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Accelerate Diagnostics, Inc (AXDX)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 net sales were $2.986M (+2.2% YoY) with gross margin of ~23%; OpEx declines continued, and net loss improved to $11.6M ($0.50 loss per share) driven by lower SG&A/R&D and absence of prior-year debt extinguishment charges .
  • WAVE pre-clinical trial achieved approximately 95% Essential and Categorical Agreement across 1,570 bug–drug combinations and delivered 4.5-hour average time-to-result; 99% of runs reported MIC, supporting clinical trial start “imminent” .
  • Financing and strategic review: Raised $15M from existing noteholders, with management asserting runway through 2025; Perella Weinberg Partners retained to review strategic alternatives .
  • Commercial KPIs: US live Pheno instruments reached 350, with 74 contracted in implementation; ~75% of US Pheno customer base secured to longer-term contracts ahead of WAVE launch .
  • No formal revenue/EPS guidance; management targets reducing operating cash burn toward ~$5M per quarter and focuses on WAVE milestones; S&P Global consensus estimates were unavailable for AXDX this quarter, limiting beat/miss assessment .

What Went Well and What Went Wrong

What Went Well

  • WAVE pre-clinical trial delivered “a great success” with ~95% EA/CA, 4.5-hour average time-to-result, 99% reportability, and strong reliability; CEO: “The preclinical trial was a great success… we are now ready to start the clinical trial” .
  • Operating discipline: SG&A fell to $5.4M (from $7.6M YoY) and R&D to $3.9M (from $5.8M YoY) as AXDX lowered employee and third-party development costs .
  • Customer base fortification: Executed contract extensions securing ~75% of US Pheno customers; 350 live instruments and 74 contracted in process support WAVE conversion opportunity .

What Went Wrong

  • Gross margin compressed to ~23% (vs ~27% YoY and ~25% in Q1), driven by a lower capital instrument sales mix; consumables grew but did not offset mix headwinds .
  • Cash declined to ~$9.7M in cash and cash equivalents (including investments) at quarter-end (vs $15.8M start), reflecting financing inflows and repayments; ongoing burn remains elevated despite reductions .
  • No formal financial guidance and limited Street coverage; S&P Global consensus estimates were unavailable, constraining external benchmarking and potentially contributing to investor uncertainty .

Financial Results

Quarterly Financials (oldest → newest)

MetricQ4 2023Q1 2024Q2 2024
Revenue ($USD Millions)$3.000 $2.921 $2.986
Gross Margin %21.0% 25.0% 23.0%
SG&A Expense ($USD Millions)$5.792 $5.706 $5.379
R&D Expense ($USD Millions)$5.570 $5.173 $3.903
Net Loss ($USD Millions)$13.000 $16.965 $11.588
Diluted EPS ($USD)$(0.89) $(0.88) $(0.50)

Year-over-Year Comparison (Q2 2023 vs Q2 2024)

MetricQ2 2023Q2 2024
Revenue ($USD Millions)$2.921 $2.986
Gross Margin %27.0% 23.0%
SG&A Expense ($USD Millions)$7.564 $5.379
R&D Expense ($USD Millions)$5.820 $3.903
Net Loss ($USD Millions)$32.735 $11.588
Diluted EPS ($USD)$(2.97) $(0.50)

KPIs and Operating Metrics

KPIQ2 2024 Value
WAVE EA/CA Performance (%)~95% / ~95%
WAVE Time-to-Result (hours, avg)4.5
WAVE Reportability (%)99% MIC runs reported
US Live Pheno Instruments (#)350
Contracted Pheno Instruments in Implementation (#)74
US Pheno Customers on Longer-Term Contracts (%)~75%
Consumable Revenue Growth YoY (%)+12%
Cash & Equivalents + Investments ($M, end of Q2)~$9.7
Subsequent Financing ($M)$15

Note: AXDX discloses non-GAAP adjustments primarily excluding stock-based compensation; reconciliations are provided in the press release .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
WAVE Clinical Trial Start2024Start Q2 2024; submission end Q3 2024; clearance mid-2025 Clinical trial “imminent”; systems installed at 4 sites; GN kits manufactured Maintained timeline with operational readiness
WAVE FDA Clearance (GN PBC)Mid-2025Anticipated mid-2025 Reiterated focus to deliver FDA-cleared WAVE GN PBC menu Maintained
Strategic Partnership2024Target signing by midyear 2024 Focusing first on milestones; ongoing partner discussions; retained PWP for strategic alternatives Deferred partnering to post-milestones; added strategic review
Operating Cash Burn TargetNear-termNot previously quantifiedTarget operating cash burn of about $5M per quarter; further SG&A/R&D reductions underway New target introduced
Funding RunwayThrough 2025N/A$15M incremental debt expected to fund co. through 2025 New financing and runway communicated

