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FDA clearance a step forward

OpGen 17 November 2021 Update
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OpGen

FDA clearance a step forward

Financial update

Pharma & biotech

17 November 2021

Price

US$1.7

Market cap

US$66m

Net cash ($m) at 30 September 2021 + offerings

19.6

Common shares in issue

39.0m

Free float

92.5%

Code

OPGN

Primary exchange

Nasdaq

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(18.7)

(36.3)

(17.1)

Rel (local)

(22.7)

(39.3)

(36.0)

52-week high/low

US$3.58

US$1.65

Business description

OpGen is a diagnostic company focused on revolutionizing the identification and treatment of bacterial infections. Following the business combination with Curetis, the company has technology to detect pathogens and predict resistance. Importantly, both the AMR Gene Panel and Unyvero platforms have the ability to provide results in hours instead of days like current methods.

Next events

Unyvero UTI panel interim analysis

Q122

Analysts

Maxim Jacobs

+1 646 653 7027

Jyoti Prakash

+91 981 880 393

OpGen is a research client of Edison Investment Research Limited

With the recent 510(k) clearance of the Acuitas AMR Gene Panel in bacterial isolates, OpGen has reached the next stage of its corporate evolution. As a reminder, the panel detects 28 genetic antimicrobial resistance (AMR) markers in isolated bacterial colonies from 26 different pathogens and provides genomic profile data much quicker than traditional methods (2.5 hours versus one to four days).

Year end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/19

3.5

(11.9)

(7.38)

0.0

N/A

N/A

12/20

4.2

(25.3)

(1.57)

0.0

N/A

N/A

12/21e

3.8

(30.9)

(0.85)

0.0

N/A

N/A

12/22e

8.3

(25.5)

(0.63)

0.0

N/A

N/A

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

Chinese NMPA approval expected in 2022

OpGen previously announced that the Chinese National Medical Products Administration (NMPA) requested additional clinical data (to be generated in China) prior to approval for the Unyvero A50 pneumonia cartridge. The company believes the study should only take approximately six months to conduct, though the exact start date would depend on the approval of the clinical study design by both the NMPA and OpGen’s partner Beijing Clear Biotech (BCB). Approval and launch are currently expected in 2022.

Registration received in Colombia

OpGen’s partner Annar Health Technologies has gained preliminary registration for the Unyvero A50 system in Colombia. As a reminder, Annar has agreed to purchase a minimum of 10 Unyvero systems over the three-year term following approval. OpGen sold the first Unyvero A50 system and kits to Annar in October.

Unyvero UTI trial interim data in Q122

OpGen has initiated a clinical trial for the Unyvero Urinary Tract Infection (UTI) Panel. The trial is expected to enroll more than 1,500 prospective patient samples. The company plans an interim data analysis after the first few hundred samples are tested prior to proceeding with full enrolment. The interim analysis is expected to be conducted in Q122 with the full trial expected to be completed in 2022.

Valuation: $98m or $2.10 per share

We have adjusted our valuation from $91m or $2.38 per share to $98m or $2.10 per share. The drivers to the change in total valuation include an increase in the probability of success from 40% to 50%. Additionally, there was an increase in net cash following a preferred stock and warrant offering in October that raised $13.9m in net proceeds. This was partially offset by more conservative near-term revenue assumptions as we believe initial orders from BCB may slip into 2023. The per share value fell due to a greater number of shares outstanding (assuming the convertible preferred stock is converted into common).

Q321 update

In October, OpGen received 510(k) clearance from the FDA for the Acuitas AMR Gene Panel in bacterial isolates. The panel detects 28 genetic AMR markers in isolated bacterial colonies from 26 different pathogens and provides genomic profile data much quicker than traditional methods (2.5 hours versus one to four days). The company believes the Acuitas AMR Gene Panel is the first FDA cleared molecular diagnostic panel that detects such a broad panel of AMR markers from isolates. The commercial launch is underway. The company is targeting over 400 institutions and well over 1,000 individual key stakeholders at these institutions directly.

The next FDA submission is expected to be for the Unyvero UTI Panel. OpGen has initiated a clinical trial that is expected to include more than 1,500 prospective patient samples. On its earnings call, the company announced plans for an interim data analysis after the first few hundred samples are tested prior to proceeding with full enrolment. The interim analysis is expected to be conducted in Q122 with the full trial expected to be completed in 2022, after which the company will seek clearance from the FDA.

With regards to the planned Unyvero Invasive Joint Infection (IJI) trial, the company has designed the trial and identified study sites but is awaiting feedback from the FDA, which is unlikely prior to 2022 due to the volume of COVID-19 related submissions to the agency.

