Good day and welcome to the Tandem Diabetes Fourth Quarter and Year-End 2024 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. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker, Susan Morrison, Executive Vice President and Chief Administrative Officer. Please go ahead..

John Sheridan, Tandem's President and CEO; Mark Novara, Executive Vice President and Chief Commercial Officer; and Leigh Vosseller, Executive Vice President and Chief Financial Officer. Following their prepared remark, the operator will open up the call for questions.

Thank you in advance for limiting yourself to 1 question before getting back in the queue. I'll now turn the call over to John..

Thanks, Susan and thank you, everyone, for joining us on today's call. 2024 was a pivotal year for Tandem, marked by an impressive 18% increase in worldwide sales. I am proud that we set new sales records, both in the U.S. and internationally, while delivering industry-leading customer satisfaction and expanding our portfolio of technology solutions.

The highlight of the year was the introduction of our category-defining pump platform, Tandem Mobi which experienced continued growth throughout 2024 as awareness of our newest offering increased. Additionally, we implemented operational efficiencies that set the stage for sustained profitability in 2025 and beyond.

These achievements were made possible, thanks to the resilience, perseverance and hard work of our employees. Thank you, everyone, including our distributors, suppliers, clinical partners for your continued dedication and efforts that contribute to furthering our mission.

Tandem now offers the most robust ecosystem in insulin therapy management in the world. With our flagship t:slim and Tandem Mobi, we provide the greatest choice in pump platforms. We offer customers a seamless cloud-based experience with our apps and operating system support and enable HCPs with our web-based data management platform, Tandem Source.

We also integrate with multiple leading CGM sensors. And next month, we will launch our third automated insulin delivery algorithm with Control-IQ+.

Control-IQ has long been considered the best automated insulin delivery algorithm with more than 240 million patient days of data logged in our system and 70-plus peer-reviewed manuscripts and published abstracts. Over the past 5 years, it has provided immediate and sustained results across all patient populations.

Now we're raising our own bar with the launch of Control-IQ+. Control-IQ+ offers superior glucose control and best-in-class outcomes by predicting, calculating and adjusting insulin doses, including delivering automated correction boluses.

Driven by customer feedback, we have added new clinical features such as an extended bolus lasting up to 8 hours and the option to set a temporary basal rate. Activating Control-IQ+ is easy. We have introduced a simple setup wizard that allows users to set it in accordance to AACE guidelines, switch it on and witness immediate results.

This is particularly beneficial to people coming from MDI. In the U.S., customers also are now able to choose between English and Spanish. Control-IQ+ was originally approved for individuals with type 1 diabetes aged 2 and older.

As highlighted in yesterday's press release, we're excited that it is now FDA cleared for people living with type 2 diabetes 18 years and up. This more than doubles our addressable market in the United States, positioning us for significant long-term growth.

This expanded label indication encompasses all insulin requiring people with type 2 diabetes and is based on our recently completed pivotal trial. This trial represents the first large-scale randomized controlled study of an automated insulin delivery system in more than 300 people with type 2 diabetes.

Full study results will be presented at the International Conference of Advanced Technologies and Treatments for Diabetes in Amsterdam next month.

With Tandem's robust expanded portfolio, we also began executing a multichannel payer strategy with the addition of the Pharmacy channel which we expect will ensure our best-of-class products are matched with ease of access and improved affordability.

We also began investing in important commercial initiatives to fortify our business fundamentals and advance our short- and longer-term sales and profitability goals. For instance, in the fourth quarter, we initiated recruitment efforts to support a strategic sales expansion and territory realignment which took effect at the beginning of this year.

We identified opportunities to modernize the tools and systems used by our commercial teams, enhance their efficiency and effectiveness.

Additionally, leveraging the robust performance of our OUS business and recognizing the vast potential within the markets we serve, we have begun a multiyear transition to direct commercial operations in select European countries. Overall, 2024 was a successful year for Tandem with a return to growth.

Importantly, we also initiated fundamental changes to key business processes, broadened market access options and expanded organizational capabilities to accelerate revenue growth and profitability in 2025 and beyond. And taking a deeper look at the fourth quarter, there are many wins to celebrate.

Outside the U.S., we delivered strong double-digit growth driven by demand for the t:slim pump platform. In the U.S., we saw strength from both t:slim and Mobi pump platforms and in key performance indicators, such as year-over-year growth in the customers coming from multiple daily injections and customers renewing from Tandem once again.

Our wins in the quarter also came with some challenges. The fourth quarter in the U.S. did not come together as anticipated. We experienced more muted seasonality in the last few weeks of the year, where historically, we have seen acceleration throughout December.

Additionally, shipping delays by carriers who did not deliver to customers before the end of the year as planned, impacted the timing of revenue reporting. Despite these factors, the underlying trends of our business remain strong and favorable. I will now ask Mark to provide more additional detail on the commercial insights.

Mark?.

Thank you, John. When I joined Tandem just over a year ago, we put a commercial strategy in place to maximize our portfolio of innovations, galvanize the customer experience and fortify our international efforts to become truly global.

Our strategy remains fully intact and we achieved meaningful progress delivering on it in 2024; and most importantly, set ourselves up well for the longer term. Starting with maximizing our portfolio. In 2024, we demonstrated our commitment to bringing new innovation to market with the launch of a new pump platform and multiple new CGM integrations.

We also scaled Tandem Source which is now used by more than 90% of our U.S. prescribers and began offering it outside the United States. The expansion of our AID portfolio with the U.S. launch of Tandem Mobi was a particular highlight. Mobi is an expansion to our portfolio, largely attracting customers who otherwise may not have selected Tandem.

At half the size of t:slim, the same weight as 2 AA batteries and the size of an AirPod case, Mobi is defining a new category in AID technology.

Its tiny form factor, coupled with mobile app operation and the flexibility to be worn as many as 20 different ways, including the ability to detach provides patients with an entirely new value proposition in wearability backed by the best-in-class Control-IQ.

This new value proposition is attracting a younger population to AID therapy and earning Mobi excellent feedback from both health care providers and Mobi customers. This was reflected in dQ&A recent survey where Mobi was rated number one in size, comfort and wear during physical activity.

I am proud of the start to Mobi's launch which we plan to continue building by amplifying awareness and trialing of this exciting technology, offering greater access and expected affordability through the pharmacy channel and by expanding its feature set.

