Investor Presentation CY 2020 - EnzoInvestor Presentation CY 2020. Enzo Biochem Inc. 1 LEGAL...

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Enzo Biochem Inc. www.enzo.com 527 Madison Avenue New York, NY 10022 Investor Presentation CY 2020

Transcript of Investor Presentation CY 2020 - EnzoInvestor Presentation CY 2020. Enzo Biochem Inc. 1 LEGAL...

Page 1: Investor Presentation CY 2020 - EnzoInvestor Presentation CY 2020. Enzo Biochem Inc. 1 LEGAL DISCLAIMER Except for historical information, the matters discussed herein may be considered

Enzo Biochem Inc.www.enzo.com527 Madison AvenueNew York, NY 10022

Investor PresentationCY 2020

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Enzo Biochem Inc. 1

LEGAL DISCLAIMER

Except for historical information, the matters discussed herein may be considered

"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. Such statements

include declarations regarding the intent, belief or current expectations of the Company and its

management, including those related to cash flow, gross margins, revenues, and expenses are

dependent on a number of factors outside of the control of the company including, inter alia, the

markets for the Company’s products and services, costs of goods and services, other expenses,

government regulations, litigations, and general business conditions. See Risk Factors in the

Company’s Form 10-K for the fiscal year ended July 31, 2019. Investors are cautioned that any such

forward-looking statements are not guarantees of future performance and involve a number of risks

and uncertainties that could materially affect actual results. The Company disclaims any obligations to

update any forward-looking statement as a result of developments occurring after the date of this

presentation.

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Enzo Biochem Inc.

An Integrated Diagnostics Company

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Enzo Biochem Inc.

ENZO BIOCHEM INC. – WHO WE ARE

Innovative company driving development of cost efficient and leading edge diagnostic technologies

Pioneers in labeling and detection – from genome to whole cell – transforming the Molecular Diagnostic market

400+ Key Patents; 75+ pending patent applications

Disruptive technology being employed to alternative business model to improve laboratory economics; reducing dependency on diagnostic manufacturers

Unique infrastructure that enables molecular platform development for use in open systems, manufacturing and distribution of reagents and kits, along with global sales and marketing reach

Global Commercial Offices: Switzerland, Belgium, France, England, Germany, Michigan, New York

Headquartered in New York

Revenue greater than $80MM with strong growth opportunity

Strong balance sheet with $57MM in cash, debt free

500+ employees

NYSE listed company for 40 years (Ticker Symbol: ENZ)

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Translating Innovations To Solutions

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Enzo Biochem Inc. 4

ENZO’S VERTICAL INTEGRATION: THREE INTERDEPENDENT BUSINESSES

Unique vertical integration enables innovation/disruption

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Enzo Biochem Inc. 5

CONCEPT TO COMMERCIALIZATION

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COMPETITIVE ADVANTAGE: OTHERS HAVE NOT VERTICALLY INTEGRATED

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Enzo Biochem Inc. 7

EFFICIENT TRANSLATION OF BIOTECH CAPABILITIES TO PLATFORMS

Non-radioactive labeling & detection of nucleic acids

Amplification and quantification of nucleic acids

Proprietary dyes, bleachers, quenchers, and blockers

Enhanced detection of target via poly enzyme compounds

Homogenous assays for nucleic acid detection

Immobilization of nucleic acids to a solid support (array)

AmpiProbe™ real-time amplification & detection(1)

FlowScript™ flow cytometry for RNA expression(1)

Super-CGHTM for genomics studies(2)

Super-sensitive ELISA for immunochemistry(3)

Immunohistochemistry (IHC) with enhanced detection(3)

In-situ Hybridization (ISH) with enhanced detection(3)

Proprietary Technologies Our MDx Platforms

Our Broad Technologies and Focused Platforms Permit Rapid, Efficient Product Development

(1) Incorporates: Non-radioactive labeling, amplification, proprietary dyes, and detection (2) Incorporates: Non-radioactive labeling and arrays(3) Incorporates: Proprietary dyes and detection

ENZO’S PATENTED PROPRIETARY TECHNOLOGIES ARE UTILIZED TO OPTIMIZE OUR MDx PLATFORMS

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Enzo Biochem Inc.

