OVERVIEW
Report of the Supervisory Board
The members of the Supervisory Board wish to thank all QIAGEN employees
and members of the Executive Committee for the progress made during 2017
toward achieving QIAGEN’s vision of making improvements in life possible.
We would also like to thank our shareholders, customers, business partners and
other stakeholders for honoring QIAGEN with their continued collaboration and
trust.
Review of 2017 performance
A key role of the Supervisory Board is to monitor the conduct and progress of QIAGEN’s business on a regular
basis, and this was done during 2017 with detailed written and oral reports from the Managing Directors, members
of the Executive Committee and other senior leaders.
The Supervisory Board was pleased with the performance of QIAGEN in 2017, and the results showed further
evidence that QIAGEN is moving ahead on a new growth trajectory and addressing the needs of a broad range of
customers with its Sample to Insight molecular testing solutions. All customer classes and regions delivered improved
results for the year. The growth drivers of QIAGEN’s Sample to Insight portfolio all performed well in 2017, led by
the QIAsymphony automation system setting a new record and reaching more than 2,000 cumulative placements,
the QuantiFERON latent TB test delivering 24% growth, and further expansion of the industry-leading Personalized
Healthcare portfolio of companion diagnostic partnerships with pharma companies for precision medicine therapies.
QIAGEN has set goals for 2018 for accelerating organic growth and for higher adjusted net sales and adjusted
earnings per share. QIAGEN looks forward to 2018 as a very exciting year on the path to achieving the mid-term
growth targets set for 2020.
Composition of the Supervisory Board and Managing Board
The composition of the Supervisory Board changed during 2017 with the addition of Dr. Håkan Björklund and it will
change in 2018 given my previously announced intention to resign with effect at the Annual General Meeting 2018
after having served on the Board since 2000. I would like to personally express my appreciation to my colleagues in
the Supervisory Board and the Managing Board for their highest level of collaboration and professionalism during
this time and their commitment to the success of QIAGEN. Following the Annual General Meeting, the Supervisory
Board plans to elect Dr. Håkan Björklund as new chairman.
Dr. Björklund brings an extensive international background in the life science industry to QIAGEN, in particular
through his current role as Operating Executive at Avista Capital Partners, as well as through previous roles as CEO
of the global pharmaceutical company Nycomed, Regional Director at Astra (now AstraZeneca) and President of
Astra Draco. In addition to QIAGEN, he currently serves as Chairman of the Board of Directors of Swedish Orpham
Biovitrum AB. Dr. Björklund earlier served as Chairman of the Board of Directors of Lundbeck A/S, and was also a
Member of the Board of Directors of several international life science companies, including Alere, Coloplast and
Danisco. Dr. Björklund has a Ph.D. in Neuroscience from Karolinska Institutet in Sweden.
All other current members of the Supervisory Board will stand for re-election at this upcoming meeting. All members,
with the exception of Dr. Metin Colpan, have served in the Supervisory Board for less than eight years as
recommended by the Dutch Corporate Governance Code. QIAGEN values the profound industry experience of Dr.
Colpan and his in-depth knowledge of the Company and therefore supports the reappointment of Dr. Colpan beyond
before stated eight-year term.
The target profile of the Supervisory Board can be found on QIAGEN’s website, and the current composition fully
complies with this profile. Further information on the individual members of the Supervisory Board is set forth in the
Corporate Governance and Compensation overview.
QIAGEN has a long-standing commitment to developing a diverse leadership team, including the Managing Board
and the Supervisory Board, with a broad range of experience, skills and capabilities. In nominating candidates for
these boards, QIAGEN supports the trend toward higher participation of women, and is committed to expanding
diversity while pursuing individuals for these boards with a unique blend of scientific and commercial expertise and
experience that will contribute to the future success of its business. Management development programs support the
career advancement of leaders regardless of gender and other factors. As a result, a number of women are in key
leadership roles around the world. In line with this long-standing commitment, the Supervisory Board continues to
take a diverse leadership team into account when proposing members for election or re-election to its Board without
compromising QIAGEN’s commitment to hiring the best individuals for positions without any discrimination. The
current size of the Managing Board is two members, so achieving a diversity goal as measured solely by a
percentage of overall membership is difficult to achieve. At the same time, QIAGEN has increased the diversity of its
senior leadership team and will continue to do so in the future. The composition of the Managing Board remained
unchanged with two members (Chief Executive Officer Peer M. Schatz and Chief Financial Officer Roland Sackers).
Principal topics discussed by the Supervisory Board
As empowered by the Dutch Corporate Governance Code, the Supervisory Board devoted considerable time during
2017 to discussing and assessing QIAGEN’s corporate strategy, main risks and opportunities, and an annual
assessment by the Managing Board of the design and effectiveness of internal risk management and control systems
as well as any significant changes in them. In addition, the Supervisory Board discussed and reviewed the
functioning of its committees and individual members, its current composition, competence, succession schedule and
desired profile in various meetings and through written surveys.
The Supervisory Board met five times during 2017 with attendance of all Supervisory Board members in all meetings
and regular attendance of the members of the Managing Board for certain agenda items. The Supervisory Board
also met to review and discuss agenda items in the absence of the Managing Board members, such as performance
and strategy as well as to discuss compensation matters. Information about the Supervisory Board members,
including positions held on other boards, is included in the Corporate Governance and Compensation overview. All
members of the Supervisory Board had adequate time available to give sufficient attention to the concerns of the
company. The Supervisory Board further discussed the performance of the Managing Board and concluded that it
and the Managing Board were functioning properly.
Committees of the Supervisory Board
The Supervisory Board has established an Audit Committee (Chair Mr. Lawrence Rosen), a Compensation Committee
(Chair Ms. Elizabeth Tallett), a Selection and Appointment Committee (Chair Dr. Karobath), and a Science and
Technology Committee (Chair Dr. Metin Colpan) from among its members. The Supervisory Board reserves the right
to establish other committees as deemed beneficial and has approved charters under which each of these committees
operates (charters are available on our website at www.QIAGEN.com). The deliberations and findings of the
committees were reported by the committee chairs to the Supervisory Board in its meetings on a regular basis. All
committee members attended all committee meetings in 2017 physically or by phone. Further detailed information on
the composition of the Supervisory Board and its committees, the number of committee meetings held in 2017 and
the main topics of discussion, the remuneration of its members, as well as other information on the Supervisory
Board, can be found in the Corporate Governance and Compensation overview, which is an integral part of this
Annual Report.
Through its Compensation Committee, the Supervisory Board executed and monitored compliance with the
Remuneration Policy approved at the Annual General Meeting held on June 25, 2014. Compensation of Managing
Board members consists of a fixed salary and variable components. Variable compensation includes one-time and
annual payments linked to business performance (bonuses) as well as long-term incentives, such as share-based
compensation, and pension plans. The Remuneration Policy and the various aspects of compensation, including the
detailed remuneration of individual Managing Board members, are described in the Remuneration Report, which is
available on QIAGEN’s website. Information on QIAGEN’s activities was communicated by the Managing Board to
the Supervisory Board through regular meetings and business reports.
Corporate Governance
All members of the Supervisory Board fulfill the independence criteria as defined by the Dutch Corporate
Governance Code. The Supervisory Board follows the principle of increasing shareholder value as the members
represent the interests of all stakeholders, including shareholders, and has always pursued the highest standards in
Corporate Governance.
QIAGEN is committed to a corporate governance structure that best suits its business and stakeholders, and that
complies with relevant rules and regulations. Since 1997, QIAGEN has endorsed the recommendations made in the
report of the Netherlands Committee on Corporate Governance, which was replaced by the Dutch Corporate
Governance Code effective January 1, 2004. The Dutch Code was last amended on December 8, 2016 and is
applicable as from January 1, 2017. Our policy is to follow the guidelines of Good Practice of Corporate
Governance as described in the Dutch Corporate Governance Code, although some minor deviations may result
from the impact of factors such as legal requirements imposed on QIAGEN or industry standards.
During 2017, QIAGEN was also subject to the rules regarding Corporate Governance set by NASDAQ, where its
common shares have been listed since 1996. In January 2018, we transferred the U.S. listing of our global shares to
the New York Stock Exchange (NYSE), which provides us with greater visibility within the healthcare sector and
opportunity to expand our global shareholder base. As a result, we will further be subject to corporate governance
practices followed by U.S. companies under the New York Stock Exchange listing standards. QIAGEN provides
detailed disclosure in the Corporate Governance and Compensation overview regarding compliance with the Dutch
Corporate Governance Code.
QIAGEN believes all of its operations are carried out in accordance with legal frameworks, including Dutch
Corporate Law, U.S. laws and regulations, EU regulations and laws of the German capital market.
QIAGEN’s common shares are registered and traded in the U.S. on the New York Stock Exchange as of January
2018 (formerly on the NASDAQ Global Select Market) and in Germany on the Frankfurt Stock Exchange in the
Prime Standard segment. Shareholders in the U.S. and Europe hold the majority of common shares.
Financial statements and audits
In this Annual Report, the financial statements for 2017 are presented as prepared by the Managing Board, audited
by KPMG (Independent Registered Public Accounting Firm). We examined the financial statements, the proposal for
the use of the distributable profit, the consolidated financial statements and the management report. We have no
objections, thus we concur with the results of the audit, and it has been approved by the Supervisory Board. In
closing, the Supervisory Board would like to again thank all QIAGEN employees for their dedication and hard work
during 2017.
Venlo, the Netherlands, April 2018
The Supervisory Board:
Dr. Manfred Karobath
Chairman of the Supervisory Board
OVERVIEW
The Executive Committee
Peer M. Schatz
Chief Executive Officer, Managing
Director
Thierry Bernard
Senior Vice President Molecular
Diagnostics Business Area
Mark Gladwell
Senior Vice President Global
Operations
Dr. Annette Koch
Senior Vice President and Chief
Human Resources Officer
Manuel O. Méndez
Senior Vice President Global
Commercial Operations
Roland Sackers
Chief Financial Officer
Dr. Thomas Schweins
Senior Vice President, Life Science
Business Area
Dr. Jonathan Sheldon
Senior Vice President, Bioinformatics
Business Area
Peer M. Schatz
Chief Executive Officer, Managing Director
Joined QIAGEN in 1993, and has been Chief Executive Officer since January 1, 2004. He was Chief Financial
Officer between 1993 and 2003 and became a member of the Managing Board in 1998. Mr. Schatz was
previously a partner in a private management buyout group in Switzerland, worked in finance and systems positions
at Sandoz AG and Computerland, and participated in the founding of start-up companies in the computer and
software trading industry in Europe and the United States.
Mr. Schatz graduated from the University of St. Gallen, Switzerland, with a Master’s degree in Finance in 1989 and
obtained an M.B.A. in Finance from the University of Chicago Graduate School of Business in 1991. Mr. Schatz
served as a member of the German Corporate Governance Commission from 2002 to 2012. He is a board member
of AdvaMedDx, a U.S. trade association that leads the effort to advance medical technology in order to achieve
healthier lives and healthier economies around the world and ALDA (the Analytical, Life Science and Diagnostics
Association), a trade association of developers and suppliers in these fields. He is also Managing Director of PS
Capital Management GmbH.
Thierry Bernard
Senior Vice President Molecular Diagnostics Business Area
Joined QIAGEN in February 2015 to lead QIAGEN’s growing presence in Molecular Diagnostics, the application of
Sample to Insight solutions for molecular testing in human healthcare. Mr. Bernard previously worked at bioMérieux,
where he served in roles of increasing responsibility for 15 years, most recently as Corporate Vice President, Global
Commercial Operations, Investor Relations and the Greater China Region. Prior to joining bioMérieux, he served in
management roles in multiple international environments. Mr. Bernard is a member of the Boards of Directors of three
privately held U.S. companies, First Light Biosciences, HepatoChem and more recently, Daktari Diagnostics, where
he also served as CEO. He has earned degrees from Sciences Po (Paris), Harvard Business School, London School of
Economics and the College of Europe and is a member of French Foreign Trade Advisors.
Mark Gladwell
Senior Vice President Global Operations
Joined QIAGEN in 2017 as Senior Vice President Global Operations. He leads Manufacturing, Supply Chain,
Customer Care, Quality Assurance & Control, and Regulatory Affairs at QIAGEN. Mr. Gladwell has more than two
decades of experience in manufacturing high-volume, high technology in vitro diagnostics and medical devices. He
joined QIAGEN from Alere Inc., where he served in positions of increasing responsibility for 12 years, most recently
as Senior Vice President, Global Operations. Previously, he was with Johnson & Johnson, Agfa HealthCare, Sterling
Medical Imaging and DuPont. Mark received a bachelor’s degree with honors from The University of Salford in the
United Kingdom and is a graduate of the General Management Program from Harvard Business School.
Dr. Annette Koch
Senior Vice President and Chief Human Resources Officer
Joined QIAGEN in 2018 as Senior Vice President and Chief Human Resources Officer, overseeing all aspects of
QIAGEN’s global Human Resources function. She came to QIAGEN from Eppendorf AG, where she had been Vice
President Human Resources since 2013, supporting about 3,200 employees in 26 countries. Previously, she held
roles of increasing responsibility from 2003 to 2013 with Boehringer Ingelheim. Dr. Koch started her career at The
Boston Consulting Group in Düsseldorf, working on projects in the pharmaceutical and chemical industries. She
earned a Ph.D. in Organic Chemistry from the University of Hannover, and during her graduate studies also worked
in the University of Southern California laboratory of Prof. George Andrew Olah, who had won the Nobel Prize in
Chemistry in 1994.
Manuel O. Méndez
Senior Vice President Global Commercial Operations
Joined QIAGEN in October 2014 as Senior Vice President, Global Commercial Operations, leading sales and
marketing worldwide. Mr. Méndez has 25 years of experience in diagnostics and life sciences, most recently as
Executive Vice President Americas for bioMérieux from 2010 – 2014. Previously he served in sales, marketing and
general management roles with Abbott Laboratories, Thermo Fisher Scientific and OraSure Technologies – with
leadership positions in the United States, Latin America, Europe and Asian markets. He is on the advisory board of
908 Devices, a maker of point-of-need chemical analyzers. Mr. Méndez received a B.S. in biomedical Engineering
from Boston University and an M.B.A. from Northwestern University Kellogg School of Management.
Roland Sackers
Chief Financial Officer
Joined QIAGEN in 1999 as Vice President Finance and has been Chief Financial Officer since 2004. In 2006, Mr.
Sackers became a member of the Managing Board. Between 1995 and 1999, he served as an auditor with Arthur
Andersen Wirtschaftsprüfungsgesellschaft Steuerberatungsgesellschaft. Mr. Sackers earned his Master Degree in
Business Administration (Diplom-Kaufmann) from the University of Münster, Germany. He is a former member of the
Supervisory Board and Audit Committee of IBS AG and a former member of the board of directors of Operon
Biotechnologies, Inc. Mr. Sackers is a board member of the industry association BIO Deutschland. He is also a non-
executive director and chair of the audit committee of Immunodiagnostic Systems Holding PLC (IDS), a leading
producer of immunological tests for research and diagnostic applications publicly listed in the United Kingdom.
Dr. Thomas Schweins
Senior Vice President, Life Science Business Area
Joined QIAGEN in 2004 as Vice President Corporate Strategy and was appointed Vice President Marketing &
Strategy in 2005, where he was deeply involved in managing the global business toward Life Science customers. In
late 2011, Dr. Schweins has assumed responsibility for Human Resources, and took over the leadership of the Life
Science Business Area in 2017. Dr. Schweins came to QIAGEN from The Boston Consulting Group. He previously
worked as Technology Manager, and later as an Assistant to the Management Board at Hoechst / Aventis. Dr.
Schweins earned an M.Sc. Degree in Biochemistry from the University of Hanover. He obtained his Ph.D. at the Max
Planck Society and received an M.Sc. from the University of Southern California in Los Angeles, where he studied
Business Administration and Chemistry.
Dr. Jonathan Sheldon
Senior Vice President, Bioinformatics Business Area
Joined QIAGEN in 2018 as Senior Vice President, Bioinformatics Business Area. He leads QIAGEN's growing
presence in bioinformatics, enabling customers to transform raw data from biological samples into valuable
molecular insights. Dr. Sheldon came to QIAGEN from Oracle, where he was Global Vice President leading
Oracle's Healthcare business globally in the Health Sciences Global Business Unit and served on the executive
committee. Previously, he established the bioinformatics group and served as Head of Bioinformatics at Roche (UK)
Pharmaceuticals, as well as providing leadership in software firms serving the life science and healthcare sectors. He
serves on the Board of Directors of the Drug Information Association (DIA). He received his B.Sc. in Biochemistry and
Molecular Biology from the University of Manchester, and his Ph.D. in Biochemistry and Molecular Biology from the
University of Cambridge.
OVERVIEW
Common Shares
After gains in 2015 and 2016, QIAGEN’s common shares had a mixed
performance in U.S. and European markets in 2017. Strategic initiatives to
accelerate growth and profitability by investing in a portfolio of differentiated
Sample to Insight solutions have begun to deliver results, and we thank
shareholders for their support. QIAGEN’s senior executives and Investor
Relations team are recognized for proactive, transparent communications with
the financial community.
Market Environment
Stock markets globally showed robust gains in 2017, with relatively low volatility and tailwinds from accelerating
economic growth and still-accommodative monetary policy. World markets benefited from broadly synchronized
strengthening of economic activity across regions, driving many asset prices to record levels in 2017. Concerns
about political uncertainties, a turn toward tighter monetary policy and the late stage of the business cycle did not
hinder equities in 2017, but stock market volatility began to increase in early 2018.
As benchmarks, the S&P 500 index in the United States was up 19.4% at year-end 2017. The DAX index of the 30
largest companies in Germany advanced 12.5% during the year, and Germany’s TecDAX, of which QIAGEN is a
member, rose 39.5% for the year. All of these indices were supported by the benefits of M&A activities.
The molecular diagnostics and life science tools segment continued to grow in 2017. Expansion of new molecular
testing applications such as next-generation sequencing, liquid biopsies and epigenetics helped drive the market for
instruments and consumables. Adoption of molecular technologies in healthcare continued to grow for precision
medicine in oncology, infectious disease detection and diagnosis of rare diseases. Government funding for
academic research remained cautious, while healthcare also faced uncertainty in reimbursement and government
policies. QIAGEN’s adjusted net sales maintained solid single-digit growth in 2017, while adjusted earnings grew at
double-digit rates, in line with mid-term goals for improving sales and profitability through 2020. QIAGEN sales
grew across all regions and customer classes in 2017, led by growth drivers including the QuantiFERON latent TB
test, QIAsymphony automation system and consumables, differentiated solutions for next-generation sequencing, and
QIAGEN’s Personalized Healthcare portfolio of companion diagnostic partnerships with pharma companies.
QIAGEN continues to invest in strategic catalysts, allocating resources to sustain sales growth while improving
profitability, enhancing shareholder value and maintaining financial flexibility.
Listings in the U.S. and Europe
QIAGEN’s common shares have been registered and traded in the United States since 1996, listing on the New
York Stock Exchange effective January 10, 2018, after trading on NASDAQ markets since the initial public offering
(IPO). The shares have traded in Germany on the Frankfurt Stock Exchange since 1997, and the Prime Standard
segment since its launch in 2003. Dual listing on NYSE and the Frankfurt exchange offers advantages for QIAGEN,
our shareholders and employees since global presence increases the potential market opportunity and enhances
liquidity. Unlike American Depositary Receipts (ADRs), QIAGEN shares provide equal corporate rights for all
shareholders and can be traded on either exchange, in U.S. dollars or euros.
Share Price and Liquidity
QIAGEN’s common share price showed mixed results in 2017, climbing about 10% in U.S. dollars to $30.93 on
NASDAQ, while declining about 1% in euros to €26.19 on the Frankfurt Stock Exchange, mainly as a result of the
appreciation of the euro against the U.S. dollar. Our common shares continued to offer high liquidity, with average
daily trading volume during 2017 of approximately 1.4 million shares (0.95 million on NASDAQ and other U.S.
trading venues, and 0.44 million on the Frankfurt Stock Exchange (XETRA) and other German exchanges). QIAGEN
continued its commitment to disciplined capital allocation, QIAGEN returned $300 million in capital to shareholders
during 2017, with a synthetic share repurchase totaling $245 million in January 2017 followed by open-market
repurchases of 1.9 million shares for $61.0 million (including transaction costs). In early 2018 QIAGEN announced
a new commitment to return $200 million to shareholders via open-market repurchases on the Frankfurt Stock
Exchange. As of December 31, 2017, the free float, which affects weighting of QIAGEN shares in various indices,
was approximately 95%.
Index Membership
QIAGEN is a constituent in various European, U.S. and global stock indices, some of which serve as benchmarks or
investment universes for mutual funds and exchange traded funds. QIAGEN ranks as one of the leading components
by market capitalization in Germany’s TecDAX index, which includes the 30 largest German technology companies
not in the benchmark DAX index. QIAGEN also is a member of the Russell 3000 index, which measures
performance of the 3,000 largest U.S. companies, and the Russell 1000, a subset with the largest 1,000 U.S.
securities. QIAGEN shares also are included in other stock market indexes such as the MSCI Europe, EMU and EAFE
indexes.
Shareholder Structure
QIAGEN has a truly global investor base comprised of more than 520 identified institutional investors distributed
around the world, including about one half in North America, about one-third in Europe and the remaining shares in
the Asia-Pacific/Japan region. Members of the Managing Board and the Supervisory Board in total held about 2.5%
of QIAGEN’s outstanding common shares at the end of 2017.
Annual Shareholders’ Meeting
At the 2017 Annual Shareholders’ Meeting, shareholders voted in favor of all resolutions proposed by the Board of
Directors, in many cases with majorities above 95% of shares present at the meeting. Shareholders present or
represented at the meeting held on June 21, 2017, in Venlo, the Netherlands, held approximately 145.8 million
shares, or 63% of the approximately 230.8 million issued shares of QIAGEN as of the record date for the meeting.
Details of attendance and voting results from our Annual Shareholders’ Meeting are available at
https://corporate.QIAGEN.com.
Investor Relations and Engagement with Shareholders
QIAGEN is committed to offering shareholders, analysts and communities around the world transparent,
comprehensive and readily accessible information on our vision, mission and strategy, as well as performance and
future prospects.
The relationship with existing and potential investors continued at an intensive pace in 2017, with a significant
number of individual discussions held during many roadshows and investor conferences around the world. Many
investors and analysts made use during 2017 of the opportunity to inform themselves about QIAGEN in personal
meetings at our sites in Hilden, Germany; Germantown, Maryland; Redwood City, California; Singapore; and
Shanghai, China.
In 2017, QIAGEN’s efforts to address the needs of the financial community were recognized by DIRK (the
association for Investor Relations in Germany) and Extel, ranking QIAGEN among the top companies, senior
executives and IR professionals compared with all TecDAX companies, as well as among European medtech sector
companies.
Approximately 24 analysts from international brokerages followed QIAGEN in 2017, with analysts based in the
United States, France, Germany and the United Kingdom.
QIAGEN Share Price Development and Average Trading Volume – NASDAQ 2017
Year-end price
High
Low
Average daily trading volume (in million shares)
* Attributable to the owners of QIAGEN N.V.
2017
$ 30.93
$ 35.37
$ 27.43
0.95
2016-12-26
2017-01-09
2017-01-23
2017-02-06
2017-02-20
2017-03-06
2017-03-20
2017-03-27
2017-04-10
2017-04-24
2017-05-08
2017-05-22
2017-06-05
2017-06-19
2017-07-03
2017-07-17
2017-07-31
2017-08-14
2017-08-28
2017-09-11
2017-09-25
2017-10-09
2017-10-23
2017-11-06
2017-11-20
2017-12-04
2017-12-18
140
130
120
110
100
90
119 %
119 %
119 %
114 %
114 %
127 %
125 %
127 %
117 %
117 %
117 %
118 %
120 % 121 %
110 %
111 %
111 %
108 %
108 %
109 %
109 %
118 %
113 %
111 %
109 %
110 %
110 %
106 %
107 %
100 %
99 %
100 %
100 %
103 %
99 %
99 %
97 %
QGEN
NASDAQ
QIAGEN Share Price Development and Average Trading Volume – Frankfurt Stock
Exchange (XETRA) 2017
Year-end price
High
Low
Average daily trading volume (in million shares)
2017
€ 26.19
€ 31.46
€ 25.71
0.44
2016-12-25
2017-01-08
2017-01-22
2017-02-05
2017-02-19
2017-03-05
2017-03-19
2017-04-02
2017-04-16
2017-04-30
2017-05-14
2017-05-28
2017-06-11
2017-06-25
2017-07-09
2017-07-23
2017-08-06
2017-08-20
2017-09-03
2017-09-17
2017-10-01
2017-10-15
2017-10-29
2017-11-12
2017-11-26
2017-12-10
2017-12-24
160
140
120
110 %
112 %
125 %
125 %
117 %
109 %
113 %
110 %
122 %
109 %
137 %
137 %
137 %
145 %
134 %
128 %
124 %
124 %
105 %
109 %
109 %
100 %
100 %
100 %
101 %
99 %
101 %
QIA
Xetra
100 %
97 %
100
102 %
102 %
100 %
99 %
80
Key Share Data
Year-end market capitalization (in $ million)
Year-end market capitalization (in € million)
Source: QIAGEN Shareholder ID
Source: QIAGEN Shareholder ID
United States
Germany
France
England
Other
47%
GARP
15%
Value
5%
4%
6%
Index
Growth
Other
Non-Institutional
23%
Non-Institutional
Source: QIAGEN Shareholder ID
Source: QIAGEN Shareholder ID
2017
7,002
5,928
18%
16%
12%
12%
19%
23%
MANAGEMENT REPORT
Business and Operating Environment
QIAGEN is a global leader in Sample to Insight solutions that transform biological samples into valuable molecular
insights. Our mission is to enable our customers in four broad classes - Molecular Diagnostics, Applied Testing,
Pharma and Academia - to achieve outstanding success and breakthroughs, all in keeping with our goal of making
improvements in life possible.
QIAGEN's solutions integrate sample and assay technologies, bioinformatics and automation systems into workflows
that help customers move from Sample to Insight. Our solutions support more than 500,000 customers worldwide in
generating insights into the molecular building blocks of life. Our proven solutions are providing answers in hospitals
and laboratories worldwide, helping make sense of the increasing volumes and complexity of biological information.
As we move deeper into “the Century of Biology,” knowledge of the molecular basis of life has been growing
exponentially, along with greater understanding of diseases and biological mechanisms. Dramatic acceleration in
the speed of analyzing DNA - and reduction in cost - is generating new discoveries and vast quantities of genomic
data. This revolution in the life sciences is transforming healthcare and influencing many other areas of everyday life.
QIAGEN’s mission is to make improvements in life possible by providing innovative technologies to enable this
ongoing wave of discovery and its wide-ranging applications.
QIAGEN began operations in 1986 as a pioneer in the emerging biotechnology sector, introducing a novel method
that standardized and accelerated extraction and purification of nucleic acids from biological samples. As molecular
biology has grown to influence many areas of life, QIAGEN has expanded to serve the full spectrum of market
needs. We believe our sample technologies are unmatched in quality for isolating and preparing DNA
(deoxyribonucleic acid), RNA (ribonucleic acid) and proteins from blood or other liquids, tissue, plants or other
materials. Our assay technologies amplify, enrich and make these biomolecules accessible for analysis, such as
identifying the genetic information of a pathogen or a gene mutation in a tumor. QIAGEN’s industry-leading
bioinformatics solutions allows users to analyze and interpret data to provide relevant, actionable insights. Our
automation systems for polymerase chain reaction (PCR), next-generation sequencing (NGS) and other technologies
tie these together in seamless and cost-effective molecular testing workflows - from Sample to Insight.
Net sales of $1.42 billion in 2017 consisted of consumable kits and other revenues (88% of sales) and automation
systems and instruments (12% of sales). Approximately 48% of net sales in 2017 were in Molecular Diagnostics, and
52% in Life Sciences customer classes in the Academia, Pharma and Applied Testing markets.
QIAGEN has grown substantially by developing new platforms, consumables and bioinformatics to meet growing
needs in the market, partnering with researchers and Pharma companies, and acquiring companies or technologies
to complement our portfolio. We believe the addressable global market for QIAGEN's portfolio of molecular testing
products for customers across the continuum of life science research and molecular diagnostics totals more than $8
billion.
We have funded our growth through internally generated funds, debt offerings, and private and public sales of
equity securities. QIAGEN has global shares that are listed on the New York Stock Exchange under the ticker symbol
“QGEN” and on the Frankfurt Prime Standard as “QIA.”
The company is registered under its commercial and legal name QIAGEN N.V. with the trade register (kamer van
koophandel) of the Dutch region Limburg Noord under file number 12036979. QIAGEN N.V. is a public limited
liability company (naamloze vennootschap) under Dutch law as a holding company. Our principal executive office is
located at Hulsterweg 82, 5912 PL Venlo, The Netherlands, and our telephone number is +31-77-355-6600.
As a holding company, QIAGEN conducts business through subsidiaries located throughout the world. Further
information about QIAGEN can be found at www.qiagen.com. By referring to our website, we do not incorporate
the website or any portion of the website by reference into this Annual Report.
Operating Environment in 2017
Economic Environment
A broad global upswing delivered stronger-than-expected economic growth in 2017, creating opportunities for
QIAGEN, despite some uncertainties in the business and political environment. Real Gross Domestic Product (GDP)
for the world grew approximately 3.0% in 2017, up from 2.4% in 2016 and 2.8% in 2015, according to World
Bank estimates. More than half of the world’s economies accelerated in 2017: The United States and Europe
stepped up growth from slow to moderate, while emerging markets such as China, India and Turkey grew much
faster than average. Macroeconomic influences included continued low financing costs, growth-oriented fiscal and
monetary policies, strong investment driven by business confidence, and a recovery in commodity prices. The U.S.
dollar declined against other major currencies in 2017, but had little overall effect on QIAGEN results, reported in
dollars.
Industry Environment
As genomic knowledge expands, molecular testing is unlocking valuable insights to meet an increasing range of
needs in healthcare, academic research, pharmaceutical R&D and public safety. The secular growth trend in sales of
instruments, reagents and other consumables, and bioinformatics solutions continued in 2017. Technologies for next-
generation sequencing (NGS) and polymerase chain reaction (PCR) continued to disseminate worldwide. Molecular
diagnostics is the most dynamically growing segment of in vitro diagnostics, enabling clinicians to identify and
profile cancers, infectious diseases, prenatal or neonatal health threats, and patients’ immune status. Regulatory and
reimbursement climates continue to evolve. In 2017, precision medicine advanced with the first FDA approvals of
cancer drugs targeted by biomarker testing rather than tumor sites, and immuno-oncology drugs using gene editing
to mobilize patients’ immune cells. In Academia, spending on NGS and other molecular technologies grew on
improving customer sentiment, despite concerns about research funding. The Pharma industry increasingly guides
drug discovery and development with advanced molecular testing, although R&D spending by individual companies
depends on company-specific issues. Applied Testing also continues to grow, led by human identification and
forensics. The migration of genomic technologies from basic research into the mainstream is a powerful driver for
long-term growth of the industry, increasing the need for scalable, user-friendly and efficient workflows from
beginning to end in molecular testing.
