Good day and thank you for standing by. Welcome to the Tandem Diabetes Care Q3 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. Please be advised that today's conference is being recorded. After the speaker's presentation, there will be a question-and-answer session. [Operator Instructions].

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

Hello, everyone, and thanks for joining Tandem's Third Quarter 2024 Earnings Call. Today's discussion will include forward-looking statements. These statements reflect management's expectations about future events, our product pipeline, development timelines, and financial performance and operating plans, and speak only as of today's date.

There are risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in our forward-looking statements.

A list of factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements is highlighted in our press release issued earlier today and under the risk factors portion and elsewhere in our most recent annual report on Form 10-K, as updated by our most recent quarterly report on Form 10-Q.

We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or other factors. Today's discussion will also include references to a number of GAAP and non-GAAP financial measures.

Non-GAAP financial measures are provided to give our investors information that we believe is indicative of our core operating performance and reflects our ongoing business operations. We believe these non-GAAP financial measures facilitate better comparisons of operating results across reporting periods.

Any non-GAAP information presented should not be considered as a substitution, independently or superior, to results prepared in accordance with GAAP.

Please refer to our earnings release issued earlier today and available on the Investor Center portion of our website for a reconciliation of these measures to their most directly comparable GAAP financial measure.

Participating on today's call are John Sheridan, Tandem's President and CEO, 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 one question before getting back into the queue.

I'll now turn the call over to John..

Thank you, Susan, and welcome everyone to our call today. 2024 has been a dynamic year. The third quarter marked a milestone achievement for Tandem as we delivered the highest quarterly sales in our company's history.

This is a result of strong execution of our strategy to drive growth through our expanding product portfolio and is underscored by outstanding feedback on our newly launched Tandem Mobi. I am also very pleased with our operational performance as we returned to positive free cash flow in the third quarter.

Driving greater leverage in our business and using innovation to improve gross margins continue to be an important focus for our company. In addition to record sales and strong operational performance, this quarter also marked a return to year-over-year new pump growth in the United States.

We have seen growth from MDI users over the past two quarters, which is evidence that we are furthering our goal to expand the insulin pump market. The favorable U.S. customer data points we observed in Q2 continued in Q3.

Most notably, more than half our pump shipments were new to customers, and over half of our new customers adopted a Tandem pump for multiple daily injections. We also once again observed a higher rate of disposable pump converters compared to years past.

Our increase in customers coming from MDI is an important shift that we anticipate will continue as our portfolio attracts more people to insulin pump therapy. We also continue to see customer enthusiasm for both t:slim X2 and Tandem Mobi in the quarter.

These results underscore our strategic position that there is no one-size-fits-all solution in insulin therapy management, and that the needs and preferences in diabetes technology create a highly segmented market. It also further indicates that there is a demand for both platforms in the large and underpenetrated market we serve.

For T:slim X2, we continue to hear customer enthusiasm for the all-in-one convenience with its controls being offered on pump, the freedom to disconnect, and our best-in-class Control-IQ technology. For Tandem Mobi, its tiny size and unparalleled versatility are redefining wearability.

These attributes, in combination with our Control-IQ technology, are driving high satisfaction scores and are attracting a younger demographic compared to T:slim. Tandem Mobi is pioneering a new category of insulin pumps, and market awareness is building as the diabetes community has increasing exposure to our new platform.

Turning to our performance outside the United States, we once again demonstrated growth in our pump placements and a high rate of customer retention. The typical seasonality we see in 3Q associated with the European holiday season was offset by greater than anticipated demand, along with the timing of certain distributor orders.

I'm proud of our scaling commercial efforts outside the U.S. and of the awareness we are building for Tandem, our technology, and the improved clinical outcomes our customers experience with Control-IQ. A reflection of this was our recent award of new tenders, which will provide enhanced customer access in select countries beginning in 2025.

Outside the United States, we also had a regulatory win in the European Union with the clearance of T:slim X2 for use with Lyumjev ultra-rapid-acting insulin. Ultra-rapid-acting insulin is a popular choice for people living with diabetes due to its response time, and this is the first step in a broader global strategy to support this offering.

The opportunity to improve the lives of people living with type 1 diabetes outside the United States is even greater than in the U.S. It's a strategic focus for us as we look to 2025 and beyond. With that, I'll turn the call over to Leigh..

Thanks, John. As a reminder, unless otherwise noted, many of the financial metrics we will be discussing today are on a non-GAAP basis. Reconciliations from GAAP to non-GAAP results can be found in today's earnings release, which is available on the Investor Center portion of our website.

At the beginning of the year, we laid out our growth expectations for top-line sales, targets for profitability, and product expansion plans. As you can see in today's results, we are demonstrating meaningful progress on all fronts, which is particularly notable with the third-quarter seasonality in our business.

Q3 sales of $243 million marked the highest worldwide sales in our company's history as we achieved record sales in both our U.S. and OUS markets. Starting with our performance in the United States, I'm proud that we demonstrated a return to growth of new customer starts, and total shipments reached nearly 21,000 pumps.