We also continue to have high expectations for our flagship t:slim pump which has a strong fan base with both new and renewing customers. Its 300-unit cartridge, broad CGM and foam compatibility and all-in-one touchscreen use provide high satisfaction and allow for Tandem to meet different needs in the diabetes community.

We now have more than 320,000 in-warranty customers in the United States and the way we serve them is a differentiating factor for Tandem. As a result, we delivered double-digit growth in renewal customers, both sequentially and year-over-year, while delivering an industry-leading customer satisfaction score.

For the first time, Tandem won Seagrove's People Choice Award, leading in 4 out of the 8 categories surveyed, including favorite pump. In dQ&A, Tandem had the highest Net Promoter Score, outperforming all other competitors. This reflects our deep dedication and commitment to delivering a best-in-class customer experience.

Turning to our business outside the U.S. where we now have more than 160,000 in-warranty customers. Our consistent outperformance this year was driven by high demand for our t:slim X2 pump; and under new international leadership, we advanced how we work with our distributor partners and strengthened our commercial capabilities.

It's also a reflection of the large and underpenetrated nature of the countries we serve and the future opportunity in these regions. As we look to 2025 and beyond, we are well positioned to drive and scale our commercial strategy. The worldwide AID market has more competitors, larger sales forces and more insulin pump offerings than ever before.

2024 highlighted this as an opportunity to invest in foundational capabilities that we are capitalizing on for the year ahead to increase our share of voice, continue driving sales force and overall commercial effectiveness and improve how we service those markets.

In the U.S., we have successfully executed a strategic realignment and expansion of our sales and clinical teams. This optimization enhanced efficiency while increasing our share of voice in high-priority growth accounts. Tandem's technology is incredibly exciting and innovative and we recognize this is a promotionally sensitive market.

So now is the time to invest selectively and responsibly to amplify our market presence and enhance both the customer and employee experience. We have enhanced our structure, targeting strategy, modernized our practices and equipped our teams with new capabilities and tools to drive commercial excellence.

These initiatives were piloted with our field team in 2024, are now being rolled out and we expect to see increasing benefits starting in the latter half of this year. Another exciting opportunity for Tandem is our scaling pharmacy channel initiatives.

2025 marks the first year that Tandem is able to offer multichannel durable medical equipment and pharmacy benefit plan coverage. Our team exceeded our market access goals for 2024 by signing multiple meaningful contracts with leading PBMs and we now have approximately 20% of U.S.

lives covered under pharmacy agreements for a mix of commercial and government lives. We believe this is a win for Tandem; and most importantly, a win for patients who previously stayed on multiple daily injections due to cost barriers.

Driving scalable growth in pharmacy is a top priority for our business this year as we work to drive broader access and sustainable growth. Pharmacy is also strategically important as we increase our focus on supporting people living with type 2 diabetes, where cost is also a barrier.

To help drive change so that cost does not prevent people from getting the therapy they want and need, we are active in a coalition as well as industry efforts to establish a sustainable Medicare pathway to broaden coverage for people living with type 2.

Addressing the needs of the type 2 insulin-dependent population is a strategic imperative for Tandem and one that provides long-term growth opportunities. With Control-IQ+ type 2 indication now FDA cleared, the size of our addressable market has doubled.

As a reminder, more than 30,000 people with type 2 use Tandem's technology today and we've seen this success without any dedicated marketing or sales efforts. Our recently completed randomized clinical trial will serve as a powerful foundation for promotion post clearance, highlighting key differentiators that set us apart in this market.

We also recognize the needs of this population can be different than people living with type 1 and we are committed to serving them with tailored solutions. We will soon begin type 2 pilot launch activities that will scale based on our key performance indicators. Turning to our business outside the United States.

We are continuing to scale our presence in the countries we serve. Historically, our sales have been exclusively through distributors. In 2024, we began laying the groundwork to expand our international presence by onboarding new talent to our regional and in-country commercial teams while continuing partnerships with our in-region distributors.

To build upon this model and drive further growth, we are preparing to initiate direct sales, training and customer support in select European countries starting in 2026.

Acknowledging that such transitions can cause some disruption, we are working closely with the distributors to minimize impact for all parties involved, particularly prescribers and Tandem pump users.

This is a natural step in our maturation as a med tech company and one that is intended to strengthen our financial position by accelerating sales growth and driving margin expansion.

It's also an opportunity to gain greater direct insights and deepen relationships within the European diabetes community which is a priority for us as we build out our teams to support local efforts and establish global leadership. As you can see, we have entered a transformational phase for our commercial organization and for Tandem.

These steps are critical as we continue to maximize our portfolio, expand our addressable market, increase our competitiveness, both near and long term and improve the lives of people with diabetes worldwide. I'd now like to turn the call over to Leigh to share some more information on our Q4 results and expectations for 2025.

Leigh?.

Thanks, Mark. As a reminder, unless otherwise noted, the financial metrics I'll be discussing today are on a non-GAAP basis. Reconciliations from GAAP to non-GAAP results can be found in today's earnings release as well as on the Investor Center portion of our website.

Annual worldwide sales were the highest ever at $910 million which was an increase of 18% year-over-year. We also achieved record fourth quarter sales of $252 million. It was the largest in our history and the second quarter in a row of greater than 20% growth over the prior year.

This sales performance was driven largely by a strong double-digit increase in pump shipments. Starting with color on the U.S. market. In the fourth quarter, we shipped more than 24,000 pumps and generated sales of $184 million, representing 13% year-over-year growth. On a full year basis, sales were $642 million.

Pump shipments of nearly 81,000 for the year increased 10% due largely to the Mobi launch and strong retention of our customers through renewal purchases, while pump sales increased 13%.

This differential is due to improvements in average selling prices, benefiting from continued price increases and favorable mix within the DME channel across the year. We are now consistently seeing nearly 40% of our U.S. pump and supply business through direct contracts versus 36% a year ago.

When looking at our sources of business during the year, we continued to see positive trends into the fourth quarter. Renewals and new starts from MDI conversions are 2 key metrics that are foundational to meeting our long-term growth objectives and we delivered on both fronts.

Renewals continue to meet historically high retention rates on pace for consistent achievement of 70% capture within 18 months of warranty expiration. Renewals were the greatest driver of pump growth but we are exiting 2024 encouraged by our trajectory with Mobi driving more MDI users to pump therapy.

