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Accelerate Diagnostics, Inc (AXDX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 net sales were $2.8M, down 6% year over year and sequentially lower vs Q3; gross margin compressed to ~16% on higher manufacturing costs; net loss was $9.6M ($0.38 per share) .
  • The company submitted the Accelerate WAVE system and Gram‑Negative positive blood culture menu to the FDA on March 21, 2025; prior commentary had targeted a Q1 2025 submission, which the company achieved and disclosed in conjunction with results .
  • Operating discipline continued: SG&A fell to $4.6M (from $5.8M YoY), R&D to $3.8M (from $5.6M YoY); quarter-end cash and equivalents were ~$16.3M (down $4.6M in Q4) .
  • Management will no longer host regular earnings calls, shifting investor communications to filings and IR materials; stock narrative catalysts are WAVE FDA review, Arc commercialization, and cash burn trajectory .

What Went Well and What Went Wrong

What Went Well

  • WAVE clinical program progressed as planned; management highlighted strong reliability and ease-of-use at 4 external labs and reaffirmed the plan to submit to FDA (achieved March 21, 2025) .
  • Arc received FDA 510(k) clearance; early customer interest and trained sales force support commercialization momentum into 2025 .
  • Cost discipline: SG&A down to $4.6M and R&D down to $3.8M in Q4, reflecting lower employee-related and third‑party development expenses .

What Went Wrong

  • Revenue softness: Q4 net sales of $2.8M declined YoY on lower consumables; capital sales remained challenging across regions .
  • Margin pressure: gross margin fell to ~16% vs ~21% YoY, driven by higher manufacturing-related costs and inflation .
  • Cash use: cash and equivalents decreased by ~$4.6M in Q4 to ~$16.3M; while burn is improving vs earlier quarters, liquidity remains a central focus .

Financial Results

Quarterly Trend (Q2 → Q3 → Q4 2024)

MetricQ2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$2.986 $2.975 $2.800
Gross Margin %23% 29% ~16%
SG&A ($USD Millions)$5.379 $5.636 $4.607
R&D ($USD Millions)$3.903 $3.838 $3.774
Net Loss ($USD Millions)$11.588 $14.639 $9.6
Diluted EPS ($USD)$(0.50) $(0.59) $(0.38)

YoY Comparison (Q4 2024 vs Q4 2023)

MetricQ4 2023Q4 2024
Revenue ($USD Millions)$3.0 $2.8
Gross Margin %~21% ~16%
SG&A ($USD Millions)$5.792 $4.607
R&D ($USD Millions)$5.570 $3.774
Diluted EPS ($USD)N/A$(0.38)

Non-GAAP Reconciliations (Company-defined)

Metric ($USD Thousands)Q4 2023Q4 2024
Cost of sales less inventory write-down and stock comp$2,341 $2,357
SG&A less stock-based compensation$4,747 $3,817
R&D less stock-based compensation$5,304 $3,610
Loss from operations less stock-based compensation$(9,365) $(6,969)

KPIs and Operating Metrics

KPIQ2 2024Q3 2024Q4 2024
Pheno installed base (US, clinically live)350 352 ~350 maintained
U.S. Pheno customers secured via extensions~75% ~75% >75%
WAVE time-to-result (avg)4.5 hours (preclinical) Clinical sites on track 4.5 hours reiterated
Cash & equivalents ($USD Millions)$8.588 (end Q2) $19.691 (end Q3) ~$16.3 (end Q4)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
WAVE FDA submission timingQ1 2025Anticipated submission in Q1 2025 Submitted March 21, 2025 Achieved/On track
Earnings calls policyOngoingRegular quarterly earnings calls (Q2/Q3 held) Company does not plan to host regular earnings calls going forward Policy change
Cash burn focus2025Target ~$5M per quarter Continue focusing on ~$5M per quarter Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 & Q3)Current Period (Q4)Trend
WAVE clinical progressPreclinical success: ~95% EA/CA across 1,570 bug‑drug combos; 4.5h results; clinical trial start imminent FDA submission completed (Mar 21, 2025); company reiterated strong site feedback in prior quarter Advancing from preclinical to submission
Arc FDA clearance & commercialization510(k) clearance received; launching with partner; trained sales force; strong early interest Continued commercial readiness; value proposition to automate rapid MALDI ID with WAVE pairing Building commercialization funnel
Installed base & contracts~75% U.S. Pheno customers secured; added contracted instruments >75% secured through WAVE launch; maintained ~350 clinically live Stable base, deeper lock-in
Cash burn and runwayFunding through 2025; focus to ~$5M per quarter; working capital gains Burn focus maintained; Q3 showed ~$5.5M cash used net of financing; Q4 cash down ~$4.6M Tight expense control, liquidity central
Communications policyHeld calls with Q&A (Q2/Q3) No regular earnings calls going forward Reduced live commentary