Our sales of $171 million delivered more than 23% year-over-year growth, and we saw a favorable mix in our business with pumps contributing 51% of sales. Sequentially, our U.S. sales represented 9% growth driven by a modest shipment increase in a seasonal period where pumps have been flat to down in the last three years.

We continue to see ASP strength driven by price increases, favorable customer mix, and a shift to more direct business benefiting both sales and margins. Sales in the U.S. billed directly to insurance payers increased to 38% of sales from 36% a year ago.

Our price improvements were achieved for pumps and supplies as we share in the benefits that our technology brings to our direct payer and distribution relationships following many years of dedicated contracting efforts. Pricing and broad market access continue to be key components of our multi-channel managed care strategy.

In addition to the progress we've made through the DME channel, we've also achieved new milestones for the company within the pharmacy channel. I'm happy to share that we signed our first agreement for Tandem Mobi and are now focused on our payer pull-through strategy for this arrangement.

This is an important first step in our multi-year strategy to drive profitable access and reduce patient out-of-pocket costs. We won't be sharing any details of the contract at this time, but I can confirm that it's not disruptive to our current business model. We have a number of additional contracting conversations underway as well.

We will provide more color to potential future benefit from pharmacy access as we continue to execute on our strategy. As previously discussed, late in the second quarter, we began offering eligible t:slim X2 customers the choice to switch to Mobi under our Tandem Choice program.

As a reminder, the pump shipments and non-GAAP financials do not include any impact from the program. On a GAAP basis only, we cease deferring any portion of sales upon Mobi's availability in the first quarter. In the second and third quarters, we recognize sales and cost of goods sold with each individual election to switch to Mobi.

The difference between our GAAP and non-GAAP financials associated with the program were not meaningful in Q3. In the fourth quarter, we will fully capture the remaining sales deferrals of $30 million on a GAAP basis, plus any additional switch sales and costs.

For further details on the GAAP accounting for this program, please refer to the accounting policy discussion in our 10-Q. Turning to our OUS performance, sales grew 31% year-over-year to $72 million, reflecting continued strong demand.

The results also benefited by approximately $5 million in orders received in the third quarter that were originally anticipated in the fourth quarter. We ship nearly 11,000 pumps in the 25 markets in which we operate outside the U.S., which represents a pump shipment increase of more than 30% year-over-year.

Overall, I'm pleased that we are demonstrating growth in our business once again, and we are increasingly focused on the profitability profile of our company. Gross margin was 51% in the third quarter, which was in line with our expectations.

We expect the 2024 gross margin pressure related to the Mobi launch to ease exiting 2024, and that the pump will begin to be accretive in 2025 as our business scales across the year.

As Mobi users become a greater portion of our installed base, we also anticipate improved gross margin in our supply, anticipated to provide benefit beginning in late 2025. From an adjusted EBITDA perspective, we turn the corner to profitability at 2% of sales in the third quarter.

As a reminder, the seasonality in our business applies to gross and operating margins, as well as sales. Our total cash and investments balance remains strong at $473 million. Q3 marks a return to positive free cash flow generation of $22 million, and we expect that trend to continue through the remainder of the year.

We began 2024 with expectations of 10% sales growth. Today, we are once again increasing our annual sales guidance to a range of $903 million to $910 million, which is 17% to 18% year-over-year growth. This breaks down to $645 million to $650 million in the U.S., and $258 million to $260 million outside the U.S.

We are reaffirming our gross margin expectation of 51% for the full year and adjusted EBITDA break-even. I would also like to take this opportunity to provide a few comments on how to think about our 2025 outlook, for which we plan to provide guidance at our fourth quarter earnings call.

Much like 2024, we expect 2025 to be another highly dynamic year with multiple new growth drivers staged across the year. We will continue to drive market awareness of Mobi in the U.S., introduce new products worldwide, and execute on our market access strategy through the Pharmacy Channel in the U.S. and through tender wins in our OUS markets.

We anticipate 2025 guidance will align with the approach we used in 2024, where we put more emphasis on the predictable revenue streams to start. Then, we set initial growth expectations based on recurring revenue from supply sales and renewals, while we assess how the new growth opportunities trended before factoring in any benefits.

As I mentioned earlier, Mobi will be a key contributing factor to margin expansion as it continues to scale. Also, our investments to drive growth will be balanced with diligent efforts to demonstrate leverage in our operations. I also want to highlight the impact of deductible-driven seasonality on the U.S. business for both pumps and supplies.

This generally results in a meaningful step down in both sales and profits from the fourth quarter to the first quarter. For example, in the last four years, U.S. sales in the first quarter declined on average over 20% compared to the fourth quarter.

As with sales, we anticipate that our growth and operating margin will be affected by seasonality and will build across 2025. We look forward to providing more details at our next call. And I'll now turn the call back to you, John..

Thanks, Leigh. In addition to our progress in commercial and operational execution, we are continuing to drive future growth by expanding our product portfolio. Tandem's roadmap is the most exciting in our industry and is designed to deliver a steady cadence of differentiating innovation.

