Executive Summary

Q3 2023 revenue was $0.70M, up vs Q3 2022 ($0.45M) and modestly down vs Q2 2023 ($0.74M); EPS was -$0.46 with operating loss of -$3.57M .
Liquidity deteriorated sharply: cash was $0.29M at quarter-end and management disclosed substantial doubt about continuing as a going concern; German and Austrian subsidiaries filed for insolvency on November 6, 2023 .
Cost actions implemented: U.S. headcount reduced from 23 to 6; Acuitas AMR Gene Panel discontinued; Fisher Healthcare distribution amended to serve existing Unyvero customers .
Capital actions: $1.0M preferred stock purchase agreement and ~$2.06M gross proceeds from warrant inducement; despite this, strategic alternatives (including potential bankruptcy relief) are being evaluated .
Stock reaction catalyst: explicit going-concern disclosure and insolvency filings are likely to drive event-risk and estimate uncertainty until the financing and strategic path is clarified .

What Went Well and What Went Wrong

What Went Well

YoY revenue growth: Q3 2023 total revenue rose to $0.70M from $0.45M in Q3 2022; operating expenses declined YoY due to lapping the Q3 2022 goodwill impairment charge .
Regulatory progress: Curetis responded to all FDA additional requests for the Unyvero UTI De Novo submission to continue review .
Channel strategy: amended Fisher Healthcare distribution agreement to cover existing U.S. Unyvero customers, preserving commercial touchpoints despite reduced internal sales resources .
Quote (earlier tone): “It's clear the momentum during the first quarter has carried over to the second quarter. We look forward to our near-term strategic goals and continue to focus on executing on our operational and commercial plans.” — Oliver Schacht, CEO (May 15, 2023) .

What Went Wrong

Liquidity crisis: cash fell to $0.29M; management disclosed substantial doubt about the company’s ability to continue as a going concern, exploring financing, restructuring, asset sales, or bankruptcy relief .
Subsidiaries’ insolvency: Curetis GmbH (Germany) and Ares Genetics GmbH (Austria) filed for insolvency on Nov 6, 2023 after unsuccessful sale/capital efforts .
Portfolio contraction and demand mix: Acuitas AMR Gene Panel discontinued; collaboration revenue moderated in Q3 ($0.09M) vs Q2 ($0.25M), pressuring near-term revenue visibility .

Financial Results

Revenue, EPS, Operating Loss, Net Loss vs Prior Periods

Note: Operating Loss Margin % is calculated as Operating Loss / Revenue using reported figures.

Metric	Q3 2022	Q1 2023	Q2 2023	Q3 2023
Revenue ($USD)	$448,713	$913,444	$736,137	$699,022
EPS ($USD)	$(5.92)	$(1.25)	$(0.93)	$(0.46)
Operating Loss ($USD)	$(13,513,298)	$(5,070,111)	$(5,156,356)	$(3,565,625)
Operating Loss Margin (%)	-3010.5% (calc)	-555.0% (calc)	-700.3% (calc)	-510.0% (calc)
Net Loss ($USD)	$(14,103,982)	$(5,736,603)	$(5,827,323)	$(4,062,957)

Segment/Revenue Mix

Metric	Q3 2022	Q1 2023	Q2 2023	Q3 2023
Product Sales ($USD)	$359,112	$410,897	$439,672	$558,965
Laboratory Services ($USD)	$31,016	$21,673	$44,003	$47,135
Collaboration Revenue ($USD)	$58,585	$480,874	$252,462	$92,922
Total Revenue ($USD)	$448,713	$913,444	$736,137	$699,022

KPIs and Cost Structure

KPI	Q1 2023	Q2 2023	Q3 2023
Cash & Equivalents ($USD)	$7,039,375	$3,237,176	$292,642
Total Operating Expenses ($USD)	$5,983,555	$5,892,493	$4,264,647
Interest Expense ($USD)	$(617,298)	$(684,498)	$(396,768)
Weighted Avg Shares	4,577,269	6,246,326	8,778,152
Deferred Revenue ($USD)	$46,003	$27,279	$194,687

