Beta Bionics Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
March 25, 2025

There are 10 speakers on the call.

Operator

Good afternoon, and welcome to the Beta Bionix Fourth Quarter twenty twenty four Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session and instructions will follow at that time. As a reminder, please be advised that today's conference is being recorded. I would now like to hand the conference over to Blake Beaver, Head of Investor Relations.

Operator

You may begin.

Speaker 1

Thank you. Good afternoon and thank you for joining Beta Bionik's fourth quarter and full year twenty twenty four earnings call and our first earnings call as a public company. With me today are Sean Saint, Beta Bionics' President and Chief Executive Officer and Stephen Feider, Chief Financial Officer. Both the replay of this call and the press release discussing our 2024 results and 2025 guidance will be available on the Investor Relations section of our website. The replay will be available for approximately one month following the conclusion of this call.

Speaker 1

Information recorded on this call speaks only as of today, 03/25/2025. Therefore, if you are listening to the replay, any time sensitive information may no longer be accurate. Also on our website is our supplemental fourth quarter twenty twenty four earnings presentation and updated corporate presentation. We encourage you to reference those documents for a summary of key metrics and business updates. Before we begin, we would like to remind you that today's discussion would be looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Speaker 1

These statements reflect management's expectations about future events, our product pipeline, development timelines, financial performance and operating plans. Please refer to the cautionary statements in the press release we issued earlier today as well as our SEC filings, including our Form 10 K filed today for a detailed explanation of the inherent limitations of such forward looking statements. These documents contain and identify important factors that may cause actual results to differ materially from current expectations expressed or implied by our forward looking statements. Please note that the forward looking statements made during this call speak only as of today's date, and we undertake no obligation to update them to reflect subsequent events or circumstances except to the extent required by law. Today's discussion will also include references to non GAAP financial measures with respect to our performance, namely adjusted EBITDA.

Speaker 1

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 press release and supplemental earnings presentation on the Investor Relations section of our website for a reconciliation of non GAAP measures to their most directly comparable GAAP financial measure. With that, I'll now turn the call over to Sean.

Speaker 2

Thanks, Blake. Good afternoon, and welcome to our first earnings call as a public company. We're excited to share with you today the details on our strong performance in the fourth quarter and full year 2024, as well as introduce our full year guidance for 2025. We'll also briefly review our technology and as you'll see, we have multiple strategic initiatives underway both commercially and in our pipeline, which we believe position the company well for success over the short, medium and long term. Before we dive in, I'd like to take this opportunity to thank all of our investors who have supported Beta Bionics throughout our journey and particularly those who supported Beta Bionics in our recent initial public offering and concurrent private placement, which together raised approximately $2.00 $6,000,000 in net proceeds.

Speaker 2

As a person living with Type one, I'd also like to thank the entire Beta Bionics team. I feel that the future of diabetes management has never been brighter and that is a testament to our unwavering dedication to people with diabetes and the broader diabetes community. Most of all, I'd like to thank our community of Violet users and the caregivers, family, friends and healthcare providers who support them. Thank you for being part of our Bionic Universe and putting your trust in Beta Bionics and our mission to simplify and alleviate the burden of managing diabetes with life changing solutions. While that burden reduction is certainly focused on those living with diabetes, it extends to what we call the four P's the patient, the provider, the payer and the pharmacist.

Speaker 2

We believe that easing the burden for each of these critical groups is key to our mission and success. On today's call, I'll cover four important topics. First, our technology, the Ilet Bionic pancreas and the unmet needs we're addressing in diabetes. Next, I'll share the key milestones that Beta Bionics has achieved over the past two years that illustrate the progress we've made both commercially and clinically. Then I'll discuss our fourth quarter and full year 2024 financial results.

Speaker 2

And lastly, review our innovation pipeline and our vision for the future. Stephen will provide additional details on our financial results and our full year 2025 guidance. We're going to cover lots of ground in our prepared remarks today, given this is our first earnings call, so bear with us. Starting with our technology, it's important to first dive into the unmet needs we're looking to address. When insulin pumps were first developed, they were essentially glorified syringes.

Speaker 2

They gave a small amount of insulin every five minutes, which was important given the less than stellar insulins of the day. Over time, these systems evolved to include hybrid closed loop algorithms, which increase or decrease insulin when needed to aid the user in managing their diabetes. And these systems work. But we have never fundamentally changed these systems to eliminate the complex setup and management that traditional pumps and hybrid closed loop pumps require for physicians and users. Complex for physicians, meaning the settings that are programmed into the pump on day one, including carb factors, correction factors, basal rates and duration of insulin action, plus the modifications the physician makes to these settings each time they see the patient.

Speaker 2

And complex for the user, meaning daily burden such as carb counting, manual correction boluses, extended boluses and sometimes even modifications to the settings of the pump. That's why we developed the Eyelet Bionic Pancreas, which we designed to cut through all that complexity without sacrificing outcomes. Eyelet represents the first fundamental disruption of the user experience of insulin pumps for both the patient and the provider since their invention. With Eyelet, you enter your wait and the system will learn and adapt to you. Doctors are no longer required to perform complex setup or modification of insulin settings, leaving their times better spent with the patient, not the pump.

Speaker 2

Users are no longer required to calculate boluses of any kind, to count carbs or to modify their pump settings. They simply tell the pump they're eating a meal that's about usual for them or more or less than normal and ILET takes care of the rest as it determines and delivers 100% of all insulin doses. For all those reasons, we see ILET as a revolution in insulin pump technology. But why was a revolution necessary you might ask? Well today, roughly twenty percent of adults living with type one diabetes in The United States meet or surpass the ADA target HbA1c of seven percent or lower.

Speaker 2

While it's true that a certain subsegment of users are able to reach goal today, far too many are not. I want to be very clear, Eyelet is not about getting the absolute best outcomes for only the most educated, engaged and motivated users out there. Eyelet is about shifting the burden of managing diabetes from the user and provider to the pump. It's about democratizing great outcomes for everyone with diabetes, regardless of their knowledge of the disease, level of engagement or access to a leading endocrinologist. We believe that the islet may be the only pump system today that is capable of improving diabetes population level, something that's been lacking to this point despite the numerous technological leaps in insulin pumping that have been made over the last thirty years.

