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US momentum offset by one-time items

OpGen 16 May 2022 Update
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OpGen

US momentum offset by one-time items

Earnings update

Pharma & biotech

16 May 2022

Price

US$0.32

Market cap

US$16.6m

Net cash ($m) at 31 March 2022

8.3

Shares in issue

46.6

Free float

92.5%

Code

OPGN

Primary exchange

NASDAQ

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(50.3)

(62.7)

(82.6)

Rel (local)

(45.1)

(59.1)

(82.3)

52-week high/low

US$3.6

US$0.3

Business description

OpGen is primarily a lab diagnostic manufacturer focused on the identification and treatment of 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 AMR Gene Panel and Unyvero, the company has the ability to provide diagnostic results in hours instead of days under legacy technologies.

Next events

Unyvero UTI panel read out data and FDA submission

H222

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

OpGen reported Q122 revenues of $470k, compared to $830k in the prior year period. The decline was largely attributable to the discontinuation of the FISH business, the conclusion of the NY Department of Health collaboration and softness in Unyvero international. In contrast, US Unyvero sales increased 76% from the prior year. In light of the current performance and anticipated slower ramp-up in China, we have trimmed our FY22–24 revenue estimates and pushed profitability to FY26 (versus FY24 previously).

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.

Unyvero performance – a mixed bag

Despite the bright spots in the US with the continued build-up of the domestic salesforce, there were several one-time offsets and softness in the international business. Management continues to build international Unyvero sales through its distributor arrangements, the latest being with AnnarDx in Colombia (and potentially other markets in South America). There was no material update to the anticipated supplementary clinical study in China (covering ~600 patients across three sites) required for the approval of the Unyvero hospitalized pneumonia (HPN) test/cartridge from the Chinese authorities (National Medical Products Administration, NMPA). These unanticipated delays are primarily driven by the stringent COVID-19 restrictions. Management anticipates US sales growth to outpace sales abroad driven by continued investments in its US salesforce. We expect this improving mix to have a positive impact on margins.

Acuitas commercialization efforts at full steam

Following FDA clearance in October 2021, OpGen’s legacy Acuitas AMR Gene Panel (Acuitas) has now been launched in the US. Sales efforts remain strong, and the company continues to market to over 400 institutions and 1,000 key stakeholders. Based on the six- to 12-month anticipated sales cycle, we are likely to see the first agreements signed in the next few weeks.

Valuation: $91m or $2.0 per share

Based on the quarterly update and lower cash position, we have adjusted our valuation to $91m or $2.0 per share, from $98m or $2.1 per share, previously. Following advancement in the commercialisation of OpGen’s product portfolio, we have now segregated our NPV valuation into separate products to better reflect their individual contributions to the group valuation. We estimate the $30.7m gross cash at end-Q122 provides an operating runway into 2023, but we project the need to raise a total of $55m before reaching profitability in FY26.

Financials

OpGen reported Q122 revenue of $470k, a 43% y-o-y decline over $830k in the prior year. Lower revenues are attributed to the exit from the fluorescence in situ hybridization (FISH) business at the end of Q121 ($170k in sales in Q121), culmination of the collaboration agreement with the New York State (NYS) Department of Health in September 2021 ($108k in sales in Q121) and lower international sales from the Unyvero business. These declines were offset by stronger than expected US sales (up 76% y-o-y to $154k in Q122).

Overall product sales of $366k declined 40% from the prior year, while laboratory services of $43k declined 56% from the prior year. Softness in laboratory services was attributable to lower requirements for COVID-19 testing. Collaboration revenues of $61k declined 49% from the prior year, mainly due to the conclusion of the NYS Department of Health project.

The company reported operating losses of $5.8m, down slightly from $6.3m in the prior year. Overall operating expenses increased as a percentage of sales with the softness in international sales. As expected, R&D expenses declined 18% to $2.3m following the completion of the Acuitas AMR clinical trials in H221 and lower associated payroll related expenses. G&A expenses were mostly in line with Q121, while S&M expenses increased 17% with the continued investment in the US salesforce to drive commercialization of both Unyvero and Acuitas systems and related consumables. The normalized loss before tax during the quarter stood at $6.8m, broadly in line with the Q121 figure of $7.1m (excluding the $7.8m warrant inducement expense during Q121).

