Beta Bionics Q4 2025 Earnings Call Transcript

Call Participants

The key participants in the call included Sean T. Saint, serving as the Chief Executive Officer, Stephen H. Feider, acting as the Chief Financial Officer, and Blake Beber, who holds the position of Head of Investor Relations.

Key Performance Highlights

For the entire year, Beta Bionics recorded net sales amounting to $100.3 million, marking a substantial 54% increase compared to the previous year, which underscores the robust growth in the adoption of their products across various markets. In the fourth quarter specifically, revenue reached $32.1 million, reflecting a 57% rise year over year, propelled by the addition of 5,592 new patients initiating therapy and positive shifts in the pharmacy distribution dynamics that enhanced accessibility and uptake.

The company’s gross margin for the full year stood at 55.4%, showing a modest improvement over the prior period, while in the fourth quarter, it achieved 59%, an expansion of 179 basis points from the year-earlier quarter. This progress can be attributed to economies of scale achieved through higher production volumes and the advantageous leverage provided by the pharmacy channel, which contributes higher margins over time.

Sales force efficiency has been a standout factor, with new users added in 2025 effectively doubling the installed base to more than 35,000 active users. This expansion was accomplished using a sales organization comprising 63 territories, which management highlights as delivering top-tier productivity per territory within the industry sector.

Penetration into the pharmacy channel has accelerated notably, representing high-twenties percentage of new patient initiations for the full year and reaching low-thirties percentage in the fourth quarter, figures that are markedly elevated compared to historical levels from earlier periods.

Regarding the patient demographics in the fourth quarter, 69% of new starts involved individuals transitioning from multiple daily injections, illustrating the device’s broadening appeal that extends well beyond the conventional base of existing pump users to capture a wider segment of the diabetes population.

Operating expenses in the fourth quarter totaled $35.1 million, reflecting a 42% increase from the prior year, with the uptick primarily due to investments in expanding the sales team, ongoing research and development efforts focused on the Mint patch pump and bihormonal initiatives, as well as additional general and administrative costs associated with public company operations.

The company maintains strong liquidity, with $265 million held in cash, cash equivalents, and investments at year-end, providing ample resources to support all planned strategic initiatives without immediate funding pressures.

Guidance for 2026

Looking ahead to 2026, Beta Bionics anticipates revenue to fall within the range of $130 million to $135 million. Gross margins are projected to be between 55.5% and 57.5%, with the pharmacy channel expected to constitute 36% to 38% of new patient starts, indicating continued momentum in this distribution pathway.

The sales organization is set for further growth, with plans to incorporate at least 20 additional territories in 2026, most of which will be onboarded during the first half of the year to enhance market coverage and drive deeper penetration into underserved areas.

On the innovation front, the Mint patch pump remains on schedule for an unconstrained commercial introduction by 2027. Additionally, the Phase 2a feasibility study for the bihormonal system has been successfully completed, with no safety concerns identified, paving the way for subsequent development milestones.

In the pharmacy channel, the iLET Bionic Pancreas is offered without an initial upfront cost to patients, generating roughly $450 in monthly recurring revenue per active user through ongoing supply sales, which supports a sustainable revenue model with predictable cash flows.

Fourth quarter inventory movements included approximately $1 million in stocking orders accelerated from the first quarter into the fourth quarter within the pharmacy channel, timed ahead of implemented supply price adjustments, which slightly influenced the quarterly revenue comparisons.

Uptake among type 2 diabetes patients represented 25% to 30% of fourth quarter new starts, showing sequential improvement, largely through off-label applications that highlight the versatility and expanding clinical utility of the device.

Pricing strategies included a low single-digit percentage increase applied to pharmacy channel supply sales, while durable medical equipment pricing was maintained stable to preserve competitiveness in that segment.

Regulatory and Risk Considerations

CEO Sean T. Saint noted that the company received communication from the FDA in late January concerning aspects of complaint management, definitions under Medical Device Reporting requirements, instances of late filings, and procedures for corrective and preventative actions at the Irvine manufacturing facility.

Saint further indicated that an elevated rate of Medical Device Reports would persist through the second quarter due to remediation efforts involving backdated reporting of complaints that were previously not deemed reportable, with the goal of achieving full compliance by the end of that quarter.

