Sign in

You're signed outSign in or to get full access.

OC

Oncocyte Corp (OCX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 revenue rose to $1.486M (largely pharma services), with 40% gross margin; non-GAAP loss from operations improved to $(4.36)M; GAAP loss was $(33.5)M driven by $41.9M non-cash impairment on legacy oncology assets partially offset by a $13.7M fair value gain on contingent consideration .
  • Management reiterated its shift to transplant diagnostics: de novo FDA pathway confirmed; targeting FDA submission by year-end 2025 and authorization in 2026; clinical trial to enroll roughly 150 biopsy-matched samples across multi-center U.S./EU sites; company aims for 20 centers signed by end of 2025 and remains “about halfway” there .
  • Cash, cash equivalents and restricted cash ended Q4 at $10.336M; subsequent February 2025 raise added $29.1M gross; target cash burn remains ~$(6)M per quarter; Q4 operating cash outflow of $(5.4)M plus $0.2M capex came in better than target .
  • Scientific and reimbursement momentum underpin the thesis: dd-cfDNA publications (NEJM and others), MolDX claims expansion for dnDSA+ monitoring, and Bio-Rad strategic/financial support position OCX for decentralized, in-lab testing adoption; key 2025 catalysts include trial initiation and first commercial RUO orders .

What Went Well and What Went Wrong

  • What Went Well

    • Transplant focus sharpened with clear regulatory path and timeline: “We’re budgeting for 7 months” review under de novo; target submission by year-end 2025 and commercialization in 2026 .
    • RUO traction and product usability: early adopters across U.S./EU/Asia with workflow simplification (“two pipetting steps… about as easy as [any] workflow”), supporting later IVD adoption .
    • Non-dilutive and strategic benefit from pharma services: Q4 pharma services revenue $1.486M at 40% GM (Q1’25 improved to 62% GM), showcasing lab execution and potential partner relationships .

  • What Went Wrong

    • GAAP loss inflated by non-cash impairment ($41.9M) tied to deprioritized oncology assets (DetermaCNI/DetermaIO), highlighting past portfolio drag despite strategic pivot .
    • RUO monetization timing: no Q4 RUO revenue recognized; management does not project material RUO revenue in 2025, pushing revenue inflection to post-authorization .
    • Regulatory/macro uncertainty: management cited federal agency staffing uncertainty; shifted from potential mid-2025 submission to “by the end of this year,” implying a cautious two-quarter push .

Financial Results

  • Headline P&L – Sequential (oldest → newest)
MetricQ2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$0.104 $0.115 $1.486
Gross Profit ($USD Millions)$0.050 $0.050 $0.595
Gross Margin %——40%
Non-GAAP Loss from Operations ($USD Millions)$(4.951) $(5.585) $(4.361)
Net Loss per Share (Basic/Diluted)$(0.36) $(0.98) $(1.93)
  • YoY Comparison (Q4 2023 vs Q4 2024)
MetricQ4 2023Q4 2024
Revenue ($USD Millions)$0.314 $1.486
Gross Profit ($USD Millions)$(0.117) $0.595
Net Loss per Share (Basic/Diluted)$(1.96) $(1.93)
  • Revenue Mix (disclosed source)
CategoryQ2 2024Q3 2024Q4 2024
Pharma Services Revenue ($USD Millions)$0.104 (pharma services) $0.115 (pharma services) $1.5 (pharma services, rounded)
  • Additional KPIs
KPIQ4 2024
Cash, Cash Equivalents & Restricted Cash ($USD Millions)$10.336
Operating Cash Outflow + Capex (Quarter) ($USD Millions)$(5.4) + $(0.2)
Weighted Avg Shares (Millions)17.382
RUO adoption markers (qualitative)Centers in field since July; adoption includes ~9% of German and ~2% of U.S. transplant volumes in early launch phase
  • Non-GAAP reconciliation
    Q4 2024 non-GAAP loss from operations $(4.361)M, adjusting for stock-based comp, D&A, change in contingent consideration, and impairment .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
FDA TimelineSubmission/AuthorizationAiming for FDA clearance late 2025 (best-case) Target FDA submission by end of 2025; authorization in 2026; budgeting ~7 months review under de novo Pushed (timing more conservative)
Centers Signed (Adoption)By end of 2025“More than 20” centers “At least 20” centers; about halfway there Maintained (execution progressing)
Cash Burn Target2025 Run-Rate~$(6)M per quarter (budget discipline) Continue targeting ~$(6)M per quarter; Q2–Q3 expected heavier due to bonuses, S&M, trial start-up Maintained (timing nuance)
RUO Revenue2025Not specifiedNo material RUO revenue expected in 2025; first commercial RUO orders expected later in 2025 Clarified (tempered near-term)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024, Q3 2024)Current Period (Q4 2024)Trend
Regulatory pathwayQ-Sub planned; best-case clearance late 2025; Class II IVD framing De novo path confirmed; budget ~7 months review; submission by YE’25; 2026 authorization Path clarified; timing slightly pushed
RUO adoptionLaunch, beta customers; growing funnel; U.S./EU/Asia interest In-field since July; expanded adoption; usability improvements from feedback Building momentum; product refined
Reimbursement/claimsMedicare reimbursement (VitaGraft) established (context) MolDX claims expansion for dnDSA+ AMR monitoring; TAM expansion via earlier detection Positive reimbursement trajectory
Technology differentiationDigital PCR speed and workflow vs NGS “Two pipetting steps”; easy add where HLA done in-house (75–80% of top centers) Strong ease-of-use narrative
Macro/regulatory risk—FDA staffing uncertainty noted; cautious on timeline Watchful; risk-managed expectations
Oncology portfolioPublications; pipeline maintained with low spend Impairment of oncology intangibles; oncology deprioritized financially Pivot intensifies to transplant