Management previously guided for a 25–50% revenue growth in the Products and Services segment in FY22 (including over 50% growth from the US). Our current estimates assume a slower ramp-up in international sales (including a slower roll out in China with COVID lockdown induced delays). For China, while we maintain our total sales potential expectations (€180m over eight years), we now assume delayed commercialization (mid-2023) and have assumed an 80% probability of approval to factor in the uncertainty. We expect the momentum in volumes/sales to start improving from FY24 with a steady growth thereafter with the continued investments in a dedicated salesforce, which also have an impact on our bottom-line projections. We expect the company to reach profitability in 2026, versus 2024 previously.

OpGen’s subsidiary Curetis and the European Investment Bank (EIB) propose to restructure the first tranche (approximately €13.35m) of debt that matured on 22 April, subject to the finalization of legal agreements. Curetis repaid €5m in cash in April 2022 and the remaining c €8.35m ($9m) is to be paid in equal instalments over the following 12-month period (monthly cash instalments of around €0.7m). The second and third tranches of EIB debt amount to €3.0m ($3.2m) and €5.0m ($5.3m) plus accumulated deferred interest, respectively, and continue to be due for repayment in June 2023 and June 2024.

At the end Q122, OpGen had $30.7m in gross cash and $22.4m in debt. With $11.3m of debt due in FY22 and an estimated upcoming quarterly operating cash burn of c $5m (consistent with the Q122 rate), we estimate the need to raise c $20m in incremental funds in FY23 (incorporated as illustrative debt in our model) excluding expected repayment of EIB debt components. We also project the need to raise another $35m in FY24–25 before reaching the scale to fund operations from internally generated cash flows. This is higher than our previous estimate of $45m and is driven by our more conservative assumptions for the sales ramp-up. These estimates will be revisited as the developmental pipeline and commercialization efforts progress.

Valuation

We have slightly adjusted our valuation from $98m or $2.10 per share to $91m or $2.0 per share. While the implied enterprise value of OpGen’s products/platforms increases to $82.9m from $78.2m, the decline in the overall valuation has been driven by a lower net cash position at the end of Q122. Given that a significant proportion of OpGen’s development pipeline has progressed towards commercialization (including the legacy AMR Gene Panel following the FDA approval in H221), we have now segregated our valuation to reflect contributions from each of these products/segments to the group NPV. Unyvero, as expected, comprises the bulk of our valuation as we now factor in the potential contributions from the complicated urinary tract infection (cUTI) and invasive joint infection (IJI) cartridges, adjusted for their respective probabilities of approval (80% and 50% respectively). This contribution has been tempered by the uncertainty we have now built in for the Chinese market (80% probability of success). Progression on the aforementioned products will create upside opportunities for the company. While OpGen is actively seeking monetization opportunities for its AresDB dataset, accurately valuing the asset given the limited information available currently has proven challenging. We have therefore used the carrying value of the asset in our valuation as the next best alternative. We will update this figure as more information becomes available. Our per share valuation remains largely unchanged at $2.0.

Exhibit 1: OpGen 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

130.9

2040

103.4

 

UTI (US)

Clinical

80%

2024

 

IJI (US)

Preclinical

50%

2025

 

 

Unyvero - China

HPN

Registration

80%

2023

42.2

2040

26.2

Acuitas AMR Panel

AMR

Market

100%

2022

22.2

2040

16.7

AresDB (book value)

Bioinformatics

Market

 

 

 

 

4.8

Unyvero A30 (book value) and others

IJI

Preclinical

 

 

 

 

11.0

Unallocated R&D costs

(25.9)

G&A costs

(53.3)

Net cash (as of March 2022)

 

 

 

 

 

 

8.3

Total firm value

91.2

Total shares outstanding (m)

46.6

Value per share ($)

 

 

 

 

 

 

