Earnings Call Transcript - BBNX Q3 2025

Operator, Operator

Good afternoon, and welcome to the Beta Bionics Third Quarter 2025 Earnings Conference Call. As a reminder, today's conference is being recorded. I would now like to hand the conference over to Blake Beber, Head of Investor Relations. Please go ahead.

Blake Beber, Head of Investor Relations

Good afternoon, and thank you for tuning in to Beta Bionics Third Quarter 2025 Earnings Call. Joining me for today's call are Chief Executive Officer, Sean Saint; and Chief Financial Officer, Stephen Feider. Both the replay of this call and the press release discussing our third quarter 2025 results will be available on the Investor Relations section of our website. The replay will be available for approximately 1 year following the conclusion of this call. Information recorded on this call speaks only as of today, October 28, 2025. Therefore, if you are listening to any replay, any time-sensitive information may no longer be accurate. Also on our website is our supplemental third quarter 2025 earnings presentation and updated corporate presentation. We encourage you to refer to those documents for a summary of key metrics and business updates. Before we begin, we would like to remind you that today's discussion will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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-Q 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. 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'd now like to turn the call over to Sean.

Sean Saint, CEO

Thanks, Blake. Good afternoon, everyone, and thank you for joining. We're proud to share with you all today the details of our strong performance in the third quarter as well as discuss our updated annual projections for the full year 2025. Starting with our performance in the third quarter, we continue to make key advances across our business, both commercially and in our innovation pipeline. Demand for the iLet, both in existing practices as well as new practices continues to exceed our expectations. And in the third quarter, we saw a record number of both new patient starts as well as the percentage of those new patient starts going through the pharmacy channel. The iLet automation and adaptation continue to set a new standard for our industry, simplifying and alleviating the burden of managing diabetes for our users, their caregivers and their health care providers. But we're not stopping there. And we're continuing to push the envelope on key innovations to our pipeline that I believe will enable Beta Bionics to disrupt ourselves in the future and deliver even more life-changing solutions to people with diabetes and the community that supports them. During today's call, I'll begin by covering our Q3 results, which exceeded our expectations across the board. Stephen will then discuss our Q3 performance and updated full year 2025 guidance in more detail. Lastly, I'll share some exciting updates across our innovation pipeline, including iLet and some new features we recently rolled out; Mint, which is our patch pump in development; and lastly, our bihormonal system in development. Let's begin with an overview of our Q3 2025 performance. I'm pleased to share that we delivered $27.3 million in net sales, which grew 63% year-over-year. Q3 revenue growth was predominantly driven by 5,334 new patient starts in the quarter, which grew 68% year-over-year as well as our growing installed base of users accessing their monthly supplies for iLet through the pharmacy channel. In Q3, a low 30s percentage of our new patient starts were reimbursed through the pharmacy channel, which is significantly higher than the high single-digit percentage we saw in Q3 of the prior year and increasing sequentially compared to the high 20s percentage we saw in Q2 of this year. As of the end of Q3, Beta Bionics has greater than 80% of insured lives in the U.S. covered under formulary agreements with pharmacy benefit managers, or PBMs, including all the major PBMs that operate in the U.S. However, patients covered under those formulary agreements do not yet benefit from the pharmacy channel until the health plans that partner with those PBMs adopt the iLet for reimbursement under their pharmacy benefit. Which is why the over 80% of covered lives under PBM agreements differs from the low 30s percent of our new patient starts that actually benefited from accessing iLet and its consumables through the pharmacy channel during the quarter. Driving adoption of the iLet as a pharmacy benefit at the health plan level remains a core focus of ours, and that is why we share the percentage of new patient starts going through the pharmacy as the right KPI to use to measure our progress in that channel, not just the PBM covered lives percentage, which does not account for pull-through at the health plan level. Shifting now to gross margin. Our gross margin in the quarter was 55.5%, up 212 basis points compared to 53.4% in Q3 of 2024 and up 167 basis points sequentially relative to 53.8% in Q2 of this year. Last quarter, we guided towards sequential gross margin expansion in Q3 of this year relative to the prior quarter, citing benefits of increased scale and manufacturing volume leverage, greater contribution of high-margin revenue from our growing pharmacy installed base and continued cost discipline. We delivered in all those areas in Q3 and expect that each of those factors will continue to provide a tailwind to gross margin in Q4, as Stephen will discuss in more detail shortly. Looking ahead, I'm confident in the direction this business is headed in. The iLet's highly differentiated, fully adaptive closed-loop algorithm is producing phenomenal real-world outcomes, and those outcomes are resonating with users, caregivers, providers and payers. We're expanding availability for the iLet in the pharmacy channel, enabling more people with diabetes to access insulin pump therapy with minimal to no upfront out-of-pocket costs. The 20 new territories we onboarded toward the end of Q1 of this year have hit the ground running, and they're validating our strategy to remain disciplined and highly selective in our sales force hiring as we look forward. With that, I'll hand the call over to Stephen to provide some additional color on our third quarter performance and full year 2025 guidance and later wrap up the call with some important updates on our pipeline. Stephen?

