3
V A R E X I M A G I N G
2 0 1 7 A N N U A L R E P O R T
3
2 0 1 7 A N N U A L R E P O R T
V
A
R
E
X
I
M
A
G
I
N
G
2
0
1
7
A
N
N
U
A
L
R
E
P
O
R
T
A W O R L D L E A D E R I N
X - R A Y I M A G I N G C O M P O N E N T S
VAREX IMAGING 2017 ANNUAL REPORT
V A R E X
I M A G I N G
We are a leading innovator, designer and manufacturer of X-ray imaging components. With a 65+ year history of successful innovation,
our components are used in medical, industrial and security imaging applications. Global OEM manufacturers incorporate our X-ray
sources, digital detectors, connecting devices and imaging software into their X-ray imaging systems to detect, diagnose and protect.
G L O B A L P R E S E N C E
AMERICAS
35%
OF REVENUES
75%
OF EMPLOYEES
EUROPE /
MIDDLE EAST
31%
OF REVENUES
13%
OF EMPLOYEES
ASIA / PACIFIC
34%
OF REVENUES
12%
OF EMPLOYEES
Corporate Headquarters
Sales / Service
Manufacturing / Service
Product Development
FY2017 REVENUES
$698M
+13%
YEAR-OVER-YEAR
A T A G L A N C E
65+
Y EAR S OF
I NNOVATI ON
CUSTOMERS
GLOBAL OEM MANUFACTURERS
SYSTEM INTEGRATORS
SEG MEN TS
MEDICAL IMAGING
INDUSTRIAL IMAGING
1900
EM PLOY EES
WO RL DW ID E
G LOBA L FOOT PR INT
AMERICAS: 867K SQ. FT.
EMEA: 142K SQ. FT.
APAC: 174K SQ. FT.
V A R E X I M A G I N G
2 0 1 7 A N N U A L R E P O R T
V A R E X I M A G I N G
2 0 1 7 A N N U A L R E P O R T
1
C T S C A N N I N G T U B E
F I N A N C I A L H I G H L I G H T S
($000s in millions, except per share data)
2015
2016
2017
F I S C A L Y E A R
R E V E N U E S
Medical
Industrial
Total revenues
G R O S S M A R G I N
Medical
Industrial
Total gross margin
Adjusted gross margin
O P E R A T I N G E X P E N S E S
Research and development
Selling, general and administrative
Total operating expenses
Operating earnings
Adjusted operating earnings
N E T E A R N I N G S
Net earnings
Diluted net earnings per share
Adjusted net earnings
Adjusted diluted net earnings per share
Dilutive shares
O T H E R D A T A
Cash and cash equivalents
Cash flow from operations
Free cash flow
Total assets
Total debt outstanding
Total stockholders’ equity
$
$
$
$
$
$
$
$
$
$
$
$
$
$
534
98
632
207
44
251
NA
50
73
123
128
NA
80
2.12
NA
NA
37.3
21
85
51
584
–
485
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
506
114
620
196
53
248
250
54
86
139
109
117
69
1.82
74
1.96
37.7
37
74
45
622
–
526
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
557
141
698
194
60
254
264
67
103
170
84
108
52
1.36
68
1.80
38.0
83
78
56
1,040
494
379
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2
V A R E X I M A G I N G
2 0 1 7 A N N U A L R E P O R T
T O O U R S T O C K H O L D E R S
Fiscal year 2017 was an exciting time for us, highlighted by our successful spin-off from Varian Medical
Systems and closing the acquisition of the imaging business of PerkinElmer, Inc. while maintaining our
focus on growing revenue and providing excellent customer service.
Our revenues increased 13% to $698 million. This reflected
Acquired Imaging Business
a 3% increase of $17 million in our organic business and the
On May 1st, we completed the acquisition of the medical
addition of $61 million in revenues in the last five months
imaging business of PerkinElmer, Inc. for $276 million. This
of the year from the acquired imaging business, which was
business provides digital flat panel detectors to manufactur-
a 5% increase in revenues from the same five-month period
ers of X-ray imaging systems and is highly complementary
in the prior year. I am proud to say that we have overcome
to Varex’s business. This acquisition added a significant
the challenges of the prior two years and have returned to
revenue stream, new anchor customers, and new technolo-
revenue growth, that our earnings exceeded expectations
gies and technical expertise, along with a strong brand and
and that we expanded our exceptional team with the
expanded footprint in the industrial sector.
additional digital detector expertise from the acquired
imaging business.
Our Spin-Off
We started off the fiscal year in the midst of a spin-off to
separate what was then the Imaging Components business
of Varian into a new, independent public company. A
We got off to a good start with integration activities,
including:
1. Immediately combining the two sales teams and opening
the full Varex product portfolio to the entire sales
organization,
tremendous amount of effort and considerably long work
2. Rationalizing digital detector product offerings and
days by numerous Varex employees made our separation
overlapping R&D projects with clear tiering and product
a reality in eight months from the time the spin-off was
positioning for each modality,
announced at the end of May 2016. I view this as an
incredible accomplishment and want to thank everyone
involved for their hard work, commitment and dedication
to successfully completing our spin-off while not disrupting
operations or customer shipments.
3. Holding corporate-level briefings with many of our new
customers, including new anchor customers, to introduce
them to our business and discuss opportunities to supply
them with a broader range of our products,
4. Improving productivity by combining best practices
Varex’s legal separation occurred on Saturday, January 28th.
in product design, supply chain management and
Our first day of trading as a new public company on the
manufacturing, and
Nasdaq Select Market under the symbol VREX was Monday,
January 30th. Our opening stock price was $25.00 per share
and we ended our fiscal year at $33.84 per share, which
equated to a market capitalization of $1.3 billion. At fiscal
year-end, our top 20 shareholders held 67% of our total
5. Initiating other projects that leverage capabilities to
generate future cost savings, provide customers with
higher performing products and strengthen Varex’s
position going forward.
shares outstanding and three research analysts provided
This acquisition also provides us with revenue and cost
coverage of our company.
synergies. By fiscal year 2021, we expect to realize $20
million to $30 million in incremental annual revenue
45671 Merrill A291712_Narrative.indd 2
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V A R E X I M A G I N G
2 0 1 7 A N N U A L R E P O R T
3
synergies with timing dependent on the customer validation
is a new integrated CT solution that combines multiple
process for new imaging components and multi-year
components into an integrated package, which incorporates
customer development cycles of new X-ray imaging
a CT tube, generator, high-voltage connector, heat
systems. By fiscal year 2021, we anticipate realizing annual
exchanger and tube control unit. We expect this solution
cost savings of $15 million to $20 million through SG&A
to be attractive to OEMs looking to accelerate their time to
leverage, greater manufacturing scale, and supply chain cost
market with new CT imaging systems.
reductions, as well as rationalization of operations, products
and R&D projects. In fiscal year 2018, we anticipate
approximately $5 million of cost savings.
We also reached a significant milestone during the third
quarter of the year with the production of our 100,000th
digital detector. As a frame of reference, in 2004 we
Customers Drive Our Growth
produced 327 detectors and this fiscal year we produced
The China imaging market represents a key long-term
more than 21,000 detectors. We estimate that Varex has
growth driver for our company. We have been investing in
more than 150,000 digital detectors in service around the
product development targeted at this market segment and
world, which is about a third of the detectors in use.
we are making excellent progress. Our sales there were
approximately 10% of revenues in fiscal year 2017. In the
second half of the year, we signed pricing agreements with
two local OEM customers for purchases of our CT X-ray
tubes. On a combined basis, we expect these agreements
to generate more than $100 million of incremental revenues
ramping up over the next three years.
Looking Ahead
We look forward to achieving further growth in fiscal year
2018 as we continue to integrate the acquired imaging
business, benefit from market growth in the medical,
industrial and security sectors, innovate to bring new X-ray
imaging components to our OEM customers, use our scale
to engineer costs out of our products, and expand our
While we continue to innovate and expand our product
customer relationships.
offerings to new customers in new markets, we are also
committed to numerous long-standing relationships with
Sincerely,
our customers that are many decades long.
Sunny Sanyal
President and Chief Executive Officer
Varex Imaging Corporation
An example is our 40+ year relationship with Toshiba
Medical Systems and renewal of a three-year pricing
agreement during the second quarter under which Varex
will continue to supply our CT tubes for integration into
Toshiba Medical’s CT imaging systems for the global market.
We also have in place separate one-year pricing agreements
to supply to Toshiba Medical other imaging components,
including digital detectors and high voltage connectors. We
look forward to continuing our long-standing relationship
with Toshiba Medical now that they are part of Canon.
During the fiscal year, we signed new and renewed
agreements with our customers for our products valued
at more than $650 million over multiple years. We also
introduced more than a dozen new and updated medical
products in fiscal year 2017. One of these exciting products
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V A R E X I M A G I N G
2 0 1 7 A N N U A L R E P O R T
W H A T W E D O
We create key components that are incorporated into X-ray imaging systems that are used in medical
applications to diagnose and treat patients, as well as industrial and security applications to help
protect ports, borders and airports. There is no greater motivation than knowing what we do every
day plays a role in helping our fellow human beings.
This became very real for our employee, Brad Hansen,
We have a 65+ year history of successful innovation and
when he wasn’t feeling well and made an appointment
have achieved this by working with global OEM customers
with his doctor. When nothing was detected, he made
to provide them with our technologically advanced
an appointment with another doctor. Same result and he
components for their next generation X-ray imaging
consulted another doctor. This cycle went on for some time
systems. We have more than 500 engineers, including 55
while Brad’s health became worse and he grew increasingly
PhDs, dedicated to improving and creating new products,
concerned. Finally, progress was made when a doctor
and in fiscal year 2017, we introduced more than a dozen
scheduled a CT examination. As Brad lay on the bed of the
new and updated medical products.
scanner waiting for the procedure to start, he looked up and
saw that the CT imaging system was made by one of our
customers. With our CT tube inside the scanner, he believed
the high quality images would help the doctors figure out
what was wrong.
We have significant manufacturing scale. We are the
world’s largest independent supplier of X-ray tubes, digital
flat panel detectors, connect and control devices and
imaging software. Our scale and expertise allow us to
develop high-quality and high performing X-ray imaging
They did and Brad underwent treatment and a lengthy
components, as well as focus on reducing product costs by
recovery. Today, Brad is healthy and back at work. As a
improving efficiency on the supply side and throughout our
factory worker involved in manufacturing our CT tubes,
manufacturing process.
it is extremely important to Brad and gives him great
satisfaction to know that Varex components play a key role
in diagnosing patients, no matter if it is himself, a family
member or millions of people around the world.
Our global headquarters and primary facilities are in Salt
Lake City, Utah, where we have more than 500,000 square
feet of R&D and manufacturing space, including a 140,000
square foot expansion completed last year that provides for
Innovation / Manufacturing Scale / Customer Relationships
future growth. This new expansion facility recently received
Innovation is our lifeblood. We are a leading innovator,
Gold Certification under LEED, the most widely used green
designer and manufacturer of X-ray imaging components
building rating system in the world.
used in medical imaging systems that span numerous
diagnostic modalities; in industrial non-destructive testing and
manufacturing inspection; and in security imaging applications
such as cargo inspection for port and border protection, and
carry-on and checked baggage screening at airports.
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V A R E X I M A G I N G
2 0 1 7 A N N U A L R E P O R T
5
M A M M O G R A P H Y
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VAREX IMAGING 2017 ANNUAL REPORT 6
V A R E X I M A G I N G
2 0 1 7 A N N U A L R E P O R T
R A D I O G R A P H Y
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V A R E X I M A G I N G
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7
We also have a substantial presence in Europe, with facilities
Key Growth Drivers
in Germany and the Netherlands, as well as in Asia with a
China represents our primary growth driver. Changes taking
manufacturing facility in the Philippines and a new service
place in the delivery of healthcare services represents a
center near Shanghai. We believe it is important to be close
substantial incremental opportunity for our CT X-ray tubes
to our customers with regional service centers in the United
to be incorporated into new locally manufactured CT
States, Europe and Asia.
imaging systems. Our belief is based on, among others, the
We have valuable long-term customer relationships.
following favorable factors:
Customer success has always been a pillar of our values and
• China has an exceedingly large population. The government
has led to a number of our customer relationships exceeding
has begun to expand healthcare services to non-urban
four decades and many more exceeding two decades. We
areas of the country over the past few years creating
have also forged new relationships with customers around
substantial demand for new X-ray imaging systems.
the world whose X-ray imaging systems are in various stages
of development, including several that are nearing market
introduction. In fiscal year 2017, we closed more than
$650 million in multi-year customer agreements for our
X-ray imaging components that included both incremental
business with new customers and renewed business with
existing customers.
To support our valuable customer relationships, we have
approximately 1,900 employees located at more than 25
manufacturing and service center sites in North America,
Europe, and Asia. On a geographic basis, in fiscal year 2017
the Americas represented 35% of our revenues and 75%
• The government in China has indicated that CT should
be one of the imaging technologies of choice due to its
diagnostic versatility and has stated a preference for local
manufacturers to bring new imaging systems to market.
We are working with around a dozen new OEMs who are
bringing their X-ray imaging systems to market.
• CT imaging is projected to grow in excess of 6% in China
compared to more than 4% in other parts of the world.
Estimates project more than 25,000 CT imaging systems
will be needed in China to meet demand over the next
10 years.
of our employees; Europe and the Middle East represented
Conversion of analog imaging to digital detectors. We are
31% of our revenues and 13% of our employees; and the
one of the innovators of digital detectors introduced more
Asia/Pacific region represented 34% of our revenues and
than a decade ago to replace analog film and CR-based
12% of our employees.
imaging methods. Today, the global digital detector market
is highly competitive, particularly in the radiographic
segment for more routine diagnostic imaging applications.
45671 Merrill A291712_Narrative.indd 7
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8
V A R E X I M A G I N G
2 0 1 7 A N N U A L R E P O R T
C A R M
“Our strong performance in the fourth quarter and the fiscal year
reinforces our belief that our emphasis and commitment to X-ray
imaging components has enabled us to serve our customers better
and provide greater value to our stockholders.”
Clarence Verhoef
Chief Financial Officer
Adoption of digital detectors is continuing due to new
The Industrial and Security markets are increasingly
technologies, as well as reimbursement changes.
seeking X-ray imaging solutions. There is growing demand
• Demand for digital detectors for surgical imaging systems
is starting to accelerate with approximately 8,000 Mobile
for X-ray sources and digital detectors in industrial and
security imaging applications.
C-Arm systems sold annually around the world. This
X-ray imaging systems for non-destructive testing and
represents a significant opportunity for us, and with the
manufacturing inspection are increasingly being adopted
addition of the acquired imaging business, we now offer
by industrial companies for applications in sectors such as
an expanded portfolio of amorphous silicon and CMOS
food and beverage, automotive, aerospace, medical joint
based digital detectors for Mobil C-Arms.
replacement sectors, oil and gas plants and nuclear power
• Adoption of radiographic detectors has progressed more
slowly. Global estimates project about 500,000 analog
based X-ray imaging systems will be replaced with digital
facilities. The acquired imaging business has a sizeable
footprint in the industrial sector and provides additional
expansion opportunities for our products.
imaging systems over the next seven to ten years.
In the security sector, we continue to work with OEM
• In the United States, reimbursement for use of film-based
radiographic imaging systems has been reduced by 20%,
and beginning in January 2018, reimbursement for use
of CR-based imaging systems will be reduced by 7% and
deepen to 10% in 2023.
customers developing new applications that incorporate
our CT tube technology into their new imaging systems to
improve screening effectiveness at airports for carry-on and
checked baggage. We also have experienced a recovery in
demand for our high-energy linear accelerators, and this
year we introduced a new platform of compact and light-
weight linear accelerators for mobile cargo screening and
industrial inspection applications.
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2 0 1 7 F O R M 1 0 - K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________________________________________________
FORM 10-K
____________________________________________________________
(cid:2)(cid:3)ANNUAL REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the year ended September 29, 2017
or
(cid:4)(cid:3)TRANSITION REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number 001-37860
____________________________________________________________
VAREX IMAGING CORPORATION
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
1678 S. Pioneer Road,
Salt Lake City, Utah
(Address of principal executive offices)
81-3434516
(I.R.S. Employer
Identification Number)
84104
(Zip Code)
(801) 972-5000
(Registrant’s telephone number, including area code)
____________________________________________________________
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common stock, par value $0.01 per share
—
—
Name of each exchange on which registered
NASDAQ Global Select Market
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes (cid:4) No (cid:2)
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes (cid:4) No (cid:2)
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes (cid:3)(cid:2)(cid:3)No (cid:3)(cid:4)
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File
required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such
shorter period that the registrant was required to submit and post such files). Yes (cid:3)(cid:2) No (cid:3)(cid:4)
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to
the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K. (cid:2)
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or
an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging growth
company" in Rule 12b-2 of the Exchange Act.
Large Accelerated filer
Non-Accelerated filer
(cid:5)(cid:3)
(cid:6)(cid:3)
Accelerated filer
Smaller reporting company
Emerging growth company
(cid:5)(cid:3)
(cid:5)(cid:3)
(cid:6)(cid:3)
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
(cid:5)(cid:3)
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes (cid:4) No (cid:2)
As of March 31, 2017, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of shares of
the registrant’s common stock held by non-affiliates of the registrant (based upon the closing sale price of such shares on the NASDAQ Global Select
Market on March 31, 2017) was $1,122,413,712. Shares of the registrant’s common stock held by the registrant’s executive officers and directors
and by each entity that owned 10% or more of the registrant’s outstanding common stock have been excluded in that such persons may be deemed to
be affiliates. This determination of affiliate status is not necessarily a conclusive determination for other purposes.
As of November 30, 2017, there were 37,739,440 shares of the registrant’s common stock outstanding.
Documents Incorporated by Reference
Portions of registrant’s proxy statement relating to registrant’s 2018 annual meeting of stockholders have been incorporated by reference in Part III of
this annual report on Form 10-K.
VAREX IMAGING CORPORATION
INDEX
Part I.
Financial Information
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
Part II.
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Part III.
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
Part IV.
Item 15.
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
Marketing for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of
Equity Securities
Selected Financial Data
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures about Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements with Accountants on Accounting and Financial Disclosures
Controls and Procedures
Other Information
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accountant Fees and Services
Exhibits and Financial Statement Schedules
Signatures
2
2
12
34
34
34
35
35
35
36
38
49
50
50
50
51
51
51
51
51
51
52
53
53
56
1
Forward-Looking Statements
This Annual Report on Form 10-K (this “Annual Report”), including the section entitled “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” (“MD&A”) contains “forward-looking” statements within the meaning of
the Private Securities Litigation Reform Act of 1995, which provides a “safe harbor” for statements about future events, products and
future financial performance that are based on the beliefs of, estimates made by, and information currently available to the
management of Varex Imaging Corporation (“we,” “our,” “us,” the “Company,” “Varex,” or “Varex Imaging”). The outcome of the
events described in these forward-looking statements is subject to risks and uncertainties. Actual results and the outcome or timing of
certain events may differ significantly from those projected in these forward-looking statements or management’s current expectations
due to the factors cited in the Risk Factors listed under Part I, Item 1A of this Annual Report, MD&A and other factors described from
time to time in our other filings with the U.S. Securities and Exchange Commission (the “SEC”), or other reasons. For this purpose,
statements concerning: industry or mark(cid:2)(cid:3)(cid:4)(cid:5)(cid:2)(cid:6)(cid:7)(cid:2)(cid:8)(cid:3)(cid:4)(cid:9)(cid:10)(cid:3)(cid:11)(cid:9)(cid:9)(cid:12)(cid:13)(cid:4)(cid:7)(cid:14)(cid:15)(cid:12)(cid:2)(cid:3)(cid:4)(cid:14)(cid:16)(cid:16)(cid:2)(cid:17)(cid:3)(cid:14)(cid:8)(cid:16)(cid:2)(cid:4)(cid:9)(cid:18)(cid:4)(cid:9)(cid:15)(cid:4)(cid:3)(cid:15)(cid:14)(cid:8)(cid:5)(cid:19)(cid:3)(cid:19)(cid:9)(cid:8)(cid:4)(cid:3)(cid:9)(cid:4)(cid:8)(cid:2)(cid:20)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:3)(cid:2)(cid:16)(cid:22)(cid:8)(cid:9)(cid:11)(cid:9)(cid:6)(cid:23)(cid:4)(cid:5)(cid:10)(cid:16)(cid:22)(cid:4)(cid:14)(cid:5)(cid:4)
advanced X-(cid:15)(cid:14)(cid:23)(cid:4)(cid:3)(cid:10)(cid:24)(cid:2)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:21)(cid:19)(cid:6)(cid:19)(cid:3)(cid:14)(cid:11)(cid:4)(cid:18)(cid:11)(cid:14)(cid:3)(cid:4)(cid:17)(cid:14)(cid:8)(cid:2)(cid:11)(cid:4)(cid:21)(cid:2)(cid:3)(cid:2)(cid:16)(cid:3)(cid:9)(cid:15)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:5)(cid:13)(cid:4)(cid:6)(cid:15)(cid:9)(cid:20)(cid:3)(cid:22)(cid:4)(cid:21)(cid:15)(cid:19)(cid:25)(cid:2)(cid:15)(cid:5)(cid:13)(cid:4)(cid:18)(cid:10)(cid:3)(cid:10)(cid:15)(cid:2)(cid:4)(cid:9)(cid:15)(cid:21)(cid:2)(cid:15)(cid:5)(cid:26)(cid:4)(cid:15)(cid:2)(cid:25)(cid:2)(cid:8)(cid:10)(cid:2)(cid:5)(cid:26)(cid:4)(cid:24)(cid:14)(cid:16)(cid:12)(cid:11)(cid:9)(cid:6)(cid:26)(cid:4)(cid:2)(cid:14)(cid:15)(cid:8)(cid:19)(cid:8)(cid:6)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:9)(cid:3)(cid:22)(cid:2)(cid:15)(cid:4)
(cid:18)(cid:19)(cid:8)(cid:14)(cid:8)(cid:16)(cid:19)(cid:14)(cid:11)(cid:4)(cid:15)(cid:2)(cid:5)(cid:10)(cid:11)(cid:3)(cid:5)(cid:13)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:14)(cid:8)(cid:23)(cid:4)(cid:5)(cid:3)(cid:14)(cid:3)(cid:2)(cid:7)ents using the terms “believe,” “expect,” “anticipate,” “can,” “should,” “would,” “could,” “estimate,”
“may,” “intended,” “potential,” and “possible” or similar statements are forward-looking statements that involve risks and
uncertainties that could cause our actual results and the outcome and timing of certain events to differ materially from those projected
or management’s current expectations. By making forward-looking statements, we have not assumed any obligation to, and you
should not expect us to, update or revise those statements because of new information, future events or otherwise.
Item 1. Business
Overview
PART I
Varex Imaging Corporation, a Delaware corporation formed in 2016, is a leading innovator, designer and manufacturer of X-
ray imaging components, which include X-ray tubes, digital flat panel detectors and linear accelerators, which are key components of
X-ray imaging systems. On January 28, 2017, Varian Medical Systems, Inc. ("Varian") completed its separation and distribution of
Varex. In connection with the distribution, Varex became an independent publicly-traded company and is listed on The NASDAQ
Global Select Market under the ticker “VREX” with 37.4 million shares of common stock distributed to Varian shareholders. With a
65+ year history of successful innovation, Varex’s components are used in medical imaging as well as in industrial and security
imaging applications. Global OEM manufacturers of X-ray imaging systems use the company’s X-ray sources, digital detectors,
connecting devices and imaging software as components in their systems to detect, diagnose and protect.
On May 1, 2017, we acquired the Medical Imaging business of PerkinElmer, Inc. ("Acquired Detector Business") for $273.3
million. The acquisition consisted of PerkinElmer Medical Holdings, Inc. and Dexela Limited, together with certain assets of PKI and
its direct and indirect subsidiaries relating to digital flat panel detectors that serve as components for industrial, medical, dental and
veterinary X-ray imaging systems. The acquired business included approximately 280 employees with operations in Santa Clara,
California as well as operations in Germany, the Netherlands and the United Kingdom.
Our products are sold in three geographic regions: the Americas, EMEA, and APAC. The Americas includes North America
(primarily the United States) and Latin America. EMEA includes Europe, Russia, the Middle East, India and Africa. APAC includes
Asia and Australia. Revenues by region are based on the known final destination of products sold.
Our success depends upon our ability to anticipate changes in our markets, the direction of technological innovation and the
demands of our customers. We continue to invest in research and development and have over 500 engineers (including 55 with a
doctorate degree) in the company. Combining this focus on innovation and product performance with strong long-term customer
relationships allows us to partner with our customers to bring industry-leading products to the x-ray imaging market. In addition, total
product lifecycle cost is important. We continue to improve the life and quality of our imaging components and leverage our scale as
the largest x-ray imaging component supplier to provide cost effective solutions.
Our Chief Executive Officer, who is our Chief Operating Decision Maker (“CODM”), evaluates the product groupings and
measures the business performance in two reportable operating segments: Medical and Industrial. The segments align our products
and service offerings with customer use in medical and industrial markets and are consistent with how the CODM evaluates the
business for the allocation of resources. The CODM allocates resources to and evaluates the financial performance of each operating
segment primarily based on revenues and gross margin.
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Medical
In our Medical business segment, we design, manufacture, sell and service X-ray imaging components for use in a range of
applications, including radiographic and fluoroscopic imaging, mammography, computed tomography (“CT”), radiation therapy and
computer-aided detection. We provide a broad range of X-ray imaging components for medical customers, including X-ray tubes,
digital flat panel image detectors, high voltage connectors, image-processing software and workstations, computer-aided diagnostic
software, collimators, automatic exposure control devices, generators, ionization chambers and buckys.
A significant portion of our revenues come from the sales of high-end X-ray tubes used in CT imaging and high-end dynamic
digital detectors used in fluoroscopic and dental applications. These upper-tier imaging components are characterized by increased
levels of technological complexity, engineering and intellectual property that typically allow these products to have a higher sales
price and gross margin.
The digital flat panel detector market continues to mature from initial product introductions more than 10 years ago. For the
past few years, we have experienced price erosion for these products, predominantly in the highly-competitive market for radiographic
detectors. We anticipate this trend will continue in the foreseeable future.
Our X-ray imaging components are primarily sold to imaging system original equipment manufacturer (“OEM”) customers
that incorporate them into their medical diagnostic, radiation therapy, dental and veterinary imaging systems. To a much lesser extent,
we also sell our X-ray imaging components to independent service companies, distributors and directly to end-users for replacement
purposes.
Industrial
In our Industrial business segment, we design, manufacture, sell and service products for use in security and industrial
inspection applications, such as airport security screening at ports and borders and nondestructive examination in a variety of
applications. The products include Linatron X-ray accelerators, X-ray tubes, digital flat panel detectors, high voltage connectors and
image-processing software that we generally sell to OEM customers that incorporate these products into their inspection systems.
The security market primarily consists of airport security (carry-on baggage, checked baggage and palletized cargo) and
cargo screening at ports and borders. The end customers for border protection systems are typically government agencies, many of
which are in oil-based economies and war zones. In 2015, we saw a significant decline in demand for border protection systems due to
the volatility of oil prices with moderate increases in demand in the following years.
The non-destructive testing market utilizes x-ray imaging to scan items for inspection of manufacturing defects and product
integrity in a wide range of industries including the aerospace, automotive, food packaging, metal castings and 3D printing industries.
We provide x-ray sources, digital flat panel detectors, high voltage connectors and image processing software to OEM customers,
system integrators and manufacturers. In addition, new applications for x-ray sources are being developed, such as sterilization of food
and its packaging.
Customers
Varex’s customers are primarily large OEMs. Its top five customers, measured by revenue, are Toshiba Medical Systems,
Hologic, Inc., Hitachi Ltd., General Electric Company and Varian, which collectively accounted for approximately 34% of Varex’s
revenues in fiscal year 2017. Varex’s largest customer, Toshiba Medical Systems, accounted for approximately 19%, 23% and 26% of
its total revenues in fiscal 2017, 2016 and 2015 respectively. The loss of one or more of Varex’s top customers would have a material
and adverse effect on Varex’s business. For more information, see “Risk Factors—Varex sells its products to a limited number of OEM
customers, many of which are also its competitors, and a reduction in or loss of business of one or more of these customers may
materially reduce its sales.”
Competition
The imaging components market is highly competitive. Our OEM customers may choose to develop and manufacture the
components in-house or they may choose to out-source to a supplier such as Varex or other providers of imaging components. Our
success depends upon our ability to anticipate changes in our markets, the direction of technological innovation and the demands of
our customers. To remain competitive, we must continue to invest in research and development focused on innovation, product
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performance and improving the quality and cost of our imaging components. Significant capital investment is required for imaging
component manufacturers and Varex leverages its high volume to reduce its per-unit costs by spreading the fixed costs over more
units.
Medical
Varex often competes with the in-house X-ray tube manufacturing operations of major diagnostic imaging systems
companies, which are the primary OEM customers for Varex’s Medical products. In order to effectively compete with these in-house
alternatives, Varex must have a competitive advantage in one or more significant areas, such as superior technology and performance,
better product quality or lower product cost. Consequently, Varex sells a significant volume of its X-ray tubes to OEM customers that
have in-house X-ray tube production capability. In addition, Varex competes with some OEM customers, such as Toshiba Medical
Systems Corporation and Dunlee, a division of Philips Healthcare, who sell X-ray tubes to other manufacturers, and other non-OEMs,
such as Industria Applicazioni Elettroniche S.p.A, as well as emerging X-ray tube manufacturers in China. High capital costs and
mastery of complex manufacturing processes that drive production yield and product life are significant characteristics of the X-ray
tubes business.
The market for digital flat panel detectors is also very competitive. Varex sells its digital flat panel detectors to a number of
OEM customers that incorporate Varex’s flat panel detectors into their medical diagnostic, radiation therapy, dental, veterinary and
industrial imaging systems. Varex’s amorphous silicon based flat panel detector technology and complementary metal-oxide-
semiconductor ("CMOS") technology competes with other detector technologies, such as amorphous selenium, charge-coupled
devices and variations of amorphous silicon scintillators. Varex believes that its products provide a competitive advantage due to
product quality and performance and lower overall product lifecycle costs. In the digital flat panel detector market, Varex primarily
competes against Trixell S.A.S., Canon, Inc., Vieworks Co., Ltd., and Hamamatsu Corporation, as well as emerging low-cost
manufacturers from China such as iRay Technology (Shanghai) Limited, and Jiangsu CareRay Medical Systems Co., Ltd.
Industrial
In the Industrial segment, Varex competes with other OEM suppliers, such as General Electric, Toshiba Medical Systems
Corporation, Nuctech Company Limited (“Nuctech”) and Comet AG. While there are other manufacturers of low-energy X-ray tubes
and digital flat panel detectors for specialized and niche industrial applications, Varex’s products are designed for a broad range of
applications in inspection, analysis, and testing. In the high-energy market, Varex competes against technologies from Nuctech,
Siemens AG, and Foton Ltd., whose X-ray sources are used in applications that include cargo and container scanning, border security,
aerospace applications, castings and pressure vessel inspections.