Recent Developments
QIAGEN has recently achieved a number of strategic milestones by continuing to focus on strategic growth
initiatives:
QuantiFERON-TB franchise growing rapidly:
QIAGEN is aiding the global fight against tuberculosis (TB), a contagious bacterial infection that strikes more than
10 million new persons and kills about 1.8 million annually. The global epidemic is complicated because an
estimated one out of three people have latent TB infection, a phase in which the bacterium infects a person but
produces no detectable symptoms. About 5-10% of those individuals, if untreated, will progress to the active TB
disease, so screening of high-risk individuals and treatment for latent TB plays an important role in global
tuberculosis control efforts.
QIAGEN's novel QuantiFERON tests, the fourth-generation QuantiFERON-TB Gold Plus (QFT-Plus) and third-
generation QuantiFERON-TB Gold (QFT), are the market-leading modern diagnostic tools for latent TB infection. In
a class known as interferon-gamma release assays (IGRAs), QuantiFERON-TB tests have been shown in clinical
studies to be faster, less labor-intensive and more accurate than the century-old tuberculin skin test. QFT is one of
two tests mentioned in the World Health Organization guidelines as an alternative to tuberculin skin tests. First
introduced in 2015, QFT-Plus adds clinical insights with antigens that measure the cell-mediated immune response
to TB infection from both CD4+ and CD8+ T cells. The addition of CD8+ assessment led WHO in its Global TB
Report 2016 to cite QFT-Plus (the only such test on the market) for its potential in identifying at-risk adults at greater
risk of progressing to active TB. QFT-Plus is now available in more than 75 countries in Europe, the Americas,
Africa, Asia and Middle East. The laboratory-based QuantiFERON-TB tests are displacing the more subjective and
time-consuming tuberculin skin test, and sales surpassed $175 million in 2017.
In October 2017 QIAGEN launched QuantiFERON-TB Gold Plus in the United States after it received Food and
Drug Administration approval. Japan also recently approved QFT-Plus. These market introductions follow adoption
of QFT-Plus in more than 75 countries across Europe, the Middle East, Africa, Asia and Latin America, where
nearly two million of the tests have been used. QFT-Plus advances the science of TB testing with innovative antigens
that measure each patient’s cell-mediated immune response from both CD4+ and CD8+ T cells, a unique
capability. An increasing number of peer-reviewed publications support the efficacy of QFT-Plus, which is the only
interferon-gamma release assay (IGRA) test on the pathway to evaluation by the World Health Organization
(WHO) for its global campaign to eradicate TB.
In January 2018, QIAGEN began a new partnership with DiaSorin that will provide a state-of-the-art automation
option for QuantiFERON-TB Gold Plus customers, embedding QFT-Plus in a broad and highly synergistic assay
menu for DiaSorin's LIAISON-family analyzers. More than 7,000 LIAISON-family analyzers are already in use
worldwide.
Next-generation sequencing solutions extending QIAGEN's reach:
As a leader in “universal” technologies for use with any next-generation sequencing system, as well as creator of
the innovative GeneReader NGS System for benchtop sequencing, QIAGEN continues to expand its presence in
the rapidly growing market for NGS solutions in laboratories around the world. QIAGEN’s NGS portfolio
produced more than $115 million in sales in 2017.
In 2017 QIAGEN continued to broaden its portfolio of platform-agnostic NGS solutions, streamlining tasks such as
automated sample and library preparation, reliable detection of DNA and RNA variations, and bioinformatics for
analysis and interpretation. Our industry-leading solutions for preparation of liquid biopsy samples, along with a
diverse offering of off-the-shelf and customized QIAseq panels, continued to expand to new applications.
QIAGEN’s GeneReader NGS System, the first complete Sample to Insight next-generation sequencing solution
designed for any laboratory to deliver actionable results, continued to gain acceptance with strong growth in
placements in 2017.
We expanded the GeneReader system's capabilities and content menu for clinical researchers in 2017. Going
beyond the original GeneRead QIAact Actionable Insights Tumor Panel (AIT), we launched the GeneRead QIAact
Lung DNA Panel and Lung RNA Panel for deep analysis of lung cancer samples and the GeneRead QIAact BRCA
1/2 Panel for in-depth insights into breast and ovarian cancers. All of the QIAact NGS panels run with the
GeneReader system and integrate seamlessly with our QCI bioinformatics software for analysis and interpretation.
We have incorporated the GeneReader NGS System into collaborations with pharmaceutical companies for co-
development of companion diagnostics.
Multiple studies demonstrating the efficacy of QIAGEN’s GeneReader system, panels and other NGS solutions
were presented in major scientific meetings in 2017, including the American Society of Clinical Oncology
(ASCO), American Society of Human Genetics (ASHG) and Association for Molecular Pathology (AMP). At the
AMP annual meeting in November 2017, about 10 percent of the more than 500 papers presented relied on
QIAGEN solutions for some aspect of molecular testing, from sample technologies for NGS to bioinformatics for
interpretation of data.
To accelerate the growth of the GeneReader system in China, QIAGEN formed a joint venture in 2017 with
Maccura, a leading in vitro diagnostics company in China. The venture, MAQGEN Biotechnology Co., Ltd.
(MAQGEN), will develop local adaptations, pursue regulatory paths to maximize the GeneReader’s value and
leverage Maccura’s broad customer network to expand adoption in laboratories across China. The NGS market in
China is growing rapidly in personalized medicine and clinical research. MAQGEN China is 60% owned by
Maccura and 40% by QIAGEN.
In late 2017, QIAGEN created a new unit, Enterprise Genomics Services, to serve the growing demand for
customization of NGS gene panels with integrated bioinformatics for dedicated applications. This initiative offers
benefits to customers in implementation time, expense and risk mitigation across the continuum from NGS
discovery to panel development, optimization, verification and implementation. QIAGEN's capabilities support
customized solutions for any NGS platform, including the GeneReader NGS System.
In Applied Testing, QIAGEN collaborated with the International Commission on Missing Persons (ICMP) in 2017
to launch a cutting-edge next-generation sequencing workflow for DNA identification at the ICMP's laboratory in
The Hague. The lab integrates the GeneReader system, other QIAGEN instruments and a new NGS panel
specifically designed to identify missing persons. QIAGEN will supply software, reagents, consumables and
technical support on an ongoing basis.
Continued Leadership in Personalized Healthcare:
QIAGEN strengthened its leading position in Personalized Healthcare in 2017, surpassing a milestone of 25
master collaboration agreements with pharma and biotech companies to develop companion and complementary
diagnostics providing individualized genomic insights to guide clinical decision-making. QIAGEN launched 15
new companion diagnostic projects in 2017, a record high for QIAGEN. In addition, we continued to achieve
regulatory approvals of companion diagnostics and to launch them commercially.
A major initiative in 2017 was QIAGEN’s expansion into developing biomarker tests to support emerging
therapies in immuno-oncology (I-O), a novel approach using drugs to target the body’s immune system to help fight
cancer. QIAGEN and Bristol-Myers Squibb launched a groundbreaking collaboration to explore the use of NGS
technology to develop gene expression profiles (GEPs) as predictive or prognostic tools for use with a number of
novel immuno-oncology molecules Bristol-Myers Squibb is developing. QIAGEN subsequently has entered into
other agreements with undisclosed industry partners to co-develop molecular tests to identify patients who could
benefit from I-O therapies. QIAGEN obtained a worldwide license in 2017 from The Johns Hopkins University for
biomarkers that play roles in identifying patients for I-O therapies.
QIAGEN continues to roll out regulator-approved companion diagnostics that deliver actionable insights for
treatment decisions based on patients’ genomic information. We launched the ipsogen JAK2 RGQ PCR Kit in
2017 as the only FDA-cleared JAK2 kit for blood cancers, diagnosing gene mutations in patients with
Polycythemia Vera. The FDA approval was expanded in early 2018 to other myeloproliferative neoplasms. The
FDA indicated use of QIAGEN's therascreen EGFR RGQ PCR Kit as a companion diagnostic also was expanded
in early 2018 to diagnose additional EGFR gene mutations involved in treatment decisions for first-line treatment of
metastatic non-small cell lung cancer (NSCLC).
We added a new liquid biopsy assay in 2017 for clinical research - the AdnaTest Prostate Cancer Panel AR-V7,
using circulating tumor cells to monitor RNA expression of a biomarker indicating resistance to prostate cancer
treatments.
As one of the world’s leading independent developers of molecular technologies, with a diverse portfolio of
sequencing platforms and solutions, QIAGEN is a preferred industry partner for developing companion or
complementary diagnostics.
QIAsymphony delivering platform growth as content menu expands:
QIAGEN surpassed its 2017 goal of 2,000 cumulative placements of QIAsymphony, a cost-effective modular
system that integrates PCR molecular testing workflows from initial biological sample processing to final insights.
The platform’s rapid dissemination and growing content menu fueled double-digit growth in consumables for
QIAsymphony.
The QIAsymphony automation system serves laboratories around the world, with the broadest test menu of any
platform in its category in Europe and other markets, plus the unique ability to handle laboratory-developed tests.
Nearly 30 diagnostic tests in infectious disease, oncology and transplant care are marketed for use on the Rotor-
Gene® Q, a component of the modular QIAsymphony workflow. In the United States, eight FDA-approved
diagnostic tests, including three companion diagnostics to guide treatment decisions in cancer, are marketed for
this detection platform.
Two new QIAGEN test kits were approved by the FDA in 2017 for use on QIAsymphony instruments: the ipsogen
JAK2 RGQ PCR Kit, a qualitative test for the detection of an important genetic variant in blood cancers; and the
artus CMV QS-RGQ MDx kit, to monitor solid organ transplant patients for cytomegalovirus (CMV), a common
infection that can be life-threatening in vulnerable patients.
The QIAsymphony system's sample processing module, QIAsymphony SP, is a market-leading “front end”
automated solution for downstream molecular testing. The growth of next-generation sequencing has highlighted
the critical need of laboratories for reliable, automated processing of samples, including liquid biopsies.
QIAsymphony SP automates the processing of nucleic acids for analysis with the GeneReader NGS System or
other sequencers.
Leadership in differentiated core technologies continuing to drive growth:
As a world leader in sample technologies enabling laboratories to obtain highest-quality DNA and RNA for
molecular testing, QIAGEN continued to expand its offerings in 2017 with differentiated solutions for front-end
challenges. QIAGEN technologies process an estimated 50,000 biological samples a day. Our strategic focus is
on rapidly growing applications in research and clinical diagnostics, such as handling microbiome samples,
where we have an estimated 75% market share.
Innovation in “liquid biopsy” technologies is increasingly enabling QIAGEN customers to unlock molecular insights
from blood or other fluids as non-invasive alternatives to surgical biopsies. Our solutions based on several different
technologies for isolation and stabilization of nucleic acids are used in an estimated 80% of liquid biopsy testing.
Partnering with leading providers of molecular testing services, QIAGEN continues to incorporate its differentiated
solutions in liquid biopsy testing. In 2017, for example, QIAGEN’s PAXgene® Blood ccfDNA Tube was adopted
by Clinical Genomics for sample collection with its assay to monitor patients for recurrence of colorectal cancer.
To facilitate the growing trend toward liquid biopsies for routine use in clinical testing, QIAGEN joined CANCER-
ID, a public-private consortium working to establish standard protocols and clinical validation for blood-based
biomarkers in lung and breast cancer. QIAGEN is helping create standardized methods and Sample to Insight
workflows.
QIAGEN launched a Custom Solutions business in 2017 to serve life science and molecular diagnostics customers
with the tools and expertise to quickly build and commercialize products that meet unique workflow requirements.
The new unit offers custom and OEM sample technologies, oligo and enzyme product options for PCR, qPCR and
NGS product development, as well as a range of other platform technologies.
In forensics, QIAGEN’s long-standing leadership in developing international standards of quality for products to
collect and test samples for human identification gained support in 2017 with third-party certification that QIAGEN
meets state-of-the-art requirements for forensics supply chain and manufacturing (ISO18385:2016).
Industry-leading bioinformatics turning raw genomic data into valuable insights:
QIAGEN’s broad offering of content-enabled bioinformatics software continues to grow both as a standalone
franchise and as a driver integrated into QIAGEN’s Sample to Insight workflows. Our bioinformatics turn vast
amounts of genomic data into actionable insights for customers, addressing a critical bottleneck in next-generation
sequencing, especially for clinical research and diagnostics. Studies by leading institutions often use solutions such
as QIAGEN Clinical Insight (QCI) or CLC Genomics Workbench to analyze and interpret genomic data. QIAGEN
pursues collaborations across the genomics and bioinformatics community to offer customers the richest access
possible to insights for research and diagnostics.
In January 2017, QIAGEN acquired OmicSoft Corporation to expand its solutions and enable scientists to
visualize and mine large institutional and publicly available “omics” datasets, in addition to the expertly curated,
literature-based datasets marketed by QIAGEN. Its OmicSoft solutions meet a growing need in discovery and
translational research to access and manage huge amounts of data on DNA, RNA and other sequencing insights.
In October 2017, QIAGEN partnered with CENTOGENE AG, a leader in testing for rare diseases and hereditary
disorders, to provide customers of both companies with more complete insights. QIAGEN integrated
CENTOGENE’s rare disease variant database into its bioinformatics offerings for genomic interpretation, while
CENTOGENE licensed QIAGEN's bioinformatics solutions for use in its diagnostic testing services for rare
diseases.
Advancing the potential of precision medicine for the diagnosis and treatment of cancer, in November 2017 we
launched enhancements in our QIAGEN Clinical Insight (QCI) bioinformatics software to automate guidelines
published by leading oncology and pathology groups for the use of next-generation sequencing in genetic
profiling of cancers. QIAGEN’s QCI-Interpret software integrates the consensus AMP/ASCO/CAP standards with
our comprehensive biomedical knowledge base to guide the selection of treatments based on findings from each
patient’s genomic testing and diagnosis.
Also in November 2017, a collaboration in women’s health with Counsyl, a company based in California,
demonstrated the value of QIAGEN Clinical Insight for interpretation of results from prenatal testing and hereditary
disease screening. Counsyl reported that using QCI for interpreting and scoring genetic variants reduced search
time for literature references by 75%, while maintaining accuracy.
Targeted action increasing returns to shareholders:
In 2017, QIAGEN fulfilled its commitment to return $300 million to shareholders through share repurchase
transactions, including the return of $245 million through a synthetic share repurchase in January 2017 and the
open-market repurchase of 1.9 million shares on the Frankfurt Stock Exchange for approximately $60 million in
September 2017. Reaffirming its commitment to a disciplined approach to capital allocation, QIAGEN announced
a new commitment to return $200 million to shareholders beginning in 2018 via open-market repurchases. Shares
will be repurchased on the Frankfurt Stock Exchange.
In 2017, QIAGEN continued to execute previously announced restructuring actions to improve efficiency and
profitability, while supporting momentum in sales growth. Key areas include consolidating activities into shared
service centers and global centers of excellence, gaining efficiencies in marketing, and embracing digital tools
across the business. In 2017, we launched a shared service center for administrative functions in the Philippines,
expanding on the efficiencies and complementing the geographic footprint of our first shared service center in
Poland. A pre-tax restructuring charge of $19.8 million ($0.06 per share after taxes) was recorded in 2017 for
these changes. In addition, following enactment of the new U.S. tax law in December 2017, QIAGEN announced
restructuring initiatives to mitigate some of its impacts, resulting in a pre-tax restructuring charge of $13.8 million
($0.04 per share after taxes) in the fourth quarter. Operating results in 2017 show the benefits in cost reduction
and profitability, and targeted actions are continuing into 2018.
In a review aimed at freeing resources to focus on high-growth market opportunities, QIAGEN took steps in late
2017 to streamline its product portfolio in China, the company's second-largest market, by discontinuing the
commercialization of some non-core PCR tests and externalizing the HPV test (cervical cancer screening) franchise
to a third-party company in China. A partnership became effective in January 2018 with a Chinese company that
has absorbed R&D, commercial distribution, and the related QIAGEN employees and infrastructure of the HPV test
franchise in China. QIAGEN has become a minority shareholder of this company. QIAGEN China will focus
additional resources on QuantiFERON-TB, the new MAQGEN China joint venture with Maccura for the
GeneReader NGS System, and the life sciences portfolio.
Products
QIAGEN's leadership in Sample to Insight solutions for molecular testing leverages our position across a wide range
of applications and customer classes. We provide more than 500 core consumable products (sample and assay
“kits”), as well as instruments and automation systems. Our bioinformatics solutions connect laboratory workflows
and process genomic data, reporting relevant insights to enable scientists or clinicians to decide on further action.
These diverse revenue streams can be seen in two main categories: consumables and related revenue, and
automation platforms and instruments.
Consumables and related revenues
Consumable products, accounting for approximately 79%-80% of net sales, typically include sample technologies to
extract and purify molecules of interest from biological samples and assay technologies that make information from
these samples available for analysis and interpretation. To maximize customer convenience and reduce user error,
these kits contain all necessary reagents and a manual of protocols and background information. Reliability,
standardization, ease of use and cost-effectiveness are keys to the success of molecular testing products.
QIAGEN’s sample technologies ensure that each biological sample is processed in a highly reproducible,
standardized method with the highest quality. A broad range of kits support applications such as plasmid DNA
purification, RNA purification and stabilization, genomic and viral nucleic acid purification, DNA cleanup after PCR
and sequencing, target enrichment, and library preparation for sequencing. We continue to expand our portfolio for
applications such as preparing DNA and RNA from minimally-invasive liquid biopsies for cancer and processing
difficult samples for research into the microbiome and metagenomics.
Our assay technologies contain all the needed reagents to enable customers to target molecules of interest for
detection on platforms supporting PCR, NGS or multimodal analysis. Each assay kit is sufficient to support a number
of applications, varying from a single application to kits containing more than 1,000 applications each. Applications
include open, general-purpose PCR reagents, as well as kits for the detection of viral or bacterial pathogens and
parasites, pharmacogenomic testing and genotyping. In PCR, examples are our therascreen family of companion
diagnostics, artus line for profiling infectious diseases, and investigator assays for forensics and human identification.
A growing portfolio of Digital NGS panels enable sequencing to target DNA or RNA variants for clinical research in
cancer or other diseases.
Related revenues, accounting for approximately 7%-8% of our net sales, include bioinformatics solutions, sold as
freestanding software or cloud-based solutions and also integrated into many QIAGEN consumables and instruments
for seamless Sample to Insight workflows. Examples of our bioinformatics solutions:
Ingenuity Variant Analysis, a powerful cloud-based platform tapping into the QIAGEN Knowledge Base, interprets
data from NGS analysis to efficiently filter genetic variants and interpret links to diseases.
QIAGEN Clinical Insight, a unique evidence-based decision support solution, draws on the QIAGEN Knowledge
Base to deliver clinically relevant insights from complex genomic variants identified in NGS.
CLC Genomics Workbench incorporates cutting-edge technology and algorithms to overcome challenges face by
scientists in analyzing and visualizing data from all major NGS platforms.
GeneGlobe, a web-based portal, enables researchers to search and select gene- and pathway-specific solutions
from approximately 25 million pre-designed and custom PCR assay kits, NGS panels and other products.
Related revenues also include royalties, milestone payments from co-development agreements with pharmaceutical
companies, payments from technology licenses and patent sales, and custom services, such as whole genome
amplification services, DNA sequencing, and non-cGMP DNA production on a contract basis.
Automation platforms and instruments
Our instrumentation systems, contributing approximately 12%-13% of net sales together with related services and
contracts, automate the use of consumables into efficient workflows for a broad range of laboratory needs. QIAGEN
platforms are designed to carry our customers from Sample to Insight - handling and preparation of biological
samples, analysis using sequencing technologies, and interpretation that delivers valuable insights. These instruments
enable laboratories to perform reliable and reproducible processes, including nucleic acid sample preparation,
assay setup, target detection, and interpretation of genomic information. Often several of these instruments are
integrated into end-to-end workflows.
Among the automation platforms that contribute to QIAGEN’s business:
QIAsymphony is a user-friendly automation system that is driving a new era of integrated workflow, making
molecular testing more efficient and helping disseminate standardized, clinically proven molecular diagnostics. The
platform includes three modules - QIAsymphony SP for sample preparation, QIAsymphony AS for assay setup, and
Rotor-Gene Q, our rotary real-time PCR cycler system, which makes sequences of DNA and RNA visible through
amplification and quantifiable. The fully integrated system with all three modules is QIAsymphony RGQ. In 2017,
our installed base surpassed 2,000 QIAsymphony systems worldwide, serving in a wide variety of laboratories
and applications. The platform offers many features to enhance workflows, such as continuous loading, random
access and the ability to process an almost unlimited range of sample types. QIAsymphony has the broadest
content menu in its category in Europe and other markets, and QIAGEN is developing more regulator-approved
assays to add value for customers.
GeneReader NGS System, introduced in late 2015, continues to gain acceptance as the first complete Sample to
Insight next-generation sequencing (NGS) solution designed for any laboratory to deliver actionable results. This
end-to-end platform provides a simpler, more cost-effective way for basic and translational research to take
advantage of NGS technology and improve outcomes. The GeneReader workflow offers the flexibility of scalable
batch sizes and continuous loading of multiple flow cells, and customers can create relevant reports using
QIAGEN's proven gene panels and bioinformatics solutions. In 2017, we continued to enhance performance and
added new content, including QIAact panels for deep analysis of lung, breast and ovarian cancers, as well as
customized panels for users' specific needs. GeneReader's digital sequencing integrates seamlessly with QIAGEN
bioinformatics solutions for interpretation.
QIAcube robotic workstations provide highly versatile solutions for automated sample processing, with novel
technologies for purification of DNA, RNA and proteins, saving laboratory staff time and enabling standardized
results in analysis using PCR or NGS.
QIAxcel replaces traditional slab-gel analysis, eliminating time-consuming nucleic acid separation methods in low-
to high-throughput labs and offering unprecedented sensitivity and time-to-results for analysis of DNA fragments
and RNA.
QIAgility is a compact benchtop instrument that enables rapid, high-precision PCR setup supporting almost all tube
and plate formats, as well as Rotor-Discs for the Rotor-Gene Q.
ESEQuant portable, battery-operated instruments enable optical measurement for Point of Need molecular testing
in physician practices, emergency rooms, remote areas, and other settings with limited or delayed access to
laboratories.
Customers
With a growing portfolio of innovative products for molecular testing, QIAGEN has built deep customer relationships
across the entire value chain of the life sciences. Discoveries often surface in universities and research institutes and
are published, then are licensed for development by pharmaceutical and biotech companies, and finally move into
widespread commercial use in healthcare and other areas of life. We serve the needs of four major customer
classes:
Molecular Diagnostics - healthcare providers engaged in patient care including hospitals, public health
organizations, reference laboratories and physician practices
Applied Testing - government or industry customers using molecular technologies in fields such as forensics,
veterinary diagnostics and food safety testing
Pharma - pharmaceutical and biotechnology companies using molecular testing to support drug discovery,
translational medicine and clinical development efforts
Academia - researchers exploring the secrets of life such as disease mechanisms and pathways, in some cases
translating findings into drug targets or other products
Molecular Diagnostics
The ability of advanced diagnostic technologies to unlock molecular information for patients is changing the practice
of medicine, creating a large and growing market for nucleic acid sample preparation, assay technologies and
bioinformatics in clinical care. Dissemination of PCR and other amplification technologies has brought molecular
diagnostics into routine use in healthcare around the world, and next-generation sequencing is rapidly disseminating,
further transforming healthcare. Technologies for molecular diagnostics enable clinicians and labs to identify and
profile microorganisms, cancer cells, bacteria and viruses by detecting specific nucleic acid sequences or
characterizing newly discovered genomic sequences related to diseases. Commercial applications are multiplying as
researchers identify new biological markers for disease and develop novel technologies to decipher these diagnostic
clues.
The molecular diagnostics market generates total sales estimated by industry experts at approximately $7 billion in
2017, including about $3-4 billion potentially addressable with QIAGEN's product portfolio. Molecular diagnostics
is the most dynamic segment of the global in vitro diagnostics market and is growing at a compound annual rate
estimated in the high single-digits or low double-digits. Given the advantages of precise genetic information over
traditional tests, QIAGEN expects the healthcare market to continue to provide significant growth opportunities.
In QIAGEN’s robustly growing Molecular Diagnostics business we focus on three priorities for fighting disease:
Oncology - accurately diagnosing cancer, enabling prevention or early detection, and guiding selection of
therapies with individualized molecular insights. QIAGEN offers a broad portfolio of companion diagnostic kits
and panels to detect mutations of genes such as KRAS, EGFR, BRAF, BRCA1/2 and others that influence the
efficacy and safety of medicines. We also provide industry-leading tests to screen for human papillomavirus (HPV)
and protect women from cervical cancer.
Infectious diseases - detecting and differentiating a broad range of viral and bacterial infections, including
diseases such as HIV, hepatitis, influenza and healthcare-associated infections. Use of molecular testing to
differentiate among pathogens can be useful in guiding treatment, such as selection of antibiotic or antiviral
therapies.
Immune monitoring - using advanced technologies that detect immune-system markers as a preventive strategy,
such as screening patients for latent TB infection to guard against active TB disease, as well as for monitoring
immune function, such as in transplantation patients.
QIAGEN offers one of the broadest portfolios of molecular technologies for healthcare. Success in Molecular
Diagnostics depends on the ability to accurately analyze purified nucleic acid samples from sources such as blood,
tissue, body fluids and stool, on automated systems that process these samples reliably and efficiently, often handling
hundreds of samples concurrently. Other success factors are the range of assays for diseases and biomarkers,
convenience and ease of laboratory workflow, and reliability and standardization of lab procedures.
The immune monitoring portfolio, using sensitive QuantiFERON technology, accurately detects infection and
measures immune response in patients. Our lead products in this field, QuantiFERON-TB Gold and QuantiFERON-TB
Gold Plus, are used in tuberculosis (TB) control efforts worldwide to detect latent TB infection (LTBI) by screening
vulnerable populations, such as close contacts of patients with active TB disease, immunocompromised persons or
patients on immunosuppressive drugs. Individuals with LTBI can then be treated, preventing the infection from
becoming active and contagious. As modern blood tests analyzed in a laboratory, the QuantiFERON-TB assays are
faster, less labor-intensive and more accurate than the century-old tuberculin skin test. The potential global market for
latent TB infection testing is estimated at up to $1 billion.
QIAGEN's oncology test portfolio includes a broad range of Personalized Healthcare technologies and biomarkers,
including regulator-approved companion diagnostics for oncogenes such as KRAS, EGFR and JAK2, as well as
comprehensive gene panels for research applications in next-generation sequencing. In 2017, we launched the
ipsogen JAK2 RGQ PCR Kit in the United States for use in blood cancers. In Europe, we already offer a market-
leading portfolio of ipsogen assays for common and rare leukemia types. The U.S. approval for our therascreen
EGFR RGQ PCR Kit was expanded in early 2018 for use as a companion diagnostic to diagnose additional EGFR
gene mutations in metastatic non-small cell lung cancer (NSCLC).
QIAGEN also offers an extensive range of kits for diagnosing infectious diseases, and we are expanding this
portfolio by seeking regulatory approvals of new tests in additional markets.
QIAGEN is the global leader in screening technologies for HPV, a viral infection that is the primary cause of cervical
cancer, which kills about 270,000 women a year. Our “gold standard” digene HC2 HPV Test and our careHPV Test
for use in low-resource regions lead the market in HPV screening around the world. In the United States, QIAGEN
remains a market leader although vigorous price competition has reduced that business to about 2% of total sales.
A key success factor for our growth in Molecular Diagnostics is enabling laboratories to efficiently use our assay
technologies on QIAGEN automation platforms. Our flagship PCR platform is QIAsymphony, based on its flexibility
and unique capabilities. We offer broad portfolios of companion diagnostics and infectious disease tests running on
the QIAsymphony system. We also are developing companion diagnostics for our GeneReader NGS System and
Modaplex platform. Nucleic acid samples purified on our instruments are ready for use in the demanding and
sensitive downstream assays performed in molecular diagnostic applications. We market assays directly via
QIAGEN sales channels, and selected assays through major diagnostic partners or other companies to broaden the
distribution of our products.
Applied Testing
Use of molecular technologies is expanding in more areas of life as industry and government organizations apply
standardized Sample to Insight solutions to diverse needs. Applied Testing is our term for applications outside of
human healthcare and research - such as human identification and forensics, food and environmental safety, and
veterinary testing. The value of genetic “fingerprinting” has been shown for criminal investigations or clarification of
paternity or ancestry, public policy compliance for food safety and genetically modified organisms (GMOs), and
containment of diseases in commercial livestock.
QIAGEN has developed relationships with diverse molecular testing laboratories and continually innovates to meet
their needs. In 2017, QIAGEN helped the International Commission on Missing Persons launch a cutting-edge next-
generation sequencing lab for forensic DNA identification, deploying the GeneReader NGS System and other
solutions. We are a leader in standardizing solutions for reliable forensic testing, and in 2017 we received
international certification for manufacturing human ID products. In environmental research, QIAGEN’s solutions for
metagenomics are increasingly used in studies of microbiomes and their effect on health.
Pharma
QIAGEN has deep relationships with pharmaceutical and biotechnology companies. Drug discovery and
translational research efforts increasingly employ genomic information, both to guide research in diseases and to
differentiate patient populations most likely to respond to particular therapies. We estimate that about half of
QIAGEN sales in this customer class support research, while the other half supports clinical development, including
stratification of patient populations based on genetic information. QIAGEN's bioinformatics solutions also are widely
used to guide pharmaceutical research.
We have built a position as the preferred partner for pharmaceutical and biotech companies to co-develop
companion diagnostics paired with targeted drugs. A wave of newly discovered biomarkers and molecular tests
indicating the likely efficacy and safety of associated drugs is now transforming the treatment of cancer and other
diseases. In 2017, we surpassed 25 master collaboration agreements with Pharma, each enabling multiple co-
development projects. These alliances have created a rich pipeline of molecular tests that can move, along with the
drugs, through clinical trials and regulatory approvals for marketing to healthcare providers. Several new companion
diagnostics are currently in the registration process.
In addition to our broad portfolio of molecular technologies, QIAGEN offers Pharma partners a full infrastructure for
co-development programs, intellectual property on platforms and content, extensive regulatory experience, global
marketing reach, and independence as a company focusing exclusively on these types of technologies.
Academia
QIAGEN provides Sample to Insight solutions to leading research institutions around the world. While many
academic laboratories continue to use manual, labor-intensive methods or create their own in-house technologies,
QIAGEN has focused on enabling labs to replace time-consuming traditional methods and internal development
efforts with reliable, fast, highly reproducible, and high-quality technologies. QIAGEN often partners with leading
institutions in research projects and develops customized solutions such as NGS panels for digital sequencing of
multiple gene targets needed for a researcher's study.
As academic institutions increasingly embrace translational research, bridging from discoveries to practical
applications in medicine, our relationships in Academia also support our presence in the Molecular Diagnostics,
Pharma and Applied Testing customer classes. Research in university settings often helps in development of
technologies for targeted biomolecules, and academic research also can result in scientific publications that validate
the usefulness of QIAGEN solutions.
Global Presence by Category of Activity and Geographic Market
Product Category Information
Net sales for the product categories are attributed based on those revenues related to sample and assay products
and similarly related revenues including bioinformatics solutions, and revenues derived from instrumentation sales.