Stephen Feider, CFO

Thanks, Sean. Approximately 70% of our 5,334 new patient starts in Q3 came from people with diabetes that used multiple daily injections prior to starting the iLet, which is an important representation of how much the iLet is expanding the market for insulin pumps and addressing an unmet need. We believe the iLet is a game changer given its unique simplicity and ease of use, powered by the most advanced adaptive algorithm available. Given its simplicity, we're able to reach a broader group of patients and providers that were previously inaccessible to existing automated insulin delivery players, and we're seeing that in our results. Turning to gross margin. The improvements we saw in our Q3 gross margin relative to the prior year and the prior quarter are driven by 2 primary factors: number one, growth in the pharmacy installed base, which generates high-margin recurring revenue and where we continue to see strong patient retention; and number two, lower cost per unit from higher manufacturing volumes, driven by growth in patient demand. Shifting to operating expenses. Total operating expenses in the third quarter were $32.2 million, an increase of 62% compared to $19.9 million in the third quarter of 2024. The increase in sales and marketing expenses relative to the prior year is driven by expansion of our field sales team, which still stands at 63 sales territories exiting Q3. The increase in R&D expenses relative to the prior year is driven by the Mint and bihormonal programs. The increase in G&A expenses relative to the prior year is driven by new costs related to operating as a public company. Let's discuss cash. As of September 30, 2025, we have approximately $274 million in cash, cash equivalents and short- and long-term investments. We are sufficiently capitalized to fund all of our key initiatives and positioned to begin generating free cash flow well ahead of historical diabetes peers. Turning to our updated full year 2025 guidance. We are raising guidance across the board. We project total revenue for the full year of 2025 will be greater than $96.5 million, up from our prior guidance of $88 million to $93 million. This means we project sales of at least $28.5 million in Q4 2025. For the full year 2025, we now expect 27% to 29% of our new patient starts to be reimbursed through the pharmacy channel versus our prior guidance of 25% to 28%. This implies that we project our pharmacy mix as a percentage of new patient starts in Q4 to be similar to the mix we saw in Q3. I want to point out a couple of factors that could create variability to the upside or downside in our pharmacy mix of new patient starts in Q4. On one hand, we continue to drive more adoption of the iLet under the pharmacy benefit at the health plan level, which pushes pharmacy mix higher. On the other hand, new patient starts in the DME channel tend to be strong in Q4 because many people have hit their out-of-pocket maximum and can receive their pump and supplies at no cost until year-end. Taking those dynamics together, we expect Q4 pharmacy mix as a percentage of new patient starts to be similar to Q3 but recognize there is potential for that mix to trend higher or lower based on those dynamics. Moving on to gross margin. We are raising our outlook to 54% to 55% gross margin for the full year 2025 versus our prior guidance of 52% to 55%. This means we project Q4 gross margin to be in line with or improve slightly relative to Q3. We are increasing guidance at the low end and midpoint of the range for a couple of reasons. Number one, embedded in our revenue guidance raise and pharmacy mix guidance raise is a raise in our expectations for new patient starts, and that increased scale should generate a lower per unit cost through manufacturing volume leverage. And number two, we expect to benefit from our growing pharmacy installed base, where the large number of new pharmacy users year-to-date, combined with the strong retention of those users, produces high margin recurring revenue in Q4 and beyond. We continue to contemplate the impact of existing and potential tariffs in our full year gross margin guidance. We are aware of recent initiatives focused on reevaluating the application of tariffs in our industry and do not have a reason at this time to believe that duty-free exemptions from custom components of the iLet and its consumables are in any jeopardy. With that, I'll hand the call back to Sean to discuss updates on our innovation pipeline. Sean?