WORLD CLASS MANAGEMENT TEAM

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Enzo Biochem Inc.

EXPERIENCED INDUSTRY LEADERS ON BOARD OF DIRECTORS

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Market Dynamics - From Challenges of Industry to Opportunities for Enzo

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TREMENDOUS DEMAND FOR MOLECULAR DIAGNOSTICS

$4.6$4.9

$5.2

$5.6

$6.0

$6.5

$7.1

$3

$4

$4

$5

$5

$6

$6

$7

$7

$8

2012 2013 2014 2015 2016 2017 2018

($ in billions)

Molecular Diagnostics Opportunity

In the span of 25 years, molecular diagnostics(MDx) have burgeoned from a practically non-existent market of approximately $10 millionin product sales to more than $7 billionglobally

MDx is only a small segment within the ~$170billion clinical lab market where Enzo sells itsoverall diagnostics offering

Thousands of labs in the U.S. can be enabled with MDx technologies, but they lack capability

Today’s MDx technologies are expensive

Closed systems, high-cost reagents

Require specially trained med-techs

Inexpensive open systems lack content due to IP barriers

Molecular Diagnostics Market Opportunity

Source: Grand View Research, Public Company Reports.$0 $500 $1,000 $1,500 $2,000 $2,500 $3,000 $3,500

Infectious Diseases

Women's Health

CT/NG

BV

HPV

HSV

HIV

HBV

HCV

Annual TAM ($ million)

Global North America

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Enzo Biochem Inc. 12

VALUE CREATION & GROWTH EFFORTS

Enzo is making meaningful progress in executing its

“three-pronged” strategy designed to unlock

shareholder value and drive future growth

Form Strategic Relationships for Diagnostic Growth

Build a New Model for the Diagnostic Marketplace

Return to Operating Profitability and Growth in the Lab Segment

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Enzo Biochem Inc. 13

VALUE CREATION & GROWTH EFFORTS

Form Strategic Relationships for Diagnostic Growth

Build a New Model for the Diagnostic Marketplace

Return to Operating Profitability and Growth in the Lab Segment

Actively engaging with several global life sciences, healthcare and medical device companies

Seeking to form strategic relationships or new venture creation across key product platforms

Retained Lazard to assist in forming strategic relationships or new venture creation

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VALUE CREATION & GROWTH EFFORTS

Form Strategic Relationships for Diagnostic Growth

Build a New Model for the Diagnostic Marketplace

Return to Operating Profitability and Growth in the Lab Segment

Rolled out new Labs-to-Labs business model, whereby Enzo will serve as the “central capability” for smaller and mid-size labs, thereby increasing capacity utilization and profitability

Initiated first three Labs-to-Labs relationships and actively forging additional relationships

Capitalizing on scale in high-value, lower-cost operations, proprietary IP and products, decades of

innovation and commitment to medical solutions

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Enzo Biochem Inc. 15

VALUE CREATION & GROWTH EFFORTS

Form Strategic Relationships for Diagnostic Growth

Build a New Model for the Diagnostic Marketplace

Return to Operating Profitability and Growth in the Lab Segment

Aggressively controlling operational costs and improving margins in the labs segment to return labs business to growth and profitability

Implemented initiatives estimated to reduce routine expenses in labs by ~$10 million in the coming calendar year

Objective remains to return to operating profitability in

calendar 2020

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Enzo Biochem Inc. 16

MARKET GROWTH AND CHALLENGES… AND ENZO’S OPPORTUNITY

Problem to Address: MDx Market Margins are Under Intense Pressure

Demand for MDx is rapidly increasing

However, reimbursement for these tests is in long-term decline

Clinical labs have already reduced labor and other expenses and, we believe,

cannot make further significant cuts

Meanwhile, the costs for performing MDx tests are increasing

Inexpensive open systems have recently become widely available, but high-value

content is lacking due to IP barriers – this presents a material opportunity for Enzo

