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Senseonics Holdings, Inc. (SENS)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue was $6.26M, up 24% year over year; U.S. revenue $4.5M and OUS $1.8M. Gross profit was $1.51M, driven by increased margins on the 365-day product .
  • Senseonics reiterated full-year 2025 guidance: global net revenue $34–$38M, gross margin 25–30%, cash used in operations $50–$60M; management expects 1/3 of revenue in H1 and 2/3 in H2 as the Eversense 365 launch scales .
  • Revenue beat Wall Street consensus for Q1 2025 by approximately $0.70M; EPS comparisons are less like-for-like because S&P Global “Primary EPS” is normalized and not GAAP (see Estimates Context) *.
  • Strategic catalysts: twiist automated insulin delivery (AID) integration targeted for Q3 launch, CE Mark submission progressing with EU launch planned in H2, and CMS Medicare fee schedule updated to reimburse full-year Eversense 365 retroactive to January 1, 2025 .

What Went Well and What Went Wrong

What Went Well

  • Revenue growth and margin expansion on the 365-day product: Q1 revenue $6.26M (+24% YoY); gross profit increased to $1.51M as margins improved on Eversense 365 .
  • Positive reimbursement and DTC traction: CMS updated physician fee schedule to cover full-year Eversense 365 retroactive to Jan 1, supporting strong Medicare conversion; DTC campaigns show promising lead conversion via Facebook, TikTok, Instagram and YouTube .
  • Strategic integrations: commercial agreement to integrate Eversense 365 with Sequel’s twiist AID, with joint launch targeted for Q3; “We look forward to jointly launching our combined products in the coming quarter” — Tim Goodnow .

What Went Wrong

  • Mercy Health Systems program paused due to executive restructuring, delaying RPM integration plans and expected back-half contribution; management reiterated guidance despite this pause .
  • Tariff exposure could be a low single-digit headwind to gross margin given global supply chain inputs, including a very small percentage from China; management expects to mitigate via exemptions and operational changes .
  • Profitability remains negative as the launch scales: Q1 net loss of $14.26M and GAAP loss per share of $0.02; manufacturing scale still limited early in the product lifecycle .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)$4.263 $8.297 $6.257
Gross Profit ($USD Millions)-$4.051 $4.000 $1.505
Gross Margin % (reported calc)-95.0% 48.2% 24.1%
Net Loss ($USD Millions)-$23.976 -$15.500 -$14.259
GAAP Loss Per Share ($USD)-$0.04 -$0.02 -$0.02

Notes: Q4 2024 gross profit includes ~$1.6M pre-approval manufacturing costs previously expensed to R&D; Q1 2025 margin color suggests ~18% if including ~$0.4M manufacturing costs previously expensed to R&D .

Segment Revenue Breakdown

SegmentQ3 2024Q4 2024Q1 2025
U.S. Revenue ($USD Millions)$2.4 $6.2 $4.5
Outside U.S. Revenue ($USD Millions)$1.9 $2.1 $1.8

KPIs and Operational Metrics

KPIQ3 2024Q4 2024Q1 2025
New patient shipments (monthly)~600 in December (highest ever)
U.S. prescribers (annual)>2,400 in 2024 (majority new)
% patients switching from competitive CGMs81%
Consignment channel share of revenue~13%
Cash, restricted cash & cash equivalents ($M)$74.8 $74.9 $64.6
Debt & accrued interest ($M)$55.9 $56.2 $35.3

Guidance Changes

MetricPeriodPrevious Guidance (Q4 2024 PR)Current Guidance (Q1 2025)Change
Global Net RevenueFY 2025$34–$38M $34–$38M Maintained
Gross Margin %FY 202525–30% 25–30% Maintained
Cash Used in OperationsFY 2025$50–$60M $50–$60M Maintained
Revenue phasingFY 2025~1/3 H1, ~2/3 H2 ~1/3 H1, ~2/3 H2 Maintained
EU launch timeline (365)2025H2 planned H2 planned; CE Mark submission in Q1 progressing Maintained
AID integration (twiist)2025Q3 launch targeted New detail

