Q4 2022 Tandem Diabetes Care Inc Earnings Call
Yeah.
Good day and welcome to the tandem diabetes care fourth quarter 2022 earnings Conference calls.
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It is now my pleasure to introduce executive Vice President and Chief administrative Officer, Susan 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.
Risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in our forward looking statements.
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.
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.
Believes 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.
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 continue to expand its record high installed base to new levels with now more than 420000 customers worldwide.
For the next two 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.
I was to continue to transform insulin therapy management.
Before diving into the 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 teasel next to pump users the bolus insulin from their iOS or Android smartphone.
This was a meaningful accomplishment.
We continue to be the only FDA cleared system delivering insulin through an iOS device.
Next is the broad range of clinical studies completed and presented this year on our Western class control IQ technology.
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 and 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 a steady sate extended wear infusion set and Ams medical the developer of the sticky patch pumps.
Both illustrates 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 though 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 puffers in the U S. We also focused on currencies, one 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 manufacturers pop.
Outside the United States. We also saw adoption of both new poppers and existing puffers of competitor pumps.
The breakdown is more difficult to quantify.
Overall, we saw approximately 20% growth in people adopting our <unk> technology and more than 25 countries, we serve with Q4 being the strongest quarter of the year.
Health care provider sentiments on a control IQ technology remains very positive worldwide.
With high regard for the immediate and 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.
The portion of people eligible to renew who actually renewed increased steadily through the year.
This coupled with strong retention of our in warranty customers demonstrates the high level of satisfaction people experience with our technology.
Customer renewals for our 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 our large and growing insulin pump market, which remains just over 35% penetrated in the U S and typically only 10% to 20% and 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 towards third party manufacturer.
Which create capacity for us to scale cartridge production for our newest pumps 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 backend of our customer portal.
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 head count intensive support costs.
It's also a meaningful step as we move towards tandem source or second generation web based data management application that we're planning to deploy on a scaled global rollout beginning this summer.
Tourists are designed to build on the success of our T connect data management application.
Which we already have more than half a million patient years of data from the <unk> to users in the U S.
Source enhances clinical data visualization and provides added interface customization for health care providers to better manage their patient's care, whether remote or in person.
In addition to source.
We also have launch planning efforts underway for tandem <unk>, which will expand our portfolio of diabetes solutions and offer people greater choice in how they want to wear their pumps as well as how they want to operate it.
As we've discussed in the past our research shows that movie largely appeals to a segment of people, who otherwise would not adopt insulin pump therapy with the options available today and as a catalyst for driving further market growth.
We received questions from the FDA in response to our 500 10-K 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 or.
Our commercial launch efforts are currently focused on the upcoming availability of the T cell next to with G. Seven integration.
Following <unk> recent clearance we are completing our final labeling updates and integration activities and our current plan is to watch with scaling availability worldwide begin later in Q2.
Our goal is to be the first to market with <unk> seven integration and AIG system will be rolled out to existing in warranty T. Slim X two customers for no charge and a software update can be done by users in the convenience of their home.
This will be the fourth generation of <unk> com sensors, we have integrated and are proud to be delivering on our commitment to bring people with diabetes integration with our latest technologies as they are cleared by the FDA.
Further this commitment is our work with Abbott to integrate the <unk> with freestyle Libre technology.
The other 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 and our shared market.
Fluent pumps integration with the <unk> technology is not available in the United States today.
Avid is working with the FDA to receive clearance for use in our system and what's 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 our second feasibility study for control IQ to point, though.
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 two indication for control IQ.
Our last major clinical trial initiative. This year is for the steady set technology, which is the extended wear infusion 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.
We work to expand lately indications for control IQ and bring new products features and benefits that 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 and 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.
This means choice <unk> features choice and device form factor and choice in how users can wear and operate their pumps.
This is why we are working to expand our family of offerings to include a next generation version of T. Slim.
Will include features like wireless software updates longer battery life, and a faster processor to support future algorithms.
We're also working on our consumable extension for Mobi.
Now it can be worn with a tube infusion set or tuba site adhere to the body provided the ultimate choice and flexibility.
The newest element in our portfolio as the <unk> patch pumps, which we acquired with a privately held Swiss developer Ams medical last month.
<unk> is designed to be an ergonomic rechargeable patch pumps that reduces the burden of managing diabetes through its use of a prefilled insulin cartridge and its compatibility with AI technology.
Now that it's closed we look forward to working more closely with the IMF team on product development regulatory and commercialization strategy.
And it was a company founded on innovation.
Our goal is to bring new technology to the diabetes community every 12 months to 18 months.
