Executive Summary

Q2 revenue was $0.736M, down 23.9% YoY (vs. $0.967M in Q2’22 due to a one-time Unyvero instrument sale last year) and down 19.4% QoQ (vs. $0.913M in Q1’23) .
Operating expenses declined to $5.89M (from $6.24M in Q2’22), but operating loss remained heavy at $5.16M; cash was $3.24M at 6/30/23, and management disclosed substantial doubt about going concern with runway beyond September 2023 absent financing or strategic actions .
Commercial catalysts progressed: U.S. distribution with Fisher Healthcare (training completed; several hundred high-priority leads), FIND collaboration extension, and new contracts totaling potential annualized revenue up to ~$1.5M .
Street consensus (S&P Global) for Q2’23 EPS and revenue was unavailable for OPGN; estimate comparisons cannot be provided (S&P Global data unavailable).

What Went Well and What Went Wrong

What Went Well
- Launched Fisher Healthcare distribution for Unyvero A50; vendor setup and national sales team training completed with several hundred high-priority leads identified, positioning for broader U.S. reach .
- FIND collaboration extended to next phase (full IVD assay development, software, analytical testing); H1’23 recognized $0.609M from FIND; management expects milestone-based payments in the next phase (~10 months; budget up to ~$0.6M) .
- Ares Genetics traction: signed an annual genomic surveillance contract (twice-weekly isolates; initial 1,000–2,000 samples/year; six-figure revenue) and successfully defended a key AMR patent in Europe .
What Went Wrong
- Revenue contracted YoY and QoQ; management attributed the YoY decline partly to the absence of a one-time Unyvero instrument pool sale realized in Q2’22 (Menarini) .
- Liquidity severely constrained: cash $3.24M at 6/30/23; management warned of substantial doubt about continuing as a going concern past September 2023 without financing or strategic actions; EIB debt under temporary standstill to Nov 30, 2023 after partial payment .
- Nasdaq minimum bid price deficiency notice received June 5, 2023, adding listing risk amid capital needs .

Financial Results

Metric	Q2 2022	Q1 2023	Q2 2023
Revenue ($)	$967,205	$913,444	$736,137
Net Loss per Share (EPS, $)	$(2.51)	$(1.25)	$(0.93)
Total Operating Expenses ($)	$6,239,410	$5,983,555	$5,892,493
Operating Loss ($)	$(5,272,205)	$(5,070,111)	$(5,156,356)
Operating Margin (%)	(545.3%) (calc from )	(555.1%) (calc from )	(700.5%) (calc from )
Weighted Avg Shares (Basic & Diluted)	2,328,725	4,577,269	6,246,326
Consensus Revenue ($)	N/A (S&P Global unavailable)	N/A (S&P Global unavailable)	N/A (S&P Global unavailable)
Consensus EPS ($)	N/A (S&P Global unavailable)	N/A (S&P Global unavailable)	N/A (S&P Global unavailable)

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

Revenue mix (segments/categories):

Revenue Category	Q2 2022	Q1 2023	Q2 2023
Product Sales ($)	$889,271	$410,897	$439,672
Laboratory Services ($)	$20,570	$21,673	$44,003
Collaboration Revenue ($)	$57,364	$480,874	$252,462

Operating expense detail (selected KPIs):

Expense Line	Q2 2022	Q1 2023	Q2 2023
R&D ($)	$2,273,756	$1,812,831	$1,388,792
G&A ($)	$2,134,266	$2,423,953	$2,425,007
Sales & Marketing ($)	$1,169,349	$1,026,087	$1,160,200

Liquidity snapshot (end of period):

Metric	Dec 31, 2022	Mar 31, 2023	Jun 30, 2023
Cash & Cash Equivalents ($)	$7,440,030	$7,039,375	$3,237,176

Context: YoY revenue down largely due to the prior-year one-time Unyvero instrument sale to Menarini (Q2’22), while operating expenses trended lower on reduced R&D spend; liquidity declined markedly through Q2 .

