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Q220 results

OpGen 19 August 2020 Update
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OpGen

Q220 results

Financial update

Pharma & biotech

19 August 2020

Price

US$2.1

Market cap

US$41m

Net debt ($m) at 30 June 2020 plus post-quarter end changes

0.8

Shares in issue

19.7m

Free float

85.2%

Code

OPGN

Primary exchange

NASDAQ

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(4.2)

5.6

(60.8)

Rel (local)

(8.8)

(8.0)

(66.6)

52-week high/low

US$8.0

US$1.0

Business description

OpGen is a diagnostic company focused on revolutionizing the identification and treatment of bacterial infections. Following the merger 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 require.

Next events

Acuitas Gene Panel (isolates) 510(k) clearance

2020

Analysts

Maxim Jacobs

+1 646 653 7027

Wiktoria O’Hare

+1 646 653 7028

OpGen is a research client of Edison Investment Research Limited

OpGen recently reported its Q220 results. Sales were $1.2m, up 18% from Q219, thanks to the inclusion of the Curetis business. Importantly, the company announced in June that it has extended its partnership with the New York State Department of Health for a second year, which will have a contract value of up to $450,000. OpGen also recently announced a strategic partnership with Menarini Silicon Biosystems to co-promote COVID-19 related products in North America.

Year end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/18

2.9

(13.4)

(44.45)

0.0

N/A

N/A

12/19

3.5

(11.9)

(7.38)

0.0

N/A

N/A

12/20e

4.6

(25.8)

(1.63)

0.0

N/A

N/A

12/21e

12.5

(21.2)

(1.05)

0.0

N/A

N/A

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

Progress continues for Ares Genetics

OpGen has an R&D and option agreement for ARESdb with an unnamed leading global in vitro diagnostic (IVD) corporation. Ares has completed all three phases of the R&D program and successfully improved molecular antibiotic susceptibility prediction performance. Importantly, the company has signed a second technology evaluation agreement with another global IVD corporation.

Developing its COVID-19 business

OpGen recently announced a strategic partnership with Menarini Silicon Biosystems to co-promote COVID-19 related products, including an antibody test that provides results in less than 10 minutes. Additionally, Curetis has successfully completed the verification and clinical validation testing of its proprietary, rapid COVID-19 test, which should provide results in less than an hour. Curetis expects to pursue a CE Mark for its product.

510(k) clearance update

In May 2019, OpGen announced it had filed for 510(k) clearance of its Acuitas AMR Gene Panel test in bacterial isolates with the FDA. The process appears to be nearing completion, although there have been delays related to COVID-19. The next deadline for submission of responses to information requests is 13 October 2020. The trial to enable a 510(k) De Novo submission for testing urine samples has been on hold since March, although some sites have recently restarted enrollment.

Valuation: $68.4m or $3.47 per share

We have adjusted our valuation to $68.4m or $3.47 per basic share from $58.7m or $3.91 per share. The total valuation increased mainly due to lower net debt, while the per-share value decreased due to an increase in the number of shares outstanding. The company had $12.9m in gross cash at the end of the quarter and added an additional $3.6m through an at-the-market (ATM) offering and $0.4m through warrant exercises after the end of the quarter.

Quarterly update

OpGen reported revenue of $1.2m for Q220, up 18% compared to $1.0m reported in the same quarter last year. Product sales were up 19% to $0.6m, mainly due to the inclusion of sales of Curetis products (although the company did not break down sales attributable to Curetis vs the organic business). The COVID-19 pandemic hampered sales during the quarter as there were fewer elective procedures at hospitals. Collaboration revenue was up 12%, mainly due to Ares Genetics, which contributed $456,000 through its partnership with a global IVD corporation. Collaboration revenue should improve as the New York State Infectious Disease Digital Health Initiative was renewed for a second year.

R&D expenses increased from $1.2m to $3.0m, while SG&A expenses were up from $2.0m to $3.8m (including $225,000 in Curetis merger transaction costs). OpGen’s Q220 operating loss was $6.5m (vs $4.0m in Q120 and $2.6m in Q219) and the post-tax loss was $7.5m, up from $2.6m in the same quarter last year.

The company announced in June that it had extended its partnership (the New York State Infectious Disease Digital Health Initiative) with the New York State Department of Health for a second year. Up to an additional 3,500 AMR Gene Panel tests are expected to be run and the contract value will be up to $450,000. Testing was put on hold in June due to the pandemic, but participating hospitals are expected to restart testing sometime in Q3.