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Global Revenue	FY 2023	~$4–$5M total revenue expected	Not reiterated; management disclosed substantial doubt about going concern and is exploring strategic alternatives ; subsidiaries have entered insolvency	Lowered/Withdrawn
Net Cash Consumption per Quarter	FY 2023	~$4.5–$5.0M per quarter from current operations	Cash management initiatives and headcount reduction implemented; no updated numeric guidance provided	Maintained qualitative cost-cutting; numeric guidance not updated
Unyvero UTI De Novo (FDA)	2023 review	Engaged in interactive review toward clearance decision	Responded to FDA additional requests; review continues	Maintained/In progress
FIND Collaboration Revenue	Q2/Q3 2023	~+$180k expected in Q2 from expansion	H1 2023 contribution $609k; Q3 collaboration revenue $92,922	Ongoing; contribution moderated in Q3

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 2023)	Previous Mentions (Q2 2023)	Current Period (Q3 2023)	Trend
FDA UTI De Novo	Submission complete; substantive review initiated	FDA requested additional information; 180 days to respond	Curetis responded to all additional requests; review continues	Progressing but timelines uncertain
Distribution (Fisher Healthcare)	Non-exclusive U.S. distribution agreement signed	Vendor setup, sales training, digital campaigns, leads identified	Amended to allow sales to existing U.S. Unyvero customers	Pivot to channel-led coverage
FIND Collaboration	Scope expanded; milestones met; revenue expected	Contract extension; H1 revenue $609k	Q3 collaboration revenue $92,922	Continuing with smaller near-term contribution
Liquidity/Going Concern	Recent financings ($7.5M and $3.5M) closed; cash consumption guidance provided	Substantial doubt beyond Sept 2023 disclosed	Cash $0.29M; substantial doubt reiterated; strategic alternatives; insolvency of subsidiaries	Worsening
Product Portfolio	Acuitas AMR Gene Panel part of portfolio	Portfolio unchanged	Acuitas AMR Gene Panel discontinued	Contraction
China BD	Strategic advisory engagements with 40+ IVD companies	Active BD campaign ongoing	Not referenced amidst restructuring/insolvency context	Deprioritized

Management Commentary

Cash preservation and restructuring: U.S. headcount reduced from 23 to 6; operations scaled down to core listed-company functions while exploring strategic alternatives, financing, and potential bankruptcy relief .
Regulatory focus: Curetis responded to all FDA queries for the Unyvero UTI De Novo submission to continue FDA review .
Channel emphasis: Amended Fisher Healthcare agreement to serve existing Unyvero customers as internal sales are minimized .
CEO tone from earlier period: “It's clear the momentum during the first quarter has carried over to the second quarter... continue to focus on executing on our operational and commercial plans.” — Oliver Schacht (May 15, 2023) .

Q&A Highlights

Q3 2023: No earnings call transcript available in the dataset; the press release did not reference a Q3 call .
Q2 2023: Management hosted a listen-only call and stated they would not take questions .
Q1 2023: A call with analyst Q&A was scheduled, but no transcript is available in the retrieved documents .

Estimates Context

Wall Street consensus estimates (S&P Global) for Q3 2023 EPS and revenue were unavailable for OPGN in our toolset; as a result, no estimate comparison is provided [SpgiEstimatesError for OPGN in tool output].

Key Takeaways for Investors

Liquidity risk dominates: cash of $0.29M and going-concern disclosure suggest urgent need for financing or strategic transaction; insolvency of Curetis/Ares heightens operational uncertainty .
Revenue mix shifting: product sales strengthened in Q3 ($0.56M), but collaboration revenue moderated ($0.09M), limiting near-term visibility .
Cost base falling: total operating expenses dropped to $4.26M in Q3, reflecting restructuring and lapping of prior impairment, yet loss magnitude remains material vs revenue scale .
Regulatory optionality persists: FDA UTI De Novo process continues and, if successful, could re-open U.S. growth avenues via Fisher Healthcare distribution .
Event-path dependency: outcomes hinge on financing and strategic alternatives; monitor 8-Ks for capital actions and any updates on preferred transaction closing and warrant exercises .
Trading setup: headline risk from going-concern statements and insolvency filings can drive volatility; catalysts include any FDA decision, financing announcements, or asset sale updates .
Thesis consideration: until liquidity is resolved, focus on preservation of core assets (Unyvero/ARES IP), regulatory status, and channel-led commercialization capability under reduced cost structure .

Footnote: Operating Loss Margin % is calculated from reported Operating Loss and Revenue figures in company filings .

OPGEN INC (OPGN)·Q3 2023 Earnings Summary