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2/22/2023
The conference will begin shortly. To raise and lower your hand during Q&A, you can dial star 1-1.
Good day, and welcome to the Tandem Diabetes Care Fourth Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand has been raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. It is now my pleasure to introduce Executive Vice President and Chief Administrative Officer, Suzanne Morrison, Susan Morrison.
Hello, everyone, and thank you for joining Tandem's 2022 Fourth Quarter and Year-End Earnings Call. Today's discussion will include forward-looking statements. These statements reflect management's expectations about future events, product development timelines, 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 in our most recent annual report on Form 10-K and in our other SEC filings. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or other factors. In addition, today's discussion includes 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. For additional information about our use of non-GAAP financial measures, please refer to our press release issued earlier today. Today's call will be led by John Sheridan, our President and CEO, and Lee Vossler, our Executive Vice President and Chief Financial Officer. Following their prepared remarks, we'll open up the call for questions. Thank you in advance for limiting yourself to one question before getting back into the queue. I'll now turn the call over to John.
Thanks, Susan, and welcome everyone to today's call. In 2022, Tandem continued to expand its record-high installed base to new levels with now more than 420,000 customers worldwide using the T-SlinX2 for their insulin therapy needs. This, in combination with the overwhelmingly positive experience our customers report having with our technology and services, demonstrates that we are advancing our mission to improve the lives of people with diabetes. Thank you to our talented employees whose efforts, passion, and dedication allow us to continue to transform insulin therapy management. Before diving into results, I wanted to first take a moment to acknowledge some of our achievements from the year. First, we received FDA clearance of our mobile app that enables the T-Slim X2 pump users to bolus insulin from their iOS or Android smartphone. This was a meaningful accomplishment as we continue to be the only FDA-cleared system delivering insulin through an iOS device. Next is a broad range of clinical studies completed and presented this year on our blessed-in-class control IQ technology. The strength and consistency of Control IQ's positive clinical outcomes is substantially linked to its automated correction bolus feature, which allows us to deliver immediate and sustained improvements in outcomes across diverse populations, including people with the most poorly controlled diabetes. Lastly, I'd like to highlight our two recent acquisitions, Capillary Biomedical, the developer of the SteadySet extended wear infusion set, and AMF Medical, the developer of the CIGI patch pump. Both illustrate how we are executing on our strategic vision we laid out just over a year ago to increase the adoption of insulin pumps worldwide by offering a portfolio of technology solutions that meets the different needs and preferences of people living with diabetes. These advancements demonstrate our commitment to innovation, even in a year that was unique in many ways. Turning to our results, in 2022, we demonstrated another year of both year-over-year top-line growth, even with a more challenging commercial environment than in recent past. Our sales efforts focused on expanding the worldwide insulin pump market, as well as introducing the benefit of Tandem's technology to existing pumpers. In the U.S., we also focused on current T-Slim users who were eligible to purchase a new Tandem pump once again. We demonstrated progress across each of these target populations, which is reflected in the fact that in each quarter throughout 2022, approximately half of our new customers in the U.S., reported that they were adopting pump therapy for the first time, and the other half converted from using a different manufacturer's pump. Outside the United States, we also saw adoption of both new pumpers and existing pumpers of competitor pumps, although the breakdown is more difficult to quantify. Overall, we saw approximately 20% growth in people adopting our T-cell technology in more than the 25 countries we serve, with Q4 being the strongest quarter of the year. Healthcare provider sentiments on our control IQ technology remains very positive worldwide, with high regard for the immediate sustained benefits it offers. This was echoed at our recent global commercial meeting, where it was great to be with such an enthusiastic team exchanging stories on the positive impact our technology makes on the lives of people with diabetes and of the excitement for the opportunities ahead. Our U.S. renewal success in 2022 was another focus of discussion. we saw very strong growth in not only the overall number of eligible people purchasing renewal pumps, but also in the rate of renewals, meaning the portion of people eligible to renew who actually renewed increased steadily throughout the year. This coupled with the strong retention of our in-warranty customers demonstrates the high level of satisfaction people experience with our technology. Customer renewals are a key continued growth catalyst for our company, as in 2023 and beyond, the number of people who are eligible to renew each year scales meaningfully. As we look to the year ahead, our focus will be on continuing to expand the large and growing insulin pump market, which remains just over 35% penetrated in the U.S., and typically only 10% to 20% in the geographies we serve outside the United States. The overall commercial market dynamics have remained consistent in recent months. In 2023, we are focused on creative ways to help drive awareness of our best-in-class control IQ technology, while preparing for multiple new product launches. Part of this preparation is in our manufacturing operations. We recently completed the transfer of our T-Slim cartridge lines to our