Our development efforts span near and longer-term initiatives and include a meaningful focus on bringing the technology we offer currently in the U.S. to the countries we serve internationally. We have demonstrated this throughout 2024, beginning with our launch of Mobi in the U.S., followed by its integration with the G7 sensor.

Next, we launched Tandem Source outside the United States, beginning in Canada, and we continue deployment on a country-by-country basis through 2025. Global platforms will be a key theme throughout 2025 as we integrate Abbott's FreeStyle Libre 3 on both t:slim and Mobi.

We also have efforts underway to offer Mobi with Android control and to bring it to the markets we serve OUS Additionally, we have new Mobi features in active development, most notably a unique cartridge option that allows the pump to be worn as a tubeless patch without an infusion set, providing even greater options in wearability.

As we've shared previously, we are not going to provide timelines for new pumps or supplies in development, but internally efforts remain underway to bring them to commercialization. This includes development activities for Sigi or ergonomic, rechargeable, and detachable patch pumps. Clinical initiatives also remain a high priority for us at Tandem.

The pivotal trial for Steadi-Set, our extended wear infusion set technology, is on track to be done by the end of the year. Our regulatory filing to support a three-day indication for Steadi-Set is currently in review by the FDA now.

This is our first infusion set submission, and although we do not intend to commercialize a three-day set, it's a risk mitigation strategy in our regulatory process. Another clinical highlight in the third quarter was the completion of our pivotal trial for people living with type 2 diabetes to expand the indication for Control-IQ.

With the insulin-dependent market opportunity even greater than people living with type 1 and a fraction of the penetration, it's a strategic priority for us to bring the benefits of our technology to people living with type 2 diabetes. Some healthcare providers today choose to prescribe our pumps and Control-IQ to their type 2 patients off-label.

As a result, more than 30,000 people living in the U.S. with type 2 use a Tandem pump. If we look at it on a quarterly basis, approximately 5% to 10% of new customers each quarter have type 2, which has been a consistent trend throughout the years.

As a market research-driven company, it's been fascinating to see the increasing interest in technology as a part of therapy management solution for people living with insulin-dependent type 2 diabetes. More people identify as near-term pumpers than ever before, and we are working through our marked strategy of how to best serve this population.

With the clinical trial now complete, we are finalizing the regulatory submission and will submit it to the FDA before the end of the year. We also completed a series of clinical feasibility studies to support our fully closed-loop program.

You'll see early insights from the most recent study presented at the upcoming ATDD-Asia Conference at the end of this month. It's been amazing to see the progress in fully closed-loop technology, and it increases my confidence that the dream of this technology is approaching reality, and we intend to keep Tandem at the forefront of these efforts.

As you can see, it continues to be a busy and exciting time for Tandem. Our employees' focus on execution throughout our business is impressive. Thank you, everyone, for your hard work.

As we wrap up 2024, we are well-positioned to achieve a record-breaking fourth quarter, are focused on closing the year strong, and continuing to deliver on our commitments. I'd now like to turn the call over to the operator for questions..

Thank you. [Operator Instructions]. Our first question comes from Mathew Blackman with Stifel. You may proceed..

Good afternoon, everybody. Thanks for taking my question.

Can you hear me okay?.

Yeah, Matt.

How are you doing?.

Great. Good, John. Thanks. Leigh, I was hoping you could give us a little bit more color on new patient starts in the third quarter, perhaps, versus the second quarter. I think I did hear you say that pump shift grew quarter-over-quarter, but what about new patients? And then I recall last quarter you told us that you saw month-over-month Mobi growth.

I'm just curious, if you're willing to give us any color on the Mobi cadence through 3Q or exiting 3Q? Thanks..

Thanks, Matt. So the way our shipments broke down in the third quarter, first, it's a celebration for us because it was a return to new start growth year-over-year, which is the first quarter we've seen in quite some time. It's the second quarter in a row where we've seen growth in MDI conversions.

And so what we saw, if you break it down, is that new pumpers were still a little more than half of the pump shipments. And then of new pumpers, a little more than half were MDI. So pretty much in line with our expectations and actually very consistent with what we saw in the second quarter.

Pump shipments from Q2 to Q3, because of the seasonal dynamics, only stepped up modestly. So everything stayed pretty much intact with what we had seen before..

Thank you. Our next question comes from Steve Lichtman with Oppenheimer & Company. You may proceed..

Thank you. Evening, everyone. Leigh, it's great to see the pharmacy contract announcement.

I appreciate you're not giving any details specific to that one, but can you sort of talk about that in the context of your broader pharmacy strategy? Give us an update of how you are thinking about that progressing in the coming quarters?.

Sure. So it's another point of celebration this quarter. We were very excited to be able to announce that we're executing on that strategy. We've talked about it for so long with everyone about our goals and the possibility of achieving them. And as we said, we would have a contract by the end of this year.

And so it's an important, very important first step. What we have to do next is to really focus on the pull through for this contract. And so it's positioning as well as we move into 2025.

