range. So some of your competitors. So it sounds like the Kols are starting to push more and more for getting these type two intensive on AIG as well and you guys, especially has been investing in the primary care channel, where I think a lot of that <unk> care is delivered so.
Jeffrey D. Johnson: And I know it's been going up in your numbers the last few quarters. We can see that, but it seems like we're still maybe not there, but getting real close to an inflection, you know, not just for the market but maybe your competitive positioning in there with O5 as well. Thanks. Thanks, Jeff. Great question.
Jeffrey D. Johnson: How close are we getting to the precipice of kind of this inflection in type two uptake and I know, it's been going up in your numbers. The last few quarters, we can see that but it seems like we're still maybe not there, but getting real close to an inflection.
Jeffrey D. Johnson: Not just for the market, but maybe your competitive positioning in there without <unk> as well thanks.
James Hollingshead: We are really excited about the opportunity for AID in the Type 2 market. And, you know, as we know, we're already the clear leader in that market with Omnipod Dash. So in the pump market, Omnipod Dash is a very clear leader.
Speaker Change: Thanks, Jeff Great question.
Speaker Change: Really excited about the opportunity for AIG in the type two market and then.
James Hollingshead: As we know we're already the clear leader in that market with Omnipod dash. So in the pump market with Omnipod Dash very clear leader and you all know we don't promote omnipod five.
James Hollingshead: And you all know, we don't promote Omnipod 5 because we don't have the label. So we don't promote Omnipod 5 in the Type 2 market. But it gets written off label fairly frequently, as you can kind of reverse engineer out of our numbers.
James Hollingshead: Because we don't have the label. So we don't promote omnipod five in the type two market.
James Hollingshead: But it gets written off label fairly frequently as you can kind of reverse engineer out of our numbers. That's why we're so excited to be getting so close to filing with the FDA for a label extension because right now we're out in the market with one arm tied behind our back and we are very firm conviction that as we get that label extension, we will be able to drive dramatic.
James Hollingshead: That's why we're so excited to be getting so close to finally getting the FDA's label extension for Omnipod 5, because right now, we're out in the market with one arm tied behind our backs. And we have a very firm conviction that as we get that label extension, we'll be able to drive dramatic growth in the use of Omnipod 5 specifically, and not just AID, obviously, but Omnipod 5 specifically in that market. So we're getting very close.
James Hollingshead: Growth in the use of Omnipod five specific not just AIB, obviously that omnipod five specifically in that market. So we're getting very close as we said about the pivotal trial.
James Hollingshead: As we said about the pivotal trial, you know, we've not just completed enrollment, but we have the last patient through the trial. So we're in the process of, you know, gathering, and cleaning up the normal steps of a pivotal trial. We're gathering and cleaning the data. We're preparing our FDA filing. We're well on track to file, you know; we've given guidance that we should file by the end of the year. We are very well on track to do that.
James Hollingshead: <unk>.
James Hollingshead: Not just completed enrollment, but we have last patient through the trial. So we are in the process of gathering cleaning that didnt normal steps of the pivot over gathering cleaning the data we're preparing our FDA filing we're well on track to file we've given guidance that we had five by the end of the year, we are very well on track to do that and.
James Hollingshead: Based upon what we've seen from our competitors.
James Hollingshead: And based on what we've seen from our competitors, we're clearly out in front of everybody else in that market. But also remember Omnipod 5, the offering itself is going to be, it has a very clear right to win in the Type 2 space because of its ease of use, its discretion, its availability and pharmacy channel, its great outcomes, which we'll demonstrate further with data and Type 2. So we are very, very bullish on the Type 2 market. It continues to be a very clear unmet need.
James Hollingshead: We're clearly out in front of everybody else in that market, but also remember omnipod five the offering itself is going to be it has a very clear right to win in the type two space because of its ease of use its discretion. It's available in the pharmacy channel is it's great outcomes, which will demonstrate further with data in type two.
James Hollingshead: So we're very very bullish on the type two market. It continues to be a very clear unmet need and we feel like we have what will be the best offering in the market and will probably be there first.
James Hollingshead: And we feel like we have what will be the best offering in the market, and we'll probably be there first. Thank you. Your next question comes from the line of Michael Pollack with Wolf Research. Good afternoon.
Michael Pollack: Thank you.
James Hollingshead: Our next question comes from the line of Michael Pollack with Wolfe Research Michael Your line is open.
Operator: Thank you for taking the question. Maybe a quick follow-up on Type 2 there. Is it the expectation that we'll see data from the SECURE trial at ADA?
Michael Pollack: Hey, good afternoon, and thank you for taking the question maybe a quick follow up on type two there is the expectation that we'll see data from the secure trial.
Michael Pollack: At Ada.
Michael Pollack: Yes, Michael, thanks for the question. It's our intent to show data from the STEP trial at ADA, and with a specific focus on showing the subset analysis of people who are on GLP-1s in that data. Yes. And your next question comes from the line of Travis Steed with Bank of America. Travis, your line is open.
Michael Pollack: Yes, Michael Thanks for the question, it's our intent to show data from the step trial at Ada and.
Travis Lee Steed: With a specific focus on showing the subset analysis of people who are on <unk> and that data yes.
Michael Pollack: And your next question comes from the line of Travis Steed with Bank of America.
Travis Lee Steed: Your line is open.
James Hollingshead: Hey, thanks for taking the question. I wanted to follow up on the Q2 guidance. It looks like the guidance you gave is sequentially down, but you said in the prepared marks.
Travis Lee Steed: Hey, Thanks for taking my question I wanted to follow up on the Q2 guidance.
Travis Lee Steed: It looks like the guidance you gave is sequentially down, but you've said in the prepared remarks.
Operator: You expect sequential growth in the second quarter, offset by the wholesalers taking down the G6 inventory. I'm curious if you could help quantify what that guide assumes for the impact of that G6 inventory piece, just so we can kind of get an underlying Q2 guide in. Hey Travis, this is Anna.
Travis Lee Steed: You expect sequential growth.
Anna: In the second quarter offset by the wholesalers, taking down the inventory and so curious if you could help quantify what that guide assumes for the.
Anna: The impact of that <unk> inventory piece.
Anna: You can kind of get the underlying Q2 guidance.
Travis Lee Steed: Thanks for the question. I think the main point here is to take a step back. And as you look at the US, we not only reaffirmed our full-year guidance, but we actually are taking up the low end. And as I mentioned in my prepared remarks, you know, as we have all these cascades of new product launches, both in the US and internationally, we're making assumptions. And, as we do that, the key here is to remember that we believe the second half will see greater growth than the first. But we continue to expect growth. And I think calling the exact timing is we're giving our best estimate.
Operator: Hey, Travis this is Anna thanks for the question.
Travis Lee Steed: I think the main point here is to take a step back and as you look at the U S.
Travis Lee Steed: We not only reaffirmed our full year guidance, we actually are taking up the low end.
Travis Lee Steed: And as I mentioned in my prepared remarks, as we have all of these cascade of new product launches both in the U S and international.
Travis Lee Steed: We're making assumptions.
Travis Lee Steed: And as we do that.
Travis Lee Steed: The key here is to remember that we believe the second half will be greater growth.
Travis Lee Steed: The first.
Travis Lee Steed: But we continue to expect the growth and I think to call. The exact timing is we're giving our best estimate.