third-party manufacturer, which creates capacity for us to scale cartridge production for our newest pump, the Tandem Mobi. Operationally, we remain diligent with spending while continuing to invest in our marketing and R&D efforts and looking at opportunities to streamline and automate internal processes. Our focus is to create better leverage in our infrastructure while continuously improving the customer experience. A good example of this effort is our recent update to the back end of our customer portal. It features mobile-first responsive technology that allows for faster iterative development. This is an important capability for us from an operational perspective as it enables a scalable infrastructure that can reduce the burden of headcount-intensive support costs. It's also a meaningful step as we move toward Tandem Source, our second generation web-based data management application that we're planning to deploy on a scaled global rollout beginning this summer. Source is designed to build on the success of our T-Connect data management application, through which we already have more than half a million patient years of data from the TSLMX2 users in the US. Source enhances clinical data visualization and provides added interface customization for healthcare providers to better manage their patients' care, whether remote or in person. In addition to SOURCE, we also have launch planning efforts underway for Tandem Mobi, which will expand our portfolio of diabetes solutions and offer people greater choice in how they want to wear their pump as well as how they want to operate it. As we've discussed in the past, our research shows that Mobi largely appeals to a segment of people who otherwise would not adopt insulin pump therapy with the options available today and is a catalyst for driving further market growth. We received questions from the FDA in response to our 510K and are preparing our responses. Clearance timing remains difficult to predict, and we are preparing for a scaled launch beginning in the second half of this year. We aim to start launch activities within one quarter following clearance. Excitingly, this is a year in which we have multiple new innovations slated to move from development to commercialization. Our commercial launch efforts are currently focused on the upcoming availability of the T-SLIM X2 with G7 integration. Following Dexcom's recent clearance, we are completing our final labeling updates and integration activities, and our current plan is to launch with scaling availability worldwide beginning later in Q2. Our goal is to be the first to market with G7 integration in an AID system. It will be rolled out to existing in-warranty T-SLIM X2 customers for no charge. and the software update can be done by users in the convenience of their home. This will be the fourth generation of Dexcom sensors we've integrated and are proud to be delivering our commitment to bring people with diabetes integration with the latest technologies as they are cleared by the FDA. Furthering this commitment is our work with Abbott to integrate the T-SLIM X2 with Freestyle Libre technology. It's another new and exciting opportunity to bring the benefits of automated insulin delivery to more people living with diabetes. It's also a catalyst for future expansion in our shared market as insulin pump integration with the Libre technology is not available in the United States today. Abbott is working with the FDA to receive Libre clearance for use in an AID system. And once received, our goal is to commence the commercial launch of an integrated offering within one to two quarters. In addition to these near-term opportunities in our pipeline, we also have a number of clinical initiatives underway in 2023. For example, we've begun enrollment in a second feasibility study for Control IQ 2.0, which is designed to offer enhanced personalization and even greater ease of use. In addition, we're preparing to start a pivotal study to support a Type 2 indication for Control IQ. Our last major clinical trial initiative this year is for the study set technology, which is the extended wear and fusion set that we acquired with Capillary Biomedical last year. We anticipate the data from these studies along with our work in 2022, will underpin future regulatory filings as we work to expand labeling indications for control IQ and bring new products, features, and benefits to people living with diabetes. Rounding out our R&D update, we are continuing to execute on our longer-term portfolio strategy, which centers around a fundamental understanding that there is not a one-size-fits-all solution in insulin therapy management. To serve the varying needs and preferences of people living with diabetes, we require a portfolio of solutions that deliver choice. This means choice in features, choice in device form factor, and choice in how users can wear and operate their pump. This is why we are working to expand our family of offerings to include a next-generation version of T-SLIM that will include features like wireless software updates, longer battery life, and a faster processor to support future algorithms. We're also working on a consumable extension for Mobi that will allow it to be worn with a tube diffuser set or a tubeless site adhered to the body, providing the ultimate choice and flexibility. The newest element in our portfolio is the CIGI patch pump, which we acquired with a privately held Swiss developer, AMF Medical, last month. CIGI is designed to be an ergonomic, rechargeable patch pump that reduces the burden of managing diabetes through its use of a pre-filled insulin cartridge. and its compatibility with AID technology. Now that it's closed, we look forward to working more closely with the AMF team on product development, regulatory, and a commercialization strategy. A&M is a company founded on innovation, and our goal is to bring new technology to the diabetes community every 12 to 18 months. With the strength of our offerings today and our new product portfolio in front of us, we are well positioned to execute on a series of growth catalysts that will allow us to drive our near and longer-term goals. With that, I'll now turn the call over to Leigh.
