Quidelortho Corporation · NASDAQ:QDEL
Quidelortho — Quidel — 2016 Wells Fargo Healthcare Conference
33 slides from Quidelortho's conference presentation, Sep 7, 2016
Slide 1: Fortify, Attack, Forge Ahead
Fortify, Attack, Forge Ahead Doug Bryant, President & CEO Randy Steward, CFO Wells Fargo 09.07.16v1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the federal securities laws that involve material risks, assumptions and uncertainties. Many possible events or factors could affect our future financial results and performance, such that our actu
Slide 3: Quidel is…
Quidel is… Traditional and Next-generation Immunoassays A market leader in the development Cellular-Based Virology assays of innovative medical diagnostic platforms… Versatile Molecular Diagnostic platforms …that is focused on delivering highly accurate, connected new products with a low total cost
Slide 4: Quidel – Building on a History of Innovation
Quidel – Building on a History of Innovation • Submitted over 25 510(k) Revenue ($, in millions) packages to the FDA • Over 20 FDA clearances, 4 CLIA waiver designations $250 • Launched Solana instrumented MDx platform • Launched Sofia and 4 FDA-cleared assays 12% CAGR 2009 - • Launched 2 first gene
Slide 5: Traditional Healthcare is Changing, and…
Traditional Healthcare is Changing, and… Total National Health Expenditures (1980-2012)1 Current Healthcare Trends Include: • Increased access points for healthcare • Investment in healthcare technology • Informed patient consumerism • Expanded clinical roles for nurse practitioners, nurses, physi
Slide 6: Quidel is Developing New Products that can Compete in the Evolving Healthcare Environment
…Quidel is Developing New Products that can Compete in the Evolving Healthcare Environment Diagnostic products will need to be connected as compliance, access to testing data and the handling of those data will increase in importance. Assays will need to be faster and easier to use Along with accura
Slide 7: Our Innovative New Products: Immunoassay
Our Innovative New Products are Designed to Meet the Various Needs of the Customer in Any POC Setting Immunoassay FDA-Cleared, CLIA - Waived In Development Sofia Immunoassay platform is the next generation, Sofia 2, at a fraction of the cost of the original Sofia, objectively-read system in support
Slide 8: Our Innovative New Products: Molecular
Our Innovative New Products are Designed to Meet the Various Needs of the Customer in Any POC Setting Molecular FDA - Cleared, FDA - Cleared, FDA - Cleared, In Development Mod - Complex Mod - Complex Highly - Complex AmpliVue, a non- Solana, our first instrumented Lyra, our Real-time molecular Savan
Slide 9: Fortify, Attack, Forge Ahead
Fortify, Attack, Forge Ahead 9
Slide 10: Our Platform Strategy is Based on Concepts
Our Platform Strategy is Based on 3 Concepts: Fortify our Core Business, Attack Competitors’ Forge Ahead to Create Gain Market Share Limitations New Products and • Sofia, Sofia 2 Influenza, • Lyra, AmpliVue Markets RSV and GAS • Solana, Savanna platforms • Sofia Vitamin D, Lyme • Virena data managem
Slide 11: Sofia 2
Sofia 2® QUIDEL
Slide 12: Sofia 2 is the Next Generation of Our Best-selling Platform
Sofia 2 is the Next Generation of Our Best-selling Platform, at an Even Lower Cost 3 Portability • Lighter than Sofia (target 2.5 lbs) • Integrated handle • 8 hour rechargeable battery with 3 years of life 2 Superior user-experience • Color touch screen • QWERTY keyboard 4 Virena capability, Integra
Slide 13: Sofia 2 Takes Sofia Immunoassay Testing to the Next Level
Sofia 2 Takes Sofia Immunoassay Testing to the Next Level Sofia Sofia 2 • Uses Sofia cartridge • Uses Sofia cartridge • Approx. $1500 instrument COGS • Approx. $350 instrument COGS • Supports external barcode reader • Integrated barcode reader • External Virena router • Integrated Virena router • Op
Slide 14: Quidel Molecular: Solana and Savanna
Quidel Molecular: Solana® and Savanna®
Slide 15: Quidel's Molecular Products are Evolving into Instrumented Molecular Systems
Quidel’s Molecular Products are Evolving from Introductory Offerings into More Sophisticated Instrumented Molecular Systems – All Based On Quidel’s Proprietary Technology First Generation Next Generation Non-instrumented MDx products Instrumented MDx systems FDA - Cleared, FDA - Cleared, Mod - Compl
Slide 16: Example: Solana Performs Better than Culture for GAS
Example: Solana Performs Better than Culture for GAS Performance Results of Solana GAS Assay for Group A β-hemolytic Streptococcus Overall Performance (All Sites) One (1) specimen (0.09%) was invalid Composite Culture (in both the initial and repeat test no internal Solana GAS control was detected)
Slide 17: Solana Group A Strep Assay Results in an Actionable Timeframe