MDI conversions in 2024 grew double digits and made up greater than 60% of our new starts overall. Q4 also marked the conclusion of our Tandem Choice program which, as previously discussed, was an opportunity for eligible t:slim X2 customers to switch to Mobi upon its availability earlier this year.

As a reminder, reported pump shipments and non-GAAP financials do not include any impact from the program. There were essentially 3 stages of this program. On a GAAP basis, we deferred a portion of the sale for each eligible X2 customer over the course of approximately 18 months prior to selling Mobi.

Upon launching Mobi this year, we ceased deferring any portion of X2 sales and began recognizing sales and cost of goods sold with each individual election to switch to Mobi. Now that the program is complete, we captured all remaining X2 sales deferrals in the fourth quarter totaling $30 million.

For further details on the GAAP accounting for this program, please refer to the accounting policy discussion in our 10-K. Turning to our results outside the United States. We shipped approximately 40,000 pumps for the full year and grew sales to $268 million which is a 39% increase year-over-year.

In the fourth quarter, we shipped approximately 10,000 pumps and grew sales 48% to $68 million. Similar to the U.S., our OUS pump and supply sales benefited both from volume and price increases. The majority of our pump sales continue to be driven by customers new to Tandem with strong demand for t:slim X2.

Renewals will begin to offer more meaningful contribution in 2025. Moving on to margin performance. Our 2024 gross margin was 51%, consistent with 2023, while absorbing headwinds associated with the Mobi launch.

As expected with scaling volumes, Mobi pump manufacturing cost per unit continued to improve across the year and will begin to benefit gross margin as we enter 2025. This positive contribution from Mobi will build in the coming years and become more meaningful as we increase the mix of Mobi pumps we are selling.

Additional leverage will come from Mobi cartridge scaling in 2026 and beyond as the size of the ordering installed base is expected to grow. Gross margins also benefited from favorable ASPs across all products.

For the full year of 2024, our adjusted EBITDA margin was consistent with 2023 at negative 1% of sales which included increased spending year-over-year to support the Mobi launch and clinical trials for new products and indications. The adjusted EBITDA margin also reflects initial investments to commence the expansion of our footprint in the U.S.

as well as build infrastructure to support direct operations outside the U.S. Even with these investments, 2024 marked a return to positive free cash flow which is early evidence of our dedication to improved financial strength in the coming year.

We ended the year with $438 million in total cash and investments and are confident in our ability to support key operating and non-operating commitments in 2025, including debt repayment of convertible notes due and final AMF purchase obligations. Turning to guidance.

With Tandem Choice behind us, we are returning to GAAP guidance for 2025 which will be most directly comparable to the non-GAAP results we provided in 2024. Worldwide sales are expected to be in the range of $997 million to just over $1 billion or 10% to 11% growth year-over-year.

This contemplates the impact of certain factors that are critical to meeting our long-term sales ambitions that may create some level of disruption in the near term. In the U.S., our sales for 2025 are expected to be in the range of $725 million to $730 million or growth of 13% to 14%.

We anticipate another strong performance with renewals from increased warranty expirations, predictable and growing supply sales and mid-single-digit growth in new pump starts. This growth in new pump starts will be driven by continued traction with Mobi and other new product innovations.

We will continue to vigorously pursue improved market access for our expanded type 2 label in the Medicare population, expecting only modest contribution in the meantime. The sales force expansion and realignment that we just completed in the U.S. have the potential to create disruption in the near term and was factored into our expectations.

Our move into the Pharmacy channel is important for addressing affordability concerns and we have a strong start with approximately 20% of covered lives under contract. We have not included material benefit from pricing or volume at this time.

We will continue to gather and assess data related to new product adoption and channel utilization to inform updates to our guidance in upcoming quarters. As a reminder, both pump and supply shipments typically reflect seasonal patterns across the quarters which is associated with insurance dynamics in the U.S.

For example, first quarter pump shipments typically decline from the fourth quarter by 25% to 30%. Accordingly, sales for the first quarter are expected to be in the range of $144 million to $147 million, representing 10% to 12% growth year-over-year.

The remainder of 2025 is expected to follow historical seasonal patterns where both pump and supply sales scale up across the year. Sales outside the U.S. for 2025 are expected to grow 2% to 4% to a range of $272 million to $277 million.

This reflects the tremendous market expansion opportunity ahead, balanced with the potential for disruption as we prepare to go direct in select European countries. Our sales assumptions factor in $15 million to $20 million of potential headwinds later in the year as we navigate this transition ahead of our planned 2026 launch.

In the first quarter, we anticipate minimal disruption and therefore, expect sales of $75 million to $77 million from strength in these markets. We expect to demonstrate our greatest progress in recent years in both gross and adjusted EBITDA margins.

While I have outlined today certain investments we are making for growth, we have meaningful efficiency initiatives underway through greater automation, process improvement and increased use of technology to support our customers. The savings expected to be generated will allow us to fund the commercial investments while expanding margins.

We expect gross margin to be approximately 54% for the full year and 51% in the first quarter, including minimal anticipated impact of tariffs, driving towards our long-term target of 65%, where Mobi will be the greatest contributor.

Adjusted EBITDA margins are expected to improve to approximately 3% of sales for the year or an improvement of 4 percentage points from 2024, with the low in the first quarter at approximately negative 6% of sales. I'll now hand the call back to John for closing remarks..

Thanks, Leigh. Alongside our operational and commercial strategies to propel business growth, we are unwavering in our dedication to innovation and focus on new technologies that will bring the greatest benefits to our people with diabetes. In 2025, we will further expand our portfolio by launching new technology solutions.

First is our integration with FreeStyle Libre 3 plus with t:slim followed by Mobi and then next is the introduction of Android app for control for Mobi. Additionally, I am thrilled to announce that we have already submitted Mobi for CE Mark and are on track to launch it outside the U.S. by the end of the year.

The international launch of Tandem Source currently underway will enable the scaling of Mobi's global expansion. Another key regulatory filing to highlight is our initial FDA submission for our SteadySet [ph] infusion set.

We are pursuing a 3-day indication as a first step in our regulatory strategy for longer wear times with additional filings to support our product targets. Our commitment to innovation and growth also extends beyond 2025. We are enhancing the features of both t:slim and Mobi platforms.