CFO Stephen H. Feider cautioned that first quarter revenue is expected to experience a sequential decline from the fourth quarter of 2025, with the drop being more pronounced than in previous years, attributed to the absence of comparable product launches and slower expansion of pharmacy coverage relative to the prior year’s first quarter.

Management recognized that a greater-than-expected proportion of new patient starts via the pharmacy channel introduces a temporary challenge to revenue recognition and exerts a short-term negative influence on the gross margin profile, though these effects are viewed as transitional.

Executive Summary and Strategic Outlook

Beta Bionics (BBNX) delivered impressive year-over-year expansions in both revenue and gross margins, fueled by sustained adoption of its flagship iLET platform and accelerated growth through the pharmacy distribution channel, even while operating with a relatively compact sales force. The detailed projections for 2026 forecast continued revenue growth at the top line, deeper integration with pharmacy networks, and a meaningful ramp-up in sales territories concentrated in the early part of the year. However, the company has indicated heightened seasonality effects in the first quarter compared to historical patterns.

Ongoing efforts to address regulatory matters, including an FDA warning letter related to quality control systems, Medical Device Reporting, and complaint processing protocols, are progressing without disruptions to internal timelines for pivotal product launches like Mint. Executives detailed planned escalations in operating expenses to bolster both commercial scaling and cutting-edge R&D programs, particularly for the Mint patch pump and the bihormonal technology platform. The firm reiterated its robust cash reserves and commitment to exemplary transparency in reporting performance metrics and channel-specific insights.

Management explained that evolving industry standards will prompt a transition from granular quarterly new patient start numbers toward more product-centric, channel-focused, and trend-oriented disclosures. Saint emphasized that revised Medical Device Reporting protocols now fully align with FDA standards, clarifying that past late submissions arose from retrospective reinterpretations of reporting criteria rather than emerging safety incidents.

Feider elaborated on the evolving nature of fourth quarter seasonality, noting that pharmacy channel growth is reshaping patient purchasing behaviors, thereby reducing peak intensity, though the first quarter persists as a comparatively softer period due to annual deductible renewals. The 2026 revenue outlook envisions a modestly front-loaded profile relative to 2025, with primary growth catalysts tied to the velocity of territory additions and fluctuations in pharmacy channel mix.

The coverage approach for Mint capitalizes on pre-existing relationships with pharmacy benefit managers established via iLET, with commercial arrangements anticipated to align closely or build upon current terms. Real-world performance data for iLET, encompassing efficacy metrics like hypoglycemia incidence rates, either matches or exceeds those from pivotal clinical trials and adheres to or surpasses American Diabetes Association standards, as corroborated by CEO-cited evidence.

Industry Terminology Reference

• iLET: Beta Bionics’ proprietary automated insulin delivery platform designed for individuals requiring insulin for diabetes management, forming the cornerstone of the company’s commercial and developmental priorities.
• DME Channel: The reimbursement pathway via durable medical equipment providers for insulin pump acquisitions, differentiated from pharmacy channels by typically higher initial patient costs and distinct seasonal demand patterns.
• PBM: Pharmacy Benefit Managers, third-party administrators that negotiate formulary inclusions and manage pharmacy benefits, facilitating access to devices such as iLET and the forthcoming Mint.
• MDR: Medical Device Reports, mandatory FDA notifications triggered by specific adverse events or complaints according to regulatory definitions.
• CAPA: Corrective and Preventative Action frameworks, standardized processes mandated for addressing and mitigating quality, safety, or compliance deficiencies throughout a product’s lifecycle.
• Phase 2a / 2b: Initial and intermediate clinical evaluation stages for combination device-drug therapies, applied here to the bihormonal system to validate feasibility, refine designs, and prepare for larger-scale confirmatory trials.

Full Earnings Conference Call Transcript

The call featured presentations from Chief Executive Officer Sean T. Saint and Chief Financial Officer Stephen H. Feider. Both a replay of the discussion and the accompanying press release detailing fourth quarter and full-year 2025 financial outcomes are accessible via the Investor Relations area on the company’s website. The replay remains available for about one year post-call. All statements made during this session are current as of February 17, 2026. Listeners accessing replays should note that time-sensitive details might no longer reflect the latest developments. Additionally, the site hosts a supplemental earnings deck for the fourth quarter 2025 and an refreshed corporate overview presentation, which provide concise summaries of critical metrics and operational progress.

