Tandem Diabetes Care, Inc.

Thank you for standing by. Welcome to Tandem Diabetes Cares, first quarter 2024 earnings. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 1-1 on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star 1-1 again. As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Susan Morrison, EVP and Chief Administrative Officer.

Please go ahead.

Hello, everyone, and thanks for joining Tandem's first quarter 2024 earnings call. As a reminder, today's discussion will include forward-looking statements. These statements reflect management's expectations about future events, our product pipeline, development timeline, and financial performance and operating plans and speak only as of today's date. There are risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in our forward-looking statements. A list of factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements is highlighted in our press release issued earlier today and under the risk factors portion and elsewhere and our most recent annual report on Form 10-K, as updated by our most recent quarterly report on Form 10-Q. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or other factors. Today's discussion will also include references to a number of GAAP and non-GAAP financial measures. Non-GAAP financial measures are provided to give our investors information that we believe is indicative of our core operating performance. and reflects our ongoing business operations. We believe these non-GAAP financial measures facilitate better comparisons of operating results across reporting periods. Any non-GAAP information presented should not be considered as a substitution, independently or superior, to results prepared in accordance with GAAP. Please refer to our earnings release issued earlier today and available in the Investor Center portion of our website for a reconciliation of these measures to their most directly comparable GAAP financial measure. Leading today's call is John Sheridan, Tandem's President and CEO, who will be joined by Lee Vossler, our Executive Vice President and Chief Financial Officer. I'll now turn the call over to John.

Thanks, Susan, and welcome everyone to our call today. 2024 is off to an impressive start with a solid first quarter performance. We met key commercial milestones with a successful launch of multiple new products worldwide. We outperformed financially, demonstrating a return to growth both in and outside the United States. Operationally, we are continuing to evolve the organization for scalable growth through investments in people, processes, and technology. We are laying the foundation for 2024 to be a transformational year for Tandem, much like when we launched our first automated insulin delivery algorithm approximately five years ago. There is growing excitement across our company as we deliver on our strategy to bring greater choice and benefits to people living with diabetes worldwide. In the first quarter, we executed on expanding our robust portfolio of delivery devices that offer choice and sensor integration, applications, and data management tools. Beginning with hardware, we marked another first for our company this quarter. We are now the only manufacturer offering multiple insulin pump form factors. This multi-platform approach is a value proposition that makes Tandem unique We can provide people options in how they wear and operate their AID systems while benefiting from our number one rated control IQ technology. Moby-Cook Center staged this quarter, being the first miniature durable pump that delivers unmatched wearability and the freedom to disconnect. We continue to hear an overwhelmingly positive response from early users. The feedback is consistent between people new to pump therapy and those who are converting from competitive offerings. Our customers comment that they forget that they're wearing Mobi, how much they love the option to disconnect, and that as a durable pump, it's more environmentally responsible than disposable devices. Healthcare providers highlight the benefit of being able to use the un-pump button to deliver a bolus even when they're away from their phone. They also greatly appreciate the efficiency it provides to their practices with wireless connectivity to tandem source, our cloud-based data management platform. This type of positive feedback is incredible to hear. With Moby just getting started on the market, it's too early to draw conclusions on trends. But customer behavior in the first quarter is supportive of our research that Moby provides an opportunity to expand the market while meaningful demand for T-SLIM X2 continues. Another area of focus where we've demonstrated a competitive advantage is the speed to market with CGM integrations. As our CGM partners advance and drive adoption of sensor technology, It increases the number of people who can benefit from Tandem's AID systems. We've seen this over the years through four generations of Dexcom sensor technology, and more recently with the U.S. launch of the T-Slim with Abbott Freestyle Libre 2+. Tandem Mobi is currently available with Dexcom's G6 sensor compatibility. We are on track to begin offering integration with Dexcom G7 later in the second quarter. Outside of the U.S., We began a successful rollout of the T-cell NEXT2 with G7 and are working to integrate both platforms with Abbott's Freestyle Liberate 3 technology worldwide in the year ahead. The next area where we've demonstrated innovation leadership is in algorithms. We're preparing for the rollout of enhancements to our number one rated control IQ technology. At the end of last year, we received FDA clearance to lower the age indication for control IQ to age two and above and expand its feature set with options for greater personalization. As a reminder, algorithms and pumps are separately indicated for age groups. The T-SLIM pump is already indicated for age 2 and above, and in the first quarter, we received FDA clearance to lower MOBI's age indication to 2 and above. We are preparing to roll out the updated Control IQ software on both bar pump platforms later this year. This is an exciting step in our plans to offer continuous improvements to our AID algorithms through software updates to our system. From a clinical perspective, we have numerous activities underway. Fully closed-loop technology that's designed to improve clinical outcomes while reducing the cognitive burden of diabetes management continues to be an important area of focus for us. We've also been making great progress on our clinical trials to support expanding control-accused indication to people living with type 2 diabetes and expect enrollment to be completed this month. In addition, we are advancing our extended wear infusion set technology and began clinical trial enrollment in the first quarter. Overall, our commitment to innovation and choice contributes to our customers' high satisfaction and loyalty, along with our dedicated training and customer support. reflected in our consistently strong renewal rates. As you can see, the year is off to a strong start and we are well positioned to achieve our goals. I'd like to thank our employees from across the organization whose diligent efforts make this possible and who continue to impress and inspire me. I'd now like to turn the call over to Lee to discuss our Q1 results and updated sales expectations.