Speaker 2

In terms of where we are in our journey, the last two years have been transformational for Beta Bionics. In May of twenty twenty three, we launched the Islet Bionic pancreas with the goal of enabling people with diabetes to manage their diabetes with less work, but without sacrificing outcomes. For the full year 2023, over 2,300 users adopted our technology and we generated $12,000,000 of net sales with a gross margin of 52.6% despite being in a relative infancy as a commercial stage company. We also pioneered a new business model and to our knowledge the iLEP became the first durable insulin pump to be eligible for pharmacy channel reimbursement when we announced our formulary contract with Express Scripts in the fourth quarter of twenty twenty three. That's an important initiative for our business and one that we'll describe in more detail later in the call.

Speaker 2

2024 was a phenomenal momentum building year for Beta. I'd like to highlight a few of the many milestones we achieved. Close to 13,000 more new users adopted our technology, including over 4,000 new users in the fourth quarter alone, and we're proud of the profound impact that The Islet is already having on people with diabetes and the broader diabetes community. We continued to make progress in securing more formulary contracts that expanded pharmacy coverage and reimbursement for The Islet, most notably our contract with CVS Caremark, which we signed in the fourth quarter of twenty twenty four. We derived our first year of real world evidence for Islet with data from 3,300 users.

Speaker 2

I want to be clear, if we had a user's data, meaning baseline A1C and at least three weeks of CGM data uploaded to our cloud, they were included in this data set. Consistent with our goal of improving population health, we believe that it's more important to show data for the entire population rather than a certain subset of users based on specific settings or use requirements that are more likely to produce favorable outcomes. The evidence in our real world dataset demonstrated ILET's effectiveness in a large and diverse real world population, driving meaningful changes from 8.5% baseline A1C to follow-up GMI of 7.3%, GMI meaning Glucose Management Indicator, which is a proxy for A1C. Although the real world dataset wasn't prospectively designed to assess this, we believe the dataset is the first in diabetes interventions that we're aware of including pumps, CGMs and SmartPens that seem to indicate that improved glycemic outcomes were achieved independent of user engagement, which reinforces our technology's differentiation and appeal to people with diabetes. To further highlight that point, we recently ran an additional analysis of our real world data to better understand how the islet is being used in a fully closed loop manner, which for purposes of this analysis we define as users who announced less than one meal per day on average over the past thirty days.

Speaker 2

I want to be clear again, if we had a user's baseline A1C data and they uploaded their data to our cloud in the thirty day period ending March 18, they were included in this dataset. Unlike sub segmenting real world datasets in ways that are likely to produce more favorable outcomes versus the broader real world user base, this subset of fully closed loop islet users makes sense for us to carve out because you typically expect their outcomes to reflect unfavorably relative to the broader user basis data. Of course, this analysis is just an ad hoc analysis of our real world data and doesn't come from a prospective study of islet closed loop safety and efficacy. Of the users we have this data for, we found that fifteen percent of them or close to 1,400 users met the criteria for using the islet in a fully closed loop manner. On average, those users announced roughly one meal every three days and went from an average baseline A1C of 9.3% to a follow-up GMI of 7.4% or close to a two percent improvement.

Speaker 2

The high baseline A1C suggests that this user population likely was not engaging much in their pre islet diabetes care And based on these data, it appears that they've continued that low level of engagement in their care with islet, but we were able to achieve much better results. They experienced an even greater improvement baseline A1C to average GMI than our overall user base and their follow-up GMI of seven point four percent was very similar to the 7.3% that we saw in our first year of real world evidence for all islet users that we had data for. What I hope you take away from these data is our belief that we have the most advanced algorithm on the market when it comes to operating in a fully closed loop manner, which again speaks to Eyelet's unique algorithm and appeal to people with diabetes. Shifting away from a real world evidence in 2024, we also launched a number of new products, particularly in the back half of the year, which contributed to our strong performance in 2024 and which we also expect to contribute to our performance in 2025. Last, but certainly not least, we continue to advance our pipeline including our patch pump program and our bihormonal pump program, the latter of which we achieved a major milestone for when we signed the exclusive collaboration and licensing agreement with Deris Pharmaceuticals and completed pump compatibility testing for their proprietary glucagon formulation for use in Beta Bionics biohormonal pump configuration.

Speaker 2

These are all fantastic achievements and a major credit to our employees' relentless execution and dedication. Shifting now to a brief overview of our fourth quarter and full year 2024 results. For the full year, I'm proud to announce that we delivered $65,100,000 in net sales, which represents 443% growth year over year. Our gross margin was 55.1 and we continue to be encouraged by our gross margin relative to our scale, especially considering our shift to the pharmacy channel weighs on our gross margin in the near term. In the fourth quarter, we generated $20,400,000 in net sales, which represents 145% growth year over year.

Speaker 2

Our gross margin was 57.2%. As we will discuss in more detail later in the call, our strong performance in the fourth quarter was driven by continued momentum in new patient starts, resulting from robust demand for the islet, new product launches and seasonality. And while shifting more of our business to the pharmacy channel negatively impacted our net sales for the quarter, our new patient starts certainly benefited from the shift to pharmacy as users are able to access the pump with minimal out of pocket costs. As Stephen will discuss in greater detail, as our business shifts toward pharmacy, we expect that to negatively impact net sales and gross margin in the near term, but is accretive to our business over the long run. Before I hand it over to Stephen, I'd like to discuss our innovation pipeline.

Speaker 2

Innovation and speed are at the heart of everything we do. We firmly believe we've developed the most advanced insulin pump system in the market with a highly competitive form factor within the durable pump category. Following our CGM integrations with both Dexcom G6 and G7 in 2023, in November of twenty twenty four, we became the first insulin pump in The U. S. To be integrated with Abbott's Freestyle Libre three plus In September 2024, we also launched our Bionic Circle mobile application, a remote monitoring experience which allows a caregiver to see a user's eyelet data and monitor performance, a particularly important capability for parents and children with diabetes who are using islet.

Speaker 2

The list goes on. I want to take this opportunity to highlight two key R and D programs that we're working on. Number one is our Patch Pump, which we expect to commercialize by the end of twenty twenty seven. The patch is a two part design with one disposable and one reusable component that we believe has the potential to be advantageous for our users because it will offer a more seamless patch change experience versus fully disposable designs and add that changes for our business from both the reimbursement channel and cost effectiveness perspective. The patch pump will be paired with the same FDA approved algorithm that powers the islet, which we already discussed the substantial advantages of for the user and physician.