As a preliminary note, the forthcoming dialogue incorporates forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. These projections encompass management’s views on prospective events, pipeline advancements, development schedules, financial outcomes, and operational strategies. For comprehensive caveats on the risks inherent in such projections, consult the press release distributed earlier today, which delineates factors potentially causing material variances from anticipated results.

Forward-looking comments are valid solely as of the call date, with no commitment to revisions barring legal mandates. The conversation will also reference non-GAAP metrics, particularly adjusted EBITDA, intended to illuminate core operational performance and ongoing business activities. Management posits these metrics aid in more effective period-over-period operating comparisons. Non-GAAP figures should not supplant GAAP-prepared results, nor be deemed superior. Reconciliations to the nearest GAAP equivalents appear in the earnings release and supplemental materials on the Investor Relations page.

With preliminaries addressed, Blake Beber transitions the proceedings to Sean Saint. Thank you, Blake. Good afternoon, and welcome to everyone dialing in. Today marks the close of our inaugural complete year operating as a publicly traded entity, a milestone year brimming with achievements worth pausing to appreciate before delving into the specifics of our fourth quarter and full-year 2025 achievements.

Beta Bionics’ mission centers on furnishing diabetes patients with innovative solutions that alleviate daily burdens, broaden therapeutic access, and elevate health results on a broad scale. The conviction is that these efforts will, for the first time, drive down the population-level average A1C among U.S. diabetes patients. Last year’s results powerfully affirm our trajectory toward this vision.

During our debut earnings discussion, we outlined principal annual targets for 2025, and as elaborated further below, we not only met but surpassed every benchmark. Nearly 20,000 fresh users embraced our technology that year, more than doubling the installed base from the start of the period to exceed 35,000 cumulative iLET adopters since initial availability. Remarkably, this growth stemmed from a sales apparatus we regard as leaner than competitors’, yielding what we assess as peak per-territory productivity in the durable insulin pump arena for 2025.

This underscores the potency of our fully adaptive control algorithm, complemented by a comprehensive suite of digital resources aiding users, caregivers, and clinicians, alongside our team’s steadfast execution prowess. We maintain leadership in pioneering pharmacy channel strategies for durable pumps, securing formulary pacts with every major U.S. pharmacy benefit manager. Moreover, we adeptly activated these agreements at the plan level, a vital progression enabling numerous users to procure iLET devices and consumables at drastically reduced personal expense.

Evidence mounts that our gross margin standing is preeminent in the durable pump category, bolstered by this year’s figures despite pharmacy channel successes exerting transient margin pressure in 2025. In research and development, we advanced substantially on Mint, our patch pump initiative, first showcased publicly at our inaugural Investor and Analyst Day in June. We also marked milestones as a biopharma entity, conducting pharmacokinetic/pharmacodynamic testing for our glucagon component and a inaugural human feasibility assessment for the complete bihormonal configuration under development.

Accomplishments in 2025 fill me with pride, and I eagerly anticipate 2026 as a year of unwavering pursuit of objectives poised to transform diabetes management in the foreseeable future.

Today’s agenda is packed, commencing with fourth quarter and full-year 2025 outcomes. Stephen will furnish deeper insights into quarterly results before unveiling 2026 guidance. I’ll conclude with regulatory and pipeline progress, followed by questions. Beginning with a high-level full-year 2025 recap, I’m delighted to report net sales of $100.3 million, a 54% surge from the prior year. Gross margin edged up to 55.4%, while pharmacy channel new patient starts climbed to high-twenties percentage for the year from high single-digits previously. In essence, outstanding delivery across the board.