(in thousands)
Net Sales
Consumables and related revenues
Instrumentation
Total
2017
2016
2015
$ 1,242,715
$ 1,166,131
$ 1,114,580
174,821
171,860
166,406
$ 1,417,536
$ 1,337,991
$ 1,280,986
Geographical Information
QIAGEN currently markets products in more than 130 countries. The following table shows total revenue by
geographic market for the past three years (net sales are attributed to countries based on the location of the
customer, as certain subsidiaries have international distribution):
(in thousands)
Net Sales
Americas:
United States
Other Americas
Total Americas
Europe, Middle East and Africa
Asia Pacific and Rest of World
Total
2017
2016
2015
$ 579,906
$ 555,676
$ 525,532
73,478
71,797
79,578
653,384
627,473
605,110
462,980
428,055
409,955
301,172
282,463
265,921
$ 1,417,536
$ 1,337,991
$ 1,280,986
QIAGEN has built an increasing presence in key emerging markets as a growth strategy. In 2017, the top seven
emerging markets - Brazil, Russia, India, China, South Korea, Mexico and Turkey - contributed approximately 16%
of net sales.
Research and Development
We are committed to expanding our global leadership in Sample to Insight solutions for molecular testing in
healthcare and the life sciences. Our strategy for managing innovation focuses on addressing the most significant
unmet medical and scientific needs. We target our resources to develop promising technologies for use by our
customers in Molecular Diagnostics, Applied Testing, Pharma and Academia - and to meet the needs of clinicians
and scientists in key geographic markets.
Innovation at QIAGEN follows parallel paths:
Creating new systems for automation of workflows - platforms for laboratories, hospitals and other users of these
novel molecular technologies.
Expanding our broad portfolio of novel “content” - including assays to detect and measure biomarkers for disease
or genetic identification.
Integrating bioinformatics with the testing process - software and cloud-based resources to interpret and transform
raw molecular data into useful insights.
As a percentage of sales, our research and development investments are among the highest in our industry. Almost
1,000 employees in research and development work in QIAGEN centers of excellence on three continents.
Strengthening our leadership in the automation of laboratories is a key to driving dissemination of molecular testing
in healthcare and other fields, as well as generating increased demand for our consumable products. We continue to
expand the applications of our modular QIAsymphony platform, enabling hospitals and other customers to adopt or
greatly expand their use of molecular diagnostics. QIAGEN also is rolling out a range of performance enhancements
and expansions for our GeneReader NGS System to add value by addressing new applications and improving
output and connectivity within labs.
We are commercializing a deep pipeline of assays for preventive screening and diagnostic profiling of diseases,
detection of biomarkers to guide personalized medicine in cancer and other diseases, and a range of other targets.
Our development program generates commercial launches of tests that add value to our QIAsymphony and
GeneReader NGS platforms. In 2017, we launched novel infectious disease tests and companion diagnostics for
QIAsymphony, as well as additional QIAact panels for deep analysis of lung, breast and ovarian cancers using the
GeneReader NGS System. In Applied Testing, we continue to develop new content for human identification and
environmental applications. We are also expanding our extensive portfolio of products for disease pathway research
by Pharma and Academic customers. In addition, we are developing assays for specific applications in key markets
such as China and Japan.
Our bioinformatics teams are developing new software solutions and adding proprietary cloud-based content to
support the latest research and clinical trends in molecular testing, especially the interpretation of large volumes of
data from next-generation sequencing. In addition, we are integrating these digital technologies with instruments and
molecular content to provide our customers seamless Sample to Insight workflows.
Sales and Marketing
We market our products in more than 130 countries, mainly through subsidiaries in markets that we believe have the
greatest sales potential in the Americas, Europe, Australia and Asia. Experienced marketing and sales staff, many of
them scientists with academic degrees in molecular biology or related areas, sell our products and provide direct
support to customers. Key accounts are overseen by business managers to ensure that we serve customers’
commercial needs, such as procurement processes, financing, data on costs and value of our systems, and
collaborative relationships. In many markets, we have specialized independent distributors and importers.
Our marketing strategy focuses on providing differentiated, high-quality products across the value chain from Sample
to Insight, integrating components into end-to-end solutions when possible, and enhancing relationships with
commitment to technical excellence and customer service. Our “omni-channel” approach seeks to engage customers
through their preferred channels - online, by phone, in person, etc. – and to optimize investment in different customer
types.
QIAGEN has initiated actions to drive the growth of our digital marketing channels - including our website
(www.qiagen.com), product-specific sites and social media. Our website makes ordering easy with a fully
searchable online product catalog and ordering. The site can be viewed in Chinese and Japanese, and contains
selected information in French, German and Korean. Our eCommerce team works with clients to provide automated
processes supporting a variety of electronic transactions and all major eProcurement systems. Information contained
on our website, or accessed through it, is not part of this Annual Report.
Our GeneGlobe Genes & Pathways web portal (www.geneglobe.com) is a valuable outreach to scientists in Pharma
and Academia, enabling researchers to search and order from approximately 25 million pre-designed and custom
PCR assay kits, NGS assay panels and other products. We have integrated GeneGlobe with our bioinformatics
solutions, linking biological interpretation with ordering of relevant assays to accelerate research.
QIAGEN uses a range of tools to provide customers with direct access to technical support, inform them of new
product offerings, and enhance our reputation for technical excellence, high-quality products and commitment to
service. For example, our technical service hotline allows existing or potential customers to discuss a wide range of
questions about our products and molecular biology procedures, online or via phone, with Ph.D. and M.Sc. scientists
at QIAGEN. Frequent communication with customers enables us to identify market needs, learn of new developments
and opportunities, and respond with new products.
We also distribute publications, including our catalog, to existing and potential customers worldwide, providing new
product information, updates, and articles about existing and new applications. In addition, we hold numerous
scientific seminars at clinical, academic and industrial research institutes worldwide and at major scientific and
clinical meetings. We conduct direct marketing campaigns to announce new products and special promotions, and
we offer personalized electronic newsletters highlighting molecular biology applications.
For laboratories that frequently rely on our consumables, the QIAstock program maintains inventory on-site to keep
up with their requirements. QIAGEN representatives make regular visits to replenish the stock and help with other
needs, and we are automating this process with digital technologies. Easy-to-use online ordering, inventory
monitoring and customer-driven changes make QIAstock an efficient system for providing ready access to our
products for the hundreds of customers worldwide who use this program.
Seasonality
Our business does not experience significant, predictable seasonality. Historically, a significant portion of our sales
have been to researchers, universities, government laboratories and private foundations whose funding is dependent
upon grants from government agencies, such as the National Institutes of Health and similar bodies. To the extent
that our customers experience increases, decreases or delays in funding arrangements and budget approvals, and to
the extent that any of our customers' activities are slowed, such as during times of higher unemployment, vacation
periods or delays in the approval of government budgets, we may experience fluctuations in sales volumes during
the year or delays from one period to the next in the recognition of sales.
Intellectual Property, Proprietary Rights and Licenses
We have made and expect to continue to make investments in intellectual property. In 2017, our purchases of
intangible assets totaled $34.3 million. While we do not depend solely on any individual patent or technology, we
are significantly dependent in the aggregate on technology that we own or license. Therefore, we consider
protection of proprietary technologies and products one of the major keys to our business success. We rely on a
combination of patents, licenses and trademarks to establish and protect proprietary rights. As of December 31,
2017, we owned 362 issued patents in the United States, 279 issued patents in Germany and 1,825 issued patents
in other major industrialized countries. We had 638 pending patent applications. Our policy is to file patent
applications in Western Europe, the United States and Japan. U.S. patents have a term of 17 years from the date of
issue (for patents issued from applications submitted prior to June 8, 1995), or 20 years from the date of filing (in the
case of patents issued from applications submitted on or after June 8, 1995). Patents in most other countries have a
term of 20 years from the date of filing the patent application. We intend to aggressively prosecute and enforce
patents and to otherwise protect our proprietary technologies. We also rely on trade secrets, know-how, continuing
technological innovation and licensing opportunities to develop and maintain our competitive position.
Our practice is to require employees, consultants, outside scientific collaborators, sponsored researchers and other
advisers to execute confidentiality agreements upon commencement of their relationships with us. These agreements
provide that all confidential information developed by or made known to the individual during the course of the
relationship is to be kept confidential and not disclosed to third parties, subject to a right to publish certain
information in scientific literature in certain circumstances and to other specific exceptions. In the case of our
employees, the agreements provide that all inventions conceived by individuals in the course of their employment will
be our exclusive property.
See “Risk Factors” included in section “Opportunities and Risks” for details regarding risks related to our reliance on
patents and proprietary rights.
Competition
In the Academic and Pharma markets, we believe our primary competition in sample technology products involves
traditional separation and purification methods, such as phenol extraction, cesium chloride density gradient
centrifugation, and precipitation. These methods utilize widely available reagents and other chemicals supplied by
companies such as Merck KGaA (MilliporeSigma business) and Roche Diagnostics GmbH (Applied Sciences
Division). We compete with these methods through innovative technologies and products, offering a comprehensive
solution for nucleic acid collection, pre-treatment, separation and purification needs and providing significant
advantages in speed, reliability, convenience, reproducibility and ease of use.
We also experience competition in various markets from other companies providing sample preparation products in
kit form and assay solutions. These competitors include, but are not limited to, Promega Corp., EMD Millipore or
Merck Millipore, and Macherey-Nagel GmbH for nucleic acid separation and purification; Thermo Fisher and
Promega Corp. for assay solutions and for transfection reagents; and Merck KGaA (MilliporeSigma business) and
Thermo Fisher for protein fractionation products. We believe our proprietary technologies and products offer
significant advantages over competitors' products with regard to purity, speed, reliability and ease-of-use.
Some of our other products within our molecular diagnostics customer class, such as tests for Chlamydia, Gonorrhea,
hepatitis B virus, herpes simplex virus and CMV, compete against existing screening, monitoring and diagnostic
technologies, including tissue culture and antigen-based diagnostic methodologies. Our competitors for gene-based
diagnostic assays include Roche Diagnostics, Thermo Fisher, Abbott, and Danaher. We believe the primary
competitive factors in the market for gene-based probe diagnostics and other screening devices are clinical
validation, performance and reliability, ease of use, standardization, cost, proprietary position, competitors' market
shares, access to distribution channels, regulatory approvals and reimbursement.
We do not believe our competitors typically have the same comprehensive approach to sample to insight solutions as
we do or the ability to provide the broad range of technologies and depth of products and services that we offer.
With our complete range of manual and fully automated solutions, we believe we offer the value of standardization
of procedures and, therefore, more reliable results. We also believe our integrated strategic approach gives us a
competitive advantage. The quality of sample technologies-an area in which we have a unique market and
leadership position-is a key prerequisite for reliable molecular assay solutions, which increasingly are being applied
in emerging markets such as Molecular Diagnostics and Applied Testing.
Current and potential competitors may be in the process of seeking FDA or foreign regulatory approvals for their
respective products. Our continued future success will depend in large part on our ability to maintain our
technological advantage over competing products, expand our market presence and preserve customer loyalty.
There can be no assurance that we will be able to compete effectively in the future or that development by others will
not render our technologies or products non-competitive.
Suppliers
As part of our supplier assessment procedures, we evaluate on a monthly basis the performance of our raw material
and component suppliers, potential new alternative sources of such materials and components, and the risks and
benefits of reliance on our existing suppliers. We buy materials for our products from many suppliers, and are not
dependent on any one supplier or group of suppliers for our business as a whole. Raw materials generally include
chemicals, raw separation media, biologics, plastics, electronics and packaging. Raw materials are generally
readily available at competitive, stable prices from a number of suppliers. Certain raw materials are produced under
our specifications, so we closely monitor stock levels to maintain adequate supplies. We believe we maintain
inventories at a sufficient level to ensure reasonable customer service levels and to guard against normal volatility in
availability.
Government Regulations
We are subject to a variety of laws and regulations in the European Union, the United States and other countries.
The level and scope of the regulation varies depending on the country or defined economic region, but may include,
among other things, the research, development, testing, clinical trials, manufacture, storage, recordkeeping,
approval, labeling, promotion and commercial sales and distribution, of many of our products.
European Union Regulations
In the European Union, in vitro diagnostic medical devices (IVDs) are regulated under EU-Directive 98/79/EC (IVD
Directive) and corresponding national provisions. The IVD Directive requires that medical devices meet the essential
requirements set out in an annex of the directive. These requirements include the safety and efficacy of the devices.
According to the IVD Directive, the Member States presume compliance with these essential requirements in respect
of devices which are in conformity with the relevant national standards transposing the harmonized standards of
which the reference numbers have been published in the Official Journal of the European Communities. These
harmonized standards include ISO 13485:2003, the quality standard for medical device manufacturers.
IVD medical devices, other than devices for performance evaluation, must bear the CE marking of conformity when
they are placed on the market. The CE mark is a declaration by the manufacturer that the product meets all the
appropriate provisions of the relevant legislation implementing the relevant European Directive. As a general rule,
the manufacturer must follow the procedure of the EC Declaration of conformity to obtain this CE marking.
Each European country must adopt its own laws, regulations and administrative provisions necessary to comply with
the IVD Directive. Member States may not create any obstacle to the placing on the market or the putting into service
within their territory of devices bearing the CE marking according to the conformity assessment procedures.
On May 25, 2017, the European Commission (EC) enacted new EU regulations for medical devices and IVDs that
impose additional legal regulatory requirements on MD/IVDs used in the EU. These new regulations will come into
full effect after a 5-year transition period. All products will require approval under the new law and no
grandfathering of existing approvals will be allowed. Once implemented, the entire EU IVD industry will have to
comply with these new requirements, which will bring the EU regulatory landscape on par with other highly
regulated markets such as the US. Many Guidance Documents and other regulatory mechanisms will need to be
established during this transition. It is anticipated that it will be late in 2019 before the infrastructure is established to
begin the new approvals process.
U.S. Regulations
In the United States, in vitro diagnostic kits are subject to regulation by the FDA as medical devices and must be
cleared or approved before they can be marketed. Failure to comply with applicable U.S. requirements may subject
a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending PMAs,
warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions,
fines, civil penalties and criminal prosecution. In addition, some of our test kits are sold for research use only in the
United States. We do not promote these tests for clinical diagnostic use, and they are labeled “For Research Use
Only,” or RUO, as required by the FDA.
In Vitro Diagnostics
The FDA regulates the sale or distribution of medical devices, including in vitro diagnostic test kits and some Lab
Developed Tests (LDTs). The information that must be submitted to the FDA in order to obtain clearance or approval
to market a new medical device varies depending on how the medical device is classified by the FDA. Medical
devices are classified into one of three classes on the basis of the controls deemed by the FDA to be necessary to
reasonably ensure their safety and effectiveness. Class I devices are subject to general controls, including labeling,
pre-market notification and adherence to the FDA’s quality system regulations, which are device-specific good
manufacturing practices. Class II devices are subject to general controls and special controls, including performance
standards and post-market surveillance. Class III devices are subject to most of the previously identified requirements
as well as to pre-market approval. All Class I devices are exempt from premarket review; most Class II devices
require 510(k) clearance, and all Class III devices must receive premarket approval before they can be sold in the
United States. The payment of a fee, that is subject to frequent adjustment, to the FDA is usually required when a
510(k) notice or premarket approval application is submitted.
510(k) Premarket Notification. A 510(k) notification requires the sponsor to demonstrate that a medical device is
substantially equivalent to another marketed device, termed a “predicate device”, that is legally marketed in the
United States and for which a premarket approval application (PMA) was not required. A device is substantially
equivalent to a predicate device if it has the same intended use and technological characteristics as the predicate; or
has the same intended use but different technological characteristics, where the information submitted to the FDA
does not raise new questions of safety and effectiveness and demonstrates that the device is at least as safe and
effective as the legally marketed device.
The FDA generally issues a decision letter within 90 days of receipt of the 510(k) if it has no additional questions or
sends a first action letter requesting additional information within 75 days. Most 510(k)s do not require clinical data
for clearance, but a minority will. Requests for additional data, including clinical data, will increase the time
necessary to review the notice. If the FDA believes that the device is not substantially equivalent to a predicate
device, it will issue a “Not Substantially Equivalent” letter and designate the device as a Class III device, which will
require the submission and approval of a PMA before the new device may be marketed. Under certain
circumstances, the sponsor may petition the FDA to make a risk-based determination of the new device and reclassify
the new device as a Class I or Class II device. The FDA continues to reevaluate the 510(k) review process, and we
cannot predict what if any changes will occur.
Premarket Approval. The PMA process is more complex, costly and time consuming than the 510(k) process. A PMA
must be supported by more detailed and comprehensive scientific evidence, including clinical data, to demonstrate
the safety and efficacy of the medical device for its intended purpose. If the device is determined to present a
“significant risk,” the sponsor may not begin a clinical trial until it submits an investigational device exemption (IDE)
to the FDA and obtains approval to begin the trial.
After the PMA is submitted, the FDA has 45 days to make a threshold determination that the PMA is sufficiently
complete to permit a substantive review. If the PMA is complete, the FDA will file the PMA. The FDA is subject to a
performance goal review time for a PMA that is 180 days from the date of filing, although in practice this review
time is longer. Questions from the FDA, requests for additional data and referrals to advisory committees may delay
the process considerably. The total process may take several years and there is no guarantee that the PMA will ever
be approved. Even if approved, the FDA may limit the indications for which the device may be marketed. The FDA
may also request additional clinical data as a condition of approval or after the PMA is approved. Any changes to
the medical device may require a supplemental PMA to be submitted and approved before changed medical device
may be marketed.
Any products sold by us pursuant to FDA clearances or approvals will be subject to pervasive and continuing
regulation by the FDA, including record keeping requirements, reporting of adverse experiences with the use of the
device and restrictions on the advertising and promotion of our products. Device manufacturers are required to
register their establishments and list their devices with the FDA and are subject to periodic inspections by the FDA
and certain state agencies. Noncompliance with applicable FDA requirements can result in, among other things,
warning letters, fines, injunctions, civil penalties, recalls or seizures of products, total or partial suspension of
production, refusal of the FDA to grant 510(k) clearance or PMA approval for new devices, withdrawal of 510(k)
clearances and/or PMA approvals and criminal prosecution.
Regulation of Companion Diagnostic Devices
If a sponsor or the FDA believes that a diagnostic test is essential for the safe and effective use of a corresponding
therapeutic product, the sponsor of the therapeutic product will typically work with a collaborator to develop an in
vitro companion diagnostic device, or IVD. IVDs are regulated by the FDA as medical devices. The FDA issued a
final guidance document in 2014, entitled “In Vitro Companion Diagnostic Devices” that is intended to assist
companies developing in vitro companion diagnostic devices and companies developing therapeutic products that
depend on the use of a specific in vitro companion diagnostic for the safe and effective use of the product. The FDA
defined an IVD companion diagnostic device as a device that provides information that is essential for the safe and
effective use of a corresponding therapeutic product. The FDA expects that the therapeutic sponsor will address the
need for an approved or cleared IVD companion diagnostic device in its therapeutic product development plan and
that, in most cases, the therapeutic product and its corresponding IVD companion diagnostic will be developed
contemporaneously.
It also issued a draft guidance on July 15, 2016, entitled, “Principles for Codevelopment of an In Vitro Companion
Diagnostic Device with a Therapeutic Product” to serve as a practical guide to assist therapeutic product sponsors
and IVD sponsors in developing a therapeutic product and an accompanying IVD companion diagnostic.
The FDA indicated that it will apply a risk-based approach to determine the regulatory pathway for IVD companion
diagnostic devices, as it does with all medical devices. This means that the regulatory pathway will depend on the
level of risk to patients, based on the intended use of the IVD companion diagnostic device and the controls
necessary to provide a reasonable assurance of safety and effectiveness. The two primary types of marketing
pathways for medical devices are clearance of a premarket notification under Section 510(k) of the Federal Food,
Drug, and Cosmetic Act, or 510(k), and approval of a premarket approval application, or PMA. We expect that any
IVD companion diagnostic device developed for use with our drug candidates will utilize the PMA pathway and that
a clinical trial performed under an investigational device exemption, or IDE, will have to be completed before the
PMA may be submitted.
The FDA expects that the therapeutic sponsor will address the need for an IVD companion diagnostic device in its
therapeutic product development plan and that, in most cases, the therapeutic product and its corresponding IVD
companion diagnostic device will be developed contemporaneously. If the companion diagnostic test will be used to
make critical treatment decisions such as patient selection, treatment assignment, or treatment arm, it will likely be
considered a significant risk device for which a clinical trial will be required.
The sponsor of the IVD companion diagnostic device will be required to comply with the FDA’s IDE requirements that
apply to clinical trials of significant risk devices. If the diagnostic test and the therapeutic drug are studied together to
support their respective approvals, the clinical trial must meet both the IDE and IND requirements.
PMAs must be supported by valid scientific evidence, which typically requires extensive data, including technical,
preclinical, clinical and manufacturing data, to demonstrate to the FDA’s satisfaction the safety and effectiveness of
the device. For diagnostic tests, a PMA typically includes data regarding analytical and clinical validation studies. As
part of its review of the PMA, the FDA will conduct a pre-approval inspection of the manufacturing facility or facilities
to ensure compliance with the Quality System Regulation, or QSR, which requires manufacturers to follow design,
testing, control, documentation and other quality assurance procedures. FDA review of an initial PMA may require
several years to complete.
If the FDA evaluations of both the PMA and the manufacturing facilities are favorable, the FDA will either issue an
approval order or an approvable letter, which usually contains a number of conditions that must be met in order to
secure the final approval of the PMA. If the FDA’s evaluation of the PMA or manufacturing facilities is not favorable,
the FDA will send the applicant a not approvable letter or an order denying approval. A not approvable letter will
outline the deficiencies in the application and, where practical, will identify what is necessary to make the PMA
approvable. The FDA may also determine that additional clinical trials are necessary, in which case the PMA
approval may be delayed for several months or years while the trials are conducted and then the data submitted in
an amendment to the PMA. Once granted, PMA approval may be withdrawn by the FDA if compliance with post
approval requirements, conditions of approval or other regulatory standards is not maintained or problems are
identified following initial marketing.
After approval, the use of an IVD companion diagnostic device with a therapeutic product will be stipulated in the
instructions for use in the labeling of both the diagnostic device and the corresponding therapeutic product. In
addition, a diagnostic test that was approved through the PMA process or one that was cleared through the 510(k)
process and placed on the market will be subject to many of the same regulatory requirements that apply to
approved drugs. The FDA has approved a number of drug/diagnostic device companions in accordance with the
Guidance.
In September 2013, the FDA issued its final rule on the Unique Device Identifier. This rule now requires an additional
registered identifier, including a special barcode, on all FDA regulated medical devices. The rule is implemented in
phases with the first deadline of September 24, 2014 being established for all Class III medical devices. For
QIAGEN, this impacted the hc2, QuantiFERON, and therascreen products. We established a task force to ensure
that the deadline was met but this will place additional administrative and regulatory burden on us related to the
annual reporting of compliance of these products to the new regulation. Class II and Class I products are required to
have this same labeling as of September 24, 2016 and 2018, respectively. QIAGEN was fully compliant with the
new rule by the September 2014 and 2016 deadlines and we continue to work to ensure that we will be able to
meet the remaining deadlines. The new rule will also require additional compliance oversight now that it has been
implemented. The requirements are now required to be confirmed as part of our annual reporting and PMA
submissions. They are also assessed during site inspections by the U.S. FDA.
Some of our products are sold for research purposes in the U.S., and labeled “For Research Use Only” (RUO) or “for
molecular biology applications.” In November 2013, the FDA issued a final Guidance for Industry and Food and
Drug Administration Staff entitled, “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or
Investigational Use Only.” In the Guidance, RUO refers to devices that are in the laboratory phase of development,
and investigational use only, or IUO, refers to devices that are in the product testing phase of development. These
types of devices are exempt from most regulatory controls. Because we do not promote our RUOs for clinical
diagnostic use or provide technical assistance to clinical laboratories with respect to these tests, we believe that these
tests are exempt from FDA’s premarket review and other requirements. If the FDA were to disagree with our
designation of any of these products, we could be forced to stop selling the product until we obtain appropriate
regulatory clearance or approval. Further, it is possible that some of our RUOs may be used by some customers
without our knowledge in their LDTs, which they develop, validate and promote for clinical use. However, as
previously noted, we do not promote these products for use in LDTs or assist in the development of the LDTs for
clinical diagnostic use.
The 21st Century Cures Act (Cures Act) was enacted into law on December 13, 2016, after a bipartisan, multi-year
effort. The Cures Act primarily affects activities of the Department of Health and Human Services (HHS) and its
agencies, including the Food and Drug Administration (FDA or the Agency). On June 6, 2017, Scott Gottlieb, M.D.,
Commissioner of Food and Drugs, reported to Congress as required by the Cures Act. This report included the Food
& Drug Administration Work Plan and Proposed Funding Allocations of FDA Innovation Account (Required by
Section 1002 of the 21st Century Cures Act (Public Law 114-255). This is now being implemented with a broad
spectrum of initiatives within the FDA with the goal to support patients with improved and timely access to safe and
efficacious medical products. For industry, it is anticipated that some processes will become less burdensome with
more rapid approval/clearance cycles while others will continue to require significant investment.
HIPAA and Other Privacy and Security Laws
Numerous privacy and data security laws apply to personal information, including health information. These laws
vary in their application. For example, the Health Insurance Portability and Accountability Act of 1996, as amended
by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations
(HIPAA), regulate the uses, disclosures and security of identifiable health information (protected health information or
PHI) in the hands of certain health care providers, health plans or health care clearing houses (covered entities).
HIPAA regulates and limits covered entities’ uses and disclosures of PHI and requires the implementation of
administrative, physical and technical safeguards to keep PHI secure. HIPAA also applies to organizations that
create, receive, maintain or transmit PHI to provide services to or for or on behalf of covered entities (business
associates). Business associates and certain of their subcontractors are required to comply with certain privacy and
all of the security standards of HIPAA. Business associates and covered entities must also comply with breach
notification standards established by HIPAA. The HIPAA breach notification standards require covered entities to
notify affected individuals, the government, and in some cases, local and national media in the event of a breach of
PHI that has not been secured in accordance with HIPAA standards, such as by encryption. The breach notification
standards require business associates to notify covered entity customers of their own breaches of unsecured PHI so
that the relevant covered entity may make required notifications. In the ordinary course, HIPAA does not apply to us
directly, but if we were to act as a HIPAA covered entity or business associate, we would be subject to these
obligations. Most of our institutional and physician customers are covered entities under HIPAA and must obtain
proper authorization or de-identify information so that we may provide services. When PHI is de-identified in
accordance with HIPAA or when the disclosure of PHI is authorized by a patient, HIPAA does not impose any
compliance obligations on the recipient, but our use and disclosure of the information may be limited by contract or
the terms of the authorization.
We are subject to enforcement by state attorneys general who have authority to enforce state data privacy or
security laws. Accordingly, we maintain an active privacy and data security program designed to address
applicable regulatory compliance requirements.
Almost all states have adopted data breach notification laws relating to the “personal information” of its residents.
Personal information typically includes an individual’s name or initials coupled with social security, financial account,
debit, credit or state-issued identification number or other information that could lead to identity theft. There is
significant variability under these laws, but most require notification to affected individuals (and some require
notification to the government) in the event of breach. Other laws of some states require that that we comply with
data security obligations. These laws may apply to us when we receive or maintain personal information regarding
individuals, including our employees.
The Genetic Information Nondiscrimination Act of 2008, also referred to as GINA, is a federal law that protects
individuals from discrimination in the health insurance and employment contexts because of DNA characteristics that
may affect their health. GINA prohibits covered employers from requesting, obtaining, or using employees’ genetic
information (subject to limited exceptions), and prohibits covered health insurers from requesting genetic information
or using any such information they may already have for purposes of making eligibility, premium, or coverage-
related decisions.
Many states have also adopted genetic testing and privacy laws. These laws typically require a specific, written
consent for genetic testing as well as consent for the disclosure of genetic test results and otherwise limit uses and
disclosures of genetic testing results. A few states have adopted laws that give their residents property rights in their
genetic information.
Privacy and data security laws, including those relating to health information, are complex, overlapping and rapidly
evolving. As our activities evolve and expand, additional laws may be implicated, for example, there are non-U.S.
privacy laws, such as the General Data Protection Regulation (GDPR) of the European Union, that impose restrictions
on the transfer, access, use, and disclosure of health and other personal information. Currently, we are implementing
the requirements set forth by the GDPR, which is set to take effect on May 25, 2018. All of these laws impact our
business either directly or indirectly. Our failure to comply with applicable privacy or security laws or significant
changes in these laws could significantly impact our business and future business plans. For example, we may be
subject to regulatory action or lawsuits in the event we fail to comply with applicable privacy laws. We may face
significant liability in the event any of the personal information we maintain is lost or otherwise subject to misuse or
other wrongful use, access or disclosure.
Compliance with Fraud and Abuse Laws
We have to comply with various U.S. federal and state laws, rules and regulations pertaining to healthcare fraud
and abuse, including anti-kickback laws and physician self-referral laws, rules and regulations. Violations of the
fraud and abuse laws are punishable by criminal and civil sanctions, including, in some instances, exclusion from
participation in federal and state healthcare programs, including Medicare and Medicaid.
Anti-Kickback Statute
The federal Anti-Kickback Statute prohibits persons from knowingly or willfully soliciting, receiving, offering or paying
remuneration, directly or indirectly, in exchange for or to induce:
The referral of an individual for a service or product for which payment may be made by Medicare, Medicaid or
other government-sponsored healthcare program; or
purchasing, ordering, arranging for, or recommending the ordering of, any service or product for which payment
may be made by a government-sponsored healthcare program.
The definition of “remuneration” has been broadly interpreted to include anything of value, including such items as
gifts, certain discounts, waiver of payments, and providing anything at less than its fair market value. In addition,
several courts have interpreted the law to mean that if “one purpose” of an arrangement is intended to induce
referrals, the statute is violated.
The Anti-Kickback Statue is broad and prohibits many arrangements and practices that are lawful in businesses
outside of the healthcare industry. Recognizing that the Anti-Kickback Statute is broad and may technically prohibit
many innocuous or beneficial arrangements, the Office of Inspector General of the Department of Health and Human
Services (OIG) has issued regulations, commonly known as "safe harbors." These safe harbors set forth certain
requirements that, if fully met, will insulate healthcare providers, medical device manufacturers, and others, from
prosecution under the Anti-Kickback Statute. Although full compliance with these safe harbor provisions ensures
against prosecution under the Anti-Kickback Statute, full compliance is often difficult and the failure of a transaction
or arrangement to fit within a specific safe harbor does not necessarily mean that the transaction or arrangement is
illegal or that prosecution under the Anti-Kickback Statute will be pursued. However, conduct and business
arrangements that do not fully satisfy each applicable safe harbor may result in increased scrutiny by government
enforcement authorities such as the OIG. The statutory penalties for violating the Anti-Kickback Statute include
imprisonment for up to five years and criminal fines of up to $25,000 per violation. In addition, through application
of other laws, conduct that violates the Anti-Kickback Statute can also give rise to False Claims Act lawsuits, civil
monetary penalties and possible exclusion from Medicare and Medicaid and other federal healthcare programs. In
addition to the Federal Anti-Kickback Statute, many states have their own kickback laws. Often, these laws closely
follow the language of the federal law, although they do not always have the same scope, exceptions, safe harbors
or sanctions. In some states, these anti-kickback laws apply not only to payment made by a government health care
program but also with respect to other payors, including commercial insurance companies.
