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OI

OPGEN INC (OPGN)·Q1 2023 Earnings Summary

Executive Summary

  • Q1 2023 revenue was $0.91M, up 94% year over year and 26% quarter over quarter, driven by FIND collaboration, Unyvero product sales, Acuitas AMR Gene Panel contracts, and Ares service revenues .
  • Operating expenses declined to $6.0M (from $6.3M YoY) and operating loss improved to $(5.07)M versus $(5.85)M YoY; cash was $7.04M at March 31, 2023 .
  • Strategic catalysts: De Novo FDA submission for Unyvero UTI with substantive review initiated, and non-exclusive U.S. distribution partnership with Fisher Healthcare to accelerate Unyvero adoption .
  • 2023 guidance maintained: revenue $4–$5M and net cash consumption ~$4.5–$5.0M per quarter; incremental ~$0.18M FIND revenue expected in Q2 2023 .
  • Street consensus (S&P Global) was unavailable for EPS/revenue; no estimate comparison could be made (S&P Global data unavailable).

What Went Well and What Went Wrong

What Went Well

  • Revenue growth accelerated: $0.91M (+94% YoY; +26% QoQ) with contributions from FIND, Unyvero sales, Acuitas contracts, and Ares services .
  • Regulatory progress: Submitted De Novo request for Unyvero UTI; FDA confirmed complete submission and initiated substantive review .
  • Commercial leverage: Signed distribution partnership with Fisher Healthcare to broaden U.S. coverage and shorten sales cycles; management expects traction and momentum in coming quarters .
  • Quote: “We continue to see revenue growth opportunities for our Unyvero products and Ares Genetics’ services globally and especially here in the U.S.” .

What Went Wrong

  • Business remains loss-making: Q1 2023 net loss $(5.74)M and diluted EPS $(1.25), though improved YoY; cash consumption remains elevated .
  • China commercialization timeline remains extended: NMPA process anticipated at ~24–30 months, with clinical study initiation still forthcoming .
  • Limited visibility on Acuitas customer count and near-term ramp; management declined to quantify new customers and emphasized Unyvero focus via Fisher .

Financial Results

Revenue, EPS, Operating Metrics (last two quarters + current)

MetricQ3 2022Q4 2022Q1 2023
Total Revenue ($USD)$448,713 $721,630 $913,444
Net Loss ($USD)$(14,103,982) $(10,535,120) $(5,736,603)
Diluted EPS ($)$(0.30) $(3.87) $(1.25)
Operating Loss ($USD)$(13,513,298) $(9,935,877) $(5,070,111)
Total Operating Expenses ($USD)$13,962,011 $10,657,507 $5,983,555
Cash & Equivalents ($USD)$10,275,654 $7,440,030 $7,039,375

Revenue Mix

Revenue Component ($USD)Q1 2022Q4 2022Q1 2023
Product Sales$366,052 $279,427 $410,897
Laboratory Services$42,929 $78,118 $21,673
Collaboration Revenue$60,764 $364,085 $480,874
Total Revenue$469,745 $721,630 $913,444

Operating Expense Breakdown (indicative KPIs)

KPI ($USD)Q1 2022Q4 2022Q1 2023
Research & Development$2,316,441 $1,552,125 $1,812,831
General & Administrative$2,625,053 $2,104,311 $2,423,953
Sales & Marketing$1,051,432 $1,092,379 $1,026,087
Weighted Avg Shares2,324,184 2,720,574 4,577,269