Guidance Changes

Metric	Period	Previous Guidance	Current Update (Q2’23)	Change
Global revenues (products, services, collaborations)	FY 2023	~$4–$5M (Q1’23 PR)	Not reiterated in Q2; no numeric update provided	Not reiterated/unclear
Net cash consumption	Per quarter 2023	~$4.5–$5.0M (Q1’23 PR)	No update; management disclosed substantial doubt to continue past Sept’23 without financing	Heightened risk to plan
FIND collaboration revenue cadence	2023	~+$180k recognition in Q2 from added work packages (Q1’23 PR)	H1’23 recognized $609k; next phase budget up to ~$600k over ~10 months with milestone tranches	Extended scope; milestone profile clarified
U.S. channel strategy (Unyvero)	2023+	Fisher distribution announced (Q1)	Vendor setup/training completed; several hundred high-priority leads identified	Progressing

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4’22 and Q1’23)	Current Period (Q2’23)	Trend
FDA/Regulatory (Unyvero UTI De Novo)	Preparing De Novo submission; aiming early Q2’23 (Q4’22) ; De Novo submitted, FDA substantive review initiated (Q1’23)	FDA requested additional info on 6/30; 180 days to respond; targeting full response in Q4’23	Advancing through FDA review; additional data work required
U.S. Commercial (Fisher distribution)	New non-exclusive distribution agreement announced (Q1’23)	Vendor setup complete; national sales training done; several hundred leads; in-territory opportunities in progress	Scaling channel; pipeline building
China/Partnerships	A50 pneumonia path via NMPA (24–30 months) and A30 corporate BD (Q4’22) ; ongoing BD dialogue in China (Q1’23)	Continued outreach to >40 Chinese IVDs; A50 with BCB moving toward clinical studies	Ongoing engagement; long-dated regulatory timeline
Ares Genetics (Services/DB/IP)	U.S. commercialization and ARESdb expansion noted (Q4’22) ; patent grant in China (Q1’23)	Six-figure U.S. surveillance contract (1–2k samples/yr); EPO patent opposition win	Commercial traction + stronger IP
Funding/Liquidity	2022 cash ~$7.4M; guided net cash burn ~$4.5–$5.0M/qtr (Q1’23)	Cash $3.24M at 6/30; substantial doubt about going concern; EIB standstill to Nov 30 after €1M partial payment	Deteriorating; urgent financing need
Non-dilutive funding	Pursuing grants/NGOs (Q4’22/Q1’23)	FIND next phase up to ~$600k; emphasizes need for co-funding to unlock non-dilutive awards	Continuing; contingent on co-funding

Management Commentary

“We extended the collaboration with FIND… and expect to begin full IVD assay development, software development as well as analytical testing during this next phase.”
“OpGen… entered into a strategic nonexclusive agreement with Fisher Healthcare… [we] have already identified several hundred high-priority leads across the U.S., [and] individual, in-depth product sales training… is already underway.”
“We recognized more than $600,000 in revenue from [FIND] in the first half of 2023… the next phase… has an assigned budget of up to approximately $600,000… first payment of about $200,000 became due upon signing.”
“We… have signed commercial contracts totaling potential annualized revenue volume of up to $1.5 million, adding to our topline revenue growth potential.”
“We do not expect that our current cash will be sufficient to fund operations beyond September 2023… there is substantial doubt about OpGen’s ability to continue as a going concern.”

Q&A Highlights

The company held a listen-only call and did not take questions, focusing remarks on commercial execution, regulatory status, and liquidity .
Clarified that FDA requested additional information for the Unyvero UTI De Novo and that OpGen aims to respond in full during Q4’23 .
Emphasized milestones and funding mechanics for the FIND extension (milestone tranches; need for co-funding to access non-dilutive sources) .

Estimates Context

Wall Street consensus (S&P Global) for Q2’23 revenue and EPS was unavailable for OPGN; as a result, we cannot provide beat/miss analysis relative to Street estimates (S&P Global data unavailable).

Key Takeaways for Investors

Revenue fell to $0.736M, with the prior-year comp inflated by a one-time instrument sale; collaboration revenue remains an important lever (FIND) while product momentum is expected to build via Fisher Healthcare’s channel .
Expense discipline (notably R&D) lowered operating expenses, but losses remain significant and operating margins are deeply negative, underscoring the need for scale and mix shift toward higher-margin revenue .
Liquidity is the near-term gating factor: ~$3.24M cash at quarter-end and explicit going-concern language point to urgent financing or strategic action; EIB standstill provides limited time but not a solution .
Commercial setup is improving (Fisher distribution; signed contracts up to ~$1.5M annualized potential), but conversion and timing risk remain amid capital constraints .
Regulatory milestone for Unyvero UTI remains a medium-term catalyst; successful FDA interaction and clearance would materially enhance U.S. commercialization prospects .
Ares Genetics offers a nascent services revenue stream and strengthened IP position; execution on signed surveillance contracts can diversify revenue nearer-term .
Given estimate unavailability and liquidity overhang, stock performance likely hinges on funding visibility (equity, strategic, asset sales) and tangible traction from the Fisher partnership and FIND milestones in 2H’23–early 2024 .

OPGEN INC (OPGN)·Q2 2023 Earnings Summary