We have and may in the future, enter into various agreements with health care providers who perform services for
us, including some who make clinical decisions to use our products. All such arrangements have been structured with
the intention of complying with all applicable fraud and abuse laws, including the Anti-Kickback Statute.
Other Fraud and Abuse Laws
The federal False Claims Act (FCA) prohibits any person from knowingly presenting, or causing to be presented, a
false claim or knowingly making, or causing to made, a false statement to obtain payment from the federal
government. Those found in violation of the FCA can be subject to fines and penalties of three times the damages
sustained by the government, plus mandatory civil penalties of between $5,500 and $11,000 for each separate
false claim. Actions filed under the FCA can be brought by any individual on behalf of the government, a "qui tam"
action, and such individual, known as a "relator" or, more commonly, as a "whistleblower," who may share in any
amounts paid by the entity to the government in damages and penalties or by way of settlement. In addition, certain
states have enacted laws modeled after the FCA, and this legislative activity is expected to increase. Qui tam actions
have increased significantly in recent years, causing greater numbers of healthcare companies, including medical
device manufacturers, to defend false claim actions, pay damages and penalties or be excluded from Medicare,
Medicaid or other federal or state healthcare programs as a result of investigations arising out of such actions.
The federal ban on physician self-referrals, commonly known as the Stark Law, prohibits, subject to certain
exceptions, physician referrals of Medicare and Medicaid patients to an entity providing certain “designated health
services” if the physician or an immediate family member of the physician has any financial relationship with the
entity. Penalties for violating the Stark Law include fines, civil monetary penalties and possible exclusion from federal
healthcare programs. In addition to the Stark Law, many states have their own self-referral laws. Often, these laws
closely follow the language of the federal law, although they do not always have the same scope, exceptions or safe
harbors.
The OIG also has authority to bring administrative actions against entities for alleged violations of a number of
prohibitions, including the Anti-Kickback Statute and the Stark Law. The OIG may seek to impose civil monetary
penalties or exclusion from the Medicare, Medicaid and other federal healthcare programs. Civil monetary penalties
can range from $2,000 to $50,000 for each violation or failure plus, in certain circumstances, three times the
amounts claimed in reimbursement or illegal remuneration. Typically, exclusions last for five years.
In addition, we must comply with a variety of other laws, such as laws prohibiting false claims for reimbursement
under Medicare and Medicaid, all of which can also be triggered by violations of federal anti-kickback laws; the
Health Insurance Portability and Accounting Act of 1996, which makes it a federal crime to commit healthcare fraud
and make false statements; and the Federal Trade Commission Act and similar laws regulating advertisement and
consumer protections.
There are also an increasing number of state “sunshine” laws that require manufacturers to provide reports to state
governments on pricing and marketing information. Several states have enacted legislation requiring manufacturers,
including medical device companies to, among other things, establish marketing compliance programs, file periodic
reports with the state, make periodic public disclosures on sales and marketing activities, and to prohibit or limit
certain other sales and marketing practices. In addition, a federal law known as the Physician Payments Sunshine
Act, requires manufacturers, including medical device manufacturers, to track and report to the federal government
certain payments and other transfers of value made to physicians and teaching hospitals and ownership or
investment interests held by physicians and their immediate family members. The federal government discloses the
reported information on a publicly available website. If we fail to track and report as required by these laws or to
otherwise comply with these laws, we could be subject to the penalty provisions of the pertinent state and federal
authorities.
Despite extensive procedures to ensure compliance, we may also be exposed to liabilities under the U.S. Foreign
Corrupt Practices Act, or FCPA, which generally prohibits companies and their intermediaries from making corrupt
payments to foreign officials for the purpose of obtaining or maintaining business or otherwise obtaining favorable
treatment, and requires companies to maintain adequate record-keeping and internal accounting practices to
accurately reflect the transactions of the company. We are also subject to a number of other laws and regulations
relating to money laundering, international money transfers and electronic fund transfers. These laws apply to
companies, individual directors, officers, employees and agents.
Environment, Health and Safety
We are subject to laws and regulations related to the protection of the environment, the health and safety of
employees and the handling, transportation and disposal of medical specimens, infectious and hazardous waste and
radioactive materials. For example, the U.S. Occupational Safety and Health Administration (OSHA) has established
extensive requirements relating specifically to workplace safety for healthcare employers in the U.S. This includes
requirements to develop and implement multi-faceted programs to protect workers from exposure to blood-borne
pathogens, such as HIV and hepatitis B and C, including preventing or minimizing any exposure through needle stick
injuries. For purposes of transportation, some biological materials and laboratory supplies are classified as
hazardous materials and are subject to regulation by one or more of the following agencies: the U.S. Department of
Transportation, the U.S. Public Health Service, the United States Postal Service and the International Air Transport
Association.
Other Country Specific Requirements
In many countries outside of the United States and the EU, coverage, pricing and reimbursement approvals are also
required. Additionally, many of the major markets are adopting regulations and requirements similar to U.S. Food
and Drug Administration (FDA) which require additional submission activities and management of country specific
regulatory requirements. This is being led by the International Medical Device Regulators Forum (IMDRF). This Forum
consists of regulators from around the world that have signed governmental agreements to align global regulations,
especially around submissions and approvals. In the long term this holds the promise of reducing volatility and
complexity in the regulatory landscape.
Reimbursement
United States
In the United States, payments for diagnostic tests come from several sources, including third party payors such as
health maintenance organizations and preferred provider organizations; government health programs such as
Medicare and Medicaid; and, in certain circumstances, hospitals, referring laboratories or the patients themselves.
For many years, federal and state governments in the United States have pursued methods to reduce the cost of these
programs. For example, in 2010, the United States enacted major healthcare reform legislation known as the Patient
Protection and Affordable Care Act (ACA). Such changes have had, and are expected to continue to have, an
impact on our business. At present, Medicare payment rates are affected by across-the-board federal budget cuts
commonly referred to as “sequestration.” Under sequestration, the Centers for Medicare & Medicaid Services (CMS),
the federal agency responsible for administering Medicare and Medicaid, reduced Medicare payments to providers
by 2% annually beginning in 2013 and through 2023.
We frequently identify value propositions on our products and communicate them to payors, providers, and patient
stakeholders and attempt to positively impact coverage, coding and payment pathways. However, we have no direct
control over payor decisions with respect to coverage and payment levels for our products. The manner and level of
reimbursement may depend on the site of care, the procedure(s) performed, the final patient diagnosis, the device(s)
and/or drug(s) utilized, the available budget, or a combination of these factors, and coverage and payment levels
are determined at each payor’s discretion. Changes in reimbursement levels or methods may positively or negatively
affect sales of our products in any given country for any given product. At QIAGEN, we work with several
specialized reimbursement consulting companies and maintain regular contact with payers.
As government programs seek to expand healthcare coverage for their citizens, they have at the same time sought to
control costs by limiting the amount of reimbursement they will pay for particular procedures, products or services.
Many third-party payors have developed payment and delivery mechanisms to support cost control efforts and to
focus on paying for quality. Such mechanisms include payment reductions, pay for performance metrics, quality-
based performance payments, restrictive coverage policies, studies to compare effectiveness and patient outcomes,
and technology assessments. These changes have increased emphasis on the delivery of more cost-effective and
quality-driven healthcare Code Assignment. In the United States, a third-party payor's decisions regarding coverage
and payment are impacted, in large part, by the specific Current Procedural Terminology, or CPT, code used to
identify a test. The American Medical Association, or AMA, publishes the CPT, which is a listing of descriptive terms
and identifying codes for reporting medical services and procedures. The purpose of the CPT is to provide a uniform
language that accurately describes medical, surgical, and diagnostic services and therefore to ensure reliable
nationwide communication among healthcare providers, patients, and third-party payors. CMS uses its own HCPCS
codes for medical billing and reimbursement purposes. Level I HCPCS codes reflect current CPT codes, while Level II
codes primarily represent non-physician services and Level III codes are local codes developed by Medicaid
agencies, Medicare contractors and private insurers.
A manufacturer of in vitro diagnostic kits or a provider of laboratory services may request establishment of a
Category I CPT code for a new product. Assignment of a specific CPT code ensures routine processing and payment
for a diagnostic test by both private and government third-party payors.
The AMA has specific procedures for establishing a new CPT code and, if appropriate, for modifying existing
nomenclature to incorporate a new test into an existing code. If the AMA concludes that a new code or modification
of nomenclature is unnecessary, the AMA will inform the requestor how to use one or more existing codes to report
the test.
While the AMA's decision is pending, billing and collection may be sought under an existing, non-specific CPT code.
A manufacturer or provider may decide not to request assignment of a CPT code and instead use an existing, non-
specific code for reimbursement purposes. However, use of such codes may result in more frequent denials and/or
requests for supporting clinical documentation from the third-party payor and in lower reimbursement rates, which
may vary based on geographical location.
CMS reimbursement rates for clinical diagnostic tests are defined by HCPS code in the Clinical Laboratory Fee
Schedule (CLFS). In 2012, the AMA added 127 new CPT codes for molecular pathology services that became
effective on January 1, 2013. These new CPT codes are biomarker specific and were designed to replace the
previous methodology of billing for molecular pathology testing, which involved “stacking” a series of non-biomarker
specific CPT codes together to describe the testing performed. CMS issued final national reimbursement prices for the
new CPT codes in November 2013. These federal reimbursement amounts are widely acknowledged to be lower
than the reimbursement obtained by the now outdated “stacking” method, but commercial payors and Medicare
contractors are still in the process of solidifying their coverage and reimbursement policies for the testing described
by these new CPT codes. As of January 1, 2018, in accordance with the Protecting Access to Medicare Act of 2014
(PAMA), CMS began calculating Medicare reimbursement rates for certain clinical diagnostic tests using weighted
median private payor rates, which are based on rate information reported by applicable laboratories. This new rate
methodology means the lower reimbursement rates previously experienced in the field of molecular pathology testing
now extends to additional diagnostic testing codes on the CLFS.
Coverage Decisions. When deciding whether to cover a particular diagnostic test, private and government third-
party payors generally consider whether the test is a contractual benefit and, if so, whether it is reasonable and
necessary for the diagnosis or treatment of an illness or injury. However, most third-party payors do not cover
experimental services. Coverage determinations are often influenced by current standards of practice and clinical
data, particularly at the local level. CMS, the government agency responsible for overseeing the Medicare program,
has the authority to make coverage determinations on a national basis, but most Medicare coverage decisions are
made at the local level by contractors that administer the Medicare program in specified geographic areas. Private
and government third-party payors have separate processes for making coverage determinations, and private third-
party payors may or may not follow Medicare's coverage decisions. If a third-party payor has a coverage
determination in place for a particular diagnostic test, billing for that test must comply with the established policy.
Otherwise, the third-party payor makes reimbursement decisions on a case-by-case basis.
Payment. Payment for covered diagnostic tests is determined based on various methodologies, including prospective
payment systems and fee schedules. In addition, private third-party payors may negotiate contractual rates with
participating providers or set rates as a percentage of the billed charge. Diagnostic tests furnished to Medicare
inpatients generally are included in the bundled payment made to the hospital under Medicare's Inpatient
Prospective Payment System, utilizing Diagnosis Related Groups (DRGs) depending on the patient’s condition.
Payment for diagnostic tests furnished to Medicare beneficiaries in outpatient settings is based on the CLF, under
which a payment amount is assigned to each covered CPT code, or through the Outpatient Prospective Payment
System (OPPS), which is the outpatient equivalent of the DRG model. The law technically requires fee schedule
amounts to be adjusted annually by the percentage increase in the consumer price index (CPI) for the prior year, but
Congress has frozen payment rates in certain years. Medicaid programs generally pay for diagnostic tests based on
a fee schedule, but reimbursement varies by state.
European Union
In the European Union, the reimbursement mechanisms used by private and public health insurers vary by country.
For the public systems, reimbursement is determined by guidelines established by the legislator or responsible
national authority. As elsewhere, inclusion in reimbursement catalogues focuses on the medical usefulness, need,
quality and economic benefits to patients and the healthcare system. Acceptance for reimbursement comes with cost,
use, and often volume restrictions, which again can vary by country.
Conflict Minerals
Recent U.S. legislation has been enacted to improve transparency and accountability concerning the sourcing of
conflict minerals from mines located in the conflict zones of the Democratic Republic of Congo (DRC) and its
adjoining countries. The term conflict minerals currently encompasses tantalum, tin, tungsten (or their ores) and gold.
Certain of our instrumentation product components which we purchase from third party suppliers contain gold. This
U.S. legislation requires manufacturers, such as us, to investigate our supply chain and disclose if there is any use of
conflict minerals originating in the DRC or adjoining countries. We conduct due diligence measures annually to
determine the presence of conflict minerals in our products and the source of any such conflict minerals. Because we
do not purchase conflict minerals directly from smelters or refineries, we rely on our suppliers to specify to us their
Conflict Minerals sources and declare their conflict minerals status. We disclosed our most recent Conflict Minerals
findings to the Securities Exchange Commission for the calendar year ending December 31, 2016 on Form SD on
April 24, 2017 and will provide updated disclosure to the Securities Exchange Commission as required.
Organizational Structure
QIAGEN N.V. is the holding company for more than 50 consolidated subsidiaries, many of which have the primary
function of distributing our products and services on a regional basis. Certain subsidiaries also have research and
development or production activities. A listing of our significant subsidiaries and their jurisdictions of incorporation is
included in Exhibit 8.1 of the 2017 Annual Report on Form 20-F files with the U.S. Securities and Exchange
Commission.
Description of Property
Our production and manufacturing facilities for consumable products are located in Germany, the United States,
China, and the United Kingdom. Our facilities for software development are located in the United States, Germany,
Poland and Romania. In recent years, we have made investments in automated and interchangeable production
equipment to increase our production capacity and improve efficiency. Our production and manufacturing
operations are highly integrated and benefit from sophisticated inventory control. Production management personnel
are highly qualified, and many have advanced degrees in engineering, business and science. We also have
installed and continue to expand production-planning systems that are included in our integrated information and
control system based on the SAP R/3 business software package from SAP AG. Worldwide, we use SAP software to
integrate most of our operating subsidiaries. Capital expenditures for property, plant and equipment totaled $90.1
million, $74.5 million and $97.8 million for 2017, 2016 and 2015, respectively.
We have an established quality system, including standard manufacturing and documentation procedures, intended
to ensure that products are produced and tested in accordance with the FDA's Quality System Regulations, which
impose current Good Manufacturing Practice (cGMP) requirements. For cGMP production, special areas were built in
our facilities in Hilden, Germany, and Germantown, Maryland. These facilities operate in accordance with cGMP
requirements.
The consumable products manufactured at QIAGEN GmbH in Germany, and QIAGEN Sciences LLC in Maryland,
are produced under ISO 9001: 2008, ISO 13485:2012, ISO 13485:2003 CMDCAS. Our certifications form part
of our ongoing commitment to provide our customers with high-quality, state-of-the-art sample and assay technologies
under our Total Quality Management system.
Our facilities in Hilden, Germany, currently occupy a total of approximately 781,000 square feet, some of which is
leased pursuant to separate contracts, the last of which expires in 2018. Our most recent expansion to these facilities
was in 2017 and included approximately 4,400 square feet of additional office and warehouse space. Our
production capacity is increased through our manufacturing and research facilities in the United States. QIAGEN
Sciences, LLC owns a 24-acre site in Germantown, Maryland. The 285,000 square foot Germantown facility consists
of several buildings in a campus-like arrangement and can accommodate over 500 employees. There is room for
future expansion of up to 300,000 square feet of facility space. In 2015, we completed expansion of our research
and production facilities in Hilden, Germany and renovations of administrative facilities in Germantown, Maryland.
We lease a facility in Frederick, Maryland comprising 42,000 square feet for manufacturing, warehousing,
distribution and research operations. We also lease facilities in Massachusetts with 32,400 square feet in Waltham
for NGS system development and 39,100 square feet in Beverly for enzyme manufacturing. Additionally, we have
leased facilities in Redwood City, California with 12,700 square feet and Cary, North Carolina with 10,900 square
feet focused on bioinformatics. Additionally, we lease smaller facilities in Shenzhen, China and Manchester, United
Kingdom for manufacturing, warehousing, distribution and research operations and have shared service centers
which lease facilities in Wroclaw, Poland and Manila, Philippines. Other subsidiaries throughout the world lease
smaller amounts of space. Our corporate headquarters are located in leased office space in Venlo, The Netherlands.
We believe our existing production and distribution facilities can support anticipated production needs for the next
36 months. Our production and manufacturing operations are subject to various federal, state, and local laws and
regulations including environmental regulations. We do not believe we have any material issues relating to these
laws and regulations.
MANAGEMENT REPORT
Opportunities and Risks
QIAGEN, like any other company, has business operations that involve
significant opportunities and risks. Effective management is paramount to
safeguarding the sustainable value creation, and the central task of the
leadership team. Managing opportunities and risks is an integral part of the
corporate governance system in place throughout QIAGEN, not the task of one
particular organizational unit. Management systems are in place to aggregate
all risks and opportunities for review at the Managing Board and Supervisory
Board levels of QIAGEN N.V., and these are reviewed on a routine basis.
According to our current assessment, we consider the opportunities and risks to
be manageable and the survival of QIAGEN not to be endangered at the end
of 2017, which was the same position taken at the end of 2016. This
assessment is supported by our strong balance sheet and the current business
outlook, and further supported by the positive historical response to our external
financing demands. As a result, QIAGEN has not sought an official rating by
any of the leading ratings agencies. We are confident in the future earnings
strength of QIAGEN and have access to the resources to pursue value-creating
business opportunities.
Opportunities
As an international company, QIAGEN is exposed to a wide variety of developments in the various markets in which
it operates. Our mission is to “make improvements in life possible” by capturing growth opportunities presented by
the dissemination of molecular technologies across the four customer classes in Molecular Diagnostics, Applied
Testing, Pharma and Academia. Due to increased life expectancy for people living in developed countries, and also
the dynamic growth of healthcare demand in many emerging markets, the need for innovative diagnostics is
increasing at a marked pace. This is underscored by the proven benefits of diagnostics to improve healthcare
outcomes, particularly the advent of companion diagnostics to personalize healthcare, while still representing a small
fraction of overall healthcare expenditures. Our internal R&D activities present major opportunities, and we are
working to find new products and improve existing ones across our portfolio of Sample to Insight solutions. We also
continuously evaluate potential additional opportunities across our four customer classes as an integral part of our
strategy. All of these factors represent future growth opportunities for QIAGEN.
One of the most important senior management tasks at QIAGEN is to identify and assess opportunities as early as
possible and to initiate appropriate measures in order to maximize the fullest value of opportunities and transform
them into business success. QIAGEN evaluates organic growth opportunities each year as part of its annual budget
planning process, and on an ongoing basis during the year, especially in dynamically changing areas of the
business portfolio. These evaluations are based on proposals for new products, services and technologies developed
within QIAGEN. This cross-functional process involves a careful analysis of the market environment and competitive
positioning, as well as additional factors such as expected development timelines, regulatory and reimbursement
issues when evaluating organic opportunities. Business plans include information about the product or service
planned to be developed, along with profiles on target customers and competitors, market size and barriers to entry.
It also outlines the resources required for implementation. As part of this process, these plans are subjected to a
uniform profitability analysis to determine the net present value of an investment and the opportunities to create value
(as measured with QIAGEN Value Added, or QVA) and generate returns that exceed the Group’s cost of capital
after a multi-year period. The monitoring of growth initiatives is done through regular reporting to the Supervisory
Board, which receives reports on a frequent basis during the year about the status and progress of key initiatives.
Project management and the supporting central functions report directly to Peer M. Schatz, the CEO of QIAGEN.
Risk Management
Our risk management approach embodies the key elements of a sound risk management system including (1) active
Supervisory Board and senior management involvement; (2) adequate policies and procedures; (3) adequate risk
management, monitoring and information systems; and (4) comprehensive internal controls.
QIAGEN is managed by a Managing Board and an independent Supervisory Board appointed by the General
Meeting of Shareholders. One of the Managing Board's responsibilities is the oversight of the risk management
system. The Managing Board has developed and implemented strategies, controls and mitigation measures to
identify current and developing risks as part of the risk management system. Risk management policies and
procedures are embodied in our corporate governance, code of ethics and financial reporting controls and
procedures. A variety of functional experts evaluate these business risks, attempting to mitigate and manage these
risks on an ongoing basis.
Identified risks are subdivided into three types:
A base business risk that is specific to us or our industry and threatens our existing business;
A business growth risk that is specific to us or our industry and threatens our future business growth; and
An underlying business risk that is not specific to us or our industry, but applies to a larger number of public
companies.
All identified risks are evaluated based on their likelihood of occurring and their potential impact (estimated in
monetary terms) in disrupting our progress in achieving our business objectives. The overall risk management goal is
to identify risks that could significantly threaten our success and to allow management on a timely basis the
opportunity to successfully implement mitigation actions. The results of the risk assessment, and any updates, are
reported to the Audit Committee of the Supervisory Board on a regular basis. A detailed risk reporting update is
provided each quarter to the Audit Committee for specific risks that have been newly identified or have changed
since the previous assessment. At least once on an annual basis, the Supervisory Board discusses the corporate
strategy and business risks as well as the results of an assessment by the Managing Board and the Audit Committee
of the structure and operations of the internal risk management and control systems, including any significant
changes.
Our corporate governance structure is based on a strong framework that outlines the responsibilities of our
Managing and Supervisory Boards (discussed in more detail in Item 10 of the 2017 Annual Report on Form 20-F
files with the U.S. Securities and Exchange Commission) and the function of the Audit Committee of the Supervisory
Board (discussed in more detail in Item 6 of the 2017 Annual Report on Form 20-F files with the U.S. Securities and
Exchange Commission). We maintain adequate internal controls over financial reporting to ensure the integrity of
financial reporting, which is described further in Item 15 of this Annual Report. Additionally, we have a Compliance
Committee that consists of senior executives from various functional areas who are responsible for ensuring
compliance with legal and regulatory requirements, as well as overseeing the communication of corporate policies,
including our Code of Ethics as described further in Item 16B of the 2017 Annual Report on Form 20-F.
Base Business
Risk
Business Growth
Risk
Underlying
Business Risk
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Risk Types
Identification and monitoring of competitive business threats
Monitoring complexity of product portfolio
Monitoring dependence on key customers for single product groups
Reviewing dependence on individual production sites or suppliers
Evaluating purchasing initiatives, price controls and changes to reimbursements
Monitoring production risks, including contamination prevention, high-quality product assurance
Ensuring ability to defend against intellectual property infringements and maintain competitive advantage after expiration
Managing development and success of key R&D projects
Managing successful integration of acquisitions to achieve anticipated benefits
Evaluating financial risks, including economic risks and currency rate fluctuations
Monitoring financial reporting risks, including multi-jurisdiction tax compliance
Reviewing possible asset impairment events
Assessing compliance and legal risks, including safety in operations and environmental hazard risks, compliance with various
regulatory bodies and pending product approvals
Monitoring risks of FCPA (Foreign Corrupt Practices Act) or antitrust concerns arising from a network of subsidiaries and
distributors in foreign countries
The risks described below are listed in the order of our current view of their expected significance. Describing the
risk factors in order of significance does not imply that a lower listed risk factor may not have a material adverse
impact on our results of operations, liquidity or capital resources.
Risks
Our continued growth is dependent on the development and success of new products.
Rapid technological change and frequent new product introductions are typical in the markets we serve. Our success
will depend in part on continuous, timely development and introduction of new products that address evolving market
requirements. We believe successful new product introductions provide a significant competitive advantage because
customers make an investment of time in selecting and learning to use a new product and are reluctant to switch
thereafter. To the extent that we fail to introduce new and innovative products, or such products suffer significant
delays in development or are not accepted in the market, we may lose market share to our competitors, which will
be difficult or impossible to regain. An inability to successfully develop and introduce new products, for technological
or other reasons, could reduce our growth rate or otherwise have an adverse effect on our business. In the past, we
have experienced delays in the development and introduction of products, including regulatory approvals, and we
may experience delays in the future.
As a result, we cannot assure you that we will keep pace with the rapid rate of change in our markets or that our
new products will adequately meet the requirements of the marketplace, achieve market acceptance or regulatory
approval or compete successfully with competitive technologies. Some of the factors affecting market acceptance of
new products include:
availability, quality and price relative to competitive products;
the timing of introduction of the new product relative to competitive products;
opinions of the new product’s utility;
citation of the new product in published research;
regulatory trends and approvals; and
general trends in life sciences research, applied markets and molecular diagnostics.
In the development of new products we may make significant investments in intellectual property and software. These
investments increase our fixed costs, resulting in higher operational costs in the short term that will negatively impact
our gross profit and operating income until products reach a minimum level of market acceptance. The expenses or
losses associated with unsuccessful product development activities or lack of market acceptance of our new products
could materially adversely affect our business, financial condition and results of operations.
Our continued growth depends significantly on the success of new products in the molecular testing markets we
serve. Important new product programs underway include our modular medium-throughput QIAsymphony automation
platform, our GeneReader NGS System for next-generation sequencing (NGS), sample and assay technologies
designed either for QIAGEN instruments or for "universal" use on other platforms, and bioinformatics solutions to
analyze and interpret genomic data.
The speed and level of adoption of our QIAsymphony and GeneReader NGS platforms will affect sales not only of
instrumentation but also of consumables, sample and assay kits, designed to run on the systems. The rollouts of
QIAsymphony and GeneReader NGS System are intended to drive the dissemination and increasing sales of
consumables for these systems. We are developing or co-developing new kits for each of these platforms and
seeking regulatory approvals for a number of these new products. In turn, the availability and regulatory approval of
more tests to run on QIAsymphony or GeneReader NGS System, especially molecular assays for specific diseases or
companion diagnostics paired with new drugs, will influence the value of the instruments to prospective buyers.
Slower adoption of QIAsymphony, including the complete QIAsymphony RGQ system, or the GeneReader NGS
System could significantly affect sales of products designed to run on these platforms.
Our strategic initiative in NGS, including rollout of the GeneReader NGS System and related consumables, aims to
drive the adoption of this technology in clinical research and diagnostics. This involves development and
commercialization of universal pre-analytic and bioinformatics products for NGS, as well as commercialization of
our proprietary GeneReader NGS workflow and related consumables. The market for next-generation sequencing
instruments is very competitive, and the speed and level of adoption of our universal solutions and the GeneReader
workflow will affect sales of our Sample to Insight solutions.
An inability to manage our growth, manage the expansion of our operations, or successfully integrate acquired
businesses could adversely affect our business.
Our business has grown, with total net sales increasing to $1.42 billion in 2017 from $1.30 billion in 2013. We
have made a series of acquisitions in recent years, including the acquisitions of OmicSoft Corporation in 2017,
Exiqon A/S in 2016, MO BIO Laboratories in 2015, Enzymatics and BIOBASE in 2014, and Ingenuity and CLC bio
in 2013. We intend to identify and acquire other businesses in the future, including the acquisition of STAT-Dx
expected in 2018, that support our strategy to build on our global leadership position in Sample to Insight solutions.
The successful integration of acquired businesses requires a significant effort and expense across all operational
areas.
We have also made significant investments to expand our business operations. We completed an expansion project
in Germany in early 2012 and another at our facility in Germantown, Maryland, for research, production and
administrative space in 2013. We completed two smaller-scale building projects in 2015. These projects increased
our fixed costs, resulting in higher operational costs in the short term that will negatively impact our gross profit and
operating income until we more fully utilize the additional capacity of these facilities. In addition, we have invested
in establishing and expanding shared service centers in Poland and the Philippines, opening new commercial
operations in emerging markets to expand our geographic footprint, and implementing digitization of business
processes to increase efficiency and improve customer experiences. The expansion of our business and the addition
of new personnel may place a strain on our management and operational systems. As we continue to upgrade our
operating and financial systems and expand the geographic presence of our operations, we intend to continue to
assess the need for reallocation of existing resources or the hiring of new employees as well as increased
responsibilities for both existing and new management personnel.
Our future operating results will depend on the ability of our management to continue to implement and improve our
research, product development, manufacturing, sales and marketing and customer support programs, enhance our
operational and financial control systems, expand, train and manage our employee base, integrate acquired
businesses, and effectively address new issues related to our growth as they arise. There can be no assurance that
we will be able to manage our recent or any future expansion or acquisitions successfully, and any inability to do so
could have a material adverse effect on our results of operations.
Our acquisitions expose us to new risks, and we may not achieve the anticipated benefits of acquisitions of
technologies and businesses.
During the past several years, we have acquired and integrated a number of companies through which we have
gained access to new technologies, products and businesses that complement our internally developed product lines.
In the future, we expect to acquire additional technologies, products or businesses to expand our operations.
Acquisitions expose us to new operating and other risks, including risks associated with the:
assimilation of new products, technologies, operations, sites and personnel;
integration and retention of fundamental personnel and technical expertise;
application for and achievement of regulatory approvals or other clearances;
diversion of resources from our existing products, business and technologies;
generation of sales to offset associated acquisition costs;
implementation and maintenance of uniform standards and effective controls and procedures;
maintenance of relationships with employees and customers and integration of new management personnel;
issuance of dilutive equity securities;
incurrence or assumption of debt and contingent liabilities;
amortization or impairment of acquired intangible assets or potential businesses; and
exposure to liabilities of and claims against acquired entities.
Our failure to address the above risks successfully in the future may prevent us from achieving the anticipated
benefits from any acquisition in a reasonable time frame, or at all.
Global economic conditions could adversely affect our business, results of operations and financial condition.
Our results of operations could be materially affected by adverse general conditions in the global economy and
financial markets. Changes in the availability or reimbursement of our diagnostic testing products by insurance
providers and healthcare maintenance organizations could also have a significant adverse impact on our results of
operations.
Access to financing in the global financial markets has also been adversely affected for many businesses during
challenging economic times. The uncertainty surrounding the resolution of the economic and sovereign debt crisis in
Europe continues to have a negative impact on financial markets and economic conditions more generally. Our
customers may face internal financing pressures that adversely impact spending decisions, the ability to purchase our
products or that lead to a delay in collection of receivables and thus negatively impact our cash flow. A severe or
prolonged economic downturn could result in a variety of risks to our business that would adversely impact our
results of operations, including the reduction or delay in planned improvements to healthcare systems in various
countries, the reduction of funding for life sciences research, and intensified efforts by governments and healthcare
payors regarding cost-containment efforts.
Our results of operations could also be negatively impacted by any governmental actions or inaction resulting in
automatic government spending cuts (sequestration) that may take effect (as in the U.S. in 2013). These conditions
may add uncertainty to the timing and budget for investment decisions by our customers, particularly, researchers,
universities, government laboratories and private foundations whose funding is dependent upon grants from
government agencies, such as the U.S. National Institutes of Health (NIH) and similar bodies.
As is the case for many businesses, we face the following risks in regard to financial markets:
severely limited access to financing over an extended period of time, which may affect our ability to fund our
growth strategy and could result in delays to capital expenditures, acquisitions or research and development
projects;
failures of currently solvent financial institutions, which may cause losses from our short-term cash investments or
our hedging transactions due to a counterparty’s inability to fulfill its payment obligations;
inability to refinance existing debt at competitive rates, reasonable terms or sufficient amounts; and
increased volatility or adverse movements in foreign currency exchange rates.
We may encounter delays in receipt, or limits in the amount, of reimbursement approvals and public health funding,
which will impact our ability to grow revenues in the healthcare market or may negatively impact our profitability.