And as we look ahead then to 2025 and we evaluate what those trends could look like in terms of both volume and potential economic benefit, we'll give more color at that time..

Thank you. Our next question comes from Brooks O'Neil with Lake Street Capital Markets. You may proceed..

Thank you. Good afternoon, everyone. I wanted to follow-up on Steve's question. Congratulations on the pharmacy contract. So here's my question. My understanding is your competitor who uses the pharmacy channel prices their product on a time equivalent basis at a substantial premium to your durable pumps and others.

Can you help us understand, you said you're not going to be disruptive to your existing business, but can you give us any feel for how your pricing might relate to the pricing of your competitor in the pharmacy channel?.

Sure. Thanks, Brooks. I can honestly only share very little about the contract today contractually, and I would say even competitively. But what we have said in the past is that we would be very selective about the contracts that we're willing to enter into.

And one of the key things, first and foremost, is that we need to be able to lower the patient out of pocket. And secondly, it has to be at least as good economically as the DME contracts that we have been in. And so I can say it met our criteria, and we were excited to move forward with it..

Thank you. Our next question comes from Matt Miksic with Barclays. You may proceed..

Tubeless cartridge option that you were describing, John. And you also mentioned the Steadi-Set.

I know you're not going to give us timing just yet on the tubeless option, but are those two technologies something that you can possibly integrate going forward? Is there any reason why tubeless could be a longer wear set than a traditional infusion set, 3-day infusion set? Love any color. Thanks so much..

Tubeless making great progress on it. It's really exciting how good the product looks at this point in time. And certainly we've got expertise in-house right now to develop longer wear sets, and there's no reason why we wouldn't consider that.

We haven't said anything specifically at this point in time, but it's definitely an option that we've got out there. I think that as we get further into development, we'll let people know if we're going to consider that. We also are very excited about Steadi-Set. We're going to complete the clinical study this quarter.

And I think that, as I mentioned, I just wanted to be clear that we did file the 3-day set as a risk mitigation strategy.

We want to answer all the questions we can right now with the FDA while the clinical study is going on and while we're preparing the clinical report, so that when we get to the point of submitting the 7-day set, it's a relatively straightforward activity, which is why we're doing that..

Thank you. Our next question comes from Larry Biegelsen with Wells Fargo. You may proceed..

Hi. Good afternoon. Thanks for taking the question, and congrats on a nice quarter here. Leigh, I wanted to follow-up on your 2025 comments. You started 2024. You mentioned 10% growth in the guidance. Now you're at 17% to 18%. Consensus next year is about 12%.

And I guess I think, why would growth slow in 2025 versus 2024? You have a full year of Mobi, Type 2 indication in the U.S., Libre integration, etc., enhanced tenders you mentioned on this call.

I'm not sure what the message is today, except it was clear you were trying to say, we're going to guide conservatively again, but it wasn't clear what you're going to bake in, and if you're comfortable with that 12%, which doesn't seem like a high bar? Thanks..

Thanks, Larry. So, first of all, thanks for laying out all the growth drivers. There are so many exciting things coming in 2025 after a very exciting 2024, even with the number of product launches we had this year. And really what we just wanted to do, a lot of people are curious.

At this time how to think about 2025, is really just talk about the philosophy and the approach. And it will be very similar to what we guided to in 2024. And I think, its two different questions about what's our aspiration for the business versus how we will set expectations to start.

And when we start the year, we start with this philosophy of first looking at our predictable revenue streams. And so, focus mostly on the growth in supply sales that comes from our large install base of almost 500,000 customers at this point. Also, the growth that comes from the renewal opportunities, both in the U.S.

The number of warranties expiring next year is growing almost 20%, as well as we're going to start to see meaningful opportunity from our OUS markets. And then we take the risks and opportunities. And so, we think really hard about what are the competitive dynamics and then how do we factor in these growth drivers.

And from a perspective of new growth drivers, we tend to think of it as something that we would like to see first the timing play out and then see some sustainable trends start to develop before we factor them in. So, it's really just about our approach to setting expectations. It's not so much about the aspirations for the business..

Thank you. Our next question comes from Matthew O'Brien with Piper Sandler. You may proceed..

Afternoon. Thanks for taking the question. We'd love to hear about the Q4 guide specifically. I think that's causing a little bit of consternation this evening. The guide, you know, good to see the Q3 result, but the guide for Q4 implies or the guide for the full year is increased by less than the beat here we saw in Q3.

So, is there anything you're worried about competitively or anything else to really think about that would cause you to not raise by more than the guide? And then I just, same question along those lines on Q3, just the upside that we saw on the top line was pretty meaningful, but we didn't get it as much, I guess, on the gross margin side or even EBITDA, I guess, that we kind of expected.

So, why didn't we see those metrics move up in Q4 as well? Thank you..

