Good day. Thank you for standing by. Welcome to the Tandem Diabetes Investor Conference Call. At this time, all participants are on a listen only to this presentation. There'll be a question and answer session. To ask a question during the session, you'll need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Susan Morrison, Executive Vice President and Chief Administrative Officer. Please go ahead.
Thank you. Hello, everyone, and thanks for joining us this morning. Today's discussion will include forward-looking statements. These statements reflect management's expectations about future events, product development timelines 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, quarterly report on Form 10-Q, and in our other SEC filings. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or other factors.
Today's discussion may include reference to GAAP and Non-GAAP financial measures. For additional information on our use of Non-GAAP financial measures, please refer to slide two of today's presentation. Our call today will be led by John Sheridan, our President and Chief Executive Officer, and Elizabeth Gasser, our Executive Vice President and Chief Strategy Officer. Following their prepared remarks, Leigh Vosseller, our Executive Vice President and Chief Financial Officer, will join for the Q&A portion of our call. We ask that participants limit themselves to one question and one follow-up before getting back into the queue, and that questions relate only to today's announcement. With that, I'll now turn the call over to John.
Thanks, Susan, thanks everyone for joining us this morning to discuss an exciting acquisition of AMF Medical. Starting on slide three. One year ago, we laid out Tandem's portfolio strategy, supported by more than a decade of research demonstrating that diabetes is a highly segmented market, and there is no one-size-fits-all solution for how people want to wear their insulin pump or how they want to control it. As you can see in slide four, we outlined our vision to be the first diabetes therapy company to move from serial product development into offering a family of insulin pumps. Today's announcement of our acquisition of AMF Medical reflects our commitment to this vision. As we've discussed on investor calls and conferences throughout 2022, we have been working toward delivering a dedicated patch pump in the latter part of our five-year product roadmap.
To this end, we pursued an internal design efforts while also evaluating the development stage patch pump landscape worldwide for innovative technologies that can benefit the diabetes community with user-friendly differentiated features. This is where the Sigi Patch Pump being developed by AMF Medical stood out. Turning to slide five. The Sigi Patch Pump upholds the Swiss reputation for quality and precision in small device design. It's an ergonomic, low-profile patch pump that is compact in size and form and is designed to be part of an automated insulin delivery system. Importantly, it offers significant feature differentiation versus end-market patch pumps with the use of prefilled insulin cartridges, underscoring our shared commitment to making diabetes management easier and more convenient.
It's also rechargeable, which further differentiates it among the patch pump landscape as a more environmentally friendly offering, which was a consideration for us designing our t:slim X2 and Mobi products. From a strategic standpoint, as you can see on slide six, we see significant potential for increased pump penetration with people who live with Type 1 diabetes and with people who live with Type 2 diabetes on insulin-intensive therapy. We see Sigi as a market expanding offering, furthering our goal to bring the benefits of our technology to more people living with diabetes worldwide. We conducted extensive user research in 2022 and believe Sigi's wearability and focus on ease of use supports the needs and preferences of people with Type 1 using multiple daily injections who have been hesitant to adopt pump therapy and the insulin-intensive Type 2 community.
Our five-year goals throughout 2027 are primarily comprised of driving pump adoption with people living with Type 1. When we look to our longer term objectives, however, our efforts will have an increased focus on people living with Type 2. This acquisition also accelerates our longer term patch pump objectives by reducing development risks while allowing for the addition of market differentiating features. In light of this, given the degree of target market overlap with Sigi, we will be suspending our internal program on patch development. In our early development work and when considering our path towards a patch offering, we have also focused on how we can satisfy the environmental and sustainability concerns of the company and increasingly our customers.
This has been a long-standing development consideration for us, and with the acquisition, we are making a conscious choice not to pursue a product that results in high volume disposal of electronics and batteries, which Liz will discuss further. I'll also highlight that Sigi's novel design provides a pathway for us to further explore business model optimization and channel expansion opportunities, which may ultimately allow us to increase customer access. Turning to slide seven. The talented AMF team of approximately 20 employees is led by co-Chief Executive Officers Mr. Pim van Wesel and Mr. Antoine Barraud, who is also a co-founder. The team brings decades of experience from the diabetes device, life science, space, and watch industries. I've had a chance to visit the group in Switzerland last month and walked away very impressed by their engineering talent, focus on design for manufacturability, and passion for helping people living with diabetes.