Travis Lee Steed: But the key important thing is that we're raising our overall guidance for revenue, including international and low end in the U S.
Travis Lee Steed: Okay.
Anna: But the key important thing is that we're raising overall guidance for revenue, including international and the low end in the US. Thank you, and your next question comes from the line of Larry Biegelsen with Wells Fargo. Larry, your line is open. Hi, good afternoon.
Travis Lee Steed: Thank you and your next question comes from the line of Larry Michelson with Wells Fargo. Larry Your line is open.
Operator: Thanks for taking the question. Jim, I wanted to circle back on new patient starts in the U.S. You know, I heard robust U.S. Type 1 and Type 2 new starts in Anna's prepared remarks. Were new patient starts up year over year in Q1 in the U.S.?
Lawrence H. Biegelsen: Hi, good afternoon. Thanks for taking the question Jim I wanted to circle back on new patient starts in the U S.
Lawrence H. Biegelsen: I heard a robust U S type one and type two new starts in <unk> prepared remarks.
Lawrence H. Biegelsen: New patient starts up year over year in Q1 in the U S D.
Lawrence H. Biegelsen: And do you still expect, you know, new starts to grow year over year in 2024? And talk about why you see G7 as the driver of new start growth in the second half of the year. Thank you.
Lawrence H. Biegelsen: Do you still expect new starts to grow year over year.
Lawrence H. Biegelsen: In 2024 and talk about why are you <unk> said that as a driver of new starts.
Lawrence H. Biegelsen: Growth in the second half of the year. Thank you.
James Hollingshead: Year over year in Q1, overall new starts were not up, but MDI was up for us. So that gives you a sense of our strength in bringing customers out of MDI into the market. We expect sequential growth over the course of the year and new customer starts in the U.S. As I said before, I expect a record for us in the U.S. and globally in NCS for 2024. And what was the last part of your question, Larry? Let's conceptually understand why G7 integration is a driver of that new startup growth. Thank you very much.
Jim: Thanks, Larry.
Jim: Year over year in Q1 overall, new starts were not up that MDI was up for us. So that gives you a sense of our strength.
James Hollingshead: And bringing customers out of MDI into the market.
James Hollingshead: We expect sequential growth over the course of the year in new customer starts in the U S. As I've said before I expect a record for us in the U S.
James Hollingshead: And globally and NCS for 2024.
James Hollingshead: And what was the last part of your question Larry.
James Hollingshead: Conceptually I understand why <unk> integration is a driver of that new start growth.
Speaker Change: Thank you very much so G. Seven G seven will be a tailwind for us once we get to full market release because of the nature of prescriptions, new customer prescriptions for CGM in the U S market. So I know you all look at this but if you go look at new customer scripts for CGM.
James Hollingshead: So G7 will be a tailwind for us once we get to full market release because of the nature of prescriptions, new customer prescriptions for CGM in the U.S. market. So I know you all look at this, but if you go look at new customer scripts for CGM, G7 has overtaken G6. And so you guys have always heard me use this metaphor of fishing in a stocked pond.
James Hollingshead: G. Seven has overtaken <unk> and so you guys are always use me her.
James Hollingshead: Heard me use this metaphor of fishing in a stocked pond.
James Hollingshead: We've done obviously very, very well fishing in the G6 pond and have led the new starts with G6. And in the quarter, I think you can see from our new customer starts, it has not been a headwind for us to have the G7 out on the market and be so well adopted because what we found, and with new customer starts right in line with our expectation, what we found is that if people want to be on Omnipod 5, they'll stay on a G6, or if they want to start AID on an Omnipod 5, they'll go get a G6.
James Hollingshead: We've done obviously very very well fishing in the G. Six bond and have led led to new starts with <unk> six.
James Hollingshead: In the quarter I think you can see from our new customer starts it has not been a headwind for us.
James Hollingshead: To have the G seven out of the market and be so well adopted because what we found with new customer starts right in line with our expectation. What we found is that if people want to be on Omnipod five.
James Hollingshead: <unk> six or if they want to start by five to go get a <unk> six so that hasnt been a headwind, but <unk> will be a tailwind because there are more and more patients out there on <unk> seven and as we've said all along.
James Hollingshead: So that hasn't been a headwind, but G7 will be a tailwind because there are more and more patients out there on G7. And as we've said all along on the Omnipod 5 ride since we launched, our CGM partners pave the road for us. And so Dexcom is now paving the road with G7. We need to get a car on that road.
James Hollingshead: The Omnipod five rides since we've launched the CGM, our CGM partners Pave road for Us and so <unk> is now paving roads with G. Seven we need to get a car on that road right. So that's why the timing of G. Seven launch is really important to us and we want to get a market with it with full release as quickly as we can and that's why we believe <unk> will be a tailwind.
Operator: So that's why the timing of the G7 launch is really important to us, and we want to get on market with it with full release as quickly as we can. And that's why we believe G7 will be a tailwind in the second half and will drive more new customer starts in the second half because we'll add G7 to the portfolio. Thank you. Your next question comes from the line of Patrick Wood with Morgan Stanley. Patrick, your line is open.
Patrick Wood: In the second half and will drive more new customer starts in the second half because we'll add G seven to the portfolio.
Patrick Wood: Brilliant, thanks for taking the question. You guys have mentioned a few times that, you know, learnings and type two and that side of things. And so I guess my basic question is, and I know you've been investing there and you've just upped the guide on the margin side of things, but, you know, these are very different patients, and PCPs are very different and require a different amount of training. As we ramp through the back half of this year and into next year, do you think there's like an investment cycle again needed from you guys in driving that type two market, particularly on Thanks, Patrick. It's a great question.
Operator: Thank you. Your next question comes from the line of Patrick Wood with Morgan Stanley Patrick Your line is open.
Speaker Change: Brian Thanks for taking my question.
Patrick Wood: You guys had mentioned a few times that learnings and type II in that side of things and so I guess my basic question is on I know you've been investing there and you just up the guide on the margin side of things, but these are very different patients and PCP is a very different and require a different amount of training as we ramp through the back half of this year and into next year do you think there is.
Patrick Wood: And investment cycle again needed from you guys in driving that type two market, particularly on the service and support side.
Patrick Wood: Okay.
James Hollingshead: That's part of the purpose of the commercial pilot, is to get out in the real world and see how those practices operate. Because historically, our call point has been endocrinology practices. And so we're calling on primary care and specifically on primary care who, when you look at their prescribing behavior overall with things like CGM and insulin, look more like endo practices than like true general practice. And so we've been out in the world calling on those practices to see how they manage patients, how they manage diabetes therapy.
Speaker Change: Thanks, Patrick Thats, a great question.
James Hollingshead: As part of the purpose of the commercial pilot is to is to get out in the real world and see how those practices operate because historically our call point has been in endocrinology practices and so we are out calling on primary care and specifically on primary care, who when you look at their scripting behavior overall with things like CGM and insulin <unk>.
James Hollingshead: Look more like Endo practices, then like true general practices right and so we've been out in the world, calling on those practices to see how they how they manage patients how they manage diabetes therapy, and we've learned a lot and what we want to do out of that learning coupled with the portfolio that we'll bring to market is to figure out.
