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Senseonics Holdings, Inc. (SENS)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 revenue rose to $8.3M, up from $8.0M in Q4’23 and nearly doubling from $4.3M in Q3’24, as initial U.S. Eversense 365 shipments ramped; GAAP EPS improved to $(0.02) vs $(0.03) in Q4’23 and $(0.04) in Q3’24 .
  • Gross profit recovered to $4.0M from a $4.1M gross loss in Q3’24, aided by higher 365 margins and a $1.6M benefit from pre-approval manufacturing costs previously expensed to R&D; management said margins would still be “north of 25%” even when including those costs .
  • 2025 outlook introduced: revenue $34–38M, gross margin 25–30%, cash utilization $50–60M, with an assumption to roughly double the global patient base; revenue seasonality expected with H1 impacted by patient assistance programs and stronger H2 pricing/margins .
  • Commercial KPIs highlight early launch traction: ~6,000 global patients (+56% YoY), ~600 new patient shipments in December (record), >2,400 annual U.S. prescribers in 2024, 81% of patients switching from competitive CGMs, and DTC leads more than doubled in Oct/Nov .

What Went Well and What Went Wrong

What Went Well

  • U.S. 365 launch traction: December new patient shipments reached ~600, the highest monthly total in company history, and annual U.S. prescribers exceeded 2,400 in 2024, with most being new prescribers .
  • Margin inflection: Q4 gross profit of $4.0M vs $1.1M YoY and $(4.1)M in Q3, driven by higher 365 margins; CFO: “we would still see margins north of 25%” even including certain costs .
  • Patient growth and competitive displacement: Global patient base ~6,000 (+56% YoY); 81% of patients switched from competitive CGMs, suggesting strong product-market fit and differentiation .

What Went Wrong

  • Continuing losses, though improved: Q4 net loss of $(15.5)M, or $(0.02) per share, remains significant despite YoY improvement; SG&A also rose YoY with personnel, consulting, commissions and legal costs .
  • Transition/one-time charges pressured 2024 gross profit: full-year gross profit fell to $0.5M vs $3.1M in 2023, primarily due to $4.8M in charges from the E3-to-365 transition (albeit partially offset by a $1.6M pre-approval manufacturing cost reclassification) .
  • Near-term seasonality/ASP headwinds: Management expects H1 revenue/GM to be dampened by patient assistance program accounting and deductible resets, with back-half skew (approx. one-third of revenue in H1 and two-thirds in H2) .

Financial Results

Income statement snapshot vs prior periods

MetricQ4 2023Q3 2024Q4 2024
Revenue ($USD Millions)$8.0 $4.3 $8.3
Gross Profit ($USD Millions)$1.1 $(4.1) $4.0
SG&A ($USD Millions)$7.4 $8.3 $8.9
R&D ($USD Millions)$10.5 $9.4
Net Loss ($USD Millions)$(17.2) $(24.0) $(15.5)
EPS (GAAP) ($)$(0.03) $(0.04) $(0.02)

Notes:

  • Management indicated Q4 gross margins would remain “north of 25%” even when incorporating $1.6M of pre-approval manufacturing costs previously expensed to R&D; the reported Q4 gross profit benefited from those accounting effects and improved 365 unit economics .
  • FY24 totals: revenue $22.5M; gross profit $0.5M (impacted by $4.8M transition charges, partially offset by ~$1.6M pre-approval manufacturing cost reclassification); net loss $(78.6)M or $(0.12) per share .

Geographic revenue breakdown

MetricQ4 2023Q3 2024Q4 2024
U.S. Revenue ($USD Millions)$6.2 $2.4 $6.2
Outside U.S. Revenue ($USD Millions)$1.8 $1.9 $2.1

KPIs and launch metrics

KPIQ4 2024
Global patient base (approx.)~6,000 (+56% YoY)
New patient shipments (December)~600 (record monthly)
U.S. prescribers 2024 (annual)>2,400; majority new prescribers
Switchers from competitive CGMs81% of patients
DTC leads vs pre-launch (Oct/Nov)>2x increase

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Global Net RevenueFY 2025N/A$34–38M New
Gross MarginFY 2025N/A25–30% New
Cash UtilizationFY 2025N/A$50–$60M New
Global Patient BaseFY 2025N/A~2x vs 2024 New
Cash OpExFY 2025 vs 2024Target ~$10M Y/Y reduction (announced with restructuring) Target unchanged Maintained
Global Net RevenueFY 2024~ $22M (Q3 reiteration) Actual $22.5M Delivered modestly above prior indication

Management also expects 2025 revenue/GM to be back-half weighted (approx. one-third of revenue in H1; two-thirds in H2) given patient assistance programs and deductible reset impact on ASPs and margins .