Customer Services and Support
Varex generally warrants its products for 12 to 24 months. In certain cases, the warranty also may be specified by usage
metrics such as number of scans. It provides technical advice and consultation to major OEM customers from its US offices in Utah,
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Switzerland, the United Kingdom, Italy and Japan. Varex’s applications specialists and engineers make recommendations to meet the
customer’s technical requirements within the customer’s budgetary constraints. Varex often develops specifications for a unique
product that will be designed and manufactured to meet a specific customer’s requirements.
Manufacturing and Supplies
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These facilities employ state-of-the-art manufacturing techniques and several have been honored by the press, governments and trade
organizations for their commitment to quality improvement. These manufacturing facilities are certified by International Standards
Organization (“ISO”) under ISO 9001 (for industrial products) or ISO 13485 (for medical devices). In addition, Varex has service
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infrastructure enables Varex to leverage production scale to achieve productivity and low cost advantage as well as research and
development synergies.
Manufacturing processes at Varex’s various facilities include machining, fabrication, subassembly, system assembly and final
testing. Varex has invested in various automated and semi-automated equipment for the fabrication and machining of the parts and
4
assemblies that it incorporates into its products. Varex may, from time to time, invest further in such equipment. Varex’s quality
assurance program includes various quality control measures from inspection of raw materials, purchased parts and assemblies
through in-line inspection. In some cases, Varex may outsource the manufacturing of sub-assemblies while still performing system
design, final assembly and testing in-house. In such cases, Varex believes outsourcing enables it to reduce or maintain fixed costs and
capital expenditures, while also providing it with the flexibility to increase production capacity. Varex purchases material and
components from various suppliers that are either standard products or customized to its specifications. Some of the components
included in Varex’s products may be sourced from a limited group of suppliers or from a single source supplier, such as the wave
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X-ray tube targets, housings, bearings and various other components. Varex requires certain raw materials, such as copper, lead,
tungsten, rhenium, molybdenum zirconium, and various high grades of steel alloy for X-ray tubes and industrial products. Worldwide
demand, availability and pricing of these raw materials have been volatile, and Varex expects that availability and pricing will
continue to fluctuate in the future.
Research and Development
Developing products, systems and services based on advanced technology is essential to Varex’s ability to compete
effectively in the marketplace. It maintains a research and development and engineering staff responsible for product design and
engineering.
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Kingdom and Germany facilities internationally, and is primarily focused on developing and improving imaging component
technology. Current X-ray source development areas include smaller footprint linear accelerators, improvements to tube life and tube
stability, reductions of tube noise and tube designs that will enable OEMs to continue to reduce dose delivered, and improve image
resolution, cost effectively. Research in digital flat panel imaging technology is aimed at developing new panel technologies with
better dose utilization, improved image quality, lower product costs and new image processing tools for advanced applications.
Industrial products share some of the same base technology competencies and platforms as medical products and Varex’s
medical and industrial development teams are therefore co-located in Salt Lake City, San Jose, Santa Clara, Dinxperlo, and in Walluf.
One of Varex’s competitive advantages is that some of the foundational technologies and software components developed for medical
applications may also be applicable in industrial components, and vice versa. In addition to these product development synergies,
Varex is also able to realize sourcing, production, service center, and logistics synergies across the different markets.
Product and Other Liabilities
Varex’s business exposes it to potential product liability claims that are inherent in the manufacture, sale, installation,
servicing and support of X-ray imaging devices, related software and other devices that contain hazardous material and/or deliver
radiation. Because its products are involved in the intentional delivery of radiation to the human body and other situations where
people may come in contact with radiation (for example, when Varex’s Industrial products are being used to scan cargo) as well as the
detection, planning and treatment of medical problems, the possibility for significant injury and/or death exists. Varex may face
substantial liability to patients, its customers and others for damages resulting from the faulty, or allegedly faulty, design, manufacture,
installation, servicing, support, testing or interoperability of Varex’s and its customers’ products, or their misuse or failure. Varex may
also be subject to claims for property damages or economic loss related to or resulting from any errors or defects in its products, or the
installation, servicing and support of its products. Any accident or mistreatment could subject Varex to legal costs, litigation, adverse
publicity and damage to Varex’s reputation, whether or not its products or services were a factor. In addition, if a product Varex
designs or manufactures were defective (whether due to design, labeling or manufacturing defects, improper use of the product or
other reasons), or found to be so by a competent regulatory authority, Varex may be required to correct or recall the product and notify
other regulatory authorities. Varex maintains limited product liability, professional liability and omissions liability insurance coverage.
Government Regulation
U.S. Regulations
Laws governing marketing a medical device. In the United States, as a manufacturer and seller of medical devices and
devices emitting radiation or utilizing radioactive by-product material, Varex and some of its suppliers and distributors are subject to
extensive regulation by federal governmental authorities, such as the U.S. Food and Drug Administration (the "FDA"), Nuclear
5
Regulatory Commission (“NRC”), and state and local regulatory agencies, such as the State of California, to ensure the devices are
safe and effective and comply with laws governing products which emit, produce or control radiation. Similar international regulations
apply overseas. These regulations, which include the U.S. Food, Drug and Cosmetic Act (the “FDC Act”) and regulations promulgated
by the FDA, govern, among other things, the design, development, testing, manufacturing, packaging, labeling, distribution,
import/export, sale and marketing and disposal of medical devices, post market surveillance and reporting of serious injuries and
death, repairs, replacements, recalls and other matters relating to medical devices, radiation emitting devices and devices utilizing
radioactive by-product material. State regulations are extensive and vary from state to state. Varex’s X-ray tube products, imaging
workstations and flat panel detectors are considered medical devices. Under the FDC Act, each medical device manufacturer must
comply with quality system regulations that are strictly enforced by the FDA.
Unless an exception applies, the FDA requires that the manufacturer of a new medical device or a new indication for use of,
or other significant change in, existing currently marketed medical device obtain either 510(k) pre-market notification clearance or
pre-market approval (“PMA”) before it can market or sell those products in the United States. The 510(k) clearance process is
applicable when the device introduced into commercial distribution is substantially equivalent to a legally marketed device. The
process of obtaining 510(k) clearance generally takes at least six months from the date the application is filed, but could take
significantly longer, and generally requires submitting supporting testing data. After a product receives 510(k) clearance, any
modifications or enhancements to a product that could significantly affect its safety or effectiveness, or that would constitute a major
change in the intended use of the device, technology, materials, labeling, packaging, or manufacturing process may require a new
510(k) clearance. The FDA requires each manufacturer to make this determination in the first instance, but the FDA can review any
such decision. If the FDA disagrees with the manufacturer’s decision, it may retroactively require the manufacturer to submit a request
for 510(k) pre-market notification clearance and can require the manufacturer to cease marketing and/or recall the product until 510(k)
clearance is obtained. The FDA has issued draft guidance that, if finalized and implemented, will result in manufacturers needing to
seek a significant number of new clearances for changes made to legally marketed devices. If we cannot establish that a proposed
product is substantially equivalent to a legally marketed device, we must seek pre-market approval through a PMA application. Under
the PMA process, the applicant submits extensive supporting data, including, in most cases, data from clinical studies, in the PMA
application to establish reasonable evidence of the safety and effectiveness of the product. This process typically takes at least one to
two years from the date the PMA is accepted for filing, but can take significantly longer for the FDA to review. Most of Varex’s
products are Class I medical devices, which do not require 510(k) clearance.
Quality systems. Varex’s manufacturing operations for medical devices, and those of its third-party manufacturers, are
required to comply with the FDA’s Quality System Regulation (“QSR”), which addresses a company’s responsibility for product
design, testing, and manufacturing quality assurance, and the maintenance of records and documentation. The QSR requires that each
manufacturer establish a quality systems program by which the manufacturer monitors the manufacturing process and maintains
records that show compliance with FDA regulations and the manufacturer’s written specifications and procedures relating to the
devices. QSR compliance is necessary to receive and maintain FDA clearance or approval to market new and existing products. The
FDA makes announced and unannounced periodic and ongoing inspections of medical device manufacturers to determine compliance
with the QSR. If in connection with these inspections the FDA believes the manufacturer has failed to comply with applicable
regulations and/or procedures, it may issue observations that would necessitate prompt corrective action. If FDA inspection
observations are not addressed and/or corrective action taken in a timely manner and to the FDA’s satisfaction, the FDA may issue a
Warning Letter (which would similarly necessitate prompt corrective action) and/or proceed directly to other forms of enforcement
action. Failure to respond timely to FDA inspection observations, a Warning Letter or other notice of noncompliance and to promptly
come into compliance could result in the FDA bringing enforcement action against us, which could include the total shutdown of
Varex’s production facilities, denial of importation rights to the United States for products manufactured in overseas locations and
denial of export rights for U.S. products and criminal and civil fines.
The FDA and the Federal Trade Commission (the “FTC”) also regulate advertising and promotion of Varex’s products to
ensure that the claims it makes are consistent with its regulatory clearances, that it has adequate and reasonable scientific data to
substantiate the claims and that its promotional labeling and advertising is neither false nor misleading. Varex may not promote or
advertise its products for uses not within the scope of its intended use statement in its clearances or approvals or make unsupported
safety and effectiveness claims.
It is also important that Varex’s products comply with electrical safety and environmental standards, such as those of
Underwriters Laboratories (“UL”), the Canadian Standards Association (“CSA”), and the International Electrotechnical Commission
(“IEC”). In addition, the manufacture and distribution of medical devices utilizing radioactive material requires a specific radioactive
material license. For the United States, manufacture and distribution of these radioactive sources and devices also must be in
accordance with a model-specific certificate issued by either the NRC or by an Agreement State. In essentially every country and state,
6
installation and service of these products must be in accordance with a specific radioactive materials license issued by the applicable
radiation control agency. Service of these products must be in accordance with a specific radioactive materials license. Varex is also
subject to a variety of additional environmental laws regulating Varex’s manufacturing operations and the handling, storage, transport
and disposal of hazardous substances, and which impose liability for the cleanup of any contamination from these substances.
Other applicable U.S. regulations. As a participant in the healthcare industry, Varex is also subject to extensive laws and
regulations protecting the privacy and integrity of patient medical information that it receives, including the Health Insurance
Portability and Accountability Act of 1996 (“HIPAA”), “fraud and abuse” laws and regulations, including, physician self-referral
prohibitions, and false claims laws. From time to time, these laws and regulations may be revised or interpreted in ways that could
make it more difficult for Varex’s customers to conduct their businesses, such as recent proposed revisions to the laws prohibiting
physician self-referrals, and such revisions could have an adverse effect on the demand for Varex’s products, and therefore its business
and results of operations. Varex also must comply with numerous federal, state and local laws of more general applicability relating to
such matters as environmental protection, safe working conditions, manufacturing practices, fire hazard control and other matters.
The laws and regulations and their enforcement are constantly undergoing change, and Varex cannot predict what effect, if
any, changes to these laws and regulations may have on its business. For example, national and state laws regulate privacy and may
regulate Varex’s use of data. Furthermore, HIPAA was amended by the HITECH Act to provide that business associates who have
access to patient health information provided by hospitals and healthcare providers are now directly subject to HIPAA, including the
associated enforcement scheme and inspection requirements.
Medicare and Medicaid Reimbursement
The federal and state governments of the United States establish guidelines and pay reimbursements to hospitals and free-
standing clinics for diagnostic examinations and therapeutic procedures under Medicare at the federal level and Medicaid at the state
level. Private insurers often establish payment levels and policies based on reimbursement rates and guidelines established by the
government.
The federal government and Congress review and adjust rates annually, and from time to time consider various Medicare and
other healthcare reform proposals that could significantly affect both private and public reimbursement for healthcare services in
hospitals and free-standing clinics. In the past, Varex has seen demand for its customers’ systems (in which Varex’s products are
incorporated) negatively impacted by the uncertainties surrounding reimbursement rates in the United States. State government
reimbursement for services is determined pursuant to each state’s Medicaid plan, which is established by state law and regulations,
subject to requirements of federal law and regulations.
The provisions of the Affordable Care Act went into effect in 2012. Specifically, one of the components of the law is a 2.3%
excise tax on sales of most medical devices, which may in the future negatively affect Varex’s customers and have an indirect negative
effect on Varex’s gross margin, although it was suspended for 2016 and 2017. Other elements of this legislation, including
comparative effectiveness research, an independent payment advisory board, payment system reforms (including shared savings
pilots) and other provisions, could meaningfully change the way healthcare is developed and delivered, and may materially impact
numerous aspects of Varex’s business, including the demand and availability of its products. Various healthcare reform proposals have
also emerged at the state level, and Varex is unable to predict which, if any, of these proposals will be enacted. In addition, it is
possible that changes in administration and policy, including the potential repeal of the Affordable Care Act, resulting from the recent
U.S. presidential election could result in additional proposals and/or changes to health care system legislation which could have a
material adverse effect on our business. Varex believes that the uncertainty created by healthcare reform in the United States has
complicated its customers’ decision-making process and, therefore, impacted its business, and may continue to do so.
The sale of medical devices, the referral of patients for diagnostic examinations and treatments utilizing such devices, and the
submission of claims to third-party payors (including Medicare and Medicaid) seeking reimbursement for such services, are subject to
various federal and state laws pertaining to healthcare “fraud and abuse.” Anti-kickback laws make it illegal to solicit, induce, offer,
receive or pay any remuneration in exchange for the referral of business, including the purchase of medical devices from a particular
manufacturer or the referral of patients to a particular supplier of diagnostic services utilizing such devices. False claims laws prohibit
anyone from knowingly and willfully presenting, or causing to be presented, claims for payment to third-party payors (including
Medicare and Medicaid) that are false or fraudulent, for services not provided as claimed, or for medically unnecessary services. The
Office of the Inspector General prosecutes violations of fraud and abuse laws and any violation may result in criminal and/or civil
sanctions, including, in some instances, imprisonment and exclusion from participation in federal healthcare programs such as
Medicare and Medicaid, which may negatively impact the demand for Varex’s products.
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Foreign Regulations
Varex’s operations, sales and service of its products outside the United States are subject to regulatory requirements that vary
from country to country and may differ significantly from those in the United States. In general, Varex’s products are regulated outside
the United States as medical devices by foreign governmental agencies similar to the FDA.
Marketing a medical device internationally. For Varex to market its products internationally, it must obtain clearances or
approvals for products and product modifications. Varex is required to affix the CE mark to its products to sell them in member
countries of the European Union (“EU”). The CE mark is an international symbol of adherence to certain essential principles of safety
and effectiveness, which once affixed enables a product to be sold in member countries of the EEA. The CE mark is also recognized in
many countries outside the EU, such as Switzerland and Norway and can assist in the clearance process. To receive permission to affix
the CE mark to its medical devices products, Varex must obtain Quality System certification, e.g., ISO 13485, and must otherwise
have a quality management system that complies with the EU Medical Device Directive. The ISO promulgates standards for
certification of quality assurance operations. Varex is certified as complying with the ISO 9001 for its security and inspection products
and ISO 13485 for its medical devices. Several Asian countries, including Japan and China, have adopted regulatory schemes that are
comparable, and in some cases more stringent, than the EU scheme. To import medical devices into Japan, the requirements of Japan’s
New Medical Device Regulation must be met and a “shonin,” the approval to sell medical products in Japan, must be obtained.
Similarly, in China, a registration certification issued by the State Food and Drug Administration and a China Compulsory
Certification mark for certain products are required to sell medical devices in that country. Obtaining such certifications on its
products can be time-consuming and can cause Varex to delay marketing or sales of certain products in such countries. Similarly, prior
to selling a device in Canada, manufacturers of Class II, III and IV devices must obtain a medical device license, though Varex does
not currently sell these types of devices in Canada. Additionally, many countries have laws and regulations relating to radiation and
radiation safety that also apply to Varex’s products. In most countries, radiological regulatory agencies require some form of licensing
or registration by the facility prior to acquisition and operation of an X-ray generating device or a radiation source. The handling,
transportation and recycling of radioactive metals and source materials are also highly regulated.
A number of countries, including the members of the EU, have implemented or are implementing regulations that would
require manufacturers to dispose, or bear certain disposal costs, of products at the end of a product’s useful life and restrict the use of
some hazardous substances in certain products sold in those countries.
Manufacturing and selling a device internationally. Varex is also subject to laws and regulations outside the United States
applicable to manufacturers of radiation-producing devices and products utilizing radioactive materials, and laws and regulations of
general applicability relating to matters such as environmental protection, safe working conditions, manufacturing practices and other
matters, in each case that are often comparable to, if not more stringent than, regulations in the United States. In addition, Varex’s sales
of products in foreign countries are also subject to regulation of matters such as product standards, packaging requirements, labeling
requirements, import restrictions, environmental and product recycling requirements, tariff regulations, duties and tax requirements. In
some countries, Varex relies on its foreign distributors and agents to assist Varex in complying with foreign regulatory requirements.
Other applicable international regulations. In addition to the U.S. laws regarding the privacy and integrity of patient medical
information, Varex is subject to similar laws and regulations in foreign countries covering data privacy and other protection of health
and employee information. Particularly within Europe, data protection legislation is comprehensive and complex and there has been a
recent trend toward more stringent enforcement of requirements regarding protection and confidentiality of personal data, as well as
enactment of stricter legislation. Varex is also subject to international “fraud and abuse” laws and regulations, as well as false claims
and misleading advertisement laws. Varex also must comply with numerous international laws of more general applicability relating to
such matters as environmental protection, safe working conditions, manufacturing practices, fire hazard control and other matters.
On June 23, 2016, the United Kingdom (the “U.K.”) held a referendum in which voters approved an exit from the E.U.,
commonly referred to as “Brexit”. Brexit could lead to legal uncertainty and potentially divergent national laws and regulations as the
U.K. determines which E.U. laws to replace or replicate. Given the lack of comparable precedent, it is unclear what financial,
regulatory and legal implications the withdrawal of the U.K. from the E.U. would have and how such withdrawal would affect Varex.
Anti-Corruption Laws and Regulations
Varex is subject to the U.S. Foreign Corrupt Practices Act and anti-corruption laws, and similar laws in foreign countries,
such as the U.K. Bribery Act of 2010, which became effective on July 1, 2011, and the law “On the Fundamentals of Health Protection
in the Russian Federation,” which became effective in January 2012. In general, there is a worldwide trend to strengthen anti-
8
corruption laws and their enforcement, and the healthcare industry and medical equipment manufacturers have been particular targets
of these investigation and enforcement efforts. Any violation of these laws by Varex or its agents or distributors could create a
substantial liability for Varex, subject Varex’s officers and directors to personal liability and also cause a loss of reputation in the
market.
Transparency International’s 2015 Corruption Perceptions Index measured the degree to which public sector corruption is
perceived to exist in 168 countries/territories around the world, and found that two-thirds of the countries in the index, including many
that Varex considers to be high-growth areas for its products, such as China and India, scored below 50, on a scale from 100 (very
clean) to 0 (highly corrupt). Varex currently operates in many countries where the public sector is perceived as being more or highly
corrupt and its strategic business plans include expanding Varex’s business in regions and countries that are rated as higher risk for
corruption activity by Transparency International.
Increased business in higher-risk countries could subject Varex and its officers and directors to increased scrutiny and
increased liability. In addition, becoming familiar with and implementing the infrastructure necessary to comply with laws, rules and
regulations applicable to new business activities and mitigating and protecting against corruption risks could be quite costly. Failure
by Varex or its agents or distributors to comply with these laws, rules and regulations could delay its expansion into high-growth
markets and could materially and adversely affect its business.
Competition and Trade Compliance Laws
Varex is subject to various competition and trade compliance laws in the jurisdictions in which it operates. Regulatory
authorities under whose laws Varex operates may have enforcement powers that can subject Varex to sanctions, and can impose
changes or conditions in the way Varex conducts its business. In addition, an increasing number of jurisdictions also provide private
rights of action for competitors or consumers to seek damages asserting claims of anti-competitive conduct. Increased government
scrutiny of Varex’s actions or enforcement or private rights of action could materially and adversely affect its business or damage its
reputation. In addition, Varex may conduct, or it may be required to conduct, internal investigations or face audits or investigations by
one or more domestic or foreign government agencies, which could be costly and time-consuming, and could divert its management
and key personnel from its business operations. An adverse outcome under any such investigation or audit could subject Varex to fines
or criminal or other penalties, which could materially and adversely affect Varex’s business and financial results. Furthermore,
competition laws may prohibit or increase the cost of future acquisitions that Varex may desire to undertake.
International sales of certain of our Linatron X-ray accelerators are subject to U.S. export licenses that are issued at the
discretion of the U.S. government. Orders and revenues for our security and inspection products have been and may continue to be
unpredictable as governmental agencies may place large orders with us or with our OEM customers over a short period of time and
then may not place additional orders until complete deployment and installation of previously ordered products. We have seen
domestic and international governments postpone purchasing decisions and delay installations of products for security and inspection
systems. Furthermore, tender awards in this business may be subject to challenge by third parties, as we have previously encountered,
which can make the conversion of orders to revenues unpredictable for some security and inspection products. The market for border
protection systems has slowed significantly and end customers, particularly in oil-based economies and war zones in which we have a
significant customer base, are delaying system deployments or tenders and have considered moving to alternative sources.
Intellectual Property
Varex places considerable importance on obtaining and maintaining patent, copyright and trade secret protection for
significant new technologies, products and processes, because of the length of time and expense associated with bringing new
products through the development process and to the marketplace.
Varex generally relies upon a combination of patents, copyrights, trademarks, trade secret and other laws, and contractual
restrictions on disclosure, copying and transferring title, including confidentiality agreements with vendors, strategic partners, co-
developers, employees, consultants and other third parties, to protect Varex’s proprietary rights in the developments, improvements
and inventions that Varex has originated and which are incorporated in its products or that fall within its fields of interest. As of
September 29, 2017, Varex owns over 250 patents issued in the United States, over 170 patents issued throughout the rest of the world
and had over another 100 patent applications on file with various patent agencies worldwide. The patents and patents issuing from the
pending applications generally expire between 2017 and 2035. Varex intends to file additional patent applications as appropriate.
Varex has trademarks, both registered and unregistered, that are maintained and enforced to provide customer recognition for its
products in the marketplace. Varex also has agreements with third parties that provide for licensing of patented or proprietary
9
technology, including royalty-bearing licenses and technology cross-licenses. These licenses generally can only be terminated for
breach.
In conjunction with the separation, Varex and Varian entered into an Intellectual Property Matters Agreement, pursuant to
which, among other things, each of Varex and Varian granted the other licenses to use certain intellectual property.
Environmental Matters
Varex’s operations and facilities, past and present, are subject to environmental laws, including laws that regulate the
handling, storage, transport and disposal of hazardous substances. Certain of those laws impose cleanup liabilities under certain
circumstances. In connection with those laws and certain of Varex’s past and present operations and facilities, Varex is obligated to
indemnify Varian for 20% of the cleanup liabilities related to corporate, discontinued or sold operations prior to the 1999 separation
and distribution (after adjusting for any insurance proceeds or tax benefits received by Varian), as well as fully indemnify Varian for
other liabilities arising from the operations of the business transferred to it as part of the separation. Those include facilities sold as
part of Varian’s electron devices business in 1995 and thin film systems business in 1997. In addition, the U.S. Environmental
Protection Agency (“EPA”) or third parties have named Varian as a potentially responsible party under the amended Comprehensive
Environmental Response Compensation and Liability Act of 1980 (“CERCLA”), at sites to which Varian or the facilities of the
businesses sold in 1995 and 1997 were alleged to have shipped waste for recycling or disposal (the “CERCLA sites”). It is anticipated
that Varex will be obligated to reimburse Varian for 20% of the liabilities of Varian related to these CERCLA sites (after adjusting for
any insurance proceeds or tax benefits received by Varian). In connection with the CERCLA sites, to date Varian has been required to
pay only a small portion of the total amount as its contribution to the cleanup efforts and Varex anticipates that any reimbursement to
Varian in the future will not be material.
Financial Information about Geographic Areas
Varex does business globally, with manufacturing and research and development in the United States, Europe, Philippines
and China, and sales and service operations throughout the world. Approximately two-thirds of Varex’s revenues are generated from
its international regions. In addition to the potentially adverse impact of foreign regulations, see “Government Regulation—Foreign
Regulations,” Varex also may be affected by other factors related to its international sales, such as: lower average selling prices and
profit margins, delays in shipments due to required export licensing, and longer time periods from shipment to cash collection (which
increases days sales outstanding (“DSO”)). To the extent that the geographic distribution of Varex’s sales continues to shift more
towards international regions, its overall revenues and margins may suffer. Although a significant portion of Varex customers are
outside of the United States, its products are generally priced in U.S. Dollars. As a result, fluctuations in foreign currency exchange
rates may impact the demand for products.
Varex is also exposed to other economic, political and other risks inherent in doing business globally. For an additional
discussion of these risks, see Item 1A, “Risk Factors.”
Employees
As of September 29, 2017, Varex had approximately 2,000 full-time and part-time employees worldwide. None of its
employees based in the United States are unionized or subject to collective bargaining agreements. Employees based in some foreign
countries may, from time to time, be represented by works councils or unions or subject to collective bargaining agreements. Varex
currently considers its relations with its employees to be good.
Information Available to Investors
As soon as reasonably practicable after our filing or furnishing the information to the SEC, we make the following available
free of charge on the Investors page of our website http://www.vareximaging.com: our annual reports on Form 10-1(cid:13)(cid:4)2(cid:10)(cid:14)(cid:15)(cid:3)(cid:2)(cid:15)(cid:11)(cid:23)(cid:4)(cid:15)(cid:2)(cid:17)(cid:9)(cid:15)(cid:3)(cid:5)(cid:4)
on Form 10-3(cid:13)(cid:4)(cid:16)(cid:10)(cid:15)(cid:15)(cid:2)(cid:8)(cid:3)(cid:4)(cid:15)(cid:2)(cid:17)(cid:9)(cid:15)(cid:3)(cid:5)(cid:4)(cid:9)(cid:8)(cid:4)"(cid:9)(cid:15)(cid:7)(cid:4)4-1(cid:4)5(cid:19)(cid:8)(cid:16)(cid:11)(cid:10)(cid:21)(cid:19)(cid:8)(cid:6)(cid:4)(cid:14)(cid:8)(cid:23)(cid:4)(cid:14)(cid:7)(cid:2)(cid:8)(cid:21)(cid:7)(cid:2)(cid:8)(cid:3)(cid:5)(cid:4)(cid:3)(cid:9)(cid:4)(cid:3)(cid:22)(cid:9)(cid:5)(cid:2)(cid:4)(cid:15)(cid:2)(cid:17)(cid:9)(cid:15)(cid:3)(cid:5)6(cid:13)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:17)(cid:15)(cid:9)$(cid:23)(cid:4)(cid:5)(cid:3)(cid:14)tements. Our Code of
Conduct, Corporate Governance Guidelines and the charters of the Audit Committee, Compensation and Management Development
Committee, Ethics and Compliance Committee, Nominating and Corporate Governance Committee and Executive Committee are also
available on the Investors page of our website. Investors and others should note that we announce material financial and operational
information to our investors using our investor relations website (http://investors.vareximaging.com/), press releases, SEC filings and
public conference calls and webcasts. Please note that information on, or that can be accessed through, our website is not deemed
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“filed” with the SEC and is not to be incorporated by reference into any of our filings under the Securities Act of 1933, as amended
(the “Securities Act”), or the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Executive Officers of the Registrant
The biographical summaries of our executive officers are as follows:
Sunny S. Sanyal, 52, has served as President, Chief Executive Officer, and Director since January 2017. Prior to the separation of
Varex from Varian, Sunny served as senior vice president and president of Varian’s Imaging Components business for Varian since
February 2014. Prior to joining Varian in 2014, Sunny was CEO of T-System, a privately held company providing information
technology solutions and services to hospitals and urgent care facilities. He also served as president of McKesson Provider
Technologies, where he led the company to significant market expansion with its clinical software, medical imaging technology, and
services solutions. Sunny has held executive positions at GE Healthcare, Accenture, and IDX Systems. He received a master of
business administration from Harvard Business School, a master of science in industrial engineering from Louisiana State University,
and a bachelor of engineering in electrical engineering from the University of Bombay.
Clarence R. Verhoef, 61, has served as Chief Financial Officer, and Senior Vice President since January 2017. Prior to the separation
of Varex from Varian, Clarence served as senior vice president, Chief Accounting Officer and corporate controller for Varian since
August 2012. He joined Varian in 2006 and served as the divisional controller of Varian’s Imaging Components business until 2012.
Prior to joining Varian, Clarence served in numerous executive management roles, including chief financial officer of Techniscan
Medical Systems, and chief financial officer and vice president of marketing for GE OEC Medical Systems. He holds a bachelor’s
degree in finance from the University of Utah.
Kimberley E. Honeysett, 46, has served as Senior Vice President, General Counsel, and Corporate Secretary since January 2017. Prior
to the separation of Varex from Varian, Kim served vice president and assistant general counsel and assistant corporate secretary for
Varian, where she advised Varian’s Board of Directors, executive management and corporate functions, including business
development, investor relations, human resources, information technology and was responsible for corporate governance, general
compliance matters, litigation and global subsidiary governance. Prior to joining Varian in 2005, Kim served as group director, legal
affairs at Siebel Systems, Inc., an enterprise software company, and as an associate with the law firm Brobeck, Phleger & Harrison
LLP. Kim holds juris doctor from Cornell Law School and a bachelor’s degree in communications from the University of California,
Los Angeles.
Brian Giambattista, 59, has served as Senior Vice President, and General Manager - X-ray Detectors since May 2017 and joined Varex
after the acquisition of the PerkinElmer Medical Imaging business. He has nearly 30 years of experience in the industry, having held
various management and engineering roles at PerkinElmer and General Electric, and received his doctorate degree in Physics from the
University of Virginia.
Mark S. Jonaitis, 55, has served as Senior Vice President, and General Manager - X-Ray Sources since 2017. Prior to the separation,
Mark served in various management positions at Varian, including most recently vice president and general manager, X-ray Tube
Products and global manufacturing. Mark joined Varian’s predecessor, Varian Associates, in 1983, where he served in various product
and engineering positions. Mark received his bachelor of science in physics from the University of Utah.
Carl E. LaCasce, 61, has served as Senior Vice President - Sales & Marketing and Customer Operations since 2017. Prior to the
separation of Varex from Varian, Carl was Vice President - Global Sales & Marketing of Varian. He is overseeing all customer facing
operations. Carl joined Varian in May 1986. Carl holds a Bachelor’s degree in Business Administration from Elmhurst College.
Richard E. Colbeth, 56, has served as Senior Vice President of Engineering, X-ray Detectors since January 2017. He is overseeing flat
panel operations. Prior to the separation of Varex from Varian, Rick served in various management roles for Varian, including Vice
President and General Manager, Imaging Products and Vice President of Engineering, Imaging Products. Rick joined Varian’s
predecessor, Varian Associates, in 1989, where he served in various research and development positions. He received a Ph.D. in
electrical engineering from Columbia University, a master of science in electrical engineering from Yale University, and a bachelor of
science in electrical engineering from Lehigh University.