The iLET excels through superior automation capabilities. Our transparently reported real-world efficacy and safety profiles are exemplary, detailed in the latest corporate deck. Beyond the device itself, we’re reshaping durable pump business models with disciplined execution and fiscal prudence. Shifting to fourth quarter details, net sales hit $32.1 million, up 57% year over year. This acceleration stemmed from three elements: first, 5,592 new patient initiations, a 37% year-over-year gain; second, expanding installed base procuring monthly iLET supplies via pharmacy with excellent retention; third, slight stocking revenue uplift in both DME and pharmacy versus prior periods.

Pharmacy-specific dynamics featured about $1 million in Q1 orders advanced into Q4 ahead of year-end price hikes. In the quarter, low-thirties percentage of new starts routed through pharmacy, up modestly sequentially and dramatically from low-teens in the prior year’s Q4. Q4 gross margin reached 59%, gaining 179 basis points year over year, powered by scale efficiencies, manufacturing leverage, pharmacy recurring high-margin flows, and cost vigilance. Over to Stephen for further quarterly elaboration and 2026 guidance.

Thank you, Sean. Q4 topped guidance on revenue, pharmacy proportion, and gross margin comprehensively. Though not formally guided, 5,592 new starts rose 5% sequentially, aligning with expectations’ lower bound. Q4 retains seasonal primacy for new starts in diabetes devices since iLET launch, yet its dominance versus other quarters appears to wane.

Traditionally, Q4 strength derived from patients delaying pump purchases until out-of-pocket maximums cleared, pre-deductible reset, saving $1,000-$2,000 via DME. Post-2023, most new U.S. pump users opt for pharmacy, affording under-$50 monthly therapy initiation and continuity. Thus, fewer delay to Q4 now. Our pharmacy strategy positions us to capture year-round adopters, fueling iLET’s broad uptake.

In Q4, 69% of new starts shifted from multiple daily injections, vividly demonstrating iLET’s market expansion and fulfillment of unmet needs. Q4 gross margin hit 59%, propelled by pharmacy base growth yielding high-margin repeats with robust retention, plus unit cost reductions from volume-driven manufacturing.

Q4 operating expenses totaled $35.1 million, up 42% from $24.7 million in 2024. Sales/marketing rose with field team growth to 63 territories end-Q4. R&D escalated for Mint and bihormonal work. G&A climbed with public entity overheads. Year-end cash, equivalents, and investments approximated $265 million, funding all priorities and priming early free cash flow versus diabetes peers historically.

Now, 2026 guidance: revenue $130-$135 million. Pharmacy new starts 36-38%. Gross margin 55.5-57.5%. This embeds iLET-driven market growth and share gains, steady retention across channels, DME pricing stability, low single-digit pharmacy supply hikes. Variables: pharmacy new start mix, sales force ramp pace. Margin guidance factors cost control, overhead leverage at scale, pharmacy recurring contributions. Pharmacy mix volatility quarter-to-quarter can sway near-term margins notably.

OpEx and CapEx expected higher as revenue percentage versus prior year, with sales/marketing and R&D accelerating on territory adds and Mint/bihormonal investments; G&A slight uptick for scaling support; CapEx mainly Mint-related. Revenue pacing: Q1 sequential drop from Q4 2025. Pharmacy growth tempers classic seasonality; Q4 strongest relatively, Q1 weakest on deductibles. Some patients still await deductible clearance, bulking back-half medical benefit initiations.

2025 Q1 mitigated seasonality via late-2024 launches (Color iLET, Bionic Circle, Libre 3 Plus) momentum and Prime Therapeutics pharmacy expansion enabling low-cost early access. Q1 2026 lacks such boosts: no late-2025 launches, pharmacy growth incremental sans step-change. Full-year 2026 revenue slightly more first-half weighted than 2025, as 2025’s pharmacy mix shift diluted H1 but accreted H2; 2026 shift milder, front-loaded. Sales force adds (at least 20 territories from 63) pace also influences cadence; future disclosures omit exact quarterly counts for peer alignment.

On new starts reporting: post-IPO exact quarterly figures illuminated DME vs. pharmacy models; now community grasps dual-channel dynamics, so shifting to peer-aligned disclosures: revenue by product/channel, pharmacy new start mix, trend commentary quarterly—exceeding sector norms. Gross margin trajectory: Q1 dip on light seasonal demand/volume and higher Q1 pharmacy mix; thereafter sequential gains via leverage.