Notes: Non-GAAP measures were not disclosed. Margin metrics (gross/EBIT/net) were not reported in the press releases; operating loss and expense trends are shown instead .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Revenue ($USD)FY 2023~$4–$5M ~$4–$5M Maintained
Net Cash Consumption ($USD/quarter)FY 2023~$4.5–$5.0M ~$4.5–$5.0M Maintained
FIND Revenue RecognitionQ2 2023Not previously quantified~ $180,000 expected New/Increased Specificity
FDA De Novo UTI Review2023–2024Submission imminent (Q4 call) Submission filed; interactive review underway Progressed (process milestone)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2022)Previous Mentions (Q4 2022)Current Period (Q1 2023)Trend
Unyvero UTI FDA pathEnrollment complete; data unblinding expected Dec 2022 Finalizing De Novo submission early Q2 2023 De Novo submitted; FDA substantive review initiated; clearance likely in 2024 Advancing through regulatory milestones
Fisher Healthcare distributionNot discussedNot discussedNon-exclusive U.S. distribution to broaden reach; expected traction New channel; commercial leverage
Ares/AI & RSDB datasetsARESiss U.S. launch; services pipeline growing 28% RSDB growth in Q1; U.S. processing started RSDB grew from 102k to >130k datasets; weekly orders; repeat customers Scaling data assets and services
China (A50 HPN)NMPA electronic resubmission; 24–30 month process Clinical initiation targeted; unchanged $180M 8-year potential In-person meetings resumed; timelines still ~24–30 months Re-engagement post-COVID; timeline intact
FIND collaboration (A30)Feasibility phase started; six deliverables Milestones triggered €200k; follow-on discussions All remaining milestones met; short-term expansion to ~$913k project; ~$180k Q2 recognition Expanded scope; near-term revenue
BioVersys trialAnticipated Phase 2 start; revenue “couple hundred thousand” over duration Systems shipped; training complete; revenue expected 2023–2024 Initial revenue recognized in Q1; more trial sites coming Execution phase; ramping

Management Commentary

  • CEO tone: “The beginning of this year has been a news rich period... momentum during the first quarter has carried over to the second quarter.”
  • Distribution channel strategy: “This was not an out-licensing deal... decision driven by desire to significantly broaden and deepen our footprint... upside is faster and broader penetration.”
  • FDA UTI timeline: “Interactive review can take 9–15 months... probably a 2024 clearance decision.”
  • CFO on growth drivers: Revenue increase “primarily due to... FIND collaboration project, Unyvero product sales, ... Acuitas AMR Gene Panel... and Ares related service revenues.”
  • China update: NMPA clearance expected to take ~24–30 months; partners meeting in China and Germany to advance clinical study planning .

Q&A Highlights

  • Thermo Fisher distribution: Clarified as distribution (not out-licensing); objective is broader U.S. market penetration and faster adoption .
  • FIND next steps: Added work packages (~$180k in Q2) and active dialogue on broader follow-on development including clinical trials and regulatory submissions in LMICs .
  • China clinical timeline: Team on-site in China; initial in-person engagement since 2020; study initiation updates pending; overall NMPA timeline ~24–30 months .
  • UTI FDA review expectations: 90-day AI letter expected; clearance likely in 2024 based on de novo process duration .
  • Commercial approach post-clearance: Leverage Fisher’s national footprint; internal sales team will not be significantly expanded; RUO UTI already commercialized .
  • Acuitas customers: No specific counts disclosed; 2023 focus on Unyvero rollout via Fisher .

Estimates Context

  • Wall Street consensus (S&P Global) for EPS and revenue was unavailable for OPGN; therefore no comparison to estimates could be provided (Values retrieved from S&P Global were unavailable due to mapping constraints).
  • Given the strong YoY and QoQ topline growth and maintained FY revenue guidance ($4–$5M), sell-side models may need to reflect increased collaboration revenues (FIND, BioVersys) and potential acceleration from Fisher distribution .

Key Takeaways for Investors

  • Revenue inflection: Collaboration revenue and initial Ares services drove Q1 growth; Fisher distribution should accelerate Unyvero placements and consumables in coming quarters .
  • Regulatory de-risking: UTI De Novo submission accepted; interactive review underway; clearance likely in 2024—near-term catalyst path is clear .
  • China optionality with long runway: NMPA timeline intact; renewed in-person engagement increases execution probability, but commercialization remains medium-term .
  • Cash burn and financing: Net cash consumption guided at $4.5–$5.0M/quarter; recent equity raises bolster liquidity but balance sheet strength remains critical to co-fund non-dilutive grants .
  • 2023 topline visibility: Maintained $4–$5M guidance with incremental ~$0.18M from FIND in Q2; BioVersys trial revenue to continue as sites add; monitor execution against distribution-led Unyvero ramp .
  • Trading implications: Near-term news flow from FDA interactive review (AI letter), Fisher-driven account wins, and FIND expansion could be catalysts; downside risk if China study initiation or distribution traction lags .
  • Medium-term thesis: Platform leverage (Unyvero A50/UTI, A30) plus AI-enabled Ares services position OPGN to shift revenue mix toward higher-margin consumables/services as regulatory clearances and partnerships mature .