2.0

Source: Edison Investment Research

Exhibit 2: Financial summary

$'000s

2019

2020

2021

2022e

2023e

Year end 31 December

GAAP

GAAP

GAAP

GAAP

GAAP

PROFIT & LOSS

 

 

Revenue

 

 

3,499

4,214

4,306

5,013

8,113

Cost of Sales

(1,632)

(3,848)

(2,848)

(2,616)

(4,515)

Gross Profit

1,867

366

1,458

2,397

3,598

Sales, General and Administrative Expenses

(8,496)

(12,367)

(13,649)

(12,542)

(10,843)

Research and Development Expense

(5,121)

(9,965)

(10,911)

(9,820)

(8,896)

EBITDA

 

 

(10,829)

(19,631)

(20,388)

(17,363)

(13,925)

Operating Profit (before amort. and excepts.)

 

(11,750)

(21,966)

(23,102)

(19,965)

(16,141)

Intangible Amortisation

0

0

0

0

0

Other

0

0

0

0

0

Exceptionals

(522)

(752)

(171)

0

0

Operating Profit

(12,272)

(22,718)

(23,273)

(19,965)

(16,141)

Net Interest

(178)

(3,294)

(4,754)

(2,857)

(2,889)

Other

2

(66)

(6,735)

0

0

Profit Before Tax (norm)

 

 

(11,928)

(24,742)

(35,742)

(22,823)

(19,031)

Profit Before Tax (reported)

 

 

(12,447)

(26,078)

(34,762)

(22,823)

(19,031)

Tax

0

(132)

(44)

0

0

Deferred tax

0

0

0

0

0

Profit After Tax (norm)

(11,928)

(24,875)

(35,786)

(22,823)

(19,031)

Profit After Tax (reported)

(12,447)

(26,211)

(34,806)

(22,823)

(19,031)

Average Number of Shares Outstanding (m)

1.6

15.8

36.7

46.6

46.6

EPS - normalised ($)

 

 

(7.38)

(1.57)

(1.17)

(0.49)

(0.41)

EPS - Reported ($)

 

 

(7.70)

(1.66)

(1.14)

(0.49)

(0.41)

Dividend per share (c)

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

3,755

32,863

31,924

29,719

27,915

Intangible Assets

1,418

24,606

21,983

20,956

20,001

Tangible Assets

2,133

5,791

5,917

4,738

3,890

Other

203

2,466

4,024

4,024

4,024

Current Assets

 

 

6,667

16,888

39,743

9,487

6,437

Stocks

473

1,486

1,239

1,075

1,856

Debtors

568

653

1,172

961

1,556

Cash

2,708

13,360

36,080

6,200

1,775

Other

2,918

1,388

1,250

1,250

1,250

Current Liabilities

 

 

4,939

7,372

19,917

15,831

14,743

Creditors

4,565

6,673

5,398

6,431

6,224

Short term borrowings

374

699

14,519

9,399

8,519

Long Term Liabilities

 

 

1,190

21,188

10,533

4,067

18,382

Long term borrowings

329

19,379

7,176

996

15,696

Other long term liabilities

860

1,809

3,356

3,070

2,685

Net Assets

 

 

4,293

21,191

41,217

19,308

1,228

CASH FLOW

Operating Cash Flow

 

 

(11,506)

(23,397)

(21,479)

(18,185)

(17,299)

Net Interest

0

0

0

0

0

Tax

0

0

0

0

0

Capex

(32)

(130)

(1,984)

(397)

(413)

Acquisitions/disposals

0

1,267

0

0

0

Equity Financing

13,062

33,793

48,159

0

0

Dividends

0

0

0

0

0

Other

0

0

(266)

0

0

Net Cash Flow

1,524

11,533

24,430

(18,582)

(17,711)

Opening net debt/(cash)

 

 

(3,514)

(2,005)

6,717

(14,385)

4,195

HP finance leases initiated

0

0

0

0

0

Exchange rate movements

(19)

(2)

(5)

(13)

(4)

Other

(3013)

(20,254)

(3,322)

15

(529)

Closing net debt/(cash)

 

 

(2,005)

6,717

(14,385)

4,195

22,440

Source: OpGen, 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 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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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

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).

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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.

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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