Thank you, John. Our full year 2022 sales exceeded $800 million, setting quarterly records throughout the year. With this achievement, we have more than doubled our sales in three years. Pumps made up 54% of our sales as we continue to expand the insulin pump market, capture competitive share, and drive success in our renewal efforts. Fourth quarter sales were $221 million on a gap basis and $223 million non-gap on 36,000 pump shipments worldwide. Our gap sales reflect an accounting deferral related to the recent introduction of our tandem choice program in the U.S., which provides a pathway for our customers to access our newest pumps. Our non-gap sales are computed to reflect pump sales consistent with historical periods in order to better aid in measuring progress of the business. It's important to note this program does not change the economics of when or how much we are reimbursed for each TSLM X2 we sell today, and none of the revenue deferred is at risk. It is merely a question of when the deferred sales will be recognized. Breaking our 2022 sales down by geography, our U.S. sales were $589 million on the GAAP basis and $592 million on the non-GAAP basis. One of the largest growth drivers year over year were supply sales from a more than 20% increase in our U.S. install base, which is now at 290,000 customers. We are also increasing our renewal numbers, both in volume and rate. Related to volume, we saw a 60% increase in renewal shipments for the year, and in the fourth quarter alone, these shipments increased 75%. From a rate perspective, we have already renewed over 50% of customers whose warranties expired in 2022. Overall, we shipped 84,000 pumps in the U.S. in 2022. Fourth quarter sales in the U.S. were $166 million on a gap basis and $169 million on a non-gap basis. We shipped 24,000 pumps, reflecting an increase in both new and renewal pump shipments when compared to Q3. Turning to our progress outside the U.S., 2022 sales were $212 million, growing 19% year-over-year. The majority of the increase came from 35% growth in supply sales, with our installed base reaching 130,000 customers by the end of 2022, as well as overall benefit from price increases and country mix. Customer placements grew approximately 20%, while actual pump shipments were flat year over year. This difference largely relates to the variation in timing of orders from our distributors. Their ordering patterns have been influenced significantly by managing logistics challenges between San Diego and their in-country warehouses. Upon completion of the transition to our European distribution center, we expect to see closer alignment of in-customer demand to orders. This transition began late in the third quarter of 2022, creating a sales headwind of approximately $6 million across both pump and supply sales with the heaviest impact in the fourth quarter. Our resulting fourth quarter sales were $55 million on 12,000 pump shipments. Looking to the year ahead, we are providing 2023 worldwide sales guidance of $885 million to $900 million on a non-GAAP basis, slightly widening the range from our initial 2023 indication to a growth rate of 10% to 12%. This does not include sales from our anticipated new product launches that John discussed, which present multiple opportunities to accelerate growth. It does factor in some shift of timing related to the scale-up of our distribution center in Europe. U.S. non-GAAP sales are expected to be in the range of $650 million to $660 million. This contemplates that the environment in which we have been operating in the U.S. largely remains consistent with what we have experienced in recent months and does not reflect benefit from potential new products in 2023. The reoccurring pieces of our business, both supplies and renewals, are expected to make up nearly 60% of our U.S. sales expectations for the year, leading to a more predictable revenue stream as we grow. Renewals create an increasing opportunity when you consider the extent to which our business scaled four years ago and the improvement in rates that we have demonstrated this past year. Keep in mind that the overall sales in the U.S., including renewals, typically decline in the first quarter from the fourth due to insurance dynamics. In the last three years, the average sequential decline for pump shipments has averaged 30%. With that in mind, U.S. sales in the first quarter are expected to be in the range of $134 million to $136 million. The remainder of the year is expected to follow historical seasonal patterns where both pump and supply sales scale up across the quarters. Sales outside the U.S. for 2023 are expected to be in the range of $235 million to $240 million. This assumes a total of approximately $25 million in headwinds related to the transition of our largest European markets to the new distribution center. The impact will be heaviest in Q1 and is expected to be complete mid-year. As a result, Q1 sales outside the U.S. are expected to be lower as a percent of sales than in historical periods, in the range of $34 million to $35 million. From a margin perspective, our 2022 gross margin was 52% compared to 54% in 2021. Our performance was consistent across the year in that we benefited from higher average selling prices and operational cost reductions as anticipated to offset pressures from our higher mix of supply sales. The two percentage points stepped