For t:slim, it's continuing to keep our flagship platform modern and competitive. For Mobi, we are prioritizing the development of a tubeless infusion site that offers even more wearability options which will be the next significant pump enhancement available within our portfolio.

Beyond that, we plan to further expand our portfolio with a third pump platform, Sigi. Sigi is an ergonomic and rechargeable patch pump. We are beginning to accelerate its development in San Diego, leveraging the expertise of our advanced pump development team and we are excited to bring this differentiated technology to the market.

We remain steadfast in our commitment to offer the best-performing fully closed-loop algorithm with industry-leading outcomes and minimal user burden.

To further this goal, we recently signed a multiyear collaboration agreement with the University of Virginia Center for Diabetes Technology to advance research and development efforts on fully closed-loop insulin delivery systems.

This exciting collaboration will build on ongoing research as we continue our successful partnership to deliver new innovations. As you can see, 2025 is positioned to be full of tremendous opportunity for Tandem. The strengths that have driven meaningful growth for us in the past are once again in place today.

These include having a differentiated portfolio of technology solutions, our industry-leading customer service and our best-in-class automated insulin delivery algorithm.

These drivers, coupled with our actions underway to fortify, strengthen and grow our business include our expanded sales force with modernized tools and systems, increased pharmacy channel access, scaling growth into type 2, preparation for direct sales in Europe and the most exciting pipeline in diabetes.

Each of these is an exciting opportunity independently. Together, they position us for near- and longer-term profitable growth as we create new possibilities for people living with diabetes. Thank you for supporting Tandem through this exciting transformation.

Operator, would you please open the call up for questions?.

[Operator Instructions] And our first question will come from the line of Matthew Blackman with Stifel..

Leigh, I was going to give you a multipart question. Apologies that we're starting off like that. But I was hoping to get you to -- if you could quantify, I think you called out 4Q shipping delays.

Can you quantify that for us? And whether that was on both the pumps and the supply side? And then also the December trends being softer, just any thoughts there on why? And to the extent you want to give us some commentary beyond, obviously, the 1Q guidance, how things are looking in early '25 on that front? And then on the guidance, I just want to confirm, I think I heard it but is type 2 baked in there? Is Libre baked in there? It didn't sound like it.

And just any clarification on what's in there and what would be potentially upside? I'll leave it at that..

Thanks, Matt. Certainly, a lot packed into that question. So I think I will start with a few comments on the fourth quarter. And so to your point, asking about where the shortfall came from, the majority of it really came from the fact that we saw a muted seasonal curve in December. So if you think about the last few weeks.

And as we normally look at seasonal trends and not only growth across the quarters but even across the weeks within the fourth quarter. December was still by far the largest shipment month we had for the year. It was really just those last few weeks that fell short and it showed growth year-over-year.

And so the comment about the shipping delays, it was a contributor. It was not the most meaningful but it was important just to call out compounding what we were seeing at the end of the year. And we did take those considerations or take those into consideration as we thought about how to set the guidance for 2025.

None of it took away from our enthusiasm or our confidence in continuing to grow the market. We still saw great strength in MDI. We still saw great traction with our renewal opportunities. And those are the fundamental key performance indicators that we expect to drive the business going forward..

One moment for our next question. And that will come from the line of Steve Lichtman with Oppenheimer..

I guess for my one question, I wanted to touch on Pharmacy. A lot of progress that you noted there.

Can you talk about the next steps for that initiative? Any 2025 goals on coverage you can share? And how you see -- now that you're at that 20% mark, how you see that playing out here in the coming quarters?.

Thanks for the question, Steve. I'll take that one. So yes, I think we're really focused on pharmacy. We recognize that out-of-pocket cost matters. And we're really pleased with the strong progress we're making in the Pharmacy. This year is the first year that we can offer multichannel DME and Pharmacy benefit plan coverage.

And the good news is we now have patients receiving product through the Pharmacy. It's a really important step. It's a win for Tandem, certainly because we believe it allows us to offer better access and experience. And we do think it will help us with our win rate with both health care professionals and patients.

But it's obviously a huge win for patients, right? Because those that have been on MDI and haven't been able to go on to cost barriers has been something we've been focused on. So yes, we've signed multiple contracts with leading PBMs. It translates to roughly 20% of covered lives across various lines of business, both commercial and government.

And we're activating our co-pay assistance capability as well to serve that market. So we have those plans to obviously pull through that with our field teams and for this year, driving scale and efficiency in the Pharmacy remains a top priority..

And just one moment for our next question. And that will come from the line of Brooks O'Neil with Lake Street Capital Markets..

This is Aaron [ph] on the line for Brooks. You've mentioned in the past that the Mobi pump compared to t:slim in the long term will be roughly 10% to 15% lower manufacturing costs and the cartridge being about roughly 20%.

Can we expect some -- to see some meaningful margin improvement from those conversions this year, recognizing the guide does call for margin improvement but just looking to digest that a little bit..

Sure. Thanks for the question, Aaron [ph]. So you do have it correct in terms of the ultimate at scale, lower manufacturing cost for Mobi compared to t:slim. As we built up this year, we were facing headwinds with Mobi having that higher per unit cost mostly because of the overhead that we were absorbing.

But I can say as we exited 2024 and going into 2025, the pump itself will start to become accretive. And that's part of the contribution to the margin improvement in 2025. The cartridges, on the other hand, still have a way to go before they scale up enough to start showing that benefit which will begin in 2026.

And so this is a multiyear margin expander for us. But everything that we're seeing, we're absolutely on the right track to achieving those targets for the Mobi pump..

One moment for our next question. And that will come from the line of Matt Miksic with Barclays..

Congrats on a really great finish despite the ebbs and flows that you mentioned in December. So I wanted to ask a question about -- you mentioned some of the additional -- the new product innovations that kind of baked into your guidance for this year.

So maybe highlight what some of those are? And then also, one of the questions we get often is, without putting a finer point on the arrival of Sigi is kind of the pathway of Sigi. It's going to use, I suppose, the current algorithms, Control-IQ now.

But maybe what other -- what are hoops and hurdles that it has to get through in order to get to market? Does that involve a large clinical trial? Maybe just some high-level background on what the pathway is to bring Sigi eventually to the U.S..