Thanks, John. As a reminder, unless otherwise noted, many of the financial metrics I will be discussing today are on a non-GAAP basis. For measures where there are differences, reconciliations from GAAP to non-GAAP results can be found in today's earnings release, which is available on the Investor Center portion of our website. We are kicking off 2024 strong with a return to growth. Our worldwide sales in the first quarter grew 12% year over year to $193 million, with well over half generated through recurring supply and renewal revenue streams from our loyal customer base. In the U.S., it was an exciting quarter with our new product offerings just beginning to take hold in the market and driving first quarter sales of $131 million on approximately 15,000 pump shipments. Our renewals continue to grow double digits year over year with strong capture rates from a larger number of warranty expirations. Shipments to new customers continue to slightly exceed renewal purchases. As expected this year, within that new customer population, we began to see a shift in mix towards more people coming from MDI. The launch of Moby in particular outperformed our expectations, generating a high level of activity from both new and renewal customers in what is typically our lowest seasonal quarter of the year. Moby was initially available in mid-February to only our direct customers, followed by our distribution network at the end of March. We saw benefit in the quarter from customers who have been waiting for MOBI availability since last year. At the same time, we are also aware of customers who are still waiting for the availability of the G7 integration. I would like to note that we will not be breaking out shipment details between pump platforms nor by sensor integration. As a reminder, our Tandem MOBI customers to date made their purchasing decision independent of our Tandem Choice program. TESOM X2 customers who are eligible for this program have not yet made an election to participate. We look forward to offering this opportunity in the coming weeks. The accounting for TandemChoice has complexities. Note that our deferral of sales for the program, which we report on a GAAP basis only, ended with the availability of MOHC in February. Up to now, we have recorded GAAP sales deferrals that have accumulated to $31 million. As eligible TSM users elect to switch to the MOBI platform, we will begin to report the reversal of those deferrals in our GAAP financials only. These switches will not be included in our future reports of non-GAAP pump sales or shipments. Any additional fees received or costs incurred from the Choice Program will also only be in our GAAP financials. Non-GAAP sales will continue to exclude any impact of the Tandem Choice Program, providing results that measure core operations, as well as providing consistency for comparisons to both historical and future periods. Another highlight from our first quarter sales performance in the U.S. was a meaningful price benefit we realized through the DME channel with improvement in average selling prices across all products from both price increases and favorable channel mix. Our success in securing higher reimbursement comes from our recognition by payers of the value that Tandem and Control IQ bring to the healthcare systems. Simultaneously, we are very pleased with our progress as we pursue pharmacy channel access for Mobi and look forward to providing future updates. Turning to markets outside the U.S., our sales grew more than 60% to 62 million on nearly 10,000 pump shipments. The large majority of our shipments are driven by market expansion and competitive conversions from the continued enthusiasm for our technology in the 25 countries where we operate today. We have a growing opportunity from renewals as warranties from our earliest customers are beginning to expire, but are still in the early stages of that cycle and do not anticipate meaningful contribution this year. This quarter specifically benefited from the initial rollout of T-SLIM with G7 integration due to certain orders that shifted into 2024 from the fourth quarter of 2023. We also saw modest pricing favorability compared to our expectations from geographical mix and foreign currency gains. As a reminder, in 2023, we executed a distribution center transition in the first half of the year to create long-term efficiency for our European operations. This created a sales headwind in the first quarter of 2023 of approximately $18 million and higher pump ASPs than we would ordinarily anticipate due to the mix of ordering customers. With that transition complete, we expect to see reduced quarter-to-quarter variability in distributor orders, more normalized ASPs, and closer alignment to pump market demand and in-customer supply ordering patterns. Moving on to margins, the outperformance in sales drove higher gross and adjusted EBITDA margins. Gross margin was 50%. This was in line with the prior year due to improvements in raw material costs and average selling prices, which combined to offset increased overhead per unit for scaling MOBI volumes and less favorable product mix. Adjusted EBITDA improved nearly five percentage points year over year to negative 7%. Operating expenses increased only 5% on 12% sales growth, which includes increased sales and marketing spend for all of our new product launches, as well as higher clinical trial costs to support advancement of our product pipeline. These investments were in part funded through facility and employee-related cost reduction initiatives in 2023 that continue to drive leverage today. From a balance sheet perspective, we took advantage of strong conditions in the convertible market to efficiently refinance existing convertible notes that were maturing in May 2025. Our total cash and investments were consistent with the end of the year at nearly $470 million. In all, we are extremely pleased with our progress in the first quarter. As a result, we are increasing our 2024 sales guidance to approximately $868 million or 12% growth year-over-year based on our first quarter sales performance. This breaks down to $634 million in the U.S. and $234 million outside the U.S. Remaining consistent with our approach to setting expectations at the beginning of the year, our sales guidance is primarily based on recurring supply and renewal revenue streams While we evaluate early purchasing behaviors for our new products as awareness grows. We are also getting consideration to the increasingly competitive environment outside the US. We are optimistic about our opportunities in 2024 but not changing the remaining outlook until we are able to observe sustainable trends. From a profitability perspective, we are maintaining our full year guidance of 51% for gross margin and break even for adjusted EBITDA. There are many moving parts across the quarters this year when considering the timing and scale of product launches, variation in the prior year baseline comps, and seasonality. Therefore, we will also provide a view into the second quarter. Our worldwide sales are anticipated to be $205 million for the quarter. In the U.S., sales are expected to grow to approximately $150 million, reflecting impact from the timing of customer purchase for Mobi with G7 integration late in the second quarter. Sales outside the U.S. are estimated to be slightly lower than the first quarter at approximately $55 million, due primarily to the timing of certain distributor orders received in the first quarter associated with the scaling launch of GSLM X2 integration with G7. Gross margin in the second quarter is anticipated to be approximately 50% in line with the first quarter, while adjusted EBITDA is expected to improve to negative 5%. As pump sales grow and MOBI volumes increase across the year, Both margins are anticipated to improve with adjusted EBITDA margins and free cash flow returning to positive in the second half of 2024. As we look ahead, the MOBI system at scale is anticipated to be a key driver of long-term margin improvement, and we remain committed to achieving our long-term goals of a 65% gross margin and 25% operating margin when we reach 1 million customers. We'll now open up the call for questions. Operator?