Selling MDx content into this large installed base of open systems presents a

significant opportunity for Enzo to disrupt the closed system market and offset

margin pressures in the market

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ENZO’S COST SAVINGS OPPORTUNITY VIA INTEGRATED WORKFLOW

Even with reimbursement erosion, Enzo can deliver 30-50% cost relief to the market while maintaining healthy margins through its integrated solutions

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Enzo’s Solution - Efficient, Self-Generated Development and Commercialization

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Enzo Biochem Inc.

Create Affordable Solutions To Alleviate Market Pressures

Enzo’s integrated structure overcomes cost of goods layering thereby producing affordable products and services needed to combat increasing

reimbursement pressures

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OUR OBJECTIVE

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OUR ASSETS - APPLYING OUR CAPABILITIES TO PROVIDE AFFORDABLE PATIENT CARE WITHIN KEY DIAGNOSTICS SEGMENTS

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Enzo Biochem Inc.

ENZO IS CHALLENGING THE NORM TO CREATE ECONOMIC VALUE

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Enzo Biochem Inc. 22

EXAMPLE: AMPIPROBE PLATFORM LEADS TO PRODUCTS THAT WE BELIEVE ARE 30%-50% THE COST OF REAL-TIME AMPLIFICATION DETECTION

Less Sample Allows paneling/reduced reaction volume/lower prep

costs

Multiplex Capability Able to run up to 30 assays simultaneously

Enhanced Sensitivity Compared to Roche and Abbott systems

Zero Background After more than 60 cycles

Competitors have issues

100% Concordance Existing FDA-approved PCR technologies

Flexible, Adaptable & Universal Any open/dedicated system

Adaptive Fits into laboratory workflow seamlessly

AMPIPROBE™NEXT-GENERATION NUCLEIC ACID DETECTION

One of Enzo’s Proprietary Platforms

DISRUPTING A MULTIBILLION REAL-TIME AMPLIFICATION REAGENTS MARKET

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Enzo Biochem Inc.

Molecular Diagnostics

Comprehensive assay able to detect 16 common pathogens related to sexual transmitted diseases and vaginal infections from a single vaginal swab NEW AND CURRENTLY BEING RUN BY ENZO IN ITS LABORATORY

WOMEN’S HEALTH

ASSAY PIPELINE• HSV1/2-VZV

• HPV HR screen

AMPIPROBE® Next Generation Nucleic Acid Amplification

Example: AMPIPROBE® Women’s Health Panel

Coming Soon

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Enzo Biochem Inc. 24

LABORATORY DEVELOPED AND MODIFIED IVD ASSAYS- ALL ARE BASED ON ENZO INTERNALLY DEVELOPED TECHNOLOGY

Analyte Approval Date Assay Type

HPV E6/E7 mRNA Oncogene Detection (E-TECT®/FLOWSCRIPT®)March 4, 2015(Conditional Approval)

Laboratory Developed Test

Candida albicans, C. glabrata, C. krusei (qualitative detection) August 5, 2015 Laboratory Developed Test

Hepatitis C Virus (HCV) RNA quantitative detection (AMPIPROBE®) for management of HCV-infected individuals

November 9, 2015 Laboratory Developed Test

HPV (high-risk genotypes 16 and 18) detection (anorectal specimen modification)

November 24, 2015 Modified IVD

Enzyme rate activity-based method for measurement of Lp-PLA2 activity in serum specimens

August 25, 2016Laboratory Developed Test

Real-time PCR-based method for quantitative detection of N. gonorrhoeae, C. trachomatis, and T. vaginalis in Aptima® vaginal swab specimens (ANCT –PCR)

May 2, 2017Laboratory Developed Test

Multiplex real-time PCR-based method for qualitative detection of Candida species (C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis) in Aptima® vaginal swab specimens