Sean Saint, CEO

Thanks, Stephen. As I've stated before, our goal with our pipeline programs is to disrupt the industry and disrupt ourselves. Let's start with an update on Mint, our patch pump in development. We've spoken at length in the past about the key advantages of Mint's 2-piece design architecture, where we believe we've chosen a design that creates an advantaged user experience relative to other patch pumps currently on the market and in development. Our design choices spanning from a patch change experience that doesn't require phone interaction to eliminating the need for recharging and to enabling firmware over-the-air updates are all in service of user experience. Add those advantages to our industry-leading algorithm, which has been shown to produce excellent clinical outcomes independent of user engagement, and we believe that Mint will be a true game changer when it commercializes. In Q3, we continued to execute according to plan on our Mint timelines and remain highly confident in our ability to gain 510(k) clearance for the product as well as manufactured at scale. Our goal remains to commercialize Mint with an unconstrained commercial launch by the end of 2027, meaning we expect to be able to fully support demand for the product by that time. Shifting to our bihormonal pump program. In September, we completed our pharmacokinetic, pharmacodynamic or PK/PD bridging trial for our glucagon asset. Full results from that trial are in line with our expectations, and we believe such results are supportive of the continued development of our glucagon asset for use in our bihormonal system and development. In Q4 of this year, we expect to initiate a feasibility trial of our biohormonal system to test it in humans for the first time with our glucagon asset before progressing the asset to any larger scale studies. As a reminder, the PK/PD study was the first-in-human trial for our glucagon asset, but the biohormonal system also includes our bihormonal pump and algorithm for insulin and glucagon dosing, and we're yet to test that system using our glucagon asset in humans such that we believe the best strategy is to run at least one biohormonal system feasibility trial before progressing to pivotal trials. There is no change to our expectations that we'll conduct concurrent pivotal trials to fulfill the requirements for a 505(b)(2) NDA with a chronic drug indication for glucagon and the ACE and IAGC 510(k)s for the pump and algorithm, respectively. We continue to be extremely excited by the biohormonal system's ability to transform clinical outcomes for people with diabetes, but more importantly, the ability to transform the way people experience their diabetes and shift their mindset from diabetes being a disease that they manage to simply a disease that they have. To highlight another recent win in our pipeline, on September 29, we received a special 510(k) clearance for certain feature updates for the iLet. These updates focused on improving the usability of the pump. We introduced an improved workflow for the cartridge change process to make it more seamless for the user and eliminated redundant low glucose alerts to ensure our users are focusing on the alerts that matter most, while reducing alert fatigue. These updates are illustrative of both the intent we have in listening to feedback from our users as well as the speed with which we operate in an effort to ensure our users' needs are consistently met every day. There's one more update that I'd like to discuss on the regulatory front. In late June, the FDA issued a Form 483 following an inspection. The Form 483 is primarily related to our customer complaint handling system and our criteria for reporting complaints to the FDA, which are ultimately reflected in the FDA's Manufacturer and User Facility Device Experience database, also known as the MAUDE database. The result of the FDA's inspection is not unusual in our industry as numerous precedents the agency has set for our peers at similar stages would suggest. We believe that in those instances, Beta Bionics and our peers likely develop similar definitions for what constitutes a reportable complaint prior to the FDA's feedback. And each company has successfully taken the steps required to align reporting with the FDA standards. We are no different, and our remediation efforts to the Form 483 are straightforward and well underway. Regarding the change to the criteria for reporting complaints to the FDA, we revised our definition of what complaints are reportable to better align with the broader industry standards. Our revised standard operating procedure for reportable complaints took effect in late July, which resulted in a notable increase in reportable complaints in August and September. To cite some examples of how our definition of reportable complaints has changed, prior to the 483, we were not reporting complaints such as the device screen cracking or a hypo or hypoglycemic event that did not require medical intervention. We now report these types of complaints to the FDA given they could result in an adverse event if ignored. I want to make something abundantly clear. While the number of complaints we have reported to the FDA increased, most notably in August and September after the new system went live, this is not the result of a change to the underlying complaint or adverse event rate relative to our installed base. In terms of what to expect going forward, since we received the Form 483 in June, we've submitted monthly progress reports to the agency. We're confident that our new complaint handling system and reporting system meets or exceeds the expectations laid out by the agency in their Form 43 observations. As part of this process, we will be applying the new reporting criteria to all historical complaints we have received since the iLet launched. That remedial filing process started very recently. As such, we expect to see the number of MAUDE entries relative to our installed base increase considerably from October to November and remain elevated until we have completed the remediation process as both current and historical complaints will layer on top of each other. We expect to complete the remediation process by the end of Q2 2026, at which time the number of MAUDE entries relative to our installed base will fall as historical reports are no longer being submitted. Shifting to the topic of type 2 diabetes. In Q3, we continued to see some health care providers prescribe iLet to their type 2 diabetes patients off label. We estimate that over 25% of our new patient starts in Q3 were from type 2, which is consistent with the prior quarter. While we're not committing to a specific timeline, we remain eager to pursue the type 2 diabetes label to the FDA. To conclude the prepared remarks portion of today's call, I want to highlight the key points that we hope you take away from our discussion. Number one, iLet's differentiation is resonating wider and deeper in the market. Number two, our commercial strategy is working, and we're continuing to execute relentlessly toward the goal of making iLet the new standard of care. Lastly, we're aiming to build the most innovative pipeline in the industry with the goal of disrupting the industry and ourselves, and we continue to make progress on each key pipeline initiative every day. This is a business that we believe is set up for sustainable success over the near, medium and long term, and we're excited to continue sharing updates with you all as we continue to execute. With that, thank you all for tuning in, and we'll now open the call for Q&A.

