OpGen — Forecasts reset ahead of busy 2023

OpGen (NASDAQ: OPGN)

Last close As at 28/02/2024

USD0.47

−0.02 (−3.53%)

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Research: Healthcare

OpGen — Forecasts reset ahead of busy 2023

OpGen’s FY22 update reflected a busy period for the company following the FY22 preliminary update in January 2023. Top-line performance continued to be affected by longer sales cycles, although the year was marked by traction across the company’s business units. Operating losses rose to $34.6m in FY22, affected by a $12.3m impairment recognized for goodwill and in-process R&D. The adjusted operating loss of $22.2m was an improvement over the FY21 figure of $23.1m, supported by tighter control of R&D and G&A expenses. We expect financing to be a strategic priority in Q223 given the expected cash runway to June 2023 and upcoming debt repayment of the European Investment Bank (EIB) loan (€3m plus interest payments due in June). We revise our estimates to reflect FY22 performance and management’s FY23 revenue guidance of $4–5m. Our valuation stands at $66.7m (vs $67.5m). Our per share valuation adjusts to $12.2/share, reflecting the 1:20 share consolidation.

Adam McCarter

Written by

Adam McCarter

Associate Analyst

Healthcare

OpGen

Forecasts reset ahead of busy 2023

FY22 update

Pharma and biotech

3 April 2023

Price

US$1.33

Market cap

US$7m

Pro-forma net cash (US$m) at 31 December 2022 (including January 2023 net equity raise)

2.4

Shares in issue

5.5m

Free float

92.5%

Code

OPGN

Primary exchange

Nasdaq

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

27.9

(52.8)

(91.1)

Rel (local)

23.6

(55.9)

(90.2)

52-week high/low

US$15.85

US$0.99

Business description

OpGen is primarily a lab diagnostic manufacturer focused on identifying and treating bacterial infections. With the acquisition of Curetis in H120, management has the technology necessary to detect pathogens and predict resistance. Through the dual platform offering of the AMR Gene Panel and Unyvero, the company can provide diagnostic results in hours instead of days under legacy technologies.

Next events

FDA filing for the UTI test panel

Q223

Completion of the FIND feasibility study

Q223

Analysts

Adam McCarter

+44 (0)20 3077 5700

Nidhi Singh

+44 (0)20 3077 5700

Jyoti Prakash, CFA

+44 (0)20 3077 5700

OpGen’s FY22 update reflected a busy period for the company following the FY22 preliminary update in January 2023. Top-line performance continued to be affected by longer sales cycles, although the year was marked by traction across the company’s business units. Operating losses rose to $34.6m in FY22, affected by a $12.3m impairment recognized for goodwill and in-process R&D. The adjusted operating loss of $22.2m was an improvement over the FY21 figure of $23.1m, supported by tighter control of R&D and G&A expenses. We expect financing to be a strategic priority in Q223 given the expected cash runway to June 2023 and upcoming debt repayment of the European Investment Bank (EIB) loan (€3m plus interest payments due in June). We revise our estimates to reflect FY22 performance and management’s FY23 revenue guidance of $4–5m. Our valuation stands at $66.7m (vs $67.5m). Our per share valuation adjusts to $12.2/share, reflecting the 1:20 share consolidation.

Year

end

Revenue
($m)

EBITDA*
($m)

PBT*
($m)

EPS*
($)

P/revenue
(x)

P/E
(x)

Net debt/
(cash) ($m)

12/21

4.3

(20.4)

(35.7)

(23.4)

1.7

N/A

(14.4)

12/22

2.6

(20.6)

(25.3)

(10.4)

2.9

N/A

4.4

12/23e

4.7

(17.7)

(21.0)

(3.8)

1.6

N/A

17.6

12/24e

7.9

(15.3)

(19.6)

(3.6)

0.9

N/A

37.5

Note: *Figures are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments. EPS adjusted for the 1:20 share consolidation in Jan 23.

Several catalysts on the horizon

We expect a strong FY23 for OpGen underscored by several anticipated operational developments, notably the FDA De Novo application for the urinary tract infection (UTI) test panel (early Q223), commencement of the Chinese Unyvero clinical trials (likely H223), completion of the FIND feasibility study for the Unyvero A30 RQ platform (€200k milestone payment received in Q123 and a similar amount expected in mid-2023) and the first commercial revenues from Ares Genetics. We understand that several contracts for Unyvero and Acuitas are in the final stages of negotiations and expect updates on these to represent future catalysts for investor attention.