OpGen previously announced that the Chinese NMPA requested additional clinical data (to be generated in China) prior to approval for the Unyvero A50 pneumonia cartridge. The company believes the study should only take approximately six months to conduct though the exact start date would depend on the approval of the clinical study design by both the NMPA and OpGen’s partner BCB. Approval and launch are currently expected in 2022. As a reminder, BCB has agreed to minimum purchase levels of 360 Unyvero A50 systems as well as more than 1.5m Unyvero cartridges over the duration of the agreement following regulatory clearance by the NMPA. Based on previously agreed transfer price levels, this volume equates to €60m in cumulative revenues from China over the first five years for OpGen and then €30m annually over the following three years (note that these are minimum purchase levels and actual revenues could be higher).

In Colombia, OpGen’s partner Annar Health Technologies has gained preliminary registration for the Unyvero A50 system in Colombia. Annar has agreed to purchase a minimum of 10 Unyvero systems over the three-year term following approval. OpGen sold the first Unyvero A50 system and kits to Annar in October.

Valuation

We have adjusted our valuation from $91m or $2.38 per share to $98m or $2.10 per share. The drivers to the change in total valuation include an increase in the probability of success from 40% to 50%. Additionally, there was an increase in net cash following a preferred stock and warrant offering in October that raised $13.9m in net proceeds. This was offset with more conservative near-term revenue assumptions as we believe initial orders from BCB may slip into 2023 due to NMPA approval potentially coming in late 2022. The per share value fell due to a greater number of shares outstanding. Note that as we assume all the preferred stock will convert into common shares, we have included them in our valuation per share calculation (see additional details in the Financials section of this report).

Exhibit 1: OpGen valuation table

Product

Main Indication

Status

Probability of successful commercialization

Launch
year

Peak sales ($m)

Patent protection

Economics

rNPV
($m)

OpGen/Curetis Diagnostic Platform

cUTI, lower respiratory

Market (RUO)/registration

50%

2020

183

2039

100.0%

78.2

Total

 

 

 

 

 

 

 

78.2

Pro forma net cash (Q321 + subsequent offerings)

19.6

Total firm value

97.8

Total shares (assuming full preferred stock conversion, m)

46.5

Value per share ($)

2.10

Options (m)

18.2

Total number of shares (m)

64.7

Diluted value per share ($)

1.51

Source: Edison Investment Research

Financials

OpGen reported Q321 revenue of $1.2m, up 17% compared to the prior year. Product sales increased 7% to almost $644,000 due to an increase in Unyvero sales, though this was offset by OpGen’s exit from the fluorescence in situ hybridization (FISH) business at the end of Q121. Laboratory Services increased 71% to almost $193,000 due to an increase in Ares Genetics’ laboratory services as well as due to COVID-19 testing services. Collaboration revenue increased 18% due to an increase in Ares Genetics collaboration revenue.

R&D expenses were down 2% to $2.4m due to reduced expenses related to Acuitas AMR clinical trials. SG&A expenses were $3.1m, down 6% compared to the same period a year ago due to a decrease in payroll expenses. OpGen’s net loss for the quarter was $6.1m, an improvement from the $7.7m loss seen in Q320.

Following these results, we have increased our FY21 revenue expectations by $0.5m due to the strong quarter. However, we have reduced our FY22 revenue estimates by $8.3m as some of the initial orders from BCB may slip into 2023 as NMPA approval may not happen until 2023 (it is a six-month study but it still needs to have the clinical trial design signed off by both BCB and the NMPA and it will also take some time to have everything in place for its initiation). We have also lowered our R&D and SG&A expense estimates for FY21 by $0.6m apiece. We have left our FY22 R&D estimate the same but lowered our forecast SG&A by $4.7m as we no longer expect a significant expense ramp compared to FY21. The company has stated on its earnings call that it will be in a better position to provide guidance on FY22 revenue and expenses on its annual results conference call in March 2022.

The company had $25.4m in gross cash (and $21.2m in debt) at the end of Q321. Subsequent to the end of the quarter, the company sold 680,000 shares for net proceeds of $1.5m in an at-the-market (ATM) offering. Additionally, the company conducted a preferred stock and warrant offering that raised $13.9m in net proceeds ($15m gross). As part of the transaction, a single healthcare institutional investor was issued 150,000 shares of convertible preferred stock and warrants to purchase up to 7.5m shares of common stock. The preferred shares convert into 7.5m common shares at a conversion price of $2.00 per share at any time after the company has received stockholder approval to increase the number of authorized shares of common stock. The warrants have an exercise price of $2.05 per share and will become exercisable either on the date of stockholder approval or six months following the date of issuance, whichever is later. They expire five years following the initial exercise date. There will be a special meeting of stockholders on 8 December 2021 to approve the proposed increase of the number of authorized shares of common stock from 50m to 100m.