With the strength of our offerings today, and our new product portfolio in front of us.
We're 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 Lee.
Thank you John .
Our full year 2022 sales exceeded 800 normal 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 pump market capture competitive share and drive success in our renewal effort.
Fourth quarter sales were $221 million.
23 million non-GAAP on 36000 pumps.
Michael.
Our GAAP sales reflect an accounting deferrals related to the recent introduction of our tandem choice program in the U S, which provides the pathway for our customers to access our newest pumps.
Our non-GAAP sales are competed to reflect pumps that are consistent with historical periods in order to better 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 Keith go next to result today and none of the revenue deferred is that risk.
Really 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 a GAAP basis, and 592 million on a non-GAAP basis.
One of the largest growth drivers year over year, where supplies sales from our more than 20% increase in our U S installed base, which is now at 290000 customers.
We are also increasing our renewal numbers, both in volume and rates related to volume, we saw a 60% increase in renewals shipments for the year and then 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 84000 pumps in the U S in 2020.
Fourth quarter sales in the U S for 166 million on a GAAP basis and $169 million on a non-GAAP basis, we shipped 24000 pumps, reflecting the increase in both new and renewal pump shipments when compared to Q3.
Turning to our progress outside the U F 2022 sales were 212 million growing 19% year over year.
It's already of the increase came from 35% growth in supplies sales with our installed base, reaching 130000 customers by the end of 2022 as well as overall benefit from price increases and country mix.
Customer placements grew approximately 20% while actual pumps shipments were flat year over year. This difference largely relates to the variation in timing of orders from our distributors.
They are 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 end customer demand to orders.
This transition began late in the third quarter of 2022, creating a sales headwind of approximately $6 million across both pumps and supplies sales with the heaviest impact in the fourth quarter.
Our resulting fourth quarter sales were $55 million on 12000 pumps shipments.
Looking to the year ahead, we are providing 2023 worldwide sales guidance at 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 presents multiple opportunities to accelerate growth.
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 $659 $660 million. This contemplate 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 recurring pieces of our business both supplies and renewals are expected to make up nearly 60% of our U S sales expectations for the year plenty to a more predictable revenue stream as we grow.
Renewals create an increasing opportunity when you consider the extent to which our business 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 pumps 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 or $136 million.
The remainder of the year is expected to follow historical seasonal patterns, where both pumps and supplies bill 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.
Assumes a total of approximately $25 million and headwinds related to the transition of our largest European markets to the new distribution center.
Impact will be heaviest in Q1 and is expected to be complete midyear.
As a result Q1 sales outside the U S are expected to be lower as a percent of sales and in historical periods and the range of 34 million to $35 million.
From a margin perspective, our 2022 gross margin was 52% compared to 54% in 2021.
Performance was consistent across the year and that we benefited from higher average selling prices and operational cost reductions anticipated to offset pressures on our higher mix of supplies deal.
Two percentage point step 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 levers is expected to come in future periods from new product introductions, such as mobile and our extended wear infusion set technology.
Our operating margin in 2022 of negative 12% reflected the impact of certain unique or nonrecurring transaction, 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 and hybrid work environment.
And $4 million for the tandem choice program.
When excluding the impact of these transactions as well as noncash stock based compensation or 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 for productivity understood alright.
Our adjusted EBITDA margin is expected to scale across the year in line with sales expectations and as benefit builds from SG&A efficiency.
Clear with the expected sales headwinds outside the United States against our current spending levels.
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 program, providing the opportunity to fund 35 million of strategic activity.
Also invested $34 million in capital expenditures largely related to manufacturing scale up and leasehold improvements 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 U S 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 noncash P&L charges for stock compensation, depreciation and amortization are expected to be approximately 115 million of which $95 million is associated with dot com and $20 million with depreciation.
I will now turn the call back to John .
Thanks Lee.
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 Beckie Robertson.
Tim has been an instrumental leader for tandem since joining the company in 2007, serving first the CEO and then as chair for several years here.
His strategic vision and mission driven focus on our company culture has helped build and shape tandem from VC backed startups, who are world wide leader in diabetes care.
While serving as chair of focus for Kim and that of our other directors has been an 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 a 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 and entrepreneur, a corporate executive and board member.
At a tremendous value to our board, bringing patient centric and strategic vision.
Along with experience with a range of technologies and business models is a natural choice with expanded leadership position.
Again to Kemet 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 one one on your telephone and wait for your name to be announced.
To withdraw your question. Please press star one one again.
And we ask that you do limit yourself to one question.
