q1 2018 update - seeking alpha
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Forward-Looking Statements
2
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 actual results and performance may
differ materially from those that may be described or implied in the forward-looking statements. As such, no forward-looking statement can be guaranteed.
Differences in actual results and performance may arise as a result of a number of factors including, without limitation, fluctuations in our operating results
resulting from seasonality, the timing of the onset, length and severity of cold and flu seasons, government and media attention focused on influenza and the
related potential impact on humans from novel influenza viruses, adverse changes in competitive conditions in domestic and international markets, changes
in sales levels as it relates to the absorption of our fixed costs, lower than anticipated market penetration of our products, the reimbursement system
currently in place and future changes to that system, changes in economic conditions in our domestic and international markets, the quantity of our product
in our distributors’ inventory or distribution channels, changes in the buying patterns of our distributors, and changes in the healthcare market and
consolidation of our customer base; our development and protection of intellectual property; our development of new technologies, products and markets;
our reliance on a limited number of key distributors; our reliance on sales of our influenza diagnostics tests; our ability to manage our growth strategy; our
ability to integrate companies or technologies we have acquired or may acquire, including integration and transition risks, the ability to achieve anticipated
financial results and synergies, and effects of disruptions or threatened disruptions to our relationships, or those of the acquired businesses, with
distributors, suppliers, customers and employees; intellectual property risks, including but not limited to, infringement litigation; our debt service
requirements; our inability to settle conversions of our Convertible Senior Notes in cash; the effect on our operating results from the trigger of the
conditional conversion feature of our Convertible Senior Notes; the possibility that we may incur additional indebtedness; our need for additional funds to
finance our operating needs; volatility and disruption in the global capital and credit markets; acceptance of our products among physicians and other
healthcare providers; competition with other providers of diagnostic products; adverse actions or delays in new product reviews or related to currently-
marketed products by the FDA or any loss of previously received regulatory approvals or clearances; changes in government policies; compliance with
other government regulations, such as safe working conditions, manufacturing practices, environmental protection, fire hazard and disposal of hazardous
substances; third-party reimbursement policies; our ability to meet demand for our products; interruptions in our supply of raw materials; product defects;
business risks not covered by insurance and exposure to other litigation claims and potential adverse outcomes of such legal proceedings; interruption to our
computer systems; competition for and loss of management and key personnel; international risks, including but not limited to, compliance with product
registration requirements, exposure to currency exchange fluctuations and foreign currency exchange risk sharing arrangements, longer payment cycles,
lower selling prices and greater difficulty in collecting accounts receivable, reduced protection of intellectual property rights, political and economic
instability, taxes, and diversion of lower priced international products into U.S. markets; dilution resulting from future sales of our equity; volatility in our
stock price; provisions in our charter documents, Delaware law and our Convertible Senior Notes that might delay or impede stockholder actions with
respect to business combinations or similar transactions; and our intention of not paying dividends. Forward-looking statements typically are identified by
the use of terms such as “may,” “will,” “should,” “might,” “expect,” “anticipate,” “estimate,” “plan,” “intend,” “goal,” “project,” “strategy,” “future,”
and similar words, although some forward-looking statements are expressed differently. The risks described in reports and registration statements that we
file with the Securities and Exchange Commission (the “SEC”) from time to time, should be carefully considered. You are cautioned not to place undue
reliance on these forward-looking statements, which reflect management’s analysis only as of the date of this presentation. Except as required by law, we
undertake no obligation to publicly release the results of any revision or update of these forward-looking statements, whether as a result of new information,
future events or otherwise.
Our Strategic Intent
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Build a broader-based diagnostic company that delivers revenue and marginmore consistently. Use existing resources to fortify price and volume in our core
businesses, while using our capabilities to attack the limitations of ourcompetitors, and to forge ahead to create new markets.
Sofia® Immunoassay platform
is the next generation,
objectively-read system in
support of our legacy lateral
flow business, designed to
deliver more value and a
higher gross margin.