They've been advancing Sigi since 2014 and gaining meaningful momentum in recent years, as illustrated by Sigi receiving Breakthrough Device designation from the FDA in November 2021. With regards to integration, we value that the AMF team brings a wealth of knowledge along with intellectual property in this space. We plan to maintain its business operations in Switzerland to ensure continuity and readiness for development efforts, which include research and development and early manufacturing operations. Our cash payable at closing is CHF 62.4 million. There is an additional cash consideration of up to CHF 129.6 million based on the achievement of certain development milestones and regulatory milestones in the coming years.
Each milestone signifies a meaningful step toward the value-creating event of product commercialization, which we believe will be in the latter part of our five-year roadmap and has the potential to drive substantial long-term revenue growth. Subject to the satisfaction of customary closing conditions, we expect this acquisition to close in January. I'll now turn the call over to Elizabeth, who will expand on the strategic rationale behind the acquisition and provide an overview of the Sigi patch pump system.
Thank you, John, and good morning, everyone. I would also like to share my excitement about this acquisition and appreciation for the AMF Medical team. We've previously shared our intention to offer a patch pump as a key element of our portfolio towards the latter end of our product development horizon, which goes to 2027. As part of this commitment, we have been evaluating existing technologies under development alongside our own early internal efforts. The AMF team, like Tandem, is laser-focused on human-centered design, the experience that their device offers, and the customers they will serve. As you can see on slide nine, the Sigi patch pump embodies our shared values. As John mentioned, its thoughtful ergonomic design provides for a low profile on body footprint. Additionally, the use of prefilled cartridges is differentiated in the patch pump segment and meaningfully simplifies the insulin fill process for users.
It is also worth noting that Sigi is a durable patch, meaning the pump body is rechargeable and reusable over a multiyear lifespan, thereby avoiding significant electronic waste. As a multi-part, durable, disposable patch system, we have more opportunities to pursue a diversity of extended wear options for the on-body infusion site. In taking a closer look at Sigi's design, Slide 10 shows that use of the system only requires a few simple steps. It starts with a one-button push on the applicator, which applies an adhesive pad with the infusion cannula. Next, users just insert the standard prefilled cartridge into the disposable cap and lock it on the pump. Thanks to Sigi's novel pumping mechanism, the pump is ready to go quickly. You attach Sigi to the on-body pad with a simple click, and done.
Sigi is managed from a user's personal smartphone, so there's no additional controller to carry. The system itself comprises two rechargeable pumps with a sleek USB charger, so one pump is always ready to pick up, click, and go. Consistent with our stated strategy, this acquisition also provides an opportunity to leverage Tandem's scalable software solution. We expect to develop the Sigi pump for compatibility with our market-leading Control-IQ AID algorithm and integration with our web-based data management platform, with the goal of bringing Sigi to market as part of a robust AID system. In looking at our criteria for M&A, we focus on addressable market expansion, enhanced user experience, market access, and business model optimization. Additionally, we consider adjacencies to our existing offerings with the potential to leverage our sales force at the same call point, our data management platform, and our customer service infrastructure.
Most importantly, we look to continue delivering on our mission to improve the lives of people with diabetes. To date, we've been selective in our M&A activities. We believe that AMF Medical directly fits these criteria.
Thanks, Elizabeth. This transaction demonstrates our deep commitment to expanding our product family to provide choice to the diabetes community, and we remain steadfast in our efforts, and we remain confident in our ability to reach the longer-term objectives for 2027. While the acquisition will impact short and medium-term profitability, we do not need to raise additional capital to support this structured transaction. We have a strong balance sheet, which is appropriately leveraged for a deal of this size, and we will remain disciplined in our spending efforts. We also believe the long-term potential of this valuable asset justifies the near-term impact to our profitability. We'll provide color on the near-term spending profile associated with AMF Medical operation on our year-end earnings call in late February.
In conclusion, our acquisition of AMF Medical positions us to further drive growth through innovation as we leverage our infrastructure and build our portfolio of diabetes solutions, bringing choice and the benefits of our technology to more people living with diabetes. We look forward to welcoming the AMF team to our Tandem family following the close of the deal and to working together in our collective mission to make a positively different impact on the lives of people with diabetes. I'll now turn the call over to the operator for questions.
Thank you. As a reminder, to ask a question, you'll need to press star one one on your telephone. Please wait for your name to be announced. Please stand by while we compile the Q&A roster. One moment for our first question. Our first question comes from Josh Jennings with TD Cowen. Your line is now open.
Hi. Good morning. Thanks for taking the questions and congratulations on the transaction. I was hoping just to understand whether Tandem had any historic collaboration with AMF and whether the integration of the Control-IQ algorithm has been de-risked to any degree, and just when first-in-human studies could be performed, but particularly with a hybrid loop trial. Thanks for taking the questions.