Third-party payors are often reluctant to reimburse healthcare providers for the use of medical tests that involve new
technologies or provide novel diagnostic information. In addition, third-party payors are increasingly limiting
reimbursement coverage for medical diagnostic products and, in many instances, are exerting pressure on diagnostic
product suppliers to reduce their prices. Since each third-party payor often makes reimbursement decisions on an
individual patient basis, obtaining such approvals is a time-consuming and costly process that requires us to provide
scientific and clinical data supporting the clinical benefits of each of our products. As a result, there can be no
assurance that reimbursement approvals will be obtained and the process can delay the broad market introduction of
new products. As a result, third-party reimbursement may not be consistent or financially adequate to cover the cost
of our products. This could limit our ability to sell our products or cause us to reduce prices, which would adversely
affect our results of operations.
Further, the ability of many of our customers to successfully market their products depends in part on the extent to
which reimbursement for the costs of these products is available from governmental health administrations, private
health insurers and other organizations. Governmental and other third-party payors are increasingly seeking to
contain healthcare costs and to reduce the price of medical products and services. For example, in 2010, the Patient
Protection and Affordable Care Act, or ACA, was enacted with the goal of expanding coverage, increasing quality
of care and reducing costs through payment innovation, among other things. Both Congress and President Trump
have expressed their intention to repeal or repeal and replace the ACA, and as a result certain sections of the ACA
have not been fully implemented or effectively repealed. The uncertainty around the future of the ACA, and in
particular the impact to reimbursement levels, may lead to uncertainty or delay in the purchasing decisions of our
customers, which may in turn negatively impact our product sales. As of January 1, 2018, in accordance with the
Protecting Access to Medicare Act of 2014 (PAMA), the Centers for Medicare & Medicaid Services began
calculating Medicare reimbursement rates for certain clinical diagnostic tests using weighted median private payor
rates, which are based on rate information reported by applicable laboratories. This new rate methodology means
the lower reimbursement rates previously experienced in the field of molecular pathology testing now extends to
additional diagnostic testing codes on the Clinical Laboratory Fee Schedule. If there are not adequate reimbursement
levels, our business and results of operations could be adversely affected.
Reduction in research and development budgets and government funding may result in reduced sales.
Our customers include researchers at pharmaceutical and biotechnology companies, academic institutions, and
government and private laboratories. Fluctuations in the research and development budgets of these organizations
could have a significant adverse effect on demand for our products. Research and development budgets are affected
by changes in available resources, the mergers of pharmaceutical and biotechnology companies, changes in
spending priorities and institutional budgetary policies. Our results of operations could be adversely affected by any
significant decrease in expenditures for life sciences research and development by pharmaceutical and
biotechnology companies, academic institutions, and government and private laboratories. In addition, short-term
changes in administrative, regulatory or purchasing-related procedures can create uncertainties or other impediments
that can have an adverse impact on our results of operations.
In recent years, the pharmaceutical and biotechnology industries have undergone substantial restructuring and
consolidation. Additional mergers or consolidation within the pharmaceutical and biotechnology industries could
cause us to lose existing customers and potential future customers, which could have a material adverse impact on
our results of operations.
Approximately 23% of our sales are generated from demand for our products used in the Academia customer class
by researchers at universities, government laboratories and private foundations, and whose funding is dependent
upon grants from government agencies, such as the NIH. Although the level of research funding has been increasing
in recent years, we cannot assure you that this trend will continue given federal and state budget constraints.
Government funding of research and development is subject to the political process, which is inherently
unpredictable. Future sales may be adversely affected if our customers delay purchases as a result of uncertainties
regarding the approval of government or industrial budget proposals. Also, government proposals to reduce or
eliminate budgetary deficits have sometimes included reduced allocations to the NIH and government agencies in
other countries that fund life sciences research and development activities. A reduction in government funding for the
NIH or government research agencies in other countries could have a serious adverse impact on our results of
operations.
Competition could reduce our sales.
The markets for most of our pre-analytical solutions and other products are very competitive. Competitors may have
significant advantages in terms of financial, operational, sales and marketing resources as well as experience in
research and development. These competitors may have developed, or could develop in the future, new technologies
that compete with our products or even render our products obsolete. Some competitors may obtain regulatory
approval from the FDA or similar non-U.S. authorities and market approved products. Our competitors’ development
of alternative products offering superior technology, greater cost-effectiveness or regulatory approval could have a
material adverse effect on our sales and results of operations.
The growth of our business depends in part on the continued conversion of these organizations to our sample and
assay technologies and other products. An inability to do so could have a material adverse effect on our sales and
results of operations.
It can be difficult for users of sample and assay technologies to switch from their current supplier of a particular
product, primarily due to the time and expense required to properly integrate new products into their operations. As
a result, if we are unable to be the first to develop and supply new products, our competitive position may suffer,
resulting in a material adverse effect on our sales and results of operations.
Also, for our commercial clinical assays, we often compete with solutions developed by our laboratory customers and
conversion from such laboratory developed tests to commercial diagnostics assays can be challenging.
The time and expense needed to obtain regulatory approval and respond to changes in regulatory requirements
could adversely affect our ability to commercially distribute our products and generate sales.
We and our customers operate in a highly regulated environment characterized by continuous changes in the
governing regulatory framework, particularly for product approvals. Genetic research activities and products
commonly referred to as “genetically engineered” (such as certain food and therapeutic products) are subject to
extensive governmental regulation in most developed countries, especially in the major markets for pharmaceutical
and diagnostic products such as the European Union, the U.S., China and Japan. In recent years, several highly
publicized scientific events (most notably in genomic research and “cloning”) have prompted intense public debates
on the ethical, philosophical and religious implications of an unlimited expansion in genetic research and the use of
products emerging from this research. As a result of this debate, some key countries may increase existing regulatory
barriers, which could adversely affect demand for our products and prevent us from fulfilling our growth
expectations. Furthermore, there can be no assurance that any future changes of applicable regulations will not
require further expenditures or an alteration, suspension or liquidation of our operations in certain areas, or even in
their entirety.
Changes in the existing regulations or adoption of new requirements or policies could adversely affect our ability to
sell our approved or cleared products or to seek approvals for new products in other countries around the world.
Sales of certain products now in development may be dependent upon us successfully conducting pre-clinical studies,
clinical trials and other tasks required to gain regulatory approvals. These trials could be subject to extensive
regulation by governmental authorities in the U.S., particularly the FDA, and regulatory agencies in other countries.
These trials involve substantial uncertainties and could impact customer demand for our products.
In addition, certain products, especially those intended for use in in vitro diagnostic applications, require regulatory
approvals in various countries. For example, since the European Union Directive 98/79/EC on in vitro diagnostic
medical devices (EU-IvD-D) went into effect in 2003, all products and kits used for in vitro diagnostic applications
must be compliant with this directive. In addition to high-risk products such as HIV testing systems (list A of Annex II of
the directive) or blood glucose testing systems (list B of Annex II of the directive), nucleic acid purification products,
which are used in diagnostic workflows, are affected by this regulatory framework. The major goals of this directive
are to standardize diagnostic procedures within the European Union, to increase reliability of diagnostic analysis
and to enhance patient safety. In addition, new Medical Device Regulations and In Vitro Diagnostic Regulations, part
of which may go into effect as early as 2018, will make major changes in IVD regulation for all medical devices and
in vitro diagnostics. Compliance with these regulations may be expensive and time-consuming. The new IVD
regulation introduces, among other things, a new risk classification system and requirements for conformity
assessments. If we fail to obtain any required clearances, approvals, or certifications, it could significantly damage
our business in these markets.
Several of our key products and programs are medical devices that are subject to extensive regulation by the FDA
under the U.S. Food, Drug and Cosmetic Act. We plan to apply for FDA clearance or approval of additional
products in the future. Regulatory agencies in other countries also have medical device and IVD approval
requirements that are becoming more extensive. These regulations govern most commercial activities associated with
medical devices, including indications for the use of these products as well as other aspects that include product
development, testing, manufacturing, labeling, storage, record-keeping, advertising and promotion. Compliance with
these regulations is expensive and time-consuming.
Each medical device that we wish to distribute commercially in the U.S. will likely require us to seek either 510(k)
clearance or approval of a pre-market approval application (PMA) from the FDA prior to marketing the device for in-
vitro diagnostic use. Clinical trials related to our regulatory submissions may take years to complete and represent a
significant expense. The 510(k) clearance pathway usually takes from three to 12 months, but can take longer. The
PMA pathway is more costly, lengthy and uncertain, and can take from one to three years, or longer. For example, it
took more than four years to receive pre-market approval from the FDA for our HPV test product for use as a test for
the presence of HPV in women with equivocal Pap test results and pre-market approval for the use of our HPV test as
a primary adjunctive cervical cancer screening test to be performed in combination with the Pap test for women age
30 and older. The uncertain time period required for regulatory review increases our costs to develop new products
and increases the risk that we will not succeed in introducing or selling new products in the U.S.
Our cleared or approved devices, including our diagnostic tests and related equipment, are subject to numerous
post-approval requirements. We are subject to inspection and marketing surveillance by the FDA to determine our
compliance with regulatory requirements. If the FDA determines that we have failed to comply, it can institute a wide
variety of enforcement actions, ranging from warning letters to more severe sanctions such as fines, injunctions and
civil penalties, recalls or seizures of our products, operating restrictions, partial suspension or total shutdown of
production, denial of our requests for 510(k) clearance or pre-market approval of product candidates, withdrawal of
510(k) clearance or pre-market approval already granted and civil or criminal prosecution. Any enforcement action
by the FDA may affect our ability to commercially distribute these products in the U.S.
Some of our products are sold for research purposes in the U.S. We do not promote these products for clinical
diagnostic use, and they are labeled “For Research Use Only” (RUO) or “for molecular biology applications.” If the
FDA were to disagree with our designation of a product as an RUO product, we could be forced to stop selling the
product until appropriate regulatory clearance or approval has been obtained. Further, some of our products are
used in LDTs, where laboratories use our materials for assays manufactured, validated and performed in house. We
do not promote these products for clinical diagnostic use.
Further, the FDA has publicly announced its intention to regulate certain LDTs in a phased-in approach, but draft
guidance that was published a couple of years ago was withdrawn at the end of the Obama administration and
replaced by an informal nonenforceable discussion paper reflecting some of the feedback that it received on LDT
regulation. LDTs represent many of the molecular tests currently in use in terms of volume, and our automation
systems - particularly the QIAsymphony platform - are designed to accommodate the automation and validation of
these tests. Moreover, laboratories creating LDTs may use some of our materials in their tests. We do not promote
these products for clinical diagnostic use, but if the FDA were to stop the use of LDTs or significantly limit their area of
application, sales of some of our products in the U.S. could be adversely affected. The flexibility to handle LDTs is an
advantage for our instruments, particularly the QIAsymphony automation system. On the consumables side, however,
LDTs can at times create competition to our own commercially approved tests. We are pursuing a strategy of
developing new content for our platforms partly by seeking regulatory approvals for new assays that incorporates
approvals for these tests to run on QIAGEN instruments. We believe standardized tests that pass regulatory scrutiny
and are clinically validated are highly attractive to reference laboratories and healthcare providers in our Molecular
Diagnostics customer class, and also to customers in Pharma and Academia who rely on molecular assays to
research and develop new products. At this point, the ultimate impact of potential new FDA policies on LDTs is
uncertain.
Changes in tax laws or their application or the termination or reduction of certain government tax incentives, could
adversely impact our overall effective tax rate, results of operations or financial flexibility.
Our effective tax rate reflects the benefit of some income being partially exempt from income taxes due to various
intercompany operating and financing activities. The benefit also derives from our global operations where certain
income or loss is taxed at rates higher or lower than The Netherlands’ statutory rate of 25%. Changes in tax laws or
their application with respect to matters such as changes in tax rates, transfer pricing and income allocation,
utilization of tax loss carry forwards, intercompany dividends, controlled corporations, and limitations on tax relief
allowed on the interest on intercompany debt, and changes to tax credit mechanisms, could increase our effective
tax rate and adversely affect our results of operations and limit our ability to repurchase our Common Shares without
experiencing adverse tax consequences. The increased tax burden as a result of changes in law may adversely
affect our results of operations. Additionally, if our tax positions are challenged by tax authorities or other
governmental bodies, such as the European Commission, we could incur additional tax liabilities, which could have
an adverse effect on our results of operations or financial flexibility.
Changes in the interpretation and application of the 2017 Tax Cuts and Jobs Act could materially affect our tax
obligations and effective tax rate.
On December 22, 2017, President Trump signed into law the Tax Cuts and Jobs Act (H.R.1) (the “2017 Tax Act”).
The 2017 Tax Act includes a number of changes to existing U.S. tax laws that impact us, most notably a reduction of
the U.S. corporate income tax rate from 35% to 21% effective as of January 1, 2018 and a new net interest expense
deduction limitation, which limits the deduction of net interest expense to 30% of the taxpayer’s adjusted taxable
income (ATI). The 2017 Tax Act also provides the acceleration of depreciation for certain assets placed into service
after September 27, 2017 as well as prospective changes including repeal of the domestic manufacturing deduction
beginning in 2018 and capitalization of research and development expenditures beginning in 2022. In December
2017, the SEC staff issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts
and Jobs Act (“SAB 118”), which allows us to record provisional amounts during a measurement period not to
extend beyond one year of the enactment date. For those specific income tax effects of the 2017 Tax Act for which
the accounting under ASC Topic 740 is incomplete, a reasonable estimate was determined. We have recognized
the provisional tax impacts related to the interest expense deduction limitation and the revaluation of deferred tax
assets and liabilities and included these amounts in our consolidated financial statements for the year ended
December 31, 2017 as discussed in Note 16 Income Taxes in the Notes to the Consolidated Financial Statements.
The ultimate impact may differ from these provisional amounts due to additional analysis, changes in interpretations
and assumptions we have made, additional regulatory guidance that may be issued, and actions we may take
because of the 2017 Tax Act, which could materially affect our tax obligations and effective tax rate.
We are subject to risks associated with patent litigation.
The biotechnology industry has been characterized by extensive litigation regarding patents and other intellectual
property rights particularly since industry competitors gravitate around common technology platforms. We are aware
that patents have been applied for and/or issued to third parties claiming technologies for the sample and assay
technologies that are closely related to those we use. From time to time, we receive inquiries requesting confirmation
that we do not infringe patents of third parties. We endeavor to follow developments in this field, and we do not
believe that our technologies or products infringe any proprietary rights of third parties. However, there can be no
assurance that third parties will not challenge our activities and, if so challenged, that we will prevail. In addition, the
patent and proprietary rights of others could require that we alter our products or processes, pay licensing fees or
cease certain activities, and there can be no assurance that we will be able to license any technologies that we may
require on acceptable terms. In addition, litigation, including proceedings that may be declared by the U.S. Patent
and Trademark Office or the International Trade Commission, may be necessary to respond to any assertions of
infringement, enforce our patent rights and/or determine the scope and validity of our proprietary rights or those of
third parties. Litigation, or threatened litigation, could involve substantial cost, and there can be no assurance that we
would prevail in any proceedings.
We rely on collaborative commercial relationships to develop and/or market some of our products.
Our long-term business strategy involves entering into strategic alliances as well as marketing and distribution
arrangements with academic, corporate and other partners relating to the development, commercialization,
marketing and distribution of certain of our existing and potential products. In 2017, we entered a new joint venture
with Sichuan Maccura Biotechnology Co., Ltd. (Maccura) for the distribution of our GeneReader NGS System in
China and are preparing for a new partnership with a Chinese company in 2018 that will take over the research
and development, commercial distribution and infrastructure of the HPV test franchise in China. We may be unable
to continue to negotiate these collaborative arrangements on acceptable terms, and these relationships also may not
be scientifically or commercially successful. In addition, we may be unable to maintain these relationships, and our
collaborative partners may pursue or develop competing products or technologies, either on their own or in
collaboration with others.
Our Personalized Healthcare business includes projects with pharmaceutical and biotechnology companies to co-
develop companion diagnostics paired with drugs that those companies either market currently or are developing for
future use. The success of these co-development programs, including regulatory approvals for the companion
diagnostics, depends upon the continued commitment of our partners to the development of their drugs, the outcome
of clinical trials for the drugs and diagnostics, and regulatory approvals of the diagnostic tests and drugs. In
addition, the future level of sales for companion diagnostics depends to a high degree on the commercial success of
the related medicines for which the tests have been designed. More companion diagnostics would be sold in
combination with a widely prescribed drug than one with limited use.
The successful marketing of QIAGEN products, in some cases, depends on commercial relationships such as joint
ventures or distributorships, particularly in emerging markets where we partner with local companies to augment our
less-established commercial relationships and infrastructure. The continued commitment of our partners to these
ventures, as well as the management of the commercial efforts, will influence QIAGEN's sales and profitability in
these markets.
We have made investments in and are expanding our business into emerging markets, which exposes us to risks.
Our top seven emerging markets are Brazil, Russia, India, China, South Korea, Mexico and Turkey, which together
accounted for approximately 16% of total sales in 2017, and we expect to continue to focus on expanding our
business in these or other fast-growing markets. In addition to the currency and international operation risks
described above, our international operations are subject to a variety of risks that include those arising out of the
economy, political outlook and language and cultural barriers in countries where we have operations or do business.
In many of these emerging markets, we may be faced with several risks that are more significant than in other
countries in which we have a history of doing business. These risks include economies that may be dependent on
only a few products and are therefore subject to significant fluctuations, weak legal systems which may affect our
ability to enforce contractual rights, exchange controls, unstable governments, and privatization or other government
actions affecting the flow of goods and currency. In conducting our business, we move products from one country to
another and may provide services in one country from a subsidiary located in another country. Accordingly, we are
vulnerable to abrupt changes in customs and tax regimes that could have significant negative impacts on our results
of operations.
Some of our customers are requiring us to change our sales arrangements to lower their costs, and this may limit our
pricing flexibility and harm our business.
Some of our customers have developed purchasing initiatives to reduce the number of vendors from which they
purchase products to lower their supply costs. In some cases, these customers have established agreements with large
distributors, which include discounts and direct involvement in the distributor’s purchasing process. These activities
may force us to supply large distributors with our products at discounts in order to continue providing products to
some customers. For similar reasons, many larger customers, including the U.S. government, have requested, and
may request in the future, special pricing arrangements, which can include blanket purchase agreements. These
agreements may limit our pricing flexibility, which could harm our business and affect our results of operations. For a
limited number of customers, and at the customer’s request, we have conducted sales transactions through
distribution and other value-added partners. If sales grow through these intermediaries, it could have an adverse
impact on our results of operations, particularly a negative impact on our gross profit.
We are subject to privacy and data security laws and rely on secure communication and information systems which,
in the event of a breach or failure, expose us to risks.
We rely heavily on communications and information systems to conduct our business. In the ordinary course of
business, we collect and store sensitive data, including our intellectual property and other proprietary business
information and that of our customers, suppliers and business partners, and personally identifiable information of our
customers and employees, in our data centers and on our networks. Our operations rely on the secure processing,
storage and transmission of confidential and other information on our computer systems and networks. We are
transforming to a digital, cloud-leveraging organization, which places our assets, customer data, and personally
identifiable data at a higher risk than in previous years. We have made significant investments to ensure our
employees are aware of cyber security risks facing our company and how to prevent data breaches, including but
not limited to, mandatory yearly trainings that are continually updated. We have modernized our cyber security
tools, and are continually modernizing our cyber security processes, in an attempt to keep pace with evolving cyber
security risks. In spite of our efforts, we are unable to completely eliminate these risks and occasionally experience
minor cyber security incidents. External phishing emails (occurring outside of our computer services) is a growing
threat that our customers are facing. These emails could lead to the disclosing of intellectual property or personally
identifiable information, which could lead to financial harm and cause reputational damage. While our cyber
security team works diligently with our customers to mitigate these threats by helping to identify and analyze phishing
emails, we cannot guarantee that sensitive data will not be lost or stolen.
A breach in cyber security due to unauthorized access to our computer systems or misuse could include the
misappropriation of assets or sensitive information, the corruption data or other operational disruption. Failures to
our computer systems and networks could be caused by internal or external events, such as incursions by intruders or
hackers, computer viruses, failures in hardware or software, or cyber terrorists. If we do experience a breach or
failure of our systems, we could experience operational delays resulting from the disruption of systems, loss due to
theft or misappropriation of assets or data, or negative impacts from the loss of confidential data or intellectual
property. We may face significant liability in the event any of the personal information we maintain is lost or
otherwise subject to misuse or other wrongful use, access or disclosure. Further, we could experience negative
publicity resulting in reputation or brand damage with customers or partners.
Additionally, we are subject to privacy and data security laws across multiple jurisdictions, including those relating to
the storage of health information, which are complex, overlapping and rapidly evolving. Currently, we are
implementing the requirements set forth by the European Union General Data Protection Regulation (GDPR), which is
set to take effect on May 25, 2018. As our activities continue to evolve and expand, we may be subject to
additional laws which impose further restrictions on the transfer, access, use, and disclosure of health and other
personal information which may impact our business either directly or indirectly. Our failure to comply with
applicable privacy or security laws or significant changes in these laws could significantly impact our business and
future business plans. For example, we may be subject to regulatory action or lawsuits in the event we fail to comply
with applicable privacy laws.
Exchange rate fluctuations may adversely affect our business and operating results.
Because we currently market our products throughout the world, a significant portion of our business is conducted in
currencies other than the U.S. dollar, our reporting currency. As a result, fluctuations in value, relative to the U.S.
dollar, of the currencies in which we conduct our business have caused and will continue to cause foreign currency
transaction gains and losses. Foreign currency transaction gains and losses arising from normal business operations
are charged against earnings in the period when incurred. Due to the number of currencies involved, the variability
of currency exposures and the potential volatility of currency exchange rates, we cannot predict the effects of future
exchange rate fluctuations. While we may engage in foreign exchange hedging transactions to manage our foreign
currency exposure, there can be no assurance that our hedging strategy will adequately protect our operating results
from the effects of future exchange rate fluctuations.
Our global operations may be affected by actions of governments, global or regional economic developments,
weather or transportation delays, natural disasters or other force majeure events (collectively, unforeseen events)
which may negatively impact our suppliers, our customers or us.
Our business involves operations around the world. Our consumable manufacturing facilities are located in
Germany, China and the U.S. We have established sales subsidiaries in numerous countries and our products are
sold through independent distributors serving more than 40 additional countries. Our facilities may be harmed by
unforeseen events, and in the event, we or our customers are affected by a disaster, we may experience delays or
reductions in sales or production, or increased costs, or may be required to identify alternate suppliers or rely on
third-party manufacturers.
To the extent that our suppliers are impacted by a natural disaster or other disruption, we may experience periods of
reduced production. Any unexpected interruptions in our production capabilities may lead to delayed or lost sales
and may adversely affect our results of operations for the affected period.
In addition, to the extent we temporarily shut down any facility following such an unforeseen event, we may
experience disruptions in our ability to manufacture or ship products to customers or otherwise operate our business.
Many of our products are manufactured in a single location and we may experience adverse effects to the extent
manufacturing operations are disrupted. While our global operations give us the ability to ship product from
alternative sites, we may not be able to do so because our customers’ facilities are shutdown or the local logistics
infrastructure is not functioning, and our sales will suffer.
Damage to our property due to unforeseen events and the disruption of our business from casualties may be covered
by insurance, but this insurance may not be sufficient to cover all of our potential losses and such insurance may not
continue to be available to us on acceptable terms, or at all. In addition, we may incur incremental costs following
an unforeseen event which will reduce profits and adversely affect our results of operations.
We depend on suppliers for materials used to manufacture our products, and if shipments from these suppliers are
delayed or interrupted, we may be unable to manufacture our products.
We buy materials to create our products from a number of suppliers and are not dependent on any one supplier or
group of suppliers for our business as a whole. However, key components of certain products, including certain
instrumentation and chemicals, are available only from a single source. If supplies from these vendors are delayed or
interrupted for any reason, we may not be able to obtain these materials timely or in sufficient quantities or qualities
in order to produce certain products, and this could have an adverse impact on our results of operations.
We heavily rely on air cargo carriers and other overnight logistics services, and shipping delays or interruptions
could harm our business.
Our customers in the scientific research markets typically only keep a modest inventory of our products on hand, and
consequently require overnight delivery of purchases. As a result, we heavily rely on air cargo carriers and logistic
suppliers. If overnight services are suspended or delayed, and other delivery carriers and logistic suppliers cannot
provide satisfactory services, customers may suspend a significant amount of their work. The lack of adequate
delivery alternatives would have a serious adverse impact on our results of operations.
Our operations have inherent IT risks
Business and production processes are increasingly dependent on information technology systems. Major disruptions
or failure of global or regional business systems may result in the loss of data and/or impairment of business and
production processes. QIAGEN has established a global IT organization with rules and regulations that define the
relevant roles and responsibilities, and also works with external partners that provide certain operative IT functions.
Technical precautions have been established together with our IT service providers to address this risk.
Our success depends on the continued employment of qualified personnel, any of whom we may lose at any time.
Although we have not experienced any difficulties attracting or retaining management and scientific staff, our ability
to recruit and retain qualified, skilled employees will continue to be critical to our success. Given the intense
competition for experienced scientists and managers among pharmaceutical and biotechnology companies as well
as academic and other research institutions, there can be no assurance that we will be able to attract and retain
employees critical to our success on acceptable terms. Initiatives to expand QIAGEN will also require additional
employees, including management with expertise in areas such as research and development, manufacturing,
digitization, sales and marketing, and the development of existing managers to lead a growing organization. The
failure to recruit and retain qualified employees, or develop existing employees, could have a material adverse
impact on our results of operations.
Our ability to accurately forecast our results during each quarter may be negatively impacted by the fact that a
substantial percentage of our sales may be recorded in the final weeks or days of the quarter.
The markets we serve are typically characterized by a high percentage of purchase orders being received in the final
few weeks or even days of each quarter. Although this varies from quarter to quarter, many customers make a large
portion of their purchase decisions late in each quarter, in particular because it is during this period that they receive
new information on both their budgets and requirements. Additionally, volatility in the timing of milestones from
companion diagnostic partnerships can be difficult to predict. As a result, even late in each quarter, we cannot
predict with certainty whether our sales forecasts for the quarter will be achieved.
Historically, we have been able to rely on the overall pattern of customer purchase orders during prior periods to
project with reasonable accuracy our anticipated sales for the current or coming quarters. However, if customer
purchasing trends during a quarter vary from historical patterns as may occur with changes in market conditions, our
quarterly financial results could deviate significantly from our projections. As a result, our sales forecasts for any
given quarter may prove not to have been accurate. We also may not have sufficient, timely information to confirm
or revise our sales projections for a specific quarter. If we fail to achieve our forecasted sales for a particular quarter,
the value of our Common Shares could be adversely affected.
We have a significant amount of debt that may adversely affect our financial condition and flexibility.
We have a significant amount of debt and debt service obligations as well as restrictive covenants imposed on us by
our lenders. A high level of indebtedness increases the risk that we may default on our debt obligations and
restrictive covenants may prevent us from borrowing additional funds. There is no assurance that we will be able to
generate sufficient cash flow to pay the interest on our debt and comply with our debt covenants or that future
working capital, borrowings or equity financing will be available to repay or refinance our debt. If we are unable to
generate sufficient cash flow to pay the interest on our debt and comply with our debt covenants, we may have to
delay or curtail our research and development programs. The level of our indebtedness could, among other things:
make it difficult for us to make required payments on our debt;
make it difficult for us to obtain any financing in the future necessary for working capital, capital expenditures,
debt service requirements or other purposes;
limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete;
and
make us more vulnerable in the event of a downturn in our business.
Our business may require substantial additional capital, which we may not be able to obtain on terms acceptable to
us, if at all.
Our future capital requirements and level of expenses will depend upon numerous factors, including the costs
associated with:
marketing, sales and customer support efforts;
research and development activities;
expansion of our facilities;
consummation of possible future acquisitions of technologies, products or businesses;
demand for our products and services;
repayment or refinancing of debt; and
payments in connection with our hedging activities.
We currently anticipate that our short-term capital requirements will be satisfied by cash flow from our operations. As
of December 31, 2017, we had outstanding long-term debt of approximately $1.8 billion, of which no amount was
current. Furthermore, as of December 31, 2017, we had capital lease obligations, including the current portion, of
$1.4 million, that expire in various years through 2020. We may need to refinance all or part of these liabilities
before or at their contractual maturities.
If at some point in time our existing resources should be insufficient to fund our activities, we may need to raise funds
through public or private debt or equity financings. The funds for the refinancing of existing liabilities or for the
ongoing funding of our business may not be available or, if available, not on terms acceptable to us. If adequate
funds are not available, we may be required to reduce or delay expenditures for research and development,
production, marketing, capital expenditures and/or acquisitions, which could have a material adverse effect on our
business and results of operations. To the extent that additional capital is raised through the sale of equity or
convertible securities, the issuance of any securities could result in dilution to our shareholders.
The accounting for the cash convertible notes we have issued will result in recognition of interest expense significantly
greater than the stated interest rate of the notes and may result in volatility to our Consolidated Statements of Income.
We will settle any conversions of the Cash Convertible Notes described under the heading “Other Factors Affecting
Liquidity and Capital Resources” elsewhere in this report entirely in cash. Accordingly, the conversion option that is
part of the Cash Convertible Notes will be accounted for as a derivative pursuant to accounting standards relating to
derivative instruments and hedging activities. Refer to Note 13, “Derivatives and Hedging” and Note 15 "Lines of
Credit and Debt," of the Notes to Consolidated Financial Statements. In general, this resulted in an initial valuation
of the conversion option separate from the debt component of the Cash Convertible Notes, resulting in an original
issue discount. The original issue discount will be accreted to interest expense over the term of the Cash Convertible
Notes, which will result in an effective interest rate reported in our financial statements significantly in excess of the
stated coupon rates of the Cash Convertible Notes. This accounting treatment will reduce our earnings. For each
financial statement period after the issuance of the Cash Convertible Notes, a gain (or loss) will be reported in our
financial statements to the extent the valuation of the conversion option changes from the previous period. The Call
Options issued in connection with the Cash Convertible Notes will also be accounted for as derivative instruments,
substantially offsetting the gain (or loss) associated with changes to the valuation of the conversion option. This may
result in increased volatility to our results of operations.
The cash convertible note hedge and warrant transactions we entered into in connection with the issuance of our
Cash Convertible Notes may not provide the benefits we anticipate, and may have a dilutive effect on our common
stock.
Concurrently with the issuance of the Cash Convertible Notes, we entered into Call Options and issued Warrants.
We entered into the Call Options with the expectation that they would offset potential cash payments by us in excess
of the principal amount of the Cash Convertible Notes upon conversion of the Cash Convertible Notes. In the event
that the hedge counterparties fail to deliver potential cash payments to us, as required under the Call Options, we
would not receive the benefit of such transaction.
Separately, we also issued Warrants. The Warrants could separately have a dilutive effect to the extent that the
market price per share of our common stock, as measured under the terms of the Warrants, exceeds the strike price
of the Warrants.
An impairment of goodwill and intangible assets could reduce our earnings.