James Hollingshead: And we've learned a lot, and what we want to do out of that learning, coupled with the portfolio that we'll bring to market, is to figure out, you know, this is kind of the term of art, the right selling motion. So that'll include what's the right sales rep design, so the role description for that sales rep, and what's the right support. Right now, we have quoted reps paired up with clinical service manager reps who do both. Does that mix of reps look the same? Is it different? What's the reach?
James Hollingshead: The term of our at the right selling motion so that will include.
James Hollingshead: What's the what's the right sales rep designs of the rule description for that sales rep, what's the right support.
James Hollingshead: Right now we have quoted reps paired up with clinical service manager reps, who do both does that mix of wrapped with the same is it different.
James Hollingshead: What's the so-called share of voice and design and commercial model? I think the reason we're so bullish on what we've learned out of the pilot is, first of all, as we've said in the past, Omnipod as a platform is so simple to use that often the phenomenon is when we walk into those practices and say, hey, we're here to talk about an insulin pump, their first reaction is, we don't do insulin pumps because they're too complicated, and then we show them Omnipod Go, and they say, wait a minute, that's an insulin pump, and it's so simple to use that it leads to a more holistic conversation about insulin delivery.
James Hollingshead: What's the reach what's the so called share of voice and design a commercial model I think the reason we're so bullish on what we've learned out of the pilot is first of all as we've said in the past.
James Hollingshead: And often then, they start to ask about basal bolus solutions, which then leads us to talk about DASH. And so one of the key learnings is that we think in those practices, there's an opportunity not just for Omnipod Go but ultimately for Omnipod 5 and intensive insulin therapy. And the other thing I think we're finding is that there's a range of patients out there. You know, the kind of stereotypical view is that type 1 patients are treated in endocrinology, and type 2, a lot of type 2 patients are treated in general practice, but we're actually finding there are both in both. And so, you know, a lot of the intensive users, intensive insulin users type 2 patients are already in endocrinology, but we also see them in primary care.
James Hollingshead: Omnipod is a platform is so simple to use that often the phenomenon is when we walk into those practices and say hey, we're here to talk about an insulin pump. The first reaction is we don't do insulin pumps because they are too complicated and then we show them Omnipod go and they say wait a minute that's an insulin pump and it's so simple to use that it leads to a more.
James Hollingshead: More holistic conversation about insulin delivery and often then they start to ask about basal bolus solutions, which then leads us to talk about dash and so one of the key learnings as we think in those practices. There is an opportunity not just for Omnipod go, but ultimately for Omnipod, five and intensive insulin therapy and the other thing I think we are finding is that.
James Hollingshead: There is a range of patients out there so I think.
James Hollingshead: <unk>.
James Hollingshead: The kind of stereotypical view is that.
James Hollingshead: Type one patients are treated in endocrinology and type two a lot of type two patients are treated in general practice, but we're actually finding there is both in both.
James Hollingshead: And so.
James Hollingshead: A lot of the intensive user intensive.
James Hollingshead: Intensive insulin using type two patients are already in endocrinology. We also see them in primary care and we see actually a surprising number of type one patients being treated in primary care as well. So we think the opportunity there is different and more promising than when we initially launched the pilot and we will be making.
James Hollingshead: And we see, actually, a surprising number of type 1 patients being treated in primary care as well. So we think the opportunity there is different and more promising than when we initially launched the pilot, and we will be making, you know, a determination about the commercial model, and then, in direct answer to your question, there probably will be some more investment in sales and support. Thank you. Your next question comes from the line of Matt Taylor with Jeffries. Now your line is open.
Matthew Charles Taylor: Making a determination about the commercial model and then there'll be two in direct answer to your question there probably will be some more investment in sales and support to capture it.
James Hollingshead: Thank you. Your next question comes from the line of Matt Taylor with Jefferies.
Matthew Charles Taylor: Your line is open.
Operator: Hi, thank you for taking the question. I guess I was wondering if you could comment on some market growth, just with all the enhancements going on with integrations and technologies across the space. Can you comment on whether you think the market growth is accelerating, or whether you think it will accelerate in the coming quarters or next year? Thanks, Matt.
Matthew Charles Taylor: Alright. Thank you for taking my question I guess I was wondering if you could comment on home market growth just with all of the <unk>.
Operator: Enhancements going on with integrations and technologies across the space can you comment on whether you think the market growth is accelerating or do you think it will accelerate.
Operator: In the coming quarters or next year.
Matthew Charles Taylor: We think that you can see the normal cyclicality in the market, but the market is growing first. And there are two drivers of market growth. The first one is the widespread adoption of CGM.
Speaker Change: Thanks, Matt.
Speaker Change: We think that you can see the normal cyclicality in the market, but the market is growing <unk>.
James Hollingshead: And the second big driver of market growth is Omnipod 5 because it makes it so simple to come on to AID. And so as we continue to lead in MDI with a very clear leadership position in MDI, those MDI patients are the growth market for AID, and we are leading the way there. So the technology itself is driving market growth, and our CGM partners are doing it, and we're leading the way in AID. Thank you! Your next question comes from the line of Matthew O'Brien with Piper Sandler. Matthew, your line is open. Hey, this is Phil on for Matt.
Phil: There is two drivers of market growth. The first one is the widespread adoption of CGM and the second big driver of market growth as Omnipod five because it makes it so simple to come on to AIG.
Phil: And so as we continue to lead in MDI with a very clear leadership in the MDI position those MDI patients our market growth rate and we are leading the way there. So the technology itself is driving market growth and our CGM partners are doing it and we're leading the way in AIB.
James Hollingshead: Yeah.
Phil: Thank you. Your next question comes from the line of Matthew O'brien with Piper Sandler.
Phil: Your line is open.
Operator: Thanks for taking our questions. And just to circle back to Travis's question from before, because I'm not sure that was explicitly clear as it relates to Q2. For total Omnipod, can you confirm that Q2 growth would be sequentially higher if you back out this wholesaler dynamic? And then, just for some who are listening who might not be familiar, can you talk about the fact that G6 pods are different than G7 pods?
Speaker Change: Hi, This is Joe on for Matt. Thanks for taking our questions and just to circle back to <unk> question from before because I'm not sure that was explicitly clear as it relates to Q2 for total Omnipod can you confirm that Q2 growth would be sequentially up if you back out this wholesaler dynamic and then just for some who are listening who might.
Operator: Be familiar can you talk about the fact that G. Six pods are different than <unk> seven pod. Thank you Len.
Operator: Thank you. Let me start on the pods and then I'll ask Anna to comment, and then we'll go back to the Q2 financials. The G6, G7 pods, when we get to full release for the G7 integration, those will be backwards compatible pods. So the current pods can only connect with G6, but when we launch G7, the G7 pods will be G7 and G6 compatible and will be backward
Operator: Start on the pods and then I'll ask Andrew to comment and I'll go back to the Q2 financials. So.
Anna: The G six G seven pods.
Anna: When we get to full release of for.
Anna: The G. Seven integration those will be backwards compatible pods. So the current pods only can only connected <unk> six but when we launched <unk> seven the G. Seven pause will be <unk>, six pods and be backwards compatible so what that will mean for our customer or user is if they want to stay on the <unk> they'll be able to stay on the <unk> because the <unk>.
Phil: So what that will mean for a customer or a user is that if they want to stay on the G6, they'll be able to stay on the G6 because the pods will work with it, but they will also accept G7. And so it'll be kind of a sensor of choice within the Dexcom family of sensors. Anna, do you want to take it?