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2023)Previous Mentions (Q1 2024)Current Period (Q2 2024)Trend
WAVE performance and milestonesDevelopment exit; <4.5h avg TTR; plan preclinical/clinical; submit end Q3; mid-2025 clearance First preclinical site installed; GN PBC focus; gram-positive development started Preclinical success (~95% EA/CA; 4.5h TTR); 99% reportability; clinical trial imminent Improving execution
Strategic partnershipStrong interest; plan to sign by midyear 2024 Continued robust interest; BD progress Focus on milestones before partnering; retained PWP; ongoing meetings Strategy pivot to value-maximizing
BD collaboration (Pheno placements)US/Europe momentum, tender inclusion in EU; complex sale cycle +12 contracted, +8 live in Q1; partnership aiding funnel +5 new contracted in Q2; 350 live; 74 contracted in process Steady build
ARC 510(k)Submitted; team trained; complements WAVE 510(k) submitted; FDA feedback received and responded No new approvals disclosed; ARC remains complementary Stable
Cash burn/OpExMeaningful reductions in 2H23 Continued reductions; Q1 burn ~$9M ex-financing Target $5M operating burn per quarter; R&D down ~20% QoQ; further SG&A cuts Improving
Regulatory expectationsFDA clearance mid-2025 for WAVE GN PBC Target end-Q2 clinical start Clinical trial imminent; maintained clearance timeline On track

Management Commentary

  • “The preclinical trial was a great success… measured by Essential Agreement and Categorical Agreement… approximately 95%… delivering true same-shift susceptibility results… 4.5 hours on average” — Jack Phillips, CEO .
  • “We worked with our existing lenders to bring in additional capital to fund the company through 2025… focus on delivering an FDA-cleared WAVE system and Gram Negative PBC menu” — Jack Phillips .
  • “Net sales were approximately $3 million… Gross margin approximately 23%… SG&A approximately $5.4 million… R&D $3.9 million… net loss approximately $11.6 million” — David Patience, CFO .
  • “Our overall goal is to get to a target of operating cash burn of about $5 million” — David Patience .

Q&A Highlights

  • Clinical performance thresholds: FDA requires EA/CA above 89.9% for approval; AXDX’s mid-90s performance gives confidence entering clinical trial .
  • Strategy on partnerships: Decision to first achieve critical WAVE milestones with financing in place, then maximize value in partner discussions; ongoing engagement with strategics .
  • Cash runway/burn: Pro forma net proceeds mid-$25M; adjusted Q2 burn ~$7M (excluding repayment and one-time partner payment); pursued OpEx cuts to reach ~$5M quarterly operating burn .
  • Commercial transition: Optionality in rapid ID (molecular vs. MALDI via ARC) to pair with WAVE susceptibility; expected customer transitions as WAVE launches .

Estimates Context

  • S&P Global consensus estimates for Q2 2024 revenue and EPS were unavailable for AXDX at the time of analysis; as a result, a formal beat/miss assessment versus Street consensus cannot be provided. Values retrieved from S&P Global were unavailable.
  • Implication: Given limited coverage, investors should focus on internal trajectory (revenue stability, margin mix, OpEx/cash burn progress) and milestone execution as near-term drivers .

Key Takeaways for Investors

  • WAVE’s strong preclinical data and 4.5-hour average time-to-result materially de-risk technical execution; near-term catalyst is clinical trial initiation and subsequent FDA submission progress .
  • Operating discipline is visible: SG&A and R&D are trending down; management targets ~$5M quarterly operating burn, extending runway with $15M financing through 2025 — a key solvency/capacity signal before commercialization .
  • Commercial base (350 live Pheno; 74 contracted in process; ~75% on longer-term contracts) provides an immediate upgrade path and annuity expansion as WAVE launches; consumables grew +12% YoY .
  • Gross margin remains sensitive to instrument mix; expect margin improvement contingent on WAVE mix/throughput and consumable attach over time .
  • Strategic alternatives and deferral of partnership until milestones may unlock better valuation/terms; retention of PWP indicates active review, adding a corporate action catalyst .
  • Street consensus scarcity raises volatility around prints; monitor filings and call updates for milestone timing and cash trajectory until broader coverage resumes .
  • Risk factors: regulatory timelines, complex hospital sale cycles, and execution towards FDA clearance mid-2025; continued OpEx and cash management is critical .