Speaker 2

The other key project we're working on is our biohormonal pump, which would deliver both insulin to bring your blood sugar down and glucagon to bring it back up, similar to how the gas and brakes work in a car. As I mentioned before, we exclusively own the rights to our glucagon product and are therefore responsible for its development and commercialization. In the past, we've conducted three pre pivotal inpatient and six pre pivotal outpatient clinical trials studying the biharmodal configuration of the islet and achieve reduced hypoglycemia and increased time in range relative to both standard of care treatment and our insulin only configuration of the islet. Importantly, this project is not just about improving clinical outcomes like time in range or A1C reduction. It's also not about giving a rescue dose of glucagon in emergency situations only.

Speaker 2

It's about incorporating glucagon as a consistent mechanism to support blood glucose control in a similar way to how a functioning pancreas would work. With that, we may have greatly reduced the burden of living with diabetes, especially the mental burden that so many people with diabetes live with because they are in constant fear of hypoglycemia or low blood sugar. So that's what this biohormonal project is all about, substantially reducing the burden of diabetes. In terms of our path to market, while it may seem abbreviated when I walk through it at the moment, it's important to remember that we've run a number of pre pivotal inpatient and outpatient clinical trials studying biohormonal that date back to 02/2008. So we developed a robust clinical data set on bihormonal dating back over sixteen years.

Speaker 2

That data set includes the first outpatient trial on a mobile platform of a closed blue blood glucose control system that we're aware of known as the Beacon Hills study, which was conducted in 2013. Now to take you through the steps that we believe are required to get our bihormonal system, including glucagon, to market. At a minimum, we believe we'll need to run a PKPD trial to bridge all of our previous clinical data to this new formulation of glucagon from XERIS. Then we're planning to conduct a one year drug pivotal trial to fulfill the requirements for a chronic drug indication and a concurrent six month device pivotal trial. These will be followed by ACE and IAGC 510s for the pump and algorithm as well as what we currently believe will be a five zero five B2 NDA application for the drug.

Speaker 2

If we're successful in getting the biohormonal system to market, we expect that we'll have a truly revolutionary therapy that completely changes the way people think about managing their diabetes. As a company, we're extremely excited by both of these key pipeline programs and believe each represents a unique and important vehicle to help us deliver life changing innovations to the people who need them. The last piece of the pipeline that I'd like to briefly touch on today is the Type two label expansion opportunity. While we aren't disclosing timelines for that project at this time, I would like to mention that there are some healthcare providers today that decide to prescribe ILA to their Type two patients off label. And in the second half of twenty twenty four, over twenty percent of our new patient starts were Type two.

Speaker 2

While we aren't necessarily going to share that metric consistently each quarter prior to obtaining a Type two indication, we feel it's an important metric to highlight on this call to give you all a better sense of how the islet is being used in the real world. As we think about the future Type two opportunity, we believe the two most important elements that drive adoption are number one, a product that is well suited to the Type two population and the providers that manage them, most of which are primary care providers and number two, pharmacy coverage. We estimate that pump penetration in the insulin intensive Type two population is less than ten percent because current products aren't well suited for those users and providers because they are too complex to set up and manage. A product that's well suited to the Type two population would be easy to set up and require minimal engagement from the user and minimal management by the physician, which again is typically a primary care physician. Pharmacy coverage is also important because it's typically more difficult for a Type two patient to get a pump through the DME channel relative to the pharmacy channel.

Speaker 2

So it isn't surprising to us that the pump with the most Type two adoption is our competitor that's exclusively reimbursed through pharmacy despite not having a Type two indication until recently. So as we think about our strategy for the Type two opportunity, we believe the islet may prove to be more suited than any other pump in the market for that population. The islet is easy to set up and manage, requires minimal engagement from the user and we have clinical evidence that demonstrates that primary care providers were able to deliver comparable outcomes on islet versus endocrinologists, which really underscores our belief that islet will resonate very well in the primary care setting. Also, the islet is currently reimbursed to the pharmacy for some patients and we expect pharmacy adoption for The Islet to continue to grow in the future, as Stephen will discuss shortly in more detail. Beyond that, we look forward to pursuing the Type two label through the FDA.

Speaker 2

As we enter 2025, having recently started our new life as a public company, we couldn't be more excited for the road ahead. We exited 2024 with significant momentum and expect that to carry into 2025 as we continue to expand the commercial reach of The Islet while advancing our key pipeline programs. With that, I'll turn the call over to Stephen, our Chief Financial Officer, to cover our fourth quarter results in more detail and discuss our full year guidance for 2025. Stephen?

Speaker 3

Thanks, Sean, and not bad for first earnings call. As Sean mentioned, in Q4 of twenty twenty four, we saw over 4,000 new patient starts on the islet, a one hundred and twenty five percent increase from approximately eighteen hundred new patient starts in the same period of the prior year and an increase of twenty eight percent relative to the third quarter of the same year. Approximately two thirds of people with Type one diabetes in The U. S. And over ninety percent of people with Type two diabetes still use multiple daily injections or MDI as their preferred approach to care.

Speaker 3

In the fourth quarter, an estimated seventy percent of our new patient starts came from MDI and we've seen that trend remain relatively stable over the last few quarters. I hope to take away a few things from this metric. Number one, we are meaningfully expanding the market for insulin pumps because of our unique technology. Number two, Eyelet isn't just for the early adopters of technology. We are often winning patients who otherwise would not use an insulin pump if the Eyelet did not exist.

Speaker 3

And number three, we believe Eyelet addresses an unmet need in the market. Net sales for the fourth quarter of twenty twenty four were $20,400,000 representing an increase of 145 percent from $8,400,000 in the fourth quarter of twenty twenty three and an increase of 22% relative to the third quarter of twenty twenty four. Our performance was driven by our growth in new users combined with strong retention of our existing installed base. We're proud of these results and they're showing us that the strategic moves we're making to compete at the highest level are the right ones. I'll dig into those strategic moves one by one as well as share some additional factors that contributed to our strong performance in the fourth quarter, most of which we expect to sustain into 2025.

Speaker 3

Let's start with new products. In September, we launched Bionic Circle, which is a remote monitoring experience that allows a caregiver to see a user's islet data and monitor performance. Everything from blood glucose levels, insulin dosing, meal announcements and all the things that you would want to see as a caregiver, especially if you are a parent of a child who has Type one. Then in October, we launched the Color Eyelet, which we believe is a highly competitive form factor relative to other durable insulin pump options. Then in November, we also became the first and only insulin pump in The U.