Solana Group A Strep Assay Results in an Actionable Timeframe, with No Culture Confirmation Required Today’s diagnostic landscape consist of tests that are rapid, but less sensitive than culture; or culture methods that are sensitive, but slow. Solana delivers results you can trust in an actionable
Slide 18: The Savanna System
The Savanna System* TAT: 45 - 60 minutes True sample to results, CLIA Waivable (assay dependent) random access work flow Low total cost of ownership Versatile • Can run both PCR and HDA chemistries • Quantitative and qualitative assays • Individual tests or panels of 3 - 4 targets Rugged and reliabl
Slide 19: Savanna Capabilities
Savanna Capabilities Low Capital Cost Low Disposable Simple Sample to TAT 45 - 60 Minutes Cost Results Operation Runs Both PCR and Isothermal (HDA) Assays Multiplex Panels Potential For • Allows selection of best option by assay • 3 – 4 targets plus a Finger Stick control with existing Plasma Sample
Slide 20: Solana and Savanna: Meant to Work Together
Solana and Savanna: Meant to Work Together Solana Savanna • Some sample handling steps • True sample to results workflow • Isothermal assays • Isothermal and PCR assays • 12 samples per 35 minute run • 2 random access bays (45-60 min) • Best for batch testing • Best for on-demand testing • Higher vo
Slide 21: Virena: An Opportunity to Expand POC Testing
Virena®: An Opportunity to Expand POC Testing
Slide 22: Virena Connectivity Adds Another Dimension of Functionality
Virena Connectivity Adds Another Dimension of Functionality to Quidel’s Diagnostic Platforms Virena Adds a New Dimension to Rapid Virena Delivers Value to Testing, Keeping You Informed Laboratories of All Sizes • Remote instrument management across • Remote instrument management multiple sites and m
Slide 23: In Summary, Virena Adds Value Through Connected Visibility
In Summary, Virena Adds Value Through Connected Visibility Creates the Ability to Remotely Manage Instrument Usage, Support Operator Training Initiatives, and Monitor QC Compliance Enables Monitoring a Community of Offers a New Level Of Control, Connected Users Oversight and Outcome Management Provi
Slide 24: Inside the Flu vs. Non-Flu Businesses
Inside the Flu vs. Non-Flu Businesses 24
Slide 25: How Volatile are We, Actually? % Influenza-like Illness
% Influenza-like Illness (ILI) 25 0 1 2 3 4 5 7 8 6 2009-1 2009-7 2009-13 2009-19 2009-25 2009-31 2009-37 2009-43 2009-49 2010-3 2010-9 2010-15 2010-21 2010-27 2010-33 2010-39 2010-45 2010-51 2011-5 2011-11 2011-17 2011-23 2011-29 2011-35 2011-41 2011-47 2012-1 National ILI 2012-7 Baseline, CDC 2012
Slide 26: Q2 Provides Visibility into Growth in Key Non-Flu Franchises
Q2 Provides Visibility into Growth in Key Non-Flu Franchises Franchises Annual Revenue* Growth in Q2 ($, in millions) Flu ~ $85-95M 21% Non-Flu: ~ $100-110M 8% Strep A (Immunoassay) ~ $30M 13% RSV ~ $7-10M 29% Graves’ Disease (TSI) ~ $10M 8% Life Science Research** ~ $12M 57% Molecular ~ $10M 63% hC
Slide 27: Financials and Capital Structure
Financials and Capital Structure
Slide 28: We are on a Path to Our Longer Term Financial Objectives
We are on a Path to Our Longer Term Financial Objectives 1 2 3 4 5 Achieve low- to mid- Invest in the Leverage Maximize cash flow Pursue outside teens in annual development and operational from the core opportunities revenue growth commercialization of efficiency driving business to complement throu
Slide 29: Quidel Financial Overview
Quidel Financial Overview Revenue Adjusted EBITDA(1) (in $ million, percent gross margin in white) (adjusted, in $ million) $250 120% $50.0 $45.0 $40.6 $40.9 $196.1 100% $38.9 $200 $184.2 $40.0 $177.3 $160.5 $35.0 $33.0 $157.7 80% $150 $30.0 $27.9 60% $25.0 63% $100 61% 62% 59% $20.0 60% 40% $15.0 $
Slide 30: 2016 Expected Operating Cost Structure
2016 Expected Operating Cost Structure Annual Investment: R&D Annual Investment: S&M (in $ million; percentage of sales in white) (in $ million; percentage of sales in white) $60.0 65% Range $45.0 Range 65% $51M - $39M - $41M $53M $40.0 $37.9 $47.9 55% 55% $50.0 $35.5 $34.2 $43.1 $35.0 45% 45% $40.0
Slide 31: We've Leveraged our Capital Structure to Pursue Outside Opportunities
We’ve Leveraged our Capital Structure to Pursue Outside Opportunities that Complement Flu Growth and Drive Non-respiratory Revenue Recent Capital Structure History Target/Action Time Period Rationale Paid approx. $130 million for $45 million annual cell Diagnostic Hybrids, Inc. (DHI) 2010 culture bu
Slide 32: Growth Objectives and Near-term Milestones
Growth Objectives and Near-term Milestones • Grow Sofia installed base • Convert Strep A culture • Continue to pursue inorganic with Sofia, Sofia 2 and testing with Solana and opportunities to diversify and gain market share. AmpliVue GAS. augment the non-respiratory part of the business. • Increase
Slide 33: Q&A Investors Contact
Q&A Investors Contact Ruben Argueta Quidel Corporation O: 858.646.8023 E: rargueta@quidel.com