Funding needs imminent

We calculate OpGen’s year-end net cash balance of $4.4m and $6.8m in net proceeds from the January 2023 equity raise to be sufficient to fund operations to end-Q223, based on our projected burn rates of $4.5–5.0m per quarter. The company is actively seeking non-dilutive financing opportunities and, factoring in upcoming EIB debt repayments (€3m in June 2023, which OpGen is seeking to restructure), we anticipate the need to raise $15m in FY23 and another $45m over FY24–26, before the company turns cash flow positive in FY27.

Valuation: $66.7m or $12.2 per share

We temper our earnings estimates for the forecast years to reflect the FY22 runrate, FY23 guidance and operational visibility. The lower enterprise value as a result has been partially offset by a higher net cash figure and benefits from rolling forward our model. Our revised equity valuation stands at $66.7m or $12.2/share.

OpGen is a research client of Edison Investment Research Limited

UTI test panel: FDA submission likely in Q223

A key near-term catalyst for OpGen, in our view, is the upcoming De Novo filing with the FDA for the company’s Unyvero UTI test panel. In December 2022, OpGen had reported encouraging final data from its Unyvero UTI panel, a diagnostic test designed to detect pathogens and antimicrobial resistance markers related to UTI, from native urine specimens without the need for culturing. The study, which recruited over 1,800 patient samples across four trial sites in the United States, met its primary endpoint with an overall weighted average sensitivity of 96.4% and specificity of 97.4% in preliminary analysis, when compared with the trial sites’ standard of care microbiology results. As a reminder, the UTI clinical trial, initiated in Q321, was conducted on 1,858 prospective patient samples across four US sites with over 3,300 Unyvero UTI cartridges used, including for controls. The primary objective was to test the effectiveness of the Unyvero UTI panel in identifying UTIs using clean-catch or catheter-related urine samples.

Complicated UTIs are one of the most prevalent hospital-acquired infections, with a rising number of infections caused by antibiotic-resistant bacteria. The Unyvero UTI panel tests for a broad range of bacterial and fungal pathogens as well as antimicrobial resistance markers (25 pathogens and 15 resistance genes) directly from native urine specimens, without the need for culturing, resulting in much quicker turnaround times (four to five hours versus days in the case of culture-based tests). This is a key advantage in our opinion as early diagnosis remains crucial for effective treatment and should lead to more optimal usage of available antibacterial treatments, decreased hospital stays and lower healthcare costs.

Based on the final study data, OpGen is preparing a submission package for the FDA under the De Novo classification, with application filing expected in the coming weeks. For the regulatory submission, the study data will be complemented by the next-generation sequencing (NGS) data, generated by the company’s ARES business team at its Rockville (US) laboratory, which processed over 1,200 isolates from the UTI trial. We view the FDA clearance as likely (assigning an 80% probability of approval in our model), which would further validate the company’s Unyvero platform and add an additional revenue stream. Note that the Unyvero UTI panel is already available in the United States as a research use only product to hospitals, public health departments, clinical laboratories, pharmaceutical companies and contract research organizations.

FIND collaboration

Another key growth opportunity for OpGen, albeit in the longer term, is the potential approval, launch and commercialization of its portable benchtop solution, the Unyvero A30 RQ system. OpGen announced an R&D collaboration with FIND (a global non-profit organization for diagnostics) and the German KfW bank in September 2022 for its Unyvero A30 RQ platform for low- and middle-income countries (LMICs). The Unyvero A30 RQ system is OpGen’s sample-to-answer benchtop system designed to test up to 33 diagnostic targets using a one-time disposable cartridge with a turnaround time of 30–90 minutes (two to three minutes of hands-on time). FIND committed to invest €700k in the initial pilot study (€300k of which was recognized as collaboration revenue in FY22) with an option to extend the collaboration, including a potential commercialization agreement. Under the feasibility phase of the project, OpGen, through its German subsidiary Curetis, is to develop a molecular test panel and an easy-to-operate workflow system compatible with currently available blood culture systems in LMICs, as well as modifying certain features of the Unyvero A30 RQ system to adapt to region-specific constraints such as unstable power grids.