Good thing, Matt. Well, first of all, we're really excited about the launch of Control-IQ and that's going to be happening here in a matter of weeks.

And it has enhancements to the algorithm, the sort of the usability of the product, personalization and also, it will enable children 2 years and older to start to use Control-IQ as well as people who have type 2. So very excited about that.

I'd say following Control-IQ+, we intend to implement FreeStyle Libre 3 on t:slim and that then will be followed on to Mobi. And then we also are working on the Android version for Mobi which will be available this year as well. So all -- we feel very good about these.

We think that they're going to be meaningful improvements to the sort of the appeal of the products and drive significant revenue growth opportunities in the market. In addition to that, we're also rolling out Tandem Source and mobile OUS [ph] which we're excited about.

And I think that that's been happening now and I think that we're going to be going country by country as we get into the year. We did also, as I mentioned, file for CE Mark for Mobi. And so certainly, there's uncertainty that comes along with the MDR certifications in Europe. They've gotten more complex over time.

But we would expect to hopefully have that on the market OUS before the end of the year. So those are a lot -- that's a lot going on here for the 2025 and we think it's really meaningful progress and I think it's our commitment to innovation. The questions about Sigi. Sigi is going to be an ACE pump. So it's going to be interoperable.

And so just like t:slim and Mobi, once it's approved as an interoperable pump, we can use any of our approved algorithms on it and we would intend to do that. And so it's still a little ways away.

So any enhancements that happen to Control-IQ or any additional improvements we make to algorithms in the meantime will be available on Sigi as soon as it does come to market. I hope that answers your question..

One moment for our next question. And that will come from the line of David Roman with Goldman Sachs..

This is Phil [ph] on for David. I thought I'd go to the OUS business, some solid outperformance in 4Q versus your guidance.

But if I do the math, even if adjusting for the direct to the distributor to direct transition that's contemplated, it still represents some slowing year-over-year, trying to adjust out some of the 2023 onetime distributor in France.

I guess the question is, is what's contemplated in the underlying there with renewal becoming a more meaningful part of the opportunity? Is there maybe some expectation for slowing ahead of the Mobi rollout and launch OUS?.

Sure. Thanks, Phil. I'll acknowledge first, there have been a lot of moving parts in our business outside the U.S. over the past couple of years and in 2025 as well. But I'll say from the perspective of the market, it's still vastly underpenetrated and we've been demonstrating great strength and traction.

If you think about where our business has been coming from in the past few years, it's really almost all new customers to Tandem. And so renewals only began to be a contribution in 2025. And so we do anticipate there will be disruption this year as we execute on this transition to going direct in preparation for 2026.

But outside of that, we feel very strongly about our opportunity in those markets and we'll continue to push forward there.

And so as we start the year, we're always thoughtful when we put our guidance into place about what the risks and opportunities are for the business and putting more weight to the risks and this is true for the whole Worldwide business.

And that's reflected in how we built the guide for 2025 for OUS but we do believe in the -- there's a great opportunity for us to grow..

One moment for our next question. And that will come from the line of Chris Pasquale with Nephron Research..

I wanted to ask about the U.S.

sales force expansion and clarify how far along you are in that process today and how we should think about the timing of any potential disruption associated with that? And then given the news about type 2, does this give you the coverage that you need to really capitalize on that opportunity and call on the primary care physicians who manage a lot of those patients? Or are you going to need to do more to really get at that opportunity?.

Mark, why don't you take that?.

Yes, Chris, thanks a lot for the question. There's a couple of questions in there. So yes, I mean, when we step back, we felt like it was the appropriate time to selectively invest in the field force expansion just based on the potential of the portfolio. Also just looking at what competition is doing with their sales forces.

We know this market is a promotionally sensitive market. And frankly, we hadn't realigned in several years. So the realignment will do a couple of things. I think, first off, it does create optimization and efficiencies as you get through a realignment process.

And then the expansion is clearly going to give us some boost in increasing our share of voice. And what's important here is this is going to allow us to really call on the right high-growth HCPs, the ones where we believe have the greatest potential and growth opportunity as we've missed some of those or haven't called on them in the prior years.

So -- and the realignment and expansion allows us to really go deeper in each of those more high potential accounts. Now in terms of disruption, I mean, this was very front and center and we did this expansion in quarter 4. So we start this year right now with higher share of voice. We are completed in the expansion, about 95-plus-percent there.

And so it's live. And we are very intentional on how we went about this to ensure that we minimize disruption. In quarter 4, the field teams were focused on selling and so there was no impact to Q4. And we've got a really good experienced team on board that knows how to manage realignments and expansions.

And so that continues to serve us well now into the second month of the year. I'll try to comment on the future sales force expansion. I think, hey, we continuously evaluate share of voice needs, what competition is doing in line with our growth and profitability goals.

For now, in type 2, we're really primarily focused on those high insulin prescribers. Think of this more as endos and endo-like PCPs [ph]. But what's very important is we designed this sales force restructure and alignment, it's designed with the type 2 expansion in mind as well as we expand in Pharmacy.

So down the road, we can easily scale up over time if we want to put more share of voice into primary care. But for the time being, we're focused on the immediate core market..

One moment for our next question. And that will come from the line of Larry Biegelsen with Wells Fargo..

John, I wanted to focus on the type 2 launch and opportunity in the U.S. So the mid-single-digit growth in new starts, how much is contemplated from type 2? How long is the pilot going to last, John? And type 2, I think about 5% to 10% of new starts today for you guys; for Pod, it's 30% now.

Is there any reason your percent of new starts from type 2 can't increase to 30% in the next few quarters?.

Yes. Let me go ahead and just kick it off and then I'm going to hand it over to Leigh and Mark to add some insights from their perspective. First thing I want to do about type 2 is I want to thank the FDA because this was a stressful time for them, as you might imagine. And I think they did a great job of getting this through their system.

And those guys are just as committed to helping people with diabetes as we are. So just a hats off to them. That being said, as you said, Larry, it's a large underpenetrated market. It's about 5% penetrated in the U.S., essentially doubles our addressable market.

And the great thing about Control-IQ is it brings the same benefits that people with type 1 have experienced to the type 2 community. And I think that as we've seen it over the last couple -- over the last year or so, as we've done marketing research, we're finding that people who have type 2 are more willing to consider pump therapy.