Speaker 3

S. To integrate with Freestyle Libre three plus We're in the very early stages of seeing all of those launches gain traction and pull through in our numbers. So we're excited for the impact they may have moving forward. Another tailwind for new user adoption in the fourth quarter was our increasing pharmacy channel mix, which enables our users who are covered by pharmacy to get the islet for little to no out of pocket cost relative to the durable medical equipment or DME channel, where users typically have to pay a considerable amount out of pocket to purchase a durable insulin pump. I want to back up for a moment and provide a little more color on the difference between these two revenue channels and why we chose to pioneer the pharmacy channel for durable insulin pumps.

Speaker 3

This section is a bit dense with details, so bear with me. The DME and pharmacy channel have massively different revenue models and understanding their differences is critical to understanding our business. The DME channel is the traditional reimbursement channel for durable insulin pumps. In this model, users and payers pay a lump sum upfront to Beta Bionics to purchase the pump and then pay a smaller monthly fee for the pump supplies. User and payer are locked into the pump typically for four years before the user is able to switch to another pump if they'd like to.

Speaker 3

By contrast, the pharmacy model is a pay as you go model, so users and payers only pay for the monthly pump supplies and pay nearly zero for the pump itself. Additionally, users are not locked into a four year commitment. The pharmacy model is advantageous for users who pay much less out of pocket to access the pump and spend less money on monthly supplies. It's less burdensome for providers to write prescriptions and get them approved in pharmacy and the user gets the pump faster as a result. For payers, they don't have to please pump commitments when members switch between plans and as a result, they're only ever paying for a pump that someone is actually using and getting the benefit from.

Speaker 3

For Beta Bionics, pharmacy allows us to offer the Eyelet through a reimbursement channel that aligns with our stakeholders' needs and the channel is accretive to our financials on the top and bottom line in the medium and long term. I want to highlight that last point, accretive to our financials on the top and bottom line in the medium and long term. As an illustrative example, Beta Bionics recognizes roughly $3,500 of revenue when we sell the pump through DME and roughly $70 per month for the pump supplies. By contrast in pharmacy, Beta Bionics recognizes roughly $0 of revenue when we sell the pump and roughly $450 per month when we sell the monthly supply kits. Because we don't collect the lump sum payment upfront for the pump in the pharmacy channel like we would in the DME channel, growth in pharmacy adoption is actually a drag on revenue in the near term relative to the DME channel.

Speaker 3

It's also a drag on our gross margin because we recognize all the cost of goods sold for the pump upfront in both models. If a new user starts on the islet in the pharmacy channel that doesn't become accretive to our financials relative to the DME channel until about the eleven month mark, at which time it becomes the most attractive reimbursement channel for Beta Bionics financially. Now let's talk about our progress in pharmacy. In the fourth quarter, we saw a nice increase in our pharmacy channel mix. A low teens percentage of our new patient starts were reimbursed through pharmacy in the quarter as compared to a high single digit percentage in the third quarter and a mid single digit percentage in the first two quarters of twenty twenty four.

Speaker 3

I want to remind you that this increase in pharmacy mix is a tailwind for our new patient starts as it enhances our access to the product, but it has a transitory headwind for our revenue and gross margin that eventually flips into a tailwind after roughly month eleven for the reasons I already discussed. Going forward, we'll continue to share our pharmacy new patient starts as a percentage of our total new patient starts because we believe this is the right metric to truly understand pharmacy coverage. The less relevant metric is the percentage of covered lives in pharmacy, which accounts only for formulary placement through PBM contracts and not downstream adoption by the underlying health plans that partner with the PBM. Lastly and importantly, the pharmacy reimbursement channel is our preferred revenue channel because it is the most profitable channel in the medium and long term. Beta Bionics sends every patient that we can through the pharmacy channel.

Speaker 3

We check each patient's insurance for pharmacy coverage. If they're covered, we send them through pharmacy. If they're not, we send them through DME. The last factor I would like to call out as it pertains to our Q4 revenue performance is seasonality. The fourth quarter tends to be the strongest in our industry as deductibles and out of pocket maximums are met such that a pump purchase is no longer constrained by out of pocket costs.

Speaker 3

We experienced the typical benefit from this seasonality in Q4 of twenty twenty four, which endured each month throughout the quarter. Turning to our gross margin profile. Gross margin in the fourth quarter was 57.2% compared to 60.6% in the fourth quarter of twenty twenty three and growing sequentially versus 53.4% in the third quarter of twenty twenty four. Our gross margin for the full year 2024 was 55.1 percent compared to 52.6% in the prior year, reflecting our continued cost discipline and better leverage of our manufacturing overhead as we continue to scale. Total operating expenses in the fourth quarter were $24,700,000 an increase of 84 compared to the $13,400,000 in the fourth quarter of twenty twenty three.

Speaker 3

The increase in operating expenses was primarily attributable to the expansion of our commercial sales efforts and a one time milestone payment of $3,000,000 made under the license and collaboration agreement with Xerus for their successful completion and delivery of a pump compatible formulation of glucagon. Shifting to our cash as of 12/31/2024, we ended the year with $103,600,000 in cash and cash equivalents and short term investments. As Sean mentioned earlier, we recently completed our initial public offering and concurrent private placement at the January, which raised approximately $2.00 $6,000,000 in net proceeds, strengthening our cash position for 2025 and beyond. We expect to spend approximately $50,000,000 of these proceeds on our Patch Pump program and another approximately $50,000,000 on our bihormonal program with the rest of our cash serving to strengthen our financial position and give us flexibility to invest in our business and drive long term sustainable growth. Now turning to our 2025 outlook.

Speaker 3

We expect another year of robust demand for the Eyelet. We project that total company revenue for the full year of 2025 will be $80,000,000 to $85,000,000 driven by strong adoption by new users as well as recurring revenue from existing users. As discussed prior, there were a number of tailwinds that we saw in the fourth quarter of twenty twenty four that we expect to persist into and through 2025, including the launch of our Color Eyelet, Abbott's Freestyle Libre three plus CGM integration and the Bionic Circle app. We also discussed the importance of the pharmacy channel mix increases in driving adoption. And we expect greater than 20% of our new patient starts to be reimbursed through the pharmacy channel in 2025, up from a high single digit percentage in 2024 overall and a low teens percentage in Q4 twenty twenty four specifically.

Speaker 3

A large driver of this expected increase in pharmacy mix relative to last year and the previous quarter is the formulary agreement we signed with Prime Therapeutics that we announced in our earnings press release. This agreement with Prime Therapeutics National Commercial Formulary expands Eyelet's formulary coverage as of February one of this year. We would remind you that while formulary agreements are critical for driving pharmacy coverage, the next step to activating that coverage is working with the health plans that partner with Prime Therapeutics as their pharmacy benefit manager to ensure that their members are able to access Eyelet through the pharmacy benefit. Prime has recommended to its health plans that they adopt Eyelet for coverage under their pharmacy benefit and we are actively working with the health plans to drive that adoption. While this anticipated increase in pharmacy mix for 2025 is expected to act as a headwind to our 2025 revenue, our guidance contemplates this impact and we want to remind you that this headwind for these new pharmacy users flips into tailwind relative to DME after eleven months.