certainly and as a reminder ladies and gentlemen we ask that you please limit yourself to one question and one follow-up and our first question comes from the line of steve lichman from oppenheimer your question please thank you hi guys and congratulations on the quarter um a number of places to uh to start here but i guess you know first of all in terms of the uh initial feedback you're seeing from ob and also in terms of what the split is, I know it's early days, between Moby and T-Slim. Just trying to get a sense of, you know, how this is starting to sort of apportion out in the field.

Hi, Steve. I'll say that, you know, what we're hearing is that Moby is redefining wearability. It's small and versatile, and its size makes it so that it's light and people forget they actually have it on. And you can also disconnect. The HEPs, they like it because of the on pump bolus button and the performance of CIQ. And they also appreciate the fact that the wireless data uploads automatically to source. And so, you know, we're obviously just getting started. But as Lee mentioned in the prepared remarks, we've absolutely achieved our commercial objectives. And, you know, we're really excited about the rest of the year, particularly as we introduce the G7 implementation in the spring. And it all comes and supports our early research that Moby is a market expander because we have seen a growing number of MDI and competitive conversions interested in the product. So it's been a great start and we're very excited about it.

Thanks. And Lee, you talked about pricing and coverage. So the implied price that we saw this quarter, which obviously did come in higher, is that a good price to use in the U.S. for the remainder of the year? And any color you can provide on your sort of initial discussions on pharmacy with Moby would be helpful. Thank you.

Sure. Yes. To the first part of the question on the average selling prices, that is a good baseline to use for the remainder of the year. We're very proud of what our team has accomplished in terms of getting price increases when they're talking to the payers on the DME side of that. But to your question on the pharmacy side, we also have active conversations underway. So the whole team is extremely busy right now. And Moby is being well received. I think what I can say right now mostly is that we're happy to be past the question of if we can move into the pharmacy channel. Now it's just a matter of when. And so we look forward to getting updates on that progress at a future date.

Great.

Thank you.

Thank you. One moment for our next question. And our next question comes from the line of Brooks O'Neill from Lake Street Capital Markets. Your question, please.

Thank you. Good afternoon. I want to be sure, Lee, that I understand your comments about the impact of tandem choice. And in particular, was there any or what, if any, revenue was recognized in Q1 that was essentially a deferral from Q4?

Thanks for the question, Brooks. So understanding that this is pretty convoluted in how this works, but the way you can think about it is from a non-GAAP basis, you won't see any impact from Tandem Choice, whether it's deferral of revenue or recognition of revenue associated with it. But on the GAAP side, what happened was when MOBI became available, eligibility ceased for people who were buying T-Slim pumps. And so at that point, they're able to go ahead and pick Moby or T-Slim when they purchase their pump. So deferrals have stopped and we accumulated $31 million in deferrals over the whole time period. When people start to make their election to switch, which will start in the coming weeks, we'll start to recognize those reversals. We'll recognize any fees that we receive and the cost to deliver the pump. But again, only in the GAAP financials. So the non-GAAP financials will be, I'll say, untainted by that program.

Okay. I'm not sure I understand it all, but that's probably normal for me. So I'll figure it out tonight. I appreciate those comments very much. I know we're excited about Mobi, and I know we're excited about the sensor integrations, but I just want to jump ahead and see if you have any updated comments on X3, SIGI, better AID, Mobi tubeless. When do you think we might begin to hear more about those, and how's the progress coming?

Well, Brooks, I think at our last call what we said is we're not going to – we're going to refrain from talking about dates on those products any longer for competitive reasons. But I will say that we're very happy with the progress, and we remain really excited about the commitment to the roadmap. And I think that there's really no change in our expectations from these products at this point in time. So the team is doing a great job. We're working very hard on these things, and we're going to bring them to market as quickly as we can.

Totally makes sense. Thank you very much, and congratulations on a terrific start to the year.

Thanks, Brooks. Thanks, Brooks. Thank you. One moment for our next question. Our next question comes from the line of Mike McLean from Lee Rink Partners. Your question, please.

Yeah, hi, everyone. Thanks for taking our questions. So a couple months into the Mobi launch, can you just help us quantify what portion of the new starts And once you overall came from Moby and how that aligned, maybe more anecdotally, just with your own expectations. And then, you know, as you've gotten into 2Q, you know, again, maybe you just qualitatively how that's kind of tracked early on.

I'm sure. Thanks for the question. So when it comes to Moby and its share, first of all, I'll start by saying it was available to a limited population in the first quarter. We didn't launch it until middle of February. And we also started with just our direct customers. And so it was scaling up across the quarter and on into the second quarter. It did exceed our expectations in terms of the uptake that we saw this first quarter. And it was, I would say, healthy both with new customers and renewal customers. And as John mentioned a few moments ago, very much in line with our market research, you know, what we were seeing from a demographics perspective. We're not providing any specific level of detail about the actual number of units, but needless to say, we're very excited about the opportunity that it's bringing for us.