Kevin B. Yankton, 51, has served as Chief Accounting Officer, Corporate Controller since January 2017. Prior to joining Varex, Kevin
held the position of VP of Global Business Services and Assistant Corporate Controller for Verifone, Inc. from July 2013 to October
2016. Having started his career with PricewaterhouseCoopers’ San Jose office, he transitioned to Applied Materials where he held
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various finance roles in their corporate, regional HQ, and business units. In addition to Applied Materials, he has held finance roles
with increasing levels of responsibility at Silicon Image, Cisco Systems, and Gap Corporate Offices. Mr. Yankton graduated from the
University of California Santa Barbara with a Bachelor of Arts in Business Economics, holds a MBA from Boston University, is a
California CPA, and is a Certified Internal Auditor.
Item 1A. Risk Factors
The following risk factors and other information included in this Annual Report on Form 10-K should be carefully
considered. Although the risk factors described below are the ones management deems significant, additional risks and uncertainties
not presently known to us or that we presently deem less significant may also adversely affect our business operations. If any of the
following risks or additional risks and uncertainties actually occur, our business, operating results, and financial condition could be
adversely affected.
Varex sells its products and services to a limited number of OEM customers, many of which are also its competitors, and a
reduction in or loss of business of one or more of these customers may materially reduce its sales.
Varex had one customer during fiscal year 2017 that accounted for 19.3% of its revenue. Varex’s ten largest customers as a
group accounted for approximately 48%, 54% and 63% of its revenue for fiscal years 2017, 2016 and 2015, respectively.
Varex sells its products to a limited number of OEM customers, many of which are also its competitors with in-house X-ray
tube manufacturing operations. Although Varex seeks to broaden its customer base, it will continue to depend on sales to a relatively
small number of major customers. Because it often takes significant time to replace lost business, it is likely that Varex’s operating
results would be materially and adversely affected if one or more of its major OEM customers were to cancel, delay, or reduce orders
in the future.
On January 28, 2017, Varian and Varex entered into a Separation and Distribution Agreement (the “Separation and
Distribution Agreement”), whereby Varex became an independent publicly-traded company. Although it is expected that Varian will
continue as a customer of Varex, and while Varex has entered into a multi-year Supply Agreement with Varian, there can be no
assurance that Varian will continue to source from Varex long-term.
Furthermore, Varex generates significant accounts receivables from the sale of its products and the provision of services to its
major customers. Although Varex’s major customers are large corporations, if one or more of these customers were to cancel a product
order or service contract (whether in accordance with its terms or otherwise), become insolvent or otherwise be unable or fail to pay
for Varex products and services, Varex’s operating results and financial condition could be materially and adversely affected.
Varex may not be able to accurately predict the demand for its products by its OEM customers.
Economic uncertainties over the past few years, natural disasters, and other matters beyond Varex’s control have made it
difficult for its OEM customers to accurately forecast and plan future business activities. Such economic uncertainties and natural
disasters, as well as other factors, have previously impacted Varex’s business, resulting in inventory reduction and slowdowns in sales
at some of these customers. Similar inventory adjustments and slowdowns in sales could occur in the future. Varex’s OEM customers
also face inherent competitive issues and new product introduction delays which can result in changes in forecasts. As such, the
market and regulatory risks faced by Varex’s OEM customers in the X-ray-based diagnostic imaging space also ultimately impact
Varex’s ability to forecast future business. Varex’s agreements for imaging components, such as the recent three-year pricing
agreement with Toshiba Medical Systems, may contain purchasing estimates that are based on its customers’ historical purchasing
patterns rather than firm commitments, and actual purchasing volumes under the agreements may vary significantly from these
estimates. The variation from forecasted purchasing volume may be due, in part, to the increasing life of X-ray tubes, which can result
in reduced demand for replacement X-ray tubes in ways Varex may not be able to accurately forecast. Reductions in purchasing
patterns have in the past and may in the future materially and adversely affect Varex’s operating results.
Varex competes in highly competitive markets, and it may lose business to its customers or other companies with greater resources
or the ability to develop more effective technologies, or it could be forced to reduce its prices.
Rapidly-evolving technology, intense competition and pricing pressure characterize the market in which Varex competes.
Varex often competes with companies that have greater financial, marketing and other resources than Varex, including Varex’s
customers. If these customers manufacture a greater percentage of their components in house or otherwise lower external sourcing
costs, which may occur for a number of reasons, including a strong U.S. Dollar, Varex could experience reductions in purchasing
volume by, or loss of, one or more of these customers. Such a reduction or loss may have a material and adverse effect on its business.
Some of the major diagnostic imaging systems companies, which are the primary OEM customers for Varex’s X-ray components, also
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manufacture X-ray components, including X-ray tubes, for use in their own imaging systems products. Varex must compete with these
in-house manufacturing operations for business. In addition, Varex competes against other stand-alone, independent X-ray tube
manufacturers for both the OEM business of major diagnostic imaging equipment manufacturers and the independent servicing
business for X-ray tubes. The market for flat panel detectors is also very competitive, and Varex faces intense competition from over a
dozen smaller competitors. As a result of these competitive dynamics, in order for Varex to effectively retain the business of its
customers and compete with its competitors, it must have an advantage in one or more significant areas, such as lower product cost,
better product quality and/or superior technology and/or performance.
With Varex’s industrial products, Varex competes with other OEM suppliers, primarily outside of the United States. The
market for its X-ray tube and flat panel products used for nondestructive testing in industrial applications is small and highly
fragmented. In addition, some of Varex’s competitors outside the United States may have resources and support from their
governments that Varex cannot replicate, such as preferences for local manufacturers, and may not be subject to the same trade
compliance regulations to which Varex is subject. Therefore, Varex’s ability to compete in certain high-growth markets may be limited
as compared to its competitors.
Existing competitors’ actions and new entrants may materially and adversely affect Varex’s ability to compete. These
competitors could develop technologies and products that are more effective than those Varex currently uses or produces or that could
render its products obsolete or noncompetitive. In addition, the timing of Varex’s competitors’ introduction of products into the market
could affect the market acceptance and sales of Varex’s products. Some competitors offer specialized products that provide, or may be
perceived by customers to provide, a marketing advantage over Varex’s products. Also, some of Varex’s competitors may not be
subject to the same standards, regulatory and/or other legal requirements to which Varex is subject, and therefore, they could have a
competitive advantage in developing, manufacturing and marketing products and services. Any inability to develop, gain regulatory
approval for and supply commercial quantities of competitive products to the market as quickly and effectively as Varex’s competitors
could limit market acceptance of Varex’s products and reduce its sales. In addition, some of its smaller competitors could be acquired
by larger companies that have greater financial strength, which could enable them to compete more aggressively. Varex’s competitors
could also acquire some of its customers, suppliers or distributors, which could disrupt supply or distribution arrangements and result
in loss of customers and less predictable and reduced revenues in Varex’s businesses. Any of these competitive factors could
negatively and materially affect Varex’s pricing, sales, revenues, market share and gross margins and its ability to maintain or increase
its operating margins.
Varex’s success depends on the successful development, introduction, and commercialization of new generations of products and
enhancements to or simplifications of existing product lines.
Rapid change and technological innovation characterize the markets in which Varex operates, particularly with respect to flat
panel technology. Varex’s customers use its products in their medical diagnostic, security, and industrial imaging systems, and Varex
must continually introduce new products at competitive costs while also improving existing products with higher quality, lower costs,
and increased features. In order to be successful, Varex must anticipate its customers’ needs and demands, as well as potential shifts in
market preferences. Varex’s failure to do so has in the past resulted, and may in the future result in the loss of customers and an
adverse impact to its financial performance. With a relatively strong U.S. Dollar, Varex’s ability to meet its customers’ pricing
expectations is particularly challenging and may result in erosion of product margin and market share.
Varex may need to spend more time and money than it expects to develop and introduce new products or enhancements, and,
even if Varex succeeds, Varex may not be able to recover all or a meaningful part of its investment. Once introduced, new products
may materially and adversely impact sales of Varex’s existing products or make them less desirable or even obsolete, which could
materially and adversely impact Varex’s revenues and operating results. In addition, certain costs, including installation and warranty
costs, associated with new products may be proportionately greater than the costs associated with other products and may therefore
disproportionately, materially, and adversely affect Varex’s gross and operating margins. If Varex is unable to lower these costs over
time, Varex’s operating results could be materially and adversely affected. Some of the electronic components and integrated circuits
used in Varex’s flat panel detectors are susceptible to discontinuance and obsolescence risks, which may force Varex to incorporate
newer generations of these components, resulting in unplanned additional R&D expenses, delays in the launch of new products,
supply disruption, or inventory write downs.
Varex’s ability to successfully develop and introduce new products and product enhancements and simplifications, and the
revenues and costs associated with these efforts, are affected by Varex’s ability to:
• properly identify customer needs or long-(cid:3)(cid:2)(cid:15)(cid:7)(cid:4)(cid:16)(cid:10)(cid:5)(cid:3)(cid:9)(cid:7)(cid:2)(cid:15)(cid:4)(cid:21)(cid:2)(cid:7)(cid:14)(cid:8)(cid:21)(cid:5)(cid:13)
• prove (cid:3)(cid:22)(cid:2)(cid:4)(cid:18)(cid:2)(cid:14)(cid:5)(cid:19)(cid:24)(cid:19)(cid:11)(cid:19)(cid:3)(cid:23)(cid:4)(cid:9)(cid:18)(cid:4)(cid:8)(cid:2)(cid:20)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:5)(cid:13)
•
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•
•
•
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accurately predict and control costs associated with inventory overruns caused by the phase-in of new products and the
phase-(cid:9)(cid:10)(cid:3)(cid:4)(cid:9)(cid:18)(cid:4)(cid:9)(cid:11)(cid:21)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:5)(cid:13)
• (cid:17)(cid:15)(cid:19)(cid:16)(cid:2)(cid:4)(cid:19)(cid:3)(cid:5)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:5)(cid:4)(cid:16)(cid:9)(cid:7)(cid:17)(cid:2)(cid:3)(cid:19)(cid:3)(cid:19)(cid:25)(cid:2)(cid:11)(cid:23)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:17)(cid:15)(cid:9)(cid:18)(cid:19)(cid:3)(cid:14)(cid:24)(cid:11)(cid:23)(cid:26)(cid:4)(cid:20)(cid:22)(cid:19)(cid:16)(cid:22)(cid:4)(cid:16)(cid:14)(cid:8)(cid:4)(cid:24)(cid:2)(cid:4)(cid:17)(cid:14)(cid:15)(cid:3)(cid:19)(cid:16)(cid:10)(cid:11)(cid:14)(cid:15)(cid:11)(cid:23)(cid:4)(cid:21)(cid:19)(cid:18)(cid:18)(cid:19)(cid:16)(cid:10)(cid:11)(cid:3)(cid:4)(cid:20)(cid:19)(cid:3)(cid:22)(cid:4)(cid:14)(cid:4)(cid:5)(cid:3)(cid:15)(cid:9)(cid:8)(cid:6)(cid:4)&+(cid:28)+(cid:4)’(cid:9)(cid:11)(cid:11)(cid:14)(cid:15)(cid:13)
• manufacture, deliver, and install its products in sufficient volumes on time and accurately predict and control costs associated
(cid:20)(cid:19)(cid:3)(cid:22)(cid:4)(cid:7)(cid:14)(cid:8)(cid:10)(cid:18)(cid:14)(cid:16)(cid:3)(cid:10)(cid:15)(cid:19)(cid:8)(cid:6)(cid:4)(cid:19)(cid:8)(cid:5)(cid:3)(cid:14)(cid:11)(cid:11)(cid:14)(cid:3)(cid:19)(cid:9)(cid:8)(cid:26)(cid:4)(cid:20)(cid:14)(cid:15)(cid:15)(cid:14)(cid:8)(cid:3)(cid:23)(cid:26)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:7)(cid:14)(cid:19)(cid:8)(cid:3)(cid:2)(cid:8)(cid:14)(cid:8)(cid:16)(cid:2)(cid:4)(cid:9)(cid:18)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:5)(cid:13)
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•
• manage customer acceptan(cid:16)(cid:2)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:17)(cid:14)(cid:23)(cid:7)(cid:2)(cid:8)(cid:3)(cid:4)(cid:18)(cid:9)(cid:15)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:5)(cid:13)(cid:4)(cid:14)(cid:8)(cid:21)
•
anticipate, respond to, and compete successfully with competitors.
Furthermore, as discussed in greater detail elsewhere in this “Risk Factors” section, Varex cannot be sure that it will be able
to successfully develop, manufacture, or introduce new products or enhancements, the roll-out of which involves compliance with
complex quality assurance processes, including the Quality System Regulation (“QSR”) of the U.S. Food and Drug Administration
(“FDA”). Failure to complete these processes timely and efficiently could result in delays that could affect Varex’s ability to attract
and retain customers or cause customers to delay or cancel orders, which would materially and adversely affect Varex’s revenues and
operating results.
Varex may face additional risks from the acquisition or development of new lines of business.
From time to time, Varex may acquire or develop new lines of business. There are substantial risks and uncertainties
associated with new lines of business, particularly in instances where the markets are not fully developed. Risks include developing
knowledge of and experience in the new business, recruiting market professionals, increasing research and development expenditures,
and developing and capitalizing on new relationships with experienced market participants. This may mean significant investment and
involvement of Varex’s senior management to acquire or develop, then integrate, the business into its operations. Timelines for
integration of new businesses may not be achieved, and price and profitability targets may not prove feasible, as new products can
carry lower gross margins than existing products. External factors, such as compliance with regulations, competitive alternatives, and
shifting market preferences may also impact whether implementation of a new business will be successful. Failure to manage these
risks could have a material and adverse effect on Varex’s business, results of operations, and/or financial condition.
Varex may be unable to complete future acquisitions or realize expected benefits from acquisitions of or investments in new
businesses, products, or technologies, which could harm Varex’s business.
Varex’s ability to identify and take advantage of attractive acquisitions or other business development opportunities is an
important component in implementing its overall business strategy. Varex needs to grow its businesses in response to changing
technologies, customer demands, and competitive pressures. In some circumstances, Varex may decide to grow its business through
the acquisition of complementary businesses, products, or technologies, rather than through internal development. For example, during
fiscal year 2015, Varex acquired Claymount Investments B.V. ("Claymount") and MeVis Medical Solutions AG ("MeVis"), and in
May 2017, Varex acquired the medical imaging business of PerkinElmer, Inc. (the “Acquired Detector Business”).
Identifying suitable acquisition candidates can be difficult, time consuming, and costly, and Varex may not be able to identify
suitable candidates or successfully complete or finance identified acquisitions, including as a result of failing to obtain regulatory or
competition clearances, which could impair Varex’s growth and ability to compete. In addition, completing an acquisition can divert
Varex’s management and key personnel from its current business operations, which could harm its business and affect its financial
results. Even if Varex completes an acquisition, Varex may not be able to successfully integrate newly-acquired organizations,
products, technologies, or employees into its operations or may not fully realize some of the expected synergies.
Integrating an acquisition can also be expensive and time consuming and may strain Varex’s resources. It may cost Varex
more to commercialize new products than originally anticipated or cause Varex to increase its expenses related to research and
development, either of which could materially and adversely impact its results of operations. In many instances, integrating a new
business will also involve implementing or improving internal controls appropriate for a public company into a business that lacks
them. It is also possible that an acquisition could increase Varex’s risk of litigation, as a third party may be more likely to assert a legal
claim following an acquisition because of perceived deeper pockets or a perceived greater value of a claim. In addition, Varex may be
unable to retain the employees of acquired companies or the acquired company’s customers, suppliers, distributors, or other partners
for a variety of reasons, including the fact that these entities may be Varex’s competitors or may have close relationships with its
competitors.
Further, Varex may find that it needs to restructure or divest acquired businesses or assets of those businesses. Even if it does
so, an acquisition may not produce the full efficiencies, growth, or benefits that were expected. If Varex decides to sell assets or a
14
business, it may be difficult to identify buyers or alternative exit strategies on acceptable terms, in a timely manner, or at all, which
could delay the accomplishment of its strategic objectives. Varex may be required to dispose of a business at a lower price or on less
advantageous terms, or to recognize greater losses than it had anticipated.
If Varex acquires a business, it allocates the total purchase price to the acquired business’ tangible assets and liabilities,
identifiable intangible assets, and liabilities based on their fair values as of the date of the acquisition and records the excess of the
purchase price over those values as goodwill. If it fails to achieve the anticipated growth from an acquisition, or if it decides to sell
assets or a business, it may be required to recognize an impairment loss on the write down of its assets and goodwill, which could
materially and adversely affect its financial results. In addition, acquisitions can result in potentially dilutive issuances of equity
securities or the incurrence of debt, contingent liabilities or expenses, or other charges, any of which could harm Varex’s business and
affect its financial results.
Additionally, Varex has investments in privately-held companies (for example, its 40% ownership in its major supplier of its
amorphous silicon-based thin film transistor arrays (flat panels) used in its digital detectors, dpiX LLC) that are subject to risk of loss
of investment capital. These investments are inherently risky, in some instances because the markets for the technologies or products
these companies have under development may never materialize. If these companies do not succeed, Varex could lose some or all of
its investment in these companies.
Our Acquired Detector Business may not achieve strategic objectives, anticipated synergies, and/or other expected potential
benefits.
Varex expects to realize strategic and other financial and operating benefits as a result of the Acquired Detector Business.
However, Varex cannot predict with certainty the extent to which these benefits will actually be achieved or the timing of any such
benefits. The following factors, among others, may prevent Varex from realizing these benefits:
(cid:3)(cid:22)(cid:2)(cid:4)(cid:19)(cid:8)(cid:14)(cid:24)(cid:19)(cid:11)(cid:19)(cid:3)(cid:23)(cid:4)(cid:9)(cid:18)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:14)(cid:16)2(cid:10)(cid:19)(cid:15)(cid:2)(cid:21)(cid:4)(cid:24)(cid:10)(cid:5)(cid:19)(cid:8)(cid:2)(cid:5)(cid:5)(cid:4)(cid:3)(cid:9)(cid:4)(cid:19)(cid:8)(cid:16)(cid:15)(cid:2)(cid:14)(cid:5)(cid:2)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:4)(cid:5)(cid:14)(cid:11)(cid:2)(cid:5)(cid:13)
•
• unfavorable customer reaction to the transaction (cid:9)(cid:15)(cid:4)#(cid:14)(cid:15)(cid:2)$/(cid:5)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:5)(cid:4)(cid:18)(cid:9)(cid:11)(cid:11)(cid:9)(cid:20)(cid:19)(cid:8)(cid:6)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:16)(cid:11)(cid:9)(cid:5)(cid:19)(cid:8)(cid:6)(cid:13)
•
competitive factors, including technological advances attained by competitors or the decision of certain companies currently
(cid:2)(cid:8)(cid:6)(cid:14)(cid:6)(cid:2)(cid:21)(cid:4)(cid:19)(cid:8)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:19)(cid:8)(cid:21)(cid:10)(cid:5)(cid:3)(cid:15)(cid:19)(cid:14)(cid:11)(cid:4)(cid:5)(cid:2)(cid:16)(cid:3)(cid:9)(cid:15)(cid:4)(cid:3)(cid:9)(cid:4)(cid:16)(cid:9)(cid:7)(cid:17)(cid:2)(cid:3)(cid:2)(cid:4)(cid:19)(cid:8)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:7)(cid:2)(cid:21)(cid:19)(cid:16)(cid:14)(cid:11)(cid:4)(cid:19)(cid:7)(cid:14)(cid:6)(cid:19)(cid:8)(cid:6)(cid:4)(cid:5)(cid:2)(cid:16)(cid:3)(cid:9)(cid:15)(cid:13)
the failure o(cid:18)(cid:4)(cid:12)(cid:2)(cid:23)(cid:4)(cid:7)(cid:14)(cid:15)(cid:12)(cid:2)(cid:3)(cid:5)(cid:4)(cid:18)(cid:9)(cid:15)(cid:4)#(cid:14)(cid:15)(cid:2)$/(cid:5)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:5)(cid:4)(cid:3)(cid:9)(cid:4)(cid:21)(cid:2)(cid:25)(cid:2)(cid:11)(cid:9)(cid:17)(cid:4)(cid:3)(cid:9)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:2)$(cid:3)(cid:2)(cid:8)(cid:3)(cid:4)(cid:9)(cid:15)(cid:4)(cid:14)(cid:5)(cid:4)(cid:15)(cid:14)(cid:17)(cid:19)(cid:21)(cid:11)(cid:23)(cid:4)(cid:14)(cid:5)(cid:4)(cid:16)(cid:10)(cid:15)(cid:15)(cid:2)(cid:8)(cid:3)(cid:11)(cid:23)(cid:4)(cid:2)$(cid:17)(cid:2)(cid:16)(cid:3)(cid:2)(cid:21)(cid:13)
(cid:16)(cid:22)(cid:14)(cid:8)(cid:6)(cid:2)(cid:5)(cid:4)(cid:19)(cid:8)(cid:4)(cid:3)(cid:2)(cid:16)(cid:22)(cid:8)(cid:9)(cid:11)(cid:9)(cid:6)(cid:23)(cid:4)(cid:3)(cid:22)(cid:14)(cid:3)(cid:4)(cid:15)(cid:2)2(cid:10)(cid:19)(cid:15)(cid:2)(cid:4)#(cid:14)(cid:15)(cid:2)$(cid:4)(cid:3)(cid:9)(cid:4)(cid:7)(cid:14)(cid:12)(cid:2)(cid:4)(cid:5)(cid:19)(cid:6)(cid:8)(cid:19)(cid:18)(cid:19)(cid:16)(cid:14)(cid:8)(cid:3)(cid:4)(cid:16)(cid:14)(cid:17)(cid:19)(cid:3)(cid:14)(cid:11)(cid:4)(cid:2)$(cid:17)(cid:2)(cid:8)(cid:21)(cid:19)(cid:3)(cid:10)(cid:15)(cid:2)(cid:5)(cid:4)(cid:3)(cid:9)(cid:4)(cid:21)(cid:2)(cid:25)(cid:2)(cid:11)(cid:9)(cid:17)(cid:4)(cid:16)(cid:9)(cid:7)(cid:17)(cid:2)(cid:3)(cid:19)(cid:3)(cid:19)(cid:25)(cid:2)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:5)(cid:13)
employment laws or regulations or other limitations in foreign jurisdictions, or other operational issues, that could have an
(cid:19)(cid:7)(cid:17)(cid:14)(cid:16)(cid:3)(cid:4)(cid:9)(cid:8)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:3)(cid:19)(cid:7)(cid:19)(cid:8)(cid:6)(cid:4)(cid:9)(cid:15)(cid:4)(cid:14)(cid:7)(cid:9)(cid:10)(cid:8)(cid:3)(cid:4)(cid:9)(cid:18)(cid:4)(cid:5)(cid:23)(cid:8)(cid:2)(cid:15)(cid:6)(cid:19)(cid:2)(cid:5)(cid:13) and
the failure to retain key employees.
•
•
•
•
Failure to achieve the strategic objectives of the transaction could have a material adverse effect on the revenues, expenses,
operating results, and cash resources of Varex and could result in Varex not achieving the anticipated potential benefits of the
transaction. In addition, there is no assurance that the growth rate of the acquired business will equal the historical growth rate
experienced by PerkinElmer.
Varex may not successfully integrate its business with the Acquired Detector Business.
Achieving the potential benefits of the Acquired Detector Business will depend in substantial part on the successful
integration of the technologies, operations, and personnel of the acquired business. Varex may face challenges integrating the Acquired
Detector Business, including:
•
•
•
•
•
consolidating and rationalizing corporate information technology, en(cid:6)(cid:19)(cid:8)(cid:2)(cid:2)(cid:15)(cid:19)(cid:8)(cid:6)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:14)(cid:21)(cid:7)(cid:19)(cid:8)(cid:19)(cid:5)(cid:3)(cid:15)(cid:14)(cid:3)(cid:19)(cid:25)(cid:2)(cid:4)(cid:19)(cid:8)(cid:18)(cid:15)(cid:14)(cid:5)(cid:3)(cid:15)(cid:10)(cid:16)(cid:3)(cid:10)(cid:15)(cid:2)(cid:5)(cid:13)
(cid:19)(cid:8)(cid:3)(cid:2)(cid:6)(cid:15)(cid:14)(cid:3)(cid:19)(cid:8)(cid:6)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:4)(cid:9)(cid:18)(cid:18)(cid:2)(cid:15)(cid:19)(cid:8)(cid:6)(cid:5)(cid:13)
(cid:16)(cid:9)(cid:9)(cid:15)(cid:21)(cid:19)(cid:8)(cid:14)(cid:3)(cid:19)(cid:8)(cid:6)(cid:4)(cid:5)(cid:14)(cid:11)(cid:2)(cid:5)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:7)(cid:14)(cid:15)(cid:12)(cid:2)(cid:3)(cid:19)(cid:8)(cid:6)(cid:4)(cid:2)(cid:18)(cid:18)(cid:9)(cid:15)(cid:3)(cid:5)(cid:13)
(cid:16)(cid:9)(cid:9)(cid:15)(cid:21)(cid:19)(cid:8)(cid:14)(cid:3)(cid:19)(cid:8)(cid:6)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:19)(cid:8)(cid:3)(cid:2)(cid:6)(cid:15)(cid:14)(cid:3)(cid:19)(cid:8)(cid:6)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:7)(cid:14)(cid:8)(cid:10)(cid:18)(cid:14)(cid:16)(cid:3)(cid:10)(cid:15)(cid:19)(cid:8)(cid:6)(cid:4)(cid:14)(cid:16)(cid:3)(cid:19)(cid:25)(cid:19)(cid:3)(cid:19)(cid:2)(cid:5)(cid:4)(cid:9)(cid:18)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:14)(cid:16)2(cid:10)(cid:19)(cid:15)(cid:2)(cid:21)(cid:4)(cid:24)(cid:10)(cid:5)(cid:19)(cid:8)(cid:2)(cid:5)(cid:5)(cid:13)(cid:4)(cid:14)(cid:8)(cid:21)
coordinating and rationalizing research and development activities to enhance introduction of new products and technologies
with reduced cost.
The integration of the Acquired Detector Business is a complex, time-consuming and expensive process. It is not certain that
the Acquired Detector Business can be successfully integrated in a timely manner, in a cost-efficient manner, or at all. Failure to do so
could have a material adverse effect on the revenues, expenses, operating results, and cash resources of Varex and could result in
Varex not achieving the anticipated potential benefits of the transaction.
15
The trading price of Varex’s common stock may decline or fluctuate significantly and fluctuations in Varex’s operating results,
including quarterly revenues, and margins, may cause its stock price to be volatile, which could cause losses for its stockholders.
A public market did not exist for Varex common stock prior to the distribution, and since the distribution, Varex's stock price
has ranged from a low of $25.41 to a high of $36.58. Varex cannot guarantee that an active trading market will be sustained for its
common stock. Nor can Varex predict the prices at which shares of its common stock may trade. Similarly, Varex cannot predict the
long-term effect of the distribution on the trading prices of its common stock. Varex has experienced and expects in the future to
experience fluctuations in its operating results, including revenues and margins, from period to period.
Varex’s quarterly operating results, including its revenues and margins, may be affected by a number of other factors,
including:
•
•
•
•
•
(cid:3)(cid:22)(cid:2)(cid:4)(cid:19)(cid:8)(cid:3)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:19)(cid:9)(cid:8)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:3)(cid:19)(cid:7)(cid:19)(cid:8)(cid:6)(cid:4)(cid:9)(cid:18)(cid:4)(cid:14)(cid:8)(cid:8)(cid:9)(cid:10)(cid:8)(cid:16)(cid:2)(cid:7)(cid:2)(cid:8)(cid:3)(cid:4)(cid:9)(cid:18)(cid:4)(cid:8)(cid:2)(cid:20)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:4)(cid:2)(cid:8)(cid:22)(cid:14)(cid:8)(cid:16)(cid:2)(cid:7)(cid:2)(cid:8)(cid:3)(cid:5)(cid:4)(cid:24)(cid:23)(cid:4)#(cid:14)(cid:15)(cid:2)$(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:19)(cid:3)(cid:5)(cid:4)(cid:16)(cid:9)(cid:7)(cid:17)(cid:2)(cid:3)(cid:19)(cid:3)(cid:9)(cid:15)(cid:5)(cid:13)
(cid:16)(cid:22)(cid:14)(cid:8)(cid:6)(cid:2)(cid:4)(cid:19)(cid:8)(cid:4)(cid:19)(cid:3)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:19)(cid:3)(cid:5)(cid:4)(cid:16)(cid:9)(cid:7)(cid:17)(cid:2)(cid:3)(cid:19)(cid:3)(cid:9)(cid:15)(cid:5)/(cid:4)(cid:17)(cid:15)(cid:19)(cid:16)(cid:19)(cid:8)(cid:6)(cid:4)(cid:9)(cid:15)(cid:4)(cid:21)(cid:19)(cid:5)(cid:16)(cid:9)(cid:10)(cid:8)(cid:3)(cid:4)(cid:11)(cid:2)(cid:25)(cid:2)(cid:11)(cid:5)(cid:13)
changes in foreign currency exch(cid:14)(cid:8)(cid:6)(cid:2)(cid:4)(cid:15)(cid:14)(cid:3)(cid:2)(cid:5)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:9)(cid:3)(cid:22)(cid:2)(cid:15)(cid:4)(cid:2)(cid:16)(cid:9)(cid:8)(cid:9)(cid:7)(cid:19)(cid:16)(cid:4)(cid:10)(cid:8)(cid:16)(cid:2)(cid:15)(cid:3)(cid:14)(cid:19)(cid:8)(cid:3)(cid:23)(cid:13)
changes in the relative portion of its revenues represented by its various products, including the relative mix between higher
margin and lower-(cid:7)(cid:14)(cid:15)(cid:6)(cid:19)(cid:8)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:5)(cid:13)
changes in the relative portion of its revenues represented by its international region as a whole and by regions within the
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the (cid:14)(cid:25)(cid:14)(cid:19)(cid:11)(cid:14)(cid:24)(cid:19)(cid:11)(cid:19)(cid:3)(cid:23)(cid:4)(cid:9)(cid:18)(cid:4)(cid:2)(cid:16)(cid:9)(cid:8)(cid:9)(cid:7)(cid:19)(cid:16)(cid:4)(cid:5)(cid:3)(cid:19)(cid:7)(cid:10)(cid:11)(cid:10)(cid:5)(cid:4)(cid:17)(cid:14)(cid:16)(cid:12)(cid:14)(cid:6)(cid:2)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:9)(cid:3)(cid:22)(cid:2)(cid:15)(cid:4)(cid:6)(cid:9)(cid:25)(cid:2)(cid:15)(cid:8)(cid:7)(cid:2)(cid:8)(cid:3)(cid:4)(cid:18)(cid:10)(cid:8)(cid:21)(cid:19)(cid:8)(cid:6)(cid:26)(cid:4)(cid:9)(cid:15)(cid:4)(cid:15)(cid:2)(cid:21)(cid:10)(cid:16)(cid:3)(cid:19)(cid:9)(cid:8)(cid:5)(cid:4)(cid:3)(cid:22)(cid:2)(cid:15)(cid:2)(cid:9)(cid:18)(cid:13)
•
•
• (cid:21)(cid:19)(cid:5)(cid:15)(cid:10)(cid:17)(cid:3)(cid:19)(cid:9)(cid:8)(cid:5)(cid:4)(cid:19)(cid:8)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:5)(cid:10)(cid:17)(cid:17)(cid:11)(cid:23)(cid:4)(cid:9)(cid:15)(cid:4)(cid:16)(cid:22)(cid:14)(cid:8)(cid:6)(cid:2)(cid:5)(cid:4)(cid:19)(cid:8)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:16)(cid:9)(cid:5)(cid:3)(cid:5)(cid:4)(cid:9)(cid:18)(cid:4)(cid:15)(cid:14)(cid:20)(cid:4)(cid:7)(cid:14)(cid:3)(cid:2)(cid:15)(cid:19)(cid:14)(cid:11)(cid:5)(cid:26)(cid:4)(cid:11)(cid:14)(cid:24)(cid:9)(cid:15)(cid:26)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:4)(cid:16)(cid:9)(cid:7)(cid:17)(cid:9)(cid:8)(cid:2)(cid:8)(cid:3)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:3)(cid:15)(cid:14)(cid:8)(cid:5)(cid:17)(cid:9)(cid:15)(cid:3)(cid:14)(cid:3)(cid:19)(cid:9)(cid:8)(cid:4)(cid:5)(cid:2)(cid:15)(cid:25)(cid:19)(cid:16)(cid:2)(cid:5)(cid:13)
•
• disruptions in its operations, including its ability to manufacture products, caused by events such as earthquakes, fires, floods,
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(cid:3)(cid:2)(cid:15)(cid:15)(cid:9)(cid:15)(cid:19)(cid:5)(cid:3)(cid:4)(cid:14)(cid:3)(cid:3)(cid:14)(cid:16)(cid:12)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:9)(cid:10)(cid:3)(cid:24)(cid:15)(cid:2)(cid:14)(cid:12)(cid:4)(cid:9)(cid:18)(cid:4)(cid:2)(cid:17)(cid:19)(cid:21)(cid:2)(cid:7)(cid:19)(cid:16)(cid:4)(cid:21)(cid:19)(cid:5)(cid:2)(cid:14)(cid:5)(cid:2)(cid:5)(cid:13)
the unfavorable outcome of any litigation or administrative proceeding or inquiry, as well as ongoing costs associated with
(cid:11)(cid:2)(cid:6)(cid:14)(cid:11)(cid:4)(cid:17)(cid:15)(cid:9)(cid:16)(cid:2)(cid:2)(cid:21)(cid:19)(cid:8)(cid:6)(cid:5)(cid:13)(cid:4)(cid:14)(cid:8)(cid:21)(cid:26)
accounting changes and adoption of new accounting pronouncements.