Great. That was a loaded question, Matt. So, I'm going to focus on the Q4 guidance piece of it. So, in fact, we did raise our guidance by the amount of the beat both in the U.S. and OUS, and I'll break those apart a little bit. So, from the U.S.

perspective, we're heading into the seasonal fourth quarter, and if you look what's implied in the guidance that somewhere in the midpoint of the guidance would imply something that falls just below 30% as a percent of the year for the fourth quarter, if you will.

And if you look at our last few years, the fourth quarter has represented just under 30% of our business for the full year in the U.S., I would say. So, we feel like that's very much in line with historical seasonal trends that we have seen.

To the OUS markets, it does represent from Q3 to Q4, it implies a step down from the third quarter, but in fact, we did have about $5 million of orders that happened to come in in the third quarter, which we were originally anticipating in the fourth quarter. So, that's really just a timing shift from Q3 to Q4.

And so, we are confident in the guidance that we put out there, and we think it plays out to be an exciting year for Tandem with the expectations that we have set. From a margin perspective, there's always a lot of moving parts there. We did have great benefit from pricing, also lower materials costs.

We are still facing, though, some modest headwinds from Mobi as that continues to scale. And as we exit this year, we expect that those headwinds, just rather being smaller volumes, will start to dissipate, and we'll begin to see some of that benefit in 2025.

And then I'll add the outperformance was more so in the OUS markets, which does tend to put a little bit of pressure on gross margins, too. So, I think that hits all the points in your question..

Thank you. Our next question comes from Patrick Wood with Morgan Stanley. You may proceed..

Beautiful, thank you. You guys gave some nice commentary around volumes of Mobi versus t:slim.

I guess, just holistically, is that landing where you had originally expected that kind of mix to go? What are you hearing from customers around the split between the two, and how should we think about that mix, I guess, slightly longer term based on what you've seen today? Thanks..

Yeah, I think we're very pleased with Mobi's performance and excited by the very positive reception that we're getting from people living with diabetes and healthcare providers. You know, the size, wearability, and Control-IQ performance are just really driving pump growth that we haven't seen in a while.

So, we've seen year-over-year growth in new pumps, and we've also seen MDI starts increase and improve two quarters in a row now. I would say that when you look at, you know, it's still early, and we are definitely in a stage of building market awareness.

And so, we're not going to say anything specifically about what the ratio is going to look like between the two of them, but we're absolutely achieving our objectives.

And I think we're very excited about the performance, and I think that the outperformance this quarter, as well as the, you know, the continued growth in MDI conversions is really being driven by Mobi..

Thank you. Our next question comes from Matt Taylor with Jefferies. You may proceed..

Hi, thanks for taking the question.

Can you hear me okay?.

Yeah, Matt..

So, I did want to do two small follow-ups.

One is, you mentioned a high rate of the patch pump conversions, and I was wondering if you thought that was notable, or if you could give us any color on that part?.

Yeah, I'll just say that we have tracked this for many, many years, and it's been relatively low percentages up until the second quarter. And we did see a meaningful step up in the second quarter, and we saw that same trend continue in the third quarter.

And so, it's interesting, because we did present data at the ADA from the early users of Mobi, and it was a group that came from MDI, from former patch, former other tube pump users, as well as former Tandem users.

And the thing that the people said, who were former patch users was they really appreciated the benefit of Control-IQ and the improved control they got in management of their diabetes.

And so that's, I think, the fact that the pump is the same size, essentially, as the patch device that's on the market today, with an improved algorithm, I think people are considering it. And we've seen positive movement in that direction and continue to be excited about it..

Thank you. Our next question comes from David Roman with Goldman Sachs. You may proceed..

Thank you. Good afternoon, everybody. I wanted just to contextualize a little bit the P&L performance this quarter in the context of some of your longer-term aspirations. And I think you've talked about mid-60s gross margins and mid-20s adjusted EBITDA.

As you kind of look at annualizing this quarter, it kind of implies that at a $1 billion of revenue, you're at kind of mid-single-digit adjusted EBITDA margins.

Is that a fair way to think about it? And how should we think about the trajectory of margins on a go-forward basis?.

Yeah, great question, David. So, in thinking about achievement of our long-term goals this year is that I'm going to call it a bit of a transition year with Mobi underway and its launch. It is the single largest contributor to our gross margin opportunity in the future.

Right now, we're still building at smaller volumes, and we're scaling up those volumes. And so, until we get to a level of scale, you won't see that benefit in the gross margin. And right now, Mobi's been a bit of a headwind on the pump side.

And as we exit this year, we expect to be at a level of scale where you'll start to see that benefit across 2025 from a pump perspective. From a supplies perspective, it's still a fraction of the users that we have worldwide, almost 500,000 people, but a very small percentage using Mobi.

So, the benefit that comes from the supplies in the long term will take a little bit longer to see. And I probably should have reiterated or stated that the Mobi pump compared to t:slim in the long term will be about a 10% to 15% lower manufacturing cost. And the cartridge is about 20%.

So, it's a matter of time before you'll start to see that come out through the margin. The other piece I'll add to the margin story comes from our market access initiative. So, particularly thinking about the pharmacy channel and the traction that we can drive in that space.