As per the latest communication from FIND in January 2023, the Unyvero A30 RQ platform has achieved of a number of milestones (triggering a €200k milestone payment) including successful DNA isolation on the Unyvero A30 cartridge from bacterial strains, 3-plex assays with both pathogen detection and AMR markers and meeting specific requirements for the target product. In addition, device specification for a prototype cockpit optimized for use with the A30 RQ platform has also been defined. OpGen plans to complete all remaining requirements of the pilot phase agreements by Q223, which will trigger another milestone payment of €200k. If successful, the agreement could be expanded to the next phase of development (including clinical studies, followed by regulatory filings and eventual commercialization) with a materially higher level of investment from FIND. Discussions are ongoing between Curetis (OpGen’s subsidiary) and the FIND team for the potential second stage contract, which might cover broader details about the final research and development framework, clinical trials required for regulatory submission, along with regulatory approvals and launch plans in a list of LMICs.

We see this collaboration as another opportunity for OpGen to expand its Unyvero franchise (particularly into developing markets) and make inroads into the benchtop diagnostics systems space.

ARES Genetics

We see the launch of NGS/genome sequencing and analysis services in OpGen’s new Rockville-based service laboratory in August 2022 as a major step towards realizing the commercial opportunity for this business division. The NGS lab, developed by its subsidiary Ares Genetics, offers short-turnaround genome sequencing of clinical isolates and artificial intelligence (AI) powered outbreak analysis that can be conveniently accessed through the company’s AREScloud web application.

Following the completion of the sequencing of close to 1,200 isolates from OpGen’s UTI clinical study, the lab has now commenced commercial services, with the company having received and processed first customer orders in Q123 (which should translate to first commercial revenues from sequencing services). A sizeable opportunity could come from a large health network with affiliated hospitals in the Southeastern United States, with which OpGen has signed a pilot agreement (Q123) to process 200 isolates over a three-month period. Provided the pilot is successful, the company expects the agreement to expand processing to several thousand isolates per year, which should translate to ‘several hundred thousand dollars’ in revenue for the company. Further details will be made available as the deal progresses.

The company also announced that its AMR knowledge database, ARESdb, has grown by 28% in Q123 with a bank of over 130,000 datasets (driven by its partnerships with a European national reference lab and two public health labs in the United States). A growing dataset of isolates should improve the robustness of the company’s AI models to predict antibiotic susceptibility, in our opinion. We note that, ARESdb, while part of the Ares Genetics suite of products, can also be monetized independently, as evidenced by the $600k deal signed with an undisclosed in vitro diagnostics player in November 2021 for non-exclusive access to 1.1% of ARESdb’s dataset.

With the company seeking to expand its Ares Genetics suite of products, we see the segment as becoming a major commercial contributor to the company’s growth in the medium term. As a reminder, in June 2022, OpGen extended its master services agreement with Sandoz (to develop a digital platform for the development and lifecycle management of antibiotics) to 31 January 2025.

Financials

Following positive sales traction in H122, the second half of the year was relatively muted for OpGen, with top-line growth adversely affected by longer than anticipated sales cycles and the overall cautious macroeconomic environment. FY22 revenue of $2.6m was slightly below the mid-point of the guidance range of $2.5–3.0m and c 18% below our estimate. This translated to a 39.5% decline over the FY21 figure of $4.3m, and while the Q422 figure was better than the previous quarter ($0.8m revenue in Q422 vs $0.5m in Q322), it was nearly 50% lower than the $1.4m figure recorded in Q421. The quarter-on-quarter growth in Q422 was primarily driven by the $300k milestone payment under the FIND collaboration, initial revenue from Acuitas commercial contracts and Unyvero product sales.

Products sales, accounting for 73% of total revenue ($1.9m), were down 28.7% y-o-y due to lower Unyvero sales and gradual ramp up to full capacity for the initial Acuitas contracts signed towards the end of the year. Collaboration revenue declined by 35.3% y-o-y to $541k (with contributions primarily coming from the milestone payments under the FIND collaboration), while softer laboratory services (a decline of 78.8% y-o-y to $173k) were due to a decrease in Ares laboratory services and lower testing requirements amid a diminishing impact from COVID-19. Gross margins contracted to -31.3% in FY22, versus 33.8% in FY21, which was primarily affected by higher inventory reserve requirements on account of delays in pneumonia cartridge approval in China.