Anna: <unk> will work with it but it will also accept <unk> seven and so it would be kind of a sensor of choice within the <unk> family of CGM.
Phil: Anna do you want to take that sure listen I'll take another stab at at here, the <unk> guidance and I just once again I want to put it in overall perspective for the year.
James Hollingshead: Sure. Listen, I'll take another stab at this 2Q guidance. And I just, once again, I want to put it in the overall perspective for the year. We're taking up our guidance in the US, even at the low end, and we expect overall that sequential growth to be there, as I stated. And I think the key point to mention here is we made our best assumption here as we have this transition of product out in the market, and we called it our best estimate, and we will update it as we progress through the year.
James Hollingshead: We're taking up our guidance.
James Hollingshead: In the U S. Even in the low end and we.
James Hollingshead: We expect overall that sequential growth to be there as I stated.
James Hollingshead: And I think the key point to mention here is.
James Hollingshead: We made our best assumption here as we have this transition of product.
James Hollingshead: Out in the market and we call our best estimate and we will update as we progress through the year, but we feel very confident over the entire calendar year.
James Hollingshead: But we feel very confident about the entire calendar year with the guide we've given. Great, thank you so much. Your next question comes from the line of Jayson Bedford with Raymond James. Jayson, your line is open.
Jayson Tyler Bedford: With the guidance we've given.
Jayson Tyler Bedford: Great. Thank you so much your next.
James Hollingshead: Question comes from the line of Jayson Bedford with Raymond James Jason Your line is open.
Operator: Thanks and good afternoon. Welcome, Anna. I guess I have a question on international growth. I think you mentioned that first and second half growth would be in the, I think you said 13 to 15% range. Just given the annuity model, given the new products, geographies, why wouldn't second half growth be higher than first half?
Jayson Tyler Bedford: Thanks, and good afternoon and welcome Ana.
Operator: I guess I have a question on international I think you mentioned that first and second half growth would be in the I think you said, 13% to 15% range just given the annuity model given the new products geographies.
Operator: Why wouldn't second half growth to be higher than first half.
Jayson Tyler Bedford: Thanks. Thank you for the question. Listen, as I mentioned here, we took the entire guidance up 500 basis points. And that's given what Jim referred to. I mean, the adoption we're seeing on Omnipot 5 is phenomenal and great.
Anna: Thank you for for the question listen as high.
Anna: And here, we took the entire guidance up 500 basis points.
Anna: And that's given what Jim referred to let me be adoption, we're seeing on Omnipod five is phenomenal and great.
Anna: We're gonna be in more markets as well, and the markets, all of these European markets have slightly different dynamics. Some of them are in four-year cycles, so on and so forth.
Anna: We're going to be in more markets as well and the markets. All of these European markets have a slightly different dynamic some of them are in four year cycle. So on and so forth. So we feel good with the guidance that were given.
Anna: So we feel good with the guidance that we're given. And, in anything that's new, you know, our goal and the philosophy of this team, and my philosophy is we want to give you numbers that we can hit. We definitely don't want to miss.
Anna: And in.
Anna: In anything that's new or goal and the philosophy of this team and my philosophy is we want to give you numbers that we can hit.
Anna: So that's kind of the philosophy in which the spirit and we felt the 500 basis point guide up was significant. We will learn a lot more as we go through the next few months and as we learn more of these launches, and we will update accordingly. Great, thank you so much. Your next question comes from the line of Steve Lichtman with Oppenheimer & Co. See if your line is open. Thank you, evening everyone.
Anna: We definitely don't want to Miss So that's kind of the philosophy in which the spirit and we felt a 500 basis point guide up was significant we will learn a lot more apps as we go through the next few months and that as we learn more of these launches and we will update accordingly.
Anna: Great. Thank you. So much. Your next question comes from the line of Steve Lichtman with Oppenheimer <unk> co.
Steven Michael Lichtman: Steve Your line is open.
Steven Michael Lichtman: Thank you evening everyone.
Operator: So yeah, just building on that last question, given the annuity model, really nice to see this near-term outperformance and assuming it's led by steeper ramp and new starts. Are there any new start metrics you can provide from outside of the U.S.? And are you getting a higher price point for O5 outside of the U.S.?
Steven Michael Lichtman: So just building on that last question, you've given the annuity model.
Operator: Really nice to see this near term outperformance.
Operator: And assuming it's led by steeper ramp in new starts.
Operator: Are there any new start metrics you can provide outs from outside of the U S. And are you getting a higher price point for all five outside of the U S. So this is a mix opportunity as well.
Steven Michael Lichtman: So this is a mixed opportunity as well. As you know, Steve, we don't give guidance on actual numbers and so on, but we did try to allude, in the prepared remarks, to the fact that Omnipod 5 is out of the gate so strong in the UK and Germany that already in Europe, more than half of our new customers start with Omnipod 5. So that'll give you some color on the strength of the adoption. We'll launch in France over the summer. We're in the Netherlands, in LMR, and we'll get to FMR in the Netherlands, and then we'll launch in France over the summer.
Steven Michael Lichtman: Sure.
Steven Michael Lichtman: We don't as you know Steve we don't.
Steven Michael Lichtman: Give guidance on actual numbers and so on but we did we did try to allude I think in the prepared remarks to the fact that Omnipod five is out of the gate. So strong in the UK and Germany that already in Europe more than half of our new customer starts for Omnipod five so thats that will give you some color on the strength of the adoption.
Steven Michael Lichtman: We'll launch in France over the summer and then the France.
Steven Michael Lichtman: In Netherlands in LMR, and we'll get we'll get to <unk> in the Netherlands, and then we'll launch in France over the summer and Theres a ramp as you all know to the dynamic.
James Hollingshead: And there's a ramp, as you all know, to the dynamic. And so that's how you should expect to see it. If we ramp up those countries the way we are, we'll see a revenue impact. And depending on how quickly we can get France actually launched, which will happen, we've given summer as kind of a range, that will have more or less effect within the year. But we expect to have great adoption in France because Omnipod Dash has been so successful and is so demanded by patients.
James Hollingshead: And so that's how you should expect to see it.
James Hollingshead: <unk>.
James Hollingshead: If we ramp in those countries. The way we are we will see a revenue impact and depending on how quickly we can get France actually launched which will happen. We've given the summer is kind of a range that.
James Hollingshead: That will have more or less effect within the year, but we expect to have great adoption in France, because omnipod dash has been so successful in its so demanded by patients. So just to give you the color on kind of the starts dynamic for us.
James Hollingshead: So just to give you some color on kind of the start dynamic for us. In terms of ASP, yeah, we've been very successful in negotiating for a premium on Omnipod 5 relative to Omnipod Dash in our European markets. That's different from what we did in the US, as you know, where we launched Omnipod 5 effectively at price parity. But in Europe, we want to take advantage of the fact that Omnipod 5 is new technology.
James Hollingshead: In terms of Asps, yes, we've been very successful in negotiating for a premium on omnipod five relative to Omnipod dash in our European markets. That's different from what we did in the U S. As you know.
James Hollingshead: Where we launched Omnipod five it effectively at price parity.
James Hollingshead: But in Europe, we want to take advantage of the fact that Omnipod five as new technology and that's been an important component of each individual country launches to go into negotiate for reimbursement that is more commensurate with the value of the additional value that omnipod five creates and so there is a there is a mix impact on revenue as we get omnipod five into each of those markets. It's a little of the actual premium itself was a little.