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•
Because many of Varex’s operating expenses are based on anticipated capacity levels, and a high percentage of these
expenses are fixed for the short term, a small variation in the timing of revenue recognition can cause significant variations in
operating results from quarter to quarter. If Varex’s gross margins fall below the expectation of securities analysts and investors, the
trading price of Varex common stock may decline.
In addition, as discussed in more detail elsewhere in this Annual Report, significant changes may occur in Varex’s cost
structure, management, financing and business operations as a result of operating as a company separate from Varian.
Our secured revolving credit facility and secured term loan credit facility restrict certain activities, and failure to comply with these
facilities may have an adverse effect on its business, liquidity and financial position.
Varex entered into a secured revolving credit facility and a secured term loan credit facility in connection with the Acquired
Detector Business, each of which contains restrictive financial covenants, including financial covenants that require Varex to comply
with specified financial ratios. Varex may have to curtail some of its operations to comply with these covenants. In addition, its credit
facilities contain other affirmative and negative covenants that could restrict its operating and financing activities. These provisions
will limit its ability to, among other things, incur future indebtedness, contingent obligations or liens, guarantee indebtedness, make
certain investments and capital expenditures, sell stock or assets and pay dividends and consummate certain mergers or acquisitions. If
Varex fails to comply with the credit facility requirements, it may be in default. Upon an event of default, if the Credit Agreement is
not amended or the event of default is not waived, the lender could declare all amounts then outstanding, together with accrued
interest, to be immediately due and payable. If this happens, Varex may not be able to make those payments or borrow sufficient funds
from alternative sources to make those payments. Even if Varex were to obtain additional financing, that financing may be on
unfavorable terms.
Varex has significant debt obligations that could adversely affect Varex’s business, profitability and ability to meet its obligations.
As of September 29, 2017, Varex’s total combined indebtedness was approximately $494 million. The borrowings under
Varex’s credit facilities bear interest at floating interest rates. As part of its overall risk management practices, Varex entered into
financial derivatives, interest rate swaps designed as cash flow hedges, to hedge the floating LIBOR interest rate on $292.5 million of
its debt As a result, Varex will be exposed to fluctuations in interest rates to the extent of the balance of its borrowings under the
LIBOR-based portion of its credit facilities.
16
This debt could potentially have important consequences to Varex and its investors, including:
•
•
•
•
requiring that a portion of Varex’s cash flow from operations be used to make principal and interest payments on this debt,
(cid:20)(cid:22)(cid:19)(cid:16)(cid:22)(cid:4)(cid:20)(cid:9)(cid:10)(cid:11)(cid:21)(cid:4)(cid:15)(cid:2)(cid:21)(cid:10)(cid:16)(cid:2)(cid:4)(cid:16)(cid:14)(cid:5)(cid:22)(cid:4)(cid:18)(cid:11)(cid:9)(cid:20)(cid:4)(cid:14)(cid:25)(cid:14)(cid:19)(cid:11)(cid:14)(cid:24)(cid:11)(cid:2)(cid:4)(cid:18)(cid:9)(cid:15)(cid:4)(cid:9)(cid:3)(cid:22)(cid:2)(cid:15)(cid:4)(cid:16)(cid:9)(cid:15)(cid:17)(cid:9)(cid:15)(cid:14)(cid:3)(cid:2)(cid:4)(cid:17)(cid:10)(cid:15)(cid:17)(cid:9)(cid:5)(cid:2)(cid:5)(cid:13)
(cid:19)(cid:8)(cid:16)(cid:15)(cid:2)(cid:14)(cid:5)(cid:19)(cid:8)(cid:6)(cid:4)#(cid:14)(cid:15)(cid:2)$/(cid:5)(cid:4)(cid:25)(cid:10)(cid:11)(cid:8)(cid:2)(cid:15)(cid:14)(cid:24)(cid:19)(cid:11)(cid:19)(cid:3)(cid:23)(cid:4)(cid:3)(cid:9)(cid:4)(cid:5)(cid:22)(cid:19)(cid:18)(cid:3)(cid:5)(cid:4)(cid:19)(cid:8)(cid:4)(cid:19)(cid:8)(cid:3)(cid:2)(cid:15)(cid:2)(cid:5)(cid:3)(cid:4)(cid:15)(cid:14)(cid:3)(cid:2)(cid:5)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:3)(cid:9)(cid:4)(cid:6)(cid:2)(cid:8)(cid:2)(cid:15)(cid:14)(cid:11)(cid:4)(cid:14)(cid:21)(cid:25)(cid:2)(cid:15)(cid:5)(cid:2)(cid:4)(cid:2)(cid:16)(cid:9)(cid:8)(cid:9)(cid:7)(cid:19)(cid:16)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:19)(cid:8)(cid:21)(cid:10)(cid:5)(cid:3)(cid:15)(cid:23)(cid:4)(cid:16)(cid:9)(cid:8)(cid:21)(cid:19)(cid:3)(cid:19)(cid:9)(cid:8)(cid:5)(cid:13)
limiting Varex’s fl(cid:2)$(cid:19)(cid:24)(cid:19)(cid:11)(cid:19)(cid:3)(cid:23)(cid:4)(cid:19)(cid:8)(cid:4)(cid:17)(cid:11)(cid:14)(cid:8)(cid:8)(cid:19)(cid:8)(cid:6)(cid:4)(cid:18)(cid:9)(cid:15)(cid:26)(cid:4)(cid:9)(cid:15)(cid:4)(cid:15)(cid:2)(cid:14)(cid:16)(cid:3)(cid:19)(cid:8)(cid:6)(cid:4)(cid:3)(cid:9)(cid:26)(cid:4)(cid:16)(cid:22)(cid:14)(cid:8)(cid:6)(cid:2)(cid:5)(cid:4)(cid:19)(cid:8)(cid:4)(cid:19)(cid:3)(cid:5)(cid:4)(cid:24)(cid:10)(cid:5)(cid:19)(cid:8)(cid:2)(cid:5)(cid:5)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:19)(cid:8)(cid:21)(cid:10)(cid:5)(cid:3)(cid:15)(cid:23)(cid:13)(cid:4)(cid:14)(cid:8)(cid:21)(cid:26)
limiting Varex’s ability to borrow additional funds as needed or increasing the costs of any such borrowing.
In addition, Varex’s actual cash requirements in the future may be greater than expected. Varex’s cash flow from operations
may not be sufficient to repay all of the outstanding debt as it becomes due, and Varex may not be able to borrow money, sell assets, or
otherwise raise funds on acceptable terms, or at all, to refinance Varex’s debt.
A disruption at Varex’s manufacturing facilities, as well as fluctuating manufacturing costs, could materially and adversely affect
its business.
The majority of Varex’s products are manufactured in its manufacturing facility in Salt Lake City, Utah. Varex’s
manufacturing operations are subject to potential power failures, the breakdown, failure, or substandard performance of equipment,
the improper installation or operation of equipment, and natural or other disasters. Loss or damage to this manufacturing facility due to
any of these factors or otherwise could materially and adversely affect Varex’s ability to manufacture sufficient quantities of its
products or otherwise deliver products to meet customer demand or contractual requirements, which may result in a loss of revenue
and other adverse business consequences. Because of the time required to obtain regulatory approval and licensing of a manufacturing
facility, Varex may not be available on a timely basis to replace any lost manufacturing capacity. The occurrence of these or any other
operational issues at Varex’s manufacturing facilities could have a material and adverse effect on Varex’s business, financial condition,
and results of operations. In addition, some of Varex’s products from the Acquired Detector Business and the Claymount acquisition
(cid:14)(cid:15)(cid:2)(cid:4)(cid:14)(cid:11)(cid:5)(cid:9)(cid:4)(cid:7)(cid:14)(cid:8)(cid:10)(cid:18)(cid:14)(cid:16)(cid:3)(cid:10)(cid:15)(cid:2)(cid:21)(cid:4)(cid:19)(cid:8)(cid:4))(cid:14)(cid:11)(cid:11)(cid:10)(cid:18)(cid:26)(cid:4)!(cid:2)(cid:15)(cid:7)(cid:14)(cid:8)(cid:23)(cid:13)(cid:4)((cid:2)(cid:2)(cid:15)(cid:11)(cid:2)(cid:8)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)’(cid:19)(cid:8)$(cid:17)(cid:2)(cid:15)(cid:11)(cid:9)(cid:26)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:27)(cid:2)(cid:3)(cid:22)(cid:2)(cid:15)(cid:11)(cid:14)(cid:8)(cid:21)(cid:5)(cid:13)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:29)(cid:14)(cid:11)(cid:14)(cid:7)(cid:24)(cid:14)(cid:4)(cid:29)(cid:19)(cid:3)(cid:23)(cid:26)(cid:4) (cid:22)(cid:19)(cid:11)(cid:19)(cid:17)(cid:17)(cid:19)(cid:8)(cid:2)(cid:5)(cid:26)(cid:4)(cid:20)(cid:22)(cid:19)(cid:16)(cid:22)(cid:4)(cid:14)(cid:15)(cid:2)(cid:4)(cid:5)(cid:10)bject
to similar risks but may also face additional regulatory and political risks, which could impact Varex’s ability to manufacture and ship
products in a timely manner or at all. Varex manufactures its security products in Las Vegas, Nevada, and certain flat panels in Santa
Clara, California, and these operations are also subject to potential power failures, the breakdown, failure, or substandard performance
of equipment, the improper installation or operation of equipment, earthquakes, and other disasters, all of which could materially and
adversely affect Varex’s ability to deliver products to meet customer demand. In addition, Varex’s costs associated with manufacturing
its products can vary significantly from quarter to quarter, and fluctuations thereof may adversely affect its business, operating results,
and/or financial condition.
Significantly more than half of Varex’s revenues are generated from customers located outside the United States, and economic,
political, and other risks associated with international sales and operations could materially and adversely affect Varex’s sales or
make them less predictable.
Varex conducts business globally. Revenues generated from customers located outside the United States accounted for
approximately 66%, 65% and 62% of Varex’s total revenues during each of fiscal years 2017, 2016 and 2015, respectively. As a
result, Varex must provide significant service and support globally. Varex intends to continue to expand its presence in international
markets and expects to expend significant resources in doing so. Varex cannot be sure that it will be able to meet its sales, service, and
support objectives or obligations in these international markets or recover its investment in attempting to do so. Varex’s future results
could be harmed by a variety of factors, including:
•
•
currency fluctuations, and in particular the strength of the U.S. Dollar relative to many currencies, which have and may in the
future adversely affect Varex’s financial results and cause some customers to delay purchasing decisions or move to in-
sourc(cid:19)(cid:8)(cid:6)(cid:4)(cid:5)(cid:10)(cid:17)(cid:17)(cid:11)(cid:23)(cid:4)(cid:9)(cid:15)(cid:4)(cid:7)(cid:19)(cid:6)(cid:15)(cid:14)(cid:3)(cid:2)(cid:4)(cid:3)(cid:9)(cid:4)(cid:11)(cid:9)(cid:20)(cid:2)(cid:15)(cid:4)(cid:16)(cid:9)(cid:5)(cid:3)(cid:4)(cid:14)(cid:11)(cid:3)(cid:2)(cid:15)(cid:8)(cid:14)(cid:3)(cid:19)(cid:25)(cid:2)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:14)(cid:5)(cid:12)(cid:4)(cid:18)(cid:9)(cid:15)(cid:4)(cid:14)(cid:21)(cid:21)(cid:19)(cid:3)(cid:19)(cid:9)(cid:8)(cid:14)(cid:11)(cid:4)(cid:21)(cid:19)(cid:5)(cid:16)(cid:9)(cid:10)(cid:8)(cid:3)(cid:5)(cid:13)
(cid:3)(cid:22)(cid:2)(cid:4)(cid:11)(cid:9)(cid:8)(cid:6)(cid:2)(cid:15)(cid:4)(cid:17)(cid:14)(cid:23)(cid:7)(cid:2)(cid:8)(cid:3)(cid:4)(cid:16)(cid:23)(cid:16)(cid:11)(cid:2)(cid:5)(cid:4)(cid:14)(cid:5)(cid:5)(cid:9)(cid:16)(cid:19)(cid:14)(cid:3)(cid:2)(cid:21)(cid:4)(cid:20)(cid:19)(cid:3)(cid:22)(cid:4)(cid:7)(cid:14)(cid:8)(cid:23)(cid:4)(cid:16)(cid:10)(cid:5)(cid:3)(cid:9)(cid:7)(cid:2)(cid:15)(cid:5)(cid:4)(cid:11)(cid:9)(cid:16)(cid:14)(cid:3)(cid:2)(cid:21)(cid:4)(cid:9)(cid:10)(cid:3)(cid:5)(cid:19)(cid:21)(cid:2)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)&(cid:8)(cid:19)(cid:3)(cid:2)(cid:21)(cid:4)(cid:28)(cid:3)(cid:14)(cid:3)(cid:2)(cid:5)(cid:13)
•
• difficulties in interpreting or enforcing agreements and collecting receivables th(cid:15)(cid:9)(cid:10)(cid:6)(cid:22)(cid:4)(cid:7)(cid:14)(cid:8)(cid:23)(cid:4)(cid:18)(cid:9)(cid:15)(cid:2)(cid:19)(cid:6)(cid:8)(cid:4)(cid:16)(cid:9)(cid:10)(cid:8)(cid:3)(cid:15)(cid:19)(cid:2)(cid:5)/(cid:4)(cid:11)(cid:2)(cid:6)(cid:14)(cid:11)(cid:4)(cid:5)(cid:23)(cid:5)(cid:3)(cid:2)(cid:7)(cid:5)(cid:13)
•
changes in restrictions on trade between the United States and other countries or unstable regional political and economic
(cid:16)(cid:9)(cid:8)(cid:21)(cid:19)(cid:3)(cid:19)(cid:9)(cid:8)(cid:5)(cid:26)(cid:4)(cid:5)(cid:10)(cid:16)(cid:22)(cid:4)(cid:14)(cid:5)(cid:4)(cid:3)(cid:22)(cid:9)(cid:5)(cid:2)(cid:4)(cid:3)(cid:22)(cid:14)(cid:3)(cid:4)(cid:7)(cid:14)(cid:23)(cid:4)(cid:15)(cid:2)(cid:5)(cid:10)(cid:11)(cid:3)(cid:4)(cid:18)(cid:15)(cid:9)(cid:7)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4),(cid:15)(cid:10)(cid:7)(cid:17)(cid:4)(cid:14)(cid:21)(cid:7)(cid:19)(cid:8)(cid:19)(cid:5)(cid:3)(cid:15)(cid:14)(cid:3)(cid:19)(cid:9)(cid:8)(cid:13)
changes in the political, regulatory, safety or economic conditions in a country or region, including as a result of the United
Kingdom’s June 2016 vote and formal notice in March 2017 to leave the European Union (“Brexit”) or the change in the U.S.
(cid:14)(cid:21)(cid:7)(cid:19)(cid:8)(cid:19)(cid:5)(cid:3)(cid:15)(cid:14)(cid:3)(cid:19)(cid:9)(cid:8)(cid:13)
the imposition by governments of additional taxes, tariffs, global economic sanctions programs, or other restrictions on
(cid:18)(cid:9)(cid:15)(cid:2)(cid:19)(cid:6)(cid:8)(cid:4)(cid:3)(cid:15)(cid:14)(cid:21)(cid:2)(cid:13)
(cid:14)(cid:8)(cid:23)(cid:4)(cid:19)(cid:8)(cid:14)(cid:24)(cid:19)(cid:11)(cid:19)(cid:3)(cid:23)(cid:4)(cid:3)(cid:9)(cid:4)(cid:9)(cid:24)(cid:3)(cid:14)(cid:19)(cid:8)(cid:4)(cid:15)(cid:2)2(cid:10)(cid:19)(cid:15)(cid:2)(cid:21)(cid:4)(cid:2)$(cid:17)(cid:9)(cid:15)(cid:3)(cid:4)(cid:9)(cid:15)(cid:4)(cid:19)(cid:7)(cid:17)(cid:9)(cid:15)(cid:3)(cid:4)(cid:11)(cid:19)(cid:16)(cid:2)(cid:8)(cid:5)(cid:2)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:14)(cid:17)(cid:17)(cid:15)(cid:9)(cid:25)(cid:14)(cid:11)(cid:5)(cid:13)
failure to comply with export laws and requirements, which may result in civil or criminal penalties and restrictions on
#(cid:14)(cid:15)(cid:2)$/(cid:5)(cid:4)(cid:14)(cid:24)(cid:19)(cid:11)(cid:19)(cid:3)(cid:23)(cid:4)(cid:3)(cid:9)(cid:4)(cid:2)$(cid:17)(cid:9)(cid:15)(cid:3)(cid:4)(cid:19)(cid:3)(cid:5)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:5)(cid:26)(cid:4)(cid:17)(cid:14)(cid:15)(cid:3)(cid:19)(cid:16)(cid:10)(cid:11)(cid:14)(cid:15)(cid:11)(cid:23)(cid:4)(cid:19)(cid:3)(cid:5)(cid:4)(cid:19)(cid:8)(cid:21)(cid:10)(cid:5)(cid:3)(cid:15)(cid:19)(cid:14)(cid:11)(cid:4)(cid:11)(cid:19)(cid:8)(cid:2)(cid:14)(cid:15)(cid:4)(cid:14)(cid:16)(cid:16)(cid:2)(cid:11)(cid:2)(cid:15)(cid:14)(cid:3)(cid:9)(cid:15)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:5)(cid:13)
•
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17
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risks unique to the Chinese market, including import barriers and preferences for local ma(cid:8)(cid:10)(cid:18)(cid:14)(cid:16)(cid:3)(cid:10)(cid:15)(cid:2)(cid:15)(cid:5)(cid:13)
failure to obtain proper business licenses or other documentation or to otherwise comply with local laws and requirements
regarding marketing, sales, service, or any other business Varex conducts in a foreign jurisdiction, which may result in civil
(cid:9)(cid:15)(cid:4)(cid:16)(cid:15)(cid:19)(cid:7)(cid:19)(cid:8)(cid:14)(cid:11)(cid:4)(cid:17)(cid:2)(cid:8)(cid:14)(cid:11)(cid:3)(cid:19)(cid:2)(cid:5)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:15)(cid:2)(cid:5)(cid:3)(cid:15)(cid:19)(cid:16)(cid:3)(cid:19)(cid:9)(cid:8)(cid:5)(cid:4)(cid:9)(cid:8)(cid:4)(cid:19)(cid:3)(cid:5)(cid:4)(cid:14)(cid:24)(cid:19)(cid:11)(cid:19)(cid:3)(cid:23)(cid:4)(cid:3)(cid:9)(cid:4)(cid:16)(cid:9)(cid:8)(cid:21)(cid:10)(cid:16)(cid:3)(cid:4)(cid:24)(cid:10)(cid:5)(cid:19)(cid:8)(cid:2)(cid:5)(cid:5)(cid:4)(cid:19)(cid:8)(cid:4)(cid:3)(cid:22)(cid:14)(cid:3)(cid:4)7(cid:10)(cid:15)(cid:19)(cid:5)(cid:21)(cid:19)(cid:16)(cid:3)(cid:19)(cid:9)(cid:8)(cid:13)(cid:4)(cid:14)(cid:8)(cid:21)(cid:26)
the possibility that it may be more difficult to protect Varex’s intellectual property in foreign countries.
Although Varex’s sales fluctuate from period to period, in recent years Varex’s international region has represented a larger
share of its business. The more Varex depends on sales in the international region, the more vulnerable Varex becomes to these factors.
Varex’s effective tax rate is impacted by tax laws in both the United States and in the countries in which its international subsidiaries
do business. Earnings from Varex’s international region are generally taxed at rates lower than U.S. rates. A change in the percentage
of Varex’s total earnings from the international region, a change in the mix of particular tax jurisdictions within the international
region, or a change in currency exchange rates could cause Varex’s effective tax rate to increase or decrease. Also, Varex is not
currently taxed in the United States on certain undistributed earnings of certain foreign subsidiaries. These earnings could become
subject to incremental foreign withholding or U.S. federal and state taxes should they either be deemed to be or actually are remitted
to the United States, in which case Varex’s financial results could be materially and adversely affected. In addition, changes in the
valuation of Varex’s deferred tax assets or liabilities, changes in tax laws or rates, changes in the interpretation of tax laws, or other
changes beyond Varex’s control could materially and adversely affect its financial position and results of operations.
Varex’s results have been and may continue to be affected by continuing worldwide economic instability, including changes in
foreign currency exchange rates and fluctuations in the price of crude oil and other commodities.
The global economy has been impacted by a number of economic and political factors. In many markets, these conditions
have shrunk capital equipment budgets, slowed decision-making and made it difficult for Varex’s customers and vendors to accurately
forecast and plan future business activities. This, in turn, has caused Varex’s customers to be more cautious with, and sometimes
freeze, delay, or dramatically reduce purchases and capital project expenditures. Some countries have adopted and may in the future
adopt austerity or stimulus programs that could positively or negatively affect Varex’s results from period to period, making it difficult
for investors to compare its financial results. In addition, the recent change in the U.S. administration, and the pending withdrawal of
the United Kingdom from the European Union ("EU") may also create global economic uncertainty, which may cause our customers
to reduce their spending, which in turn, could adversely affect our business, financial condition, operating results, and cash flows. An
uncertain economic environment may also disrupt supply or affect our service business, as customers’ constrained budgets may result
in pricing pressure, extended warranty provisions, and even cancellation of service contracts.
In addition, concerns over continued economic instability could make it more difficult for Varex to collect outstanding
receivables. A continued weak or deteriorating healthcare market would inevitably materially and adversely affect Varex’s business,
financial conditions, and results of operations.
Because Varex’s products are generally priced in U.S. Dollars, the strengthening of the U.S. Dollar in the last several years
has caused, and could continue to cause, some customers to ask for additional discounts, delay purchasing decisions, or consider
moving to in-sourcing supply of such components or migrating to lower cost alternatives. Further, because Varex’s business is global
and some payments may be made in local currency, fluctuations in foreign currency exchange rates can impact its results by affecting
product demand, revenues and expenses, and/or the profitability in U.S. Dollars of products and services that Varex provides in foreign
markets.
Changes in monetary or other policies here and abroad, including as a result of economic and/or political instability or in
reaction thereto, would also likely affect foreign currency exchange rates. Furthermore, in the event that one or more European
countries were to replace the Euro with another currency, Varex’s sales in these countries, or in Europe generally, would likely be
materially and adversely affected until such time as stable exchange rates are established.
Additionally, fluctuations in commodities prices could materially and adversely affect Varex’s performance. Rising
commodities prices will increase Varex’s costs and those of Varex’s medical OEM customers, which could in turn result in reduced
demand for Varex’s products. Further, Varex’s security product revenues from oil-producing countries, in which Varex has a
significant customer base, have in the past suffered as a result of volatility in oil prices and remain sensitive to fluctuations in the
future.
The loss of a supplier or any inability to obtain supplies of important components could restrict Varex’s ability to manufacture
products, cause delays in its ability to deliver products, or significantly increase its costs.
Varex obtains from a limited group of suppliers or from sole-source suppliers some of the components included in its
products, such as wave guides for industrial linear accelerators, transistor arrays, cesium iodide coatings and specialized integrated
18
circuits for flat panel detectors, X-ray tube targets, housings, glass frames, high-voltage cable, bearings and various other components.
For example, Varex’s major supplier of its amorphous silicon-based thin film transistor arrays (flat panels) used in its digital image
detectors is dpiX LLC. Although Varex holds a 40% ownership interest in dpiX, Varex does not have majority voting rights and does
not have the power to direct the activities of dpiX. In addition, Varian is Varex’s sole source supplier for a key component in linear
accelerators used in Varex’s security and inspection products subsystems, which are specially made for Varex. While Varex entered
into a Supply Agreement for this component, there can be no assurance that this component will continue to be available on reasonable
terms, or at all.
If Varex loses any of these limited- or sole-source suppliers, if their operations are substantially interrupted, or if any of them
fail to meet performance or quality specifications, Varex may be required to obtain and qualify one or more replacement suppliers.
Such an event (i) may then also require Varex to redesign or modify its products to incorporate new parts and/or further require Varex
to obtain clearance, qualification, or certification of these products, including by the FDA, or obtain other applicable regulatory
approvals in other countries, or (ii) could significantly increase costs for the affected products and cause material delays in delivery of
those and other related products. In addition, manufacturing capacity limitations of any of Varex’s limited- or sole-source suppliers or
other inability of these suppliers to meet increasing demand could limit growth opportunities for the affected product lines and damage
customer relationships. Shortage of, and greater demand for, components and subassemblies could also increase manufacturing costs if
the supply/demand imbalance increases the price of the components and subassemblies. Any of these events could materially and
adversely affect Varex’s business and financial results.
A shortage or change in source of, or increase in price of, raw materials could restrict Varex’s ability to manufacture products,
cause delays, or significantly increase its cost of goods.
Varex relies upon the supplies of certain raw materials such as tungsten, lead, iridium, and copper for security and inspection
products and copper, lead, tungsten, rhenium, molybdenum zirconium, and various high grades of steel alloy for X-ray tubes.
Worldwide demand, availability, and pricing of these raw materials have been volatile, and Varex expects that availability and pricing
will continue to fluctuate in the future. If supplies are restricted or become unavailable or if prices increase, this could constrain
Varex’s manufacturing of affected products, reduce its profit margins, or otherwise materially and adversely affect its business.
Pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act, the SEC has promulgated rules regarding
disclosure of (1) the presence in a company’s products of certain metals known as “conflict minerals,” which are metals mined from
the Democratic Republic of the Congo and adjoining countries, as well as (2) procedures regarding a manufacturer’s efforts to identify
the sourcing of those minerals from this region. Varex’s complex supply chain may inhibit Varex’s ability to sufficiently verify the
origins of the relevant minerals used in its products through the due diligence procedures that it implements, which may harm Varex’s
reputation. In addition, Varex may encounter challenges in satisfying customers who require that all of the components of Varex
products are certified as conflict-free, which could place Varex at a competitive disadvantage if it is unable to do so. Moreover,
complying with these rules requires investigative efforts, which has and will continue to cause Varex to incur associated costs and
could materially and adversely affect the sourcing, supply, and pricing of materials used in Varex’s products or result in process or
manufacturing modifications, all of which could materially and adversely affect its results of operations.
Compliance with U.S. laws and regulations applicable to the marketing, manufacture, and distribution of Varex’s products may be
costly, and failure or delays in obtaining regulatory clearances or approvals or failure to comply with applicable laws and
regulations could prevent Varex from distributing its products, require Varex to recall its products, or result in significant penalties
or other harm to Varex’s business.
Some of Varex’s products and those of OEMs that incorporate Varex’s products are subject to extensive and rigorous
government regulation in the United States. Compliance with these laws and regulations is expensive and time-consuming, and failure
to comply with these laws and regulations could materially and adversely affect Varex’s business.
Most of Varex’s products are Class I devices, with a small number of software products designated as Class II devices.
Generally, Varex’s manufacturing operations for medical devices, and those of its third-party manufacturers, are required to comply
with the FDA’s QSR, as well as other federal and state regulations for medical devices and radiation-emitting products. The FDA
makes announced and unannounced periodic and on-going inspections of medical device manufacturers to determine compliance with
QSR and, in connection with these inspections, issues reports known as Form FDA 483 reports when the FDA believes the
manufacturer has failed to comply with applicable regulations and/or procedures. If observations from the FDA issued on Form FDA
483 reports are not addressed and/or corrective action is not taken in a timely manner and to the FDA’s satisfaction, the FDA may
issue a Warning Letter and/or proceed directly to other forms of enforcement action. Similarly, if a Warning Letter were issued,
prompt corrective action to come into compliance would be required. Failure to respond in a timely manner to Form FDA 483
observations, a Warning Letter, or any other notice of noncompliance and to promptly come into compliance could result in the FDA
bringing an enforcement action, which could include the total shutdown of Varex’s production facilities, denial of importation rights to
19
the United States for products manufactured in overseas locations, adverse publicity, and criminal and civil fines. The expense and
costs of any corrective actions that Varex may take, which may include product recalls, correction and removal of products from
customer sites, and/or changes to its product manufacturing and quality systems, could materially and adversely impact Varex’s
financial results and may also divert management resources, attention, and time. Additionally, if a Warning Letter were issued,
customers could delay purchasing decisions or cancel orders, and Varex could face increased pressure from its competitors, who could
use the Warning Letter against Varex in competitive sales situations, either of which could materially and adversely affect Varex’s
reputation, business, and stock price.
