OpGen — Clinical peer-review supports the HPN panel

OpGen (NASDAQ: OPGN)

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Research: Healthcare

OpGen — Clinical peer-review supports the HPN panel

A recent peer-review in The Lancet Respiratory Medicine recapped the effectiveness of the Unyvero Hospitalized Pneumonia (HPN) panel in identifying gram-negative bacteria, leading to a reduction in use and duration of inappropriate antibiotic therapy in combination with antibiotic stewardship. This large, clinical investigator-initiated, multi-center, randomized, controlled and interventional study was conducted between May 2017 to September 2019 at two tertiary care centers in Switzerland (University Hospital of Basel and Kantonsspital St. Gallen). We view this announcement as a positive differentiator for the Unyvero HPN panel, which has been marketed in Europe since 2015 and in the United States since late 2019 as a lower respiratory tract bronchoalveolar lavage (LRT BAL) panel.

Jyoti Prakash

Written by

Jyoti Prakash

Analyst, Healthcare

Healthcare

OpGen

Clinical peer-review supports the HPN panel

Research update

Pharma and biotech

27 May 2022

Price

US$0.48

Market cap

US$22m

Net cash ($m) at 31 March 2022

8.3

Shares in issue

46.6m

Free float

92.5%

Code

OPGN

Primary exchange

NASDAQ

Secondary exchange

N/A

Share price performance

Business description

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

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Jyoti Prakash

+44 (0)20 3077 5700

Nidhi Singh

+44 (0)20 3077 5700

OpGen is a research client of Edison Investment Research Limited

A recent peer-review in The Lancet Respiratory Medicine recapped the effectiveness of the Unyvero Hospitalized Pneumonia (HPN) panel in identifying gram-negative bacteria, leading to a reduction in use and duration of inappropriate antibiotic therapy in combination with antibiotic stewardship. This large, clinical investigator-initiated, multi-center, randomized, controlled and interventional study was conducted between May 2017 to September 2019 at two tertiary care centers in Switzerland (University Hospital of Basel and Kantonsspital St. Gallen). We view this announcement as a positive differentiator for the Unyvero HPN panel, which has been marketed in Europe since 2015 and in the United States since late 2019 as a lower respiratory tract bronchoalveolar lavage (LRT BAL) panel.

Year end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/20

4.2

(24.7)

(1.57)

0.0

N/A

N/A

12/21

4.3

(35.7)

(1.17)

0.0

N/A

N/A

12/22e

5.0

(22.8)

(0.49)

0.0

N/A

N/A

12/23e

8.1

(19.0)

(0.41)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

The recently published peer-review in The Lancet Respiratory Medicine recapped the findings of an investigator-initiated, multi-center, randomized, controlled, interventional clinical trial conducted at two centers in Switzerland between May 2017 and September 2019. The clinical study assessed the impact of Unyvero HPN panel (in combination with antibiotic stewardship) in hospitalized adult patients with pneumonia at risk of infection with gram-negative bacteria. Within the scope of the study, 740 pneumonia patients were screened and out of 208 eligible patients, 100 were allocated to the intervention group, where bronchoalveolar lavage (BAL) samples were analyzed using conventional culture and Unyvero HPN panel was used for identifying gram-negative bacteria. The remaining 108 patient samples were analyzed using only traditional microbiology culture (control group).

The study concluded that Unyvero HPN panel with antibiotic stewardship is more effective and results in reducing time on inappropriate antibiotic therapy in patients admitted to hospital with pneumonia and at risk of gram-negative infection. More specifically, the use of Unyvero HPN panel reduced the use of inappropriate antibiotic therapy by 45%, decreased inappropriate therapy time to 47 hours (versus 86 hours in control group) and resulted in a 22.5% shorter overall antibiotic therapy duration for the group using Unyvero panel. The Unyvero panel detected gram-negative bacteria more frequently (39 patients) than traditional microbiology culture (30 patients).

The HPN panel has already been marketed in Europe and United States (as LRT BAL panel) since 2015 and late 2019, respectively, and we see the current publication as supporting the efficacy of the company’s HPN/LRT BAL panels. The study reiterates the importance of quick and timely molecular diagnostics in antibiotic therapy and the underlying contribution of Unyvero systems in this area; this is in line with OpGen’s strategy of rapid and effective diagnosis of infection.

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.

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Copyright: Copyright 2022 Edison Investment Research Limited (Edison).

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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.

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Frankfurt +49 (0)69 78 8076 960

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60325 Frankfurt

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United Kingdom

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1185 Avenue of the Americas

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United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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 2022 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.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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