down from the prior year was primarily attributed to certain higher-cost raw materials acquired in early 2022. Our fourth quarter gross margin was 52% on a GAAP basis and 53% on a non-GAAP basis, the difference due to the sales impact of the Tandem Choice program. In 2023, we expect our non-GAAP gross margin to be in line with our 2022 results at approximately 52%. The remaining inventory of the higher cost raw materials is expected to turn in the first half of 2023. Gross margin progress generally follows U.S. pump sales, improving across the year in line with sales expectations. The most meaningful leverage is expected to come in future periods from new product introductions, such as MOBI and our extended wear infusion set technology. Our operating margin in 2022 of negative 12% reflected the impact of certain unique or non-recurring transactions, including A $31 million charge in the third quarter associated with the closing of the capillary biomedical acquisition. $12 million in the fourth quarter for facility consolidation costs as we continue to evaluate our long-term footprint in a hybrid work environment. And $4 million for the Tandem Choice Program. When excluding the impact of these transactions, as well as non-cash stock-based compensation, our adjusted EBITDA at 7% of non-GAAP sales for 2022 was in line with our range of expectations. As we move into 2023, we expect that our adjusted EBITDA margin will be in the range of 5% to 6% of non-GAAP sales. This includes additional R&D investment for the operating costs related to our recent acquisitions of approximately 3% of sales. This increased investment in R&D will be partially offset by leverage in SG&A from productivity initiatives. Our adjusted EBITDA margin is expected to scale across the year in line with sales expectations and as benefit builds from SG&A efficiencies. To be clear, with the expected sales headwinds outside the United States against our current spending levels, we anticipate that adjusted EBITDA margins will be negative in the first half of 2023 with a return to a positive margin in the second half of the year. Turning to cash, we remain diligently focused on generating free cash flow to provide flexibility to grow the business both organically and inorganically. Our balance sheet is strong with $617 million in total cash and investments at the end of the year compared to $624 million at the end of 2021. We generated $50 million in operating cash flow and $17 million from employee stock programs, providing the opportunity to fund $35 million of strategic activities. We also invested $34 million in capital expenditures largely related to manufacturing scale-up and leasehold improvement for our new tech center, which is near completion. To summarize our 2023 outlook, worldwide non-GAAP sales are estimated to be in the range of $885 million to $900 million, including OUS sales of $235 million to $240 million. Our gross margin expectation is approximately 52%, and adjusted EBITDA is estimated to be in the range of 5% to 6% of non-GAAP sales. Our non-cash P&L charges for stock compensation, depreciation, and amortization are expected to be approximately 115 million, of which 95 million is associated with dot-comp and 20 million with depreciation. I will now turn the call back to John.
Thanks, Leigh. Before we begin Q&A, I'd like to acknowledge the separate press release we issued today announcing that Kim Blickenstaff will be handing over the duties of chair of our board of directors to our fellow board member, Becky Robertson. Kim has been an instrumental leader for Tandem since joining the company in 2007, serving first as CEO and then as chair for several years. His strategic vision and mission-driven focus on our company culture has helped build and shape Tandem from VC back to startup to our worldwide leader in diabetes care. While serving as chair, the focus for Kim and that of our other directors has been on evolving our board, bringing on a number of new, talented individuals with diverse perspectives and skills and expertise in consumer technology, connected health, managed care, and global expansion. Becky Robertson joined Tandem's board in early 2019 with an impressive track record of helping medical device companies scale in her roles as an engineer, an entrepreneur, a corporate executive, and board member. She's added tremendous value to our board, bringing patient-centric and strategic vision, along with experience with a range of technologies and business models. It's a natural choice for the expanded leadership positions. Thank you again to Kim and Becky, and we appreciate your continued contributions to the board of our company. And with that, I'll turn the call back over to the operator for questions.
Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. And we ask that you do limit yourself to one question.
Please stand by while we compile the Q&A roster. And our first question comes from the line of Matt Mixick with Barclays. Hi, Matt. Hi.
Thanks so much for taking the time. I just wanted to make sure we understand the questions around that we're getting around sort of margin direction. You know, the investments that you're making in this coming year, I appreciate the conservatism on the top line, but could you kind of walk us through, again, maybe just the puts and takes that get you to that sort of 5% to 6%, even that number you mentioned?