In addition, Varex is required to timely file various reports with the FDA, including reports required by the medical device
reporting regulations (“MDRs”), that require that Varex report to regulatory authorities if its devices may have caused or contributed
to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the
malfunction were to recur. In addition, if Varex initiates a correction or removal of a device to reduce a risk to health posed by the
device, Varex would be required to submit a publicly-available Correction and Removal Report to the FDA and, in many cases, similar
reports to other regulatory agencies. This report could be classified by the FDA as a device recall, which could lead to increased
scrutiny by the FDA, other international regulatory agencies, and Varex’s customers regarding the quality and safety of Varex’s
devices. If these MDRs or correction and removal reports are not filed on a timely basis, regulators may impose sanctions, sales of
Varex’s products may suffer, and Varex may be subject to product liability or regulatory enforcement actions, all of which could harm
its business.
Government regulation may also cause significant delays or even prevent the marketing and full commercialization of future
products or services that Varex may develop and/or may impose costly requirements on Varex’s business. Further, as Varex enters new
businesses or pursues new business opportunities, Varex will become subject to additional laws, rules, and regulations, including FDA
and foreign rules and regulations. Becoming familiar with and implementing the infrastructure necessary to comply with these laws,
rules, and regulations is costly and time consuming. In addition, failure to comply with these laws, rules and regulations could delay
the introduction of new products and could materially and adversely affect Varex’s business.
If Varex or any of its suppliers, distributors, agents, or customers fail to comply with FDA, Federal Trade Commission, or
other applicable U.S. regulatory requirements or are perceived to potentially have failed to comply therewith, Varex may face:
(cid:14)(cid:21)(cid:25)(cid:2)(cid:15)(cid:5)(cid:2)(cid:4)(cid:17)(cid:10)(cid:24)(cid:11)(cid:19)(cid:16)(cid:19)(cid:3)(cid:23)(cid:4)(cid:14)(cid:18)(cid:18)(cid:2)(cid:16)(cid:3)(cid:19)(cid:8)(cid:6)(cid:4)(cid:24)(cid:9)(cid:3)(cid:22)(cid:4)#(cid:14)(cid:15)(cid:2)$(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:19)(cid:3)(cid:5)(cid:4)(cid:16)(cid:10)(cid:5)(cid:3)(cid:9)(cid:7)(cid:2)(cid:15)(cid:5)(cid:13)
(cid:19)(cid:8)(cid:16)(cid:15)(cid:2)(cid:14)(cid:5)(cid:2)(cid:21)(cid:4)(cid:17)(cid:15)(cid:2)(cid:5)(cid:5)(cid:10)(cid:15)(cid:2)(cid:5)(cid:4)(cid:18)(cid:15)(cid:9)(cid:7)(cid:4)(cid:16)(cid:9)(cid:7)(cid:17)(cid:2)(cid:3)(cid:19)(cid:3)(cid:9)(cid:15)(cid:5)(cid:13)
inve(cid:5)(cid:3)(cid:19)(cid:6)(cid:14)(cid:3)(cid:19)(cid:9)(cid:8)(cid:5)(cid:4)(cid:24)(cid:23)(cid:4)(cid:6)(cid:9)(cid:25)(cid:2)(cid:15)(cid:8)(cid:7)(cid:2)(cid:8)(cid:3)(cid:14)(cid:11)(cid:4)(cid:14)(cid:10)(cid:3)(cid:22)(cid:9)(cid:15)(cid:19)(cid:3)(cid:19)(cid:2)(cid:5)(cid:13)
(cid:18)(cid:19)(cid:8)(cid:2)(cid:5)(cid:26)(cid:4)(cid:19)(cid:8)7(cid:10)(cid:8)(cid:16)(cid:3)(cid:19)(cid:9)(cid:8)(cid:5)(cid:26)(cid:4)(cid:16)(cid:19)(cid:25)(cid:19)(cid:11)(cid:4)(cid:17)(cid:2)(cid:8)(cid:14)(cid:11)(cid:3)(cid:19)(cid:2)(cid:5)(cid:26)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:16)(cid:15)(cid:19)(cid:7)(cid:19)(cid:8)(cid:14)(cid:11)(cid:4)(cid:17)(cid:15)(cid:9)(cid:5)(cid:2)(cid:16)(cid:10)(cid:3)(cid:19)(cid:9)(cid:8)(cid:13)
•
•
•
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• (cid:17)(cid:14)(cid:15)(cid:3)(cid:19)(cid:14)(cid:11)(cid:4)(cid:5)(cid:10)(cid:5)(cid:17)(cid:2)(cid:8)(cid:5)(cid:19)(cid:9)(cid:8)(cid:4)(cid:9)(cid:15)(cid:4)(cid:3)(cid:9)(cid:3)(cid:14)(cid:11)(cid:4)(cid:5)(cid:22)(cid:10)(cid:3)(cid:21)(cid:9)(cid:20)(cid:8)(cid:4)(cid:9)(cid:18)(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:19)(cid:9)(cid:8)(cid:4)(cid:18)(cid:14)(cid:16)(cid:19)(cid:11)(cid:19)(cid:3)(cid:19)(cid:2)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:19)(cid:7)(cid:17)(cid:9)(cid:5)(cid:19)(cid:3)(cid:19)(cid:9)(cid:8)(cid:4)(cid:9)(cid:18)(cid:4)(cid:9)(cid:17)(cid:2)(cid:15)(cid:14)(cid:3)(cid:19)(cid:8)(cid:6)(cid:4)(cid:15)(cid:2)(cid:5)(cid:3)(cid:15)(cid:19)(cid:16)(cid:3)(cid:19)(cid:9)(cid:8)(cid:5)(cid:13)
•
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• (cid:21)(cid:2)(cid:11)(cid:14)(cid:23)(cid:5)(cid:4)(cid:19)(cid:8)(cid:4)(cid:17)(cid:10)(cid:15)(cid:16)(cid:22)(cid:14)(cid:5)(cid:19)(cid:8)(cid:6)(cid:4)(cid:21)(cid:2)(cid:16)(cid:19)(cid:5)(cid:19)(cid:9)(cid:8)(cid:5)(cid:4)(cid:24)(cid:23)(cid:4)(cid:16)(cid:10)(cid:5)(cid:3)(cid:9)(cid:7)(cid:2)(cid:15)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:16)(cid:14)(cid:8)(cid:16)(cid:2)(cid:11)(cid:11)(cid:14)(cid:3)(cid:19)(cid:9)(cid:8)(cid:4)(cid:9)(cid:18)(cid:4)(cid:2)$(cid:19)(cid:5)(cid:3)(cid:19)(cid:8)(cid:6)(cid:4)(cid:9)(cid:15)(cid:21)(cid:2)(cid:15)(cid:5)(cid:13)
•
• difficulty in obtaining product liability or operating insurance at a reasonable cost, or at all.
increased difficulty in obtaining required cle(cid:14)(cid:15)(cid:14)(cid:8)(cid:16)(cid:2)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:14)(cid:17)(cid:17)(cid:15)(cid:9)(cid:25)(cid:14)(cid:11)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:11)(cid:9)(cid:5)(cid:5)(cid:2)(cid:5)(cid:4)(cid:9)(cid:18)(cid:4)(cid:16)(cid:11)(cid:2)(cid:14)(cid:15)(cid:14)(cid:8)(cid:16)(cid:2)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:14)(cid:17)(cid:17)(cid:15)(cid:9)(cid:25)(cid:14)(cid:11)(cid:5)(cid:4)(cid:14)(cid:11)(cid:15)(cid:2)(cid:14)(cid:21)(cid:23)(cid:4)(cid:6)(cid:15)(cid:14)(cid:8)(cid:3)(cid:2)(cid:21)(cid:13)
(cid:5)(cid:2)(cid:19)-(cid:10)(cid:15)(cid:2)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:15)(cid:2)(cid:16)(cid:14)(cid:11)(cid:11)(cid:5)(cid:4)(cid:9)(cid:18)(cid:4)#(cid:14)(cid:15)(cid:2)$(cid:4)(cid:17)(cid:15)(cid:9)(cid:21)(cid:10)(cid:16)(cid:3)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:3)(cid:22)(cid:9)(cid:5)(cid:2)(cid:4)(cid:9)(cid:18)(cid:4)(cid:19)(cid:3)(cid:5)(cid:4)(cid:16)(cid:10)(cid:5)(cid:3)(cid:9)(cid:7)(cid:2)(cid:15)(cid:5)(cid:13)
the inability to sell Varex products(cid:13)(cid:4)(cid:14)(cid:8)(cid:21)(cid:26)
Varex is also subject to federal and state laws and regulations of general applicability relating to matters such as
environmental protection, safe working conditions, manufacturing practices, and other matters. Insurance coverage is not
commercially available for violations of law, including the fines, penalties, or investigatory costs that Varex may incur as the
consequence of regulatory violations. Consequently, Varex does not have insurance that would cover this type of liability.
Varex sells certain X-ray tube products as replacements which are subject to medical device certification and product registration
laws and regulations, which vary by country, and are subject to change, and Varex may be unable to receive registration approval
or renewal of existing registrations if it fails to meet regulatory approval requirements or if the process of gaining approval
becomes commercially infeasible or impractical.
Varex markets and distributes certain X-ray tubes through distributors and third-party/multi-vendor service organizations that
are used as equivalent replacements for specific OEM tubes. Varex is subject to medical device certification and product registration
laws, which vary by country and are subject to periodic reviews and changes by regulatory authorities in those countries. For example,
to sell X-ray tubes for replacement applications in China, product registrations have to be approved by the Chinese FDA or province-
specific authorities. Registration requirements are subject to change, and Varex may not be able to receive registration approval or
renewal of existing registrations if Varex fails to meet regulatory approval requirements or if the process of gaining approval becomes
commercially infeasible or impractical. Certain of these local laws and regulations have the effect of serving as a barrier to trade and
can be difficult to navigate predictably.
20
In addition, certain countries in which Varex products are sold require products to undergo re-registration if the product is
altered in any significant way, and it may be determined that the separation of Varex from Varian, including Varex’s new name, will
require these products to be re-registered as Varex products, even if they are physically unchanged.
These registration processes can be costly and time consuming, and customers may decide to purchase products from Varex’s
competitors that do not have to be involved in a re-registration process. In addition, Varex’s inability to receive or renew product
registrations may prevent Varex from marketing and/or distributing those particular products for replacement applications in the
specific country.
Compliance with foreign laws and regulations applicable to the marketing, manufacture, and distribution of Varex’s products may
be costly, and failure to comply may result in significant penalties and other harm to Varex’s business.
Regulatory requirements affecting Varex’s operations and sales outside the United States vary from country to country, often
differing significantly from those in the United States. In general, outside the United States, some of Varex’s products are regulated as
medical devices by foreign governmental agencies similar to the FDA.
For Varex to market its products internationally, Varex must obtain clearances or approvals for products and product
modifications. These processes (including, for example, in the EU, the European Economic Area (“EEA”), Switzerland, China, Japan
and Canada) can be time consuming, expensive and uncertain, which can delay Varex’s ability to market products in those countries.
Delays in the receipt of or failure to receive regulatory approvals, the inclusion of significant limitations on the indicated uses of a
product, the loss of previously obtained approvals or failure to comply with existing or future regulatory requirements could restrict or
prevent Varex from doing business in a country or subject Varex to a variety of enforcement actions and civil or criminal penalties,
which would materially and materially and adversely affect its business. In addition, compliance with changing regulatory schemes,
such as what may occur in connection with Brexit, may add additional complexity, cost and delays in marketing or selling Varex’s
products. Brexit could lead to legal uncertainty and potentially divergent national laws and regulations and, given the lack of
comparable precedent, it is unclear what financial, regulatory and legal implications the withdrawal of the United Kingdom from the
EU would have and how such withdrawal would affect Varex.
Within the EU/EEA, Varex must obtain, and in turn affix, a CE mark certification, which is a European marking of
conformity that indicates that a product meets the essential requirements of the Medical Device Directive. Compliance with the
Medical Device Directive is done through a self-certification process that is then verified by an independent certification body called a
“Notified Body,” which is an organization empowered by the legislature to conduct this verification. Once the CE mark is affixed, the
Notified Body will regularly audit Varex to ensure that it remains in compliance with the applicable European laws and Medical
Device Directive. By affixing the CE mark to its product, Varex is certifying that its products comply with the laws and regulations
required by the EU/EEA countries, thereby allowing the free movement of its products within these countries and others that accept
CE mark standards. If Varex cannot support its performance claims and demonstrate compliance with the applicable European laws
and the Medical Device Directive, Varex would lose its right to affix the CE mark to its products, which would prevent Varex from
selling its products within the EU/EEA/Switzerland territory and in other countries that recognize the CE mark. In April 2017, the
European Commission adopted two new regulations on medical devices. One MDR, which will enter into force in 2020, replaced
Medical Device Directive 93/42/EEC and Active Implantable Medical Device 90/385/EEC, and the other MDR, entitled In Vitro
Diagnostic Medical Devices Regulation, replaced IVD Directive 98/79/EEC and will enter into force in 2022. These new regulations
impose stricter requirements for placing medical devices in the market, as well as for Notified Bodies. Varex may be subject to risks
associated with additional testing, modification, certification, or amendment of its existing market authorizations, or Varex may be
required to modify products already installed at its customers’ facilities to comply with the official interpretations of these revised
regulations.
Varex is also subject to international laws and regulations of general applicability relating to matters such as environmental
protection, safe working conditions, and manufacturing practices, as well as others. These are often comparable to, if not more
stringent than, the equivalent regulations in the United States. Sales overseas are also affected by regulation of matters such as product
standards, packaging, labeling, environmental and product recycling requirements, import and export restrictions, tariffs, duties, and
taxes.
In addition, Varex is required to timely file various reports with international regulatory authorities similar to the reports it is
required to timely file with U.S. regulatory authorities, including reports required by international adverse event reporting regulations.
If these reports are not timely filed, regulators may impose sanctions, including temporarily suspending Varex’s market authorizations
or CE mark, and sales of its products may suffer.
Further, as Varex enters new businesses or pursues new business opportunities internationally, or as regulatory schemes
change, Varex may become subject to additional laws, rules, and regulations. Becoming familiar with and implementing the
21
infrastructure necessary to comply with these laws, rules, and regulations is costly. Additionally, in some countries, Varex relies or
may rely in the future on foreign distributors and agents to assist in complying with foreign regulatory requirements, and Varex cannot
be sure that they will always do so. The failure of Varex or its agents to comply with these laws, rules, and regulations could delay the
introduction of new products, cause reputational harm, or result in investigations, fines, injunctions, civil penalties, criminal
prosecution, or an inability to sell Varex’s products in or to import its products into certain countries, which could materially and
adversely affect Varex’s business.
Existing and future healthcare reforms, including the Affordable Care Act and changes to reimbursement rates, may indirectly
have a material adverse effect on Varex’s business and results of operations.
Sales of Varex’s products to OEMs in the medical sector indirectly depend on whether adequate reimbursement is available
for its customers’ products from a variety of sources, such as government healthcare insurance programs, including U.S. Medicare and
Medicaid programs, foreign government programs, private insurance plans, health maintenance organizations, and preferred provider
organizations. Without adequate reimbursement, the demand for Varex’s customers’ products, and therefore indirectly Varex’s
products, may be limited.
Healthcare reform proposals and medical cost containment measures in the United States and in many foreign countries could
limit the use of both Varex’s and its customers’ products, reduce reimbursement available for such use, further tax the sale or use of
Varex’s products, and further increase the administrative and financial burden of compliance. These reforms and measures, including
the uncertainty in the medical community regarding their nature and effect, could have a material and adverse effect on Varex’s and its
customers’ purchasing decisions regarding its products and treatments and could harm Varex’s business, results of operations, financial
condition, and prospects. Varex cannot predict the specific healthcare programs and regulations that will be ultimately implemented by
local, regional, and national governments globally. However, any changes that lower reimbursements for Varex’s or its customers’
products and/or procedures using these products, including, for example, existing reimbursement incentives to convert from analog to
digital X-ray systems, or changes that reduce medical procedure volumes or increase cost containment pressures on Varex or others in
the healthcare sector could materially and adversely affect Varex’s business and results of operations.
On March 23, 2010, President Obama signed into law the Affordable Care Act. Although the continuation of this Act is
currently in question under the Trump administration, it could adversely impact the demand for Varex’s and its customers’ products
and services and therefore its financial position and results of operations, possibly materially. Changes in access to diagnostic
radiology or the reimbursement rates associated with diagnostic radiology as a result of the Affordable Care Act and similar state
proposals would likely affect domestic demand for Varex’s and its customers’ products and services.
In general, employers and third-party payors in the United States have become increasingly cost-conscious, with higher
deductibles imposed or encouraged in many medical plans. The imposition of higher deductibles tends to restrain individuals from
seeking the same level of medical treatments as they might seek if the costs they bear were lower, particularly in the medical
diagnostic portion of Varex’s business. Third-party payors have also increased utilization controls related to the use of its products by
healthcare providers.
Furthermore, there is no uniform policy on reimbursement among third-party payors, and Varex cannot be sure that third-
party payors will reimburse its customers for procedures using its products that will enable Varex to achieve or maintain adequate
sales and price levels for its products. Without adequate support from third-party payors, the market for Varex’s products may be
limited.
Varex is unable to predict what effect new healthcare reform proposals or ongoing uncertainty surrounding foreign, federal,
and state health reform proposals will have on its customers’ purchasing decisions. However, an expansion in any government’s role in
the healthcare industry may materially and adversely affect Varex’s business. In addition, it is possible that changes in administration
and policy, including the repeal of all or parts of the Affordable Care Act by the U.S. Congress and Trump administration could result
in additional proposals and/or changes to health care system legislation, which could have a material adverse effect on Varex’s
business. The effect that a full or partial repeal of the Affordable Care Act would have on Varex's business remains unclear at this time.
Varex is subject to federal, state, and foreign laws governing its business practices which, if violated, could result in substantial
penalties. Additionally, challenges to or investigations into Varex’s practices could cause adverse publicity and be costly to respond
to and thus could harm its business.
Anti-corruption laws and regulations. Varex is subject to the U.S. Foreign Corrupt Practices Act and anti-corruption laws, as
well as similar laws in foreign countries, such as the U.K. Bribery Act and the Law On the Fundamentals of Health Protection in the
Russian Federation. In general, there is a worldwide trend to strengthen anti-corruption laws and their enforcement, and the healthcare
industry and medical equipment manufacturers have been particular targets of these investigation and enforcement efforts. Any
violation of these laws by Varex or its agents or distributors could create substantial liability for Varex, subject its officers and
22
directors to personal liability, and cause a loss of reputation in the market. Transparency International’s 2015 Corruption Perceptions
Index measured the degree to which public sector corruption is perceived to exist in 168 countries/territories around the world and
found that two-thirds of the countries in the index, including many that Varex considers to be high-growth areas for Varex’s products,
such as China and India, scored below 50 on a scale from 100 (very clean) to 0 (highly corrupt). Varex currently operates in many
countries where the public sector is perceived as being more or highly corrupt. Varex’s strategic business plans include expanding its
business in regions and countries that are rated as higher risk for corruption activity by Transparency International. Becoming familiar
with and implementing the infrastructure necessary to comply with laws, rules, and regulations applicable to new business activities
and mitigating and protecting against corruption risks could be quite costly. In addition, failure by Varex or its agents or distributors to
comply with these laws, rules, and regulations could delay its expansion into high-growth markets and could materially and adversely
affect its business. This notwithstanding, Varex will inevitably do more business, directly and potentially indirectly, in countries where
the public sector is perceived to be more or highly corrupt and will be engaging in business in more countries perceived to be more or
highly corrupt. Increased business in higher-risk countries could subject Varex and its officers and directors to increased scrutiny and
increased liability from its business operations.
Competition and trade compliance laws. Varex is subject to various competition and trade compliance laws in the
jurisdictions in which it operates. Regulatory authorities under whose laws Varex operates may have enforcement powers that can
subject Varex to sanctions and can impose changes or conditions in the way Varex conducts its business. In addition, an increasing
number of jurisdictions also provide private rights of action for competitors or consumers to seek damages asserting claims of anti-
competitive conduct. Increased government scrutiny of Varex’s actions or enforcement or private rights of action could materially and
adversely affect its business or damage its reputation. In addition, Varex may conduct, or it may be required to conduct, internal
investigations or face audits or investigations by one or more domestic or foreign government agencies, which could be costly and
time consuming and could divert its management and key personnel from its business operations. An adverse outcome under any such
investigation or audit could subject Varex to fines and/or or criminal or other penalties, which could materially and adversely affect
Varex’s business and financial results. Furthermore, competition laws may prohibit or increase the cost of future acquisitions that
Varex may desire to undertake.
Laws and ethical rules governing interactions with healthcare providers. Generally, Varex does not sell its products directly
to healthcare providers, although occasionally it may sell its products to healthcare providers through distributors. The U.S. Medicare
and Medicaid “anti-kickback” laws, and similar state laws, prohibit payments or other remuneration that is intended to induce
hospitals, physicians, or others either to refer patients or to purchase, lease, or order, or to arrange for or recommend the purchase,
lease, or order of healthcare products or services for which payment may be made under federal and state healthcare programs, such as
Medicare and Medicaid. These laws affect Varex’s sales, marketing, and other promotional activities by limiting the kinds of financial
arrangements Varex may have with hospitals, physicians, or other potential purchasers of its products. They particularly impact how
Varex structures its sales offerings, including discount practices, customer support, education and training programs, physician
consulting, research grants, and other fee-for-service arrangements. These laws are broadly written, and it is often difficult to
determine precisely how these laws will be applied to specific circumstances.
Federal and state “false claims” laws generally prohibit knowingly presenting, or causing to be presented, claims for payment
from Medicare, Medicaid, or other government payors that are false or fraudulent, or for items or services that were not provided as
claimed. Although Varex does not submit claims directly to payors, manufacturers can be, and have been, held liable under these laws
if they are deemed to “cause” the submission of false or fraudulent claims by providing inaccurate billing or coding information to
customers or through certain other activities, including promoting products for uses not approved or cleared by the FDA, which is
called off-label promotion. Violating “anti-kickback” and “false claims” laws can result in civil and criminal penalties, which can be
substantial, as well as potential mandatory or discretionary exclusion from healthcare programs for noncompliance. Even an
unsuccessful challenge or investigation into Varex’s practices could cause adverse publicity and be costly to defend and thus could
harm its business and results of operations. Additionally, several recently-enacted state and federal laws, including laws in
Massachusetts and Vermont, and the federal Physician Payment Sunshine Act, now require, among other things, extensive tracking
and maintenance of databases regarding the disclosure of equity ownership and payments to physicians, healthcare providers, and
hospitals. These laws may require Varex to implement the necessary and costly infrastructure to track and report certain payments to
healthcare providers. Failure to comply with these new tracking and reporting laws could subject Varex to significant civil monetary
penalties.
Varex is subject to similar laws in foreign countries where it conducts business. For example, within the EU, the control of
unlawful marketing activities is a matter of national law in each of the member states. The member states of the EU closely monitor
perceived unlawful marketing activity by companies. Varex could face civil, criminal, and administrative sanctions if any member
state determines that Varex has breached its obligations under such state’s national laws. Industry associations also closely monitor the
activities of member companies. If these organizations or authorities name Varex as having breached its obligations under their
23
regulations, rules, or standards, its reputation would suffer, and its business and financial condition could be materially and adversely
affected.
Warranty claims may materially and adversely affect Varex’s business.
Varex could experience an increase in warranty claims as a result of issues with product quality or product failures as a direct
result of Varex’s design, manufacturing, or issues in its supply chain. Such an occurrence may damage Varex’s market reputation,
cause sales to decline, or require repairs or voluntary remedial measures to enhance customer satisfaction, which could materially and
adversely impact Varex’s financial results. Increased warranty claims on any given product could cause Varex to halt production on
that product and could significantly impair Varex’s liquidity and profitability, as well as cause reputational harm to Varex. Because
some categories of products tend to experience higher numbers of warranty claims than others, a shift in the types of products that
Varex’s customers purchase could lead to an increase in warranty claims. If actual levels of warranty claims are greater than the level
of claims Varex estimates, cost of sales could increase, and Varex’s financial condition could be materially and adversely affected. In
addition, product quality issues could result in significant follow-on effects for Varex, including, among other things, reputational
harm to Varex and its customers, loss of customers, and liability as a result of product quality issues. These outcomes would materially
and adversely affect Varex’s business and financial condition.
If Varex is not able to match its manufacturing capacity with demand for its products, its financial results may suffer.
Many of Varex’s products have a long production cycle, and Varex needs to anticipate demand for its products to ensure
adequate manufacturing or testing capacity. If Varex is unable to anticipate demand, and its manufacturing or testing capacity does not
keep pace with product demand, Varex will not be able to fulfill orders in a timely manner, which may negatively impact its financial
results and overall business. Conversely, if demand for Varex’s products decreases, the fixed costs associated with excess
manufacturing capacity may harm its financial results.
Additionally, Varex’s manufacturing is primarily conducte(cid:21)(cid:4)(cid:14)(cid:3)(cid:4)(cid:19)(cid:3)(cid:5)(cid:4)(cid:28)(cid:14)(cid:11)(cid:3)(cid:4)%(cid:14)(cid:12)(cid:2)(cid:4)(cid:29)(cid:19)(cid:3)(cid:23)(cid:26)(cid:4)&(cid:3)(cid:14)(cid:22)(cid:13)(cid:4)%(cid:14)(cid:5)(cid:4)#(cid:2)(cid:6)(cid:14)(cid:5)(cid:26)(cid:4)(cid:27)(cid:2)(cid:25)(cid:14)(cid:21)(cid:14)(cid:13)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:29)(cid:14)(cid:11)(cid:14)(cid:7)(cid:24)(cid:14)(cid:4)
City, Philippines facilities. If any of these facilities experiences a disruption, Varex would have no other means of manufacturing the
components manufactured at each respective facility until Varex is able to restore the capability at its current facilities or develop the
same capability at an alternative facility.
Delivery schedules for Varex’s security, industrial, and inspection products tend to be unpredictable.
Varex designs, manufactures, sells, and services Linatron X-ray accelerators, image-processing software, and image detection
products for security and inspection, such as cargo screening at ports and borders and nondestructive examination for a variety of
applications, as well as industrial applications. Varex generally sells security and inspection products to OEMs who incorporate its
products into their inspection systems, which are then sold to customs and other government agencies, as well as to commercial
organizations in the casting, power, aerospace, chemical, petro-chemical, and automotive industries. Varex believes growth in its
security and inspection products will be driven by security cargo screening and border protection needs, as well as by the needs of
customs agencies to verify shipments for assessing duties and taxes. This business is heavily influenced by domestic and international
government policies on border and port security, political change, and government budgets. In addition, Varex believes growth in this
product line may be driven in part by industrial customers engaged in 3-D printing, which, as a developing market, may be difficult to
predict. Orders for Varex’s security and inspection products have been and may continue to be unpredictable, as governmental
agencies may place large orders with Varex or its OEM customers in a short time period and then may not place any orders for a long
time period thereafter. Because it is difficult to predict Varex’s OEM customer delivery, the actual timing of sales and revenue
recognition varies significantly. The market for border protection systems has slowed significantly, and end customers, particularly in
oil-based economies and war zones in which Varex has a significant customer base, are delaying system deployments or tenders and
considering moving to alternative sources, resulting in a decline in the demand for security and inspection products.
In addition, demand for Varex’s security and inspection products is heavily influenced by U.S. and foreign governmental
policies on national and homeland security, border protection, and customs activities, which depend upon government budgets and
appropriations that are subject to economic conditions, as well as political changes and oil prices. Varex has seen customers freeze or
dramatically reduce purchases and capital project expenditures, delay projects, or act cautiously as governments around the world
wrestle with spending priorities. As economic growth remains sluggish in various jurisdictions and appears to be deteriorating in
others, and as concerns about levels of government employment and government debt continue, Varex expects that these effects will
also continue. Furthermore, bid awards in this business may be subject to challenge by third parties, as Varex has previously
encountered with a large government project. These factors make this business more unpredictable and could cause volatility in
Varex’s revenues and earnings, and therefore the price of Varex’s common stock.
24
Varex’s international manufacturing operations subject it to volatility and other risks, including high security risks, which could
result in harm to its employees and contractors or substantial costs.
Varex conducts certain manufacturing operations internationally in order to reduce costs and streamline its manufacturing
operations. There are administrative, legal, and governmental risks to operating internationally that could increase operating expenses
or hamper the development of these operations. The risks from operating internationally that could increase Varex’s operating
expenses and materially and adversely affect its operating results, financial condition, and ability to deliver its products and grow its
business include, among others:
• difficulties in staffing and managing employee relations and foreign operations, particularly in attracting and retaining
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•
• difficulties in coordinating its operations globally and in maintaining uniform standards, controls, procedures, and policies
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• (cid:21)(cid:19)(cid:18)(cid:18)(cid:19)(cid:16)(cid:10)(cid:11)(cid:3)(cid:19)(cid:2)(cid:5)(cid:4)(cid:19)(cid:8)(cid:4)(cid:2)(cid:8)(cid:18)(cid:9)(cid:15)(cid:16)(cid:19)(cid:8)(cid:6)(cid:4)(cid:16)(cid:9)(cid:8)(cid:3)(cid:15)(cid:14)(cid:16)(cid:3)(cid:5)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:17)(cid:15)(cid:9)(cid:3)(cid:2)(cid:16)(cid:3)(cid:19)(cid:8)(cid:6)(cid:4)(cid:19)(cid:8)(cid:3)(cid:2)(cid:11)(cid:11)(cid:2)(cid:16)(cid:3)(cid:10)(cid:14)(cid:11)(cid:4)(cid:17)(cid:15)(cid:9)(cid:17)(cid:2)(cid:15)(cid:3)(cid:23)(cid:13)
• (cid:21)(cid:19)(cid:25)(cid:2)(cid:15)(cid:5)(cid:19)(cid:9)(cid:8)(cid:4)(cid:9)(cid:18)(cid:4)(cid:7)(cid:14)(cid:8)(cid:14)(cid:6)(cid:2)(cid:7)(cid:2)(cid:8)(cid:3)(cid:4)(cid:14)(cid:3)(cid:3)(cid:2)(cid:8)(cid:3)(cid:19)(cid:9)(cid:8)(cid:13)
•
imposition of burdensome governmental regulations, including changing laws and regulations with respect to collection and
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regional and country-(cid:5)(cid:17)(cid:2)(cid:16)(cid:19)(cid:18)(cid:19)(cid:16)(cid:4)(cid:17)(cid:9)(cid:11)(cid:19)(cid:3)(cid:19)(cid:16)(cid:14)(cid:11)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:2)(cid:16)(cid:9)(cid:8)(cid:9)(cid:7)(cid:19)(cid:16)(cid:4)(cid:19)(cid:8)(cid:5)(cid:3)(cid:14)(cid:24)(cid:19)(cid:11)(cid:19)(cid:3)(cid:23)(cid:26)(cid:4)(cid:14)(cid:5)(cid:4)(cid:21)(cid:19)(cid:5)(cid:16)(cid:10)(cid:5)(cid:5)(cid:2)(cid:21)(cid:4)(cid:19)(cid:8)(cid:4)(cid:6)(cid:15)(cid:2)(cid:14)(cid:3)(cid:2)(cid:15)(cid:4)(cid:21)(cid:2)(cid:3)(cid:14)(cid:19)(cid:11)(cid:4)(cid:24)(cid:2)(cid:11)(cid:9)(cid:20)(cid:13)(cid:4)(cid:14)(cid:8)(cid:21)
inadequacy of the local infrastructure to support its operations.