Yeah, understood. Thanks. And then maybe just a quick follow-up. You know, in terms of the guidance that you provided, can you just confirm that that really isn't building in any additional credit for Moby in the second quarter just based on the step-up?

Correct. And so it's the same philosophy that we started off the year with in that we're basing the guidance mostly on the renewal opportunity that already existed, which is a nice growth for us because just the number of warranty expirations this year alone is stepping up more than 30% from last year. Also, it's predicated on the continuing supply sales across the year. When we thought about new pumpers, we thought about it from the perspective of we could deliver as many as we did last year. Now, obviously, we've taken into consideration the overachievement in the first quarter, but for the remainder of the year, it's back to those baseline expectations. What we want to see are some sustainable trends. Right now, we see data points. We haven't even drawn a line on those yet, much less developed a trend. So we'll continue to evaluate that in the coming quarters before we start factoring in any incremental sales that come from those new products.

Understood. Thanks very much.

All right.

Thank you. Thank you. One moment for our next question. And our next question comes from the line of Matthew Blackman from Stifel. Your question, please.

Good afternoon, everybody. Can you hear me okay?

Yes, we can.

How are you doing, Matt?

Good. Good, John. Thanks. I'm just going to ask more directly here. Just hoping you could give some indication of 1Q new patient growth, and if not precision, simply, I mean, it does seem like there was new patient growth, but you also did have a price lift. Just any indication you can give us on at least the first quarter, whether you saw a new patient growth, and if you want to give us magnitude, uh wouldn't mind that either um and then the follow-up question uh just throw it all out there at once you know just thinking about the p l the i think the one number that sort of stuck uh stood out to us was the sgna number being less intense than we're modeling i think we were anticipating stepped up spend for these new launches uh so is this a timing item or is this sort of low 90 millions obviously with a different cadence throughout the rest of the year but is this sort of the right uh starting point or is there is there more incremental spend to come as you continue to roll out these new products. Thanks.

Sure. I'll go back to the first question, which was new patient growth. And I'm going to speak to it in context of all pump shipments in the first quarter in the U.S. The information that we're able to share is that we did see new pump starts continue to exceed renewal pumps. And so when you look at the split of new versus renewal, new pumps were slightly above renewals. Within that new pump population, we've often discussed where they are coming from, and it usually has been a split of about 50-50 between the MDI conversions and the competitive conversions. This year, we expected to begin to see a shift more towards MDI, which makes a lot of sense considering that population is so much larger, and all of our new products are really pointed towards meeting the needs of people who haven't chosen pump therapy before. So in the first quarter, we did start to see a slight shift in the MDI starting to outpace the growth in competitive conversion. So everything was as expected. We're really excited about how the quarter played out. Nothing really unusual to report there. And then turning to your second question, looking at SG&A. And so we did make investments in sales and marketing in particular, thinking about the field. We had our global commercial meeting in the first quarter and really talked about the launch of the products. We also amped up our marketing spend. And the reason you probably don't see it increase as much as some of the investments actually did is because we continue to have cost efficiency programs in place. where we've really focused on our customer service activities and a lot of automation, process improvement, leaning out some of those processes. And so those programs that we implemented last year are really starting to show their leverage and they're allowing us to make more investments without growing operating expenses in total so much overall.

That's really helpful. I appreciate all the color.

Thanks, Matt. Thank you. One moment for our next question. And our next question comes from the line of Chris Pascal from Ephron Research. Your question, please.

Thanks, and congrats on the quarter, guys. Lee, wanted to follow up on the pricing commentary, specifically OUS. I think you had talked about a $2,300 being the right place for the year there. It was higher in the first quarter, closer to what we saw in 23. So just wanted to double check. Is 23 still where you think things shake out?

Sure. So, excuse me, so 2023 and the first quarter in particular was unusually high from a pump perspective that was back when we were undergoing the transition to our new European distribution center. So we didn't have a natural mix of all of our distributor customers ordering in that quarter this quarter. It was, I would say, a little more normalized. And we expected that ASPs could look something like they did prior to the transition, which was more like the $2,300 mark. The mix was a little bit more favorable to us this time, as well as we had some slight, very modest foreign currency benefit there. But otherwise, I would say for now, continue to think of the $2,300 as a good baseline. And then we'll continue to discuss any favorability to that across the year.

Okay, thanks. And then, John, I know we've barely gotten the first iteration of Mobi out of the gate here, but you've highlighted flexibility of this platform as a big selling point in its current incarnation. And so I'm curious whether the feedback you've gotten so far makes you think any differently about the need to offer a true tubeless configuration of this product, if there's enough daylight between what you've got now and what you were thinking about with that tubeless chassis to really make it additive.

Yeah, I think that you're right. We're very excited about the feedback we've gotten so far. But we do believe having a tubeless version of Mobi will only drive additional demand for the product. And so we absolutely intend to continue to develop it. I can tell you that we've made a lot of good progress, and it looks awesome. And I think that people, when they see it and understand what it's going to do, it just gives people the full opportunity to wear it tubed or tubeless and anywhere they'd like. So Very excited about it. We definitely continue to invest and then develop it.

Great. Thanks. Thank you.

One moment for our next question. And our next question comes from the line of Matthew O'Brien from Piper Sandler. Your question, please.

Afternoon. Thanks for taking the questions. Maybe, John, for starters, the comments you made about Moby and expanding the market, I thought was interesting, just given what we've seen with O5 in this space. Where do you think you guys are expanding the market? And are you, is it more, you know, head-to-head with O5 in terms of maybe pediatric patients or something along those lines? Or is it something completely different where just a group of patients that historically wanted something with tubing, with, you know, maybe a better algo and a better form factor that you're able to access now that you couldn't before?