And so in the past, we might have said that we can get from 5% maybe to 15%. I think that with the new smaller, easier-to-use technology in the market, we think we can get to over 25% in the next 3.5 years. So, I think that -- with that, I think I'll let Mark talk a little bit more about our go-to-market strategy and we'll go from there.

Mark, I think you're on mute..

Thank you. I just will echo the gratitude and the excitement we have about being able to scale our impact in type 2 diabetes. And so we'll soon in this quarter in March, begin our type 2 pilot launch activities and we'll scale that based on how things go and based on various performance KPIs.

As I mentioned earlier, we're going to target high insulin prescribers. A big focus is going to be around activating and expanding the pharmacy channel, recognizing how important that is for type 1 and type 2 and work to establishing a sustainable Medicare pathway to broaden coverage.

There is naturally a lot of market development work in this particular category of type 2. So we recognize with our other industry partners, we have our work cut out for us. It's going to take some time to develop the market and to ensure that we've got really good long-term growth potential.

But we're excited to roll out the results we will be presenting next month in Amsterdam, ATTD. We're really excited about unveiling those results. And then, of course, all the follow-on medical communication, clinical training and so forth that comes along with it. So we have a big year ahead of us.

And the last thing I think we'll say is that we do recognize that the population needs here in type 2 are different from type 1 [ph] and how we're approaching it; we're committed to serving this population with tailored solutions..

Thank you. One moment for our next question. And that will come from the line of Shagun Singh with RBC..

I wanted to touch on the 2025 guidance and I appreciate you guys have this base case guidance philosophy. You've factored in some of the headwinds. But is it possible for you to share maybe a range of outcomes like given that you have type 2, you have the OUS renewal opportunity, Libre integration, the Pharmacy channel where you're making progress.

Anything you can share on the range of outcomes or to help us really put that into -- those opportunities into perspective for '25 would be helpful?.

Sure. Happy to take the question. So from a guidance perspective, to your point, we looked very closely at what are the predictable recurring revenue streams to start. And obviously, renewals have been something that we have a consistent track record with that, will already just because of the new opportunities in 2025, create a step-up in growth.

Consistency in our supply sales from our very large installed base of over 480,000 people.

And then when we thought about the new factors, if you want to call it, or the new product and feature introductions that we have in 2025, we're super excited about all of these opportunities tied to the new products, the pharmacy initiative but some of these are really multiyear contributors and we're just getting started.

Mark just talked about the pilot for type 2, Pharmacy where at the very beginning phase, really building out the infrastructure and just testing the waters there, if nothing else here in the first quarter at least. And so from a guidance perspective, we factored in modest contribution from those in 2025.

And so what's important, I think, is it really is the impact it could have on new starts for Tandem and we factored in about a mid-single-digit growth in new starts year-over-year in the U.S., I should say, in particular..

And Shagun, this is not unusual. We have done this in the past where we're pressing hard to get these systems into the market and to benefit from them. But until we have evidence and understand exactly how they're going to affect us, we're going to take a more conservative position..

One moment for our next question. And that will come from the line of Matthew Taylor with Jefferies..

This is also Matt [ph] on for Matt Taylor. I wanted to ask a little bit about the integration with Libre users, especially those not on the pump.

So maybe if you can help us understand how that launch has progressed thus far and maybe the kind of momentum you're seeing about it and maybe how you think about this from a guidance perspective in terms of it being a driver of your new starts next year?.

Yes. We have Libre 2 integrated today with t:slim and we're working on bringing Libre 3 to market here in the relatively near future. I think that the availability of the product is going to be -- it will be shipped on new pumps and also be made available to people who currently own pumps through a software upgrade.

Right now, though, if you look at the installed base in the U.S. for FreeStyle Libre 3, there's roughly 300,000 or 400,000 people who have -- who use the system, use the sensor that have type 1 who don't use pumps.

And so I would say that there is a large market development opportunities -- opportunity to collaborate with Abbott as we bring this technology to market and we see the benefits. So if you look out over time, we've said we can get upwards of close to 1 million people using our technology. And these 400,000 people in the U.S.

represent a big part of that. And so we will be working closely with Abbott and our own sales team to make sure that we take advantage of that..

One moment for our next question. And that will come from the line of Mike Kratky with Leerink Partners..

Maybe just to go back to an earlier one on understanding the dynamics of the fourth quarter. I think you mentioned the unexpected timing of revenue reporting in the fourth quarter but it looks like the guidance for 1Q is still down about over 20% at the midpoint in the U.S.

So was there anything specific that fundamentally contributed to that December weakness that you saw? And I think you mentioned that there was no impact to your 4Q sales from the sales force realignment.

So just wanted to clarify what's giving you the confidence that that's the case?.

Mark, would you like to talk about the commercial environment a bit in the fourth quarter going into first?.

Yes, of course. Happy to, Leigh and thanks for the question, Mike. So yes, I mean, as John and Leigh both pointed to some of the things that happened in Q4. I mean there was a little bit of a muting on the seasonality.

I think, I step back and I reflect on the full year and there are some macro factors that I think we continue to observe that continue to be a challenge. I mentioned out-of-pocket costs for patients and how important it is to make these accessible. And so that really underscored the importance for us to strengthen our position in pharmacy.

And so I think that played into some parts of it. I think overall, from a competitive standpoint, I think we recognize that, first off, this is like a super large underpenetrated growth market. There's going to be some entrants here and there. And we continue to see kind of 2 large competitors, a new one that's been scaling.

But we feel good, we feel like we're holding our own. And as Leigh mentioned, despite December, I mean, it was still a really good, I think, month. In fact, it was like the largest shipment month we had all year and with really sizable growth versus last year's December in '23. So the underlying fundamentals, we feel good about.

It was a record quarter, healthy year-over-year and quarter-over-quarter growth. We really like what we're seeing on the MDI side and of course, from a renewal perspective..

One moment for our next question. And that will come from the line of Danielle Antalffy with UBS..

Just a follow-up on the type 2 opportunity. Just curious, so I appreciate there's still a lot of market development to happen and you guys are going to pilot this and all that. But just curious about -- and by the way, congrats on getting that approval.