OpGen recently announced a strategic partnership with Menarini Silicon Biosystems to co-promote COVID-19 related products in the US, Canada and Mexico. The partnership will focus on promoting Menarini’s CELLSEARCH system for the enrichment and enumeration of circulating endothelial cells (CEC) from whole blood. CEC count is used to measure the progression of COVID-19 and potentially in identifying patients at risk of developing more severe complications. Included in this partnership is an antibody test that provides results in less than 10 minutes. The test has received an emergency use authorization from the FDA for use by authorized laboratories. Additionally, Curetis has successfully completed the verification and clinical validation testing of its own proprietary, rapid COVID-19 test, which should provide results in less than an hour. The company expects to pursue a CE Mark for its product and hence it appears that this offering will be focusing on different geographies from the Menarini-based products (co-promotion agreement directed at North America).

Subsidiary Ares Genetics also continues to make progress. It has an R&D and option agreement for its ARESdb platform with an unnamed leading global IVD corporation. The company has now completed all three phases of the R&D program and successfully improved molecular antibiotic susceptibility prediction performance. The partner may now exercise an option for a 90-day exclusive negotiation period for certain partnering, licensing and commercial rights (the option expires in mid-October). Importantly, Ares Genetics has signed a second technology evaluation agreement with another global IVD corporation.

With regards to the Acuitas 510(k) submissions, OpGen announced in May 2019 that it had filed for 510(k) clearance of its Acuitas AMR Gene Panel test in bacterial isolates with the FDA. The process appears to be nearing completion, although there have been delays related to COVID-19. The next deadline for submission of responses to information requests is 13 October 2020.

With regards to the trial that will enable a 510(k) De Novo submission for testing urine samples in the Acuitas AMR Gene Panel, nine sites are under contract and the trial is expected to involve 1,500 samples. By early March, completion of the clinical trial had been anticipated by mid-spring given the rate of accruals, but was put on hold due to the pandemic. Some sites have recently restarted enrollment, although the exact timing for completion of the trial is uncertain (as the progression of the pandemic and its future impact on the healthcare system is uncertain).

One potential issue that has emerged is that the German Federal Ministry for Economic Affairs and Energy (BMWi) has initiated an investigation into the merger with Curetis due to its potential impact on German national healthcare interests in light of the pandemic. The company has responded to all questions and will seek swift completion of the process. While it is theoretically possible for BMWi to try to undo the merger, such actions are extremely rare and seem unlikely in this case as Curetis was having trouble funding itself prior to the merger.

Valuation

We have adjusted our valuation to $68.4m or $3.47 per basic share from $58.7m or $3.91 per share. The total valuation increased mainly due to lower net debt, while the per-share value decreased due to an increase in the number of shares outstanding, as described below.

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

40%

2020

183

2039

100.0%

69.2

Total

 

 

 

 

 

 

 

69.2

Net debt (Q220 plus ATM, warrant exercise and convertible debt conversion)

0.8

Total firm value

68.4

Total basic shares (m)

19.7

Value per basic share ($)

3.47

Options (m)

1.0

Total number of shares (m)

20.7

Diluted value per share ($)

3.30

Source: Edison Investment Research

Financials

Our FY20 revenue estimate has decreased from $7.1m to $4.6m, mainly due to uncertainty regarding the continued impact of the COVID-19 pandemic on product sales, as well as the timeline for 510(k) clearance from the FDA for the Acuitas AMR Gene Panel test in bacterial isolates. We have also made changes to our operating expense estimates for FY20. We have decreased our SG&A estimate by $1.4m due to continued expense controls in this area and increased our R&D estimate by $0.6m. We are largely maintaining our FY21 estimates, which assume a pick-up in the base business as elective surgery volumes recover from COVID-19, as well as new products, such as the Acuitas AMR Gene Panel tests in bacterial isolates and urine.

During Q220, the company raised $5.9m (net) through the issuance of 2.74m shares under its at-the-market (ATM) facility. The company had $12.9m in gross cash at the end of the quarter and subsequent to quarter-end, added an additional $3.6m (net) through the ATM offering and $0.4m through warrant exercises. There is also $18.2m in Q220 debt on the balance sheet. Also, following the end of the quarter, the company issued 0.3m shares following the conversion of $550,000 worth of convertible notes.