Like I said earlier, we've made a very important first step there, and we'll continue to drive that access, which we believe can improve margins in the long term as well. And so, like I said, it's a bit of a transition year right now, just getting Mobi up to the scale that we need it to be in order to demonstrate the margin improvement opportunity..

Thank you. Our next question comes from Chris Pasquale with Nephron Research. You may proceed..

Thanks. Supply revenue came in well ahead of where we were thinking, really more so than pump sales. You mentioned the order pull forward, OUS, which sounds like it may have contributed to that. Did the U.S.

strength in supplies come down to that direct sales dynamic that you talked about, or was there something else that helped you there?.

Sure. In the U.S., you did already address the OUS part, which was a piece of it. And in the U.S., we did see a bit higher bump in sales in the third quarter. It was really a timing shift from Q2 to Q3. It wasn't material enough for us to really quantify, but it did have some level of impact. And also, we continue to see favorable pricing.

So, between those two pieces, that drove some benefit in the U.S. in the third quarter..

Thank you. Our next question comes from Joshua Jennings with TD Cowen. You may proceed..

Hi, good evening. Congratulations on that strong quarter. John, I appreciate some of the details you gave on Type 2 prescriptions and volumes quarterly.

I was wondering, what you're seeing in the third quarter? Are you seeing those pre-aughts requests increase? Do you expect them to increase in front of label expansion? I guess the question is, can the real-world data that's out there for Control-IQ and maybe piggybacking off the Omnipod 5 SECURE-T2D data, can you see that channel pick up even in front of label expansion? Thanks..

Well, as we said on the call, if you look back over the last couple of years, we've seen a pretty steady use of the Control-IQ system by people with Type 2 diabetes. And it's been about 5% to 10% of our new starts on a quarterly basis. And now we have about a 30,000 number of people, who are using Control-IQ off-label.

So that's been pretty steady, and certainly we're not marketing it or anything like that. So I would expect that it really won't turn up until we begin to actively market the actual software improvements to Control-IQ to enable it for Type 2.

The good news, though, Al, is we've been doing quite a bit of research, market research, and we've been doing this consistently for some time now. I think in more recent times, we've seen that there's a greater propensity of people who we would characterize as near-term bumpers.

And because of that, we think that it's very likely that the penetration rate for Type 2 is going to be higher than what we originally anticipated. And so if you were to ask us a couple of quarters ago, I think we would have said, we can get from 5% today maybe up to 15%.

And now with this new data we're seeing, I think it's very likely to get from 5% to over 25%, which is great for us. I think the other good news is that we've finished the study. We're in the midst of preparing the clinical report to get it into the FDA. We were on schedule to do that this quarter. And the FDA has seen Control-IQ four times now.

So we expect this to go through pretty quickly, and we're excited to get to market next year. So we do think it's going to be a meaningful part of our growth as we get into 2025 and beyond..

Thank you. Our next question comes from Shagun Singh with RBC. You may proceed..

Thank you so much for taking the question. I just wanted to follow-up on Larry's question on 2025.

Is 12% a reasonable base case? And then as you think about all the catalysts that were mentioned, where do you see the most upside in anything you can share on which ones could start to impact sooner versus later in the year?.

Hi, thanks for the question. So I'm going to just be very clear. We're not giving any 2025 guidance today. We're going to reserve that for our fourth quarter earnings call. I'm not going to speak to any specific numbers there. But we are excited about the number of opportunities that we laid out earlier.

It's hard for me to say right now which one I would rank order first in terms of opportunity. They all provide benefit in different ways for us. The expansion of CGM integrations to help us reach a part of the market we haven't been able to before.

The pharmacy channel initiative can help with the affordability question and so might be able to pull people through that haven't been able to buy pumps before. So there's a lot of ways that we can grow the business in exciting ways next year.

But as I said earlier, as we set expectations, we're really focused more on starting with the baseline of what are the predictable revenue streams between renewals and our supply sales that provide growth all on their own. And then we'll continue to evaluate these new opportunities and how to factor those in when they become available to us..

I'll just add to that that we have a lot of very important things coming to place next year. We expect new products. We expect pharmacy. We expect type 2. These are all very, very exciting initiatives. And we think it's going to do a lot to help grow the company, grow the business from 2025 and onward.

But as Leigh is saying, we have to balance the guidance philosophy, the risks, and produce something that's highly predictable. But we're very excited about what's going on and we think it's going to be a great year for us..

Thank you. Our next question comes from William Plovanic with Canaccord Genuity. You may proceed..

Great, thanks. Good evening. Just a point of clarification in the commentary on the type 2 penetration. Saying from 5% to 15% and now thinking 25%. Is that 25% of your new patient starts or 25% of the type 2 IIT market? And then just, you have the T2D label out there from a competitor.

Is that, like, are you starting to see just more awareness in general by that population? That's all from me. Thanks..

Yeah, Bill, I would say that what I'm talking about is I'm talking about the overall penetration in the marketplace. Today in the U.S. there's roughly 2 million people who have insulin-intensive type 2. It's roughly 5% penetrated. We think that over the next several years it's reasonable to assume that they can get over 25%.