James Hollingshead: And that's been an important component of each individual country launch, to go in and negotiate for reimbursement that's more commensurate with the value, the additional value that Omnipod 5 creates. And so there is a mixed impact on revenue as we get Omnipod 5 into each of those markets. The actual premium itself is a little different by market, but so far, we've been very successful in securing a premium for Omnipod 5.
James Hollingshead: Different by market, but so far we've been very successful in security in the premium for Omnipod five.
Operator: Thank you. Your next question comes from the line of Joanne Wuensch with Citi. Joanne, your line is open.
James Hollingshead: Thank you. Your next question comes from the line of Joanne Wuensch with Citi. Joanne Your line is open.
Joanne Karen Wuensch: Thank you very much for taking the questions. I have two, and the first one is I want to make sure I have an idea of what to expect when Labor Day 2 is integrated with OmniPod 5 and how you think about launching that and uptake. And then the second one is, in addition to the Type 2 clinical data at ADA, what else should we be looking for? Thank you. Thanks, Joanne. Libre2, we're very excited.
Joanne Karen Wuensch: Thank you very much for taking my questions.
Joanne Karen Wuensch: I have two the first one is I want to make sure I have an idea of what to expect when Labour IQ is integrated with all the top five and how you think about launching that and uptake and then the second one is.
Joanne Karen Wuensch: In addition to the type two clinical data at Ats.
Speaker Change: Are you looking for thank you.
James Hollingshead: As you can imagine, we're very excited to get our Libre2 integration into the market in LMR. So far, we're having great results with the patient experience in both the UK and the Netherlands. And as you know, the Libre2 form factor, that sensor for our partner Abbott is their most adopted sensor. And so it opens up an entirely new kind of side to the market for us, a serviceable, addressable market, if you want to think in those terms, of all of those Libre2 users who may, therefore, also want to go on to an AID system, an Omnipod 5. And Omnipod 5 is so simple to use, and the form factor is so great, that we think it will have very high appeal among the Libre2 user population.
Speaker Change: Thanks Joanne.
Joanne Karen Wuensch: Libre two we're very excited as you can imagine we're very excited to get our libre two integration into market in LMR. So far we're having great results with the patient experience in both the UK and the Netherlands and as you know.
James Hollingshead: The Libre two form factor that sensor for for our partner Abbott as Theyre, most adopted sensor and so it opens up an entirely new kind of side to the market for us kind of serviceable addressable market. If you want to think in those terms of all of those libre two users who who may therefore also want to go on too.
James Hollingshead: I'd system and Omnipod five and Omnipod five is so simple to use in the form factor is so great that we think it will have very high appeal to that libre.
James Hollingshead: Libre two user population. So we're very very excited to get it out to market great to see the early results.
James Hollingshead: So we're very, very excited to get it out to market, and great to see the early results. Turning to GLP-1 and ADA data, there will be other things we'll show at ADA. We're going to show some subset analysis out of our pivotal trial. And I'm sure we'll show an update on our real-world evidence, which has consistently shown that we deliver fantastic time and range, along with very low hypoglycemia, in increasingly large populations of real-world data sets.
James Hollingshead: Turning to <unk> and <unk> data.
James Hollingshead: Data there'll be other there'll be other things we'll show at 88, we're going to show we'll show some subset analysis out of our pivotal trial I'm sure will show an update on our real world evidence, which has consistently shown that we deliver fantastic time in range, along with very low hypoglycemia in increasingly large populations of real world data sets and we.
James Hollingshead: And we'll have some other studies that we haven't yet discussed. No later than ADA, you should see us report an update on our analysis of GLP-1, which I alluded to briefly in our prepared comments, because in real claims data, you can see that people who adopt GLP-1s are more likely to adopt insulin in the same year. And so we'll be documenting that with a robust presentation of the claims data, which is very exciting. Great, thank you. Your next question comes from the line of Danielle Antalffy with UBS. Danielle, your line is open. Hey, good afternoon, everyone.
James Hollingshead: We'll have some other studies that we haven't yet discussed.
Danielle Joy Antalffy: No later than Ada you should see us.
Danielle Joy Antalffy: Report an update on our analysis of GOP, one, which I refer I alluded to briefly in our prepared comments because it's in real claims data you can see that people who adopt <unk>.
Danielle Joy Antalffy: Are more likely to adopt insulin in the same year and so we'll be documenting that.
Danielle Joy Antalffy: With the robust presentation of the claims data, which is very exciting.
Danielle Joy Antalffy: Great. Thank you. Your next question comes from the line of Danielle <unk> with UBS Danielle Your line is open.
Operator: Thanks so much for taking the question. Congratulations on a great start to the year. Just a quick question on new patient starts from competitive switches. Jim, I know you guys talked last quarter about the fact that, you know, one of your competitors was holding on to their installed base a little bit, a little bit more. Just curious, has that gotten worse?
Danielle Joy Antalffy: Hey, good afternoon, everyone. Thanks, so much for taking the question congrats on a great start to the year. Just a quick question on the new patient starts from competitive switches. Jim I know you guys talked last quarter about the fact that you know one of your competitors list was holding on to their installed base a little bit.
Operator: Bit more just curious what you think has that gotten worse do you have another competitive what's happening wondering if theyre also holding a little bit tighter to their installed base and how you see this evolving is this something that we should be thinking an 80 515, MDI competitive switch split and I appreciate that MDI.
Danielle Joy Antalffy: You have another competitive launch happening, and I wonder if they're also holding a little bit tighter to their installed base. And how do you see this evolving? Is this something that, you know, we should be thinking about in an 85-15 MDI competitive switch split?
James Hollingshead: And I appreciate that MDI is the key to the growth story, but just curious. Yeah, it's a great question, Danielle. The first thing I'll say just quickly is, you know, on the 85-15, that was actually a pretty subtle shift in mix. That is a mixed percentage. And it was fairly subtle.
Speaker Change: The key to the growth story, but just curious yes, yes, it's a great question Danielle the first thing I'll say just quickly as you know.
James Hollingshead: On the $85 15 that was actually a pretty subtle shift in mix that as a mix percentage and it was it was fairly subtle and we tend to give you guys. You know we have an estimation on that we don't have perfect insight into those those mixed data that we give on.
James Hollingshead: And we tend to give you guys, you know, we have an estimation on that. We don't have perfect insight into those mixed data that we give on MDI versus competitive T1, T2. There's kind of an estimation range in those. And so I wouldn't over-index on the modeling and what we reported. It was a pretty subtle shift.
James Hollingshead: MDI versus competitive <unk>. There is there is kind of an estimation range in those.
James Hollingshead: So I wouldn't over index on the modeling and what we reported it was a pretty subtle shifts having said that what we see and I can't really speak to the challenges our competitors face in retaining the customers in their installed base is what we see consistently both with our own proprietary market research, which we've put in place in the last few quarters and also a third party.
James Hollingshead: Having said that, what we see, you know, I can't really speak to the challenges our competitors face in retaining the customers in their installed bases. But what we see consistently, both with our own proprietary market research, which we've put in place in the last few quarters and also with third-party data, is that we are the clear net winners in the competitive switch game. So if you're a manufacturer, you can typically get a sense of how many customers you're converting from a competitor, but you don't often have great insight into what your loss rate is.