Speaker 3

We expect to have also expanded our field sales force to 63 territories exiting Q1 twenty twenty five, which compares to 43 territories exiting Q4 of twenty twenty four. In terms of how to think about the revenue cadence throughout the year, we expect the relative weighting of new patient starts and revenue across each quarter to be similar to the relative weighting we saw across each quarter in 2024. We anticipate new patient starts in the first quarter will decline sequentially relative to the fourth quarter of the prior year due to normal seasonal trends, although we expect to be able to offset that seasonality to some degree as the recent product launches I mentioned continue to gain traction. In 2025, we anticipate observing the pharmacy mix of new patient starts increase at a faster rate in the first half of the year compared to the second half given the formular agreement with Prime Therapeutics went into effect on February 1 and we are working with the health plans to drive coverage of the islet in the pharmacy. While these efforts to expand pharmacy adoption will continue throughout the year, we anticipate a larger impact from them in the first half of twenty twenty five relative to the second half.

Speaker 3

So in addition to the typical seasonality where our industry tends to see revenue decline in the first quarter relative to the fourth quarter of the prior year, the sequential increases in pharmacy mix that we expect to see in Q1 will also weigh on revenue. We believe that our recent product launches and our increasing pharmacy mix will drive strength in our new patient starts that will enable us to partially offset those headwinds I discussed in Q1. So to summarize, we expect a similar weighting of revenue across quarters in 2025 as we saw in 2024. Q1 revenue will step down sequentially versus Q4 of twenty twenty four due to seasonality and increasing pharmacy adoption, but there are some offsets to that seasonality that we expect to see. We expect pharmacy adoption to decelerate in the back half of twenty twenty five relative to the front half and that combined with our new territories continuing to mature and seasonality being favorable in Q4 will result in heavier weighting of revenue towards the back half of the year than the front half of the year.

Speaker 3

Again, these factors are all contemplated in our annual guidance, but the details I'm sharing are meant to give you all a sense of what to expect with regards to our revenue trajectory as we move through the year. Shifting to gross margin. We expect to see at least 50% gross margin for the full year 2025, which at the low end represents a decline relative to the prior year driven by the expected increase in pharmacy new patient starts as a percentage of our total new patient starts. We expect gross margin to increase slightly throughout the year as the increasing pharmacy adoption as a percentage of new patient starts weighs on gross margin, while increasing manufacturing volumes and growing pharmacy installed base improve gross margin. Our actual gross margins may differ materially from these projections in any given quarter or for the year overall if pharmacy new patient starts as a percentage of total new patient starts deviates considerably from our guidance.

Speaker 3

Despite the margin compression, we expect to see in 2025 relative to 2024, we view this trajectory as a positive for our business in the long run because the expected increase in pharmacy mix bodes well for our gross margin outlook beyond 2025. I'd also like to briefly note that as it pertains to the tariffs recently enacted by the Trump administration, we believe our overall exposure is currently de minimis and anticipate that will remain true. While we do source some components for The Islet and its associated supplies internationally, the vast majority of these are custom components and as such they are exempt from international tariffs under the Nairobi protocol. There are limited number of off the shelf components that we source internationally that are not exempt, but to reiterate, we believe the impact of tariff increases on our overall cost of goods is currently de minimis and we expect that will remain the case. If the Trump administration chooses to eliminate the Nairobi protocol, which we have no reason to suspect, we expect the impact of a tariff increase on our overall cost of goods would be nominal.

Speaker 3

This is a dynamic that we will continue to monitor. In summary, we are pleased with our performance in the fourth quarter and the full year 2024. We are also confident in our 2025 guidance and particularly excited about our forecasted growth in pharmacy adoption. Following our IPO, we are in a strong position to invest in the business and advance critical innovations that have the ability to transform diabetes care as we know it. With that, I'll hand the call back to Sean for some closing remarks.

Speaker 2

Thanks, Steven, and thank you all for your time today. We appreciate your continued support and interest in Beta Bionics as we work to simplify and alleviate the burden of managing diabetes with life changing solutions. I hope that what you all take away from this is that we have a number of compelling short, medium and long term initiatives that we expect will ultimately deliver better outcomes to a much larger group of people living with diabetes. Along with that, we believe we are building a durably robust business. While our journey has just begun, we have conviction that we have made and will continue to make the right investments that will pay off in the long run.

Speaker 2

Specifically, we appreciate your willingness to dig in and understand what amounts to a new business model with the pharmacy channel that in the long run will prove to be a benefit for Beta Bionics and most importantly, people living with diabetes. With that, operator, please open the call for Q and A.

Operator

Our first question comes from Travis Steed of Bank of America. Please go ahead, Travis.

Speaker 4

Everybody, congrats on your first earnings call. It was a very thorough call, so thanks for that. I guess to start out, one on the guidance, just kind of thinking about the visibility of the pharmacy percentages because you've got there's a lot of assumptions you made in the guidance on the pharmacy mix. So just curious on the visibility there. And on the Q1, I think the math you were doing was $16,500,000 Just wanted to kind of confirm if we were doing the math right for Q1 revenue.

Speaker 4

And then the second question would be more around kind of the commercial team and as you kind of rolled that out over the course of the last few months and getting a little more traction. One of your competitors has talked about a slowdown in the market end of last year and just curious kind of what you're seeing in the market with the commercial team?

Speaker 3

Yes. Well, thanks, Travis. Yes, and great questions. So I think we got all those down. We may have to ask you to restate some of that.

Speaker 3

So, and yes, this is Steven. So regarding the guidance on the and the visibility of the pharmacy mix, so I think importantly, we have seen this agreement that we just signed with Prime Therapeutics, the largest national formulary. And so that's in place and we expect to see some impact from that in the near future. Then the second thing I'll state is that, look, just due to the timing of when we did our IPO and that's why this fourth quarter earnings call is happening here towards three months into the year, we're seeing some of the pharmacy impact already through the first three months. So I'm not going to give you a prediction on exactly what we're expecting to see in the first quarter, but we have had the benefit of course of now almost three full months of commercial results to see the traction that we're feeling in pharmacy in 2025.