That's what I meant to say, if I wasn't clear. You know, and I also say that it's a new market. We're building this new market.

And the fact that there's others out there that have the label as well is beneficial because we are working, we'll both be working to make the technology and the clinical benefits and increase awareness to the healthcare providers. So I would say that, as I've mentioned, the uptake that we've seen over the last couple of years has been pretty steady.

But once we begin to market directly, share clinical data, talk about the benefits of our products, we would expect, and just all of the market development activities that are needed to develop a new market like this, we could definitely expect to see uptake. Prior to that, it's, I wouldn't expect it to change dramatically..

Thank you. Our next question comes from Joanne Wuensch with Citi. You may proceed..

Good evening, and thank you for taking the questions. One of the things that strikes me as you're speaking is it sounds as if the core market, not just in the United States, but outside the United States is accelerating the adoption of pump therapy.

First of all, is that the right read? And second of all, how much of that is reimbursement, patients, new products? I mean, it feels like just a year ago we were very worried about the type 2 population and just diabetes utilization in general. And now things look quite good. Thank you..

Joanne, I would say that last year was a bumpy year because there were several new product introductions that occurred. I think that Beta, Medtronic, and Tandem all introduced new products last year. And when that happens, there's positive. And so I think it had an effect on the overall market growth. This year, we're not seeing any of that.

And in addition to that, there's the type 2 indication that's coming forward. So I do think that this is going to be a year where we see growth. Certainly since we're in the middle of the year from our competitors to how they're doing, and it's typically difficult to assess exactly what has happened until the end of the year.

We won't know, but I believe this will be a year of growth. And I think that as we continue to drive innovation and bring new products to market, as well as get new indications, we'll continue to see that growth in the future..

Thank you. Our next question comes from Issie Kirby with Redburn Atlantic. You may proceed..

Hi, guys. Thanks so much for taking my question. I just wanted to talk a little bit more around the type 2 opportunity and some of the bottlenecks around getting to that 25%.

To what extent is it really on the patient awareness side? Or is it really around addressing the provider? And to what extent do you feel like there's really clinical inertia around putting type 2s, particularly in the primary care channel, onto pumps? Thanks..

I think it's both. I think when you get to the physician, I think you have to help them understand the clinical benefit of it. And certainly, we have strong clinical data that we'll be presenting soon. We'll make sure that that's available to the broad cross-section of people who are prescribing pumps in type 2. So that's direct.

The clinical data is definitely directed at the physician. But there's so many other factors about wearability, ease of use, the reduction in the cognitive burden, things that really improve the lives of people who have type 2, as well as the reduction in the longer-term comorbidities.

Those are things that I think we really need to market, advertise, and help the user community themselves see the benefits. But the exciting thing is, I think they're beginning to understand what AID systems can provide in terms of therapy. And they're also seeing how much easier these things are to use.

So I believe that it's really encouraging to see the uptick in near-term pumpers in our market research. And so that's very encouraging for us as we go into 2025 to get the indication..

Thank you. Our next question comes from Danielle Antalffy with UBS. You may proceed..

Hey, good afternoon, guys. Thanks so much for taking the question and congrats on another good quarter here. So, Leigh, I'm not going to ask you a 2025 guidance question.

But what I do want to ask you is a question around market growth and where you see Tandem? And specifically maybe let's talk about the U.S., where you see Tandem? Relative to where you think the market is growing? If we look ahead to 2025, do you see Tandem as being in a position to grow above the market with Mobi continuing to launch? You have a full year.

You now have a pharmacy contract signed, albeit I'm sure that's not going to contribute a ton, at least initially. Or maybe put it in context of market growth. Thanks so much..

It's difficult to talk about market share at this point in time not knowing how the other competitors are doing. But if I were to step back, I would say that, we're absolutely holding our own and have for the last several quarters.

We think that the new products that we're bringing to market are certainly going to enable us to grow the market and grow with it. And, again, when we have a new indication for type 2, that's certainly something that's going to help, as well as the improved access will through pharmacy.

So there have been a number of things that I would say have sort of, there are headwinds for sure that are now becoming tailwinds as we deal with the pharmacy, as we deal with our new products, and as we have the opportunity for new indications. So, I think we're dealing with the issues that have been problematic for us over the last 18 months.

And I think that in 2025, we're going to see the benefits of that..

Thank you. Our next question comes from Mike Kratky with Leerink Partners. You may proceed..

Hi, everyone. Thanks for taking our question.

Going back to the pharmacy migration, can you help us understand the degree to which you're expecting that initial pharmacy contract to open up your business in that channel? You know, I appreciate it's probably too early to give anything specific, but is your sense that pharmacy orders will likely represent a very, very small fraction of your overall business next year? And how quickly do you expect that to scale going forward?.

Yeah, thanks for the question, Mike. So I would say, in relation to the one single contract, it's too soon to talk about the volume that could come through it. But what I would like to highlight is that we still have a number of conversations underway that can open the door for even more opportunity.