Sure. Thanks for the question, Matt. I'll start with gross margin. Obviously, that makes a big difference in what we can achieve on the bottom line. And with the moderated sales that we have projected for this year, we didn't really anticipate much gross margin expansion. We do anticipate that we will have pricing improvements as well as cost efficiencies that will offset any product mix pressures that we may see. But the real benefit is to come in the future from new product launches, which I can talk to you in a bit, But then when you think about the puts and takes in the operating expense area, you know, we took a lot of time to be very deliberate in thinking about which projects and programs will provide the biggest benefit or impact to the organization going forward. And so we prioritized a number of the R&D investments. We're taking measures such as consolidation of facilities as we rethink how we work in this hybrid environment and other programs along those lines. And then we're continuing to look for ways to optimize the business model. A lot of that comes from how we support our customer base, and with the launch of Pandem Source, that will greatly improve our abilities to digitize and automate some of those customer-facing activities that we have today that require a heavy headcount burden. So when you put all those factors together and you think about where we ended 2022 at about a 7% adjusted EBITDA margin, with the onset of the new acquisitions this year, it does put a little pressure on the bottom line, but we still felt very confident to expand those margins in the longer term.
Thank you.
And our next question comes from the line of Brooks O'Neill with Lake Street Capital Markets.
Well, thank you for taking my question. I'm just curious, John and Lee, as you think about Q4 and maybe what you're beginning to see in Q1, could you just parse out what you think are the impacts of the softening economy and the macro factors, as well as give us your sense for the impact of competition and whether perhaps you're seeing anything different than you expected on the competitive side of the equation. Thanks a lot.
Hi, Brooks. Yeah, I mean, I would say that, you know, if you look back to the third quarter call in November, you know, we've seen things remain fairly consistent. And by that, I would mean it's been no better, it's been no worse. And that being said, I think that we anticipate that this is the way it's going to be throughout this year and the entire year. And so I think, as we said in the prepared remarks, our intent really is to increase the awareness and benefits of ControlIQ and really focus on execution of these new product activities that we've got planned for the year because they are really going to drive the change in the growth curve of the company and get us back to a growth rate that we're used to in the past. But I would say that there's really been not much change. It's no better, no worse. In competition, John?
Yeah, I mean, I would say the same thing with competition as well. Okay.
Thank you. And our next question comes from the line of Chris Packel with Nefron Research.
Thanks for taking the questions. Just want to dig in on the U.S. guidance. As we run the math on the renewal opportunity, seems like guidance is probably baking in new patient starts being down low double digits this year so first just be curious if that's right or your math gets you to a different place um i think that's in the ballpark chris that one of the biggest drivers this year especially one that we've seen some tremendous growth in that we can really count on is the renewal opportunity
And we expect that with the environment being similar to what we were seeing in the fourth quarter as we go into this year, that we will continue to see some level of pressure on new pumpers, although we still will be adding new pumpers to the organization. It's just part of it is also the comp we had to last year, which the first half was a much healthier environment.
Right. Okay. And are you assuming any benefit from OUS renewals? You've been on the international market for a little over four years now, so it seemed like that might start to flow through.
You're right. We're just at the beginning of that. It's in 2023. 2019 was our first full year of operations, and we shipped 20,000 pumps in that year. But keeping in mind that there's a longer lag from when we ship those pumps to when they get placed on patients, it's more of a back half phenomenon for us, and really moving into 2024 is where we'll begin to see noticeable benefit.
Thanks. Thank you. And our next question comes from the line of Steve Lichman with Oppenheimer.
Thank you. Hi, guys. I'm wondering if you could just touch a little bit more on international. I think the implied guidance is low double digits, I guess even including that headwind you talked about in terms of the transition. So can you talk a little bit about sort of the underlying dynamics on how things are trending outside of the U.S. and any new regions we should be focused on for you guys in terms of control IQ here in 2023?
Sure. I could start with saying that you can still think of the opportunity for us outside the U.S. It's still about 4 million customers living with type 1 diabetes in the approximate 25 countries in which we're operating. So that would be the opportunity. And we've seen really great growth there. In fact, although hard to see on the top line because of some of the shipping dynamics, we've seen 20% growth in patient claimants. placements in 2022. So I think it's a great place for us to continue to push on penetration. So we're expanding the market as well as attracting competitive conversions there.
I'd also say, Steve, that this is an important week, OUS, as the ATD is starting today, I believe, and that we've got a symposium on Friday in which we'll have a number of papers that are presented, one of which is going to be the results of the Control IQ NICE study, which is in the UK. And the UK is looking at, you know, creative means to use AID technology to help people with diabetes in that country, and it's a big opportunity for us this year.
