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MarketScreener Homepage  >  Equities  >  Nasdaq  >  OpGen, Inc.    OPGN

OPGEN, INC.

(OPGN)
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OpGen : Corporate Presentation (PDF)

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08/20/2020 | 12:47pm EDT

OpGen

Corporate Overview

August 2020

Forward looking statements disclaimer

This presentation contains forward-looking statements that are subject to many risks and uncertainties. These statements, among other things, relate to our business strategy, goals and expectations concerning our products, future operations, prospects, plans and objectives of management. The words "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "will" and similar terms and phrases are used to identify forward-looking statements in this presentation. These statements and other statements regarding our future plans constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1955. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond OpGen's control, and that may cause results to differ materially from expectations.

Factors that could cause results to differ materially from those described include, but are not limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and service offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the realization of expected synergies from our business combination transaction with Curetis GmbH, the successful integration of our company with the operations and business of Curetis GmbH and its subsidiaries and the implementation of the combined company's strategic and business goals and objectives, the impact of COVID- 19 on our operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, the ability to comply with the complexities of operating a global business, the success of our commercialization efforts, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen's business, please review our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this presentation and speak only as of the date of this presentation. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

©2020 OpGen, Inc.

2

Recent newsflow

OpGen has recently announced several key updates and milestones

  • Curetis has successfully obtained CE IVD marking of its proprietary, rapid SARS CoV-2 PCR test kit - expect to launch in Europe in Q3 and cease distribution of BGIO kit immediately
  • OpGen announced a strategic co-promotion partnership with Menarini Silicon Biosystems to market and sell Menarini's portfolio of COVID-19 related products including the Healgen 10-minute antibody test kit that detects both IgG and IgM
  • OpGen Releases Preliminary Data from Collaboration with Karolinska Institute, Stockholm, Sweden. Investigator-initiated clinical study demonstrates that Unyvero HPN Panel for Pneumonia Identifies Life-Threatening Bacterial Co-Infections in COVID-19 Patients in Just Five Hours
  • OpGen expands partnership with New York State Department of Health and IDC to detect antimicrobial resistant infections
  • OpGen publishes first half year 2020 financial results and provides business update
  • OpGen expects that its submission to the U.S. Food and Drug Administration ("FDA") for clearance of the Acuitas® AMR Gene Panel (Isolates) for the detection of antimicrobial resistance genes in bacterial isolates is nearing completion.
  • Ares Genetics completed all three phases of the R&D program on ARESdb in its R&D collaboration. Won new undisclosed global IVD company for feasibility and technology evaluation. Won Siemens Technology Accelerator and Austrian AGES agency as new customers. Published strong results from its collaborations with Sandoz, Johns Hopkins and Mayo Clinic

©2020 OpGen, Inc.

3

OpGen and its group companies:

Striving to innovate molecular microbiology

Fast

Comprehensive

Smart

Easy

Rapid Pathogen

Broad Pathogen &

AI-Powered AMR

Sample-To-Answer

Detection For Life

Antimicrobial Resistance

Prediction &

Platforms

Threatening Infections

(AMR) Marker Coverage

Bioinformatics

©2020 OpGen, Inc.

4

Combined company's portfolio:

Synergistic products & capabilities

Unyvero Platform

Acuitas Tests &

Global Commercial

Ares Genetics NGS &

& Syndromic Tests

Acuitas Lighthouse

Presence

Bioinformatics

Unyvero FDA-cleared platform for lower respiratory tract infection (LRT & LRT BAL) as well as 5 CE IVD tests; Unyvero A30 RQ platform

in development

Acuitas AMR Gene Panel tests in clinical trials (Urine) and pending FDA clearance (isolates) to improve antibiotic decision making; Lighthouse knowledge base deployed for public health use

Direct sales in U.S., European and China distribution with partners; 18 distributors covering

43 countries; CoV-2 test kit distribution in EMEA

Ares Technology for AI-powered AMR prediction combining ARESdb with NGS; Strategic partnerships with globally leading IVD & pharma companies

©2020 OpGen, Inc.

5

Strategic rationale and benefits

Well positioned to capitalize on global opportunities in infectious disease and rapid AMR detection

Proprietary molecular diagnostic tests and platforms

Premier AI-powered bioinformatics solutions for multi-drug resistance diagnostics

Global commercial channel capabilities & partners

Financial leverage, operational synergies, and positive growth-driven business outlook

©2020 OpGen, Inc.