•
•
In addition, Varex’s international locations expose it to high security risks, which could result in both harm to its employees
and contractors or substantial costs. Some of its services are performed in or adjacent to high-risk locations where the country or
location and surrounding area is suffering from political, social, or economic turmoil, war or civil unrest, or has a high level of
criminal or terrorist activity. In those locations where Varex has employees or operations, Varex may incur substantial costs to
maintain the safety of its personnel. Despite these precautions, the safety of its personnel in these locations may continue to be at risk,
and Varex may in the future suffer the loss of employees and contractors, which could harm its business and operating results.
Certain of Varex’s products are subject to regulations relating to use of radioactive material, compliance with which may be costly,
and a failure to comply therewith may materially and adversely affect Varex’s business.
As a manufacturer and seller of medical devices and devices emitting radiation or utilizing radioactive by-product material,
Varex and some of Varex’s suppliers and distributors are subject to extensive regulation by United States governmental authorities,
such as the FDA, the Nuclear Regulatory Commission (“NRC”), and state and local regulatory agencies, such as the State of
California, to ensure the devices are safe and effective and comply with laws governing products which emit, produce, or control
radiation. These regulations govern, among other things, the design, development, testing, manufacturing, packaging, labeling,
distribution, import/export, sale, and marketing and disposal of Varex’s products. Varex is also subject to international laws and
regulations that apply to manufacturers of radiation-emitting devices and products utilizing radioactive materials. These are often
comparable to, if not more stringent than, the equivalent regulations in the United States.
Varex’s industrial and medical devices utilizing radioactive material are subject to NRC clearance and approval requirements,
and the manufacture and sale of these products are subject to extensive federal and state regulation that varies from state to state and
among regions. Varex’s manufacture, distribution, installation, service, and removal of industrial devices utilizing radioactive material
or emitting radiation also requires Varex to obtain a number of licenses and certifications for these devices and materials. Service of
these products must also be in accordance with a specific radioactive materials license. Obtaining licenses and certifications may be
time consuming, expensive, and uncertain.
In addition, Varex is subject to a variety of environmental laws regulating its manufacturing operations and the handling,
storage, transport, and disposal of hazardous substances, which impose liability for the cleanup of any contamination from these
substances. In particular, the handling and disposal of radioactive materials resulting from the manufacture, use, or disposal of Varex’s
products may impose significant costs and requirements. Disposal sites for the lawful disposal of materials generated by the
manufacture, use, or decommissioning of Varex’s products may no longer accept these substances in the future or may accept them on
unfavorable terms.
If Varex is unable to obtain required FDA clearances or approvals for a product or is unduly delayed in doing so, or the uses of
that product were limited, Varex’s business could suffer.
Typically, Varex’s OEM customers are responsible for obtaining 510(k) pre-market notification clearance on their systems
that integrate Varex products, the substantial majority of which are Class I devices. A small portion of Varex’s products, however, is
software that is classified as a Class II device subject to 510(k) clearance. Unless an exception applies, Varex may be required by FDA
25
regulations to obtain a 510(k) pre-market notification clearance in connection with the manufacture of a new medical device or a new
indication for use of, or other significant change in, an existing currently marketed medical device before it can market or sell those
products in the United States. Modifications or enhancements to a product that could significantly affect its safety or effectiveness, or
that would constitute a major change in the intended use of the device, technology, materials, labeling, packaging, or manufacturing
process also require a new 510(k) clearance. Although manufacturers make the initial determination whether a change to a cleared
device requires a new 510(k) clearance, Varex cannot assure you that the FDA will agree with its decisions not to seek additional
approvals or clearances for particular modifications to its products or that Varex will be successful in obtaining new 510(k) clearances
for modifications. Obtaining clearances or approvals is time consuming, expensive, and uncertain. Varex may not be able to obtain the
necessary clearances or approvals or may be unduly delayed in doing so, which could harm its business. Furthermore, even if Varex is
granted regulatory clearances or approvals, they may include significant limitations on the indicated uses of the product, which may
limit the market for the product. If Varex is unable to obtain required FDA clearance or approval for a product or is unduly delayed in
doing so, or the uses of that product were limited, Varex’s business could suffer.
Disruption of critical information systems or material breaches in the security of Varex’s products may materially and adversely
affect its business and customer relations.
Information technology helps Varex operate efficiently, interface with and support its customers, maintain financial accuracy
and efficiency, and produce its financial statements. There is an increasing threat of information security attacks that pose risks to
companies, including Varex. Because the techniques used to obtain unauthorized access, or to sabotage systems, change frequently and
generally are not recognized until launched against a target, Varex may be unable to anticipate these techniques or to implement
adequate preventative measures. If Varex does not allocate and effectively manage the resources necessary to build and sustain the
proper technology infrastructure, Varex could be subject to, among other things, transaction errors, processing inefficiencies, the loss
of customers, business disruptions, or the loss of or damage to intellectual property through a security breach or misappropriation of
intellectual property. Such security breaches could expose Varex to a risk of loss of information, litigation, and possible liability to
employees, customers, and/or regulatory authorities. If Varex’s data management systems do not effectively collect, secure, store,
process, and report relevant data for the operation of its business, whether due to equipment malfunction or constraints, software
deficiencies, or human error, Varex’s ability to effectively plan, forecast, and execute its business plan and comply with applicable
laws and regulations will be impaired, perhaps materially. Any such impairment could materially and adversely affect Varex’s
financial condition, results of operations, cash flows, and the timeliness with which Varex reports its operating results internally and
externally.
Moreover, Varex offers cloud-based training software. A security breach, whether of Varex’s products, of Varex’s customers’
network security and systems, or of third-party hosting services could disrupt access to Varex’s customers’ stored information and
could lead to the loss of, damage to or public disclosure of Varex’s customers’ stored information, including patient health
information. Such an event could have serious negative consequences, including possible patient injury, regulatory action, fines,
penalties and damages, reduced demand for Varex’s solutions, an unwillingness of its customers to use its solutions, harm to its
reputation and brand, and time-consuming and expensive litigation, any of which could have a material and adverse effect on Varex’s
financial results.
Protecting Varex’s intellectual property can be costly, and Varex may not be able to maintain licensed rights, and, in either case, its
competitive position would be harmed if Varex is not able to do so.
Varex files applications as appropriate for patents covering new products and manufacturing processes. Varex cannot be sure,
however, that its current patents, the claims allowed under its current patents, or patents for technologies licensed to Varex will be
sufficiently broad to protect its technology position against competitors. Issued patents owned by, or licensed to, Varex may be
challenged, invalidated, or circumvented, or the rights granted under the patents may not provide Varex with competitive advantages.
Varex also cannot be sure that patents will be issued from any of Varex’s pending or future patent applications. Asserting Varex’s
patent rights against others in litigation or other legal proceedings is costly and diverts managerial resources. In addition, Varex may
not be able to detect patent infringement by others or may lose its competitive position in the market before Varex is able to do so.
Varex also relies on a combination of copyright, trade secret, and other laws, and contractual restrictions on disclosure, copying and
transferring title (including confidentiality agreements with vendors, strategic partners, co-developers, employees, consultants, and
other third parties), to protect its proprietary, and other confidential rights. These protections may prove to be inadequate, since
agreements may still be breached, Varex may not have adequate remedies for a breach, and its trade secrets may otherwise become
known to or be independently developed by others, including as a result of misappropriation by unauthorized access to Varex’s
technology systems. In the event that Varex’s proprietary or confidential information is misappropriated, its business and financial
results could be materially and adversely impacted. Varex has trademarks, both registered and unregistered, that are maintained and
enforced to provide customer recognition for its products in the marketplace, but unauthorized third parties may still use them. Varex
also has agreements with third parties that license to Varex certain patented or proprietary technologies. In some cases, products with
26
substantial revenues may depend on these license rights. If Varex were to lose the rights to license these technologies, or its costs to
license these technologies were to materially increase, its business would suffer.
Third parties may claim that Varex is infringing upon their intellectual property, and Varex could suffer significant litigation or
licensing expenses or be prevented from selling its products.
There is a substantial amount of litigation over patent and other intellectual property rights in the industries in which Varex
competes. Varex’s competitors, like companies in many high technology businesses, continually review other companies’ activities for
possible conflicts with their own intellectual property rights. In addition, non-practicing entities may review Varex’s activities for
conflicts with their patent rights. Determining whether a product infringes upon a third party’s intellectual property rights involves
complex legal and factual issues, and the outcome of this type of litigation is often uncertain. Third parties may claim that Varex is
infringing upon their intellectual property rights. Varex may not be aware of intellectual property rights of others that relate to its
products, services, or technologies. From time to time, Varex has received notices from third parties asserting infringement, and Varex
has been subject to lawsuits alleging infringement of third-party patent or other intellectual property rights. Any dispute regarding
patents or other intellectual property could be costly and time consuming and could divert Varex’s management and key personnel
from its business operations. Varex may not prevail in a dispute. Varex does not maintain insurance for intellectual property
infringement, so costs of defense, whether or not Varex is successful in defending an infringement claim, will be borne by Varex and
could be significant. If Varex is unsuccessful in defending or appealing an infringement claim, Varex may be subject to significant
damages, and its combined financial position, results of operations, or cash flows could be materially and adversely affected. If actual
liabilities significantly exceed its estimates regarding potential liabilities, its combined financial position, results of operations, or cash
flows could be materially and adversely affected. Varex may also be subject to injunctions against development and sale of its
products, the effect of which could be to materially reduce its revenues. Furthermore, a third party claiming infringement may not be
willing to license its rights to Varex, and even if a third-party rights holder is willing to do so, the amounts Varex might be required to
pay under the associated royalty or license agreement could be significant. As such, Varex could decide to alter its business strategy or
voluntarily cease the allegedly infringing actions rather than face litigation or pay a royalty, which could materially and adversely
impact its business and results of operations.
Product defects or misuse may result in material product liability or professional errors and omissions claims, litigation,
investigation by regulatory authorities, or product recalls that could harm Varex’s future revenues and require it to pay material
uninsured claims.
Varex’s business exposes it to potential product liability claims that are inherent in the manufacture, sale, installation,
servicing, and support of components that are used in medical devices and other devices that deliver radiation. Because Varex’s
products, through incorporation in OEMs’ systems, are involved in the intentional delivery of radiation to the human body and other
situations where people may come into contact with radiation (for example, when Varex’s security and inspection products are being
used to scan cargo or in the diagnosis of medical problems), the possibility for significant injury and/or death exists to the intended or
unintended recipient of such delivery. In addition, although Varex’s products are incorporated into OEMs’ systems, and thus only
perform pursuant to the design and operating systems of OEMs, Varex may also be subject to claims for property damage, personal
injury, or economic loss related to or resulting from any errors or defects in its products or the installation, servicing, or support of its
products. Any accident or mistreatment could subject Varex to legal costs, litigation, adverse publicity, and damage to its reputation,
whether or not its products or services were a factor.
If Varex’s X-ray inspection systems fail to detect the presence of bombs, explosives, weapons, contraband, or other threats to
personal safety, Varex could be subject to product and other liability claims or negative publicity, which could result in increased costs,
reduced sales, and a decline in the market price of Varex’s common stock. There are many factors beyond Varex’s control that could
result in the failure of its products to detect the presence of bombs, explosives, weapons, contraband, or other threats to personal
safety. Examples of these factors include operator error and misuse of or malfunction of Varex equipment. The failure of Varex’s
systems to detect the presence of these dangerous materials may lead to personal injury, loss of life, and extensive property damage
and may result in potential claims against Varex.
Product liability actions are subject to significant uncertainty and may be expensive, time consuming, and disruptive to
Varex’s operations. For these and other reasons, Varex may choose to settle product liability claims against it, regardless of their actual
merit. If a product liability action were ultimately determined against Varex, it could result in adverse publicity or significant damages,
including the possibility of punitive damages, and Varex’s combined financial position, results of operations, or cash flows could be
materially and adversely affected.
In addition, if a product Varex designs or manufactures were defective (whether due to design, labeling or manufacturing
defects, improper use of the product, or other reasons) or found to be so by a competent regulatory authority, Varex may be required to
correct or recall the product and notify other regulatory authorities. The adverse publicity resulting from a correction or recall,
27
however imposed, could damage Varex’s reputation and cause customers to review and potentially terminate their relationships with
Varex. A product correction or recall could consume management time and have an adverse financial impact on its business, including
incurring substantial costs, losing revenues, and accruing losses under GAAP.
Varex maintains limited product liability insurance coverage. Varex’s product liability insurance policies are expensive and
have high deductible amounts and self-insured retentions. Varex’s insurance coverage may also prove to be inadequate, and future
policies may not be available on acceptable terms or in sufficient amounts, if at all. If a material claim is successfully brought against
Varex relating to a liability that is in excess of its insurance coverage, or for which insurance coverage is denied or limited, Varex
could have to pay substantial damages, which could have a material and adverse effect on its financial position and/or results of
operations.
Unfavorable results of legal proceedings could materially and adversely affect Varex’s financial results.
From time to time, Varex is a party to or otherwise involved in legal proceedings, claims, government inspections or
investigations, and other legal matters, both inside and outside the United States, arising in the ordinary course of its business or
otherwise. Legal proceedings are often lengthy, taking place over a period of years with interim motions or judgments subject to
multiple levels of review (such as appeals or rehearings) before the outcome is final. Litigation is subject to significant uncertainty and
may be expensive, time consuming, and disruptive to Varex’s operations. For these and other reasons, Varex may choose to settle legal
proceedings and claims, regardless of their actual merit.
If a legal proceeding were ultimately resolved against Varex, it could result in significant compensatory damages, and, in
certain circumstances, punitive or treble damages, disgorgement of revenue or profits, remedial corporate measures, or injunctive
relief imposed on Varex. If Varex’s existing insurance does not cover the amount or types of damages awarded, or if other resolution
or actions taken as a result of such legal proceeding were to restrain its ability to market one or more of its material products or
services, its combined financial position, results of operations, or cash flows could be materially and adversely affected. In addition,
legal proceedings, and any adverse resolution thereof, can result in adverse publicity and damage to Varex’s reputation, which could
materially and adversely impact its business.
Varex’s business may suffer if it is not able to hire and retain qualified personnel.
Varex’s future success depends, to a great degree, on its ability to retain, attract, expand, integrate, and train its management
team and other key personnel, such as qualified engineering, service, sales, marketing, and other staff. Varex competes for key
personnel with other medical equipment and software manufacturers and technology companies, as well as universities and research
institutions. Because this competition is intense, particularly in Utah, where unemployment rates are relatively low, compensation-
related costs could increase significantly if the supply of qualified personnel decreases or demand increases. If Varex is unable to hire
and train qualified personnel, Varex may not be able to maintain or expand its business. Additionally, if Varex is unable to retain key
personnel, Varex may not be able to replace them readily or on terms that are reasonable, which also could hurt its business.
Changes in interpretation or application of generally accepted accounting principles may materially and adversely affect Varex’s
operating results.
Varex prepares its financial statements to conform to GAAP. These principles are subject to interpretation by the FASB,
American Institute of Certified Public Accountants, the SEC, and various other regulatory and/or accounting bodies. A change in
interpretations of, or its application of, these principles can have a significant effect on Varex’s reported results and may even affect its
reporting of transactions completed before a change is announced. In addition, when Varex is required to adopt new accounting
standards, Varex’s methods of accounting for certain items may change, which could cause its results of operations to fluctuate from
period to period and make it more difficult to compare its financial results to prior periods.
As its operations evolve over time, Varex may introduce new products and/or new technologies that require Varex to apply
different accounting principles, including ones regarding revenue recognition, than Varex has applied in past periods. The application
of different types of accounting principles and related potential changes may make it more difficult to compare its financial results
from quarter to quarter, and the trading price of Varex common stock could suffer or become more volatile as a result.
Environmental laws impose compliance costs on Varex’s business and may also result in liability.
Varex is subject to environmental laws around the world. These laws regulate many aspects of its operations, including its
handling, storage, transport, and disposal of hazardous substances, such as the chemicals and materials that Varex uses in the course of
its manufacturing operations. They can also impose cleanup liabilities, including with respect to discontinued operations. As a
consequence, Varex can incur significant environmental costs and liabilities, some recurring and others not recurring. Although its
follows procedures intended to comply with existing environmental laws, Varex, like other businesses, may mishandle or inadequately
28
manage hazardous substances used in its manufacturing operations and can never completely eliminate the risk of contamination or
injury from certain materials that it uses in its business and, therefore, it cannot completely eliminate the prospect of resulting claims
and damage payments. Varex may also be assessed fines and/or other penalties for failure to comply with environmental laws and
regulations. Insurance has provided coverage for portions of cleanup costs resulting from historical occurrences, but Varex does not
expect to maintain insurance coverage for costs or claims that might result from any future contamination.
Future changes in environmental laws could also increase its costs of doing business, perhaps significantly. Several countries,
including some in the EU, now require medical equipment manufacturers to bear certain disposal costs of products at the end of the
product’s useful life, increasing its costs. The EU has also adopted directives that may lead to restrictions on the use of certain
hazardous substances or other regulated substances in some of its products sold there. These directives, along with another that
requires substance information to be provided upon request, could increase Varex’s operating costs in order to maintain its access to
certain markets. All of these costs, and any future violations or liabilities under environmental laws or regulations, could have a
material adverse effect on its business.
Varex’s operations are vulnerable to interruption or loss due to natural or other disasters, power loss, strikes, and other events
beyond its control.
Varex conducts some of its activities, including manufacturing, research and development, administration, and data
processing at facilities located in areas that have in the past experienced or may in the future experience natural disasters. Varex’s
insurance coverage for such disasters may not be adequate or continue to be available at commercially-reasonable terms, or at all. A
major disaster (such as a major fire, hurricane, earthquake, flood, tsunami, volcanic eruption or terrorist attack) affecting Varex’s
facilities, or those of its suppliers, could significantly disrupt its operations and delay or prevent product manufacture and shipment
during the time required to repair, rebuild, or replace its or its suppliers’ damaged manufacturing facilities. These delays could be
lengthy and costly. If any of Varex’s customers’ facilities are adversely affected by a disaster, shipments of its products could be
delayed. Additionally, customers may delay purchases of Varex’s products until its operations return to normal. For example,
following the earthquake and tsunami disasters in Japan in 2011, the operations of Toshiba Medical, our largest customer, were
impacted, and, as a consequence, orders to and product shipment from our business were delayed for several months. Even if Varex is
able to quickly respond to a disaster, the ongoing effects of the disaster could create some uncertainty in the operations of its business.
In addition, Varex’s facilities may be subject to a shortage of available electrical power and other energy supplies. Any shortages may
increase its costs for power and energy supplies or could result in blackouts, which could disrupt the operations of its affected facilities
and harm its business. Further, Varex’s products are typically shipped from a limited number of ports, and any disaster, strike, or other
event blocking shipment from these ports could delay or prevent shipments and harm its business. In addition, concerns about
terrorism, the effects of a terrorist attack, political turmoil, or an outbreak of epidemic diseases could have a negative effect on Varex’s
business operations, those of its suppliers and customers, and the ability to travel, resulting in adverse consequences on its revenues
and financial performance.
Varex is an “emerging growth company,” and, as a result of the reduced disclosure and governance requirements applicable to
emerging growth companies, its common stock may be less attractive to investors.
Varex is an “emerging growth company,” as defined in the JOBS Act, and it intends to take advantage of some of the
exemptions from the reporting requirements that are afforded to emerging growth companies, including, but not limited to, scaled
disclosure requirements relating to financial statements and executive compensation, not being required to comply with the auditor
attestation requirements of Section 404 of the Sarbanes-Oxley Act, and exemptions from the requirements of holding a nonbinding
advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. Varex
cannot predict if investors will find its common stock less attractive because it intends to rely on these exemptions. If some investors
find its common stock less attractive as a result, there may be a less active trading market for its common stock, and its stock price
may become more volatile. Varex may take advantage of these exemptions until it is no longer an emerging growth company.
Certain provisions in Varex’s Amended and Restated Certificate of Incorporation and Bylaws, and of Delaware law, may prevent or
delay an acquisition of Varex, which could decrease the trading price of Varex’s common stock.
Varex’s Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws contain, and Delaware law
contains, provisions that are intended to deter coercive takeover practices and inadequate takeover bids by making such practices or
bids unacceptably expensive to the bidder and to encourage prospective acquirers to negotiate with Varex’s board of directors rather
than to attempt a hostile takeover. These provisions include, among others:
•
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(cid:3)(cid:22)(cid:2)(cid:4)(cid:19)(cid:8)(cid:14)(cid:24)(cid:19)(cid:11)(cid:19)(cid:3)(cid:23)(cid:4)(cid:9)(cid:18)(cid:4)#(cid:14)(cid:15)(cid:2)$/(cid:5)(cid:4)(cid:5)(cid:3)(cid:9)(cid:16)(cid:12)(cid:22)(cid:9)(cid:11)(cid:21)(cid:2)(cid:15)(cid:5)(cid:4)(cid:3)(cid:9)(cid:4)(cid:16)(cid:14)(cid:11)(cid:11)(cid:4)(cid:14)(cid:4)(cid:5)(cid:17)(cid:2)(cid:16)(cid:19)(cid:14)(cid:11)(cid:4)(cid:7)(cid:2)(cid:2)(cid:3)(cid:19)(cid:8)(cid:6)(cid:13)
(cid:3)(cid:22)(cid:2)(cid:4)(cid:19)(cid:8)(cid:14)(cid:24)(cid:19)(cid:11)(cid:19)(cid:3)(cid:23)(cid:4)(cid:9)(cid:18)(cid:4)#(cid:14)(cid:15)(cid:2)$/(cid:5)(cid:4)(cid:5)(cid:3)(cid:9)(cid:16)(cid:12)(cid:22)(cid:9)(cid:11)(cid:21)(cid:2)(cid:15)(cid:5)(cid:4)(cid:3)(cid:9)(cid:4)(cid:14)(cid:16)(cid:3)(cid:4)(cid:20)(cid:19)(cid:3)(cid:22)(cid:9)(cid:10)(cid:3)(cid:4)(cid:14)(cid:4)(cid:7)(cid:2)(cid:2)(cid:3)(cid:19)(cid:8)(cid:6)(cid:4)(cid:9)(cid:18)(cid:4)(cid:5)(cid:3)(cid:9)(cid:16)(cid:12)(cid:22)(cid:9)(cid:11)(cid:21)(cid:2)(cid:15)(cid:5)(cid:13)
rules re(cid:6)(cid:14)(cid:15)(cid:21)(cid:19)(cid:8)(cid:6)(cid:4)(cid:22)(cid:9)(cid:20)(cid:4)(cid:5)(cid:3)(cid:9)(cid:16)(cid:12)(cid:22)(cid:9)(cid:11)(cid:21)(cid:2)(cid:15)(cid:5)(cid:4)(cid:7)(cid:14)(cid:23)(cid:4)(cid:17)(cid:15)(cid:2)(cid:5)(cid:2)(cid:8)(cid:3)(cid:4)(cid:17)(cid:15)(cid:9)(cid:17)(cid:9)(cid:5)(cid:14)(cid:11)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:8)(cid:9)(cid:7)(cid:19)(cid:8)(cid:14)(cid:3)(cid:2)(cid:4)(cid:21)(cid:19)(cid:15)(cid:2)(cid:16)(cid:3)(cid:9)(cid:15)(cid:5)(cid:4)(cid:18)(cid:9)(cid:15)(cid:4)(cid:2)(cid:11)(cid:2)(cid:16)(cid:3)(cid:19)(cid:9)(cid:8)(cid:4)(cid:14)(cid:3)(cid:4)(cid:5)(cid:3)(cid:9)(cid:16)(cid:12)(cid:22)(cid:9)(cid:11)(cid:21)(cid:2)(cid:15)(cid:4)(cid:7)(cid:2)(cid:2)(cid:3)(cid:19)(cid:8)(cid:6)(cid:5)(cid:13)
(cid:3)(cid:22)(cid:2)(cid:4)(cid:15)(cid:19)(cid:6)(cid:22)(cid:3)(cid:4)(cid:9)(cid:18)(cid:4)#(cid:14)(cid:15)(cid:2)$/(cid:5)(cid:4)(cid:24)(cid:9)(cid:14)(cid:15)(cid:21)(cid:4)(cid:9)(cid:18)(cid:4)(cid:21)(cid:19)(cid:15)(cid:2)(cid:16)(cid:3)(cid:9)(cid:15)(cid:5)(cid:4)(cid:3)(cid:9)(cid:4)(cid:19)(cid:5)(cid:5)(cid:10)(cid:2)(cid:4)(cid:17)(cid:15)(cid:2)(cid:18)(cid:2)(cid:15)(cid:15)(cid:2)(cid:21)(cid:4)(cid:5)(cid:3)(cid:9)(cid:16)(cid:12)(cid:4)(cid:20)(cid:19)(cid:3)(cid:22)(cid:9)(cid:10)(cid:3)(cid:4)(cid:5)(cid:3)(cid:9)(cid:16)(cid:12)(cid:22)(cid:9)(cid:11)(cid:21)(cid:2)(cid:15)(cid:4)(cid:14)(cid:17)(cid:17)(cid:15)(cid:9)(cid:25)(cid:14)(cid:11)(cid:13)
29
•
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the division of Varex’s board of directors into three classes of directors, with each class serving a staggered three-year term,
and this classified board provision could have the effect of making the replacement of incumbent directors more time-
consuming and difficult, until the 2022 annual meeting of stockh(cid:9)(cid:11)(cid:21)(cid:2)(cid:15)(cid:5)(cid:26)(cid:4)(cid:14)(cid:18)(cid:3)(cid:2)(cid:15)(cid:4)(cid:20)(cid:22)(cid:19)(cid:16)(cid:22)(cid:4)(cid:21)(cid:19)(cid:15)(cid:2)(cid:16)(cid:3)(cid:9)(cid:15)(cid:5)(cid:4)(cid:20)(cid:19)(cid:11)(cid:11)(cid:4)(cid:24)(cid:2)(cid:4)(cid:2)(cid:11)(cid:2)(cid:16)(cid:3)(cid:2)(cid:21)(cid:4)(cid:14)(cid:8)(cid:8)(cid:10)(cid:14)(cid:11)(cid:11)(cid:23)(cid:13)
(cid:14)(cid:4)(cid:17)(cid:15)(cid:9)(cid:25)(cid:19)(cid:5)(cid:19)(cid:9)(cid:8)(cid:4)(cid:3)(cid:22)(cid:14)(cid:3)(cid:4)(cid:5)(cid:3)(cid:9)(cid:16)(cid:12)(cid:22)(cid:9)(cid:11)(cid:21)(cid:2)(cid:15)(cid:5)(cid:4)(cid:7)(cid:14)(cid:23)(cid:4)(cid:9)(cid:8)(cid:11)(cid:23)(cid:4)(cid:15)(cid:2)(cid:7)(cid:9)(cid:25)(cid:2)(cid:4)(cid:21)(cid:19)(cid:15)(cid:2)(cid:16)(cid:3)(cid:9)(cid:15)(cid:5)(cid:4)(cid:20)(cid:19)(cid:3)(cid:22)(cid:4)(cid:16)(cid:14)(cid:10)(cid:5)(cid:2)(cid:4)(cid:20)(cid:22)(cid:19)(cid:11)(cid:2)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:24)(cid:9)(cid:14)(cid:15)(cid:21)(cid:4)(cid:19)(cid:5)(cid:4)(cid:16)(cid:11)(cid:14)(cid:5)(cid:5)(cid:19)(cid:18)(cid:19)(cid:2)(cid:21)(cid:13)
the ability of Varex’s directors, and not stockholders, to fill vacancies on Varex’s board of director(cid:5)(cid:13)(cid:4)(cid:14)(cid:8)(cid:21)(cid:26)
the requirement that the affirmative vote of stockholders holding at least 66 2/3% of Varex’s voting stock is required to
amend certain provisions in Varex’s amended and restated certificate of incorporation (relating to the term and removal of its
directors, the filling of its board vacancies, the calling of special meetings of stockholders, stockholder action by written
consent, the elimination of liability of directors to the extent permitted by Delaware law and indemnification of directors and
o(cid:18)(cid:18)(cid:19)(cid:16)(cid:2)(cid:15)(cid:5)6(cid:13)(cid:4)(cid:17)(cid:15)(cid:9)(cid:25)(cid:19)(cid:21)(cid:2)(cid:21)(cid:26)(cid:4)(cid:22)(cid:9)(cid:20)(cid:2)(cid:25)(cid:2)(cid:15)(cid:26)(cid:4)(cid:3)(cid:22)(cid:14)(cid:3)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:17)(cid:15)(cid:9)(cid:25)(cid:19)(cid:5)(cid:19)(cid:9)(cid:8)(cid:5)(cid:4)(cid:9)(cid:18)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:14)(cid:7)(cid:2)(cid:8)(cid:21)(cid:2)(cid:21)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:15)(cid:2)(cid:5)(cid:3)(cid:14)(cid:3)(cid:2)(cid:21)(cid:4)(cid:16)(cid:2)(cid:15)(cid:3)(cid:19)(cid:18)(cid:19)(cid:16)(cid:14)(cid:3)(cid:2)(cid:4)(cid:9)(cid:18)(cid:4)(cid:19)(cid:8)(cid:16)(cid:9)(cid:15)(cid:17)(cid:9)(cid:15)(cid:14)(cid:3)(cid:19)(cid:9)(cid:8)(cid:4)(cid:15)(cid:2)(cid:11)(cid:14)(cid:3)(cid:19)(cid:8)(cid:6)(cid:4)(cid:3)(cid:9)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)88(cid:4)
2/3% voting threshold will be of no force and effect effective as of the completion of the 2021 annual meeting of
stockholders, and the amended and restated certificate of incorporation may thereafter be amended by the affirmative vote of
the holders of at least a majority of the outstanding voting stock.