Thanks, John and Lee. I'll jump back in here.
Take care. Thank you.
Thank you. And our next question comes from the line of Alex Nowak with Craig Hallam.
Okay, great. Good afternoon, everyone. I know you're not seeing this in the guidance, but I'm just curious, how are we thinking about the uptake of the eventual pump demand following the preprocedure launches, whether it be G7 or Vero 3, and then also going to be going to pump mobile. Just remind us what happened back when G6 came online. and also when Basel IQ Control IQ started to roll out.
Alex, we had a really hard time understanding you.
I think the question was, what type of sales catalyst is the launch of our CGM partners, new sensors? And if you could maybe compare that to what we saw in the past with Control IQ launch and the Basel IQ launch.
Yeah, certainly. I think that... You know, the interesting thing is if you look back with basal IQ and with the control IQ, the G6 sensor had a meaningful impact in improving just the overall patient experience in both products. But at the same time, we were introducing new algorithms that also had an important impact. I would say that, you know, clearly with basal IQ, it was really the first device that reduced the burden of diabetes that people in the market had an opportunity to experience. And then with control IQ, the first really effective AID system, in addition to the great sensor, and obviously the sensor and the finger sticks were important. I think if you look forward to this year, and in the case of, you know, Dexcom and the G7 integration, it's a much better product. It's clearly got a painless insertion. It's got, you know, faster warm-up times and a much more ergonomic form factor, all of which are going to drive share growth for us. We think it's going to definitely be a favorable effect on sales, and we're going to see, you know, strengthen our sales from that product. You know, and as I said in the call, we anticipate that we would have the product in a scaling launch of the second half, excuse me, the second half of the second, excuse me, the second quarter, at the end of the second quarter.
Okay, thanks for the update. Sure thing.
Thank you. And our next question comes from the line of Matt Taylor with Jefferies.
Hi, thanks for taking the question. Hey, good afternoon. And so I wanted to ask you more about the assumptions around the U.S., the new pumps, ex-renewals. And I know you're expecting some pressure this year. I guess I was hoping to understand better, you know, in the second half of the year when you get maybe some new product help and the competitive launch, you know, the conditions improve. Do you think that you can grow new starts, extra mills in the US in the second half of 23 and maybe extend that thinking to 24 if you can?
Sure. It's a great question. And so I guess the first point I'll make is just the reminder that our guidance expectations for this year do not have those new product introductions in there. And so even with that, we still expect that we can expand the market with new pumpers, just slightly pressured. And part of that is just the baseline that we're comparing to. But with those new product launches, we do anticipate inflections in the business as it will continue to attract more and more people from shops. than what we're seeing today, just reaching a different segment, you know, whether it's with the CGM integrations or with our own Lobie product.
Okay. All right. I'll leave it there. Thanks, Lee.
Thank you. And our next question comes from the line of Matthew O'Brien with Piper Sandler.
Thanks for taking the question. Hey, John and Lee and Susan. Thanks for taking the question. You know, I guess over the last year or so, there's been kind of a downward trajectory to revenue guidance. And now it's a point where I think we're in good shape. But as I look at the EBITDA outlook for the company this year, and maybe I misheard Lee, but I think she said negative in the first half of the year adjusted and then positive in the back. That would assume a massive ramp in the back half if I'm hearing that right. And I mean, how do you get there? I just don't want to be in another situation where You've got to cut that outlook on the EBITDA line as we progress through the year as some of these expenses come through. So, can you just, are there programs that are going to fall off or something else there to really call out that gets you up to that full year adjusted EBITDA number? Thanks.
Sure. A great deal of it is not so much tied to the spending levels themselves. As we expect that to stay moderated across the year, it's really a function of the sales levels. So, if you think about how sales are scaling in the US, we have the typical seasonal curve where pump shipments start lower at the beginning of the year. In fact, coming off of Q4, pump shipments could, you know, our history suggests that they could come down 30% in the first quarter. And so you have that on current spending levels. And then when you think about the OUS dynamics with that headwind that we're expecting to see in the first half and really most heavily loaded into the first quarter, It makes for a challenging sales number, which really puts pressure on that adjusted EBITDA at the beginning of the year. So the ramp through the end of the year is as much about the sales going up across the year or scaling as it is about spending levels. But we are implementing programs today that I do expect to start to see benefit from that on the spending side. And a lot of it would be initiatives in our customer care organization for new productivities that will help drive down the cost to support the install base as it continues to expand.
Okay, thank you.
Thank you. And our next question comes from the line of Joanne Wench with Citi.