I think it's a little bit early for us to actually start to talk about specific groups that are beginning to use the product. I think what we can say is that, you know, there is over the last 18 months, certainly, you know, OP5 has taken more of the MDI starts than we have had historically. And I think what we believe Mobi is going to do, it's going to help us return to where we were. And maybe we don't get all the way back to a 50-50 split, but we certainly think that we're going to take more of the MDI starts that we have over the last 18 months. And I think the early data suggests that. And I think that, you know, what we're hearing is that people, the physicians that are actually prescribing it, they believe that they've got an option to OPU5 now. They've got something they can show people and that actually, you know, has roughly the same form factor and has a lot of advantages and has a really good algorithm. So I think what we have, the T-SLIM out there, the comp was difficult, but with Mobi now in the market, I think they've got something that stands up very strongly against them. And I think that as we get to the tubeless version, it's even better.

Understood. Thanks for that. And then the follow-up is just, I know it's early and I don't want numbers, but just the feedback or interest level from Abbott Freestyle users in terms of starting on T-Slim and, you know, is it something that you're starting to see a little bit of traction in or do you need L3 support? before you start to really access that patient population? Thanks.

Yeah, I mean, I'll say that, first of all, we're really excited about the integration with Freestyle Libre 2 in the U.S., and we're now working on Freestyle Libre 3 for U.S., OUS, and both Key Slim and Mobi. But, you know, it's early in the launch process. We've certainly seen uptake, and we've talked to a number of people who have used, who are currently using the Freestyle sensors, and there are definitely a lot of people who are what we call near-term pumpers. people who are interested in the product and interested in the benefits of an AID system. But, you know, it's really, it's a different situation. It's a market development opportunity. It's a new market. And we have to work with Abbott to develop it, which includes training and marketing and informing the customers and HCPs on the benefits. So it's early, but the work is underway. And I think we're really excited about the partnership. And I think it's going to have a meaningful long-term impact on our growth as a business.

Thank you. One moment for our next question.

And our next question comes from the line of Larry Beetleson from Wells Fargo. Your question, please.

Good afternoon. Thanks for taking the question. Lee, I wanted to ask first about international. We typically don't see Q2 sales below Q1. So how much was shifted from Q4 of last year to Q1 of this year? And You shipped 45,000 pumps internationally in 2021 and 2022. Is there any reason you can't achieve at least that this year, given you're starting to see some benefit from renewals? And I had one follow-up.

I'm sure. So from an OUS perspective, we didn't quantify it specifically, but Pointing to the fact that we are guiding to a step down from Q1, you can kind of get an idea of how much those shifted orders, I guess I would say, were valued. And so what we saw were one large distributor in particular and a few others moved orders from the fourth quarter into the first quarter of this year, waiting for G7 to be available on the pumps. And so that was more of a one-timer, which is why I would look to Q2 as being what I would say a more normalized run rate for what pump shipments would look like. And so in terms of just opportunity outside the U.S., and you asked about comparison to the past few years, we still see a large and growing opportunity there, not just from bringing up our renewal customers, but the market's so vastly underpenetrated. And with the products that we have today and the products we are expecting to launch, we expect to continue to grow even in that new population, so expanding the market with MDIs and more competitive conversions. So we're looking forward to growing that business outside the U.S. even further.

That's helpful. And, John, CMS is hosting the Med-CAC meeting, I think, on May 21st on health outcome studies for devices in type 1 and type 2 insulin-intensive patients. What are your expectations for the meeting? And specifically, what could this mean for the potential pump NCD review? Thanks. I'll let Lee answer that.

Yeah. So, Larry, it's... It's interesting, right? So we see this as a very positive move. The fact that they are reviewing the endpoints and inviting the diabetes community to come in and speak about it from the manufacturer's perspective. And so you can guarantee that we're going to have representatives there talking about the wealth of data that we've accumulated and what we think is the best way to look at those endpoints. And we think it's positive because that NCD is sitting out there and it's expected to be reviewed. And so we hope that this is a positive step in that direction that we'll hear something on that in the near future. But for now, there's nothing that says they're directly tied, but we're optimistic that this will be beneficial for us in the long term.

Thank you. Thank you. One moment for our next question. And our next question comes from the line of Danielle Antafi from UBS. Your question, please.

Hey, good afternoon, everyone. Thanks so much for taking the question. Congrats, guys, on this quarter. It's great to see. Excuse me. Lee and John, just a question on what you're seeing from a market growth perspective. I mean, we all run surveys. Our survey is actually quite bullish on what we're seeing from a market growth thinking installed base more than anything. perspective here in the US. I mean, based on our survey, it looks like it's tracking high teens, which I know sounds quite high relative to historical averages. Any comments there? I mean, are you seeing acceleration here, given the number of integrated pumps out on the market, how technology has evolved over the last five years? Any comments there would be helpful. And then, of course, how sustainable that is, or could it actually accelerate even further?

Yeah, great question, Danielle. And it's really hard to put a fine point on the numbers specifically, you know, trying to triangulate what everyone's reporting based on that information. But what we think today is by the time we exited 2023, that pump penetration had grown to nearly 40% in the Type 1 population. And that was up from mid to high 30% range in 2022. And so the market has seemed to have grown every year, probably since about 2018. And we point to the advancement in technology. So if you think about the CGM advancements, you think about the algorithm advancements. And so we have every reason to believe that with the new product portfolio that we're offering, that will continue to grow in the future. And so we have great expectations for what this portfolio that we offer will bring to the market and how we'll be attracting new patients. And so we expect continued growth in 2024 and the long term.