At December 31, 2017, our consolidated balance sheet reflected approximately $2.0 billion of goodwill and
approximately $499.3 million of intangible assets. Goodwill is recorded when the purchase price of a business
exceeds the fair value of the tangible and separately measurable intangible net assets. U.S. generally accepted
accounting principles (U.S. GAAP) requires us to test goodwill for impairment on an annual basis or when events or
circumstances occur indicating that goodwill might be impaired. Long-lived assets, such as intangible assets with
finite useful lives, are reviewed for impairment whenever events or changes in circumstances indicate that the
carrying amount may not be recoverable. The impairment review often cannot be done at the level of the individual
asset and it must instead be applied to a group of assets. For the purpose of our annual goodwill impairment testing
based on the current circumstances of how we manage our business, this group of assets is the Company as a
whole. If we determine that any of our goodwill or intangible assets were impaired, we will be required to take an
immediate charge to earnings and our results of operations could be adversely affected.
Our strategic equity investments may result in losses.
We have made, and may continue to make, strategic investments in businesses as opportunities arise. We
periodically review the carrying value of these investments for impairment, considering factors that include the most
recent stock transactions, book values from the most recent financial statements, and forecasts and expectations of
the investee. The results of these valuations may fluctuate due to market conditions and other conditions over which
we have no control.
Estimating the fair value of non-marketable equity investments in life science companies is inherently subjective. If
actual events differ from our assumptions and unfavorable fluctuations in the valuations of the investments are
indicated, we could be required to write-down the investment. This could result in future charges on our earnings that
could materially adversely affect our results of operations. It is uncertain whether or not we will realize any long-term
benefits from these strategic investments.
Doing business internationally creates certain risks.
Our business involves operations in several countries outside of the U.S. Our consumable manufacturing facilities are
located in Germany, China, and the U.S. We source raw materials and subcomponents to manufacture our products
from different countries. We have established sales subsidiaries in numerous countries including the U.S., Germany,
Japan, the United Kingdom, France, Switzerland, Australia, Canada, the Netherlands, Sweden, Italy, Hong Kong,
Singapore, Turkey, Thailand, South Korea, Taiwan, Malaysia, China, Spain, Brazil, Mexico, South Africa and India.
In addition, our products are sold through independent distributors serving more than 40 other countries. Conducting
and launching operations on an international scale requires close coordination of activities across multiple
jurisdictions and time zones and consumes significant management resources. We have invested heavily in
computerized information systems in order to manage more efficiently the widely dispersed components of our
operations. If we fail to coordinate and manage these activities effectively, our business and results of operations will
be adversely affected.
Our operations are subject to other risks inherent in international business activities, such as general economic
conditions in the countries in which we operate, longer accounts receivable payment cycles in certain countries,
overlap of different tax structures, unexpected changes in regulatory requirements, and compliance with a variety of
foreign laws and regulations. Other risks associated with international operations include import and export licensing
requirements, trade restrictions, exchange controls and changes in tariff and freight rates, as may occur as a result of
rising energy costs. As a result of these conditions, an inability to successfully manage our international operations
could have a material adverse impact on our business and results of operations.
Unethical behavior and non-compliance with laws by our sales agents, consultants, distributors or employees could
seriously harm our business.
Our business in countries with a history of corruption and transactions with foreign governments increase the risks
associated with our international activities. Based on our international operations, we are subject to the U.S. Foreign
Corrupt Practices Act (FCPA), the U.K. Bribery Act and other laws that prohibit improper payments or offers of
payments to foreign governments and their officials and political parties by business entities for the purpose of
obtaining or retaining business. We have operations, agreements with third parties and make sales in countries
known to experience corruption. Further international expansion may involve increased exposure to such practices.
Our activities in these countries, and in all countries as well, create risks of unauthorized payments or offers of
payments, non-compliance with laws, or other unethical behavior by any of our employees, consultants, sales agents
or distributors, that could be in violation of various laws, including the FCPA, even though these parties are not
always subject to our control. It is our policy to implement safeguards to discourage these or other unethical practices
by our employees and distributors including online and in-person employee trainings, periodic internal audits and
standard reviews of our distributors. However, our existing safeguards and any future improvements may not prove
to be effective, and our employees, consultants, sales agents or distributors may engage in conduct for which we
might be held responsible. Violations of the FCPA and other laws may result in criminal or civil sanctions, which
could be severe, and we may be subject to other liabilities, which could negatively affect our business, results of
operations and financial condition.
We depend on patents and proprietary rights that may fail to protect our business.
Our success depends to a large extent on our ability to develop proprietary products and technologies and to
establish and protect our patent and trademark rights in these products and technologies. As of December 31, 2017,
we owned 362 issued patents in the United States, 279 issued patents in Germany and 1,825 issued patents in
other major industrialized countries. In addition, at December 31, 2017, we had 776 pending patent applications,
and we intend to file applications for additional patents as our products and technologies are developed. The patent
positions of technology-based companies involve complex legal and factual questions and may be uncertain, and the
laws governing the scope of patent coverage and the periods of enforceability of patent protection are subject to
change. In addition, patent applications in the United States are maintained in secrecy until patents issue, and
publication of discoveries in the scientific or patent literature tends to lag behind actual discoveries by several
months. Therefore, no assurance can be given that patents will issue from any patent applications that we own or
license or if patents do issue, that the claims allowed will be sufficiently broad to protect our technology. In addition,
no assurance can be given that any issued patents that we own or license will not be challenged, invalidated or
circumvented, or that the rights granted thereunder will provide us competitive advantages. Further, as issued patents
expire, we may lose some competitive advantage as others develop competing products and as a result, we may
lose revenue.
Certain of our products incorporate patents and technologies that are licensed from third parties and for certain
products, these in-licensed patents together with other patents provide us with a competitive advantage. These
licenses impose various commercialization, sublicensing and other obligations on us. Our failure to comply with
these requirements could result in the conversion of the applicable license from being exclusive to non-exclusive or, in
some cases, termination of the license, and as a result, we may lose some competitive advantage and experience a
loss of revenue.
We also rely on trade secrets and proprietary know-how, which we seek to protect through confidentiality
agreements with our employees and consultants. There can be no assurance that any confidentiality agreements that
we have with our employees, consultants, outside scientific collaborators and sponsored researchers and other
advisors will provide meaningful protection for our trade secrets or adequate remedies in the event of unauthorized
use or disclosure of such information. There also can be no assurance that our trade secrets will not otherwise
become known or be independently developed by competitors.
We currently engage in, and may continue to engage in, collaborations with academic researchers and institutions.
There can be no assurance that under the terms of such collaborations, third parties will not acquire rights in certain
inventions developed during the course of these collaborations.
Our business exposes us to potential product liability.
The marketing and sale of our products and services for certain applications entail a potential risk of product liability.
Although we are not currently subject to any material product liability claims, product liability claims may be brought
against us in the future. Further, there can be no assurance that our products will not be included in unethical, illegal
or inappropriate research or applications, which may in turn put us at risk of litigation. We carry product liability
insurance coverage, which is limited in scope and amount. There can be no assurance that we will be able to
maintain this insurance at a reasonable cost and on reasonable terms, or that this insurance will be adequate to
protect us against any or all potential claims or losses.
We are subject to various laws and regulations generally applicable to businesses in the different jurisdictions in
which we operate, including laws and regulations applicable to the handling and disposal of hazardous substances.
The risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of
such an accident, we could be held liable for any damages that result, and any such liability could have a material
adverse impact on us.
Our operating results may vary significantly from period to period and this may affect the market price of our
Common Shares.
Our operating results may vary significantly from quarter to quarter, and also from year to year, since they are
dependent upon a broad range of factors that include demand for our products, the level and timing of customer
research budgets and commercialization efforts, the timing of government funding budgets of our customers, the
timing of our research and development activities and related regulatory approvals, the impact of sales and
marketing expenses, the impact of restructuring activities, the introduction of new products by us or our competitors,
competitive market conditions, exchange rate fluctuations and general economic conditions. Our expense levels are
based in part on our expectations as to future sales trends. As a result, sales and earnings may vary significantly
from quarter to quarter or from year to year, and actual sales and earnings results in any one period will not
necessarily be indicative of results to be anticipated in subsequent periods. Our results may also fail to meet or
exceed the expectations of securities analysts or investors, which could cause a decline in the market price of our
Common Shares.
Our holding company structure makes us dependent on the operations of our subsidiaries.
QIAGEN N.V. is incorporated under Dutch law as a public limited liability company (naamloze vennootschap), and
is organized as a holding company. Currently, the material assets are the outstanding shares of the QIAGEN
subsidiaries, intercompany receivables and other financial assets such as cash and short-term investments. As a
result, QIAGEN N.V. is dependent upon payments, dividends and distributions from the subsidiaries for funds to pay
operating and other expenses as well as to pay future cash dividends or distributions, if any, to holders of our
Common Shares. Dividends or distributions by subsidiaries in a currency other than the U.S. dollar may result in a
loss upon a subsequent conversion into U.S. dollars.
Our Common Shares may have a volatile public trading price.
The market price of our Common Shares since our initial public offering in September 1996 has increased
significantly and been highly volatile. In the last two years, the price of our Common Shares has ranged from a high
of $36.34 to a low of $19.94 on NASDAQ, and a high of €31.52 to a low of €17.76 on the Frankfurt Stock
Exchange. In addition to overall stock market fluctuations, factors that may have a significant impact on the price of
our Common Shares include:
announcements of technological innovations or the introduction of new products by us or our competitors;
developments in our relationships with collaborative partners;
quarterly variations in our operating results or those of our peer companies;
changes in government regulations, tax laws or patent laws;
developments in patent or other intellectual property rights;
developments in government spending budgets for life sciences-related research;
general market conditions relating to the diagnostics, applied testing, pharmaceutical and biotechnology
industries; and
impact from foreign exchange rates.
The stock market has from time to time experienced extreme price and trading volume fluctuations that have
particularly affected the market for technology-based companies. These fluctuations have not necessarily been related
to the operating performance of these companies. These broad market fluctuations may adversely affect the market
price of our Common Shares.
Holders of our Common Shares should not expect to receive dividend income.
In January 2017, we completed a synthetic share repurchase that combined a direct capital repayment with a
reverse stock split and in early 2018 we announced plans to return up to an additional $200.0 million through
open-market purchases. We do not anticipate paying any cash dividends on our Common Shares for the foreseeable
future, and until the January 2017 distribution in connection with a synthetic share repurchase, we have not paid
cash dividends since our inception. Although we do not anticipate paying any cash dividends on a regular basis, the
distribution of any cash dividends in a currency other than the U.S. dollar will be subject to the risk of foreign
currency transaction losses. Investors should not invest in our Common Shares if they are seeking dividend income;
the only return that may be realized through investing in our Common Shares would be through an appreciation in
the share price.
Holders of our Common Shares may not benefit from continued stock repurchase programs.
In January 2017, we completed a synthetic share repurchase that combined a direct capital repayment with a
reverse stock split. The transaction was announced in August 2016 and involved an approach used by various large,
multinational Dutch companies to provide returns to all shareholders in a faster and more efficient manner than
traditional open-market purchases. $243.9 million was returned to shareholders through the transaction, which
reduced the total number of issued common shares by approximately 3.7% or 8.9 million shares as of January 31,
2017.
The purpose of our share repurchases has been to hold the shares in treasury in order to satisfy obligations from
exchangeable debt instruments, warrants and/or employee share-based remuneration plans and thus to reduce
dilution to existing holders of our Common Shares. We may decide not to continue such programs in the future, the
covenants we have with our lenders may limit our ability to use available cash to do so, and the market price of our
Common Shares may make such repurchases less desirable. In any of these cases, holders of our Common Shares
may suffer dilution from conversion of our indebtedness or issuance of shares pursuant to employee remuneration
plans that would otherwise be at least partially offset by repurchased shares.
Future sales and issuances of our Common Shares could adversely affect our stock price.
Any future sale or issuance of a substantial number of our Common Shares in the public market, or any perception
that a sale may occur, could adversely affect the market price of our Common Shares. Under Dutch law, a company
can issue shares up to its authorized share capital provided for in its Articles of Association. Pursuant to our Articles
of Association, our authorized share capital amounts to EUR 9.0 million, which is divided into 410.0 million common
shares, 40.0 million financing preference shares and 450.0 million preference shares, with all shares having a EUR
0.01 par value. As of December 31, 2017, a total of approximately 226.6 million Common Shares were
outstanding along with approximately 9.3 million additional shares reserved for issuance upon exercise or release of
outstanding stock options and awards, of which 1.1 million were vested. A total of approximately 22.0 million
Common Shares are reserved and available for issuances under our stock plans as of December 31, 2017,
including the shares subject to outstanding stock options and awards. The majority of our outstanding Common
Shares may be sold without restriction, except shares held by our affiliates, which are subject to certain limitations on
resale. Additionally, the Warrants issued in connection with the Cash Convertible Notes Call Spread Overlays cover
an aggregate of 35.4 million shares of our common stock (subject to anti-dilution adjustments under certain
circumstances).
Shareholders who are United States residents could be subject to unfavorable tax treatment.
We may be classified as a “passive foreign investment company,” or a PFIC, for U.S. federal income tax purposes if
certain tests are met. Our treatment as a PFIC could result in a reduction in the after-tax return to holders of Common
Shares and would likely cause a reduction in the value of these shares. If we were determined to be a PFIC for U.S.
federal income tax purposes, highly complex rules would apply to our U.S. shareholders. We would be considered a
PFIC with respect to a U.S. shareholder if for any taxable year in which the U.S. shareholder held the Common
Shares, either (i) 75% or more of our gross income for the taxable year is passive income; or (ii) the average value
of our assets (during the taxable year) which produce or are held for the production of passive income is at least
50% of the average value of all assets for such year. Based on our income, assets and activities, we do not believe
that we were a PFIC for U.S. federal income tax purposes for our taxable year ended December 31, 2017, and do
not expect to be a PFIC for the current taxable year or any future taxable year. No assurances can be made,
however, that the Internal Revenue Service will not challenge this position or that we will not subsequently become a
PFIC. In countries outside the U.S., other or similar tax regimes may apply and result in unfavorable tax treatment for
any dividends received.
Provisions of our Articles of Association and Dutch law and an option we have granted may make it difficult to
replace or remove management and may inhibit or delay a takeover.
Our Articles of Association (Articles) provide that our shareholders may only suspend or dismiss our Managing
Directors and Supervisory Directors against their wishes with a vote of two-thirds of the votes cast if such votes
represent more than 50% of our issued share capital. If the proposal was made by the joint meeting of the
Supervisory Board and the Managing Board, a simple majority is sufficient. The Articles also provide that if the
members of our Supervisory Board and our Managing Board have been nominated by the joint meeting of the
Supervisory Board and Managing Board, shareholders may only overrule this nomination with a vote of two-thirds of
the votes cast if such votes represent more than 50% of our issued share capital.
Certain other provisions of our Articles allow us, under certain circumstances, to prevent a third party from obtaining
a majority of the voting control of our Common Shares through the issuance of Preference Shares. Pursuant to our
Articles and the resolution adopted by our General Meeting of Shareholders, our Supervisory Board is entitled to
issue Preference Shares in case of an intended takeover of our company by (i) any person who alone or with one or
more other persons, directly or indirectly, have acquired or given notice of an intent to acquire (beneficial) ownership
of an equity stake which in aggregate equals 20% or more of our share capital then outstanding or (ii) an “adverse
person” as determined by the Supervisory Board. If the Supervisory Board opposes an intended takeover and
authorizes the issuance of Preference Shares, the bidder may withdraw its bid or enter into negotiations with the
Managing Board and/or Supervisory Board and agree on a higher bid price for our Shares.
In 2004, we granted an option to the Stichting Preferente Aandelen QIAGEN, or the Foundation (Stichting), subject
to the conditions described in the paragraph above, which allows the Foundation to acquire Preference Shares from
us. The option enables the Foundation to acquire such number of Preference Shares as equals the number of our
outstanding Common Shares at the time of the relevant exercise of the option, less one Preference Share. When
exercising the option and exercising its voting rights on these Preference Shares, the Foundation must act in our
interest and the interests of our stakeholders. The purpose of the Foundation option is to prevent or delay a change of
control that would not be in the best interests of us and our stakeholders. An important restriction on the Foundation’s
ability to prevent or delay a change of control is that a public offer must be announced by a third party before it can
issue (preference or other) protective shares that would enable the Foundation to exercise rights to 30% or more of
the voting rights without an obligation to make a mandatory offer for all shares held by the remaining shareholders.
In addition, the holding period for these shares by the Foundation is restricted to two years, and this protective stake
must fall below the 30% voting rights threshold before the two-year period ends.
MANAGEMENT REPORT
Performance Review
Our future operating results may be affected by various risk factors, many of
which are beyond our control. Certain statements included in this Annual Report
and the documents incorporated herein by reference may be forward-looking
statements within the meaning of Section 27A of the U.S. Securities Act of
1933, as amended, and Section 21E of the U.S. Securities Exchange Act of
1934, as amended, including statements regarding potential future net sales,
gross profit, net income and liquidity. These statements can be identified by the
use of forward-looking terminology such as “believe,” “hope,” “plan,” “intend,”
“seek,” “may,” “will,” “could,” “should,” “would,” “expect,” “anticipate,”
“estimate,” “continue” or other similar words. Reference is made in particular to
the description of our plans and objectives for future operations, assumptions
underlying such plans and objectives, and other forward-looking statements.
Such statements are based on management’s current expectations and are
subject to a number of factors and uncertainties that could cause actual results
to differ materially from those described in the forward-looking statements. We
caution investors that there can be no assurance that actual results or business
conditions will not differ materially from those projected or suggested in such
forward-looking statements as a result of various factors. Factors which could
cause such results to differ materially from those described in the forward-
looking statements include those set forth in the risk factors below. As a result,
our future success involves a high degree of risk. When considering forward-
looking statements, you should keep in mind that the risk factors could cause our
actual results to differ significantly from those contained in any forward-looking
statement.
Results of Operations
Overview
We are a leading global provider of Sample to Insight solutions to transform biological materials into valuable
molecular insights. QIAGEN sample technologies isolate and process DNA, RNA and proteins from any biological
sample, such as blood or tissue. Assay technologies make these biomolecules visible and ready for analysis, such as
identifying the DNA of a virus or a mutation of a gene. Bioinformatics solutions integrate software and cloud-based
resources to interpret increasing volumes of biological data and report relevant, actionable insights. Our automation
solutions tie these together in seamless and cost-effective molecular testing workflows.
We sell our products - consumables, automated instrumentation systems using those technologies, and bioinformatics
to analyze and interpret the data - to four major customer classes:
Molecular Diagnostics - healthcare providers engaged in many aspects of patient care including Prevention,
Profiling of diseases, Personalized Healthcare and Point of Need testing
Applied Testing - government or industry customers using molecular technologies in fields such as forensics,
veterinary diagnostics and food safety testing
Pharma - pharmaceutical and biotechnology companies using molecular testing to support drug discovery,
translational medicine and clinical development efforts
Academia - researchers exploring the secrets of life such as the mechanisms and pathways of diseases, and in
some cases translating that research into drug targets or commercial applications
We market products in more than 130 countries, mainly through subsidiaries in markets we believe have the greatest
sales potential in Europe, Asia, the Americas and Australia. We also work with specialized independent distributors
and importers. As of December 31, 2017, we employed approximately 4,700 people in more than 35 locations
worldwide.
Recent Acquisitions
We have made a number of strategic acquisitions and implemented other strategic transactions since 2015,
targeting innovative technologies and aiming to achieve market-leading positions in high-growth areas of molecular
diagnostics and research. These transactions have enhanced our product offerings and technology platforms, as well
as our geographic footprint. They include:
In early 2018, QIAGEN entered into a purchase agreement to acquire STAT-Dx, a privately-held company
developing advanced multiplex diagnostics for widespread syndromes such as serious respiratory or
gastrointestinal infections. Subject to successful completion of defined development activities by STAT-Dx, QIAGEN
has agreed to acquire all shares of STAT-Dx for approximately $147 million in cash and additional payments of
up to about $44 million based on the achievement of regulatory and commercial milestones. The acquisition is
expected to be completed in the second quarter of 2018 and funded from existing cash reserves. The transaction
will expand QIAGEN's instrument and consumables portfolio by adding a novel CE-IVD marked system, to be
branded as QIAstat-Dx, enabling Sample to Insight processing of up to 48 molecular targets with cost-efficient,
easy-to-use assays. The first two QIAstat-Dx tests, extensive respiratory and gastrointestinal panels, are expected to
be launched in Europe and other markets in the second half of 2018, and in the U.S. following expected
regulatory approval in 2019.
QIAGEN entered into a joint venture in May 2017 with Maccura Biotechnology Co., Ltd., a leading in vitro
diagnostics company in China, to accelerate the growth of QIAGEN’s GeneReader NGS System. Known as
MAQGEN China and based in Chengdu, Sichuan Province, the venture will develop local adaptations, pursue
regulatory paths for the GeneReader and leverage Maccura’s broad customer network to expand the system’s
adoption in laboratories across China. Maccura owns 60% of the joint venture and QIAGEN owns 40%.
QIAGEN’s own operations in China continue as a stand-alone company, focusing on our other products and
services for customers such as QuantiFERON-TB and the Life Sciences portfolio.
QIAGEN took steps in late 2017 to streamline its product portfolio and focus on growth areas by discontinuing
commercialization of some non-core PCR tests and externalizing the HPV test franchise for cervical cancer
screening in China to a third-party company. In January 2018, a partnership became effective with a Chinese
company that has taken over R&D, commercial distribution, and the related QIAGEN employees and infrastructure
of the HPV test franchise in China. QIAGEN is a minority shareholder of this company.
In January 2017, QIAGEN acquired OmicSoft Corporation, a privately held company based in the Research
Triangle area of North Carolina, to expand our industry-leading bioinformatics offering with complementary
solutions enabling scientists to visualize and mine large institutional and publicly available “omics” datasets. The
OmicSoft software solutions meet a growing need in discovery and translational research to access and manage
huge amounts of data on DNA, RNA and other biological variables generated by next-generation sequencing
studies.
In 2016, QIAGEN acquired Exiqon A/S, a publicly traded company based in Vedbaek, Denmark, expanding our
leadership position in Sample to Insight solutions for RNA analysis. Exiqon’s RNA analysis solutions, with
proprietary Locked Nucleic Acid (LNA) technology, are used by academic, biotech and pharmaceutical
researchers worldwide to explore correlations between gene activity and the development of cancer and other
diseases. In two steps during 2016, we paid a total of $100.7 million for 100% of the shares of Exiqon. In 2017,
Exiqon’s product offering was fully integrated into QIAGEN, providing customers of both companies ready access
to the combined portfolio of solutions.
In 2015, we acquired MO BIO Laboratories, Inc., a privately-held provider of cutting-edge sample technologies
for studies of the microbiome and metagenomics, analyzing the impact of microbial diversity on health and the
environment. The acquisition added a complementary portfolio of sample technologies to QIAGEN's universal
solutions for next-generation sequencing. MO BIO kits, based on proprietary Inhibitor Removal Technology, enable
the isolation of pure DNA from challenging samples like soil, water, plants and stool.
In 2015, we acquired an innovative technology from AdnaGen GmbH, a subsidiary of Alere Inc., that enables
enrichment and molecular analysis of circulating tumor cells (CTCs) from blood samples. The acquisition added to
QIAGEN’s pipeline of technologies for molecular testing through non-invasive liquid biopsies as an alternative to
costly and risky tissue biopsies. Other assets acquired include two marketed CE-IVD marked products, AdnaTest
BreastCancer and AdnaTest Prostate Cancer, for treatment monitoring and detection of tumor relapse.
In February 2015, we announced the spin-off of teams and activities of QIAGEN Marseille S.A. (formerly Ipsogen
S.A.), a majority-owned and fully consolidated entity. In the divestiture, QIAGEN Marseille agreed to the sale of
all its assets and liabilities, except its intellectual property portfolio, to a stand-alone company. QIAGEN retained
rights to commercialize the ipsogen line of products, including companion diagnostics for blood cancers. As part
of this initiative, we acquired the remaining QIAGEN Marseille shares through a tender offer during 2015 and
2016.
Our financial results include the contributions of recent acquisitions and the QIAGEN Marseille spin-off from their
effective dates, as well as costs related to the transactions and integration of the acquired companies, such as the
relocation and closure of certain facilities.
We determined that we operate as one business segment in accordance with ASC Topic 280, Segment Reporting.
Our chief operating decision maker (CODM) makes decisions on business operations and resource allocation based
on evaluations of the QIAGEN Group as a whole. Considering the acquisitions made during 2017, we determined
that we still operate as one business segment. We provide certain revenue information by customer class to allow
better insight into our operations. This information is estimated using certain assumptions to allocate revenue among
the customer classes.
Year Ended December 31, 2017, Compared to 2016
Net Sales
In 2017, net sales grew 6% to $1.42 billion compared to $1.34 billion in 2016 with organic business expansion
contributing four percentage points to total sales growth with two percentage points of additional growth from the
June 2016 acquisition of Exiqon A/S, a leader in RNA analysis technologies, and the January 2017 acquisition of
OmicSoft Corporation, a software provider unlocking valuable insights from large “omics” datasets. Sales growth of
6% includes an adverse impact of one percentage point related to growth of non-core PCR tests and the China HPV
franchise, which beginning in January 2018 have either been discontinued or externalized through a partnership
with a Chinese company which has taken over the commercial distribution of the HPV test franchise in China. All
regions and customer classes supported higher sales of consumables and related revenues (+7% / 88% of sales) and
instruments (+2% / 12% of sales).
Net sales by geographic region
Americas
Europe / Middle East / Africa
Asia-Pacific / Japan
Full-year 2017
Sales (In $ m)
% change
% of sales
$ 653
$ 463
$ 299
+4%
+8%
+7%
46%
33%
21%
Top 7 emerging markets: Brazil, Russia, India, China, South Korea, Mexico and Turkey ($234 million, +12%, 16% of sales)
FY 2017: Rest of world represented less than 1% of net sales.
Geographic regions: Europe / Middle East / Africa led the geographic performance with 8% growth in 2017,
including adverse currency movements of one percentage point of sales growth, and benefited from gains in
Germany, Italy and Turkey. The Asia-Pacific / Japan region advanced 7%, due partially to strong performance in
South Korea and India, which more than offset lower sales in Japan. Excluding the business portfolio change in
China, the Asia-Pacific / Japan region experienced 13% growth, including one percentage point of favorable
currency movements. The Americas advanced at a 5% pace, excluding U.S. HPV test sales, on higher sales of
QuantiFERON-TB tests and improved conditions among Life Science customers. Excluding adverse currency
movements of one percentage point, the top seven emerging markets expanded 12%, with key contributions from
Turkey, South Korea, India and Brazil.
Customer classes: An overview of performance in QIAGEN's four customer classes:
Net sales by product category and customer class
Consumables and related revenues
Instruments
Molecular Diagnostics(1)
Applied Testing
Pharma
Academia
Full-year 2017
Sales (In $ m)
% change
% of sales
$ 1,243
$ 175
$ 683
$ 137
$ 275
$ 323
+7%
+2%
+5%
+14%
+7%
+4%
88%
12%
48%
10%
19%
23%
(
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d
d
l
($4
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(1) Includes companion diagnostic co-development revenues ($43 million, +32%) and U.S. HPV sales ($28 million, -16%, 2%
of sales).
Molecular Diagnostics, which contributed approximately 48% of net sales, expanded 5% in 2017, after being
reduced by adverse currency movements of one percentage point. The core portfolio delivered approximately 7%
growth before adverse currency movements and the ongoing decline in sales of U.S. HPV test products (-16% / 2%
of sales). Sales of consumables used on the QIAsymphony automation platform also grew at a solid pace for the full
year, as QIAGEN exceeded its goal for new QIAsymphony placements in 2017. Sales growth of 5% includes an
adverse impact of 1% related to the China HPV franchise, which beginning in January 2018 has been externalized
through a partnership with a Chinese company.
Applied Testing represented approximately 10% of net sales and grew 14% in 2017 compared to 2016, with
negligible favorable currency movements. Applied Testing advanced for instruments as well as consumables and
related revenues, in part due to gains in the human identification / forensics portfolio.
Pharma experienced 7% sales growth in 2017 compared to 2016 and provided 19% of net sales, with negligible
adverse currency movements. Pharma grew in consumables and related revenues that more than offset weaker
instruments growth during the course of the year.
Academia represented approximately 23% of net sales and rose 4% in 2017 compared to 2016, with modestly
favorable currency movements. Academia advanced on consumables and related revenues, while the EMEA and
Asia Pacific / Japan regions showed growth during 2017.
Gross Profit
Gross profit was $922.6 million, or 65% of net sales, in 2017, compared with $844.7 million, or 63% of net sales,
in 2016. Generally, our consumables and related products have a higher gross margin than our instrumentation
products and service arrangements. Fluctuations in the sales levels of these products and services can result in
changes in gross margin between periods. Further, gross profit in 2017 was impacted by $4.4 million in
restructuring charges while 2016 was impacted by restructuring charges of $12.0 million. Additionally, during
2016, we incurred incremental costs in connection with the relocation and centralization of the manufacturing of
certain products to our European production site in Hilden, Germany and also in connection with the in-sourcing of
the manufacturing of our QuantiFERON product to our U.S. site in Germantown, Maryland.
Amortization expense related to developed technology and patent and license rights, which have been acquired in
business combinations, is included in cost of sales. The amortization expense on acquisition-related intangibles within
cost of sales decreased to $72.7 million in 2017 from $80.1 million in 2016 reflecting the end of the amortization
period of intangibles acquired in 2007. Acquisition-related intangible amortization may increase in the future should
we make further acquisitions.
Research and Development
Research and development expenses increased 3% to $154.1 million (11% of net sales) in 2017, compared to
$149.8 million (11% of net sales) in 2016. The increase in research and development costs during 2017 reflects our
ongoing investments in NGS and our life sciences portfolio, as well as our acquisitions of Exiqon in 2016 and
OmicSoft in 2017 together with regulatory activity in support of new products. As we continue to discover, develop
and acquire new products and technologies, we expect to incur additional expenses related to facilities, licenses and
employees engaged in research and development. Additionally, research and development costs are expected to
increase as a result of seeking regulatory approvals, including U.S. FDA Pre-Market Approval (PMA), U.S. FDA
510(k) clearance and EU CE approval of certain assays or instruments. Further, business combinations, along with
the acquisition of new technologies, may increase our research and development costs in the future. We have a
strong commitment to innovation and expect to continue to make investments in our research and development
efforts.
Sales and Marketing
Sales and marketing expenses were largely unchanged at $375.6 million (26% of net sales) in 2017 compared to
$376.3 million (28% of net sales) in 2016. Sales and marketing expenses were primarily associated with personnel,
commissions, advertising, trade shows, publications, freight and logistics expenses, and other promotional expenses.
We experienced efficiencies due to a lower cost base following the realignment of marketing activities as part of the
2016 restructuring project. These incremental savings were slightly offset by higher compensation costs including
share based compensation expense when compared to the prior period due to reassessment of stock units with
performance criteria. We anticipate that absolute sales and marketing costs will increase along with new product
introductions and growth in sales of our products, but decrease as a percentage of sales. Further, looking forward
we expect a lower cost base following the realignment of marketing activities as part of the 2016 restructuring
project.