Total operating loss was reported at $34.6m in FY22, higher than $23.3m in FY21, mainly attributed to impairment of goodwill ($6.9m) and in-process R&D-related intangible assets ($5.4m). The goodwill write-off was related to the acquisitions of AdvanDx (July 2015) and Curetis (April 2020), reflecting OpGen’s assessment of the current market valuation of the assets based on progress to date and the outlook. Excluding these one-off impairment charges, the adjusted operating loss improved to $22.2m in FY22 from $23.1m in FY21 due to lower R&D and G&A expenses. R&D expenses declined 25.1% y-o-y and G&A expenses reduced by 10.6% y-o-y as management implemented cost controls to extend the runway. In line with OpGen’s strategy to focus on self-commercialization in the United States, sales and marketing expenses increased 17.0% y-o-y to $4.3m and we expect this figure to continue to rise as commercialization efforts gather pace. Normalized loss before tax came in at $25.3m, an improvement from $35.7m in FY21.

Forecast revisions

Based on FY22 results and management guidance of $4–5m in revenue in FY23 (based on slower than expected signing of new contracts, ramp-up in utilization of consumables in existing contracts and collaboration agreement deal traction), we revise our forecasts. We have revised our FY23 revenue estimates to $4.7m from $5.3m previously. We also adjust our FY23 estimates for operating expenses, reducing R&D (to $7.8m from $8.2m) and G&A expectations (to $8.4m from $9.3m previously) and increasing our estimates for sales and marketing related expenses (to $4.6m from $3.6m previously). Based on our revised estimates, we project a quarterly operating cash outflow of $4.5m in FY23, in line with management guidance of $4.5–5.0m per quarter. We also introduce FY24 estimates, with revenue projected at $7.9m, factoring in continued sales acceleration for the core Unyvero and Acuitas platforms as well as incremental sales from Ares and other collaboration agreements. The operating loss is estimated at $16.4m in FY24 ($18.8m in FY23). Key changes to our forecasts are highlighted in Exhibit 1.

Exhibit 1: Key change to forecasts

FY21

FY22

FY23e

FY24e

($000)

Actual

Estimated

Actual

Change (%)

Old

New

Change (%)

Estimated

Total revenues

4,306

3,172

2,607

-17.8%

5,283

4,668

-11.7%

7,878

– Product sales

2,657

2,409

1,894

-21.4%

4,549

3,884

-14.6%

7,222

– Lab services

813

163

173

6.1%

146

155

6.1%

140

– Collaboration revenue

836

601

541

-10.0%

588

629

7.0%

517

Gross Profit

1,458

(25)

(817)

nm

2,208

1,953

-11.5%

3,368

Gross margin

33.8%

-0.8%

-31.3%

41.8%

41.9%

42.7%

Adjusted EBITDA

(20,388)

(19,886)

(20,576)

-3.5%

(16,678)

(17,737)

-6.4%

(15,288)

Adjusted EBIT

(23,102)

(22,488)

(22,219)

1.2%

(18,894)

(18,844)

0.3%

(16,361)

Adjusted EPS ($)

(19.47)

(10.22)

(10.37)

-1.5%

(7.52)

(3.83)

-49.1%

(3.58)

Source: OpGen reports, Edison Investment Research

As per the EIB debt restructuring announced in May 2022, OpGen repaid €5m in April 2022 followed by monthly repayments of €700k until April 2023 (April 2023 payout pending) as part of the repayment of tranche 1. A further two tranches worth €3.0m ($3.3m) and €5.0m ($5.5m) plus accumulated deferred interest are due for repayment in June 2023 and June 2024, respectively. OpGen has indicated that it is in dialog with the EIB to restructure the second debt tranche as well, which we anticipate would take a similar form of monthly payouts, if negotiations are successful.

Post period, OpGen effected a 1:20 reverse stock split in January to regain Nasdaq’s compliance of maintaining a minimum threshold price of $1 per share. The stock consolidation resulted in the issued capital reducing from 58m to 2.9m common shares. Following the share consolidation, management announced an equity issue to raise $7.5m in gross proceeds ($6.8m net) against an issue of 2,586,207 common shares or pre-funded warrants priced at $2.90 per share. Following the exercise of 2,265,00 prefunded warrants issued as part of the offering, the current issued common shares stand at 5.5m.