How to think about type -- what's important to a type 2 patient based on the small percentage of patients that you have on pump today and some of the market research you've already done from a feature perspective, time and range versus pharmacy versus footprint of the pump, flexibility, etcetera? And also how a patient utilizes that pump? Is it pretty in line with what you see from type 1s like 24/7, 365? Is there -- or is there some different adoption patterns we should be -- or utilization, excuse me, patterns we should be considering?.

Mark, I'll just kick that off and hand it over to you. But I would just say that a couple of things are important to people with type 1 -- first of all -- type 2, excuse me. First of all, I think it's the simplicity of the system. It really does have to be easy to use. Discretion is another very important factor.

So therefore, it needs to be small and convenient. And I think the financial elements are something that we need to deal with. And so I think that when you look at this, we've got Mobi, it is small. It's convenient. We're moving into the pharmacy channel.

It is addressing some of the out-of-pocket expenses that the type 2 community will have to deal with. And I think that we feel pretty well positioned to take advantage of this marketplace. And I think we're going to kick off this pilot and learn a lot more.

But I think it's one of those opportunities that we think it's giant for us and we're excited to be in it.

Mark, do you want to add anything to that?.

Yes. Thanks, John. I think the only thing I would add is that 2 points is that from a portfolio perspective, what we feel good about is that we can offer choice and that is one similarity between type 1 and type 2 is that not one size fits all.

And that we, through our market research, recognize that there are unique segments in type 1 but also in type 2. And in some cases, type 2 really favor a larger reservoir with 300 units of insulin and they like the on-screen compatibility and use of t:slim.

Others, we know we're going to really like Mobi because of its small form factor and its versatile wear. So I think we feel good about being able to offer that choice. And as we load up more CGM integration on Mobi, we believe that's going to be equally important. The other point I'd say is that we have a lot of experience working with type 2.

As I think we've shared before, we've got about 30,000 people living with type 2 using our technology today. And so we've got great experience training them, working with them. We understand some of the important nuances to deliver a compelling and effective training.

And we're naturally looking at how to scale that, digitize it, modernize it and make it the best experience possible..

One moment for our next question. And that will come from the line of Jayson Bedford with Raymond James..

Just maybe on the Pharmacy, the 20% of lives is bigger than I thought.

So I guess my question is, how does this impact the P&L and your guidance in '25? Meaning, is it a driver of revenue growth? Does it impact margins? Or is it just a little early right now?.

Thanks for the question, Jayson. So I'll start by saying we're very pleased with the progress we've already made acquiring these contracts coming into the year. And we're still in the very early stages. And so from a guidance perspective, we have only factored in very modest contribution from a volume and an ASP perspective.

But I think that's the point as we look forward, this complements our channel strategy and will help us drive towards meeting our future profitability goals. And I think most importantly, overcome the affordability question for many patients.

So the 60% of people in type 1 not using pumps today, there's a cost sensitivity there and this gives us that opportunity to really lower that out-of-pocket cost and drive more people to pump therapy..

One moment for our next question. And that will come from the line of William Plovanic with Canaccord..

I want to go back to the Pharmacy. You've been signing these contracts. I think one of the questions I get is, how does this impact cash flow? Typically, if with the pay-as-you-go product, you'll get -- you have a capital piece.

Do you get paid that capital piece upfront? Or is that smoothed over the length of the contract? And then -- so how is this going to impact your free cash flow? And how are you thinking about longer term, just the business in general? I mean, I see -- it seems like as you're crossing that CASM into a positive free cash flow, you're taking the opportunity to transition the international business, realign the U.S.

sales force, kind of like turning '25 into a transition year.

Is this just taking the incremental free cash available and investing in the business now for leverage in the future?.

Yes, a couple of really good questions. I can touch on the Pharmacy very quickly. The Pharmacy gives us the opportunity to think about our business model and our structure and how reimbursement may work. At this point, the volume we've anticipated is very small and there's no change to the business model that we have in place.

So bottom line, no cash flow impact with the contracts that we've kicked off right now. And then to your point on the long term of the business and this is more generally about cash flow, there are very important things that we need to do to set up the business appropriately to drive that long-term growth to meet our ambitions for growing top line.

And we are always looking for ways to make those investments but fund them in other ways with cost-saving initiatives. And so as we turn the corner to being free cash flow positive again this year, we look forward to the opportunity to be able to make these investments that will have multiyear benefit for the organization.

We also have initiatives in place so that we can show a bit of leverage in 2025 even in this investment year..

One moment for our next question. That will come from the line of Mike Polark with Wolfe Research..

Just one model question. I appreciate the 2025 guidance comment, mid-single-digit growth expectation for new U.S. pumpers -- we all stab at this number but Leigh, I'm interested if you're willing to comment on 2024 U.S.

new pumpers, what was the growth rate either for the full year or in the fourth quarter?.

Sure. Great question, Mike. And so what I can share about new pumpers, so we've often talked about our sources of growth being renewal and new pumpers. And within new pumpers, we often break it down into MDI and competitive conversions. Our focus is purely on MDI conversions.

2024 was a year where we knew, we anticipated and we saw that competitive conversions would start to decline purely because the opportunity was declining. And so our focus is driving the growth of the business through the MDI conversions.

MDI did return to growth in the second quarter, grew each of the quarters, Q2, Q3 and Q4 and it was double-digit growth year-over-year. And so that's one of the key underpinnings as we thought about the 2025 guide in building -- in that buildup..

One moment for our next question. That will come from the line of Matthew O'Brien with Piper Sandler..

It's a 2-parter as well. I just want to be clear about a couple of things that you've said on the call.

The Q4 end of year impact that you saw, I'm just wondering if that wasn't competitive, specifically with another durable pump company in the market with a good product there, the halo effect that's probably happening on the patch pump side of things.

Is that something you saw in Q4 that's lingering here somewhat into Q1 and could impact the full year? And then secondly, the guide, Leigh, if I look at the number of additional pump sales you need to make this year, I know there'll be a little bit more bump from the renewal cycle but it's also at a time where you've got a restructured sales force where that didn't go well for one of your CGM partners recently.

And it's just assuming a big, big ramp in the back half of the year, especially that I think a lot of folks are going to be concerned about you being able to hit without getting a massive tailwind from type 2s and a massive tailwind on the Pharmacy side.

So how do we get comfortable you can do all that again with a restructured sales force?.

Sure. Great, great question, Matt. I'll kick this off. Mark may want to chime into it. So first of all, from the sales force expansion perspective and the impact on 2025, we did anticipate there could be disruption no matter how well you plan or execute.