6

Combined company to address unmet clinical needs and large available market opportunities

U.S. and European markets with ~10 million hospitalized patients annually addressed through hospital-focused sales channels

Pneumonia (HPN/LRT)

Implant and Tissue Infections (ITI)

10M cases

Blood Culture (BCU)

per year

Intra-Abdominal Infections (IAI)

Sepsis Host Response (SHR)

Urinary Tract Infections (UTI)

The current Unyvero portfolio and pipeline of cartridges according to management estimates target about 10 million patients annually in EU and U.S. with additional upside in Asia / Pacific and ROW markets.

©2020 OpGen, Inc.

7

Strategic rationale and benefits

Well positioned to capitalize on global opportunities in infectious disease and rapid AMR detection

Proprietary molecular diagnostic tests and platforms

Premier AI-powered bioinformatics solutions for multi-drug resistance diagnostics

Global commercial channel capabilities & partners

Financial leverage, operational synergies, and positive growth-driven business outlook

©2020 OpGen, Inc.

8

We help fight the COVID-19 global pandemic

SARS CoV-2 Kit with PULB, PCR-compatible universal lysis buffer, COVID-19 pneumonia co-infections

CE-IVD marked SARS CoV-2 Kit with PULB

HPN/LRT cartridges CE marked & FDA cleared for lower respiratory tract infections such as bacterial pneumonia

  • Real-timefluorescent RT-PCR kit for detecting SARS-CoV-2, developed by our team in Germany
  • Time to result in ~1 hour
  • Can be used with RNA isolated by performing standard RNA isolation processes, as well as with oropharyngeal or nasopharyngeal swabs collected in PCR compatible viral transport medium treated with PULB provided in the kit
  • Runs on Real-Time PCR systems such as QuantStudio™ 5 and Bio-Rad CFX96™
  • PCR-compatibleUniversal Lysis Buffer (PULB)
  • Multiplex PCR system capable of detecting COVID-19 bacterial co- infections such as bacterial pneumonia
  • HPN: Coverage of 29 pathogens and 19 resistance markers
  • LRT (LRT BAL): Coverage of 36 (37) pathogens and 10 (10) antibiotic resistance markers
  • Range of sample materials: sputum, bronchoalveolar lavage and tracheal aspirates
  • Results in 4-5 hours

©2020 OpGen, Inc.

9

Sample-to-answerhigh-throughput testing capabilities

Innovating molecular microbiology through proprietary platforms and content

Striving for molecular microbiology innovation

MDx Platforms

MDx Content

**

Unyvero A50

Unyvero A30 RQ*

ARESdb

High-Plex PCR

Low- to Mid-Plex PCR

MDx Content & NGS Applications

Low- to high-plex PCR

Proprietary PCR & NGS applications based on

Broad range of sample types

leading AI-powered AMR knowledgebases

*Unyvero A30 RQ Analyzer in development, latest design concept; final product may differ.

**Pending 510(k), not for diagnostic use.

©2020 OpGen, Inc.

10

Broad Unyvero cartridge portfolio

HPN / LRT BAL*

BCU

Hospitalized

Pneumonia / Lower

Blood Culture

Respiratory Tract Infections

IAI

Intra-Abdominal Infection

UTI

Urinary Tract

Infection

ITI

Implant & Tissue Infection

©2020 OpGen, Inc.

* Unyvero LRT / LRT BAL are FDA cleared -

11

all other products CE IVD marked.

Unique and differentiated syndromic panels

Cartridge

Indication area

Number of targets covered

Sample types

Clearance status

HPN**

Severe cases of

48 targets****,

Sputum, broncho-alveolar lavage, tracheal aspirate

CE-IVD marked

Pneumonia

pathogens (29) and

Singapore (HAS)

antibiotic resistance markers (19)

Thailand

Malaysia

LRT &

Lower Respiratory

LRT (LRT BAL): 46 (47) targets****,

LRT: Tracheal aspirates

LRT: FDA cleared

LRT BAL

Tract Infections

pathogens 36 (37) and

LRT BAL: Bronchoalveolar Lavage (BAL)

(4/2018)

antibiotic resistance markers 10 (10)

LRT BAL: FDA cleared

(12/2019)

ITI

Severe cases of Implant

102 targets,

Sonication fluid, swabs, striche, tissue, pus, aspirate/

CE-IVD marked

and Tissue Infections

pathogens (85) and

exudate, etc.

antibiotic resistance markers (17)