Thank you for taking the question. I just want to check a couple of things. If I put all the pieces into my model, it looks like new pumpers were down high teens in the quarter. Is that the right math?
I would say that's in the ballpark. You're talking about Q4. It did have the most pressure of the year in terms of new pumpers. When you're looking year over year, I would like to highlight, though, Joanne, that going from Q3 to Q4, we did see a modest increase in new pumpers as well as renewal customers.
Okay. And then just as a follow-up, I'm just a little thoughtful on how we're going to get from essentially 3% more or less revenue growth in the first quarter to to ramp to get to your full year guide. Other than easy comps, since you're not including new products in there, are you assuming maybe easing trialing or something else that is helping you figure out that ramp? Thank you.
Yeah, so really the ramp about separating, it's important to separate the U.S. from the OUS market. But the ramp across the year would follow what I would call a typical seasonal curve. The challenge is that when we're comparing year-over-year, we had a much healthier environment in the first quarter of last year and even the second quarter compared to the back half. So part of the year-over-year conversation is just about comps in the baseline and not so much about something that's beyond belief in the 2023 expectations. So if you think about renewals continuing to drive growth this year, you think about continuing to have new pumpers come to tandem. And then in the OUS markets, particularly with a $25 million headwind in the first half, again, mostly in the first quarter, that's really a pressure on that top-line growth rate. And so it's as much about those elements and the comp every year as it is about anything else.
Okay, thank you.
Thank you. And our next question comes from the line of Travis Speed with Bank of America.
Hey, thanks for taking the question. I heard your comments on things no better, no worse. But curious, the guidance did change. The low end went down a little bit. So I just want to make sure I understood the reason for the guided change on revenue. And then a quick clarification. It looks like U.S. supply revenue per patient was down about 5% every year. So I just want to understand the math on that. U.S. supply revenue. Thank you.
Sure. So starting with the guidance question, I would characterize that, Travis, as just now that we're giving guidance top to bottom on the P&L and giving it in a whole dollar number rather than a growth rate, you know, we're starting with that typical $15 million range that we usually start the year with. And an important point is that the midpoint of that range is right in line with consensus, so obviously very comfortable with where consensus is sitting today from that regard. And then when looking at the supplies on a per patient basis, nothing in our data suggests that there was anything out of the norm or unusual in terms of a per person usage of supplies. And so I don't have anything really to speak to from a supplies perspective. I guess I would clarify, if you're looking at it on a worldwide basis, We did see some headwinds on supplies outside the U.S. because of the transition to the distribution center that began in the fourth quarter. But when you look at the U.S. independently, it was really very much in line with our expectations.
Okay, great. Thank you.
Thank you. And our next question comes from the line of Larry Beagleson with Wells Fargo.
Hi, this is Nathan Trebek calling for Larry. Just a question in terms of the multi-launch. Are you expecting any delay in new starts or renewals because patients will wait for the launch?
So that's something that does typically occur in advance of a new launch, but I would say it's much closer to the launch time itself and not really that far in advance. In fact, it usually doesn't begin until you get to a clearance point. So between then and when you start your commercial launches, when you see sometimes some level of pause. But we're continuing to – we have a program today to help mitigate the pause as much as possible, and we'll continue to evaluate the effectiveness of that. At this point, I can say that we're not hearing anything from a field perspective that says there's even much knowledge of Mobi coming from a customer perspective. And so today we're not seeing any pausing related to it.
Thanks. And just as a follow-up, So, we've seen most diabetes devices delayed at the FDA in recent years. Do you expect a few rounds of questions with Moby? And I guess, what's a reasonable base case for launch timing?
Yeah, I mean, we are in the process of responding to the questions right now. I would say that the communications that we're having and the interaction is normal for this stage of the process. And you're right, it's, I mean, clearance timing is difficult to predict. And the way we're dealing with that is that we're planning on a scaled launch in the second half of the year. And roughly, we would expect that to start a quarter after clearance. And I think that's just the way we're looking at it. I mean, I think that we can't control it, but we can be prepared. And that's what we're planning on doing.
Thanks. Thank you. And our next question comes from the line of Jeff Johnson with RW Baird.
Thank you. Good evening, guys. Hey, John, how are you? You know, first off, I guess, first, can you just pass along, I'm sure, from all of us, well wishes to Kim and just let him know personally, I hope he continues his generosity with Peoria, Illinois. It's near and dear to my heart and my hometown. So if you could pass that message on, I would appreciate it.
Absolutely.
