OpGen — Guidance revision triggered by softer Q322

OpGen (NASDAQ: OPGN)

Last close As at 26/12/2024

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Research: Healthcare

OpGen — Guidance revision triggered by softer Q322

OpGen’s Q322 revenues of $0.4m missed consensus estimates (following a strong Q222 performance), with management attributing the softness to longer than expected sales cycles for ARES and lower Unyvero A50 sales in international markets. Encouragingly though, the quarter was marked by business advancements – signing a second Acuitas AMR Gene Panel commercial contract, completing the UTI test panel patient enrollment in the US, launching ARES sequencing services in the US and announcing collaborations with FIND and BioVersys – which all present monetization opportunities to potentially support revenue uplift starting in FY23. The Q322 miss, however, has triggered a guidance downgrade, with FY22 revenue expected to be $2.5–3.0m (previously 25% y-o-y growth; c $4.5m in revenue). In light of these developments, we withdraw our estimates and valuation while we await further clarity on the installed base, revenue mix and margins.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

OpGen

Guidance revision triggered by softer Q322

Q322 results

Pharma and biotech

14 November 2022

Price

US$0.2

Market cap

US$11m

Gross cash (US$m) including net funding proceeds at 3 October 2022

13.3

Shares in issue

56.3m

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 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.

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Jyoti Prakash, CFA

+44 (0)20 3077 5700

Ken Mestemacher, CFA

+44 (0)20 3077 5700

OpGen is a research client of Edison Investment Research Limited

OpGen’s Q322 revenues of $0.4m missed consensus estimates (following a strong Q222 performance), with management attributing the softness to longer than expected sales cycles for ARES and lower Unyvero A50 sales in international markets. Encouragingly though, the quarter was marked by business advancements – signing a second Acuitas AMR Gene Panel commercial contract, completing the UTI test panel patient enrollment in the US, launching ARES sequencing services in the US and announcing collaborations with FIND and BioVersys – which all present monetization opportunities to potentially support revenue uplift starting in FY23. The Q322 miss, however, has triggered a guidance downgrade, with FY22 revenue expected to be $2.5–3.0m (previously 25% y-o-y growth; c $4.5m in revenue). In light of these developments, we withdraw our estimates and valuation while we await further clarity on the installed base, revenue mix and margins.

Year end

Revenue ($m)

EBITDA*

($m)

PBT*
($m)

EPS*
($)

EV/rev

(x)

P/E
(x)

Net debt**

($)

12/20

4.2

(19.6)

(24.7)

(1.6)

2.5

N/A

6.7

12/21

4.3

(20.4)

(35.7)

(1.2)

2.4

N/A

(14.4)

Note: *EBITDA, PBT and EPS are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.

OpGen reported Q322 revenues of $0.4m (down from Q321’s $1.2m) and EBITDA losses of $6.0m (versus a $4.3m loss in Q321). It also wrote off $7.0m in goodwill from the AdvanDx (July 2015) and Curetis (April 2020) acquisitions, reflecting its assessment of the current market valuation of the assets based on progress to date and the outlook. While we await more detail from management, we understand the Q322 miss was due to slower international Unyvero sales as well as longer than anticipated sales cycles for ARES. The revised full-year guidance suggests Q422 revenues will be $0.6–1.1m, which we see as achievable, contingent on the anticipated contribution from the two Acuitas antimicrobial resistance installed systems and improved traction from Unyvero and ARES.

We also anticipate a ramp-up in revenue in FY23, based on our expectation of the two Acuitas systems reaching full capacity, commercial conversions of the strong sales pipeline (Unyvero, ARES and Acuitas) and the contribution from the FIND collaboration ($700k over Q123) and BioVersys clinical trials ($100–200k across 18 months, starting in 2023). Management also anticipates the unblinding of data from the Unyvero UTI trial around year-end 2022 and FDA admission in 2023.

Importantly, OpGen notes that a new Chinese government directive now requires its subsidiary Curetis to resubmit the Unyvero clinical trial application under a new electronic filing system, which could potentially result in the rollout being delayed by 24–30 months. This would push commercialization to 2025, versus our earlier estimate of 2023, and would likely affect our valuation of the company.

We expect the pro forma gross cash balance of c $13.3m (including $3m in net proceeds from the October private placement) to fund operations into Q123 based on anticipated operating cash burn of c $5m per quarter and $700k/month in EIB loan repayment. OpGen will continue to explore other financing opportunities, as well as potential strategic alternative options to strengthen its cash position.

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Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

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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

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United States of America

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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.

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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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