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Achieved $100.3 million in 2025 net sales, representing 54% year-over-year growth driven by a doubling of the installed base to 35,000 users.
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Attributed sales force productivity to the iLet’s fully automated algorithm and digital ecosystem, which allowed a smaller team of 63 territories to compete effectively against larger incumbents.
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Successfully executed a pharmacy channel strategy, establishing formulary agreements with all major U.S. PBMs to lower patient out-of-pocket costs and drive high-margin recurring revenue.
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Maintained the strongest gross margin profile in the durable pump space at 55.4%, despite the short-term dilutive effects of rapid pharmacy channel expansion.
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Observed significant market expansion through the iLet, with 69% of new patient starts coming from individuals previously using multiple daily injections rather than switching from other pumps.
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Reported that 25% to 30% of Q4 new patient starts were off-label type 2 diabetes users, highlighting strong organic demand ahead of a formal regulatory indication.
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Addressed the January 2026 FDA warning letter, clarifying that findings related to complaint handling definitions (e.g., reporting self-treated hypoglycemia) and software update filing procedures rather than product safety.
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Projected 2026 revenue of $130 million to $135 million, assuming stable DME pricing and a low single-digit price increase for pharmacy supplies.
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Anticipates 2026 gross margins between 55.5% and 57.5%, with sequential quarterly improvement as manufacturing leverage and pharmacy recurring revenue scale.
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Plans to expand the sales force by at least 20 new territories in 2026, focusing on high-quality reps in priority markets to increase endocrinologist and primary care reach.
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Expects Q1 2026 revenue to decline sequentially from Q4 2025 due to annual deductible resets and the absence of the specific product launch tailwinds seen in early 2025.
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Committed to an unconstrained commercial launch of the Mint patch pump by the end of 2027, leveraging existing PBM contracts for rapid coverage.
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Confirmed a remediation timeline for the FDA warning letter, with the goal of having all historical complaint filings fully compliant by the end of Q2 2026.
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Noted a $1 million pull-forward of stocking orders from Q1 2026 into Q4 2025 as pharmacy channels anticipated year-end price increases.
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Identified pharmacy mix volatility as a key risk factor, as rapid shifts toward pharmacy starts create short-term revenue and margin headwinds despite long-term accretion.
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Transitioned disclosure practices to no longer provide exact quarterly new patient start figures, aligning with industry peers while maintaining revenue transparency by channel.