We forecast that OpGen will need to raise approximately $45m in additional capital prior to reaching profitability (up from $30m due to more conservative revenue estimates in the near term), which we now expect to occur in 2024 (previously 2023). The precise amount raised will depend on the timing of Chinese and FDA approvals, and whether it uses cash on hand to repay the $25.4m (nominal value) in long-term debt obligations owed to the European Investment Bank (EIB) prior to sustainable profitability (repayments related to the €10m first tranche of the EIB loan taken out in April 2017 are due in April 2022 and will also include deferred interest). Note that these long-term debt obligations are higher in nominal value than the carrying value on the balance sheet due to an unamortized debt discount.

Exhibit 2: Financial summary

$'000s

2019

2020

2021e

2022e

Year end 31 December

GAAP

GAAP

GAAP

GAAP

PROFIT & LOSS

Revenue

 

 

3,499

4,214

3,807

8,300

Cost of Sales

(1,632)

(3,848)

(5,511)

(5,810)

Gross Profit

1,867

366

(1,704)

2,490

Sales, General and Administrative Expenses

(8,496)

(12,367)

(13,550)

(14,096)

Research and Development Expense

(5,121)

(9,965)

(10,914)

(11,569)

EBITDA

 

 

(11,741)

(21,966)

(26,169)

(23,174)

Operating Profit (before amort. and except.)

 

 

(11,741)

(21,966)

(26,169)

(23,174)

Intangible Amortisation

0

0

0

0

Other

10

0

0

0

Exceptionals

(521)

(752)

(171)

0

Operating Profit

(12,261)

(22,718)

(26,340)

(23,174)

Net Interest

(188)

(3,294)

(4,711)

(2,296)

Other

2

(66)

(6,963)

0

Profit Before Tax (norm)

 

 

(11,928)

(25,260)

(30,880)

(25,471)

Profit Before Tax (reported)

 

 

(12,446)

(26,078)

(38,014)

(25,471)

Tax

0

(132)

0

0

Deferred tax

(0)

(0)

(0)

(0)

Profit After Tax (norm)

(11,928)

(25,392)

(30,880)

(25,471)

Profit After Tax (reported)

(12,446)

(26,211)

(38,014)

(25,471)

Average Number of Shares Outstanding (m)

1.6

15.8

36.3

40.6

EPS - normalised ($)

 

 

(7.38)

(1.57)

(0.85)

(0.63)

EPS - Reported ($)

 

 

(7.70)

(1.66)

(1.05)

(0.63)

Dividend per share ($)

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

3,755

32,863

34,617

38,251

Intangible Assets

1,418

24,606

24,781

26,576

Tangible Assets

2,133

5,791

6,300

8,140

Other

203

2,466

3,536

3,536

Current Assets

 

 

6,667

16,888

34,456

22,833

Stocks

473

1,486

1,357

1,357

Debtors

568

653

751

830

Cash

2,708

13,360

30,028

18,326

Other

2,918

1,388

2,320

2,320

Current Liabilities

 

 

(4,939)

(7,372)

(19,166)

(8,148)

Creditors

(4,565)

(6,673)

(4,498)

(4,498)

Short term borrowings

(374)

(699)

(14,668)

(3,650)

Long Term Liabilities

 

 

(1,190)

(21,188)

(9,824)

(36,485)

Long term borrowings

(329)

(19,379)

(6,484)

(32,834)

Other long term liabilities

(860)

(1,809)

(3,339)

(3,651)

Net Assets

 

 

4,293

21,191

40,083

16,450

CASH FLOW

Operating Cash Flow

 

 

(11,505)

(23,397)

(26,676)

(21,625)

Net Interest

0

0

0

0

Tax

0

0

0

0

Capex

(32)

(130)

(1,825)

(1,898)

Acquisitions/disposals

0

1,267

0

0

Financing

13,062

33,793

48,224

0

Dividends

0

0

0

0

Other

(3,836)

0

0

0

Net Cash Flow

(2,310)

11,533

19,723

(23,523)

Opening net debt/(cash)

 

 

(3,514)

(2,005)

6,717

(8,876)

HP finance leases initiated

0

0

0

0

Exchange rate movements

4

(1,587)

727

0

Other

798

(18,669)

(4,857)

(3,511)

Closing net debt/(cash)

 

 

(2,005)

6,717

(8,876)

18,159

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 2021 Edison Investment Research Limited (Edison).

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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.

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1185 Avenue of the Americas

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Level 4, Office 1205

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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 2021 Edison Investment Research Limited (Edison).

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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.

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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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