James Hollingshead: Data is that we are the clear net winners in the competitive switch game. So if you're a manufacturer you can typically get a sense of how many customers you are converting from from a competitor, but you don't often have great insight into what your loss rate is and so we've put in place and market analysis that allows us to better estimate that and it's a very consistent.
James Hollingshead: And so we put in place a market analysis that allows us to better estimate that. And it's been a very consistent dynamic for us since we launched Omnipod 5 that we are the net winners in that game. So we gain we gain way more customers than we lose, both head to head with our competitors and then, obviously, overall in the market. And so that just speaks to how strong our competitive position is with Omnipod 5. It's It's clearly the best offer on the market, and that's what the market says with those.
James Hollingshead: Dynamic for us since we launched Omnipod five that we are the net winners in that game. So we gain we gain way more customers than we lose.
James Hollingshead: <unk> head to head with our competitors and that obviously overall in the market.
James Hollingshead: So that's just speaks to how strong our competitive position is with Omnipod five it's clearly the best offer on the market and that's what the market says with those results.
James Hollingshead: Okay.
Operator: Great, thank you. Your next question comes from the line of Bill Wolvanek with CanaCore Genuity. Bill, your line is open.
James Hollingshead: Great. Thank you. Your next question comes from the line of Bill.
Bill Wolvanek: Organic with Canaccord Genuity.
Bill Wolvanek: Bill Your line is open.
Bill Wolvanek: Great, thanks. Good evening, and thanks for taking my questions. Just really wanted to go back to Type 2 and Omnipod Go, and I don't know if I missed this, but did you give any detail on timing for the full market release? And if not, are you kind of waiting for the O5 to be available before you roll out so you have a full product set?
Bill Wolvanek: Great. Thanks, Good evening and thanks for taking my questions.
Bill Wolvanek: Just really wanted to go back to type two and Omnipod go and I don't know if I missed this is did you give any detail on timing for full market release, and if not are you kind of waiting for the old five to be available before you roll out. So you have a full product set and then with the <unk> data.
James Hollingshead: And then, you know, with the AAD, and ATDD data with time and range on the AIDs, I was wondering if, you know, some of this data has been driving kind of a shift in the market there as well. Thanks. Thanks, Bill.
James Hollingshead: With time and range.
James Hollingshead: So I was wondering.
James Hollingshead: If some of this data has been driving kind of a shift in the market there as well thanks.
James Hollingshead: We haven't given timing on Omnipod Go, and obviously, we haven't yet filed Omnipod 5. And so the commercial pilot's intended to make sure that we have enough learning in place to put the right commercial model in place, and we'll figure out exactly how we'll bring the portfolio to market. So we have not updated on timing for Omnipod Go, but I think you can easily imagine that with a portfolio of products, the commercial model looks different than with a single product. So I'll put it that way, I think. With the ATTD data, to me, the real-world evidence that we were able to show makes it really clear that the Omnipod 5 algorithm is a world-class algorithm.
Speaker Change: Thanks, Bill we haven't given timing.
James Hollingshead: If I go and obviously, we havent yet filed Omnipod five.
James Hollingshead: And so the commercial pilots intended to make sure that we have we have enough funding in place to put the right commercial model in place.
James Hollingshead: And.
James Hollingshead: We'll figure out exactly how we'll bring the portfolio. So we have not updated on timing for Omnipod go but you can I think you can easily envision that with a portfolio of products. The commercial model looks different than with the single product right. So I'll put it that way I think.
James Hollingshead: The ATT data to me the real World evidence that we were able to show.
James Hollingshead: <unk> makes it really clear that the Omnipod five algorithm is a world class algorithm. It produces fantastic results.
James Hollingshead: It produces fantastic clinical results. It does so across age groups, across demographics. And as we've said before, one of the things that's unique about our real-world evidence is that it's from all comers. And so it's not only from highly engaged patients who upload their data; it's from all patients who are on Omnipod 5. And so when it has robust results, you can sort of see it as extra robust because it's a clear view into every corner of the user population.
James Hollingshead: Clinical results it produces it across age groups across demographics and as we've said before one of the things Thats unique about our real world evidence is that its from all comers and so it's not only from highly engage patients who upload their data it's.
James Hollingshead: From all patients who are on Omnipod five and so when it has robust results you can sort of see it as extra robust because it's a clear view into every corner of the user population.
James Hollingshead: And on top of that, what it shows is that we produce great time and range, as I said, but we continue to have very low hypoglycemia in our algorithm, which is a big competitive advantage for us. So, you know, that data is helping us now out in the field as we talk to physicians and continue to introduce Omnipod 5 to new users. Demonstrate just how clinically effective Omnipod 5 is on top of and in addition to its great ease of use. Great, thank you so much. Your next question comes from the line of Marie Thibault with BTIG. Marie, your line is open. Hi, good evening.
James Hollingshead: And on top of that what it shows as we produce great time and range as I said, but we continue to have very low hypoglycemia in our algorithm, which is a which is a big competitive advantage for us. So.
Marie Yoko Thibault: That data is helping us now out in the field as we talk to physicians and continue to introduce Omnipod five to new users to demonstrate just how clinically effective omnipod five years on top of and in addition to its great ease of use.
Marie Yoko Thibault: Great. Thank you. So much. Your next question comes from the line of Maury Chemo with <unk>. Your line is open.
Operator: Thanks for taking the questions. I'll move away from the top line here and focus on margins. You had excellent operating margin again this quarter. I wanted to ask a little bit about the near-term cadence. I saw that you raised the guidance, but also heard that you're expecting some incremental expansion of the sales force, so any guidance on a quarterly cadence on that metric. Thank you. Yes, this is Ana.
Marie Yoko Thibault: Hi, good evening, thanks for taking the questions I'll move away from the top line here and focus on margins you had excellent operating margin again this quarter wanted to ask a little bit about the near term cadence saw that you raise the guidance, but also heard that youre expecting some incremental expansion of the sales force. So just any guidance on a quarterly cadence on that metric.
Operator: Thanks.
Marie Yoko Thibault: Thanks for the question. We're in a really strong position as we look at our operating margins. And I'll break it down, you know, from a gross margin perspective. We did that 69 and a half. That's very strong.
Operator: Yes.
Operator: Yes.
Ana: This is ana thanks for the question.
Ana: We're in a really strong position as we look at our.
Ana: Our operating margin.
Ana: And I'll break it down you know from a gross margin perspective, we did that 69 and a half.
Ana: That's very strong.
Ana: We look to have.
Ana: Strength on that as we progress through the year now from an operating perspective, what we need to balance out here is.
Anna: We look to have strength in that as we progress through the year. Now, from an operating perspective, what we need to balance out here are the investments because we want to really position ourselves for the future. And as Jim and I have talked, it's kind of a good problem to have. And we have a rhythm around analyzing our investments and making sure there's that rigor of those returns. So as we sit here, yes, we see upward mobility here in our margins.
Anna: The investments because we want to really position ourselves into the future and.
Anna: As Jim and I have talked it's kind of a good problem to have.
Anna: And we have a cadence around.
Anna: Allies in our investments and making sure there's that rigor of those returns.
Anna: So as we sit here, yes, we see upper.
Anna: And at the same time, we want to be prudent in our capital allocation to continue to fuel growth. And as you mentioned here, you know, the sales force and the different investments in our product and product features and other things. So it's a real balance.