General and Administrative, Restructuring, Integration and Other
General and administrative, restructuring, integration and other costs increased by 11% to $200.1 million (14% of
net sales) in 2017 from $180.6 million (13% of net sales) in 2016. The increase in 2017 reflects an increase in
acquisition and integration costs which totaled $68.9 million in 2017, which included $45.3 million in costs from
acquisition related legal settlements partially offset by $3.3 million gains recorded from the reduction in the fair value
of contingent consideration following unmet milestones, as compared to $31.1 million in 2016, of which $6.3
million related to the transaction costs incurred in connection with the acquisition of Exiqon A/S. Acquisition and
integration related costs in 2016 are net of $5.0 million of the total $6.5 million gains recorded in general and
administrative costs from the reduction in the fair value of contingent consideration following unmet milestones. 2016
also includes the impact of lower share based compensation costs following a reassessment of stock units with
performance criteria. Restructuring costs of $29.1 million were lower in 2017 compared to $56.2 million in 2016
related to internal activities, including severance and retention costs as discussed fully in Note 6. As we further
integrate the acquired companies and pursue other opportunities to gain efficiencies, we expect to continue to incur
additional restructuring and business integration costs in 2018. Over time, we believe the restructuring and
integration activities will reduce expenses as we improve efficiency in operations.
Acquisition-Related Intangible Amortization
Amortization expense related to developed technology and patent and license rights acquired in a business
combination is included in cost of sales. Amortization of trademarks and customer base acquired in a business
combination is recorded in operating expense under the caption “acquisition-related intangible amortization.”
Amortization expenses of intangible assets not acquired in a business combination are recorded within cost of sales,
research and development, or sales and marketing line items based on the use of the asset.
During 2017, amortization expense on acquisition-related intangibles within operating expense increased to $39.4
million, compared to $39.1 million in 2016. We expect acquisition-related intangible amortization will increase as a
result of our future acquisitions.
Other Income (Expense)
Total other expense, net was $39.0 million in 2017, compared to $41.9 million in 2016. Total other expense, net is
primarily the result of interest expense and other expense, partially offset by interest income.
For the year ended December 31, 2017, interest income increased to $10.6 million from $6.8 million in 2016.
Interest income includes interest earned on cash, cash equivalents and short term investments, income related to
certain interest rate derivatives as discussed in Note 13 in the accompanying consolidated financial statements and
other components including the interest portion of operating lease transactions.
Interest expense increased to $49.7 million in 2017, compared to $39.0 million in 2016. Interest costs primarily
relate to debt, discussed in Note 15 in the accompanying consolidated financial statements.
Other expense, net for the year ended December 31, 2017 includes a $3.5 million gain in connection with the sale
of our interest in an equity-method investment as well as $3.2 million in income from equity-method investments offset
by a $5.1 million loss recognized in connection with the impairments of cost-method investment and net losses on
foreign currency in 2017. Included in $9.7 million other expense, net in 2016 is a $8.3 million loss recognized in
connection with the impairment of an equity-method investment and a $2.6 million charge for the disposal of
goodwill following the transfer of the research and development activities of our instrumentation business as part of
the restructuring program initiated late in 2016. For the year ended December 31, 2017, we recorded net losses on
foreign currency of $3.3 million compared to less than $0.1 million in 2016 due to foreign currency rate
fluctuations.
Provision for Income Taxes
Our effective tax rates differ from The Netherlands statutory tax rate of 25% due in part to our operating subsidiaries
being exposed to effective tax rates ranging from zero to more than 40%. In 2017 and 2016, our effective tax rates
were 64.7% and (41.1)%, respectively. The comparison is impacted by pre-tax book income which was higher in
2017 at $114.4 million compared to $56.9 million in 2016. Pretax book income was lower in 2016 primarily due
to charges incurred in connection with the restructuring program initiated in the fourth quarter of 2016. Fluctuations
in the distribution of pre-tax (loss) income among our operating subsidiaries can lead to fluctuations of the effective
tax rate in the consolidated financial statements.
During 2017, the 64.7% reflects the impacts of the U.S. tax reform. Because of the tax reform, we revalued of our
U.S. deferred tax assets and liabilities to reflect the corporate income tax rate change from 35% to 21% and
provided for a full valuation allowance of $60.8 million which was recorded against deferred tax assets related to
U.S. interest carry forwards. Based on the current debt level in the U.S., along with the new restrictive interest
limitation enacted with the new U.S. tax reform, it is highly unlikely that the historic U.S. interest carry forward will
ever be utilized. We also recorded full valuation allowances against other deferred tax assets on tax losses due to
unlikely future profits in other jurisdictions. Following the adoption of ASU 2016-09 Compensation - Stock
Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, $5.2 million of excess tax
benefit was recognized directly to the tax provision for the year ended December 31, 2017 and during 2017, we
increased accruals for tax contingencies by $22.1 million, primarily related to ongoing income tax audits. In 2016,
tax expense on foreign operations was favorably impacted by lower income tax rates and partial tax exemptions on
foreign income primarily derived from operations in Germany, Singapore, Luxembourg, Ireland and Switzerland.
These foreign tax benefits are due to a combination of favorable tax laws, regulations, rulings, and exemptions in
these jurisdictions. In particular, we have pre-tax income in Germany which is statutorily exempt from trade tax on
intercompany foreign royalty income. Further, we have intercompany financing arrangements through Luxembourg
and Ireland in which the intercompany income is partially exempt. See Note 16 to the consolidated financial
statements for a full reconciliation of the effective tax rate to The Netherlands statutory rate.
In future periods, our effective tax rate may fluctuate from similar or other factors as discussed in “Changes in tax
laws or their application could adversely affect our results of operations or financial flexibility” in Item 3 Risk Factors
of the 2017 Annual Report on Form 20-F files with the U.S. Securities and Exchange Commission.
Foreign Currencies
QIAGEN N.V.’s reporting currency is the U.S. dollar, and most of our subsidiaries’ functional currencies are the local
currencies of the countries in which they are headquartered. All amounts in the financial statements of entities whose
functional currency is not the U.S. dollar are translated into U.S. dollar equivalents at exchange rates as follows: (1)
assets and liabilities at period-end rates, (2) income statement accounts at average exchange rates for the period,
and (3) components of shareholders’ equity at historical rates. Translation gains or losses are recorded in
shareholders’ equity, and transaction gains and losses are reflected in net income. The net loss on foreign currency
transactions in 2017 was $3.3 million and in 2016 and 2015 was less than $0.1 million, and $0.5 million,
respectively, and is included in other expense, net.
Derivatives and Hedging. In the ordinary course of business, we use derivative instruments, including swaps,
forwards and/or options, to manage potential losses from foreign currency exposures and variable rate debt. The
principal objective of such derivative instruments is to minimize the risks and/or costs associated with global
financial and operating activities. We do not utilize derivative or other financial instruments for trading or speculative
purposes. We recognize all derivatives as either assets or liabilities on the balance sheet, measure those instruments
at fair value and recognize the change in fair value in earnings in the period of change, unless the derivative
qualifies as an effective hedge that offsets certain exposures. In determining fair value, we consider both the
counterparty credit risk and our own creditworthiness, to the extent that the derivatives are not covered by collateral
agreements with the respective counterparties. To determine our own credit risk, we estimated our own credit rating
by benchmarking the price of our outstanding debt to publicly-available comparable data from rated companies.
Using the estimated rating, we quantify our credit risk by reference to publicly-traded debt with a corresponding
rating.
Foreign Currency Derivatives. As a globally active enterprise, we are subject to risks associated with fluctuations in
foreign currencies in our ordinary operations. This includes foreign currency-denominated receivables, payables,
debt, and other balance sheet positions including intercompany items. We manage our balance sheet exposure on a
group-wide basis using foreign exchange forwards, options and cross-currency swaps.
Interest Rate Derivatives. We use interest rate derivative contracts on certain borrowing transactions to hedge interest
rate exposures. We have entered into interest rate swaps in which we agree to exchange, at specified intervals, the
difference between fixed and floating interest amounts calculated by reference to an agreed-upon notional principal
amount.
We also make use of economic hedges. Further details of our derivative and hedging activities can be found in Note
13 to the accompanying consolidated financial statements.
Liquidity and Capital Resources
To date, we have funded our business primarily through internally generated funds, debt, and private and public
sales of equity. Our primary use of cash has been to support continuing operations and our investing activities
including capital expenditure requirements and acquisitions. As of December 31, 2017 and 2016, we had cash
and cash equivalents of $657.7 million and $439.2 million, respectively. We also had short-term investments of
$359.2 million at December 31, 2017. Cash and cash equivalents are primarily held in U.S. dollars and euros,
other than those cash balances maintained in the local currency of subsidiaries to meet local working capital needs.
At December 31, 2017, cash and cash equivalents had increased by $218.5 million from December 31, 2016,
primarily as a result of cash provided by operating activities of $286.8 million and cash provided by financing
activities of $387.2 million, partially offset by cash used in investing activities of $464.3 million. Working capital as
of December 31, 2017 increased to $1.323 billion as compared to $729.1 million as of December 31, 2016,
reflecting the cash provided by the operating and financing activities in 2017 as described below.
Operating Activities. For the years ended December 31, 2017 and 2016, we generated net cash from operating
activities of $286.8 million and $341.6 million, respectively. While net income was $40.4 million in 2017, non-
cash components in income included $216.4 million of depreciation and amortization and $5.1 million of non-cash
impairments due to the impairment of cost-method investments as further discussed in Note 10.
Operating cash flows include a net decrease in working capital of $95.2 million excluding changes in fair value of
derivative instruments. The current period change in working capital is primarily due to increased inventories and
accounts receivable and decreased taxes payable. Because we rely heavily on cash generated from operating
activities to fund our business, a decrease in demand for our products, longer collection cycles or significant
technological advances of competitors would have a negative impact on our liquidity.
Investing Activities. Approximately $464.3 million of cash was used in investing activities during 2017, compared to
$179.1 million during 2016. Investing activities during 2017 consisted principally of $450.6 million for purchases
of short-term investments, $90.1 million in cash paid for purchases of property and equipment, as well as $34.3
million paid for intangible assets and $4.8 million paid for strategic investments in privately and publicly held
companies as discussed in Note 10, partially offset by $189.0 million from the sale of short-term investments.
Additionally, during 2017 cash paid for acquisitions, net of cash acquired, totaled $50.5 million. Cash used in
other investing activities during the year ended December 31, 2017 and 2016 consisted primarily of $20.7 million
and $1.2 million, respectively, paid in connection with derivative collateral arrangements.
Financing Activities. For the year ended December 31, 2017, cash provided by financing activities was $387.2
million compared to cash used in financing activities of $10.6 million in 2016. Financing activities during 2017
consisted primarily of $329.9 million net cash proceeds from the German private placement and $394.4 million net
cash proceeds from the cash convertible offering. We used $73.6 million of the proceeds from the from the cash
convertible offering to pay the premium for a call option related to the cash convertible notes, and simultaneously
received $45.4 million from the sale of Warrants, for a net cash outlay of $28.3 million for the call spread overlay.
Additionally in 2017, we used $243.9 million for a capital repayment made to shareholders in connection with the
January 2017 synthetic share buyback and repurchased QIAGEN shares of $61.0 million in connection with the
fourth share repurchase program discussed in Note 17 "Equity." Cash used in other financing activities during the
year ended December 31, 2017 and 2016 consisted primarily of $4.4 million and $3.1 million paid for contingent
consideration, respectively, together with $4.1 million and $0.8 million paid in connection with derivative collateral
arrangements, respectively.
Other Factors Affecting Liquidity and Capital Resources
In September 2017, we issued $400.0 million aggregate principal amount of Cash Convertible Senior Notes which
are due in 2023 (2023 Notes), which are discussed fully in Note 15 "Lines of Credit and Debt". Interest on the
2023 Notes is payable semiannually in arrears at a rate of 0.500% per annum. The 2023 Notes will mature on
September 13, 2023 unless repurchased or converted in accordance with their terms prior to such date.
Additionally in 2017, we completed a German private placement of $329.9 million, net of issuance costs, consisting
of several tranches denominated in either U.S. dollars or Euro at either floating or fixed rates and due at various
dates through June 2027 as described in Note 15 "Lines of Credit and Debt."
In October 2016, we extended the maturity of our €400 million syndicated revolving credit facility, which now has
a contractual lifetime until December 2021 of which no amounts were utilized at December 31, 2017. The facility
can be utilized in Euro, British pounds sterling, Swiss franc or U.S. dollar and bears interest of 0.40% to 1.20%
above three months EURIBOR, or LIBOR in relation to any loan not in euro, and is offered with interest periods of
one, two, three or six months. We have additional credit lines totaling €26.6 million with no expiration date, none
of which were utilized as of December 31, 2017. We also have capital lease obligations, including interest, in the
aggregate amount of $1.5 million, and carry $1.8 billion of long-term debt, of which no amounts are current as of
December 31, 2017.
In March 2014, we issued $730.0 million aggregate principal amount of Cash Convertible Senior Notes of which
$430.0 million is due in 2019 (2019 Notes) and $300.0 million is due in 2021 (2021 Notes). We refer to the
2019 Notes, the 2021 Notes and the 2023 Notes collectively as the “Cash Convertible Notes” which are discussed
fully in Note 15 to the consolidated financial statements. Interest on the 2019 and 2021 Notes is payable
semiannually in arrears on March 19 and September 19 of each year, at rates of 0.375% and 0.875% per annum
for the 2019 Notes and 2021 Notes, respectively, commencing on September 19, 2014. The 2019 Notes will
mature on March 19, 2019 and the 2021 Notes will mature on March 19, 2021, unless repurchased or converted
in accordance with their terms prior to such date.
In October 2012, we completed a U.S. private placement through the issuance of new senior unsecured notes at a
total amount of $400 million with a weighted average interest rate of 3.66% (settled on October 16, 2012). The
notes were issued in three series: (1) $73 million 7-year term due in 2019 (3.19%); (2) $300 million 10-year term
due in 2022 (3.75%); and (3) $27 million 12-year term due in 2024 (3.90%).
We had notes payable, which were the long-term borrowings of the proceeds from the issuances of $150.0 million
senior unsubordinated convertible notes, with a 1.5% coupon due in 2024 through QIAGEN Finance (2004 Notes).
The 2004 Notes were convertible into our common shares at a conversion price of $12.6449, subject to adjustment.
In connection with conversions of $14.9 million of the 2004 Notes, we previously repaid $14.5 million of the debt
to QIAGEN Finance. During 2015, we paid $250.9 million for the redemption of the remaining loan and
repurchased the warrant agreement with QIAGEN Finance and recognized a loss of $7.6 million in other expense,
net.
In connection with certain acquisitions, we could be required to make additional contingent cash payments totaling
up to $18.5 million based on the achievement of certain revenue and operating results milestones as follows: $11.5
million in 2018 and $7.0 million, payable in any 12-month period from now until 2029 based on the
accomplishment of certain revenue targets. Of the $18.5 million total contingent obligation, we have assessed the
fair value at December 31, 2017, to be $11.5 million, which is included in accrued liabilities in the accompanying
balance sheet as of December 31, 2017.
In July 2014, we announced the launch of our third $100 million share repurchase program to purchase up to
another $100 million of our common shares (excluding transaction costs). In 2014, 2.1 million QIAGEN shares
were repurchased for $49.1 million (excluding transaction costs) and in 2015 0.8 million QIAGEN shares were
repurchased for $20.8 million. This program expired in December 2015.
In April 2016, we announced the launch of our fourth $100 million share repurchase program. In August 2016, we
announced our intention to return a total amount of approximately $300 million to our shareholders by the end of
2017. In January 2017, we completed a synthetic share repurchase that combined a direct capital repayment with a
consolidation of shares. This approach has been used by various large, multinational Dutch companies to provide
returns to shareholders in a faster and more efficient manner than traditional open-market purchases. $243.9 million
was repaid to shareholders through the transaction and the outstanding number of common shares was reduced by
8.9 million or 3.7%. As discussed further in Note 17 "Equity", the capital repayment program was completed in
January 2017. During the remainder of 2017, 1.9 million QIAGEN shares were repurchased for $61.0 million
(including transaction costs) to complete the total program.
In January 2018, we announced our fifth share repurchase program of up to $200 million of our common shares.
Repurchased shares will be held in treasury in order to satisfy various obligations, which include employee share-
based remuneration plans.
We expect that cash from financing activities will continue to be impacted by issuances of our common shares in
connection with our equity compensation plans and that the market performance of our stock will impact the timing
and volume of the issuances. Additionally, we may make future acquisitions or investments requiring cash payments,
the issuance of additional equity or debt financing.
We believe that funds from operations, existing cash and cash equivalents, together with the proceeds from our
public and private sales of equity, and availability of financing facilities, will be sufficient to fund our planned
operations and expansion during the coming year. However, any global economic downturn may have a greater
impact on our business than currently expected, and we may experience a decrease in the sales of our products,
which could impact our ability to generate cash. If our future cash flows from operations and other capital resources
are not adequate to fund our liquidity needs, we may be required to obtain additional debt or equity financing or to
reduce or delay our capital expenditures, acquisitions or research and development projects. If we could not obtain
financing on a timely basis or at satisfactory terms, or implement timely reductions in our expenditures, our business
could be adversely affected.
Off-Balance Sheet Arrangements
Other than our former arrangements with QIAGEN Finance as discussed in Note 15 to the consolidated financial
statements, we did not use special purpose entities and do not have off-balance sheet financing arrangements as of
and during the years ended December 31, 2017, 2016 and 2015.
Contractual Obligations
As of December 31, 2017, our future contractual cash obligations are as follows:
Payments Due by Period
Contractual
Obligations
Long-term deb(1)
Total
2018
2019
2020
2021
2022
Thereafter
$ 1,865,393
$ 24,426
$ 510,267
$ 20,485
$ 330,029
$ 493,910
$ 486,276
Purchase obligations
99,489
65,073
22,556
10,472
Operating leases
64,877
18,483
16,011
11,762
License and royalty
payments(2)
55,092
12,907
11,858
11,558
943
8,457
8,860
11
6,126
6,161
434
4,038
3,748
Capital lease obligations(3)
1,470
1,411
45
14
—
—
—
Total contractual cash
obligations
$ 2,086,321
$ 122,300
$ 560,737
$ 54,291
$ 348,289
$ 506,208
$ 494,496
(1) Amounts include required principal, stated at the current carrying values, and interest payments.
(2) As of December 31, 2017, $11.8 million and $35.3 million are included in accrued and other current liabilities and
other long-term liabilities, respectively.
(3) Includes future cash payments, including interest, due under capital lease arrangements.
In addition to the above and pursuant to purchase agreements for several of our recent acquisitions, we could be
required to make additional contingent cash payments totaling up to $18.5 million based on the achievement of
certain revenue and operating results milestones as follows: $11.5 million in 2018 and $7.0 million, payable in any
12-month period from now until 2029 based on the accomplishment of certain revenue targets, the launch of certain
products or the grant of certain patent rights. As of December 31, 2017, we have accrued $11.5 million for these
contingent payments which is included in accrued and other current liabilities.
Liabilities associated with uncertain tax positions, including interest and penalties, are currently estimated at $47.1
million as of December 31, 2017 and are not included in the table above, as we cannot reasonably estimate when,
if ever, an amount would be paid to a government agency. Ultimate settlement of these liabilities is dependent on
factors outside of our control, such as examinations by each agency and expiration of statutes of limitation for
assessment of additional taxes.
Dividend
QIAGEN has not paid a cash dividend since its inception and does not intend to pay any dividends in the
foreseeable future. We intend to retain any earnings for the development of our business.
Credit Rating
QIAGEN is currently not rated by any credit rating agency.
MANAGEMENT REPORT
Human Resources
Overview
The skills, knowledge, dedication and passion of our employees are critical for the success of QIAGEN. We want to
recruit, support and retain the best employees, offering performance-based remuneration, development opportunities
and measures to balance work and family life. We are committed to diversity in our teams, fueling innovation and
engagement with our customers and business partners. In a fast-changing, competitive business environment,
QIAGEN has a significant commitment to being an employer of choice and further enhancing our position as a great
place to work. At the end of 2017, QIAGEN had 4,688 full-time equivalent employees, a small increase from 4,684
at the end of 2016. Total personnel expenses including share-based compensation in 2017 were $453.6 million
compared to $464.4 million in 2016.
Code of Ethics
QIAGEN has in place a Code of Conduct which qualifies as a code of ethics, as required by SEC and NASDAQ
Marketplace Rules. The Code of Conduct applies to all of QIAGEN’s employees, including our principal executive
officer, principal financial officer, principal accounting officer or controller and other persons performing similar
functions. The full text of the Code of Conduct is available on our website at www.QIAGEN.com.
Training and Retention
At QIAGEN, we recognize that employees are our most important resource. Their exceptional talent, skill, and
passion are key to our long-term success and corporate value. Employee development is therefore viewed as an
integral success factor in creating lasting value for our customers, patients, colleagues, partners, and shareholders.
QIAGEN maintains a transparent framework, the QIAGEN Profile Navigator (QPN), to make career paths, job
requirements and performance expectations clear based on objective criteria for all positions across our growing
global organization. Our global Performance Enhancement System (PES) provides all employees and their managers
with regular, one-on-one review sessions to discuss career development topics. PES sessions include discussion of an
employee’s goals and achievements, training needs and interests, career planning drawing upon the QPN role
profile system, organizational development, and results of regular “180° surveys.” Professional training and
development are an ongoing process for all employees, tailored to different career paths. An employee’s pursuit of
training cycles from PES session to training participation, review, follow-up, and back to PES review. QIAGEN’s
compensation structure (see below) ties in with the QPN role profiles and PES performance evaluations.
Leadership Campus (LC)
This program, composed of three components, is designed to ensure the ongoing development of QIAGEN’s future
management generations. LC for Starters prepares high-performing employees to take an initial leadership position.
The program provides leadership basics and an overview of relevant business management topics. LC I accelerates
the careers of our professionals by providing further insights into advanced leadership and management topics while
focusing on individual development and business-related innovative actions. LC II is a senior executive program that
is designed to increase the leadership skills and management knowledge of outstanding QIAGEN senior managers
by a more individual development approach. The program mainly focuses on leadership coaching sessions, as well
as on business-related innovative actions.
QIAGEN Executive MBA Program
To support our future growth, QIAGEN offers employees the opportunity to participate in the QIAGEN Executive
MBA Business Integration Program in cooperation with the University of Würzburg, Germany. The program provides
professionals with a wide range of management skills and knowledge, which are key to an executive career in the
industry and at QIAGEN in particular. Participants study in an international environment with colleagues from around
the world. Two modules are conducted with partner universities in the U.S.: at Boston University in Boston,
Massachusetts, and at Florida Gulf Coast University in Fort Myers, Florida.
QIAGEN Academy
To support all QIAGEN employees in individual development, QIAGEN has implemented an online learning
management system (LMS), the QIAGEN Academy. It manages the entire training process from enrollment to
certificate conveniently in one platform. The QIAGEN Academy is available to every employee 24/7 via the internet.
Continual access to all training materials at any time allows employees to blend different learning methods such as
virtual classrooms, web-based training, videos or classroom training into holistic and sustainable learning concepts.
We offer a huge training catalog with a wide range of development options aligned to our competency model. This
includes courses in soft skills, product training and training in QIAGEN-specific processes.
For more information about our training system, please also refer to the section “Employee matters” in our non-
financial statement included in this report.
Compensation System
Since the creation of QIAGEN, management has formed a culture that seeks to attract and retain the best talent
worldwide and reward associates for performance. This compensation system fosters a focus on achieving corporate
strategic initiatives as well as personal accountability.
It is critical for QIAGEN to offer attractive compensation packages on a global basis. According to the QIAGEN
philosophy, an employee who achieves his or her performance objectives should generally be awarded
compensation comparable to the median levels of compensation provided by relevant benchmark companies.
QIAGEN participates in various compensation benchmarking surveys that provide information on the level and mix
of compensation awarded by various companies and industries for a broad range of positions around the world. In
the case of QIAGEN, these include many peer life science and diagnostics companies based in the U.S.
QIAGEN has a “pay for performance” culture, with the compensation of employees linked to the achievement of
corporate financial and individual performance goals. Business goals are established by senior management. These
goals are set at ambitious levels each year to motivate and drive performance, with a focus on both short-term and
long-term quantifiable objectives. Performance metrics used for these goals include the achievement of targets for net
sales, adjusted operating income and free cash flow. In 2017, the payments for short-term variable compensation
were based on 97% achievement of the business goals. Compensation for a significant majority of employees
worldwide includes fixed base compensation and benefits, which vary according to local market customs, as well as
a short-term variable cash bonus. The level of fixed compensation is paid in cash, usually on a monthly basis, and is
designed to provide the employee with a reasonable standard of living relative to the compensation offered by peer
companies. The amount of short-term variable cash bonus is designed to reward performance, with the payout
amount based on the achievement of overall corporate financial results as well as individual performance against a
written set of objectives.
For the Chief Executive Officer the target annual short-term variable cash bonus is set at 57.6% of the annual base
salary and the maximum is equivalent to 87.8% of the annual base salary. The Chief Financial Officer has a target
annual short-term variable cash bonus set at 41.2% with the maximum being equivalent to 62.8% of the annual fixed
salary. Furthermore, to align our compensation programs with the interests of shareholders, senior executives receive
a portion of their total compensation in the form of long-term compensation, which is granted as equity as a reward
for performance. These grants are determined on an individual basis and approved by the Compensation
Committee. These equity grants are made in the form of Performance Stock Units (PSUs) with a staggered vesting
period typically over three (40%), five (50%) and 10 years (10%).
For enhanced Work-Life Balance, QIAGEN offers services to help employees balance their personal life with our
dynamic and driven work environment, including in-house corporate childcare and sabbatical programs, as well as
company-sponsored fitness and health facilities, and programs. Flexible working hours apply to all employees except
for functions that require critical on-time presence.
Workplace Health
In today’s business climate, the health of employees is often directly related to the health of the company. Increased
job satisfaction, improved morale, reduced injuries, and increased productivity are just some of the benefits which a
healthy work environment can have. At its headquarters, QIAGEN regularly offers “health days” where all
employees are invited to receive free counsel and to participate in screening and nutrition programs, medical check-
ups, etc. QIAGEN provides in-house gyms open to all employees, sports courses coached by professional trainers,
and on-site soccer fields and beach volleyball courts, all free of charge. All female employees have free access to
screening for HPV, the primary cause of cervical cancer.
Employees worldwide
Americas
EMEA
APAC & RoW
Total
2015
Production
R&D
Sales
Marketing
Admin
2015
1310
2403
846
4559
2016
1260
2543
881
4684
2016
2017
22%
Production
21%
Production
22%
R&D
39%
Sales
7%
Marketing
10%
Admin
21%
R&D
41%
Sales
7%
Marketing
10%
Admin
2017
1245
2567
876
4688
23%
20%
40%
6%
11%
MANAGEMENT REPORT
Non-Financial Statement
Our approach to sustainability
QIAGEN integrates sustainability throughout our business. We aim to save energy and reduce environmental
impacts of our operations, drive long-term economic success with healthy, high-performance workplaces, and make
improvements in life possible as a good corporate citizen.
These three dimensions of sustainability are interlinked, reinforcing each other. We pledge to continually evaluate the
potential environmental impact of our business, its economic influence and our corporate citizenship around the
world. Our commitment to sustainability does not stop with formal regulations. As a market and innovation leader in
life sciences and molecular diagnostics, we strive to go above and beyond simply following requirements of
environmental and labor laws. There is much room for innovation in driving sustainable development in our industry,
and we are resolved to continue to move forward. Please find information about our business model, organizational
structure, products, customers, business strategy as well as main trends and factors in our Management Report.
We recognize that ongoing success for QIAGEN also depends on the sustainability of society’s resources, as well as
continuous reduction of any negative impact from our business. By engaging in intensive discussions with our various
stakeholders – employees, customers, patients, suppliers, shareholders, NGOs and communities –, we gain a better
understanding of our operating environments, including market developments and cultural dynamics. Depending on
the subject matter, we use different approaches ranging from standardized questionnaires to one to one
conversations.
Material non-financial information
For guidance on materiality and non-financial disclosures, we base our non-financial reporting on the international
standards of the Global Reporting Initiative (GRI Standards, 2016) as well as on the sustainability accounting
standards for Medical Equipment and Supplies and Biotechnology of the Sustainability Accounting Standards Board
(SASB).
To identify the relevant information, we have conducted a systematic materiality analysis in 2016. For each thematic
aspect (environmental, social and employee matters, respect for human rights, anti-corruption and bribery) we
identified a series of topics that possess high business relevance, highly influence the decisions of our stakeholders
and where QIAGEN’s activities have significant impact on the thematic aspects. In a joint workshop with
representatives from our different departments, the various perspectives had been assessed and discussed. The final
list had been validated by our senior management and resulted in twelve material topics:
Environmental matters: energy consumption, emissions
Employee matters: training, diversity, employee satisfaction, employee retention
Social matters: quality and product safety, customer satisfaction, access to medicine
Respect for human rights: conflict minerals
Anti-corruption and bribery matters:anti-trust, anti-corruption
Environmental matters
Protecting the environment, health and safety has always been a hallmark of QIAGEN. As a pioneer in the effort to
eliminate harmful substances and waste products in laboratories throughout the world, we strive to reduce energy
and water consumption, and set limits on packaging, waste, and transport. With these efforts, we aim to operate in
the most cost efficient and environmentally friendly way possible. As effects and concerns over climate change and
dwindling natural resources continue to impact pricing, we will be exposed to fluctuations in costs of these key
inputs. By being able to improve our manufacturing efficiencies and limit our dependence on finite resources, we are
engaging in active risk management and enhancing the value of our company.
For QIAGEN, commitment to safe, environmentally sound practices comes with a culture of operational excellence –
reinforced by training, decision-making and standard procedures. Operations employ a concept called QIAzen,
derived from the Japanese word KAIZEN, which means “continuous improvement.” Key employees in Operations
have received QIAzen training to identify and prioritize avenues to improve our manufacturing organization, initiate
projects, and monitor implementation with cross-functional teams. By constantly optimizing workflows in
manufacturing and production, QIAGEN reduces transportation, saves electricity and minimizes other impacts on
natural resources.
Energy Consumption and Emissions
QIAGEN regards climate change as one of the most pressing global challenges. To increase transparency regarding
our own global energy consumption and greenhouse gas emissions, QIAGEN recently introduced a systematic
approach to sustainability data management. Energy consumption and other parameters are gathered worldwide at
all significant sites and monitored at our Hilden headquarters. Currently, our reporting covers direct emissions from
combustion of fossil fuels on our own premises as well as indirect emissions from procured electricity and heat.
QIAGEN sites use about the same amount of energy from electricity and heat, as well as a smaller fraction of fuel for
our own vehicle fleet. A total of 35.3 GWh of energy has been used by QIAGEN around the globe in 2017.
When it comes to greenhouse gas emissions, QIAGEN emits approximately 30% - or 3.6 kilotons CO2 equivalents
(ktCO2e) - directly through natural gas heating and other fossil fuel use. The remaining 70% - about 8.9 ktCO2e -
are indirect emissions originating from external generation of electricity for our operations. The total energy use
causes greenhouse gas emissions of 12.5 ktCO2e. We calculate greenhouse gas emissions from grid-bound energy
sources such as electricity using emission factors for regional production mixes. This method ensures good
comparability between different carbon footprints and is also referred to as the “location-based” method.
QIAGEN is committed to reduce its energy consumption and respective CO2-emissions in the long-term and to
increase its energy efficiency in a continuous improvement process. To this end, an energy management system has
been introduced at our operational headquarter in Hilden, Germany and been certified according to EN ISO
50001:2011 in 2017. We have set ourselves the goal to reduce our energy consumption from electricity and gas by
10% by 2020 compared to 2017.