These standby, while we compile the Q&A roster.
And our first question comes from the line of Matt mixing with Barclays.
Hi, Matt Hi.
Thanks, so much for taking the time.
I just wanted to make sure we understand the questions around.
We're getting around sort of margin direction.
The investments that Youre, making in this coming year I appreciate the conservatism on the 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 five 6% EBITDA number you mentioned.
Sure. Thanks for the question Matt.
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.
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 prioritize the number of the R&D investment.
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 well continue to look for ways to optimize their business model a lot of that comes from how we support our customer base and with the launch of tandem stores that will greatly improve our abilities to digitize and automate some of those customer.
Activities that we have today that require a heavy and head count 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 does put a little pressure on the bottom line, but we still feel very confident to expand those margins in the longer term.
Thank you.
And our next question comes from the line of Brooks O'neil with Lake Street capital markets.
Thank you for taking my question I'm, just curious John and Lee as you.
Think about Q4, and maybe what youre beginning to see in Q1 could you just parse out what do you. What do you think are the impacts.
The softening economy, and the macro factors as well as give us your sense for.
For the impact of competition.
And whether perhaps you are seeing anything different than you expected on the competitive side.
Of the equation, thanks a lot.
Hi, Brooks.
I mean, I would say that if you.
Look back to the third quarter call in November .
We've seen things remain fairly consistent and by that I would mean, it's been no better its been networks.
And that being said I think that we anticipate that this is the way it's going to be throughout this year.
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 control IQ 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 that.
Change in the <unk>.
Growth curve of the company and get us back to a growth rate that were you.
Used to in the past.
But I would say that theres really been not much change it's no better no worse.
And competition yet.
Yes, I would say the same thing with competition as well.
Okay.
Thank you and our next question comes from the line of Chris <unk> with Nephron research.
Thanks for taking the questions just wanted to dig in on the U S guidance as we run the math on the renewal opportunity. It seems like guidance is probably baking in new patient starts being down low double digits. This year. So first of all just be curious if thats right Matt.
It gets you to a different place.
And I think thats in the ballpark, Chris one of the biggest drivers this year, especially one that we've seen some tremendous growth 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 pampers, although we still will be at.
Adding new pumps to the organization. It's just part of it is also the comp we had to last year, which the first half with a much healthier environment.
Right, Okay and are you assuming any benefit from <unk> 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 are right. We're just at the beginning of that in 2023, and 2019 was our first full year of operations and we shipped 20000 pumps in that year, but keeping in mind that there is a longer lag from when we ship those pumps when they get placed on placed on patients. It's more of a back half phenomenon for us and really moving into 2024 hours.
We'll begin to see noticeable benefit.
Thanks.
Yes.
Thank you and our next question comes from the line of Steve Richmond with Oppenheimer.
Thank you hi, guys.
If you can 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 debt.
Transition so.
Can you talk a little bit about sort of the underlying dynamics on how things are trending outside of the U S.
Any new regions, we should be focused on for you guys in terms of control IQ here in 2023.
Sure I can start with saying that and you can still think of the opportunity for us outside the U S is still about 4 million customers living with type one diabetes and 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 21.
Growth in patient payments placements in 2022.
It's a great place for us to continue to push on penetration.
Expanding the market as well as attracting competitive conversions there.
I'd also say Steve that this.
<unk> is the ACD is starting today I believe and that we've got a.
Posey them on on Friday, and which will have a number of papers that are presented one of which is going to be the results of the control acute nice study, which is in the U K U K is looking at creative means to use AI technology to help people with diabetes in that country and it's a big opportunity for us this year.
Thanks, John I will jump back in queue. Thanks, Sir Thanks, Steve.
Thank you.
Next question comes from the line of Alex Nowak with Craig Hallum.
Okay, great good afternoon.
And that's in the guidance.
How are we thinking about.
And eventually once the main purpose CDM launches that <unk> be very familiar with and then also can be done.
Just a reminder back in June 6th.
And also you can bet that we control key sites.
Right.
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 in the basal IQ launch.
Yes, certainly I think that.
The interesting is if you look back with basal IQ and with control IQ.
The <unk> center.
It had a meaningful impact in improving.
The overall patient experience in both products.
At the same time, we are introducing new algorithms that also had a.
An important impact I would say that clearly with basal IQ is really the first device that reduce the burden of diabetes that people in the market had an opportunity to experience intent with control IQ the first really effective.
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.
<unk> com and the <unk> integration.
Much better product, it's clearly got a painless insertion it's Scott.
Faster warm up times and much 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 strength in our sales from that product.