BCU***

Bloodstream infections

103 targets,

Positively flagged blood cultures

CE-IVD marked

pathogens (86) and

Singapore (HAS)

antibiotic resistance markers (17)

Thailand

IAI

Severe Intra-Abdominal

130 targets,

Paracentesis fluids, biliary fluids, peritoneal fluids, drainage

CE-IVD marked

Infections

pathogens (105),

fluids, retroperitoneal fluids, pus, swabs, samples from

toxins (3) and

positively flagged blood culture bottles inoculated with other

antibiotic resistance markers (22)

fluids than blood (IAI fluids such as ascites)

UTI

Severe cases of

103 targets,

Midstream urine, suprapubic aspiration, tissue

CE-IVD marked

Urinary Tract Infections

pathogens (88) and

antibiotic resistance markers (15)

**HPN: Hospitalized Pneumonia ***BCU: Blood Culture Application ****Difference between HPN and LRT (BAL) due to different reporting requirements between CE-IVD and U.S. FDA-cleared products.

©2020 OpGen, Inc.

12

Current U.S. product offerings: Unyvero LRT & LRT BAL

Providing Clear Direction

  • FDA-cleared,sample-to-answer, in less than 5 hours with just about 2 min hands-on time
  • Direct from native specimen, FDA-cleared for bronchoalveolar lavage fluids and tracheal aspirates
  • Multiplex PCR with array detection
  • Detects the most clinically relevant pathogens (incl. atypicals) and antibiotic resistance markers associated with lower respiratory tract infections including pneumonia
  • Broadest carbapenemase resistance coverage
  • The only FDA-cleared LRT panel that detects Pneumocystis jirovecii
  • Critical information for life-saving treatment decisions

©2020 OpGen, Inc.

13

Current U.S. product offerings: Acuitas AMR Gene Panel*

Panel available for RUO in outbreak monitoring and epidemiology settings (for isolates FDA clearance decision pending) - and in clinical trials for cUTI

Detects most deadly superbugs

E. coli, K. pneumoniae, P. mirabilis, P. aeruginosa, E. faecalis

Identifies

Up to 47 Resistance Genes, spanning 9 Antibiotic Classes

Tests

Directly from Urine (in Clinical Trials) or Isolated Colonies (FDA Clearance Decision

Pending), Sample-to-Answer Multiplex PCR from Bacterial Isolates (or Native Urine

Specimen) in under 3 hours

*For Research Use Only. Not for use in diagnostic procedures.

©2020 OpGen, Inc.

14

Unyvero A30 RQ

Rapid sample-to-answer testing platform in development

Platform available for partnering to rapidly create menu of tests and commercial channel(s)

Key Design Features

  • Fully integrated, closed, sample-to-answer MDx platform
  • Universal real-time PCR technology for low- to mid-plex testing
  • Flexible cartridge fluidics for numerous chemistries and assay formats
  • Fast turn-around time of 45-90 minutes
  • Light-weight,stackable benchtop design with small footprint
  • Modular and scalable from 1 to 8 cartridge slots
  • Designed for ease-of-use and flexible deployment in labs and near-patient settings
  • Attractive COGS for instruments and reagents

Development Status

  • Currently working towards clinical proof of concept from sample to answer with various assays including SARS CoV-2
  • Multiplex PCR successfully demonstrated on functional prototypes
  • Manufacturing aspects fully specified and in development or implementation phase
  • Curetis aims at having Unyvero A30 RQ platform ready for partnering in 2020

©2020 OpGen, Inc.

15

Strategic rationale and benefits

Well positioned to capitalize on global opportunities in infectious disease and rapid AMR detection

Proprietary molecular diagnostic tests and platforms

Premier AI-powered bioinformatics solutions for multi-drug resistance diagnostics

Global commercial channel capabilities & partners

Financial leverage, operational synergies, and positive growth-driven business outlook

©2020 OpGen, Inc.

16

Ares Genetics & ARESdb*

Bioinformatics powerhouse with industry-leading proprietary AI-powered AMR knowledgebase for molecular microbiology

*In development; For Research Use Only. Not for use in diagnostic procedures.

©2020 OpGen, Inc.