Got it. Thanks so much for that. And how important to that growth is the business model here? So you guys are, it looks like making progress on the pharmacy channel, but how critical is that piece of it? Thanks so much.

Yeah, you know, I do think it's important. There's a couple of factors. I mean, one really is the product portfolio, particularly for us. As we continue to offer choice and wearability, it gives people, we're going to be meeting the needs of more people who haven't chosen pump therapy before. So to flip that around from a second ago, 60% of type 1, 60% of almost 2 million people haven't chosen pump therapy today. So we've got to figure out how to meet the needs of what they want in order to use from a product perspective. The business model will certainly complement that because improving the access, lowering the out-of-pocket, will make a great difference in affordability for people. And so that's why we're focused on both pathways, and I think that they will work together to drive business for us and grow the market overall.

Thank you.

Thanks, Danielle.

Thank you. One moment for our next question. And our next question comes from the line of Matt Taylor from Jefferies. Your question, please.

Hi, thanks for taking the question. I was hoping you could spend a minute on Type 2 and maybe give us an update on what you're seeing in any Type 2 trends. I'm curious what you would say to an investor who might be worried about GLP-1s impacting the Type 2 opportunity. And then given you have now enrolled your trial, could you talk about when the data could come out, what that could show, and the potential for Type 2 to be a growth driver in the future?

Sure. Well, Matt, I think recently we just published some data from an early study we did on type 2. And, you know, there was a significant percentage of the people in the study were using GLP-1s. And when they started the study, they had to be on them for at least six months, and they had to have insulin-intensive type 2. And all of them were using MDI, and none of them were achieving their diabetes objectives. They all had high A1Cs. And after they started using Control IQ, they actually required less insulin, and they dropped their A1Cs substantially. So, you know, we believe that Control IQ, the AID systems that are out in the marketplace today, and when it comes to the type 2 population are complementary to the use of the GLP-1s. And I don't think we believe that it's going to have a substantial impact on the need for insulin, particularly in these groups where they do use a lot of insulin. I would say that the study is, as you say, it's nearly complete. It's nearly enrolled. It's a three-month study. We're certainly going to try to get through it as quickly as we can. I think that it's possible that at the end of this year, when you look at some of the fall conferences, that we might have some data to present at those. But we'll just have to wait and see. There's some unpredictability about it. You know, I think that we are definitely getting ready internally. We're preparing the organization. We're developing our commercial strategy. And we're definitely getting ready to be very active in the Type 2 space.

Great. Thanks a lot, John. Thanks a lot.

Yeah. Thank you. One moment for our next question. Our next question comes from the line of Joanne Wunsch from Citi.

Your question, please.

Hey, good afternoon. This is Anthony on for Joanne. Thanks for taking our questions. On the guidance for EBITDA break-even this year, does that imply some sort of volume or user base going through MOBI to hit that, just given the lower COGS profile? Or are you sort of able to hit that regardless of how many patients you get on MOBI this year?

Yeah, great question. So, Moby is unique in this year in that, or not unique necessarily, but because we're at lower volumes and still scaling, we're not going to see that great gross margin benefit that we expect to see in the years beyond. And so, this year at the beginning, it's a bit of a headwind. In the back half of the year, it starts to become accretive, but really 2025 is when we expect it to make a difference. And so, I would say that our goal of break even this year is is somewhat independent of MOBI in this first scaling phase. But we're monitoring closely, and we're also paying attention to our investments to make sure we're investing in an appropriate way to drive the top line, but still achieve that break-even target.

Got it. Helpful. And then, can you just talk about what you're seeing in the competitive environment, OUS, just as Omnipod 5 starts to ramp a little bit more here? Thanks.

Yeah, I would say that... The competitive environment OUS is within our expectations. I mean, we certainly, there's the two large players are on the market and have been on the market for a while. I think that, you know, Omnipod is getting into new markets. There's also another competitor out there, Ipsomed, that's getting into the markets as well. There's more noise OUS for sure. I would say that there's also a lot of variability because it's not homogeneous. There's multiple different markets and the competitive environment is different in many of them. So, you know, I think that, you know, right now what we're focused on is really getting our technology into the OUS markets. We're really focused on bringing everything that we've got here in the US to the OUS markets as quickly as possible. We think that'll be a significant competitive response to what's going on there. And so there's things happening this year and next that are exciting. And we're also expanding the size of our footprint, OUS, by adding people in the markets who are in-country who can support the distributors and also work closely with our KOLs so that people are aware of the technology and the company's goals in terms of where we're going. So I know it's a really important market for us. I think that we've got a lot going on. We're excited about it.

And stay tuned.

Thank you.

Thank you. One moment for our next question.

And our next question comes from the line of Jason Bedford from Raymond James. Your question, please.

Good afternoon, and congrats on the quarter. Lee, I thought I heard you mention some benefit from U.S. customers waiting for Moby, and I got the impression that this was separate from the Moby Choice dynamic. I guess first, is that correct? And if so, is there a way to quantify this benefit? And then I'll ask my second one up front here. Typically, you give an installed base of users. Do you have that number for this quarter? Thanks.