September 14, 2017Laboratory Developed Test

Real-time PCR-based method for qualitative detection of Bacterial Vaginosis in Aptima® vaginal swab specimens

January 18, 2018Laboratory Developed Test

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Enzo Biochem Inc. 25

LABORATORY DEVELOPED AND MODIFIED IVD ASSAYS- ALL ARE BASED ON ENZO INTERNALLY DEVELOPED TECHNOLOGY

Analyte Approval Date Assay Type

Real-time PCR-based method for qualitative detection of Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) in SurePath® vaginal/cervical swab specimens and male/female urine specimens

April 24, 2018Laboratory Developed Test

Real-time PCR-based method for qualitative detection of Ureaplasma spp./M. genitalium/M. hominis (UMM) in Aptima® swab specimens

Oct 15, 2018 Laboratory Developed Test

Real-time PCR-based method for qualitative detection of Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) in Aptima® oral/rectal swab specimens

July 11, 2019Laboratory Developed Test

Hepatitis B Virus (HBV) DNA quantitative detection (AMPIPROBE®) for management of HBV-infected individuals

September 9, 2019Laboratory Developed Test

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Enzo Biochem Inc. 26

ENZO HAS A ROBUST MDx PIPELINE

Rapid Roll-Out

Product / Test Availability Platform Opportunity(1)

Available FLOWSCRIPT® GENE EXPRESSION $200mm+ product$500mm service

HCV Viral Load AvailableAMPIPROBE® REAL-TIME AMPLIFICATION AND DETECTION

$300mm product$450mm service

Cardiac Marker Available ENHANCED IMMUNOASSAY$20mm product$30mm service

Fertility Assay Q4 2020 ENHANCED IMMUNOASSAY$15mm product$40mm service

Women’s Health Panel AvailableAMPIPROBE® REAL-TIME AMPLIFICATION AND DETECTION

$500mm product$1bn service

HBV Viral Load AvailableAMPIPROBD® REAL-TIME AMPLIFICATION AND DETECTION

$250mm product$375mm service

HIV Viral Load Q2 2020AMPIPROBE® REAL-TIME AMPLIFICATION AND DETECTION

$600mm product$900mm service

IHC/ISH Detection Available ENHANCED DETECTION $50mm+ (clinical)

TH1/TH2 In development FLOWSCRIPT® GENE EXPRESSION$10mm product$15mm service

FISH Q2 2020 DEEPSEE® FISH DETECTION$60mm product$40mm service

RNA ISH Q3 2020 In situ Hybridization ENHANCED DETECTION$40mm product$10mm service

HPV High Risk Screen Q3 2020AMBIPROBE® REAL-TIME AMPLIFICATION & DETECTION

$150mm product$225mm service

HSV/VZV Q4 2020AMBIPROBE® REAL-TIME AMPLIFICATION & DETECTION

$90mm product$180mm service

1 Company estimates

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Enzo Biochem Inc. 27

Translational Capability

Bridge between product development from MDx platforms and service and product validation

Enzo rapidly adapts its development efforts to the clinical services market through constant feedback

Rapid Clinical Assay Validation (Clinical Trials)

New York State regulation is extremely rigorous, and it allows the tests to be offered on a national basis

Enzo validates all of its assays under actual clinical conditions using real clinical specimens, not just control samples – as a result, our products are evaluated under the same conditions experienced by our customers

The access to thousands of previously characterized specimens allows us to perform validations at a fraction of the cost of others that need to obtain such specimens from outside sources

Our integrated premarketing insights and efforts provide for material efficiencies in development and commercialization of our assays

Accelerated Commercialization

Technical support and service

Market to clinical labs and payors

Enzo’s integrated structure provides unparalleledmarket knowledge and expertise as Enzo’s clinical laboratory is one of its own customers