So as we continue to size this up and when we move into 2025, we'll be able to give you more color on what that opportunity looks like for us. But also keep in mind that it has been and will continue to be a multiyear strategy as well as we anticipated that we could open up all of pharmacy overnight.

As a reminder, it's really just Tandem Mobi that we're putting into the pharmacy channel. And we do need to build this. We need to continue to work on this pull-through strategy with payers and then solidify some of these other contract opportunities. So we're super excited about it.

Again, I said earlier, we've been celebrating it with a huge first step for us. And I think it's a signal that we are on the right track..

And I would just underscore that what Leigh said, there are a number of other opportunities that were working on aggressively as well. So it's not just this one and we expect to see many more in the near future..

Thank you. Our next question comes from Jeff Johnson with Baird. You may proceed..

Thank you. Good evening, guys. John, maybe I can put together your type 2 comments and your pharmacy comments and just ask one combined question there.

But as we think about that penetration going from the five to maybe someday the 25, as you're saying, and as the market starts moving in multiple points, so not just half a point a year, a point a year, 10,000, 20,000 patients, but 30,000, 50,000, 70,000 patients a year coming in on type 2.

How inherently necessary is it that you get to that pharmacy contract? Especially in Medicare, I know a C-peptide test is still required for type 2 pump use in a lot of those patients.

And is pharmacy really a way for you to better access that type 2, especially as those volumes really scale up and those docs are probably not going to want to take those risks of getting a C-peptide test that comes back positive and having to go through that kind of situation? Thanks..

Yeah, I would agree with you. I think that pharmacy is important for type 2, certainly something we're working on and we're making progress there. The other thing that's going on is there has been a coalition of diabetes companies and physicians who have been working to basically eliminate these tests that are basically unnecessary.

And we've made a recommendation, the recommendation's under review, and we haven't heard back yet. But we're certainly hoping that these are considered. And there's been some success with CGM companies where they've seen favorable rulings. We anticipate that that'll happen here. It's just difficult to anticipate when that's going to happen.

But I think you're right that, when we get into the type 2 area and arena, we're going to need to have pharmacy contracts in place to support that..

Thank you. Our next question comes from Jayson Bedford with Raymond James. You may proceed..

Good afternoon. And congrats on the progress. I didn't catch the full commentary on renewals. Leigh, in the past, I think you've given us some framework around growth, and I think you had quite a few users come up for renewal.

So can you give us a few more details on renewals in the quarter and can we assume that renewals grew sequentially?.

Thanks for the question, Jayson. So renewals, I would just say, renewals continue to be on track. It’s been a very bright spot in our story, even as John described with some of the challenges we experienced in the last few years, where we've been renewing at our highest rates ever. And so the opportunities do continue to grow.

We're very convicted in our ability to renew the patients. And so it was a nice growth year-over-year in the third quarter..

Thank you. Our next question comes from Michael Polark with Wolfe Research. You may proceed..

Good afternoon. Thank you. I have a renewal question, too, but it's about the OUS opportunity. Can you remind us the timing of this next year, 2026? What does that look like? And maybe remind us numerically how you'd frame this opportunity as it starts to mature? Thank you..

Yeah, sure. Thanks for the question. Yeah, we haven't talked a lot about renewals outside the U.S. It hasn't really been as meaningful of an opportunity until we start to exit this year. And just a reminder, we first launched in our markets outside the U.S. in 2018. And we were -- some of it started with a timing element.

There's a stocking piece that goes to it. And so I would say, first people on pumps didn't occur until late '18, early '19. And so that meant this year was the first time for some of our smaller markets. The larger markets that we launched into, that didn't happen until 2020. So those are just beginning become opportunity as we exit this year.

So long story short, 2025 is going to be the first year, where we will start to see something more meaningful from a renewals perspective. And we're partnering closely with our distributors on lessons learned and best practices from our experience here in the U.S. as well. So we believe we'll be just as successful there as we have been here..

Thank you. [Operator Instructions]. Our next question comes from Travis Steed with Bank of America. You may proceed..

Hey, just maybe an election day question. Since tariffs look a little more likely going forward, I know, you do a lot of U.S. manufacturing, but how do you think about like components, U.S.

components and supplies that are sourced from international sources? And if you've thought through that in any way or could help put some color on the potential for tariff impacts or how to think about tariffs for your business?.

Yeah, thanks, Travis. That's definitely something we're thinking about. And it's obviously very early and we'll have to see where he actually goes with some of the commitments he's made while, in the actual campaigning process. But we have a wide supply chain that does cross into some of the Asian countries that could potentially be problematic.

But it's flexible and we have the flexibility to move things as we need to. And we have other mechanisms to offset expenses that may come in one market versus another. So definitely thinking about it. It's sort of a top of mind right now. And good news is that we've got flexibility in the supply chain.

And as we see things begin to become more specific, we can address it with various actions at that point in time..

Thank you. This concludes the conference. Thank you for your participation. You may now disconnect..