Great. Yes. So with the first question, Jason, there were two dynamics in the first quarter. We had benefit from people who had been waiting for Moby from last year. And so that really helped the quarter. But we also know of and saw that where people were waiting to buy their Moby in the second quarter from G7. So it's a little bit of both in the first quarter. And so it's going to be, that's why at this point we're not talking about real trends because we're not going to see a normalized quarter probably for another quarter or two until we get fully launched with the G7 integration. But I would say if you take it away from not just the numbers, but just the level of enthusiasm and excitement, it's been really buzzing around the company, people calling in. There's a lot of activity. Everyone's interested in the product. And so we'll be excited to see how that settles out into a normalized pattern. When it comes to the install base, you're right, we didn't comment to it specifically this quarter. It's really a simple four-year rolling shipment calculation, which for end of first quarter would have put us at about 460,000 customers worldwide. And it puts us at 315,000 in the U.S. and about 145,000 outside the U.S. Thank you.

Thanks, Jason.

Thank you. One moment for our next question. And our next question comes from the line of Jeff Johnson for Baird. Your question, please.

Yeah, thanks. Good evening, guys. Lee, maybe just a couple of cleanups or clarifying questions at this point. On the pricing side, would we expect in the U.S. pricing for both Moby and T-Slim to be at these elevated levels? They're both at similar levels going forward. And was that price increase contemplated when you first gave guidance for 2024 last quarter? Thanks.

Yes, so yes to both questions. Pricing is the same for TFLIM and MOBI, and the pricing benefit that we saw this quarter is really a lot of work across all of last year from our market access team negotiating price improvements with various payers, you know, and going in and talking about control IQ, the value proposition, and we're really just seeing it all come to fruition this quarter. And so That is roughly the 4,000 mark for pumps you can assume for the rest of the year, and it's very much in line with what we used in our guidance expectations.

Okay, and then I was hoping you could maybe help me triangulate pump number in the U.S. a little bit better. So you've said two things. You've said that new starts a little bit higher than renewals, and then you've said that the split was a little bit higher to new starts as well. And, you know, not to parse words, but if I put like a 55-45 ratio, split on your 15,000 U.S. number, I get like a 1,500, obviously that's the math, but a 1,500 patient difference between new starts and renewals. If I take your word that, you know, it's just a little bit higher in patient numbers in new starts versus renewals, like maybe there's a 500 split. Can you help us titrate? I mean, was the split between new users and renewals A few hundred patients, a thousand patients, just anything so we can keep our model kind of going as we've built out on these new starts versus renewals over the years. I would appreciate anything you can give there.

Yeah, I mean, really, it's just slightly more than half when you think about it from a new perspective. And so it was a good outcome from what we had been seeing last year, and MOBI really helped drive that. And our other new sensor integrations were also beneficial to it. And we expect over time that Moby and the new products will continue to drive more in that new population. Keep in mind renewal stepped up pretty significantly, double digits this quarter like we've been seeing last year because of the growing opportunity base there. But I would say just roughly new is just a little more than cash.

Thank you. Thank you. One moment for our next question.

And our next question comes from the line of Josh Jennings from TD Cowan. Your question, please.

Hi. Good evening. Thanks. I was hoping to just follow up on Matt's question on the type 2 study and that indication. I think, John, you've mentioned in previous discussions about potentially, if all goes well, being able to commercialize next year in that type 2 insulin-intensive spot. I was hoping you could just walk us through, again, assuming all goes well with the data and we get into next year, is from the data and is there submission, then there's coverage, and any just timing that we should be thinking about in terms of potential to commercialize in that indication next year? And then just Moby coming on board for that indication as well, what are the steps that are required? Thanks for taking the questions. Yeah, sure.

I think that the, you know, the timing is, we said we're about a month away from complete enrollment, and then we have, you know, approximately, it's approximately a three-month study. So that takes us, and then we've got to prepare the clinical report, and we've got to get it into the FDA. The FDA has seen this product now multiple times, and I think that the, you know, the results are actually fantastic with the type 2 community. So I really feel that it's going to be a 2025 product. It's just difficult to predict when. You know, I think that the commercial team is ready. We're getting all of the, you know, the strategy set up so that, you know, in terms of just the sales messaging, et cetera. But from a reimbursement point of view, it's already being reimbursed, and I don't think that's going to be a challenge for us. I think that we will be reimbursed as soon as it's available. And once the control IQ algorithm is approved for type 2, you can use it on any interoperable pump. And so both T-SLIM and MOBI are interoperable pumps. So we will introduce it on both products simultaneously.

Great. Thanks a lot, John. Yeah. Thank you. One moment for our next question.

And our next question comes to the line of Travis from B of A. Your question, please.

Hey, thanks for taking the questions. I'll ask both up front. Just a quick clarification on the full year guidance. I think before you'd said new patient growth would be flat to slightly down this year. I'm just curious if you're still expecting new patients this year to be flat to slightly down at this point, given what you're seeing with MOBI. And then In the US, it looks like the ASP, at least in our model, consumables were a little lower than they had been. I don't know if that's a trade-off to the higher-pump ASP. Just curious if there was something going on on the consumer side there. Just any color there would be helpful. Thanks a lot.

Sure. From a guidance perspective, Still thinking about along the lines of new starts being flat to slightly down, I would say barring the outperformance we had in the first quarter because that's where that came from. But the way the guidance was structured initially, it's still with those thoughts in mind for the remainder of the year. And until we see some sort of trend that we can build models off of, we won't be informing anything new to guidance for the new products. So probably at least not for another quarter or two. When it comes to your question on supplies, nothing unusual from the U.S. perspective on the supply side. Supply sales grew roughly in line with the install base growth. We continuously monitor activity in the install base in terms of who's using the product, if we see any different signs of attrition, and we haven't seen any changes in that regard. So it's probably just noise in your numbers.