As I said in the call we anticipate that we would have the product.
Scaling launch in the second half 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 Dan.
Thank you and our next question comes from the line of Matt Taylor with Jefferies.
Good afternoon.
And so I wanted to ask you more about the assumptions around the U S. The new context renewals.
You're expecting some pressure this year I guess I was hoping to understand better the second half of the year. When you get maybe some new products help and lap the competitive launch if conditions improve do you think that you can grow new starts extra renewals in the U S. In the second half of 'twenty, three and maybe extend that thinking too.
24, if you can.
Sure. It's a great question and so I guess, the first point I'll make as just a 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 pumper shift slightly pressured and part of that is just the baseline that we're comparing Q, but with those new product launches.
We do anticipate infections in the business as it will continue to attract more and more people from shots than what we're seeing today.
<unk> a different segment, whether it's whether it's with the CGM integration to part with their own multi product.
Okay, Alright ill 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 my question.
Hey, John .
Thanks for taking the question.
I guess over the last year or so there has been kind of a downward trajectory.
Revenue guidance.
And now it's at a point, where I think we're in good shape, but as I look at the EBIT outlook for the company this year and maybe I misheard you, 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 it.
In another situation, where <unk> 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 speak just are there other 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 unless we expect that the state moderated across the year, it's really a function of the sales levels. So if you think about how sales are scaling in the U S. We have the typical seasonal curve where pumps shipments start lower at the beginning of the year in fact coming off of Q4 pumps shipments too.
Our history would suggest 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 O U S 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 scaling as it is about.
Spending levels, but we are implementing programs today that I do expect to see start to see benefit from that on the spending side and a lot of it would be initiatives in our customer care organization to FERC for any productivity that will help drive down the costs to support the installed base as it continues to expand.
Okay. Thank you.
Thank you and our next question comes from the line of Joanne <unk> with Citi.
Thank you for taking the question just wanted to check a couple of things if I put all the pieces into my model it looks like new pampers for down high teens in the quarter is that the right Matt.
I would say that's in the ballpark Youre talking about Q4. It did have the most pressure of the year in terms of a new Congress when youre looking year over year I would like to highlight though Julian that going from Q3 to Q4, we did see a modest increase in new pumps as well as renewals customers.
Okay, and then just as a follow up I'm, just a little thoughtful on how we're going to get from essentially <unk>.
3% more or less revenue growth in the first quarter to ramp to get to your full year guide other than easy comps since youre, not including new products and there are you, assuming maybe easing trialing or something else that that is helping you figure out that ramp. Thank you.
Yeah, so really the ramp about separating its important to separate the U S from the U S market, but the ramp across the year with followed what I recall, a typical seasonal occur the challenges that we were 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 Carter.
The year over year conversation is just about pumps in the baseline and not so much about.
Something that's beyond belief in the 2023 expectations.
Do you think about renewals continue to drive growth this year as we think about.
Continuing to have new pumps <unk> come to candle and then in the U S markets, particularly with a $25 million headwind in the first half again, mostly in the first quarter.
Really a pressure on that top line growth rate and so.
It's as much about those elements and the comp year over year as it is about anything else.
Okay. Thank you.
Thank you and our next question comes from the line of Travis Steed with Bank of America.
Hey, Thanks for taking the question.
I heard your comments on things no better no worse, but the.
The guidance at the low end went down a little bit so just want to make sure I understood. The reason for the guidance change on revenue and then a quick clarification. It looks like U S supply revenue for patient was down about 5% year over year. So just want to understand the math on that you have to apply revenue. Thank you.
Sure. So starting with the guidance question I would characterize that Travis has just now that we're giving guidance top to bottom on the P&L and give you again in a whole dollar number rather than a growth rate.
With that typical $15 million range that we usually start the year with an important point is that the midpoint of that range is right in line with consensus 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 suggest that there was anything out of the norm or unusual in terms of a per person usage of supplies and so on.
How many can really just speak to from a supplies perspective I guess.
I would clarify if youre looking at it on a worldwide basis.
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 pretty much in line with our expectations.
Thank you.
Our next question comes from the line of Larry <unk> with Wells Fargo.
Hi, This is Nathan trade back on 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 not really that far in advance in fact that usually doesn't begin until you get to a clearance point.
Then 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 cost as much as possible and we will continue to evaluate the effectiveness of that at this point I can say that we're not hearing anything from a field perspective that sensors, even much knowledge of mobi tunnel from from a customer perspective.
Thanks, and just as a follow up so we've seen most diabetes devices delayed the FTAA in recent years do you expect a few rounds of questions with mobile and I guess, what's a reasonable base case for launch timing.