In addition, because Varex did not elect to be exempt from Section 203 of the Delaware General Corporation Law (the
“DGCL”), this provision could also delay or prevent a change of control that stockholders may favor. Section 203 provides that,
subject to limited exceptions, persons that acquire, or who are affiliated with a person that acquires, more than 15% of the outstanding
voting stock of a Delaware corporation (an “interested stockholder”) shall not engage in any business combination with that
corporation, including by merger, consolidation, or acquisitions of additional shares, for a three-year period following the date on
which the person became an interested stockholder, unless: (i) prior to such time, the board of directors of such corporation approved
either the business combination or the transaction that resulted in the st(cid:9)(cid:16)(cid:12)(cid:22)(cid:9)(cid:11)(cid:21)(cid:2)(cid:15)(cid:4)(cid:24)(cid:2)(cid:16)(cid:9)(cid:7)(cid:19)(cid:8)(cid:6)(cid:4)(cid:14)(cid:8)(cid:4)(cid:19)(cid:8)(cid:3)(cid:2)(cid:15)(cid:2)(cid:5)(cid:3)(cid:2)(cid:21)(cid:4)(cid:5)(cid:3)(cid:9)(cid:16)(cid:12)(cid:22)(cid:9)(cid:11)(cid:21)(cid:2)(cid:15)(cid:13)(cid:4)5(cid:19)(cid:19)6 upon
consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned
at least 85% of the voting stock of such corporation at the time the transaction commenced (excluding for purposes of determining the
voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) the voting stock owned by
directors who are also officers or held in employee benefit plans in which the employees do not have a confidential right to tender or
(cid:25)(cid:9)(cid:3)(cid:2)(cid:4)(cid:5)(cid:3)(cid:9)(cid:16)(cid:12)(cid:4)(cid:22)(cid:2)(cid:11)(cid:21)(cid:4)(cid:24)(cid:23)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:17)(cid:11)(cid:14)(cid:8)6(cid:13)(cid:4)(cid:9)(cid:15)(cid:26)(cid:4)5(cid:19)(cid:19)(cid:19)6 on or subsequent to such time the business combination is approved by the board of directors of
such corporation and authorized at a meeting of stockholders by the affirmative vote of at least two-thirds of the outstanding voting
stock of such corporation not owned by the interested stockholder.
Varex believes these provisions will protect its stockholders from coercive or otherwise unfair takeover tactics by requiring
potential acquirers to negotiate with Varex’s board of directors and by providing Varex’s board of directors with more time to assess
any acquisition proposal. These provisions are not intended to make Varex immune from takeovers. However, these provisions will
apply even if the offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that Varex’s board
of directors determines is not in the best interests of Varex and Varex’s stockholders. These provisions may also prevent or discourage
attempts to remove and replace incumbent directors.
In addition, an acquisition or further issuance of Varex’s stock could trigger the application of Section 355(e) of the Internal
Revenue Code of 1986, causing the distribution to be taxable to Varian. Under the Tax Matters Agreement, Varex would be required to
indemnify Varian for the resulting tax, and this indemnity obligation might discourage, delay, or prevent a change of control that Varex
stockholders may consider favorable.
Varex’s Amended and Restated Certificate of Incorporation contains an exclusive forum provision that may discourage lawsuits
against Varex and Varex’s directors and officers.
Varex’s Amended and Restated Certificate of Incorporation provides that unless the board of directors otherwise determines,
the state courts in the State of Delaware or, if no state court located within the State of Delaware has jurisdiction, the federal court for
the District of Delaware, will be the sole and exclusive forum for any derivative action or proceeding brought on behalf of Varex, any
action asserting a claim of breach of a fiduciary duty owed by any director or officer of Varex to Varex or Varex’s stockholders, any
action asserting a claim against Varex or any director or officer of Varex arising pursuant to any provision of the DGCL or Varex’s
amended and restated certificate of incorporation or bylaws, or any action asserting a claim against Varex or any director or officer of
Varex governed by the internal affairs doctrine. This exclusive forum provision may limit the ability of Varex’s stockholders to bring a
claim in a judicial forum that such stockholders find favorable for disputes with Varex or Varex’s directors or officers, which may
discourage such lawsuits against Varex and Varex’s directors and officers. Alternatively, if a court outside of Delaware were to find
this exclusive forum provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or
proceedings described above, Varex may incur additional costs associated with resolving such matters in other jurisdictions, which
could materially and adversely affect Varex’s business, financial condition or results of operations.
30
Prior to its separation from Varian, Varex had no history of operating as an independent company, and its historical financial
information is not necessarily representative of the results that it would have achieved as a separate, publicly-traded company and
may not be a reliable indicator of its future results.
The historical information about Varex in this Annual Report prior to January 28, 2017 refers to Varex’s business as operated
by and integrated with Varian. Varex’s historical financial information prior to January 28, 2017 included in this Annual Report is
derived from the consolidated financial statements and accounting records of Varian. Accordingly, this historical financial information
does not necessarily reflect the financial condition, results of operations, or cash flows that Varex would have achieved as a separate,
publicly-traded company during the periods presented or that which Varex will achieve in the future, primarily as a result of the factors
described below:
• Prior to the separation, Varex’s business was operated by Varian as part of its broader corporate organization, rather than as an
independent company. Varian or one of its affiliates performed various corporate functions for Varex such as accounting,
legal, human resources, information technology, treasury, tax, facilities, research and development, insurance, and other
corporate and infrastructure services. Varex’s historical financial results reflect allocations of corporate expenses from Varian
for such functions and are likely to be less than the expenses Varex would have incurred had it operated as a separate
publicly-traded company. Following the separation, Varex’s costs related to such functions previously performed by Varian
may therefore increase.
• Prior to the separation, Varex’s business was integrated with the other businesses of Varian. Historically, Varex has shared
economies of scope and scale in costs, employees, vendor relationships, and customer relationships. Although Varex entered
into a Transition Services Agreement with Varian, the arrangements provided by such agreement may not fully capture the
benefits that Varex enjoyed when integrated with Varian and may result in Varex paying higher charges than in the past for
these services. This could have a material and adverse effect on Varex’s results of operations and financial condition.
• Generally, Varex’s working capital requirements and capital for its general corporate purposes, including acquisitions and
capital expenditures, have historically been satisfied as part of the corporate-wide cash management policies of
Varian. Following the separation, Varex may need to obtain additional financing from banks, through public offerings or
private placements of debt or equity securities, strategic relationships or other arrangements, which may or may not be
available and may be more costly.
• The cost of capital for Varex’s business is expected to be higher than Varian’s cost of capital prior to the separation.
Other significant changes are likely to occur in Varex’s cost structure, management, financing, and business operations as a
result of operating as a company separate from Varian, including as a result of additional costs incurred by Varex as a result of the
separation.
Potential indemnification liabilities to Varian pursuant to the Separation and Distribution Agreement could materially and
adversely affect Varex’s business, financial condition, results of operations, and cash flows.
The Separation and Distribution Agreement provides for, among other things, indemnification obligations designed to make
#(cid:14)(cid:15)(cid:2)$(cid:4)(cid:18)(cid:19)(cid:8)(cid:14)(cid:8)(cid:16)(cid:19)(cid:14)(cid:11)(cid:11)(cid:23)(cid:4)(cid:15)(cid:2)(cid:5)(cid:17)(cid:9)(cid:8)(cid:5)(cid:19)(cid:24)(cid:11)(cid:2)(cid:4)(cid:18)(cid:9)(cid:15)9(cid:4)(cid:14)(cid:8)(cid:23)(cid:4)#(cid:14)(cid:15)(cid:2)$(cid:4)(cid:11)(cid:19)(cid:14)(cid:24)(cid:19)(cid:11)(cid:19)(cid:3)(cid:19)(cid:2)(cid:5)(cid:13)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:18)(cid:14)(cid:19)(cid:11)(cid:10)(cid:15)(cid:2)(cid:4)(cid:9)(cid:18)(cid:4)#(cid:14)(cid:15)(cid:2)$(cid:4)(cid:3)(cid:9)(cid:4)(cid:17)(cid:14)(cid:23)(cid:26)(cid:4)(cid:17)(cid:2)(cid:15)(cid:18)(cid:9)(cid:15)(cid:7)(cid:26)(cid:4)(cid:9)(cid:15)(cid:4)(cid:9)(cid:3)(cid:22)(cid:2)(cid:15)(cid:20)(cid:19)(cid:5)(cid:2)(cid:4)(cid:17)(cid:15)(cid:9)(cid:7)(cid:17)(cid:3)(cid:11)(cid:23)(cid:4)(cid:21)(cid:19)(cid:5)(cid:16)(cid:22)(cid:14)(cid:15)ge any Varex
(cid:11)(cid:19)(cid:14)(cid:24)(cid:19)(cid:11)(cid:19)(cid:3)(cid:19)(cid:2)(cid:5)(cid:4)(cid:9)(cid:15)(cid:4)(cid:16)(cid:9)(cid:8)(cid:3)(cid:15)(cid:14)(cid:16)(cid:3)(cid:5)(cid:4)(cid:19)(cid:8)(cid:4)(cid:14)(cid:16)(cid:16)(cid:9)(cid:15)(cid:21)(cid:14)(cid:8)(cid:16)(cid:2)(cid:4)(cid:20)(cid:19)(cid:3)(cid:22)(cid:4)(cid:3)(cid:22)(cid:2)(cid:19)(cid:15)(cid:4)(cid:15)(cid:2)(cid:5)(cid:17)(cid:2)(cid:16)(cid:3)(cid:19)(cid:25)(cid:2)(cid:4)(cid:3)(cid:2)(cid:15)(cid:7)(cid:5)(cid:13)(cid:4)(cid:14)(cid:8)(cid:23)(cid:4)(cid:6)(cid:10)(cid:14)(cid:15)(cid:14)(cid:8)(cid:3)(cid:2)(cid:2)(cid:26)(cid:4)(cid:19)(cid:8)(cid:21)(cid:2)(cid:7)(cid:8)(cid:19)(cid:18)(cid:19)(cid:16)(cid:14)(cid:3)(cid:19)(cid:9)(cid:8)(cid:4)(cid:9)(cid:24)(cid:11)(cid:19)(cid:6)(cid:14)tion, surety bond or other credit
support agreement, arrangement, commitment, or understanding by Varian for the benefit of Varex, unless related to Varian lia(cid:24)(cid:19)(cid:11)(cid:19)(cid:3)(cid:19)(cid:2)(cid:5)(cid:13)(cid:4)
any breach by Varex of the Separation and Distribution Agreement or any of the ancillar(cid:23)(cid:4)(cid:14)(cid:6)(cid:15)(cid:2)(cid:2)(cid:7)(cid:2)(cid:8)(cid:3)(cid:5)(cid:13)(cid:4)(cid:14)(cid:8)(cid:23)(cid:4)(cid:14)(cid:16)(cid:3)(cid:19)(cid:9)(cid:8)(cid:4)(cid:24)(cid:23)(cid:4)#(cid:14)(cid:15)(cid:2)$(cid:4)(cid:19)(cid:8)(cid:4)
(cid:16)(cid:9)(cid:8)(cid:3)(cid:15)(cid:14)(cid:25)(cid:2)(cid:8)(cid:3)(cid:19)(cid:9)(cid:8)(cid:4)(cid:9)(cid:18)(cid:4)(cid:19)(cid:3)(cid:5)(cid:4):(cid:7)(cid:2)(cid:8)(cid:21)(cid:2)(cid:21)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4).(cid:2)(cid:5)(cid:3)(cid:14)(cid:3)(cid:2)(cid:21)(cid:4)(cid:29)(cid:2)(cid:15)(cid:3)(cid:19)(cid:18)(cid:19)(cid:16)(cid:14)(cid:3)(cid:2)(cid:4)(cid:9)(cid:18)(cid:4)(cid:31)(cid:8)(cid:16)(cid:9)(cid:15)(cid:17)(cid:9)(cid:15)(cid:14)(cid:3)(cid:19)(cid:9)(cid:8)(cid:4)(cid:9)(cid:15)(cid:4):(cid:7)(cid:2)(cid:8)(cid:21)(cid:2)(cid:21)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4).(cid:2)(cid:5)(cid:3)(cid:14)(cid:3)(cid:2)(cid:21)(cid:4)*(cid:23)(cid:11)(cid:14)(cid:20)(cid:5)(cid:13)(cid:4)(cid:14)(cid:8)(cid:21)(cid:26)(cid:4)(cid:14)(cid:8)(cid:23)(cid:4)(cid:10)(cid:8)(cid:3)(cid:15)(cid:10)(cid:2)(cid:4)(cid:5)(cid:3)(cid:14)(cid:3)(cid:2)(cid:7)ent
or alleged untrue statement of a material fact or omission or alleged omission to state a material fact required to be stated therein or
necessary to make the statements therein not misleading, with respect to all information contained in the Registration Statement on
Form 10 (as amended or supplemented) or any other disclosure document that describes the separation, the distribution, Varex and its
subsidiaries, or the transactions contemplated by the Separation and Distribution Agreement, subject to certain exceptions. If Varex is
required to indemnify Varian under the circumstances set forth in the Separation and Distribution Agreement, Varex may be subject to
substantial liabilities.
In connection with Varex’s separation from Varian, Varian has agreed to indemnify Varex for certain liabilities. However, there
can be no assurance that the indemnity will be sufficient to insure Varex against the full amount of such liabilities or that Varian’s
ability to satisfy its indemnification obligation will not be impaired in the future.
Pursuant to the Separation and Distribution Agreement and certain other agreements with Varian, Varian agreed to indemnify
Varex for certain liabilities. However, third parties could also seek to hold Varex responsible for any of the liabilities that Varian
retained, and there can be no assurance that the indemnity from Varian will be sufficient to protect Varex against the full amount of
such liabilities or that Varian will be able to fully satisfy its indemnification obligations. In addition, Varian’s insurers may attempt to
deny coverage to Varex for liabilities associated with certain occurrences of indemnified liabilities prior to the separation. Moreover,
even if Varex ultimately succeeds in recovering from Varian or such insurance providers any amounts for which Varex is held liable,
31
Varex may be temporarily required to bear these losses. Each of these risks could negatively affect Varex’s business, financial position,
results of operations, and/or cash flows.
If the distribution, together with certain related transactions, does not qualify as a transaction that is generally tax-free for U.S.
federal income tax purposes, Varian, Varex, and Varian stockholders could be subject to significant tax liabilities, and, in certain
circumstances, Varex could be required to indemnify Varian for material taxes and other related amounts pursuant to
indemnification obligations under the Tax Matters Agreement.
It was a condition to the distribution that Varian receive an opinion of counsel, satisfactory to the Varian board of directors,
regarding the qualification of the distribution, together with certain related transactions, as a transaction that is generally tax-free for
U.S. federal income tax purposes under Sections 355 and 368(a)(1)(D) of the Code. The opinion of counsel was based upon and relied
on, among other things, certain facts and assumptions, as well as certain representations, statements, and undertakings of Varian and
Varex, including those relating to the past and future conduct of Varian and Varex. If any of these representations, statements, or
undertakings are, or become, inaccurate or incomplete, or if Varian or Varex breaches any of its covenants in the separation
documents, the opinion of counsel may be held to be invalid, and the conclusions reached therein could be jeopardized.
Notwithstanding the opinion of counsel, the Internal Revenue Service (the “IRS”) could determine that the distribution, together with
certain related transactions, should be treated as a taxable transaction if it determines that any of the facts, assumptions,
representations, statements, or undertakings upon which the opinion of counsel was based are false or have been violated or if it
disagrees with the conclusions in the opinion of counsel. The opinion of counsel is not binding on the IRS, and there can be no
assurance that the IRS will not assert a contrary position.
If the distribution, together with certain related transactions, fails to qualify as a transaction that is generally tax-free for U.S.
federal income tax purposes under Sections 355 and 368(a)(1)(D) of the Code, Varian would recognize taxable gain as if it had sold
the Varex common stock in a taxable sale for its fair market value, and Varian stockholders who received Varex shares in the
distribution would be subject to tax as if they had received a taxable distribution equal to the fair market value of such shares.
Under the Tax Matters Agreement entered into by Varian and Varex in connection with the separation, Varex is generally
required to indemnify Varian for any taxes resulting from the separation (and any related costs and other damages) to the extent such
amounts resulted from (i) an acquisition of all or a portion of the equity securities or assets of Varex, whether by merger or otherwise
(and regardless of whether Varex participated in or otherwise facilitated the acquisition), (ii) other actions or failures to act by Varex,
or (iii) should any of the representations or undertaking of Varex contained in any of the separation-related agreements or in the
documents relating to the opinion of counsel be incorrect or violated. Any such indemnity obligations could be material.
Varex may not be able to engage in certain desirable strategic or capital-raising transactions following the separation.
Under current law, a spin-off can be rendered taxable to the parent corporation and its stockholders as a result of certain post-
spin-off acquisitions of shares or assets of the spun-off corporation. For example, a spin-off may result in taxable gain to the parent
corporation under Section 355(e) of the Code if the spin-off were later deemed to be part of a plan (or series of related transactions)
pursuant to which one or more persons acquire, directly or indirectly, shares representing a 50% or greater interest (by vote or value)
in the spun-off corporation. To preserve the tax-free treatment of the separation and the distribution, and in addition to Varex’s
indemnity obligations described above, the Tax Matters Agreement restricts Varex, for the two-year period following the separation,
except in specific circumstances, from: (i) entering into any transaction pursuant to which all or a portion of the shares of Varex
(cid:16)(cid:9)(cid:7)(cid:7)(cid:9)(cid:8)(cid:4)(cid:5)(cid:3)(cid:9)(cid:16)(cid:12)(cid:4)(cid:20)(cid:9)(cid:10)(cid:11)(cid:21)(cid:4)(cid:24)(cid:2)(cid:4)(cid:14)(cid:16)2(cid:10)(cid:19)(cid:15)(cid:2)(cid:21)(cid:26)(cid:4)(cid:20)(cid:22)(cid:2)(cid:3)(cid:22)(cid:2)(cid:15)(cid:4)(cid:24)(cid:23)(cid:4)(cid:7)(cid:2)(cid:15)(cid:6)(cid:2)(cid:15)(cid:4)(cid:9)(cid:15)(cid:4)(cid:9)(cid:3)(cid:22)(cid:2)(cid:15)(cid:20)(cid:19)(cid:5)(cid:2)(cid:13)(cid:4)5(cid:19)(cid:19)6 (cid:19)(cid:5)(cid:5)(cid:10)(cid:19)(cid:8)(cid:6)(cid:4)(cid:2)2(cid:10)(cid:19)(cid:3)(cid:23)(cid:4)(cid:5)(cid:2)(cid:16)(cid:10)(cid:15)(cid:19)(cid:3)(cid:19)(cid:2)(cid:5)(cid:4)(cid:24)(cid:2)(cid:23)(cid:9)(cid:8)(cid:21)(cid:4)(cid:16)(cid:2)(cid:15)(cid:3)(cid:14)(cid:19)(cid:8)(cid:4)(cid:3)(cid:22)(cid:15)(cid:2)(cid:5)(cid:22)(cid:9)(cid:11)(cid:21)(cid:5)(cid:13)(cid:4)5(cid:19)(cid:19)(cid:19)6(cid:4)
repurchasing shares of Varex common stock other than in certain open-(cid:7)(cid:14)(cid:15)(cid:12)(cid:2)(cid:3)(cid:4)(cid:3)(cid:15)(cid:14)(cid:8)(cid:5)(cid:14)(cid:16)(cid:3)(cid:19)(cid:9)(cid:8)(cid:5)(cid:13)(cid:4)(cid:14)(cid:8)(cid:21)(cid:26)(cid:4)5(cid:19)(cid:25)6(cid:4)(cid:16)(cid:2)(cid:14)(cid:5)(cid:19)(cid:8)(cid:6)(cid:4)(cid:3)(cid:9)(cid:4)(cid:14)(cid:16)(cid:3)(cid:19)(cid:25)(cid:2)(cid:11)(cid:23)(cid:4)(cid:16)(cid:9)(cid:8)(cid:21)(cid:10)(cid:16)(cid:3)(cid:4)
certain of its businesses. The Tax Matters Agreement also prohibits Varex from taking or failing to take any other action that would
prevent the distribution and certain related transactions from qualifying as a transaction that is generally tax-free for U.S. federal
income tax purposes under Sections 355 and 368(a)(1)(D) of the Code. These restrictions may limit Varex’s ability to pursue certain
strategic transactions, equity issuances or repurchases, or other transactions that it may believe to be in the best interests of its
stockholders or that might increase the value of its business.
As a result of the distribution, certain members of management and directors hold stock in both Varian and Varex, and as a result
may face actual or potential conflicts of interest.
After the distribution, certain of the management and directors of each of Varian and Varex own both Varian common stock
and Varex common stock. This ownership overlap could create, or appear to create, potential conflicts of interest when Varex
management and directors and Varian’s management and directors face decisions that could have different implications for Varex and
Varian. For example, potential conflicts of interest could arise in connection with the resolution of any dispute between Varex and
Varian regarding the terms of the agreements governing the distribution and Varex’s relationship with Varian thereafter. These
agreements include the Separation and Distribution Agreement, the Tax Matters Agreement, the Employee Matters Agreement, the
32
Transition Services Agreement, the Intellectual Property Matters Agreement, the Trademark License Agreement, and one or more
Supply/Distribution Agreements. Potential conflicts of interest may also arise out of any commercial arrangements that Varex or
Varian may enter into in the future.
Varex may not achieve some or all of the expected benefits of the separation, and the separation may materially and adversely
affect Varex’s business.
Varex may not be able to achieve the full strategic and financial benefits expected to result from the separation, or such
benefits may be delayed or not occur at all. The separation and distribution is expected to provide the following benefits, among
others:
• (cid:7)(cid:9)(cid:15)(cid:2)(cid:4)(cid:2)(cid:18)(cid:18)(cid:2)(cid:16)(cid:3)(cid:19)(cid:25)(cid:2)(cid:4)(cid:17)(cid:10)(cid:15)(cid:5)(cid:10)(cid:19)(cid:3)(cid:4)(cid:9)(cid:18)(cid:4)(cid:2)(cid:14)(cid:16)(cid:22)(cid:4)(cid:16)(cid:9)(cid:7)(cid:17)(cid:14)(cid:8)(cid:23)/(cid:5)(cid:4)(cid:21)(cid:19)(cid:5)(cid:3)(cid:19)(cid:8)(cid:16)(cid:3)(cid:4)(cid:9)(cid:17)(cid:2)(cid:15)(cid:14)(cid:3)(cid:19)(cid:8)(cid:6)(cid:4)(cid:17)(cid:15)(cid:19)(cid:9)(cid:15)(cid:19)(cid:3)(cid:19)(cid:2)(cid:5)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:5)(cid:3)(cid:15)(cid:14)(cid:3)(cid:2)(cid:6)(cid:19)(cid:2)(cid:5)(cid:13)
• (cid:7)(cid:9)(cid:15)(cid:2)(cid:4)(cid:2)(cid:18)(cid:18)(cid:19)(cid:16)(cid:19)(cid:2)(cid:8)(cid:3)(cid:4)(cid:14)(cid:11)(cid:11)(cid:9)(cid:16)(cid:14)(cid:3)(cid:19)(cid:9)(cid:8)(cid:4)(cid:9)(cid:18)(cid:4)(cid:16)(cid:14)(cid:17)(cid:19)(cid:3)(cid:14)(cid:11)(cid:4)(cid:18)(cid:9)(cid:15)(cid:4)(cid:24)(cid:9)(cid:3)(cid:22)(cid:4)#(cid:14)(cid:15)(cid:19)(cid:14)(cid:8)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)#(cid:14)(cid:15)(cid:2)$(cid:13)
• (cid:21)(cid:19)(cid:15)(cid:2)(cid:16)(cid:3)(cid:4)(cid:14)(cid:16)(cid:16)(cid:2)(cid:5)(cid:5)(cid:4)(cid:24)(cid:23)(cid:4)#(cid:14)(cid:15)(cid:2)$(cid:4)(cid:3)(cid:9)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:16)(cid:14)(cid:17)(cid:19)(cid:3)(cid:14)(cid:11)(cid:4)(cid:7)(cid:14)(cid:15)(cid:12)(cid:2)(cid:3)(cid:5)(cid:13)
•
facilitation of incentive compensation arrangements for employees more directly tied to the performance of the relevant
company’s business, and potential enhancement of employee hiring and retention by, among other things, improving the
alignment of management and employee incentives with performance and growth objectives, while at the same time creating
an independent equity structure that will facilitate Varex’s ability to effect future acquisitions utilizing Varex common sto(cid:16)(cid:12)(cid:13)(cid:4)
and
a distinct investment identity of Varex, allowing investors to evaluate the merits, performance, and future prospects of Varex
separately from Varian.
•
Varex may not achieve these and other anticipated benefits for a variety of reasons, including, among others: (i) following the
separation, Varex may be mo(cid:15)(cid:2)(cid:4)(cid:5)(cid:10)(cid:5)(cid:16)(cid:2)(cid:17)(cid:3)(cid:19)(cid:24)(cid:11)(cid:2)(cid:4)(cid:3)(cid:9)(cid:4)(cid:7)(cid:14)(cid:15)(cid:12)(cid:2)(cid:3)(cid:4)(cid:18)(cid:11)(cid:10)(cid:16)(cid:3)(cid:10)(cid:14)(cid:3)(cid:19)(cid:9)(cid:8)(cid:5)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:9)(cid:3)(cid:22)(cid:2)(cid:15)(cid:4)(cid:14)(cid:21)(cid:25)(cid:2)(cid:15)(cid:5)(cid:2)(cid:4)(cid:2)(cid:25)(cid:2)(cid:8)(cid:3)(cid:5)(cid:4)(cid:3)(cid:22)(cid:14)(cid:8)(cid:4)(cid:19)(cid:18)(cid:4)(cid:19)(cid:3)(cid:4)(cid:20)(cid:2)(cid:15)(cid:2)(cid:4)(cid:5)(cid:3)(cid:19)(cid:11)(cid:11)(cid:4)(cid:14)(cid:4)(cid:17)(cid:14)(cid:15)(cid:3)(cid:4)(cid:9)(cid:18)(cid:4)#(cid:14)(cid:15)(cid:19)(cid:14)(cid:8)(cid:13)(cid:4)(cid:14)(cid:8)(cid:21)(cid:26)(cid:4)
(ii) following the separation, Varex’s business is less diversified and has less scale than Varian’s business prior to the separation. If
Varex fails to achieve some or all of the benefits expected to result from the separation, or if such benefits are delayed, the business,
operating results, and financial condition of Varex could be materially and adversely affected.
Varex or Varian may fail to perform under various transaction agreements that have been executed as part of the separation, or
Varex may fail to have necessary systems and services in place when certain of the transaction agreements expire.
In connection with the separation, Varex and Varian entered into a Separation and Distribution Agreement, as well as various
other agreements, including a Transition Services Agreement, an Intellectual Property Matters Agreement, a Tax Matters Agreement,
one or more Supply/Distribution Agreements, a Trademark License Agreement, and an Employee Matters Agreement. The Separation
and Distribution Agreement, the Tax Matters Agreement, the Employee Matters Agreement, and the Intellectual Property Matters
Agreement determine the allocation of assets and liabilities between the companies following the separation for those respective areas
and include any necessary indemnifications related to liabilities and obligations. The Transition Services Agreement provides for the
performance of certain services by each company for the benefit of the other for a limited period of time after the separation, and the
Supply/Distribution Agreements provide for the provision of products and services by each company and for the benefit of the other.
Varex will rely on Varian to satisfy its performance and payment obligations under these agreements. If Varian is unable to satisfy its
obligations under these agreements, including its indemnification obligations, Varex could incur operational difficulties or losses. If
Varex does not have in place its own systems and services, or if Varex does not have agreements with other providers of these services
once certain transaction agreements expire, Varex may not be able to operate its business effectively, and its profitability may decline.
Potential liabilities may arise due to fraudulent transfer considerations, which could materially and adversely affect Varex’s
financial condition and its results of operations.
In connection with the separation and distribution, Varian has undertaken several corporate restructuring transactions, which,
along with the separation and distribution, may be subject to federal and state fraudulent conveyance and transfer laws. If, under these
laws, a court were to determine that, at the time of the separation and distribution, any entity involved in these restructuring
transactions or the separation and distribution:
• (cid:20)(cid:14)(cid:5)(cid:4)(cid:19)(cid:8)(cid:5)(cid:9)(cid:11)(cid:25)(cid:2)(cid:8)(cid:3)(cid:13)
• (cid:20)(cid:14)(cid:5)(cid:4)(cid:15)(cid:2)(cid:8)(cid:21)(cid:2)(cid:15)(cid:2)(cid:21)(cid:4)(cid:19)(cid:8)(cid:5)(cid:9)(cid:11)(cid:25)(cid:2)(cid:8)(cid:3)(cid:4)(cid:24)(cid:23)(cid:4)(cid:15)(cid:2)(cid:14)(cid:5)(cid:9)(cid:8)(cid:4)(cid:9)(cid:18)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:5)(cid:2)(cid:17)(cid:14)(cid:15)(cid:14)(cid:3)(cid:19)(cid:9)(cid:8)(cid:4)(cid:14)(cid:8)(cid:21)(cid:4)(cid:21)(cid:19)(cid:5)(cid:3)(cid:15)(cid:19)(cid:24)(cid:10)(cid:3)(cid:19)(cid:9)(cid:8)(cid:13)
• had remaining assets constituting unreasonably small capit(cid:14)(cid:11)(cid:13)(cid:4)(cid:9)(cid:15)(cid:26)
•
intended to incur, or believed it would incur, debts beyond its ability to pay these debts as they matured,
then the court could void the separation and distribution, in whole or in part, as a fraudulent conveyance or transfer. The court could
then require Varex’s stockholders to return to Varian some or all of the shares of Varex common stock issued in the distribution or
require Varian or Varex, as the case may be, to fund liabilities of the other company for the benefit of creditors. The measure of
insolvency will vary depending upon the jurisdiction whose law is being applied. Generally, however, an entity would be considered
33
insolvent if the fair value of its assets was less than the amount of its liabilities or if it incurred debt beyond its ability to repay the debt
as it matures.
Fulfilling obligations incidental to being a public company, including with respect to the requirements of and related rules under
the Sarbanes-Oxley Act of 2002, will place significant demands on Varex’s management, administrative, and operational
resources, including accounting and information technology resources.
As a public company, Varex is subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), the Sarbanes-Oxley Act, and the Dodd-Frank Act and is required to prepare its financial statements according to the
rules and regulations required by the SEC. In addition, the Exchange Act requires that Varex file annual, quarterly, and current reports.
Varex’s failure to prepare and disclose this information in a timely manner or to otherwise comply with applicable law could subject it
to penalties under federal securities laws, expose it to lawsuits and restrict its ability to access financing.
In addition, the Sarbanes-Oxley Act requires that Varex, among other things, establish and maintain effective internal controls
and procedures for financial reporting and disclosure purposes. Internal control over financial reporting is complex and may be revised
over time to adapt to changes in Varex’s business or changes in applicable accounting rules. Varex cannot assure that its internal
control over financial reporting will be effective in the future or that a material weakness will not be discovered with respect to a prior
period for which it had previously believed that internal controls were effective.
Matters impacting Varex’s internal controls may cause Varex to be unable to report its financial information on a timely basis
or may cause Varex to restate previously-issued financial information, thereby subjecting Varex to adverse regulatory consequences,
including sanctions or investigations by the SEC or in respect of violations of applicable stock exchange listing rules. There could also
be a negative reaction in the financial markets due to a loss of investor confidence in Varex and the reliability of its financial
statements. In addition, by virtue of its smaller size, Varex will be subject to a lower materiality threshold than Varian.