Sofia captures market share
with the first wave of assays
(for Respiratory Disease) in
physician offices, hospitals
and alternate sites.
FDA-Cleared, CLIA -Waived
Immunoassay
Sofia® 2, at a fraction of the cost of
the original Sofia,
can further penetrate the lower-
volume and higher-volume
segments of the POC testing
market.
Sofia 2’s integrated wireless options
will expand connectivity with the
potential increase overall diagnostic
testing.
FDA-Cleared, CLIA – Waived
Our Innovative New Products are Designed to Meet the Various Needs of the Customer in Any POC Setting
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Triage® MeterPro® is our cost effective, easy to use instrument for cardiovascular and toxicology diagnostic assays. Multipleimmunoassays can run on the same platform, with rapid resultsin about 15-20 minutes
The MeterPro instrument can run multiple sample types, such as whole blood, plasma, or urine,with process controls built into the meter, software and test device
FDA-Cleared
Molecular
AmpliVue, a non-
instrumented, hand-held
disposable molecular device
requires no thermocycler or
upfront costs. Moderately
complex claim provides an
easy-to-use entry point into
molecular testing for smaller
hospitals and lower-volume
users wishing to convert from
legacy testing methods.
FDA - Cleared, Mod - Complex
Solana, our first instrumented
molecular system, extends
AmpliVue’s proprietary HDA
technology to offer a low-cost,
medium volume molecular
solution that can multiplex,
running up to 12 samples at a
time in approx. 30 minutes.
Solana is designed for
samples that do not require
extraction or quantitation in
the mod-complex setting.
FDA - Cleared, Mod - Complex
Lyra, our Real-time molecular
PCR assays, are designed to
run on a hospital lab’s existing
thermocycler, and provides a
real-time testing solution to
higher throughput labs using a
hospital’s established systems
– with no upfront costs.
Lyra molecular assays can be
paired with other Lyra assays
to create customized multiplex
Respiratory Disease panels.
FDA - Cleared, Highly - Complex
Savanna is our low-cost, fully
integrated “sample-to-answer”
molecular diagnostic system.
Target cartridge cost is less
than $5 and target instrument
cost is $10,000, designed for
low-volume and potentially
CLIA-waived settings.
Savanna can run either
traditional PCR or HDA
assays for samples that do not
require extraction.
In Development
Our Innovative New Products are Designedto Meet the Various Needs of the Customer in Any POC Setting
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6
Mod -
Complex
Our R&D and Regulatory expertise is what fuels our growth…
Since 2011, Quidel has submitted over 30 510(k) packages resulting in over 25 FDA clearances and expanded product claims, 5 CLIA - waiver designations and numerous product introductions,
contributing $95M in annual revenues1
Quidel Recent Commercial Initiatives: FDA-cleared Products since 2011
Mod -
Complex
Highly -
Complex
Highly -
Complex
Highly -
Complex
Highly -
Complex
Highly -
Complex
Highly -
Complex
Highly -
Complex
Sofia®
Instrumented Immunoassay
AmpliVue® HDA IsothermalMolecular
Solana® HDA IsothermalMolecular
Lyra® Real-Time PCRMolecular
CLIA -
Waived
CLIA -
Waived
CLIA -
Waived
CLIA -
Waived
Sofia Analyzer
Influenza
A + B
Group A Strep
RSV
hCG
Lyme Disease
Legionella
(CE Mark
only)
Mod -
Complex
Mod -
Complex
Mod -
Complex
Mod -
Complex
C. difficile
Group A Strep
Group B Strep
Pertussis
Mod -
Complex
Mod -
Complex
Trichomonas
HSV 1 + 2
Mod -
Complex
Mod -
Complex
Mod -
Complex
Solana
Instrument
Influenza A + B
Group A Strep
Influenza A + B
RSV + hMPV
Adenovirus
Parainfluenza
123
Strep A + C/G
C. difficile
HSV 1+ 2/VZV
Mod -
ComplexStrep Complete
(A + C/G)
Mod -
ComplexTrichomonas
Mod -
ComplexHSV 1+2/VZV
Sofia 2®
Instrumented Immunoassay
CLIA -
Waived
CLIA -
Waived
Sofia 2
Analyzer
RSV
1. Latest TTM combined revenues for Sofia and Molecular products.
Not all FDA submissions and clearances since 2011 are shown.