The year-end net cash balance stood at $4.4m (gross cash balance of $7.4m), which has been bolstered by the $6.8m in net proceeds raised in the January 2023 equity issue. Based on management guidance of $4.5–5.0m in quarterly cash burn, we anticipate the pro-forma cash at hand to fund operations to end Q223. We anticipate the need to raise another $15m by mid-2023 and a further $45m over FY24–26, before OpGen reaches the scale to fund operations from internally generated cash flow (FY27). We reflect the capital raise as illustrative debt in our model as per Edison policy. Alternatively, if the funds are raised through an equity issue, we calculate the need to issue 45m shares (at the current trading price of $1.33/share), which would be highly dilutive to existing shareholders. Management has indicated that it is seeking non-dilutive sources of funding.

Valuation

We continue to value OpGen using a risk-adjusted net present value (rNPV) approach for its different business units. We update our valuation for OpGen to reflect the FY22 performance, FY23 management guidance and our projections for business growth thereafter, keeping our underlying assumptions unchanged across the businesses. Given the longer sales cycles experienced and delayed decision-making by customers/hospitals, our revised valuation incorporates a slower sales ramp-up for Unyvero and Acuitas, which results in our peak sales estimates and rNPVs for the two segments decreasing. For Unyvero, we now estimate peak sales (excluding China) of $118m, from $134m previously, with an associated rNPV of $93.0m (previously $98.1m). We continue to estimate a 2024 launch for the UTI test panel in the United States. For Acuitas, our updated projections peg peak sales potential at $17.3m (from $20.2m) and rNPV at $9.0m (vs $14.2m previously).

We see the removal of the COVID-19-related restrictions in China (from January 2023) as a major positive for OpGen, given the magnitude of the deal with Chinese partner Beijing Clear Biotech (purchase commitments of c $180m over an eight-year period for up to 360 Unyvero systems and up to 1.5m pneumonia cartridges) and anticipate clinical studies to initiate in 2023. OpGen had previously indicated that under a new Chinese government directive, Curetis (OpGen’s subsidiary) is required to resubmit the Unyvero clinical trial application under a new electronic filing system. As a result, management anticipates potential launch to take 24–30 months from trial initiation. We therefore push out our launch estimate in China by another year (to 2026) but maintain an 80% probability of approval (we will revisit these assumptions as the regulatory process progresses). We now estimate an rNPV contribution of $18.6m from China (previously $20.5m). For Ares Genetics, for which management has indicated first commercial revenue inflows from Q123, we continue to value the business at carrying value at present. As we gain more clarity and visibility on sales development and traction, we will update our model to reflect the valuation potential. Our revised valuation stands at $66.7m or $12.2/share.

Exhibit 2: OpGen’s valuation

Product

Main indication

Status

Probability of successful commercialization

Launch
year

Peak sales ($m)

Patent protection

rNPV
($m)

Unyvero excluding China

 

 

Lower respiratory

Market

100%

2020

118.3 

2040 

93.0

UTI (US)

Clinical

80%

2024

IJI (US)

Pre-clinical

50%

2025

Unyvero - China

HPN

Registration

80%

2026

36.0

2040

18.6

Acuitas AMR Panel

AMR

Market

100%

2022

17.3

2040

9.0

Aresdb (book value)

Bioinformatics

Market

 

 

 

 

4.8

Unyvero A30 book value and others

IJI

Preclinical

 

 

 

 

8.4

Unallocated R&D costs

(22.9)

G&A costs

(46.2)

Pro-forma net cash (end Dec 2022+Jan 2023 net equity raise) 

 

 

 

 

2.4

Total firm value

66.7

Total shares outstanding (m)*

5.5

Value per share ($)

 

 

 

 

 

 

12.2

Source: Edison Investment Research. Note: *Shares outstanding as of 15 February 2023.