Anna: Upward mobility here in our margins and at the same time, we want to be prudent in our capital allocation to continue to fuel the growth and as you mentioned here the sales force and the different investments in our product and product features and other things. So so it's a real balance and.
Anna: And we will continue to drive margins up as our priority and continue to prioritize our investments. Great, thank you so much. Your next question comes from the line of Chris Pasquale with Nefron. Chris, your line is open.
Christopher Thomas Pasquale: We will continue to drive margins up is our priority and continue to prioritize our investments.
Anna: Thank you so much. Our next question comes from the line of Chris Pasquale with Nephron, Chris Your line is open.
Operator: Thanks. Jim, I wanted to understand your GLP-1 comment better. The thesis around GLP-1 use in type 2 diabetes is that it would help those patients take a couple of steps back on the disease progression escalator, if you will.
Christopher Thomas Pasquale: Thanks, Jim I wanted to understand your GOP, one comment better the thesis around <unk> use in type two is that it would help those patients take a couple of steps back on the disease progression escalator. If you will so maybe the insulin use can be delayed or if they're already on insulin. They can use lesson and now you're talking about.
Christopher Thomas Pasquale: With transition to insulin use actually being accelerated so.
Christopher Thomas Pasquale: So maybe insulin use can be delayed, or if they're already on insulin, they can use less. Now you're talking about the transition to insulin use actually being accelerated. So do you think being on a GLP-1 is really making them more likely to need insulin, or is what you're picking up there just that these patients were not engaging with their disease previously, and now they are, and GLP-1s are the catalyst to get them more active?
Christopher Thomas Pasquale: Do you think being on a <unk> is really making them more likely to need insulin or is what you are picking up there just that these patients were not engaging with their disease previously and now they are in GOP ones are the catalysts to get them more active.
Christopher Thomas Pasquale: Yeah, great question, Chris. Yeah, obviously, we'd be speculating. So just to, and we'll be publishing an update that will give you all more details. And so I don't want to steal the thunder of what we'll put out.
Speaker Change: Yes, Great question, Chris Yeah, obviously, we'd be speculating so just to.
Christopher Thomas Pasquale: We'll be we'll be publishing an update that will give you a more detailed and so I don't want to still this under a what we'll put out.
James Hollingshead: So you can also look at the slides, and we can have a better conversation about it, but I'll just say we'd have to speculate about what's actually happening. It's it's it's the analysis is based on claims data, and so it's very robust.
Speaker Change: So you can also look at the slides.
James Hollingshead: We can have a better conversation about it but I'll just say we'd have to speculate what's actually happening.
James Hollingshead: The analysis is based on claims data and.
James Hollingshead: It's very large in claims data, and what it shows is that for those patients who adopt GLP-1, they are much more likely to also adopt insulin in the same year. And, you know, given what we see, I'm now going to speculate just for a second, okay? Given what we see with GLP-1s, we know GLP-1s lower A1c.
James Hollingshead: So it is very robust, it's very large and claims data and what it shows is that for those patients who adopt GOP. One they are much more likely to also adopt insulin in the same year.
James Hollingshead: And given what we see so I'm not going to speculate just for a second okay.
James Hollingshead: Given what we see with GOP once we know GOP ones.
James Hollingshead: So I think the dynamic is more likely the second, your second suggestion, which is patients go in, they get put on GLP-1 because their A1c is really high, and then either they drop off of GLP-1, which we'll also have some information on that in our deck, or they stay on GLP-1, but they haven't resolved their A1c issue, and therefore they also go on. And so that's what we see in the claims data, but we can't assert from the claims data what's actually happening in the clinic. And I'm sure it's different for every patient, but at the population level, that's very clear and striking. Great Thank you so much.
James Hollingshead: Lower <unk>. So I think the dynamic is more likely the second your second suggestion, which is patients go in they get put on a GOP one because theyre aon's. He has a really high and then you did it drop off of the <unk>, one which will also have some information on that in our deck or they stay on <unk>, but they haven't resolved the <unk> issue and therefore, they also go on.
James Hollingshead: Insulin and so that's what we see in the claims data, but we can assert out of the claims data what's actually happening in the clinic and I'm sure. It's different for every patient, but at the population level, that's the very clear and striking dynamic.
Speaker Change: Thank you so much.
Operator: Your next question comes from the line of Mike Kratky with Lee Rink Partners. Mike, your line is open. Hey guys, this is Brett on behalf of Mike.
James Hollingshead: Our next question comes from the line of Mike Kratky with Leerink Partners, Mike Your line is open.
Michael Holden Kratky: Thanks for taking the question. I guess, in the high and the low end, in particular, what are some of the assumptions in terms of just the G7 launch? Like, does it take a certain time in the summer that that's going to launch to hit the high end of the guide or the, you know, the midpoint of the guide?
Operator: Hey, guys. This is Brad on for Mike. Thanks for taking the question just wanted to go back to the guide I guess on the high and the low end in particular, what are some of the assumptions in terms of just the G. Seven launched like does it take a certain time and some of that that's going to launch to hit the high end of the guide.
Anna: Or is there anything that we should be thinking about in terms of timing there? And then, you know, with that, just overall attrition and then the timing of the French launch as well, if there's any, you know, swing factors there in the OUS guide. All right, there are a few questions here; maybe we'll tag them here between Jim and I. Let me take the guide first.
Anna: The midpoint of the guide or is there anything we should be thinking about in terms of timing there and then with that just overall attrition and then the timing of the France launch as well if there is any swing factors there I know U S guidance.
Anna: Alright.
Speaker Change: Theres a few questions here, maybe we'll tag team here between Jim and I, Let me take the guide first.
Anna: Listen, it goes back to the fundamentals. First and foremost, we're increasing our revenue gap. Second point in terms of timing. We are absolutely assuming that as we put the new G7 pods into our channels, there's going to be a reduction in the G6 as it gets sold through the channel. So there is a destocking of that G6. And we have an assumption there. I'll call it roughly in the $10 million or so.
Jim: Listen it goes back to the fundamental first and foremost we're increasing our revenue guide.
Anna: <unk> point in terms of timing.
Anna: We are actually assuming that as we put the new G. Seven pods into our channels, there's going to be a reduction of the <unk> six so as it gets sold through the channel.
Anna: So there is a destocking of that <unk> six and we have an assumption there I'll call it roughly in the $10 million or so dollars now.
Anna: Now, the timing of all of this is really hard to predict. That's why, as I get the question asked, I keep bringing everybody back to the full year, the second half of the year. But that I just wanted to clarify, because it's been asked a few times and that's really our underlying assumption. And I want to go back to your second question about international cooperation. Can you repeat that? France Lodge. Oh, the France Lodge.
Anna: Timing of all of this is really hard to call. That's why as I get the question I keep bringing everybody back up to the full year the second half of the year.
Anna: But I just wanted to clarify because it's been asked a few times and that's really our underlying assumption.
Anna: And I want to go back to your second question around International can you repeat that.
Anna: France launch.
Anna: Brian.
Speaker Change: Yes, yes.
Anna: Yeah. I'll start. I mean, as we've said, the timing of the French launch will be here over the summer, and the teams are ready.
Anna: So good morning.
Speaker Change: Alright, alright.
Anna: As we've said.