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 & Q4 2024)Current Period (Q1 2025)Trend
AID integrationFDA iCGM clearance and launch; planning for pump connectivity Commercial agreement with Sequel’s twiist; joint Q3 launch targeted Advancing integration; near-term catalyst
ReimbursementEarly payer transitions; Mercy case study CMS updated to reimburse full-year 365 retroactive to Jan 1; majority of commercial plans expected to convert to 365 by Q3/Q4 Access improving; accelerates adoption
EU regulatoryiCGM approval in US; CE Mark submission planned CE Mark submitted in Q1; EU launch planned for H2 On track
Supply chain & tariffsOne-time transition costs; restructuring Tariff headwind low single-digit to GM; mitigation via exemptions and ops changes Managed risk
DTC marketingNoted interest post-approval Social channels driving geo-targeted leads; plan to increase awareness Scaling lead gen
Health systems (Mercy)First commercial insertion; RPM case study Program paused due to restructuring; management reiterates FY guide Timing risk contained
Pipeline (Gemini, Freedom)Foundational base for next-gen systems IDE submission for Gemini pivotal by YE; Freedom (sensor BT to phone) advancing Continued innovation

Management Commentary

  • “Securing positive CMS reimbursement of our one-year CGM, effective from January 1, was a major milestone for access… Together with progress towards launching Eversense 365 in Europe, collaborations such as Sweet Spot, and development on Gemini and Freedom…” — Tim Goodnow, CEO .
  • “We look forward to jointly launching our combined products in the coming quarter.” — Tim Goodnow on twiist AID integration .
  • “Gross profit was $1.5 million… driven by increased margins on the 365-day product; including ~$0.4M previously expensed manufacturing costs, margins would be ~18%” — Rick Sullivan, CFO .
  • “We continue to expect gross profit margins to steadily increase each quarter in 2025, with full year gross margins projected to be between 25% and 30%” — CFO .

Q&A Highlights

  • Guidance durability despite Mercy pause: Management expects U.S. momentum, EU launch, and DTC-driven conversions to offset timing risk; reiterated FY 2025 revenue guide .
  • DTC strategy: Focus on Facebook, TikTok, Instagram, YouTube with geo-targeting supporting rep activity; strongest conversion in Medicare population given clear reimbursement .
  • Reimbursement conversion: Vast majority of commercial plans expected to shift to 365 by Q3/Q4; some moving from DME to buy-and-bill (consignment) channels .
  • AID timeline: Verification/validation work ongoing on the pump side; teams from Ascensia and Sequel engaged; Q3 integration on track .

Estimates Context

MetricQ1 2024Q4 2024Q1 2025
Revenue Consensus Mean ($USD)$4.608M*$7.948M*$5.558M*
Revenue Actual ($USD)$5.047M $8.297M $6.257M
Primary EPS Consensus Mean ($USD)-$0.60*-$0.60*-$0.47*
GAAP Loss Per Share (Reported) ($USD)-$0.03 -$0.02 -$0.02

Disclaimer: Values marked with * retrieved from S&P Global (Capital IQ). Primary EPS consensus and “actual” figures are normalized and may not be directly comparable to reported GAAP EPS; revenue consensus/actual are comparable.

Highlights: Q1 2025 revenue beat consensus by ~$0.70M; EPS comparisons to S&P normalized “Primary EPS” are not like-for-like vs GAAP reported loss per share *.

Key Takeaways for Investors

  • Revenue momentum with Eversense 365 is building; Q1 beat vs consensus and reiteration of FY guide point to accelerating H2 phasing as payer transitions and DTC awareness scale * .
  • Near-term catalysts: Q3 launch of twiist AID integration and H2 EU launch should broaden adoption and drive ASP/margin benefits over time .
  • Reimbursement tailwinds: CMS full-year coverage retroactive to Jan 1 and expected >90% commercial conversion by Q3/Q4 reduce friction and support Medicare-heavy demand .
  • Margin trajectory: Management targets 25–30% FY gross margin with sequential quarterly improvement; monitor tariff impacts (low single-digit) and scaling efficiencies .
  • Channel mix: Consignment program (~13% of Q1 revenue) and buy-and-bill transitions can accelerate insertions and influence commission expense/SG&A trends .
  • Balance sheet improved: Debt reduced with note repayment; ATM proceeds extend runway into mid-2026 under current plans, supporting launch and pipeline execution .
  • Trading implications: Expect narrative to center on execution of AID integration, EU timing, and reimbursement conversions; watch H2 revenue skew (365 reorder dynamics) and margin progression as potential stock-moving data points .