And then, Leo, just two follow-up questions here, just some things that have been asked. One, on the 30% normalized sequential decline from 4Q to 1Q, we do have some macro uncertainty in this environment and obviously competitive headwinds or at least competitive uncertainties. Are you comfortable that a normalized sequential pattern is something that could happen this year? We don't have to build in a bigger pattern? cushion there. And then just to Joanne's question, she had asked about upper teens decline and new patient starts. I just want to confirm that's on a global basis, right? We have you down, I think, closer to 25% on a U.S. basis. I just want to make sure my math's not off on that U.S. number. Thank you.
Sure. So starting with the sequential decline question, I would say that that history that we've seen, I feel comfortable is going to hold true in this first quarter. And part of that's back to John's commentary that since the last earnings call, we've seen the environment maintain consistency, no better, no worse than what we've seen. And so we're comfortable that thinking about it from along the lines of those same historical seasonality trends would make sense at this point. And then in terms of new patient declines, the conversation that we've been having, or at least when I've been talking about new patients, I've been very focused on the U.S. market. And so that's where I would agree with the percentages that people have been commenting to and suggesting that they've come up with in their models are pretty much in line with what we have been seeing and what we're anticipating. Thank you.
So sorry, just to clarify, you're down high team for U.S. That was a U.S. comment? Because again, I've got you down 25, and we can talk about the math offline, but I just want, you're saying closer to down high team for U.S. new starts in the 4Q?
I would say it's in the ballpark, Jeff. And we're talking about 4Q, and then as we look ahead, someone had asked the question about next year as well, and I agree with their indication.
Fair enough. Thank you. Thank you. And our next question comes from the line of Matthew Blackman with Stiefel.
Good afternoon, everybody. Thanks for taking my question. Lee, I appreciate the specific call-out on the EBITDA headwind from AMF and capillary in 2023. If I can get greedy, though, for AMF specifically, conceptually, does spend accelerate from 23 into 24 and 25 as you likely move into more intense clinical and regulatory work, or should we think about it being a a fairly consistent annual investment rate through commercialization. Thanks.
Sure. You know, the way to think about it, Matt, is that even in our own, let's say pre-AMF, In our own plans, we had expected that we would be accelerating spending on our own patch pump program. And so, by acquiring AMF and closing down our own internal program, it's going to follow suit with what we anticipated. And so, that falls in line with our original R&D expectations across the five years and meeting our operating margin target.
Okay. Appreciate that.
Thank you. Thank you.
And our next question comes from the line of Joshua Jennings with Cowen.
Hi, good evening. Thanks for taking the question. I wanted to ask about the tech access program and just how sales have tracked the first internal expectations and maybe what's a fair amount to assume for 23 to account for the difference between gap sales and the non-gap guidance?
Sure, Jas, thanks for the question. And so, just a little bit more information on the Tandem Choice Program. is that today, I guess I would highlight that it doesn't change the economics of a transaction when we sell a T-SLIM pump today. We receive the same amount of cash at the same amount of time. What this program does is it offers people an opportunity for the future. So as of today, no one's making an election. People don't even have to actually be aware of it. They are all eligible to participate if they're buying a T-SLIM today. So there's no tracking of progress or intent to use it in the future. And the reason we're providing non-GAAP sales versus GAAP sales is today you could probably pretty easily predict what the deferrals will be that we've reported in the fourth quarter and apply that to the future. But as soon as we get clearance for MOBI, you know, all bets off the table because the timing at which you recognize that revenue will be highly varied based on if and when people do elect to participate in the program. And so I strongly encourage people to focus on the non-GAAP sales because we are reflecting those with the same economics that you have seen from our business historically, and it's the best way to compare the progress of the business.
Great. Thank you for that. And then just on the pipeline, I just wanted to ask about a piece of the next three and And just any updates on development or regulatory progress for that platform? Thanks again.
Well, we're – sure. We're definitely in the middle of developing the product right now. I mean, I think it's – we said that T21X3 would be available on the market shortly after Moby's commercialized. So, it's next in line as a result of that, you know, we're working diligently on that. We haven't given specific timeframes other than that to say it's going to occur after Moby. And, you know, it's going to be an important product. We believe that a portfolio is very important for the business. It's just there's many different segments out there and to teach from appeals to a significant portion of people living with diabetes. And so it's going to be technology enhanced. It'll have, you know, wireless charging. It'll have a more powerful processor, better battery life, you know, a lot of technology enhancements that come along with that just to extend the lifetime of the product into the distant future.
Great. Thanks. Thank you. Take care.
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