Operator, Operator

Our first question comes from Mike Kratky with Leerink Partners.

Michael Kratky, Analyst

The fact that you're creeping up on $100 million in revenue for the year and at a much higher rate of pharmacy mix than we've been expecting is super impressive. So, congrats on the ongoing execution. Just to that point, can you share some additional color on what's driving that momentum you're seeing? What factors really seem to be contributing to that demand? And can you talk about the cadence of new starts throughout the third quarter, specifically that's shaping your assumptions on the fourth quarter?

Sean Saint, CEO

Thank you, Mike, for that. In terms of what is driving the quarter, I believe it is largely consistent with the factors that have contributed to our success so far. We consider the iLet as a new category of device, and it requires a shift in thinking. This launch is not just another insulin pump but a different approach that takes time to gain acceptance. We expect to see increased adoption as people become more familiar with it over time, and we’ve noticed that trend continuing. However, I don't think there was any specific initiative in Q3 that notably influenced the quarter. Stephen, could you elaborate on this further?

Stephen Feider, CFO

Yes. Cadence in demand, I'll just address that briefly. It was generally consistent across the entire quarter. So, nothing really to read into in terms of timing of demand and where it was relative to the upcoming quarter.

Michael Kratky, Analyst

Understood. And maybe just one quick follow-up. In terms of things that are out of your control, how does the government shutdown impact your assumptions on the timing for the Mint launch, if at all?

Sean Saint, CEO

I would say it doesn't currently have an impact on our expectations for timing. We reiterated those earlier in the call. Yes, I'll leave it at that.

Operator, Operator

Our next question comes from David Roman with Goldman Sachs.

David Roman, Analyst

Maybe I'll just start with a further question on kind of what you're seeing in the underlying market dynamics. You talked about the 70% of patients coming from MDI converts. Can you maybe give us a flavor on the remaining 30% of the patients, whether that's coming from conversions of patients who are coming up for renewal. It looks to be a big bolus of renewal patients coming to market. Is that conversions from different pump therapy? Maybe just help us understand the balance of the growth drivers there and how you see that unfolding through the rest of '25 and into '26.