Yeah, happy to take that one. Good morning to you. In terms of our collaboration with AMF to date, we have a long-standing interaction with them and have been talking with the company throughout much of 2022. There is no formal program in place for implementation of Control-IQ today. That is something that we anticipate working on after the close of the transaction. We have done substantial diligence to substantiate our confidence that we have a clear path to integrating with CGM and to implementing our own algorithm. In terms of first-in-human, we'll be providing more commentary on our plans for future in-human trials and clinical work post-close.
Great. If I could ask one follow-up just to, as you vetted the patch pump technology landscape, do you believe Tandem will be second to market at the end of the day, or are there other platforms that are further down the clinical development road, that could be commercialized in front of Sigi in the United States? Thanks for taking the questions.
As we said in our prepared remarks, we looked extensively at the inorganic opportunities ahead of us and concluded that Sigi represents the best path for us to engage with the type of product that we want to bring to market, which is fundamentally a durable patch offering.
There are other patch companies out there, smaller companies, that have devices on the market in OUS countries. It's possible that they may get here before we do. We think we have a highly differentiated product, which is going to be very positive in terms of just developing the market both in the US and OUS.
Great. Thanks a lot.
Thank you. One moment for our next question, please. Our next question comes from Matthew O'Brien with Piper Sandler. Your line is now open.
Morning. Thanks for taking the questions. Just to follow up a little bit on what Josh is asking about, you know, it sounds like you've been interacting with them for about a year now, but the landscape is littered with other patch pumps that didn't work, especially two-piece patch pumps. I'm just curious what you saw in Sigi that is so unique and differentiated and de-risked that you decided to go ahead and do this transaction now. I know the upfront is manageable versus the milestones that are coming, just given, you know, how much you're potentially going to pay for this, you know, why are you so comfortable that this pump is the one that can get to the market in a couple of years?
Thanks for the question, Matt. I think to your comment about prior patch pumps in the space, today we successfully commercialize a multi-part system of our own, which serves 400,000 users worldwide. It's not clear to us that componentry is the issue here. What has been appealing to us in engaging with the Sigi team is fundamentally the quality of the design. It's ergonomic, it's low profile, it's well thought through. We have very much appreciated the fact that it offers differentiating features versus other available solutions. The use of pre-fill very much satisfies our goal for delivering ease of use to our customer base and is currently differentiated in the patch space.
I think some of the other things that really resonated with us as we've engaged with the team, as John mentioned in his prepared remarks, is that they come with a long-standing history of precision device manufacturing experience, in particular design for manufacturability experience across this and other precision small device industries. We've got a lot of confidence in both the quality of the design and the path to manufacturability. You added a comment at the end about why now. I think for us, the really important thing is to ensure that we have a good and close collaboration to bring the best of our CGM integration expertise and our algorithm to bear on the product as part of a system over time. The timing felt right.
The product is at the stage of being a functional prototype that is ready to embark upon this type of integration. That's why we chose to act now versus maybe deferring this until a later stage and/or pursuing alternate pathways and structures here.
Okay. Makes sense. As the follow-up, I don't know if this is for Elizabeth or for John, but you know, the model here being, you know, a reusable pump and then the cap that goes on top of it, why are you confident you can go the pharmacy route with this or get better access with this technology?
I think, from our perspective, it-
It certainly satisfies many of the conversations that we're having with pharmacy today around utilization, ease of use. I appreciate that there's not an analog in the pharmacy channel today for the cap type structure. We will need to have conversations with our payer partners on how we bring this to market with them. I would say, though, we're very familiar with the economics of both pharmacy and the DME channel. At this point, we understand what we need to do to fit within that economic profile, and we have every confidence that the product itself will allow us to do that.
Got it. Thanks so much.
Thank you. One moment for our next question. Our next question comes from Alex Nowak with Craig-Hallum. Your line is now open.
Okay, great. Good morning, everyone. I just want to confirm, is the pump design currently frozen, or what other changes do you need to make to the hardware side before locking it down before starting studies?
Hey, Alex. I would just say that the design is a very advanced prototype and that, you know, there's definitely evolution that has to occur between now and the final device. I think it's a really strong prototype. We'll be working on issues that have to do with, you know, just testing for safety, reliability, and manufacturability over the, you know, the next couple of years. I think that the fundamental design, I think, is there, and I think it's just really optimization. As Liz mentioned, we need to add CGM integration as well as the algorithm. There's a few things that we'll have to change, but I'd say it's a really strong prototype at this point in time.