Mod -
ComplexRSV + hMPV
CLIA -
WaivedInfluenza A+B
S. Pneumo
(CE Mark
only)
Mod -
ComplexC. difficile
CLIA -
WaivedStrep A+
Mod -
ComplexGroup B Strep
7
Integration Progress Since Day 1
7
IntegrateTransitio
n Assess
Apr 17 Jul 17 Oct 6
October 2017
Transitioned 472 US employees
Successfully implemented US Order-
to-Cash for US and 24 direct export
markets (53% of Revenue): Assumed
US contracts and Sales & Marketing
functions
November 2017
Selected EU Shared Service Center
site in Galway IR; Lease under
negotiation
Deal
Announced Day 1
December 2017 January 2018
Hired 50 commercial employees
across China, Germany, Italy, and
Austria
Completed Sale/Leaseback of
Summers Ridge Facility - $149M
Moved 100% of Employees to Bldg
C&DRestructured North American Sales to
incorporate Triage and BNP products Began Synergy planning
Developed Global Order to Cash
transition plan
Geographical Footprint of Combined Business
Note: All revenues correspond to FY ‘16
Canada
$8 M
2%
EMEA
$56 M
12%
52%
Quidel
10%
BC-BNP
38%
Triage
52%
Quidel
23%
BC-BNP
25%
Triage
US
$305 M
66%
39%
Quidel
1%
BC-BNP
61%
Triage
LATAM
$17 M
4%
17%
Quidel
38%
BC-BNP
45%
Triage
China
$50 M
11%
5%
Quidel
36%
BC-BNP
59%
Triage
Asia
$22 M
5%48%
Quidel
11%
BC-BNP
41%
Triage
9
We Now Ship to 150+ Distributors Serving 90+ Countries and Creating Demand in 12 Markets
SAN DIEGO
10
Direct
Shipments
Triage Acquisition Was Transformational for the International Business
Note: All revenues correspond to FY ’16
*Includes sales for ‘Specialty Products’ group
$33M
Quidel
$33 M*
Quidel
Int’l Sales
$77M
Triage
65%
$42M
BC-BNP
35%
$120 M
Triage + BC-
BNP
Int’l Sales
$153 M
Combined
Entity Int’l
Sales
$77M
Triage
50%
$42M
BC-BNP
28%
$33M
Quidel
22%
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Quidel’s Multiple Near-Term Catalysts will Grow the Non-flu Business.
Category Product
Sofia and Sofia 2
Immunoassays
Sofia/Sofia 2 Strep A
Sofia/Sofia 2 RSV
Sofia Lyme
Sofia Vitamin D
InflammaDry and AdenoPlus for Eye Care Market
Alternate/Adjacent Markets
Bio Assays Graves’ Disease/Hashimoto’s (TBI)
Solana
Molecular
Strep A
C. difficile
GBS, HSV 1+2/VZV, Trichomonas
Research - Bone Health New Bone Health and Renal Markers
Cell Culture Custom Cells
TriageCardiovascular internationally, and through BNP;
Toxicology output via operational improvements
12 Reflects products in development and other anticipated catalysts.
M&A Strategy
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Use cash on hand to pay down debt and pursue inorganic opportunities to diversify and augment
the non-respiratory part of the business
• Targets range from tuck-ins up to equal size
• New technology that accelerates the advancement of in-house
MDx abilities
• Products that reduce the seasonality, volatility of flu season
• Firms that can leverage our international market presence
• Accretive within 12-24 months
What we’re looking for…
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