Global ARESdb Database

  • Unique Knowledgebase on Antibiotic Resistance Markers building on SIEMENS Microbiology Strain Collection
  • Demonstrated up to > 99 % Accuracy for Antibiotic Susceptibility Prediction in evaluation studies
  • Based on > 55,000 Pathogens and associated Resistance Data for > 100 Antibiotics

First RUO applications launched through NGS service laboratory and cloud platform

Partners and customers include globally leading IVD & pharma companies

17

Acuitas Lighthouse®: Diagnostics data management platform for antibiotic resistant pathogens*

Successfully met all development

Cloud-based bioinformatics platform

milestones under 1st year contract -

powers our ability to trace AMR

potential state-wide

in real-time with the potential to change

AMR surveillance network and expanded

the landscape of clinical infectious

the partnership for 2nd year contract term -

Rapid molecular

disease management and improve

Currently discussing re-start of testing post

antibiotic resistance prediction

outcomes for patients

COVID-19 related testing pause at all sites

*In development; For Research Use Only. Not for use in diagnostic procedures.

©2020 OpGen, Inc.

18

Strategic rationale and benefits

Well positioned to capitalize on global opportunities in infectious disease and rapid AMR detection

Proprietary molecular diagnostic tests and platforms

Premier AI-powered bioinformatics solutions for multi-drug resistance diagnostics

Global commercial channel capabilities & partners

Financial leverage, operational synergies, and positive growth-driven business outlook

©2020 OpGen, Inc.

19

Dual commercial model

Leveraging synergies from our now combined commercial team structures

Multiple products to same hospital call points via same sales channel to drive synergies and cost efficiencies

Direct Partners

Expanding global commercial reach though direct sales in U.S. and via global distributors

Direct sales in the U.S.

European distribution through Menarini Diagnostics

China distribution through Beijing Clear Biotech

26 distributors covering 45 countries in EU, ME, LATAM, and Asia

EMEA distribution and sales of BGI's SARS CoV-2 test kits

©2020 OpGen, Inc.

20

Pan-European distribution via Menarini

Currently 11 EU countries - option to expand relationship to further EMEA markets and additional product lines

Menarini Diagnostics

Other distributors

Menarini Diagnostics & Curetis

Collaboration (since Q1-2019)

Covers entire Unyvero A50 product line

Currently covered countries:

BE, CH, DE, ES, FR, IT, LU, NL, PT,

UK, GR

Option to expand relationship to further EMEA countries

©2020 OpGen, Inc.

21

OpGen and MSB Co-MarketCOVID-19 Antibody Test Kit

OpGen is marketing and promoting CELLSEARCH system, CELLSEARCH CEC kit, and certain COVID-19 related products sold and distributed by Menarini Silicon Biosystems

Co-Promotion Agreement

  • OpGen is authorized to market and promote such products in the United States, Canada, and Mexico under a strategic co-promotion agreement entered into by OpGen and MSB
  • COVID-19related products include an IgG/IgM Rapid Test Cassette that is manufactured by Healgen and sold by MSB, which is an antibody test that provides results in as fast as 10 minutes
  • IgG/IgM Rapid Test Cassette has been authorized by the FDA under an emergency use authorization for use by authorized laboratories
  • The test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens
  • Under the terms of the co-promotion agreement, OpGen is entitled to certain payments based on MSB's net sales from customers referred by OpGen for such products, including the IgG/IgM Rapid Test Cassette
  • The parties expect to continue to expand the portfolio of COVID-19 products available as part of the non-exclusiveco-promotion relationship

©2020 OpGen, Inc.

22

Strategic rationale and benefits

Well positioned to capitalize on global opportunities in infectious disease and rapid AMR detection

Proprietary molecular diagnostic tests and platforms

Premier AI-powered bioinformatics solutions for multi-drug resistance diagnostics

Global commercial channel capabilities & partners

Financial leverage, operational synergies, and positive growth-driven business outlook

©2020 OpGen, Inc.

23

Financial considerations as of June 30, 2020

Proforma Combined Revenue:

  • FY 2018 revenues of $4.5
  • FY 2019 revenues of $6.0 million
  • H1 2020 revenues of $2.8 million

Reported Revenue:

  • 2Q 2020 revenues of $1.2 million
  • H1 FY revenues of $1.8 million (excluding $1.0 million of Curetis revenue during Q1 2020)
  • No revenue guidance for 2020 at this time due to COVID-19 situation

Cash position:

  • June 30, 2020- $12.9 million
  • Cash raised via ATM and warrant exercises through June 2020 - $20.1 million
  • ATM gross capacity - $3.7 million
  • ATM gross capacity reset for another $ 6.4 million
  • EUR 5 million tranche in non-dilutive debt financing for COVID-19 related R&D from the European Investment Bank (EIB)
  • Warrants outstanding - 1,033k (864k at average price of $2.16)
  • Cash Burn - estimated to be approximately $5.0-$6.0 million per quarter

Capital Structure - Shares Outstanding

  • Common Stock - 17,693,932
  • Warrants - 1,033,386 (864,000 warrants avg. exercise price $2.16)
  • Convertible - 311,003
  • Equity Awards - 152,189
  • Fully Diluted Shares Outstanding - 19,190,510

©2020 OpGen, Inc.