Anna: The timing of the France launch will be here over the summer and the teams are ready.
Anna: You know, they worked out all the pricing, and they're working all the sales force and everything. So we expect, as we mentioned, that every country is slightly different. In France, there tends to be more of this four-year cycle of contract renewals, as people might have been previously in pumps and so on.
Anna: They worked out all the pricing and they are working all the sales force and everything so.
Anna: We expect that as we mentioned that every country is slightly different.
Anna: In France are tends to be more of this four year cycle.
Anna: Contract renewals as people might have been previously in pumps and so on so we are assuming in our financials more of that uptick into the later half of the year very like later into the year as it ramped and it takes time, but really being a tailwind for us in 2025.
Anna: So we are assuming in our financials more of that uptick into the later half of the year, very like later into the year as it ramps up and it takes time, but really being a tailwind for us in 2020. Great. Thank you so much. Your next question comes from the line of Josh Jennings with TD Cowen.
Operator: Josh, your line is open. Hi. Good evening. Thanks so much.
Anna: Great. Thank you. So much. Your next question comes from the line of Josh Jennings with TD Cowen Josh Your line is open.
Joshua Thomas Jennings: I wanted to just ask about the pharmacy channel, Insulet has enjoyed exclusivity for getting patient access through their pharmacy benefit. Our team doesn't think there's really much risk to the current model reimbursement levels that Insulet is achieving or securing. But are there any theoretical risks as some of the two pump competitors start to open up that channel for patients and start thinking about either reimbursement levels or just the model overall in terms of pump reimbursement and through the pharmacy channel? Thanks for taking the question. Thanks, Josh. A really, really good question and something we could have a very complicated conversation about, right?
Joshua Thomas Jennings: Hi, good evening. Thanks, so much I wanted to just.
Joshua Thomas Jennings: Ask on the pharmacy channel and so it has enjoyed exclusivity so getting patient access through their pharmacy benefit.
Joshua Thomas Jennings: Our team doesn't think there's really much risk to the current model reimbursement levels.
Joshua Thomas Jennings: Is achieving or securing but are there any theoretical risk as some of the two pump competitors.
Joshua Thomas Jennings: Start to open up that channel for patients and just thinking about either reimbursement levels or.
Joshua Thomas Jennings: The model overall in terms of pump reimbursement through the pharmacy channel. Thanks for taking my question.
Speaker Change: Thanks, Josh.
Joshua Thomas Jennings: Really really good question and it's something we could have a very complicated conversation right, but it's a very simple answer from our point of view is that.
James Hollingshead: But the very simple answer from our point of view is that what's unique about Pharmacy Access for Omnipod 5 is that the product fits the channel really, really well. And tube pumps are durable equipment, and they don't fit the channel very well. So anybody trying to enter the market and get into the pharmacy channel with some sort of, you know, durable equipment plus some consumables will find it very difficult. For them to do it, they'll have to do it with lots of workarounds.
James Hollingshead: What's unique about pharmacy access for Omnipod five is that the product fits the channel really really well.
James Hollingshead: And two pumps are durable equipment and they don't fit the channel very well so as anybody trying to enter entered the market and get into the pharmacy channel with.
James Hollingshead: Some sort of.
James Hollingshead: Durable equipment, plus some consumable thing.
James Hollingshead: It'll be very difficult.
James Hollingshead: For them to do what they'll have to do with lots of workarounds.
James Hollingshead: There's going to be reimbursement challenges, there's going to be scripting challenges, and all kinds of things that we could have a much longer conversation about. And never say never, you know; we're very mindful of competition, and we have a lot of respect for our competitors. But it's taken us several years to build out the scale and scope we have in the pharmacy channel. And as we referred to in our prepared remarks, you know, Omnipod 5 is available at retail pharmacies within five miles of 85% of the U.S. population.
James Hollingshead: There's going to be reimbursement challenges, there's going to be scripting challenges and all kinds of things that we could have much longer conversation about and never say never.
James Hollingshead: Sure.
James Hollingshead: We're very mindful of competition and we have a lot of respect for our competitors, but it's taken us several years to.
James Hollingshead: Build out the scale and scope, we havent pharmacy channel and as we referred to in our prepared remarks.
James Hollingshead: Omnipod five is available in retail pharmacy within five miles of 85% of the U S population that is going to be very very difficult for any of our durable pump competitors to replicate in the overall model of Omnipod five with its very very.
James Hollingshead: That is going to be very, very difficult for any of our durable pump competitors to replicate. And the overall model of Omnipod 5, with its, you know, very easy access, ease of use, ease of setup, you know, getting in a box at the pharmacy where you get your insulin, that model just fits very, very well. And I think the durable pump model does not fit the channel well.
James Hollingshead: Very easy access ease of use ease of setup.
James Hollingshead: And in a box of the pharmacy, where you get your insulin that model just fits very very well and I think the durable pump model does not fit the channel well.
Operator: Great, well, thank you all so much for your questions. This does conclude our Q&A section, and I would like to turn the conference back to Jim Hollingshead. Thanks, Operator. In closing, we're off to a great start in 2024. We're transforming diabetes care globally with Omnipod 5, which now also includes our limited commercial launches with G7 in the U.S. and with G6 and Libre 2 Plus International.
James Hollingshead: Well. Thank you all so much for your questions. This does conclude our Q&A session and I would like to turn the conference back to you Jim Hollingshead.
James Hollingshead: Thanks, operator in closing we're off to a great start in 2024, we're transforming diabetes care globally with Omnipod five which now also includes our limited commercial launches with <unk> seven in the U S and with <unk> and Libre two plus internationally.
James Hollingshead: We've got a very strong market leadership position, the right product portfolio to address the needs of both the Type 1 and the Type 2 global markets, and a clear and focused strategy to drive continued growth, leveraging our significant competitive advantages. Looking ahead, the balance of the year is going to include a number of important milestones for us, as we discussed on the call. We expect all of those milestones to help us drive new customer starts and margin expansion in the second half of this year and lay the foundation for significant long-term growth.
James Hollingshead: We've got a very strong market leadership position the right product portfolio to address the needs of both the type one and the type two global markets and a clear and focused strategy to drive continued growth leveraging our significant competitive advantages looking ahead. The balance of the year is going to include a number of important milestones for US is we've been through on the call. We expect all.
James Hollingshead: All of that while continuing to deliver on our mission to simplify the lives of people with diabetes all over the world. I just want to thank the entire Insulet Global team for your dedication and passion for our customers and for our mission. You're doing a great job, Global Insulet team. Thank you very much. Thanks, everybody, for joining us today, and we look forward to updating you next quarter. Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day. You may now disconnect.
James Hollingshead: Those milestones to help us drive new customer starts and margin expansion in the second half of this year and lay the foundation for significant long term growth all of that while continuing to deliver on our mission to simplify the lives of people with diabetes all over the world I just want to thank the entire global Insulet team for your dedication and passion.
Speaker Change: For our customers and for our mission.
Speaker Change: Youre doing a great job equivalent so team. Thank you very much thanks, everybody for joining us today, and we look forward to updating you next quarter.
Speaker Change: Ladies and gentlemen. This concludes today's conference. Thank you for your participation and have a wonderful day you may now disconnect.
James Hollingshead: Okay.
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Speaker Change: Thank you.
James Hollingshead: Okay.
James Hollingshead: Okay.