Speaker 3

So feeling pretty good about our visibility there for those reasons. Regarding the revenue number that you stated, so look, I'm not going to call a particular number on the first quarter. I don't think we gave any guidance on this call that stated exactly what you should expect. We gave kind of directionally that the weighting of revenue for 2025 would be consistent generally with 2024. So I hear your math, but I won't kind of confirm your number specifically.

Speaker 3

And then maybe on the last point, Sean, do you want to take a drop of comment on the call?

Speaker 2

Yes, sure. Just generically, I would just say that first of all, thanks, Travis, for the question. I really appreciate it. First one for us. Thank you.

Speaker 2

Anyway, we have more limited experience than some of the other companies in terms of seasonality, but I will say that we, from our perspective, did not see a slowdown near the end of the year. So no real comment beyond that.

Speaker 4

Great. Thank you. And I didn't hear a bunch of the patch pump on this call. I assume that was intentional, but I'm curious if there's anything to say on the patch pump and update on that front?

Speaker 2

Not really beyond what we had to say. Reiterating, we expect to commercialize by the end of twenty twenty seven and we like our form factor.

Speaker 3

Okay, great. Thanks a lot. Thank you. Yes, thanks, Travis.

Operator

Thank you. Our next question comes from Matthew O'Brien of Piper Sandler. Please go ahead, Matthew.

Speaker 5

Afternoon. Can you guys hear me okay?

Speaker 3

Yes. We heard you loud and clear, Matt. How's it going?

Speaker 5

Fantastic. It's great. Thanks for the questions and congrats on getting public. Maybe just a follow-up on Travis' question a little bit on Patch. I had thought that we should be expecting that approval kind of middle of twenty twenty seven with some revenue contribution in 2027.

Speaker 5

Is that not the case anymore? And are you just trying to be a little bit conservative with that timing there? Is that just any finer points you can provide on that would be helpful? Thanks.

Speaker 2

And then I do have a follow-up. Okay, got you. Yes, Matt, first of all, thanks very much. Appreciate your question as well and thanks for the congrats going public. Our timeline on patches never evolved.

Speaker 2

We've been very consistent in our messaging here and I don't believe it's changed in any way. So you didn't hear a signal of any description except that we intend to commercialize by the end of twenty twenty seven.

Speaker 3

When we say by commercializes, starting to actually sell it. So you're right that generating revenue by the end of twenty twenty seven is exactly what we mean by commercializing.

Speaker 2

A great point, Steven. We haven't guided toward clearance in any way. No.

Speaker 5

Got it. Okay. Appreciate that. And then one of your durable competitors is introducing a new algorithm that's supposed to make it easier for patients to start on their pumps. I'm not sure if you've seen that.

Speaker 5

At this point, I think it was just released. Something that comes up all the time is just your ability to stay ahead in terms of ease of use. Is that an area that could be at risk somewhat for IOLIT versus the competitors that are out there? Or are you comfortable that the form factor and the algo specifically will stay ahead in terms of ease of use? Thanks.

Speaker 2

Yes. Thanks for that one, Matt. We're pretty familiar with that, sure. And look, I'll be respectful of the fact that what they've done is they've sort of made it automatic to enter the ACE guidelines into the pump. So it removes a few steps and that's nice, but it's very different and I want to be clear on the differentiation from what we are doing.

Speaker 2

Our product starts up based on weight and then learns and adapts to you. So the question I would suggest is how often are users set up with the ACE guidelines and then left with those guidelines and never modified. Our product the learning and the adaptation is the tough part about what we do. The real time controllers are comparatively simple. We heard some noise lately that nobody's learning these days.

Speaker 2

Well, that's not true because we are 100% as evidenced by the fact that we are solely starting up based on your weight. So yes, we see a pretty big chasm between the ease of use aspects of what we're up to and those of our the particular competitor you're referring to. And let me reiterate, actually let me additionally state, Matt, that I think that the industry as a general sense is been stating that they really are moving toward ease of use, right. We launched and everybody all of a sudden started talking about small, medium and large. They started talking about simplified.

Speaker 2

They started trying to leapfrog to fully closed loop. We get that. There was a reason we took the opportunity to present our fully closed loop mode data today, which we put up against anything in development today and I think we can do the research on that. So thank you.

Operator

Thank you. Our next question comes from Mike Kratchi of BlueRink Partners. Please go ahead, Mike.

Speaker 6

Hi, everyone. Thanks for taking our questions and congrats on all the recent progress. So first, I'd just like to circle back on the comments on the expected cadence of pharmacy as a percent of new starts throughout 2025 that gets you to that over 20% guidance for the full year. Do you expect that that will increase sequentially every quarter throughout the year? And in that case, is it fair to assume that you could actually be exiting 4Q '20 '5 percent well over 20%?

Speaker 6

And I have a follow-up.

Speaker 3

Yes. Look, so we are expecting there to be some steady increase to the pharmacy new patient starts as a percentage of total new patient starts throughout the year. So absolutely, I was just calling the increase that we're going to see relative to 2024 as more stark in the first half of twenty twenty five relative to the uptick that we're forecasting in the second half of twenty twenty five. So that's the

Speaker 2

first one.

Speaker 3

And what was your second question, Mike, increase? Could we

Speaker 2

expect to see an exit of 2025?

Speaker 3

Yes. Look, I guess by very virtue of us just saying that we will see we expect to see over twenty percent pharmacy new patient starts as a percentage of total new patient starts. By virtue of us saying that that's going to be above twenty percent, it could certainly be higher later in the year, but I don't want to call like an exact number that we expect to exit 2025 or Q4 twenty twenty five with.

Speaker 6

Got it. Yes, totally understood. And then in terms of your Type two off label use, to what extent have you started to see some early use within the primary care setting versus this predominantly being from endo offices?

Speaker 2

Hey, Mike, this is Sean. First of all, thanks for your question. Appreciate it. It's tough to call that one exactly and I'm not going to give percentages on it. What I will say is at some level we're certainly calling on high prescribing primary care providers today.

Speaker 2

Additionally, the word is getting out sort of somewhat organically. So it's happening, no question about that. But I don't think we want to give a percentage or a rate that's happening in primary there. I think we all do know that the lion's share of Type 2s are managed by primary care providers. So that's going to be a much more important channel to be able to access in order to meaningfully impact the Type two market.