There can be a little bit of turbulence initially as people are going out and meeting their docs and getting excited with their new territories and realignments. Mark can speak to how diligent we were in how we are executing on this. But we factored in, in the beginning of the year that it could be a bit more disruptive.

And so to that point, on the ramp across the year, it's partially seasonality, taking into consideration the impact we saw at the end of 2024 with a little bit muted seasonality really in just the last few weeks of the year but also assuming that these -- with the territory realignments and the expansion, we'll start to see more productivity as they get to the back half of the year.

And so to that Q4 softness, I would say there's a myriad of factors that contributed. It's hard to pinpoint a single one. It was and it has been across the year, an increasingly competitive environment. Mark mentioned the macro factors we've seen across recent years more and more people becoming sensitive to cost, use of high deductible plans and such.

There are so many things but I can't say that there's any one thing that turned on the dime in those last few weeks. It just was a little bit more muted than what we've seen in the past..

Yes. I would just say that nothing changed competitively throughout the year. I mean it was basically -- it was static. And I think that we held our own. Certainly, there's a lot of competition but I think we held our own..

[Operator Instructions] One moment for our next question. And that will come from the line of Josh Jennings with TD Cowen..

I want to ask on the type 2 indication. I guess, first, just to ask you your views on the basal opportunity.

Is that in play with the current label? Or do you need to show more data for Control-IQ to be approved there and for you to take advantage of that opportunity? And maybe just touch on type 2 coverage for Tandem pumps where it stands and when it will be full?.

Yes. Josh, the approval we got was for type 2 diabetes in general, for insulin use with type 2 using our algorithm. And so it involves -- it's all insulins and it's all manners in which insulin can be delivered either through basal or basal bolus. So it's all there.

And so -- and I think basal-only is something that's not necessarily an area we're focused on. But if we decide to, then we can do that with this algorithm. Leigh, do you want to just comment on this a little bit [ph]? Yes..

Sure. The type 2 coverage. And so I'll say, first and foremost, from a commercial perspective, it's pretty much the same coverage as it would be for type 1. So there aren't any real limitations from a type 2 perspective.

From a Medicare perspective, there's still some onerous requirements and we are engaged in working actively with other industry players in order to get changes made with that national coverage determination which has been received by CMS [ph] and is on the docket for review. We just don't yet have any color today on when they will actually get to it.

So we are working hard to pursue that improved coverage overall..

One moment for our next question. And that will come from the line of Jeff Johnson with Baird..

Congrats on the type 2 coverage. I wanted to focus another question there which I apologize. I know a lot of the questions have been on type 2. But I've really been trying to game this out. And John, I'd love to hear your thoughts or anyone else's thoughts.

If I look over the last 2.5 years up until 6 months ago, both you and your biggest AID competitor essentially were off-label for type 2. And I think during that time, as best I can break out numbers, you guys were winning about 25% share of the type 2 new starts that were coming in, the other company winning maybe 75%.

Now when you're both going to be on label, do you think those share shift? I think a rising tide is going to help everybody. But do you think that 25%-75% split or maybe my math is off a little bit but somewhere in there.

Does that share shift -- or does the share shift at all now that you're both going to be competing on label? And how is it different if you're both on label versus maybe 6, 9 months ago when you were both off label?.

Yes. The first thing I'll say is what I mentioned a moment ago and that is that certainly, as new technology comes to market, it's smaller, it's more convenient to use and the therapy benefits are substantial. We believe more and more people are coming to market.

So the opportunity is big and I think the penetration is bigger than we had thought it was in the past. I would say when it comes to type 2 and on the competition in the marketplace, it really comes back to the pipeline, market access and the things that we're working on.

And so I would anticipate that we're very confident in our pipeline and we think it's going to be more competitive as more of these features and systems comes to market. So I think that -- I think we're going to begin to take more share in type 2 and in type 1..

One moment for our next question. And that will come from the line of Travis Steed with Bank of America..

I did want to ask on the gross margin ramp over the course of 2025. I think it was 51% in Q1 and 54% for the full year.

Just if there's any other additional color on that? And then the impetus for why doing the sales force expansion now, I don't know if there was a specific reason why now is the time to do it, if it was related to type 2 or if it's what you're seeing in the competitive environment? And if it's -- if you're calling on more primary care doctors or if it's all kind of just focused on going deeper with the end of?.

Yes. Thanks for the question, Travis. I'll start with the gross margin and turn it over to Mark from the commercial expansion perspective. For gross margin, what you typically see in, again I'll say the normal year is that gross margin improves across the quarters as pump sales ramp in the U.S. with pumps being the highest gross margin contributor.

In 2025, in particular, we have I'm going to call it the added benefit of Mobi scaling up across the year. So as we sell more and more Mobi pumps, that will also provide even greater contribution to the margin. So we're starting the year at 51%.

And I think I'd like to point out that, that's flat to what we just demonstrated in the fourth quarter when usually we take a bit of a step back in Q1 for gross margin. So we're at a new starting point for the year and confident in our ability to deliver on that.

So Mark?.

Yes. Thanks, Travis, for the question. I think the timing was right for us to do this at the end of last year and set up ourselves for 2025. I think it's a combination of factors of timing. I mean, number one is that we do think the portfolio has got a lot of potential. We're really excited about what we can offer with our technology.

And the market is promotionally sensitive. We know that. We've done our research. We understand it. And there is an efficiency play here, too. We haven't realigned in several years. And what that sort of means is that the marketplace has grown and changed tremendously over the last few years.

And for us to recut territories and alignment creates greater efficiency for our sales teams. It gives them better workload balance. They have better reach and frequency and can just really concentrate on those high potential accounts. But -- it's really important.

And then secondly, we believe we needed some extra share of voice in order to compete and continue in this current market within the U.S. And alongside that, there's also new tools and capabilities. It's not just about sales force expansion.

As John mentioned, we've been piloting a number of different tools to better understand and segment HCPs and help enrich our messaging, new selling tools. And so again, we feel good starting this year where we have stronger share of voice.

We know exactly where to go, what to say, how to say it with a bunch of high-impact tools that really can support the field..

Thank you. I'm showing no further questions in the queue at this time. Thank you all for participating. This concludes today's program. You may now disconnect..