Management Commentary

  • “We’re budgeting for 7 months [FDA review]. … There isn’t [a predicate for dd-cfDNA], so I think we were put on this path because we were the first ones going through.” — CEO, Joshua Riggs .
  • “It’s two pipetting steps, and you’re done. … If you’re doing HLA today, you can do this, no problem.” — CEO, Joshua Riggs .
  • “We are targeting submission to the FDA by the end of this year, followed by FDA authorization in 2026.” — Shareholder letter .
  • “We remain on track … to have at least 20 transplant centers signed up for our assay by the end of 2025.” — Shareholder letter .

Q&A Highlights

  • Regulatory timing and pathway: De novo confirmed; company budgeting ~7 months review; caution added due to federal staffing uncertainty; submission target shifted from mid-2025 to year-end 2025 .
  • Trial design and scale: ~150 biopsy-matched samples; minimum 3 sites for reproducibility; plan to double U.S. sites plus 1–2 EU centers for IVDR; ~20% of samples ex-U.S. .
  • RUO and commercialization cadence: No material 2025 RUO revenue expected; focus on feedback and second-half RUO commercial orders; primary monetization post-IVD .
  • Bio-Rad support: Expected in instruments/consumables; offsets a significant portion of 2025 trial/commercialization spend (no specific $ disclosed) .
  • Adoption dynamics: Expect gradual ramp as centers integrate; faster adoption inside MolDX jurisdiction; largest revenue lift anticipated in 2027 as day-one sites optimize protocols .

Estimates Context

  • S&P Global consensus estimates for Q4 2024 revenue and EPS were unavailable for OCX at this time despite attempted retrieval; as a result, we cannot present a vs-consensus comparison. Values retrieved from S&P Global were unavailable due to missing mapping.
MetricQ4 2024 ActualQ4 2024 Consensus
Revenue ($USD Millions)$1.486 N/A (Unavailable via S&P Global)
EPS (Basic/Diluted)$(1.93) N/A (Unavailable via S&P Global)

Key Takeaways for Investors

  • Transplant-first pivot is firmly in place with de novo FDA pathway and a defined clinical plan; expect submission by YE’25 and authorization in 2026, making interim catalysts (trial site announcements, first patient in, final Q-Sub) especially stock-relevant in 2025 .
  • RUO traction and a simplified digital PCR workflow should lower customer friction and support eventual in-house adoption, a key differentiator vs NGS send-out models; monitor first commercial RUO orders in 2H 2025 .
  • Reimbursement tailwinds (MolDX claims expansion for dnDSA+ monitoring) and growing clinical evidence (NEJM and additional publications) expand TAM and strengthen payer/physician positioning .
  • Near-term P&L is driven by pharma services variability and disciplined cash management; Q4 showed 40% GM on $1.486M revenue; cash burn targeted ~$(6)M/quarter with a bolstered balance sheet post-February financing .
  • Large Q4 non-cash impairment cleans up legacy oncology exposure and aligns capital with transplant; non-GAAP operating loss trended better sequentially; investors should focus on operating metrics and cash runway rather than GAAP noise .
  • Adoption goal (≥20 centers by YE’25) remains on track and ~halfway achieved; confirmation of top-tier U.S. centers in the clinical trial could accelerate institutional confidence and future IVD adoption .
  • Execution risks include regulatory timelines and macro agency capacity; however, Bio-Rad’s strategic and in-kind support partially de-risks trial execution and early commercialization .

Supporting Documents and Data Points

  • Q4 2024 8-K (Press Release/Shareholder Letter and Financials): revenue $1.486M; GM 40%; GAAP loss $(33.5)M with $41.9M impairment and $13.7M contingent consideration gain; non-GAAP op loss $(4.361)M; cash $10.336M; burn/capex within target .
  • Q4 2024 Earnings Call: regulatory path/timing; trial design; RUO monetization expectations; Bio-Rad support; adoption cadence and workflow ease .
  • Prior quarters: Q3 2024 revenue $0.115M (pharma services); non-GAAP op loss $(5.585)M; loss/share $(0.98); Q2 2024 revenue $0.104M; non-GAAP op loss $(4.951)M; loss/share $(0.36) .
  • Relevant Q4 press: dd-cfDNA randomized interventional data reduces time to AMR diagnosis; supports claims expansion with MolDX .