Subsequent to the end of the quarter, the company concluded an amendment to its European Investment Bank (EIB) financing facility for an additional €5m tranche. This tranche can be drawn down over the next nine months, and will have a five-year term and 10% interest, which will be payable at maturity. Additionally, on maturity, the EIB will be entitled to an additional equity-linked payment equivalent to 0.7% of the then total equity value of OpGen.

We model an additional financing need of $32.4m ($36m previously) in total through to profitability in FY23 (including $7.4m through the end of FY20 and an additional $12.5m in FY21). As per our policy, we assume future financings are to be funded with illustrative debt.

Exhibit 2: Financial summary

$'000s

2018

2019

2020e

2021e

Year end 31 December

GAAP

GAAP

GAAP

GAAP

PROFIT & LOSS

Revenue

 

 

2,946

3,499

4,567

12,482

Cost of Sales

(1,848)

(1,632)

(2,900)

(4,142)

Gross Profit

1,098

1,867

1,666

8,341

Sales, General and Administrative Expenses

(8,601)

(8,496)

(13,172)

(15,971)

Research and Development Expense

(5,677)

(5,121)

(11,197)

(10,316)

EBITDA

 

 

(13,180)

(11,741)

(22,702)

(17,947)

Operating Profit (before amort. and except.)

 

 

(13,180)

(11,741)

(22,702)

(17,947)

Intangible Amortisation

0

0

0

0

Other

0

10

0

0

Exceptionals

0

(521)

(751)

0

Operating Profit

(13,180)

(12,261)

(23,453)

(17,947)

Net Interest

(186)

(188)

(3,091)

(3,215)

Other

(2)

2

89

0

Profit Before Tax (norm)

 

 

(13,366)

(11,928)

(25,793)

(21,162)

Profit Before Tax (FRS 3)

 

 

(13,368)

(12,446)

(26,455)

(21,162)

Tax

0

0

0

0

Deferred tax

(0)

(0)

(0)

(0)

Profit After Tax (norm)

(13,366)

(11,928)

(25,793)

(21,162)

Profit After Tax (FRS 3)

(13,368)

(12,446)

(26,455)

(21,162)

Average Number of Shares Outstanding (m)

0.3

1.6

15.6

20.1

EPS - normalised ($)

 

 

(44.45)

(7.38)

(1.63)

(1.05)

EPS - Reported ($)

 

 

(44.49)

(7.70)

(1.69)

(1.05)

Dividend per share (c)

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

3,167

3,755

29,184

30,994

Intangible Assets

1,686

1,418

22,943

24,775

Tangible Assets

1,222

2,133

5,932

5,910

Other

259

203

309

309

Current Assets

 

 

5,783

6,667

14,023

5,477

Stocks

544

473

2,898

2,898

Debtors

374

568

231

243

Cash

4,572

2,708

10,894

2,336

Other

293

2,918

0

0

Current Liabilities

 

 

(4,381)

(4,939)

(10,524)

(9,705)

Creditors

(3,983)

(4,565)

(9,705)

(9,705)

Short term borrowings

(399)

(374)

(819)

0

Long Term Liabilities

 

 

(1,260)

(1,190)

(31,686)

(44,316)

Long term borrowings

(660)

(329)

(30,386)

(42,886)

Other long term liabilities

(600)

(860)

(1,300)

(1,430)

Net Assets

 

 

3,309

4,293

998

(17,549)

CASH FLOW

Operating Cash Flow

 

 

(11,074)

(11,505)

(22,826)

(18,572)

Net Interest

0

0

0

0

Tax

0

0

0

0

Capex

(137)

(32)

(23)

(24)

Acquisitions/disposals

0

0

1,267

0

Financing

14,128

13,062

23,488

0

Dividends

0

0

0

0

Other

(293)

(3,836)

0

0

Net Cash Flow

2,624

(2,310)

1,905

(18,596)

Opening net debt/(cash)

 

 

(836)

(3,514)

(2,005)

20,311

HP finance leases initiated

0

0

0

0

Exchange rate movements

(13)

4

(326)

0

Other

66

798

-23896

-1643

Closing net debt/(cash)

 

 

(3,514)

(2,005)

20,311

40,550

Source: company reports, Edison Investment Research


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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 £49,500 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 2020 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.

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.

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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

1,185 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 £49,500 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 2020 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

1,185 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

1,185 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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