For as long as Varex is an emerging growth company under the recently enacted JOBS Act, its independent registered public
accounting firm will not be required to attest to the effectiveness of Varex’s internal control over financial reporting pursuant to
Section 404(b). An independent assessment of the effectiveness of Varex’s internal controls could detect problems that Varex’s
management’s assessment might not. Undetected material weaknesses in Varex’s internal controls could lead to financial statement
restatements and require Varex to incur the expense of remediation.
Item 1B. Unresolved Staff Comments
None.
Item 2. Properties
Our business is primarily located in Salt Lake City, Utah, where we own approximately 37 acres of land and approximately
494,000 square feet of space used for manufacturing, administrative functions and research and development, for both our Medical
and Industrial segments. We also own or lease 34 other facilities throughout North America, Europe and Asia that comprise over 2
million square feet of manufacturing facilities, warehouses, sales and service, research and development and office space located in 7
states and 16 foreign countries.
In addition to our location in Salt Lake City, Utah, primary owned facilities include approximately 5 acres of land in Las
Vegas, Nevada and approximately 61,000 square feet in Franklin Park, Illinois, both which are used for manufacturing and
administrative functions for our Industrial segment.
Primary leased facilities include approximately 111,000 square feet in Laguna, Philippines, approximately 73,000 square feet
in Santa Clara, California, approximately 46,000 square feet in Wuxi, China, approximately 47,000 square feet in Dinxperlo, the
Netherlands, approximately 34,000 square feet in Bremen, Germany and approximately 33,000 of square feet in Walluf, Germany, all
of which are used for manufacturing and administrative functions for our Medical and Industrial segments.
Item 3. Legal Proceedings
From time to time, we are involved in legal proceedings arising in the ordinary course of business or otherwise. We do not
believe that any material liability will be imposed as a result of these matters. If actual liabilities significantly exceed the estimates
34
made, our combined financial position, results of operations, comprehensive earnings or cash flows could be materially and adversely
affected. Legal expenses relating to legal matters are expensed as incurred.
Item 4. Mine Safety Disclosures
Not applicable.
PART II
Item 5. Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
We became an independent publicly-traded company after separating from Varian on January 28, 2017. Varex's common
stock is traded on the NASDAQ Global Select Market (the "NASDAQ") under the symbol “VREX.” The following table sets forth the
high and low closing sales prices for Varex common stock as reported in the consolidated transaction reporting system for the
NASDAQ in fiscal year 2017.
Fiscal Year 2017
First Quarter
Second Quarter (beginning January 30, 2017)
Third Quarter
Fourth Quarter
High
Low
— $
35.14 $
36.04 $
34.18 $
—
27.27
32.77
28.25
$
$
$
$
Since our inception, we have not paid any cash dividends and have no current plan to pay cash dividends on Varex common
stock. As of September 29, 2017, there were 1,911 holders of record of Varex common stock.
35
This graph shows the total return on VREX common stock with comparative total returns for the Russell 2000 Index ("RUT")
and the Dow Jones Medical Equipment Index ("DJUSAM").
January 30, 2017- September 29, 2017
$120
$110
$100
1/30/17
3/31/17
6/30/17
9/29/17
Item 6. Selected Financial Data
VREX US Equity
RUT
DJUSAM
On January 28, 2017, we separated from Varian. Prior to the date of separation, the financial statements were prepared on a
stand-alone basis and derived from Varian’s consolidated financial statements as we operated as part of Varian.
The following data, insofar as it relates to each of the fiscal years from 2013 through 2017, has been derived from annual
financial statements, including the consolidated balance sheets at September 29, 2017 and September 30, 2016 and the related
consolidated statements of earnings, of comprehensive earnings, and of cash flows for the fiscal years in the period ended September
29, 2017 and notes thereto appearing elsewhere herein. In addition, the following financial data should be read in conjunction with our
consolidated financial statements and the accompanying notes and the MD&A included elsewhere herein.
36
Summary of Operations:
Fiscal Years
(In millions, except per share amounts)
2017(1)
2016
2015
2014
2013
Revenues
Gross margin
Earnings before taxes
Taxes on earnings
Net earnings
Less: Net earnings attributable to noncontrolling interests
Net earnings attributable to Varex
Net earnings per share attributable to Varex
Net earnings per share - basic
Net earnings per share - diluted
Financial Position at Fiscal Year End:
Working capital
Total assets
Total debt (including current maturities)
$
$
$
$
$
$
698.1 $
253.5 $
74.8
22.8
52.0
0.4
51.6 $
1.37 $
1.36 $
620.1 $
248.4 $
105.0
36.0
69.0
0.5
68.5 $
1.83 $
1.82 $
632.3 $
250.6 $
127.6
46.8
80.8
0.8
80.0 $
2.14 $
2.12 $
685.2 $
278.6 $
174.2
64.1
110.1
—
110.1 $
2.94 $
2.92 $
343.5 $
1,040.1
483.9
282.1 $
622.4
—
237.5 $
583.6
—
201.8 $
433.1
—
669.8
268.1
171.3
61.7
109.6
—
109.6
2.93
2.91
195.3
399.8
—
(1) The summary of operations for fiscal year 2017 includes operating results from the Acquired Detector Business for the period from May 1, 2017 through September 29, 2017.
Selected Quarterly Financial Data (Unaudited)
The following table sets forth selected financial data from our unaudited quarterly consolidated statements of earnings for the
eight quarters ended fiscal year 2017. The information for each quarter has been derived from unaudited financial statements and in
the opinion of management, include all adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of
the results for the unaudited interim periods and includes certain reclassifications and rounding differences. The quarterly data should
be read together with our consolidated financial statements and related notes appearing elsewhere in this annual report.
On January 28, 2017, Varian completed its separation and distribution of Varex. In connection with the distribution, Varex
became an independent publicly-traded company and is listed on The NASDAQ Global Select Market under the ticker “VREX” with
37.4 million shares of common stock distributed to Varian shareholders.
(In millions, except per share amounts, unaudited)
Fiscal Year 2017
First
Quarter
Second
Quarter
Third
Quarter
Fourth
Quarter
Total revenues
Gross Margin
Net earnings
Net earnings attributable to Varex
Net earnings per share - basic
Net earnings per share - diluted
(In millions, except per share amounts, unaudited)
Total revenues
Gross Margin
Net earnings
Net earnings attributable to Varex
Net earnings per share - basic
Net earnings per share - diluted
$
$
$
$
$
$
$
$
$
$
$
$
157.4 $
58.8 $
11.2 $
11.1 $
0.30 $
0.29 $
154.8 $
57.6 $
15.0 $
15.0 $
0.40 $
0.40 $
170.1 $
59.5 $
10.7 $
10.6 $
0.28 $
0.28 $
Fiscal Year 2016
First
Quarter
Second
Quarter
Third
Quarter
Fourth
Quarter
146.8 $
57.1 $
14.2 $
14.1 $
0.38 $
0.37 $
149.8 $
59.1 $
14.8 $
14.7 $
0.39 $
0.39 $
151.4 $
63.0 $
17.8 $
17.6 $
0.47 $
0.47 $
37
Total Year
698.1
253.5
52.0
51.6
1.37
1.36
215.7 $
77.8 $
15.1 $
15.0 $
0.40 $
0.39 $
Total Year
620.1
248.4
371.7
68.5
1.83
1.82
172.1 $
69.2 $
22.1 $
21.9 $
0.59 $
0.58 $
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Basis of Presentation
On January 28, 2017, Varian completed its separation and distribution of Varex. In connection with the distribution, Varex
became an independent publicly-traded company and is listed on The NASDAQ Global Select Market under the ticker “VREX” with
37.4 million shares of common stock distributed to Varian shareholders.
Prior to the separation, we operated as part of Varian and not as a stand-alone company. Accordingly, certain shared costs
have been allocated to us and are reflected as expenses in the accompanying financial statements. Management considers the
allocation methodologies used to be reasonable and appropriate reflections of the related expenses attributable to us for purposes of
the carve-out financial statement(cid:5)(cid:13)(cid:4)(cid:22)(cid:9)(cid:20)(cid:2)(cid:25)(cid:2)(cid:15)(cid:26)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:2)$(cid:17)(cid:2)(cid:8)(cid:5)(cid:2)(cid:5)(cid:4)(cid:15)(cid:2)(cid:18)(cid:11)(cid:2)(cid:16)(cid:3)(cid:2)(cid:21)(cid:4)(cid:19)(cid:8)(cid:4)(cid:3)(cid:22)(cid:2)(cid:5)(cid:2)(cid:4)(cid:18)(cid:19)(cid:8)(cid:14)(cid:8)(cid:16)(cid:19)(cid:14)(cid:11)(cid:4)(cid:5)(cid:3)(cid:14)(cid:3)(cid:2)(cid:7)(cid:2)(cid:8)(cid:3)(cid:5)(cid:4)(cid:7)(cid:14)(cid:23)(cid:4)(cid:8)(cid:9)(cid:3)(cid:4)(cid:24)(cid:2)(cid:4)(cid:19)(cid:8)(cid:21)(cid:19)(cid:16)(cid:14)(cid:3)(cid:19)(cid:25)(cid:2)(cid:4)(cid:9)(cid:18)(cid:4)(cid:3)(cid:22)(cid:2)(cid:4)(cid:14)(cid:16)(cid:3)(cid:10)(cid:14)(cid:11)(cid:4)
expenses that would have been incurred during the periods presented if we had operated as a separate stand-alone entity. The
allocation methods include revenue, headcount, actual usage of services, and others. In addition, the expenses reflected in the financial
statements may not be indicative of expenses that will be incurred by us in the future.
Our products are sold in three geographic regions: The Americas, EMEA, and APAC. The Americas includes North America
(primarily United States) and Latin America. EMEA includes Europe, Russia, the Middle East, India and Africa. APAC includes Asia
and Australia. Revenues by region are based on the known final destination of products sold.
On May 1, 2017, we completed the acquisition of the Acquired Detector Business for net cash consideration of $271.8
million (the "Acquired Detector Business"). The acquisition consisted of PerkinElmer Medical Holdings, Inc. and Dexela Limited,
together with certain assets of PKI and its direct and indirect subsidiaries relating to digital flat panel X-ray detectors that serve as
components for industrial, medical, dental and veterinary X-ray imaging systems. The Acquired Detector Business has about 280
employees, is headquartered in Santa Clara, California and has additional operations in Germany, the Netherlands and the United
Kingdom. We believe the acquisition complements our existing imaging detector business and will provide increased expertise and
opportunities for Varex in the future.
Our business performance is measured in two reportable operating segments: Medical and Industrial. The segments align our
products and service offerings with customer use in medical and industrial markets and are consistent with how resources are allocated
and evaluated for financial performance by our Chief Operating Decision Maker. Each operating segment is primarily evaluated for
financial performance based on revenues and gross margin.
Medical
In our Medical business segment, we design, manufacture, sell and service X-ray imaging components for use in a range of
applications, including radiographic and fluoroscopic imaging, mammography, computed tomography (“CT”), radiation therapy and
computer-aided detection. We provide a broad range of X-ray imaging components for medical customers, including X-ray tubes,
digital flat panel image detectors, high voltage connectors, image-processing software and workstations, computer-aided diagnostic
software, collimators, automatic exposure control devices, generators, ionization chambers and buckys.
A significant portion of our revenues come from the sales of high-end X-ray tubes used in CT imaging and high-end dynamic
digital detectors used in fluoroscopic and dental applications. These upper-tier imaging components are characterized by increased
levels of technological complexity, engineering and intellectual property that typically allow these products to have a higher sales
price and gross margin.
The digital flat panel detector market continues to mature from initial product introductions more than 10 years ago. For the
past few years, we have experienced price erosion for these products, predominantly in the highly-competitive market for radiographic
detectors. We anticipate this trend will continue in the foreseeable future.
Our X-ray imaging components are primarily sold to imaging system original equipment manufacturer (“OEM”) customers
that incorporate them into their medical diagnostic, radiation therapy, dental and veterinary imaging systems. To a much lesser extent,
we also sell our X-ray imaging components to independent service companies, distributors and directly to end-users for replacement
purposes.
Industrial
In our Industrial business segment, we design, manufacture, sell and service products for use in security and industrial
inspection applications, such as airport security, cargo screening at ports and borders and nondestructive examination in a variety of
38
applications. The products include Linatron X-ray accelerators, X-ray tubes, digital flat panel detectors, high voltage connectors and
image-processing software that we generally sell to OEM customers that incorporate these products into their inspection systems.
The security market primarily consists of airport security (carry-on baggage, checked baggage and palletized cargo) and
cargo screening at ports and borders. The end customers for border protection systems are typically government agencies, many of
which are in oil-based economies and war zones. In 2015, we saw a significant decline in demand for border protection systems due to
the volatility of oil prices with moderate increases in demand in the following years.
The non-destructive testing market utilizes x-ray imaging to scan items for inspection of manufacturing defects and product
integrity in a wide range of industries including aerospace, automotive, food packaging, metal castings and 3D printing. We provide x-
ray sources, digital flat panel detectors, high voltage connectors and image processing software to OEM customers, system integrators
and manufacturers. In addition, new applications for x-ray sources are being developed, such as sterilization of food and its packaging.
Fiscal Year
Our fiscal year is the 52- or 52-week period ending on the Friday nearest September 30. Fiscal year 2017 was the 52-week
period that ended September 29, 2017, fiscal year 2016 was the 52-week period ended September 30, 2016, and fiscal year 2015 was
the 53-week period ended on October 2, 2015. Set forth below is a discussion of our results of operations for fiscal years 2017, 2016
and 2015.
Discussion of Results of Operations for Fiscal Year 2017 and 2016
Revenues
(In millions)
Medical
Industrial
Total revenues
Medical as a percentage of total revenues
Industrial as a percentage of total revenues
Fiscal Years
2017
2016
$ Change
% Change
556.9
141.2
698.1
80%
20%
505.8
114.3
620.1
82%
18%
51.1
26.9
78.0
10%
24%
13%
Medical revenues increased $51.1 million primarily due to $41.1 million in revenue from the Acquired Detector Business.
The remaining increase is due to higher sales of X-ray tubes in APAC partially offset by lower digital detector sales. Industrial
revenues increased $26.9 million primarily due to $20.2 million in revenue from the Acquired Detector Business. The remaining
increase is due to higher sales of industrial X-ray tubes and higher service and linear accelerator revenues for our security products.
These increases in Industrial revenues were partially offset by a decrease in revenue from industrial detectors.
Revenues by Region
(In millions)
Americas
EMEA
APAC
Total revenues
Americas as a percentage of total revenues
EMEA as a percentage of total revenues
APAC as a percentage of total revenues
Fiscal Years
2017
2016
$ Change
% Change
$
$
239.8
219.5
238.8
698.1
$
$
34%
31%
34%
224.7
179.5
215.9
620.1
$
$
36%
29%
35%
15.1
40.0
22.9
78.0
7%
22%
11%
13%
The Americas revenues included $20.7 million in revenue from the Acquired Detector Business, partially offset by lower
sales of X-ray tubes. EMEA revenues included $31.2 million in revenue from the Acquired Detector Business, as well as higher sales
39
of security and industrial products. APAC revenues included $9.3 million in revenue from the Acquired Detector Business and higher
sales of X-ray tubes, partially offset by lower sales of digital detectors.
Gross Margin
(In millions)
Medical
Industrial
Total gross margin
Medical gross margin %
Industrial gross margin %
Total gross margin %
$
$
Fiscal Years
2017
2016
$ Change
% Change
$
$
193.6
59.9
253.5
34.8%
42.4%
$
$
195.8
52.6
248.4
38.7%
46.0%
(2.2)
7.3
5.1
(1)%
14 %
2 %
36.3%
40.1%
The decrease in total gross margin percentage was primarily due to higher amortization of intangible assets, a step-up
inventory costs as a result of purchase price accounting related to the Acquired Detector Business, and continued price erosion in
digital detectors. The decrease in medical gross margin percentage was primarily due to the reasons stated above and higher sales of
CT tubes in the prior-year. The decrease in industrial gross margin percentage was primarily due to the reasons stated above and a
change in product mix.
Operating Expenses
(In millions)
Research and development (1)
As a percentage of total revenues
Selling, general and administrative (2)
As a percentage of total revenues
Operating expenses
As a percentage of total revenues
$
$
$
Fiscal Years
2017
2016
$ Change
% Change
$
67.3
9.6%
$
102.5
14.7%
169.8
24.3%
$
$
$
53.5
8.6%
85.8
13.8%
139.3
22.5%
$
13.8
16.7
30.5
26%
19%
22%
(1) Research and development expenses included $0.0 million and $1.2 million allocated to us by Varian in fiscal years 2017 and 2016, respectively.
(2) Selling, general and administrative expenses include $12.4 million and $37.7 million of corporate costs allocated to us by Varian in fiscal years 2017 and 2016,
respectively.
Research and Development
The increase in research and development expenses in fiscal year 2017 was due to acceleration and development of CT X-ray
tubes and digital detectors, and includes approximately $7.2 million related to the Acquired Detector Business. We are committed to
investing in the business to support long-term growth and believe long-term research and development expenses of approximately 8%
to 10% of annual revenues is the appropriate range that will allow us to continue to innovate and bring new products to market for our
global OEM customers.
Selling, General and Administrative
Selling, general and administrative expenses in fiscal year 2017 increased due to approximately $5.0 million of acquisition
and integration related costs, increased marketing personnel expenses, partially offset by lower corporate and administration expenses
as the prior year included costs allocated from Varian. Selling, general and administrative expenses includes approximately $7.7
million related to the Acquired Detector Business.
40
Interest and Other Income (Expense), Net
The following table summarizes our interest and other income (expense), net:
(In millions)
Interest income
Interest expense
Other
Interest and other income (expense), net
Fiscal Years
2017
2016
$ Change
$
$
0.2 $
(12.3 )
3.2
(8.9) $
0.3 $
(1.9)
(2.5)
(4.1) $
(0.1)
(10.4)
5.7
(4.8)
The increase in interest and other income (expense), net was due to increases in interest expense as a result of borrowings
under our credit agreement, partially offset by income from an equity method investment and foreign currency translation gains.
Interest and other income (expense) in fiscal year 2016 primarily represents allocations of Varian’s interest expense and loss in an
equity method investment.
Taxes on Earnings
Effective tax rate
Fiscal Years
2017
2016
30.5%
34.3%
The decrease in the effective tax rate for the current year results from a difference in the mix of earnings by jurisdiction and
overall global tax structure for Varex as a stand-alone company compared to the prior year when it was part of Varian. It is also
impacted by the benefit of adjustments to certain deferred tax assets and the release of valuation allowances in jurisdictions where
increased earnings allowed for the utilization of net operating loss carryforwards.
In general, our effective income tax rate differs from the U.S. federal statutory rate due to increases resulting from U.S. state
income tax expense and earnings in certain foreign jurisdictions that are taxed currently in the U.S. These increases are partially offset
by decreases due to earnings in foreign jurisdictions that are taxed at lower rates, a U.S. domestic production activities deduction, and
research and development credits.
Discussion of Results of Operations for Fiscal Year 2016 and 2015
Revenues
(In millions)
Medical
Industrial
Total revenues
Medical as a percentage of total revenues
Industrial as a percentage of total revenues
Fiscal Years
2016
2015
$ Change
% Change
$
$
505.8
114.3
620.1
$
$
82%
18%
534.3
98.0
632.3
$
$
85%
15%
(28.5)
16.3
(12.2)
(5)%
17 %
(2)%
Medical revenues decreased in fiscal year 2016 over fiscal year 2015 primarily due to decreases in revenues from flat panel
products and X-ray tube products, partially offset by an increase in revenues of $36.9 million from our acquisitions completed in the
second half of fiscal year 2015. Revenues from our flat panel and X-ray tube products decreased primarily due to pricing pressures
resulting from a strong U.S. Dollar, customers migrating to lower cost alternatives, and the decision of a key customer to in-source
some of its flat panel products in the second half of fiscal year 2015. In addition, lower purchases from a key customer with higher X-
ray tube inventory, due in part to longer tube life, also contributed to the declines in revenues.
41
Industrial revenues increased in fiscal year 2016 over fiscal year 2015 primarily due to an increase in revenues from our flat
panel Industrial customers, in addition to an increase in revenues of $5.7 million from our acquisitions, and to a lesser extent an
increase from security products.
Revenues by Region
(In millions)
Americas
EMEA
APAC
Total revenues
Americas as a percentage of total revenues
EMEA as a percentage of total revenues
APAC as a percentage of total revenues
Fiscal Years
2016
2015
$ Change
% Change
$
$
224.7
179.5
215.9
620.1
$
$
36%
29%
35%
249.2
153.0
230.1
632.3
$
$
39%
24%
36%
(24.5)
26.5
(14.2)
(12.2)
(10)%
17 %
(6)%
(2)%
The Americas revenues decreased in fiscal year 2016 over fiscal year 2015 primarily due to a decrease in revenues from flat
panel products, partially offset by an increase of $16.8 million in revenues from our acquisitions completed in the second half of fiscal
year 2015. The decrease in revenues from flat panel products was primarily due to a decision of a key customer to in-source some of
the products they had purchased from us, in the second half of fiscal year 2015.
EMEA revenues increased in fiscal year 2016 over fiscal year 2015 primarily due to an increase of $16.7 million in revenues
from our acquisitions completed in the second half of fiscal year 2015 and increases in revenues from flat panel products and security
and inspection products, partially offset by a decrease in revenues from X-ray tube products.
APAC revenues decreased in fiscal year 2016 over fiscal year 2015 primarily due to a decrease in revenues from X-ray tube
products, and to a lesser extent, a decrease in revenues from flat panel products, partially offset by an increase of $8.8 million in
revenues from our acquisitions completed in the second half of fiscal year 2015. The decrease in revenues from X-ray tube products
was primarily due to lower purchases from a key customer with higher X-ray tube inventory, due in part to longer tube life. In
addition, the decrease in revenues from flat panel products was primarily due to pricing pressures resulting from a strong U.S. Dollar.
Gross Margin
(In millions)
Medical
Industrial
Total gross margin
Medical gross margin %
Industrial gross margin %
Total gross margin %
$
$
Fiscal Years
2016
2015
$ Change
% Change
$
$
195.8
52.6
248.4
38.7%
46.0%
$
$
207.1
43.5
250.6
38.8%
44.4%
(11.3)
9.1
(2.2)
(5)%
21 %
(1)%
40.1%
39.6%
Medical gross margin percentage remained flat in fiscal year 2016 over fiscal year 2015. Favorable product mix and
productivity improvements were offset by increased quality costs and pricing pressures.
Industrial gross margin percentage increased in fiscal year 2016 over fiscal year 2015 primarily due to favorable product mix
partially offset by lower margins from industrial products from our acquisitions.
42
Operating Expenses
(In millions)
Research and development (1)
As a percentage of total revenues
Selling, general and administrative (2)
As a percentage of total revenues
Operating expenses
As a percentage of total revenues
$
$
$
Fiscal Years
2016
2015
$ Change
% Change
$
$
53.5
8.6%
85.8
13.8%
139.3
22.5%
$
$
$
50.4
8.0%
72.7
11.5%
123.1
19.5%
$
3.1
13.1
16.2
6%
18%
13%
(1) Research and development expenses include $1.2 million and $1.4 million allocated to us by Varian in Fiscal Years 2016 and 2015, respectively.
(2) Selling, general and administrative expenses include $37.7 million and $38.0 million of corporate costs allocated to us by Varian in Fiscal Years 2016 and 2015,
respectively.
Research and Development
Research and development expenses increased in fiscal year 2016 over fiscal year 2015 primarily due to $7.1 million in
additional expenses from our acquisitions completed in the second half of fiscal year 2015, partially offset by a reduction in spending
on our current projects.
Selling, General and Administrative
Selling, general and administrative expenses increased in fiscal year 2016 over fiscal year 2015 due to $10.2 million in
additional operating expenses from our acquisitions completed in the second half of fiscal year 2015.
Interest and Other Income (Expense), Net
The following table summarizes our interest and other income (expense), net:
(In millions)
Interest income
Interest expense
Other
Interest and other income (expense), net
Fiscal Years
2016
2015
$ Change
$
$
0.3 $
(1.9 )
(2.5 )
(4.1) $
0.5 $
(1.2)
0.8
0.1 $
(0.2)
(0.7)
(3.3)
(4.2)
The change in interest and other income (expense), net in fiscal year 2016 compared to fiscal year 2015 was primarily due to
a loss from our equity method investments in fiscal year 2016, compared to income in the year-ago period, and higher interest expense
allocated to us as a result of Varian’s increased borrowings in fiscal year 2016.
Taxes on Earnings
Effective tax rate
Fiscal Years
2016
2015
34.3%
36.7%
Our effective tax rate decreased in fiscal year 2016 over fiscal year 2015 primarily due to the retroactive reinstatement of the
federal research and development credit. Due to the timing of the prior lapse and the retroactive reinstatement of the federal research
and development credit, the Company received seven quarters of benefit in fiscal year 2016, but only four quarters of benefit in fiscal
year 2015.
43
Liquidity and Capital Resources
Prior to the separation, Varian provided financing, cash management and other treasury services to us. As part of Varian, we
were dependent upon Varian for all of our working capital and financing requirements, as Varian uses a centralized approach to cash
management and financing of its operations. Cash transferred to and from Varian is reflected in net parent investment in the
accompanying historical condensed consolidated financial statements. Accordingly, none of Varian’s cash, cash equivalents or debt at
the corporate level has been assigned to us in the condensed consolidated financial statements. Cash and cash equivalents included in
the condensed consolidated balance sheets primarily reflect cash and cash equivalents from acquired entities that are specifically
attributable to us.
We assess our liquidity in terms of our ability to generate cash to fund our operating and investing activities. We continue to
generate substantial cash from operating activities and believe that our operating cash flow, credit facility, and other sources of
liquidity will be sufficient to allow us to continue to invest in our existing businesses, consummate strategic acquisitions and manage
our capital structure on a short and long-term basis. Although we believe that our future cash from operations, together with our access
to banking and capital markets, will provide adequate resources to fund our operating and financing needs, our access to, and the
availability of, financing on acceptable terms in the future will be affected by many factors, including: (i) the liquidity of the overall
capital markets and (ii) the current state of the economy. There can be no assurances that we will continue to have access to these
markets on terms acceptable to us. See “Risk Factors” for a further discussion. At September 29, 2017 we had $463.9 million in long-
term debt and $20.0 million of current maturities of long-term debt, net of deferred issuance costs of $10.1 million.
Cash and Cash Equivalents
The following table summarizes our cash and cash equivalents:
(In millions)
Cash and cash equivalents
September 29, 2017 September 30, 2016
$ Change
% Change
$
83.3 $
36.5 $
46.8
128%
In accordance with the Separation and Distribution Agreement, we transferred $27.1 million of cash during the twelve
months ended September 29, 2017, which represented all cash and cash equivalents in excess of $5 million to Varian, other than any
cash and cash equivalents held by MeVis on January 28, 2017 and held by any Varex entities in order to complete the transfer of
certain assets and subsidiaries from Varian. Funds held to complete these asset and subsidiary transfers was approximately $7.9
million as of September 29, 2017.
Cash Flows
(In millions)
Net cash flow provided by (used in):
Operating activities
Investing activities
Financing activities
Effects of exchange rate changes on cash and cash equivalents
Net increase in cash and cash equivalents
Fiscal Years
2017
2016
2015
$
$
74.6 $
(292.0)
263.3
0.9
46.8 $
74.2 $
(21.6)
(36.8)
0.1
15.9 $
85.2
(102.1)
36.7
0.3
20.1
Net Cash Provided by Operating Activities. Cash from operating activities consists primarily of net earnings adjusted for
certain non-cash items, including share-based compensation, depreciation, amortization of intangible assets, deferred income taxes,
income and loss from equity investments and the effect of changes in operating assets and liabilities.
For fiscal year 2017, net cash provided by operating activities was $74.6 million and consisted of net earnings of $52.0
million, increases from non-cash items of $29.2 million and decreases from operating assets and liabilities activities of $6.6 million.
Operating assets and liabilities activity primarily consisted of increases in accounts receivables of $23.1 million and increases in
inventories of $4.2 million, partially offset by increases in accounts payable and accrued liabilities of $33.0 million.
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For fiscal year 2016, net cash provided by operating activities was $74.2 million and consisted of net earnings of $69.0
million, non-cash items of $31.4 million and decreases from operating assets and liabilities activities of $26.2 million. Operating
assets and liabilities activity included increases in inventories of $23.5 million and increases in accounts receivable of $4.6 million.
For fiscal year 2015, net cash provided by operating activities was $85.2 million and consisted of net earnings of $80.8
million, non-cash items of $19.5 million and decreases from operating assets and liabilities activities of $15.1 million. Operating
assets and liabilities activity included increases in inventories of $25.9 million, decreases in accrued liabilities of $7.2 million and
decreases in accounts receivable of $19.3 million.
Net Cash Used in Investing Activities. Net cash used in investing activities was $292.0 million, $21.6 million, and $102.1
million for the fiscal years 2017, 2016 and 2015, respectively. Net cash used in investing activities for fiscal year 2017 related to the
Acquired Detector Business for $271.8 million and capital expenditures for property plant and equipment of $20.2 million. Net cash
used in investing activities for fiscal year 2016 related to capital expenditures for property plant and equipment of $28.9 million offset
by sales of available-for-sale securities of $8.6 million. Net cash used in investing activities for fiscal year 2015 related to capital
expenditures for property plant and equipment of $34.3 million and acquisitions for $67.9 million.
Net Cash Provided by (Used in) Financing Activities. Financing activities for the fiscal year 2017 primarily consisted of
borrowings under our credit agreements of $749.0 million and net transfers from Varian of $5.0 million, partially offset by
distributions to Varian of $227.1 million, repayments of borrowings of $255.0 million and payment of debt issuance costs of $11.9
million. Financing activities for the fiscal years 2016 and 2015 primarily consisted of transfers to Varian of $36.7 million and from
Varian of $35.8 million, respectively.
Days Sales Outstanding
Trade accounts receivable days sales outstanding (“DSO”) was 66 days at September 29, 2017 and September 30, 2016. Our
accounts receivable and DSO are impacted by a number of factors, primarily including the timing of product shipments, collections
performance, payment terms, the mix of revenues from different regions and the effects of economic instability.
Contractual Obligations
In October 2013, we entered into an amended agreement with dpiX and other parties that, among other things, provides us
with the right to 50% of dpiX’s total manufacturing capacity produced after January 1, 2014. The amended agreement requires us to
pay for 50% of the fixed costs (as defined in the amended agreement), as determined at the beginning of each calendar year. For the
remainder of calendar year 2017, we estimate that we have fixed cost commitments of $4.1 million related to this amended agreement.
The fixed cost commitment for future periods will be determined and approved by the dpiX board of directors at the beginning of each
calendar year. The amended agreement will continue unless the ownership structure of dpiX changes (as defined in the amended
agreement).
In October 2015, we committed to grant the noncontrolling shareholders of MeVis: (1) an annual recurring net compensation
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