ENZO’S CLINICAL LABORATORY SERVICES

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Enzo Biochem Inc. 28

ENZO’S NATIONAL AND GLOBAL REACH

NEW YORK STATE LICENSURE ALLOWS FOR A NATIONAL REACH, WHILE ENZO ACCREDITATIONS AND GLOBALFOOTPRINT ALLOW FOR WORLDWIDE REACH

Hawaii

Alaska

Continued expansion of national and worldwide sales and marketing presence

Enzo’s strategy provides optionality to the market

Products with 30%-50% savings

Comprehensive service for less than price of competitors’ product alone

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Enzo Biochem Inc. 29

ENZO’S STRATEGY CAN PROVIDE BENEFIT FOR PATIENTS, PHYSICIANS & PAYORS

Insurance Payors are facing pricing pressure as well

Enzo is currently in-network with a number of major payors

We are well positioned to become the “first-choice” service provider to payors for MDx as the low-cost, high-quality provider

Because of the unique vertically integrated structure which has led to a plethora of self-generated platforms, products and services, Enzo can offer significant savings to payors in return for increases in MDx sample volume nationwide

Sample Volume

New In-Network Partnerships:Pending In-Network Partnership:

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Financial / Investor Info

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Enzo Biochem Inc.

FINANCIAL SNAPSHOT

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Current Price of $2.55, Mcap of $121mm and EV of $64mm

Enzo BioChem Financial Info (FYE July) FY 2019 1Q 2020

Revenue $81.2mm $20.2mm

Adj. EBITDA $7.1mm ($7.2mm)

Cash & Cash Equivalents $60mm $57mm

Total Debt $4mm $4mm

Shareholders Equity $86mm $78mm

Shares Outstanding 47.6mm 47.6mm

Market Capitalization $166mm $162mm

Enterprise Value $110mm $109mm

EV / Revenue 1.4x 1.3x

EV / EBITDA 15.7x NM

VWAP $3.50 $3.41

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Enzo Biochem Inc.

LAB SERVICES ACCESSIONS

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Consistency despite pricing pressures: +4% in 1Q 2020 in Unit Volume

-

100

200

300

400

500

600

700

800

900

1,000

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019

Lab Services Accessions(000)

Accessions (000)

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Enzo Biochem Inc.

SELF-FUNDED R&D

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Enzo Had 74 Patents Issued in 2019

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Enzo Biochem Inc.

R&D INVESTMENT YIELDS RESULTS

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ENZO’S STOCK PERFORMANCE PROVIDES INVESTMENT OPPORTUNITY

Hurdle Solution

Lower PAMA Reimbursements Lab-to-Lab & Strategic Initiatives

Genetic Testing Volume Issues Innovative Testing / Self Testing

Revenue Decline Low Cost Strategy

Operating Loss / EBITDA Accession count increases in stable environment

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Recent Highlights & Summary

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RECENT HIGHLIGHTS

On Track To Deliver Meaningful Progress

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Enzo Biochem Inc. 38

MANAGEMENT & BOARD WORKING IN THE BEST INTEREST OF SHAREHOLDERS

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Enzo Biochem Inc. 39

SUMMARY

Developing strategy for low cost diagnostic services and products for enhancing clinical laboratory profitability

The Company evaluated multiple internally generated technologies and platforms and selected those to further advance based on the development of:

Products that could be sold at 30%-50% less than the current market

Products that could perform at or superior to market leaders’ products

Medically relevant information

Products that could fit into existing operations

Products that result in greater margins for Enzo

We have demonstrated that Enzo has the assets and capabilities to engineer a system that can generate products based on these features

We have been able to design proprietary products and protocols that are in lock step with current market operations WITHOUT the need to utilize third-party intellectual property

As a result, we can provide the highest quality services while providing savings from current fee schedule

ENZO’S SYNERGISTIC STRATEGY AND INTEGRATED STRUCTURE ADDRESSES THE CHALLENGES IN MDx MARKET

Company Strategically Positioned for Substantial Growth

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Enzo Biochem Inc. 40

David Bench, CFOEnzo BioChem [email protected]

Barry Weiner, PresidentEnzo BioChem [email protected]