Speaker 2

One of the things I said in the call is that we do think it's important for the product to be applicable in a certain market. And I think that in the primary care market, the things that make the product applicable are things like the ease of setup and more importantly learning and adaptation for a particular user. But look, as we all know, we do not have a Type two indication today. We are not advertising in any way for Type two. What we have seen is purely organic and we're pretty surprised by the number I suppose.

Speaker 3

Thanks, Mike. Yes. I guess maybe just a bit more on that. Look, clearly from the metric that we stated in this call, the island from what Sean just explained, our product is highly applicable for people with Type two diabetes, even though there's no indication. But I think the other thing that we have going for us as a durable pump company relative to maybe what we're seeing with other durable pump companies is that it makes it a lot easier for the doctor to prescribe for a primary care doctor to prescribe, or for any HCP, I should say, to prescribe the islet with pharmacy coverage.

Speaker 3

So that has eliminates the need for a negative C peptide lab. It also is just an easier prescribing process. And the actual like filling out a statement of medical necessity form that's traditional with DME pumps and get the associated reimbursement, that's no longer required with pharmacy. So it's a much easier process than any and HCP doesn't have to be as familiar with managing a pump and with the whole prescription process. So because we have that characteristic to our business where we're seeing a real amount of our patients go through pharmacy, that's helping our Type two adoption as well.

Speaker 6

Understood. Thanks very much.

Operator

Thank you. Our next question comes from Matthew Blackman of Stifel. Please go ahead, Matthew.

Speaker 7

Good afternoon, everybody. Appreciate you taking my questions. Maybe to start, Sean or Stephen, just a bigger picture question. Just curious if you could provide us some sense, even if just qualitative, where you're seeing commercial success, are there any common threads on the patients adopting who they are, where they are or anything about the physicians writing the scripts again along the lines of that primary care comment. Just curious how you're seeing the business execute across multiple channels and different patient populations?

Speaker 7

And then I've got a follow-up.

Speaker 2

Hey, Matt, this is Sean. Thanks very much for your question. Appreciate it. Let me give a little bit of color here. What we said in the prepared remarks is that our cross section of users looks very much like population with type one diabetes in this country.

Speaker 2

And we try very hard to be our goal is to impact population health, right, which means you at some level have to be for most people. And I think that's central to where we're finding success, right. We're very much designed to be successful with endos, yes. We're designed to be successful with primaries, yes. People with high A1Cs, yes.

Speaker 2

People with low A1Cs, yes. Everywhere in between and that's what our patient population looks like. So it's a little bit hard to say specifically where because we're not really being niched very well right now. We're in fact being used more evenly and broadly across the population as we would hope. So I hope that's a good answer, but yes, no real niche that we're seeing.

Speaker 7

Yes. Well, I mean, it sounds like successful across multiple channels, multiple patients. So that's a good answer. And maybe Stephen and look I appreciate this is my math, but if I try to break down the 2025 revenue guide, it seems like just again running some numbers, it assumes something in the neighborhood of let's call it roughly 100 basis points of share gains. So the first part is, is that sort of roughly in the ballpark?

Speaker 7

And just for context, and I get it, it's still early days of the rollout, but I think in 2024, if our math is right, you gained at least several hundred basis points of share. Just am I thinking about all those moving parts correctly, Steven?

Speaker 3

Look, I'm actually not I'm not prepared to talk about specifics regarding share gain. So, like the actual number of new of installed base that all of our competition has and what we expect from 2025 in terms of new patient starts coming from MDI going to pump site, it's not something that we're prepared or at this time commenting on. So sorry, Matt, I won't be able to answer that one. Good question, but I don't want to confirm your math.

Speaker 7

Appreciate it. Thanks guys.

Speaker 3

Thank

Operator

you. Our next question comes from Brooks O'Neil of Lake Street Capital Markets. Please go ahead, Brooks.

Speaker 8

Thank you. Good afternoon, guys, and welcome to the public markets. It's nice to be interacting with you in this venue. So, I have a couple of questions. Obviously, a lot of questions have been asked and answered.

Speaker 8

But you guys called out that you're the first pump to integrate with Abbott Libre three plus I'm curious if you're seeing anything you would call noteworthy about that integration, about acceptance and excitement from the population, anything that stands out to you would be interesting to me?

Speaker 2

Yes, Brooks, thanks for your question. I appreciate it. I don't think we're really prepared to comment on the details of Libre three plus with the exception of Banking Abbott for their partnership, which has been great. We're CGM agnostic at Beta Bionics and I think it's important for us to not get into the details of the differences between our CGM partners to maintain that agnosticity award. So sorry for that.

Speaker 8

I'll just press you a little bit, Steven, because obviously there's a big difference between the pump users, between the Dexcom base and the Abbott base. And I'm just curious if you think you're seeing a meaningful uptick from the new Abbott users who for the first time really have a chance to integrate with a sophisticated pump?

Speaker 3

Yes, yes. Look, our internal tracking tools, of course, monitor the adoption of Libre three plus for our business and it's something we monitor very closely and we report to our CGM partners. But in fairness to them, we've communicated that we're not going to be sharing or bifurcating the new patient starts as to which CGM they're choosing or what our installed base like which CGM they're choosing. So I'm sorry, Brooks, that's not a metric that we're sharing and it's something that we've aligned with our CGM partners that won't be something we're going to share going forward.

Speaker 2

To my knowledge, the industry has worked differences between Libre and Dexcom.

Speaker 3

So I

Speaker 2

think we should maintain

Speaker 3

Well, to be fair, in The United States, we're the only system we're the only pump system on the market that integrates with Libre three plus So I don't think there's no one else has had to make that distinction. But, yes, there's a Libre two, I guess, integration. But for Libre three, you're right.

Speaker 8

Interesting. Let's move on. So, one of the things you called out is the significant economic difference between the DME channel and the pharmacy channel, which is pretty exciting. But I'm curious if you could just talk to us a little bit about how you see the patient impact of those economic differences. Obviously, no upfront fee is significant, but $450 a month over the lifetime of the user, how are the patients reacting to that and how do you guys think about that?

Speaker 3

Yes. Look, great question, Brooks. I'm glad you're asking for the clarification there. So there's a stark difference between the out of pocket that a patient has in the DME channel versus the pharmacy channel and it's massively better for the patient in pharmacy. So in DME, the average out of pocket payment, I should say it more like this, that the out of pocket payment in DME for us to get the pump for a patient depending on where they are with their deductible, depending on their health plan, it can vary significantly.