Earnings Call Themes & Trends

TopicQ2 2024 (Q-2)Q3 2024 (Q-1)Q4 2024 (Current)Trend
365 Launch/Commercial MomentumPreparing for Q4 launch; H2 revenue weighted; new patient starts doubled in H1; Eon Care insertion network ramping FDA approval received; first insertions; inventory transition impacted Q3; strong early demand signals December record new patient shipments; >2,400 U.S. prescribers; >2x DTC leads; 81% switchers Accelerating
MarginsGP modest; higher fixed mfg costs; FY24 GM 10–15% ex one-time FY25 GM approaching 30% by YE; path to 50% longer-term post-sharing Q4 GP $4.0M; CFO: margins “north of 25%” even including certain costs; FY25 GM 25–30% outlook Improving
Regulatory/Ex-U.S.Building toward 365; pipeline advancing 365 approved U.S.; planning CE submission CE Mark submission completed Q1’25; EU launch targeted 2H’25 Positive milestones
Pipeline (Gemini, Freedom)Initiated first-in-human for Gemini; vision for Freedom direct-to-phone Reinforced differentiation; iCGM enables pump integration Gemini feasibility completing; IDE pivotal filing by YE; Freedom progressing; pump integration efforts ongoing Advancing
Reimbursement/AccessCoverage broadening; health systems RPM strategy (Mercy) 365 covered by most private + Medicare; Mercy first system Medicare G-codes published; working on pricing with MACs; broader prescriber expansion into PCPs underway Expanding access
Seasonality/ASPH2 weighted in 2024 2024 sales to accelerate in Q4 2025 H1 ASP/margin headwinds from PAPs; stronger H2 pricing/margins Back-half skew

Management Commentary

  • “We took a giant step forward in diabetes care in 2024… We see our 365 day product as the catalyst for revenue growth, as well as for the future of blood glucose monitoring.” — Tim Goodnow, CEO .
  • “When we include these costs in our gross profit and margin calculation, we would still see margins north of 25%… very encouraging considering… early in the product life cycle.” — Frederick (Rick) Sullivan, CFO .
  • “We expect to launch Eversense 365 in the second half of 2025 [in the EU].” — Tim Goodnow, CEO .
  • “We expect full year 2025 global net revenue to be approximately $34–$38 million… assume approximately doubling the global patient base…” — Frederick (Rick) Sullivan, CFO .
  • “The successful initial launch of our 365-day product represents one of the most significant catalyst in the company's history.” — Tim Goodnow, CEO .

Q&A Highlights

  • Ex-U.S. launch cadence: Europe inventory build will be more gradual; U.S. target inventory levels expected in next 3–4 months from Q4 call .
  • Prescriber metrics clarification: 1,000 prescribers since launch vs 2,400 annual prescribers in 2024; a mix of heavy prescribers and many “onesie-twosies,” with DTC contributing to new prescriber adds, especially PCPs .
  • Reimbursement: Medicare G-codes published; working with MACs on pricing; expect progress over “the next quarter or so” .
  • 2025 cadence and seasonality: H1 revenue ~one-third, H2 ~two-thirds; patient assistance programs pressure ASP and margins in H1; more favorable ASP/margins in H2 .

Estimates Context

  • We attempted to retrieve Wall Street consensus estimates from S&P Global; data were unavailable due to a daily request limit at the time of analysis. As a result, we are not including “vs. consensus” beat/miss determinations for Q4’24, nor forward consensus comparisons. If you’d like, we can refresh this once access resets.
  • Where estimate updates may adjust: Given 2025 revenue guidance of $34–38M and GM of 25–30% with a pronounced H2 skew, we would expect models to incorporate: (1) H1 ASP/margin headwinds from patient assistance programs; (2) H2 uplift as PAP effects abate and EU launch begins; (3) unit economics improvement as 365 scales; and (4) cash utilization of $50–60M and OpEx discipline (target $10M reduction Y/Y) .

Key Takeaways for Investors

  • Launch momentum is real: strong December shipments, prescriber expansion, and high competitive switch rates (81%) point to differentiated value prop for 365 .
  • Margin trajectory is improving: Q4 gross profit inflected; management sees 25–30% GM in 2025 with further upside longer term, supporting a credible path toward more self-funding operations as scale builds .
  • Expect back-half 2025 skew: plan for H1 ASP/margin pressure from assistance programs and deductible resets, with H2 carrying the growth/margin expansion and potential EU contribution in 2H’25 .
  • Balance sheet cleaner with extended runway: debt reduced post-Q4 (2025 notes repaid), ATM proceeds raised, preferred converted, runway targeted into mid-2026 under current plans .
  • Watch reimbursement/pricing and payer penetration: Medicare G-codes are live, pricing discussions ongoing; broader PCP prescriber activation is a key growth lever .
  • Pipeline/events as catalysts: EU CE decision and launch timing, Gemini IDE filing and pivotal start, progress toward pump integration, and additional health system wins could drive sentiment .
  • Execution focus: inventory normalization, Eon Care insertion throughput, DTC funnel conversion, and cost discipline (targeted $10M OpEx cut) are operational levers to hit 2025 guide .