24

Operations

Other Key Items

  • 20,000 sq. ft. Corporate HQ and FDA registered R&D/ manufacturing facility in Gaithersburg, Maryland, USA
  • 17,000 sq. ft. FDA registered R&D, operations and G&A facility in Holzgerlingen, southern Germany
  • 17,000 sq. ft. FDA registered manufacturing facility in Bodelshausen, southern Germany
  • 15 Acuitas AMR Gene Panel system placements in the U.S.
  • Legacy FISH products from AdvanDx sold via combined U.S. commercial team and via Curetis GmbH in Europe
  • ~170 Unyvero Analyzer placements globally

Employee count:

  • Approximately 110 employee's globally:
    • ~57 R&D, Operations, SW & Bioinformatics
    • ~20 Manufacturing, QM /QA /QC & RA
    • ~18 Sales & Marketing
    • ~15 General & Administration

©2020 OpGen, Inc.

25

OpGen Inc. executive leadership team and board

Team has decades of experience in precision medicine, molecular diagnostics and capital markets

Chief Executive Officer: Oliver Schacht, Ph.D.

Chief Financial Officer: Timothy (Tim) C. Dec

Chief Operating Officer: Johannes (Jan) Bacher

Board Members: William (Bill) Rhodes (Chairman)

Evan Jones

Mario Crovetto

Don Elsey

Prabhavathi Fernandes, Ph.D.

Oliver Schacht, Ph.D. (CEO)

©2020 OpGen, Inc.

26

Upcoming milestones, newsflow & catalysts

Unyvero & Acuitas® rapid molecular tests

  • Final study data from Karolinska Institutet, Stockholm, Sweden in COVID-19 bacterial pneumonia co-infection clinical study
  • FDA clearance decision Acuitas® AMR Gene Panel (isolates)
  • USA commercial updates on Unyvero LRT / LRT BAL
  • Unyvero A30 RQ partnering deal(s)
  • Clinical trial updates (FDA trial enrollment, data read-out, China clinical trial etc.)
  • Regulatory submissions (e.g. next FDA submission upon trial completion)
  • China NMPA approval and launch for Unyvero HPN test

Ares Genetics

  • Potential future expansion of the partnership with global IVD corporation (e.g. option for 90 day exclusive negotiation about licensing)
  • Further partnering / licensing deal(s)

©2020 OpGen, Inc.

27

Contact info

OpGen Inc. (Global HQ)

Curetis GmbH

Ares Genetics GmbH

708 Quince Orchard Road

Max-Eyth-Str. 42

Karl-Farkas-Gasse 18

Gaithersburg, MD 20878 USA

71088 Holzgerlingen, Germany

1030 Wien, Austria

+1 301.869.9683

+49 (0)7031 49195-10

+43 (0)1 361 8880 10

InvestorRelations@opgen.com

contact@curetis.com

contact@ares-genetics.com

©2020 OpGen, Inc.

28

Thank You!

©2020 OpGen, Inc.

29

Disclaimer

OpGen Inc. published this content on 20 August 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 August 2020 15:47:08 UTC


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Financials (USD)
Sales 2020 4,29 M - -
Net income 2020 -24,7 M - -
Net Debt 2020 - - -
P/E ratio 2020 -1,53x
Yield 2020 -
Capitalization 48,7 M 48,7 M -
Capi. / Sales 2020 11,3x
Capi. / Sales 2021 4,38x
Nbr of Employees 39
Free-Float 99,9%
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Mean consensus HOLD
Number of Analysts 3
Average target price 5,00 $
Last Close Price 2,47 $
Spread / Highest target 102%
Spread / Average Target 102%
Spread / Lowest Target 102%
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Managers
NameTitle
Oliver Schacht Chief Executive Officer & Director
Bill E. Rhodes Non-Executive Chairman
Johannes Bacher Chief Operating Officer
Timothy C. Dec CFO, Secretary & Chief Accounting Officer
Vadim Sapiro Chief Information Officer
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