Exhibit 3: Financial summary

Year end 31 December

$'000s

2020

2021

2022

2023e

2024e

PROFIT & LOSS

 

 

 

Revenue

 

4,214

4,306

2,607

4,668

7,878

Cost of Sales

(3,848)

(2,848)

(3,424)

(2,714)

(4,511)

Gross Profit

366

1,458

(817)

1,953

3,368

Sales, General and Administrative Expenses

(12,367)

(13,649)

(13,229)

(13,015)

(12,289)

Research and Development Expense

(9,965)

(10,911)

(8,173)

(7,783)

(7,439)

EBITDA

 

(19,631)

(20,388)

(20,576)

(17,737)

(15,288)

Operating profit (before amort. and excepts.)

 

(21,966)

(23,102)

(22,219)

(18,844)

(16,361)

Exceptionals

(752)

(171)

(12,348)

0

0

Operating Profit

(22,718)

(23,273)

(34,567)

(18,844)

(16,361)

Net Interest

(3,294)

(4,754)

(3,209)

(2,152)

(3,246)

Other

(66)

(6,735)

493

0

0

Profit Before Tax (norm)

 

(24,742)

(35,742)

(25,315)

(20,996)

(19,606)

Profit Before Tax (reported)

 

(26,078)

(34,762)

(37,283)

(20,996)

(19,606)

Tax

(132)

(44)

0

0

0

Profit After Tax (norm)

(24,875)

(35,786)

(25,315)

(20,996)

(19,606)

Profit After Tax (reported)

(26,211)

(34,806)

(37,283)

(20,996)

(19,606)

Average Number of Shares Outstanding (m)

0.8

1.8

2.4

5.5

5.5

EPS - normalised ($)

 

(31.2)

(19.47)

(10.37)

(3.83)

(3.58)

EPS - Reported ($)

 

(33.2)

(22.89)

(15.27)

(3.83)

(3.58)

Dividend per share (c)

0.0

0.0

0.0

0.0

0.0

Gross Margin (%)

9

34

-31

42

43

EBITDA Margin (%)

-466

-473

-789

-380

-194

Operating Margin (before GW and except.) (%)

-521

-537

-852

-404

-208

BALANCE SHEET

Fixed Assets

 

32,863

31,924

15,158

14,665

14,232

Intangible Assets

24,606

21,983

7,441

7,025

6,633

Tangible Assets

5,791

5,917

4,920

4,844

4,803

Other

2,466

4,024

2,796

2,796

2,796

Current Assets

 

16,888

39,743

10,655

7,311

5,004

Stocks

1,486

1,239

1,345

1,023

1,727

Debtors

653

1,172

514

921

1,554

Cash

13,360

36,080

7,440

4,011

367

Other

1,388

1,250

1,356

1,356

1,356

Current Liabilities

 

7,106

19,874

10,588

9,096

3,710

Creditors

1,869

1,307

421

398

411

Short term borrowings

699

14,519

7,024

5,300

0

Current lease liabilities

964

460

378

632

534

Others

3,573

3,588

2,766

2,766

2,766

Long Term Liabilities

 

21,188

10,533

7,646

18,540

39,821

Long term borrowings

19,379

7,176

4,851

16,287

37,910

Non-current lease liabilities

1,539

2,981

2,566

2,024

1,682

Other long-term liabilities

269

375

229

229

229

Net Assets

 

21,458

41,260

7,579

(5,659)

(24,296)

CASH FLOW

Operating Cash Flow

 

(23,397)

(21,479)

(20,450)

(18,175)

(17,265)

Net Interest

0

0

0

0

0

Tax

0

0

0

0

0

Capex

(130)

(1,984)

(591)

(614)

(639)

Acquisitions/disposals

1,267

0

0

0

0

Equity Financing

33,793

48,159

4,072

6,800

0

Other

0

(266)

0

0

0

Net Cash Flow

11,533

24,430

(16,968)

(11,989)

(17,904)

Opening net debt/(cash)

 

(2,005)

6,717

(14,385)

4,435

17,576

HP finance leases initiated

0

0

0

0

0

Exchange rate movements

(2)

(5)

(13)

(4)

6

Other

-20,254

-3,322

-1,838

-1,148

-2,068

Closing net debt/(cash)

 

6,717

(14,385)

4,435

17,576

37,543

Source: Company reports, Edison Investment Research

General disclaimer and copyright

This report has been commissioned by OpGen and prepared and issued by Edison, in consideration of a fee payable by OpGen. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

General disclaimer and copyright

This report has been commissioned by OpGen and prepared and issued by Edison, in consideration of a fee payable by OpGen. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

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