Okay. Understood. I know you wanna save some of the R&D costs roll expansion for the Q4 call, but I do think it's prudent to talk about it here since you are suspending the internal patch development. Can you maybe just speak to what's gonna happen? Is the team that was working on the internal patch gonna switch over to Sigi here? Maybe just speak to, you know, kind of on a rough basis, what we should expect for our ongoing R&D costs and that scale-up.
I would say that there's going to be some people from Tandem who'll be working closely with the Sigi team. I think we wanna keep the Sigi team intact. They've done a great job up until this point in time. They've got momentum, and we wanna continue to see the progress that they're making now into the future. You know, I think we'll talk more about that, as we said, in the fourth quarter call in February. You know, the team that we have in place, some will be sort of reallocated to support Sigi. There's a lot of other projects that we've got going on in the organization that I think that others will be working on as well.
All right. Thank you.
You're welcome.
Thank you. One moment for our next question. Comes from Travis Steed with Bank of America. Your line is now open.
Hi. Congrats on the acquisition. I was looking back at my old notes from AMF, and I think they were planning on submitting the to the FDA by late 2023, early 2024, with a launch in 2024, 2025. Are those, like, just to clarify, are those timelines shifting out a little bit, or? I'm just kind of curious if you could give a little more color on the actual launch timing here.
I think that, you know, when we talked about patch availability, you know, we've been talking about the end of the 5-year horizon. I mean, we're thinking, you know, in the 2027 timeframe. We think this certainly provides more certainty when it comes to those dates and has the potential to accelerate as well. I think we are comfortable in saying that we believe that there will be revenue in 2027 from this product.
Okay. That's helpful. How do you think about the gross margin profile at scale? I'm sure that's something you thought about whenever you were doing the diligence here. Revenue per year, is it gonna be similar to the other patch pump profiles or more of the durable pump profiles when you think about total revenue per year? Leigh, I wanted to ask about the investment required to scale this. It does sound like it's gonna impact short-term profitability. Is 2023 EBITDA the message that probably goes negative in 2023, or can you still maintain profitability?
Sure. Thanks, Travis. I'll start with the revenue questions in the longer term. As John mentioned, we do expect revenue in 2027 that we think about this more as a beyond the five-year timeframe in terms of meaningful contribution on the revenue side. We feel confident that, from a system perspective, that we can achieve the same reimbursement levels we will have with t:slim and or Mobi at that time. You can think about it from a system perspective and totality to be at least as good as or better from a reimbursement perspective.
In terms of the spending as we look forward, just like our revenue levels in the next five years, we don't expect the spending to, you know, track linearly across the years, and we've always anticipated that R&D would be a heavier investment in the early years of our five-year timeframe. As we look to 2023, you know, just based on the indications we've given for top line, we likely weren't expecting to see expansion on margins anyway, neither gross margins or operating margins. You know, we'll give more color to that at our year-end earnings call when we talk about profit targets for next year, but I wouldn't expect significant expansion.
Okay. Still profitability potentially? Still positive EBITDA?
Yes.
Okay. Thank you.
Thanks, Travis.
Thank you. One moment. Our next question comes from the line of Lawrence Biegelsen with Wells Fargo. Your line is now open.
Hey guys, thanks for taking the question. Just to follow up on Travis's question, the fact that this is reusable, does that change how you're thinking about the gross margin, at least the path to, you know, a similar gross margin to what you have today or your long-term goals? It took, you know, insulin a long time to get to where they are. Does this change, you know, the fact that it's reusable, expedite that?
Sure. What I'll say is that we're still very confident in our long-term gross margin target, which is 65% in 2027. Considering that we'll have a portfolio of products, it'll look a little bit differently when you think about scale because we'll already have, you know, Mobi and t:slim X scale driving significantly improved gross margins from where we are today. You can think about Sigi fitting into that model for us on the go forward in that, again, in that beyond 2027 time frame.
Thank you. John, I'll say.
Yeah.
Yeah.
I was just gonna say that I think when it comes to the manufacturing capability and capacity, while we absolutely expect this product to be automated, it's not gonna have the same level of automation of a fully disposable patch would. I think that the capital investment is going to be less for us, to get to that point where we have higher margins.
Okay. Just for follow-up, John, are there any other differences between Sigi and Omnipod besides the pre-filled syringe and the rechargeability? Anything that you can say on just kind of the dimensions, the weight, anything else you would highlight? Thanks for taking the questions.
I can jump in there actually, on some of the product differentiation. I just think the other thing I would seek to highlight with regard to the product is the value of detachability. A lot of our user research over the past year showed segments of the market placing a distinct premium on the idea of not wasting insulin, should a site fail. I think in addition to the, you know, the ergonomic design, the pre-fill, the reusability, which speaks to many environmental concerns, that management of waste, management of when you choose to wear versus not, because it is a two-part system does actually resonate well with a segment of users.