Yes, I mean, we are in the process of responding to questions right now.
I would say that the communications that we're having in the interaction as normal.
For this stage of the process and you are right.
Timing is difficult to predict.
The way we are dealing with that is that we're planning on a scale launch in the second half of the year and roughly we would expect that to start a quarter after clearance.
And I think Thats 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 demand.
Thanks.
Thank you.
And our next question comes from the line of Jeff Johnson with RW Baird.
Okay.
Thank you good evening guys.
John how are you.
First off I guess first can you just pass along I'm sure for all of us well wishes to Kim.
Personally I will be continues his generosity with Peoria, Illinois, it's near and Dear to my heart in my hometown. So if you could pass that John I would appreciate it.
Absolutely, Yes, and then we will adjust.
No.
Follow up questions here.
Just some things that are going to ask one on the 30% normalized sequential decline from <unk>.
We do have some national uncertainty in this environment.
Obviously.
Headwinds or at least competitive uncertainties when you.
Comes from all of that like a normalized sequential pattern is something that could happen. This year, we don't have to build in a bigger.
Question, There and then just to Joanne as questions. You had asked about upper change decline in new patient starts I just want to confirm just on a global basis right. We have you down I think closer to 25% on a U S basis. So just want to make sure my math.
Thank you.
Sure.
Starting with the sequential decline question I would say that that history that we've seen I would feel comfortable is going to hold true in this first quarter and part of that back to John's commentary that since the last earnings call. We've seen the environment and maintain consistency no better no worse than what we've seen is that we're comfortable that thinking.
Got it from along the lines of the same historical seasonality trends.
Makes sense at this point and then in terms of new patient declined the conversation.
We've been having at least when I've been talking about new patients I have been very focused on the U S market and so that's where I would agree with the comp with the percentages that people have been commenting to you and suggesting that they've come up within their models are pretty much in line with what we have been seeing and what were anticipating so sorry, just to clarify your nose down high flow for you that would be.
U S comments and again that was 25% and we can talk about the math offline, but just what youre, saying closer to down high teens for USA starts in <unk>.
I would say it's in the ballpark, Jeff and we're talking about <unk> and then as we look ahead at someone had asked the question about next year as well.
Agree with their indications.
Fair enough. Thank you.
Okay.
Thank you.
And our next question comes from the line of Mathew Blackman with Stifel.
Good afternoon everybody.
Thanks for taking my question.
I appreciate the specific call out on the EBITDA headwind from MFS and capillary in 2023, if I can get greedy, though for Ams, specifically conceptually does spend accelerate from 23 into 'twenty four 'twenty five as you likely move into more intense clinical and regulatory work or should we think about it being a fairly.
<unk> annual investment rate through commercialization.
Sure.
<unk> to think about it Matt is this is that even in our own let's say pre Ams in our own plans. We had expected that we would be accelerating spending on our own patch pump program and so by acquiring Ams, including 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 X.
Patients across the five years and meeting our operating margin target.
Okay I 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, just health sales of track to date first internal expectations.
And maybe what's fair amount to assume for 2003 to account for that there was between GAAP sales in the non-GAAP guidance.
Sure Josh 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 felt let's see some pumps today. We received the same amount of cash at the same amount of time.
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 theyre buying a T. Slim today, so theres no tracking of progress or intent to use it in the future.
The reason, we're providing non-GAAP sales versus GAAP sales is today, you can probably pretty easily predict what the deferrals will be that we've recorded in the fourth quarter and apply that to the future, but as soon as we get clearance from Obi.
Thats 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 means 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 piece of the next three.
And just any updates on development or regulatory progress for that platform. Thanks.
Thanks Scott.
Sure we're definitely in the middle of developing the product right now I mean, I think it's that we said that <unk> would be available on the market.
Shortly after <unk> commercialized so its next in line as a result of that we're working diligently on that we haven't given specific timeframes.
I can say its going to occur after Bobby and.
It's going to be an important product we believe that our portfolio is very important for the business is just theres. Many different segments out there entities kind of appeals to a significant portion of people living with diabetes and so that's going to be technology enhanced it'll have.
Wireless charging they will have a more powerful processor better battery life, a lot of technology enhancements that come along with that just to extend the lifetime of the product into the into the distant future.
Great. Thanks.
Thank you Kevin.
And this concludes today's conference call. Thank you for participating and you may now disconnect.
The conference will begin shortly to raise and lower Johan during Q&A, you can dial star one one.
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Okay.
Okay.
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