Management Commentary

  • “We anticipate submitting to the FDA in Q1 of 2025 with a review timeline of approximately 9 months… WAVE systems are demonstrating strong reliability, and laboratorians like the ease of use and workflow.” — Jack Phillips, CEO .
  • “Customer receptivity [to Arc] is high… automate MALDI, turn MALDI into a rapid ID solution for labs… sales force is very excited.” — Jack Phillips .
  • “Our net loss for the quarter was approximately $14.6 million… Cash used for the quarter was approximately $5.5 million net of financing… we anticipate sufficient operating cash through year‑end 2025 assuming contingent contractual payments.” — David Patience, CFO .

Q&A Highlights

  • WAVE conversion plan: Management expects to convert the majority of Pheno customers to WAVE upon launch, with ongoing education and long-term contract efforts .
  • Arc ramp: Too early for financial guidance; trained sales, marketing plans in place, strong interest; positioning Arc to automate rapid MALDI workflows .
  • Cash usage: Target ~$5M per quarter going forward; noted Q3 working capital gains and reduced operating cash use (down >$2M QoQ) .
  • Preclinical thresholds: FDA requires ≥89.9% EA/CA; WAVE preclinical showed mid‑90s EA/CA, reinforcing confidence for clinical success .
  • Strategy vs partnering: Secured financing to focus on achieving FDA clearance first to maximize stakeholder value; continued dialogue with strategic partners .

Estimates Context

  • Wall Street consensus via S&P Global for AXDX Q4 2024 revenue and EPS was unavailable for this period; no validated consensus mapping was present, so a beat/miss assessment vs estimates cannot be provided at this time. Values retrieved from S&P Global were unavailable for AXDX due to data coverage/mapping limitations.

Key Takeaways for Investors

  • Execution: Q4 delivered continued cost discipline and WAVE program progress, but revenue softness and margin compression reflect consumable and manufacturing cost headwinds .
  • Catalysts: FDA submission of WAVE (completed March 21, 2025) and Arc commercialization are near-term narrative drivers; review timelines and early Arc adoption will shape estimate revisions and sentiment .
  • Installed base durability: >75% of U.S. Pheno customers secured through the anticipated WAVE launch suggests a credible base for migration and upsell .
  • Liquidity: Quarter-end cash of ~$16.3M and ongoing ~$5M/quarter burn focus make working capital and non‑dilutive inflows critical; monitor cash trajectory and any financing/partnering updates .
  • Communication shift: No regular earnings calls going forward reduces real-time commentary; investors should track SEC filings and IR updates for milestones and operational detail .
  • Margin path: Mix, inflation/ manufacturing costs weighed on Q4 gross margin; WAVE/Arc scale and product mix will be key to structurally improving margins over time .
  • Estimates: With consensus unavailable, focus on internal milestones (FDA, Arc uptake, expense control) to frame near‑term trading and medium‑term thesis until coverage normalizes.

Sources: Q4 2024 8‑K and press release ; Non‑GAAP reconciliations ; Q3 and Q2 2024 earnings materials ; Q3 and Q2 earnings call transcripts ; WAVE FDA submission press release .