I think the other thing I would highlight, is also that because of the way the micro pumping mechanism is designed, it has very rapid occlusion detection, which is a, it's, you know, less of a headline feature in our announcement this morning, but it is nevertheless a valuable feature for users.
Thank you.
Thank you. One moment for our next question. Our next question comes from Joanne Wuensch with Citi. Your line is now open.
Good morning, thank you for hosting the call. Two questions. Are you going to be selling this as sort of a standalone pump as well as an AID system or just an AID system?
Hi, Joanne. I think it's gonna be an AID system. It'll be an ACE pump that fits into our portfolio of products, we intend to continue to sell the t:slim, Mobi, and the Sigi patch. We would expect that the, you know, the algorithm that, you know, the whatever the revision of the algorithm is that's available at that point in time would be on the Sigi pump as well.
Okay. A follow-up question then is, I'm trying to figure out how the market starts to look in terms of, you know, which patient chooses which product. Is this aligned, you know, as a direct competition or competitor to other patch pumps, or because of the uniqueness, you know, et cetera, it serves a different need? How do you see the portfolio playing out as sort of a sister question to that? Thank you.
That's a great question, Joanne. I think, you know, certainly with the site position, we're acknowledging the fact that for a segment of Type 1s and insulin-intensive Type 2s, that the patch form factor resonates well. I think from our perspective, though, the goal is to really understand how the market needs to segment and how to deliver a differentiated and competitive offering here. The work we've been doing over 2022 has really been testing, for whom the ideas of ease of use and pre-fill resonate, disposability and environmental friendliness. You know, where and how the form factor is best aligned. You know, and you do find very distinctive pockets. You know, for example, teens, the message of reusability resonates very strongly with them.
Same with, users in international markets where environmental concerns index a little bit higher. Our goal really is to focus on, you know, a highly differentiated offering here. We're confident that, the Sigi product allows us to do that. It's not a me-too offering.
Thank you. One moment for our next question. Our next question comes from Jeff Johnson with R.W. Baird. Your line is now open.
Thank you. Good morning, guys. Most of my questions have been answered, but John, I just wanna go back. When you were answering one of Larry's questions, you mentioned something in passing, and I'm just not sure I understood what you meant. You said it, you know, the Sigi pump may not have all the capabilities of a fully disposable patch pump. I guess if you could just, you know, flesh that out or help me understand what you meant by that.
No, I didn't say that, Jeff. What I was saying is.
Oh, okay.
I was saying that we don't need to have the same level of automation that's required to build a fully disposable system. The automation won't be as capital intensive as it would be for a fully disposable system. I would say that this device, you know, will meet all of the capabilities of a patch device. Again, it's highly differentiated, it's got a great form factor, and it has these really interesting features like the prefilled cartridge, environmentally sensitive, and the ability to attach, which we think are all meaningful new features that'll cause a great deal of excitement in the market.
Understood. That's helpful. Thank you. Just my follow-up on that is just I would assume this doesn't change anything, but what is the commitment then to Mobi at this point, but also the Capillary Biomedical deal where, you know, that's gonna add some cost next year on the pivotal as well? Just fully committed to both of those products still at this point after this deal? Thanks.
Yeah, absolutely. We're totally committed to Mobi. Obviously, it's under review right now by the FDA. We're excited to bring that to market next year. Obviously, we've just recently invested in Capillary Bio. We think they have a great product, which is also going to help provide choice to our customers as well as help us on the margin side. We're very excited and very committed to both of those.
Thank you.
Thank you. Our next question comes from Jayson Bedford with Raymond James. Your line is now open.
Good morning. Just a couple quick ones. Thinking through a few of the comments you made on the business model and approach here, just to clarify, the expectation is that this product goes through the pharmacy in the U.S., correct?
We absolutely will be pursuing the pharmacy channel for this product. Actually, those conversations begin with Mobi today. It's about part of it's about relationship building, and that's something we can start now. We feel confident that Sigi can fit into the pharmacy channel.
Okay. On manufacturing, where will this be manufactured?
You know, we really haven't, and probably won't be discussing, those facts for a little while here. I would say that, you know, we have the manufacturing facility here in San Diego. We have partners that are across the border in Tijuana. But it's just one of those things where we, you know, we still are in the process of just analyzing the best locations for us.
Okay, thank you.
Thank you. Currently, I'm showing no further questions at this time. Ladies and gentlemen, thank you for participating in today's conference. You may now disconnect. Everyone, have a wonderful day.