Executive Summary

Q4 revenue of $0.72M grew 61% sequentially (vs. $0.45M in Q3) on FIND collaboration, Unyvero product sales, and Acuitas AMR Gene Panel contracts; FY22 revenue was $2.6M, in line with guidance . Year-over-year, Q4 revenue declined vs. $1.4M in Q4’21 as prior-year included items not repeated in 2022 .
Operating expenses rose to $10.7M in Q4 (vs. $7.2M in Q4’21) due to a $5.4M non-cash impairment of in-process R&D/intangibles; operating loss was $(9.94)M .
2023 guidance: revenue of ~$4–$5M; quarterly net cash consumption of ~$4.5–$5.0M; active EIB debt discussions; FDA de novo submission for Unyvero UTI expected early Q2 2023 with interactive review thereafter .
Strategic catalysts: strong UTI panel clinical performance (96.4% sensitivity/97.4% specificity), Ares Genetics U.S. NGS commercialization starting Q1’23, and BioVersys trial collaboration ramping in 2023–2024 .

What Went Well and What Went Wrong

What Went Well

Sequential revenue re-acceleration: Q4 revenue rose 61% q/q on FIND collaboration, Unyvero products, and Acuitas AMR panel revenue; FY22 revenue met guidance at $2.6M .
Strong UTI clinical data supports FDA de novo submission: weighted average sensitivity 96.4% and specificity 97.4%, with FDA package being finalized for submission early Q2’23 .
Pipeline and commercialization momentum: Ares U.S. NGS lab processed first commercial orders; BioVersys collaboration initiated (systems shipped, training completed) with bulk revenue expected in 2023–2024 .

What Went Wrong

Persistent operating losses with non-cash charges: Q4 operating expenses of $10.7M include $5.4M impairment; operating loss $(9.94)M .
Lower y/y revenues: Q4’22 $0.72M vs. $1.43M in Q4’21 and FY22 $2.6M vs. $4.3M FY21, reflecting termination of FISH line and absence of a one-off ARES database sale recorded in 2021 .
Cash burn and leverage overhang: year-end cash $7.4M (vs. $36.1M prior year); additional EIB tranches due in 2023 and 2024; company guiding to ~$4.5–$5.0M quarterly net cash consumption in 2023 .

Financial Results

Income Statement Summary – Last 3 Quarters

Metric	Q2 2022	Q3 2022	Q4 2022
Revenue ($)	$967,205	$448,713	$721,630
Cost of Products Sold ($)	$646,389	$1,886,191	$495,009
Cost of Services ($)	$15,650	$17,239	$40,955
Gross Margin %	31.6% (computed from )	-324.2% (computed from )	25.7% (computed from )
Operating Expenses ($)	$6,239,410	$13,962,011	$10,657,118
Operating Loss ($)	$(5,272,205)	$(13,513,298)	$(9,935,488)
Basic & Diluted EPS ($)	$(0.13)	$(0.30)	$(3.87)

Notes: Q3 operating expenses include a ~$7.0M goodwill impairment; Q4 includes ~$5.4M intangible impairment (non-cash), impacting comparability .

Revenue Mix – Last 3 Quarters

Revenue Component ($)	Q2 2022	Q3 2022	Q4 2022
Product Sales	$889,271	$359,112	$279,427
Laboratory Services	$20,570	$31,016	$78,118
Collaboration Revenue	$57,364	$58,585	$364,085
Total Revenue	$967,205	$448,713	$721,630

Balance Sheet KPI

KPI	Q2 2022	Q3 2022	Q4 2022
Cash & Cash Equivalents ($)	$16.6M	$10.3M	$7.4M

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue (Products/Services/Collabs)	FY 2023	N/A	~$4–$5M	Introduced
Net Cash Consumption (Operations)	FY 2023 (per quarter)	~$5–$6M/qtr (prior commentary)	~$4.5–$5.0M/qtr	Improved burn guidance
EIB Debt	2023	N/A	In active dialogue to potentially restructure €3M tranche due end-June 2023	New update
Unyvero UTI FDA	2023	UTI data readout/submit in 2023	De novo submission early Q2’23; expect interactive review	Timed submission & next step
FY 2022 Revenue	FY 2022	~$2.5–$3.0M	Actual ~$2.6M; Preliminary ~$2.7M	Achieved/in line