Speaker 3

But it typically falls somewhere between $500 to $1,500 And that's for the again on day one for the pump itself. And then to buy the monthly supplies, again, it can kind of run the gamut as to the amount you have to pay out of pocket, but it can be as low as $0 or maybe if you're late in the year and you've met your out of pocket deductible, or if you met your out of pocket max your deductible, but as high as $50 to $100 per month and again in DME for the supplies. Now contrast that to pharmacy, right, again I said hugely beneficial for the patient. The patient on day one when they buy the pump, they buy it for, somewhere around $100 or less. And it and it the most common claim for the pump itself is $0.

Speaker 3

So again, you get the pump upfront for nothing out of pocket relative to, you know, the big number I just shared in DME. And then for the supply monthly supply kits in pharmacy, the patient's paying $25 or less per month. So that four fifty dollars number that I shared, Brooks, that's Beta Bionics' revenue that we generate each month. But the patient is out of pocket if they're covered in pharmacy $25 or less. So massive benefit for the patient if they're covered in pharmacy and if they want to use the islet.

Speaker 8

Great. That's a fantastic clarification. Thanks for that information, Steven. I'll just ask one last one is obviously Prime is a significant pharmacy benefit provider. My sense is a lot of their customers are Blue Cross Blue Shield plans.

Speaker 8

Can you just give us any indication of whether you think that insurance channel is going to be very receptive to providing coverage to their patients? Or what are you seeing so far from the Blues plans?

Speaker 3

Yes, I don't so yes, good question, Brooks. I don't want to speak to the exact underlying plans and like what the names of them are that we expect the adoption and when. But we have had discussions

Speaker 4

with

Speaker 3

the prime the folks at Prime Therapeutics, and we have a general understanding of when we can expect some of the downstream impact from this PBM contract that we signed to be. And yes, we do expect that there will be some coverage coming in the near term and then sort of trickling in later as we continue to have success activating the plans in the future. So again, I don't want to speak to exactly which you mentioned Blue Cross Blue Shield. I'm not going to address that specifically, but I think my answer there should be sufficient for you.

Speaker 8

Sure. Very helpful. Thanks a lot and congratulations on being public and getting going.

Speaker 2

Thanks Brooks. Thanks Brooks.

Operator

Thank you. Our next question comes from the line of Jeffrey Cohen of Ladenburg. Please go ahead, Jeffrey.

Speaker 9

Hey, thank you for taking our questions. Much appreciated. So I wonder if you could expand upon a little bit on the payer side, particularly on the pharmacy side as far as payers and covered lives and increases there and how that may compare to the other channel? Maybe talk about how much of that has been factored into the guidance from share gains side of point of view?

Speaker 3

Okay. Yes, I think I'm understanding what you're asking there. And hey, Jeff, thanks for joining. I appreciate the question. So look, I think the right metric to understanding pharmacy reimbursement is the percentage of new patient starts that get reimbursed through pharmacy relative to our total percentage of new patient starts.

Speaker 3

And in order for us to actually see that impact, meaning where we have a patient that on the islet that gets reimbursed through that channel, three things have to happen. First, we have to sign a PBM contract. And we've signed various PBM contracts, some of which we've announced, some of which we haven't. We just announced one today with this Prime Therapeutics contract, but that that being the first step. The second step is then we have to actually, the plans have to make a decision.

Speaker 3

The underlying plans have to make a decision to offer this, the islet, as a benefit to their particular patient base. And so again, PBM first makes the decision, which like kind of gets the islet or the device on the menu for the plan to then say, okay, we want to offer this to our covered lives. Then the third step is that usually when that when the PBM and then the, the underlying plan make that decision, it's for a future date. So the third step is time. And once that only once all three of those things happen, then do do you then have coverage and you start to see again new patients start actually getting reimbursed through that channel.

Speaker 3

So again, that's why I think I believe that's the right metric. In terms of the share gain that we expect associated with the uptick in pharmacy, look, we think it's important because of the reasons that I just addressed with Brooks' question where we talk about the benefits for the patient, the financial benefit associated to the patient because it's much easier to access now the islet with the out of pocket cost. It's also easier for the provider, which I think I addressed with Matt's question earlier. And so I certainly think there is some benefit that we get and lift to our new patient starts numbers because of this benefit that we're offering through pharmacy. And then I'll just reiterate that in the medium and long term, it's more lucrative for Beta Bionics too, which is why it's a core strategy for our businesses.

Speaker 3

It's an advantage pricing structure for our company too. So, Jeff, I yes, it was a good question and that sort of gives you the landscape of why pharmacy is our strategy.

Speaker 9

That's helpful. And then one more if I may. So, I'm showing you some other commentary in the call about this study from 9.3% down to 7.9 GMI as far as somewhat non compliant user population. Are you noticing is was the pointer and please expand upon this was the pointer to show the increased data control that the pump provides or was Pointer as far as the potential upside as far as compliance of those types of patients and if not they've improved themselves?

Speaker 2

Yes. Good question. I want to make sure to be fair, it's a little difficult to hear you. The data we presented was baseline A1C of 9.3 down to a follow-up GMI of 7.4% when used in the current fully closed loop mode, which we defined as less than one meal bolus per day. But on average, that group, I think was it help me out it was less than half a day I think.

Speaker 2

Anyway, half a meal call per day. Anyway, I think the point of that data is that it's sort of several fold. The first is that the industry now is talking to fully closed loop. So we've heard statements about fully closed loop being far off in the future. But the reality is that any current system can be used in fully closed loop mode, which means just don't call a meal.

Speaker 2

So the question that we all have to answer is how do these systems today work when used in that mode because they can be and where do we need to get to with that. And the reason for that point number two is because the fact of the matter is there are users out there today that historically have not been willing to engage in their technology in a way that produces a great outcome. And fully closed loop, if it works, is a way to ease that burden, which is our goal. So we presented this data, I think indicating 70.4% being I think a pretty decent follow-up GMI that there are technologies today notably islet that can get this comparatively disengaged group to really quite good control today. These are not technologies that we're waiting for in the future.

Speaker 2

We're not looking we're not developing them, they're here. Yes, we will all continue to try and improve outcomes and produce burden. But I think the real point is that there are better technologies available to produce better outcomes today. Does that clarify?

Speaker 9

Yes, that's super. Thank you very much. I appreciate you taking our questions.

Speaker 2

And I've just been reminded the metric that I was struggling with earlier is on average in that group one meal call every three days. So that's not a whole lot.

Speaker 9

Got

Operator

it. Thank you. Ladies and gentlemen, that does end the Q and A session and conclude today's call for today. Thank you for participating. You may now disconnect.

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Earnings Conference Call
Beta Bionics Q4 2024
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