Okay, great. I might have had the wrong number or something. Thanks a lot.

That's okay. Thanks, Travis. Thanks, Travis.

Thank you. And once again, as a reminder, if you do have a question at this time, please press star 1-1 on your telephone. One moment for our next question. And our next question comes from the line of Michael Pollard from Wolf Research. Your question, please.

Good afternoon. Thank you. I just have one on this potential shift into the pharmacy channel. Lee, I heard you say it's no longer a question of if but when. I'm interested philosophically in how you think about managing this, because as I look at it, it's potential for a license to subscription conversion, taking a big upfront revenue recognized amount and spreading it over some period of time. So how do you think about managing that? And when you say it's a question of when, is that Is that, you know, suggesting you will have a lot of room to manage this if this is a desirable channel? Or is the when more just, hey, now we have to get in front of payers and get contracts up and running? Any color on this would be great. Thank you so much.

Sure. A lot of good questions there. Probably first I should start off just saying what is our primary goal for pharmacy channel? And number one, it's increasing access for patients and reducing out-of-pocket costs. Number two is when we look at the economics, it should be at least as good as or better than what we see in DME today. And what pharmacy provides for us is a unique opportunity when we think about the business model. And it will allow us to shape it in a way that could look different from DME, but also could look just like DME. And so in some cases, you know, I think we're going to see variability payer by payer and PBM by PBM in terms of how that shapes up. And so when we think about that in the longer term, I would say we are being very selective about which contracts we take, which ones are going to be good for the business, just considering all options with what it comes down to. And so we don't think this will be materially disruptive to our top line. It's going to be a multi-year build. And remember, it's focused on Moby only, so it's not touching the whole business altogether. And so we're really excited for it. We think it will be really good for the business. And stay tuned. We look forward to giving you updates as we have more conversations with payers.

Helpful. Thank you. Thank you. One moment for our next question.

And our next question comes from the line of Matt Missick from Barclays. Your question, please.

Yes, thanks so much for taking the questions and congrats on a really terrific quarter here. So first, I know someone had asked earlier about guidance. I just wanted to make sure we understand how you're thinking about going about it. And then I had one follow-up to that. On guidance, just sticking to the plans, renewal only, not yet sort of making any bold predictions about MOBI. Is that... begin in Q2, do you think? To begin in Q3, you know, when do you think you'll have enough to know on that front? A color there, I guess, given that, you know, things seem to be picking up pretty quickly, and then I had one follow-up.

Sure. So, So it is the same philosophy for guidance now as when we started the year. The only difference is that the outperformance we had in the first quarter, we've now added into the guidance for the remainder of the year. So still heavily based on the renewal opportunity that we have in front of us, the increasing supply sales. And from a new pumper perspective, we want to see more trends. And so thinking about Moby and watching it through its launch, it's a staged launch. And so we started with direct customers only, just shifted to the distribution channel at the end of the first quarter. G7 integration won't come until late in the second quarter. And so that's causing, you know, impact on customer behavior on when they're making their pump purchases. So I think we probably need at least third quarter to kind of see how things settle in. The exciting part about it all is through all of this, even though it's limited data, the data points tell us that things are in line with our market research. And so we think there's great opportunity here, but we're going to be reluctant to factor anything into the guidance until we can feel more confident about how it settles out.

that's helpful and then um i just the other questions the more uh sort of general one i think someone else again had asked you earlier in the call about like where you're expanding the market where you're maybe maybe seeing more traction but you know anything that you can if you're seeing a uh a pattern of you know boy these folks really really seem to gravitate towards one of the two platforms or the other um and then it also came up on the call is, is it often does this idea of tube and tubeless and, and, uh, I, you know, I, I know that you, you have a somewhat different philosophy about, you know, the, the product portfolio that you're building out and how you think about, you know, defining, you know, your, your pump offerings and that around tube tubeless or, you know, where ability, if you could maybe kind of, uh, more broadly expand on your, your, philosophy there as you kind of get through to this MOBI and into SIGI. Thanks.

Yeah, Matt, I think when you look at the data that we've collected so far, of course, we're paying very close attention to it. We know the age, you know, we know how long people have had diabetes. We know all the characteristics of the people who are using the MOBI at this point in time. But as Lee had said, you know, it's really been the stage launch and it hasn't been out there yet long enough, I think, for us to draw any conclusions. We're very excited about how many people are coming to use Mobi from MDI, which we think is a real positive. But it's a bit too early for us to say, here are some of the characteristics of the people, because I don't think it would be reflective. And I'm afraid that if we, you know, after we get more people on it, you know, in a quarter or so, it might change. So just stay tuned, and we'll definitely keep you informed about how how it looks, and we'll just go from there. And then when it comes to our portfolio approach, we think that it's important to provide people choice, choice in how they wear, how they control, and how they interact with the product. And our research suggests that there are distinct groups of people out there with type 1 and type 2 that want a pump that has a controller on it that has the interface on the system that's small and gives you another device, Mobi, that gives you the flexibility of various wear options, mobile control, and great outcome performance. And then finally, a complete tubeless system that's a very wearable and rechargeable system. So our research suggests that those are all meaningful market segments And we intend to continue to pursue that. Each of them are different. And, you know, I think that we think that's the right strategy. And I think that, you know, it resonates with a lot of the people we are talking about as we do this research. Thanks so much, John. Yeah. Take care, Matt.

Thank you. This does conclude the question and answer session as well as today's program. Thank you for your participation. You may now disconnect. Good day.