Earnings Call Themes & Trends

Topic	Q2 2022 (Prior-2)	Q3 2022 (Prior-1)	Q4 2022 (Current)	Trend
Unyvero UTI FDA path	Enrolled >1,300; aiming 1,500; plan FDA submission post readout	Enrollment complete; anticipate Dec data unblinding; FDA submission early 2023	Sensitivity 96.4%/specificity 97.4%; de novo submission package finalized for early Q2’23	Advancing to submission
Ares Genetics U.S. NGS	U.S. service lab launch planned; process validation underway	Launched ARESiss in U.S.; internal UTI sequencing; sales funnel growing	First customer orders processed; revenue started Q1’23	Commercial traction building
FIND collaboration (A30)	New R&D collaboration; feasibility phase by Q1’23	Feasibility to conclude by end-March; €700k funding; revenue recognition Q4/Q1	Milestones achieved; €200k received Q1’23; further €300k expected; discussing follow-on contract	Executing; potential expansion
BioVersys clinical trial	Announced collaboration	Trial expected to start early 2023; a “couple hundred thousand” revenue over 18+ months	Systems shipped; training completed; revenue to ramp in 2023–2024	Moving into execution
China (NMPA/HPN)	COVID-related delays; pending update	New e-filing regime; 24–30 mo timeline; ~10–12 mo clinical	Post zero-COVID shift may enable trial start; unchanged 8-year, up to $180M distribution contract	Re-opening creates path
Hospital procurement	Post-COVID backlog lengthening cycles (implied) —	Expect new contracts; signing slower than anticipated	Hospitals taking longer; several contracts in final review	Gradual normalization expected

Management Commentary

“Preliminary analysis… showed… weighted average sensitivity of 96.4% and… specificity of 97.4%… used to prepare a submission package for the FDA de novo request” — Oliver Schacht, CEO .
“Q4 2022 revenue… approximately $722,000… a 61% increase over… Q3 2022 revenue of $449,000… due to… FIND… Unyvero… and Acuitas AMR Gene Panel contracts” — Albert Weber, CFO .
“We expect revenue from our products, services and collaborations globally for 2023 to be… approximately $4 million to $5 million” — CFO .
“Hospitals have a significant backlog… taking longer… to complete contracts… we have multiple contracts… in final review” — CEO .
“We believe we’re well positioned to… expand… AI models to predict antibiotic susceptibility from genomic data” — CEO on ARESdb/AI .

Q&A Highlights

Ares Genetics revenue potential: first U.S. pilot for ~200 isolates over ~90 days at a large health network; goal to scale to “several thousand isolates per year” if pilot succeeds, implying several hundred thousand dollars annually per key account .
FIND milestones: feasibility expected to conclude with an additional ~€300k milestone; follow-on deal under discussion to fund development/clinical/regulatory for A30 in LMICs .
China opportunity: unchanged 8-year post-NMPA opportunity up to $180M; plan to initiate clinical in 2023 post zero-COVID policy change .
Gross margin outlook: at scale, 60–70% for consumables; P&L may be distorted by inventory reserve adjustments in the interim .
2023 revenue guidance context: $4–$5M includes current FIND contract but excludes any follow-on FIND contracts .

Estimates Context

Wall Street consensus for Q4 2022 revenue and EPS via S&P Global Capital IQ was unavailable for OPGN at the time of analysis (no CIQ mapping returned). As a result, no estimate comparison is provided; coverage for microcaps can be limited [GetEstimates error].

Key Takeaways for Investors

Sequential recovery: Q4 revenue inflected +61% q/q on collaboration and product traction; FY22 revenue aligned with guidance, setting a low base for 2023 growth .
Regulatory catalyst: UTI panel’s strong clinical performance underpins a near-term FDA de novo submission; positive FDA interactions would be a material de-risking event .
Commercial funnel: Ares U.S. NGS services and BioVersys clinical deployment should contribute in 2023–2024; hospital purchasing cycles remain elongated but multiple contracts are in final review .
Cash and burn: Year-end cash was $7.4M; company guides to ~$4.5–$5.0M quarterly net cash consumption and is negotiating EIB debt restructuring—financing and balance sheet remain central watch items .
Non-cash charges affected optics: Q3 goodwill and Q4 intangible impairments increased operating expenses; underlying R&D and G&A trended lower y/y, highlighting cost discipline .
China optionality: With reopening, the NMPA clinical may start; the long-dated, up to $180M distribution agreement provides strategic upside if execution proceeds .

Appendices

Full-Year 2022 Snapshot (as disclosed)

Metric	FY 2022	FY 2021
Total Revenue ($)	$2,607,293	$4,306,031
Operating Expenses ($)	$37,174,025	$27,579,067
Net Loss ($)	$(34,805,712)	$(34,805,712)
Cash & Equivalents (12/31) ($)	$7,440,030	$36,080,392

Disclosures: Management noted FY22 revenue “in line” with guidance; the decline vs. FY21 reflects the 2021 FISH product line termination and a one-off ARES database sale in 2021 .

OPGEN INC (OPGN)·Q4 2022 Earnings Summary