Stephen Feider, CFO

Yes, thanks, David. This is Stephen here. Regarding the remaining 30% from competitive pump systems, it's approximately evenly split among our three main competitors. Looking ahead, our demand has consistently been divided with 70% from injections and 30% from competitive pumps over the last four to eight quarters. We do not foresee any changes in this trend. The market for insulin pumps, for both type 1 and type 2 diabetes, is still significantly underrepresented. I want to emphasize those percentages. Therefore, there remains a substantial opportunity for a company like ours with a new and differentiated system, and I expect that most of our demand will continue to come from MDI.

David Roman, Analyst

That's very helpful. I appreciate you reiterating the timelines for the Mint full commercialization by the end of 2027. Could you remind us of the different steps that need to occur before that? For instance, have you completed human factor testing? Also, what updates will you be able to provide us along the way?

Sean Saint, CEO

Yes. I don't think we're going to provide any additional information on where we are at the moment. I mean, we would reiterate that generically, the 3 main steps that we need to look for here are 510(k) clearance followed by manufacturing readiness followed by launch. We've talked about those in the past. But I don't want to get into the details of exactly where our internal program is, less people read more or less into them than they deserve. So, for the moment, we'll reiterate our timelines, and we reserve the right, of course, at all times to update you as we know more.

Operator, Operator

Our next question comes from Matt O'Brien with Piper Sandler.

Matthew O'Brien, Analyst

Can you hear me okay? I've had some technical issues.

Sean Saint, CEO

Loud and clear. You got it, Matt?

Matthew O'Brien, Analyst

All right. Great. I appreciate the questions. Maybe just starting with those 20 new territories that you added in Q1. Maybe if you can just tease out the impact that those 20 territories are having here in Q3 because you don't typically see such a meaningful step-up here in the third quarter versus Q4 based on seasonality. So just maybe talk about how those reps are ramping and then kind of what's left for that group and that cohort as we think about maybe the next 18 months?

Stephen Feider, CFO

The new territories that we added at the beginning of the year are definitely maturing and becoming more productive, and overall, the sales force is also improving. If you look at the growth in new patient starts from Q2 to Q3, we experienced an 8% increase. This growth is largely due to the 20 new territories we added, but the iLet product is still relatively new in nearly every territory across the country. As a result, we are seeing an increase in both new store sales and same-store sales nationwide.

Matthew O'Brien, Analyst

Okay. I wanted to ask more about Mint and the 483 issue, as it's new information. Can you explain the seriousness of the 483 and your remediation efforts? It seems like you're already on track. Please frame the 483 in terms of its seriousness and your ability to respond quickly.

Sean Saint, CEO

Yes. Great question, Matt. I mean, it's tough to put a qualifier on something like that. I mean, obviously, the FDA issues Form 483 when they find something to be important. But I think with the Form 483 as long as you're aggressive with dealing with the problem and you don't have a big problem, and we've certainly been that. We're very far along in our remediation efforts. New systems are fully in place at this time. And what we're seeing now, as we stated on the prepared remarks, is just the implementation of those systems and sort of remediating past complaints. But the new systems are in place at this time. And no, we don't foresee any ongoing challenges at all. Stephen, do you got anything to add to that?

Stephen Feider, CFO

Sure. I think the interpretation of the rules regarding reportable and nonreportable complaints allows for a lot of flexibility. Before the FDA observation, we had a confident interpretation of the rules that we stood by. However, the FDA disagreed with our interpretation during their observation, which is acceptable. They requested that we adjust our approach to align with their new definition, and we complied. To us, this is not a major issue as long as we follow through on our commitments. We wanted to bring this up to ensure transparency, as there may be some misinformation about the recent increase in reportable complaints in the MAUDE database. We don’t see this as a problem, and it's typical for us to address concerns directly. That is why we mentioned it today.

Operator, Operator

Our next question comes from Travis Steed with Bank of America Securities.