To meet our goals and limit the footprint of our business on the environment, we have introduced a broad panel of
activities and programs. We run simulations to reduce energy consumption and have installed energy recovery and
control systems to provide only the minimum of power required for operations. Improvements encompass energy
extraction from co-generators, better insulation, heat recovery and installation of intelligent building systems.
In 2011, we opened Europe’s first “green” laboratory complex at our site in Hilden. This state-of-the-art research and
production facility has been awarded gold-level certification for sustainable construction by the internationally
recognized US quality system LEED. In addition, our German facility in Stockach is certified according to DIN EN
16247, a European norm defining quality standards for energy audits.
As a significant part of the energy consumption associated with our business occurs beyond our own premises,
transportation of people and cargo is an additional focus. At QIAGEN’s headquarters, discounted train and bus
tickets encourage employees to use public transportation, and we have installed charging stations for electric cars
and bikes. The pool of company cars has been changed to ecological and CO2-efficient models in a continuous
adjustment process. Low emissions play a critical role in the decision process for new company cars. At most sites,
video conferencing systems have been installed to encourage virtual team meetings and reduce travel between sites.
Employee matters
The exceptional talent, skill and passion of our people are key to our long-term success and growth. We are
convinced that a focus on human capital drives our economic performance and sustainability. The development of
our employees at all levels is viewed as an integral factor in creating lasting value for our customers, patients,
colleagues, partners and shareholders. It is a central element of our initiatives for growth and effectiveness to
expand, develop and strengthen QIAGEN’s leadership and talent base.
Being the industry’s employer of choice by attracting and developing top talents is one of our global goals. To
achieve that, QIAGEN creates a work environment that empowers and involves employees at all levels.
Employee training
As a fast-growing technology and knowledge-based company, we consider high-quality training and career
development as an integral part of our success. As part of our talent and succession management, we have
established transparent career paths with the QIAGEN Profile Navigator (QPN). It defines jobs, core competencies
and approaches to advancement across the global organization. QIAGEN’s global Performance Enhancement
System (PES) creates a clear framework of regular, one-on-one review sessions for each employee and their manager
to discuss career development. These include discussions of goals and achievement levels, assessment of relevant
competencies, as well as training needs and career planning steps. Professional Training & Development at QIAGEN
is an ongoing process, cycling from PES discussion to training participation and learning transfer, and back to PES.
In 2016 we introduced the QIAGEN Academy: It provides the possibility to either take part in e-learning sessions
globally or to participate in in-person trainings. The focus is on job-specific skills, competencies and leadership
development. In 2017, 3,772 employees took part in a respective internal training, totaling to 7,309 training hours.
We place great importance on transparent and responsible leadership. Our future leaders are trained in
entrepreneurial and leadership competencies such as strategic thinking and acting, decision making, risk taking,
change management, performance management and employee development. Every year our employees are invited
to evaluate their superiors with a standardized questionnaire within our QIALead evaluation process. The
summarized and anonymized results are provided to the executive managers.
QIAGEN has implemented a pilot program to identify and develop the most promising specialists and managers to
prepare for senior positions. In cooperation with the University of Würzburg, Germany, we offer the opportunity to
participate in the QIAGEN Executive MBA Business Integration Program. Participants benefit not only from a
curriculum providing them with a wide range of management skills and knowledge. They also experience an
international environment, learning with colleagues from around the world. A total of 75 QIAGEN employees had
completed the MBA program by the end of 2017, with a new class enrolled in 2016.
We are currently working on different digital solutions to further enhance our development programs. In 2017, we
have updated the QIAGEN Academy Interface (3.0) while further extending the range of available trainings and
simplifying the enrollment process. We have also launched new leadership insight tools on and e-learning soundbites
and rolled-out a talent management suite, which has been already used to conduct our annual personnel
enhancement and salary review processes and will see further functional enhancements in 2018.
Diversity
We are committed to create an environment where all individuals have the opportunity to grow and contribute to our
progress, regardless of their age, educational background, gender, nationality, physical abilities, race and ethical
background, religion, or sexual orientation. Strategic consideration of diversity not only makes QIAGEN a better
place to work. We consider it to be a key success factor on the path to achieving our mission and goals. Individuals
and teams alike understand the diverse needs of our customers, identify and realize cross-functional opportunities for
our business areas, can quickly adapt to a fast-changing environment. Further information about the diversity policy
for the composition of the management board and the supervisory board can be found in the corporate governance
report.
In 2017, our multicultural workforce was composed of 71 nationalities with an average age of 40.3 With 49.2%
women we are well balanced in terms of gender on an aggregate level. We also have significantly increased the
diversity of our senior leadership team and will continue to do so in the future. In 2017, almost 31% of our
management positions in the four leadership levels below the Executive Committee were held by women. To further
improve diversity on a senior level, we have started different initiatives in 2017 to raise awareness for the value of
diversity and leverage diverse talents towards management positions. They focus on team discussions around the
subject, champion diverse talents and the development of a global recruiting standard to promote diversity in
executive positions. Concrete actions in the reporting period included the establishment of diversity forums, manager
training tools on the intranet, mandatory unconscious bias trainings within the QIAGEN Academy for all managers,
mentorship programs and more significant access for our top talents to our senior management. All initiatives are
designed to engage the organization and follow best practices for developing active inclusion. Our goal is to
leverage diversity as a great opportunity for QIAGEN to positively impact our business performance through diverse
team contributions.
Employee satisfaction and retention
Various measures to enhance career development and diversity within QIAGEN are important factors to maintain the
satisfaction of our employees and their dedication for our company. Alongside this, QIAGEN has implemented
frameworks for performance-based compensation, equity-based compensation and incentive programs for new ideas
and innovation. They aim to ensure fair and attractive compensation and to encourage each employee to work for
the company’s long-term benefit. With our new compensation plan, we are planning to gradually roll-out starting in
late 2018, we intend to have our salary structures based on the QIAGEN Profile Navigator: Each described role is
graded into the QIAGEN Job Matrix which comprises three career paths and twelve grades. All three career paths,
Specialist, Project Management and Leadership are basically equivalent. Lateral moves between roles in the different
career path are possible. This allows us to compare our pay grades with market averages and to ensure our
attractiveness as an employer. In early 2018 we plan to complete the adaption in our pilot countries, United
Kingdom and China, and we will evaluate the results.
Equally important to us is our employees’ work-life balance. We provide services to help employees balance their
personal lives with the company’s dynamic work environment, including in-house corporate child care, sabbatical
programs and flexible work hours. Beyond that, QIAGEN offers a wide range of measures for a good workplace
health: from "health days" with free counselling, screening and medical check-ups to opportunities to get exercise
like in-house gyms, on-site soccer-fields and beach volleyball courts.
At QIAGEN we believe that good leadership performance is key to our success and employee satisfaction. The
results of our annual QIALead survey, which provides a comprehensive view on the performance of all line managers
at QIAGEN, are hence are an important indicator for the development of our corporate culture and employee
satisfaction are the. For 2017, employees rated their managers with an average total score of 4.2 out of 5.0 points.
QIAGEN’s efforts to become an employer of choice are also reflected by the high number of applications for open
positions, which exceeded 37.700 applications in 2017. At the same time, the average voluntary annual turnover
rate remained largely unchanged, increasing by 0.28 percent points compared to 2016. Going forward, QIAGEN
has set a goal to reduce the voluntary turnover rate to ensure business continuity, while still allowing for a healthy
influx of fresh talent.
Social matters
QIAGEN’s mission is to make improvements in life possible by enabling our customers to achieve outstanding
success and breakthroughs in life sciences, applied testing, pharma and molecular diagnostics. We are committed to
customers and patients to deliver innovative solutions that unlock new insights for scientific research, forensics, food
safety or better treatment decisions.
To leverage our leadership in Sample to Insight technologies and create value for our company and stakeholders, it
is imperative to understand and target the diverse needs and expectations of our global customers. Only then can we
develop ever more innovative and improved solutions. We understand and live up to our responsibility to customers
and patients who depend on us for reliable, efficient workflows that enable molecular testing and help to unlock
valuable insights.
Customer Satisfaction
Customer satisfaction is an integral part of the QIAGEN mission of “Making improvements in life possible” which is
therefore under direct authority of the Chief Executive Officer. Our customers have high expectations on reliability,
safety and ecological manufacturing of our products. We rely on close contact with our customers and incorporate
their feedback into our product development process and service offers.
It is our commitment to customers to constantly improve customer experience acknowledging ever evolving customer
requirements and expectations. QIAGEN has therefore established a global systematic approach to measure
customer experience culminating in an aggregated Customer Experience Indicator. Performance of this indicator is
embedded in our annual goal setting process and results are communicated to all employees on a monthly basis with
the goal of ensuring a seamless and perfect customer experience to every customer, for all products and services
along the workflows. With an average Customer Experience Indicator (CEI) of 1,467 of possible 2,000 points in
2017, we have managed to further maintain our strong performance, also exceeding our internal target for the year.
The CEI is measured on a monthly basis through a set of internal KPIs (product and delivery performance, phone
support, etc.) that are directly linked to customer experience in transactional interactions and a customer feedback
survey program we are able to identify quickly and systematically areas for improvement while staying closely
connected with our customers.
Quality and Product Safety
QIAGEN stands for quality. Since QIAGEN’s founding 30 years ago we are committed to ultimate quality and
always strive to exceed our customers’ expectations. QIAGEN’s reputation as quality supplier is best in class in our
industry and the foundation of our loyal global customer base. To achieve and maintain QIAGEN quality we
established Total Quality Management systems in all our manufacturing facilities around the globe. These quality
systems assure constant high quality as well as safe and effective medical devices. QIAGEN’s quality systems are
certified according ISO 9001, ISO 13485, ISO 18385 as well as 21 CFR 820 and all other applicable medical
device standards around the globe (see section “Government Regulations” in the Management Report).
QIAGEN like other companies is exposed to the financial implications of recalls and other adverse events.
Equipment failures, manufacturing defects, design flaws, or inadequate disclosure of product-related risks can lead to
significant product liability claims. With a systematic quality and product safety management, QIAGEN meets the
highest standards to protect shareholder value. In the period under review, there were no major recalls.
Access to medicine
QIAGEN is aware of the importance to provide access to healthcare and research products around the world. In
developing countries with scarce resources, new ways are needed to ensure access to affordable diagnostics to help
prevent and treat diseases. Especially infectious diseases and various malignancies require an early and precise
detection to interrupt the infection chain and enable targeted treatment, yet many emerging countries lack educated
personnel and technical infrastructures to employ latest, cutting-edge molecular testing technologies. For low-income
countries in particular, early disease detection can significantly lower therapeutic costs and stop further dissemination
more effectively.
For QIAGEN, a strategic approach to access to novel diagnostic technologies can yield opportunities for growth,
innovation, and unique partnerships. We focus on developing products and pricing frameworks that account for
different levels of economic development and health care needs. By targeting widespread diseases such as cervical
cancer or tuberculosis, we can provide the means to fight infectious and potentially fatal diseases.
To support our growth strategy in emerging markets, we are constantly expanding our presence in these markets and
adapting our products to local needs, if required. An example is the development of careHPV tests for high-risk
human papillomavirus (HPV), the primary cause of cervical cancer. In corporation with the NGO PATH and support
from the Bill & Melinda Gates Foundation, we developed a dedicated testing system for use in regions with limited
healthcare-resources, such as Africa, Asia and Latin America. The main advantages of decentralized HPV testing are:
immediate analysis at the point of care
instant treatment decisions
higher compliance of patients
Our careHPV tests are already directly available in 19 countries worldwide. In the reporting period over 680,000
tests were distributed in total.
Another example is our effort to advance diagnostics for tuberculosis (TB) in low income countries. Already in 2015,
we have signed five-year memorandum of understanding with the NGO FIND to develop innovative and affordable
tests to detect those patients with latent TB who are at risk of active TB. In 2017, our overall revenue share for the
emerging markets rose by 13% to over $237 million.
We are furthermore providing financial support to a number of organizations and initiatives focusing on global
health projects. In 2017, we continued to work with organizations such as the International Agency for Research on
Cancer in Tanzania, Basic Health International in El Salvador or the Pink Ribbon Red Ribbon initiative in different
countries.
Respect for human rights
We believe that respect for human rights is an essential component of promoting sustainability in our global
business. Our vision is to transition QIAGEN’s procurement towards leading practices by implementing global best-
in-class procurement methods and standards in terms of processes and governance. This includes to ensure
compliance with our mission “Making improvements in life possible” from which we derive our commitment towards
sustainable practices and good corporate citizenship.
We expect our employees as well as our business partner to comply with national regulations and with the
specifications of our compliance manual that includes provisions with regard to human rights issues. Responsibility
for implementing and overseeing these issues is assumed by HR department and Procurement. Respect for human
rights is part of our supplier code of conduct which contains binding rules for all suppliers. As part of our supplier
selection process, we assess the suppliers’ policy with regard to human rights issues. In addition, first-tier suppliers
have to confirm REACH, RoHS and SEC compliance as appropriate. Violations against human rights in our supply
chain inherits reputational as well as legal risks for QIAGEN. Supplier audits are conducted if non-compliance is
suspected. To our knowledge, there were no violations with regard to human rights in the reporting period.
Conflict minerals
Certain minerals (known as “conflict minerals”) have been linked with human rights abuses in the Democratic
Republic of Congo and other conflict zones. QIAGEN has performed an extensive inquiry into the company’s supply
chain to ensure that no conflict minerals from the Democratic Republic of Congo or adjoining countries are used in
the company’s laboratory instruments.
Our products consist of sample and assay kits, known as consumables, and automated instrumentation systems. We
do not believe that any Conflict Minerals are necessary to the production or functionality of any of our consumable
products. We conduct due diligence measures annually to determine the presence of Conflict Minerals in our
instrumentation products and the source of any such Conflict Minerals. Because we do not purchase Conflict
Minerals directly from smelters or refineries, we rely on our suppliers to specify to us their Conflict Minerals sources
and declare their Conflict Minerals status. We disclosed our Conflict Minerals findings to the SEC for the calendar
year ending December 31, 2016 on Form SD on April 24, 2017 and will provide updated disclosure to the SEC
annually.
Anti-corruption and bribery matters
Unethical behavior and non-compliance with laws and regulations has the potential to seriously harm our business.
QIAGEN has established a comprehensive Compliance Program which translates legal and regulatory requirements
as well as our fundamental values into clear, precise and understandable guidelines as our Corporate Code of
Conduct and Ethics and supplementing specific policies for our employees.
Antitrust and Anti-corruption
Special attention is paid to infringements of antitrust and anticorruption law because these can cause substantial
financial or reputational damage (see section “Opportunities and Risks” in the Management Report) Our specific
Antitrust and Anti-Corruption Policies set forth our commitment to ensure that QIAGEN and its subsidiaries abide by
the antitrust and anti-corruption laws of the countries in which we operate.
All our policies are provided to all employees worldwide. Online training reaches all employees in local language,
supported by multiple communication resources. All new employees are required to take online training on our
Corporate Code of Conduct and Ethics at a minimum. Additional trainings which are customized to the specific area
of responsibility are mandatory. All employees in Sales and Marketing as well as Upper Management are required
to take training on corruption and anti-trust laws. Such basic trainings are followed by refresher courses on a regular
basis.
We have established a hotline for reporting accounting-related concerns on an anonymous basis in good faith. We
also offer a direct email and telephone hotline for employees to address questions or make suggestions for our
Compliance Program. In the reporting period no cases with regard to antitrust or corruption had been reported.
Our Compliance Program is overseen by the Compliance Committee under the leadership of the Head of Legal
Affairs and Compliance, that coordinates our efforts, consisting of managers from Legal, Internal Audit, HR,
Commercial Operations, Trade Compliance and Regulatory functions. The Compliance Program is overseen by the
Audit Committee of the Supervisory Board.
The Head of Legal and Compliance coordinates investigations and enforcement as necessary and gives regular
updates to the Executive Committee. In the reporting period QIAGEN had no legal actions pending or completed
with regard to antitrust or corruption.
More information about QIAGEN’s activities and the progress we are making is available online at
https://corporate.qiagen.com/about-us/Sustainability/overview.
MANAGEMENT REPORT
Future Perspectives
QIAGEN Perspectives for 2018
Building on global leadership in differentiated Sample to Insight solutions for molecular testing, QIAGEN expects to
sustain its sales and earnings growth in 2018 and beyond. Delivering solutions that exceed the expectations of
customers is a key competitive advantage in serving customers across the value chain, from healthcare users of
Molecular Diagnostics to researchers in Academia and the pharmaceutical industry, as well as public safety
laboratories. QIAGEN is two years into executing on mid-term strategic plans to enhance financial performance and
returns to shareholders from 2016 through 2020. Focused investments in innovation and commercial support have
created a faster sales trajectory for a set of growth drivers, while efficiency and capital allocation initiatives are
delivering on operating leverage and increased profitability.
In 2018 QIAGEN continues to focus on the expansion of its business activities for differentiated molecular testing
solutions in fast-growing markets. QIAGEN’s growth engines include expanding the market for QuantiFERON-TB
technology in tuberculosis control; driving the adoption of next-generation sequencing in clinical research and
diagnostics; extending QIAGEN’s leadership in Personalized Healthcare for cancer and other diseases; increasing
placements of the QIAsymphony platform with its growing menu of applications; and deepening QIAGEN’s long-
standing leadership in innovative core technologies for sample processing. This portfolio is united by the Sample to
Insight approach enabling customers to embrace efficient, automated workflows with integrated tools for interpreting
molecular data.
QuantiFERON-TB is growing rapidly as global efforts intensify to control tuberculosis (TB), the world’s most deadly
infectious disease. As the most accurate, cost-effective screening test for latent TB infection, QuantiFERON-TB is
displacing the antiquated tuberculin skin test. The fourth-generation QuantiFERON-TB Gold Plus test launched in the
United States in 2017, after adoption in more than 75 other countries. This new test will be introduced in Japan in
2018. Also in 2018, QIAGEN and DiaSorin plan to offer customers a state-of-the-art automation option to run
QuantiFERON-TB Gold Plus on 7,000-plus DiaSorin LIAISON analyzers worldwide.
Next-generation sequencing (NGS) is rapidly emerging from elite research labs into clinical research and diagnostics
because high-throughput analysis enables new depths of genomic insights. In 2017, QIAGEN sales of NGS solutions
grew at double-digit rates, passing $115 million. We are targeting more than $140 million in 2018. Our broad
portfolio of “universal” solutions includes the leading sample technologies, “Digital NGS” assays and bioinformatics.
The GeneReader NGS System, the first purpose-built NGS system for clinical panel testing, is gaining acceptance. In
2017, we expanded GeneReader’s capabilities and content menu and added the platform to Pharma collaborations.
In China, QIAGEN launched a joint venture with a leading IVD company to accelerate adoption of the GeneReader
system.
Personalized healthcare, using a patient’s unique genomic characteristics to guide treatment decisions, is driving the
growth of QIAGEN’s companion diagnostics and collaborations with Pharma companies. As the leading
independent developer of companion diagnostics, QIAGEN achieved a milestone of 25 master collaborations in
2017, with15 new co-development projects, including groundbreaking projects to develop diagnostics guiding
immuno-oncology therapies. QIAGEN is the only industry partner developing companion diagnostics for both PCR
and NGS platforms. At least five FDA approvals or submissions are planned in 2018.
QIAsymphony, a medium-throughput platform for Sample to Insight analysis with polymerase chain reaction (PCR) as
well as efficient sample preparation for other needs, soundly beat its target of 2,000 cumulative placements in 2017.
Consumable sales achieved double-digit growth. The QIAsymphony SP module is the market-leading “front end”
solution for reliable, automated processing of samples, including liquid biopsies – a critical need in NGS as well as
PCR. QIAGEN expects to launch several new regulator-approved diagnostic tests for QIAsymphony in 2018 and has
set a target of 2,300 cumulative placements by year-end.
Differentiated core technologies, enabling labs to efficiently process samples and obtain high-quality DNA and RNA
for testing, built QIAGEN’s global reputation– and continue to drive growth with innovative solutions to new
challenges. QIAGEN technologies process an estimated 50,000 biological samples a day. Our focus is on rapidly
growing applications in research and diagnostics such as liquid biopsies, single-cell analysis, epigenetics and the
microbiome. By leading the way in innovative sample processing solutions, QIAGEN continues to generate double-
digit growth in differentiated technologies.
Bioinformatics continues to grow rapidly as QIAGEN adds software applications and augments our expertly curated,
literature-based datasets to offer new insights. In 2017, we acquired OmicSoft Corporation to address customers’
growing need to access and manage huge amounts of data on DNA, RNA and other “omics.” QIAGEN Clinical
Insight (QCI) software added an important tool for precision medicine by automating guidelines for use of next-
generation sequencing in cancer. Bioinformatics promises to help drive growth as a standalone franchise and a
value-added element in Sample to Insight workflows.
QIAGEN also creates value with targeted acquisitions expanding our presence in fast-growing fields. In early 2018,
QIAGEN agreed to acquire STAT-Dx and its portfolio of multiplex diagnostics for syndromes such as serious
respiratory or gastrointestinal infections. Pending the completion of the acquisition, QIAGEN plans to launch the first
two tests, extensive respiratory and gastrointestinal panels, in Europe and other markets in the second half of 2018,
followed by U.S. launch pending regulatory clearance in 2019.
QIAGEN has begun to streamline its product portfolio by divesting smaller activities to focus on growth opportunities.
In late 2017 and early 2018, we stopped commercialization of some non-core PCR tests in China and transferred
the HPV test franchise there (including R&D, distribution, and related staff and infrastructure) to a third-party company
in China. This will free up resources to support QuantiFERON-TB, NGS and the Life Sciences portfolio.
Ongoing actions to improve efficiency are expected to continue to benefit results in 2018. Key areas include
consolidating activities into shared service centers and global centers of excellence, gaining efficiencies in
marketing, and embracing digital tools across the business. Digital channels account for a growing portion of sales
(reaching 37% in 2017).
Global Economic Perspectives for 2018
A broad-based global recovery is driving expectations for continued growth in economic output, with a slight
acceleration in 2018 from stronger-than-expected 2017 expansion. The World Bank forecasts global GDP growth of
3.1% in 2018, up from 3.0% in 2017, and moderating back to 3.0% in 2019. The momentum reflects a rebound in
investment, manufacturing and trade amid continued low interest rates, firming commodity prices and rising
confidence. Risks remain, including geopolitical unrest, a shift toward tighter monetary policy and the possibility of a
financial market disruption. In the United States, recently enacted tax reform is expected to stimulate investment and
output. Europe, which saw demand strengthen in 2017, may expand at a more moderate pace in 2018. China is
expected to continue gradual cooling of its rapid growth, amid brisk expansion across emerging markets broadly.
Japan remains in a slow-growth trend. Economic momentum tends to benefit the business environment for QIAGEN,
while a downturn could hurt customer funding budgets. Currency exchange rates also affect results reported in U.S.
dollars.
Industry Perspectives for 2018
The value of genomic insights is increasingly recognized in medicine and other fields, offering opportunities for
QIAGEN to sustain its growth trajectory in 2018 and beyond. Discovery and innovation continue to drive market
expansion.
Molecular diagnostics is growing briskly as healthcare providers adopt genomic testing to evaluate and monitor
patients for cancer, infectious diseases and other conditions. Personalized medicine, using molecular tests to guide
treatment decisions, is expanding rapidly as new discoveries develop into marketed therapies. In 2017, the U.S.
Food and Drug Administration for the first-time approved use of an oncology drug based on results of genetic
biomarker tests rather than the location of the cancer. Also in 2017, the FDA approved the first CAR T-cell therapies,
which genetically modify immune cells to fight cancer. These developments presage a wave of new therapies based
on genomic insights. Molecular diagnostics also are migrating from research institutions into hospitals in need of
quick, accurate results – driving demand for standardized tests and automated workflows. Diagnostic customers
embrace a range of diverse technologies, ranging from single-target or multiplex PCR analysis to in-depth next-
generation sequencing. In each application, easy-to-use technologies and decision-support software are critical.
Life science research in Academia and the Pharma industry rely on novel sample and sequencing technologies for
discovery of disease pathways and biomarkers, and increasingly to guide drug development and clinical trials.
Applications of molecular testing also are expanding for public safety needs such as forensics and environmental
monitoring.
Subsequent Events
On January 31, 2018, we announced our fifth share repurchase program of up to $200 million of our common
shares beginning in 2018 as well as the acquisition of STAT-Dx for approximately $147 million in cash and
additional payments of up to approximately $44 million based on the achievement of regulatory and commercial
milestones. The acquisition is expected to be completed in 2018 and funded from existing cash reserves.
In January 2018, a partnership became effective with a Chinese company that has taken over R&D, commercial
distribution, and the related QIAGEN employees and infrastructure of the HPV test franchise in China.
GOVERNANCE
Overview
We recognize the importance of clear and straightforward rules on corporate governance and, where appropriate,
have adapted our internal organization and processes to these rules. This section provides an overview of QIAGEN’s
corporate governance structure and includes details of the information required under the Dutch Corporate
Governance Code (the Dutch Code). The Dutch Code is applicable to QIAGEN N.V. (in the following also referred
to as the “Company”), as it is a publicly listed company incorporated under the laws of The Netherlands with a
registered seat in Venlo, The Netherlands. The Dutch Code contains the principles and concrete provisions which the
persons involved in a listed company (including Managing Board members and Supervisory Board members) and
stakeholders should observe in relation to one another.
Our corporate governance practices generally derive from the provisions of the Dutch Civil Code and the Dutch
Corporate Governance Code. Further, due to our listing on the New York Stock Exchange in the U.S., the Managing
Board and the Supervisory Board of QIAGEN N.V. declared their intention to disclose in QIAGEN’s Annual Reports
the Company’s compliance with the corporate governance practices followed by U.S. companies under the New
York Stock Exchange listing standards or state the deviations recorded in the period.
A brief summary of the principal differences follows.
Corporate Structure
QIAGEN is a ‘Naamloze Vennootschap,’ or N.V., a Dutch public limited liability company similar to a corporation
in the United States. QIAGEN has a two-tier board structure. QIAGEN is managed by a Managing Board consisting
of executive management acting under the supervision of a Supervisory Board (non-executives), similar to a Board of
Directors in a U.S. corporation. It is in the interest of QIAGEN and all its stakeholders that each Board performs its
functions appropriately and that there is a clear division of responsibilities between the Managing Board, the
Supervisory Board, the general meeting of shareholders (General Meeting) and the external auditor in a well-
functioning system of checks and balances.
GOVERNANCE
Managing Board
General
The Managing Board manages QIAGEN and is responsible for defining and achieving QIAGEN’s aims, strategy,
policies and results and is expected to act in a sustainable manner by focusing on long-term value creation in the
performance of their work. The Managing Board is also responsible for complying with all relevant legislation and
regulations as well as for managing the risks associated with the business activities and the financing of QIAGEN. It
reports related developments to and discusses the internal risk management and control systems with the Supervisory
Board and the Audit Committee. Under Dutch Law, QIAGEN's Managing Board, which has two members, has
chosen to work with an Executive Committee and is accountable for the actions and decisions of the Executive
Committee, which is comprised of the CEO, the CFO and certain experienced leaders who have responsibilities for
the operational management of the Company and the achievement of its objectives and results. The Managing Board
has ultimate responsibility for the Company’s external reporting and is answerable to shareholders of the Company
at the Annual General Meeting of Shareholders. Pursuant to the two-tier corporate structure, the Managing Board is
required to render account for the performance of its duties to the Supervisory Board and the General Meeting of
Shareholders (General Meeting). The Managing Board provides the Supervisory Board with timely information
necessary for the exercise of the duties of the Supervisory Board. In discharging its duties, the Managing Board takes
into account the interests of QIAGEN, its enterprises and all parties involved in QIAGEN, including shareholders and
other stakeholders.
Composition and Appointment
The Managing Board consists of one or more members as determined by the Supervisory Board. The members of the
Managing Board are appointed by the General Meeting upon the joint meeting of the Supervisory Board and the
Managing Board (the Joint Meeting) having made a binding nomination for each vacancy. However, the General
Meeting may at all times overrule the binding nature of such a nomination by a resolution adopted by at least a two-
thirds majority of the votes cast, if such majority represents more than half the issued share capital. Managing
Directors are appointed annually for the period beginning on the date following the Annual General Meeting up to
and including the date of the Annual General Meeting held in the following year.
Members of the Managing Board may be suspended and dismissed by the General Meeting by a resolution adopted
by a two-thirds majority of the votes cast, if such majority represents more than half of the issued share capital, unless
the proposal was made by the Joint Meeting, in which case a simple majority of votes cast is sufficient. Furthermore,
the Supervisory Board may at any time suspend (but not dismiss) a member of the Managing Board.
Our Managing Directors for the year ended December 31, 2017 and their ages as of January 31, 2018, are as
follows
Managing Directors
Name
Peer M. Schatz
Roland Sackers
Age
Position
52
49
Managing Director, Chief Executive Officer
Managing Director, Chief Financial Officer
The following is a brief summary of the background of each of the Managing Directors. References to “QIAGEN”
and the “Company” in relation to periods prior to April 29, 1996 mean QIAGEN GmbH and its consolidated
subsidiaries:
Peer M. Schatz, 52, joined QIAGEN in 1993, when the Company had just 30 employees and revenues of
approximately $2 million, and has been Chief Executive Officer since January 1, 2004. He was Chief Financial
Officer between 1993 and 2003 and became a member of the Managing Board in 1998. Mr. Schatz was
previously a partner in a private management buyout group in Switzerland, worked in finance and systems positions
in Sandoz, Ltd. and Computerland AG, and participated in the founding of start-up companies in the computer and
software trading industry in Europe and the United States. Mr. Schatz graduated from the University of St. Gallen,
Switzerland, with a Master's degree in Finance in 1989 and obtained an M.B.A. in Finance from the University of
Chicago Graduate School of Business in 1991. Mr. Schatz served as a member of the German Corporate
Governance Commission from 2002 to 2012. He is Managing Director of PS Capital Management GmbH. He is a
board member of AdvaMedDx, an advocacy dedicated to issues facing the in vitro diagnostics industry in the United
States and Europe, and ALDA (the Analytical, Life Science and Diagnostics Association), a trade association of
developers and suppliers in these fields.
Roland Sackers, 49, joined the Company in 1999 as Vice President Finance and has been Chief Financial Officer
since 2004. In 2006, Mr. Sackers became a member of the Managing Board. Between 1995 and 1999, he served
as an auditor with Arthur Andersen Wirtschaftsprüfungsgesellschaft Steuerberatungsgesellschaft. Mr. Sackers earned
his Diplom-Kaufmann from University of Münster, Germany. He is a former member of the Supervisory Board and
Audit Committee of IBS AG and a former member of the board of directors of Operon Biotechnologies, Inc. Mr.
Sackers is a board member of the industry association BIO Deutschland. He is also a non-executive director and
chair of the audit committee of Immunodiagnostic Systems Holding PLC (IDS), a leading producer of immunological
tests for research and diagnostic applications publicly listed in the United Kingdom.
Conflicts of Interest, Loans or Similar Benefits
Resolutions to enter into transactions under which members of the Managing Board could have a conflict of interest
with QIAGEN, and which are of material significance to QIAGEN and/or the relevant member of the Managing
Board, require the approval of the Supervisory Board. A Managing Director that has a personal conflict of interest
will not participate in the decision making process regarding such item. QIAGEN has not entered into any such
transactions in 2017. No credit, loans or similar benefits were granted to members of the Managing Board.
Additionally, the Managing Board Members did not receive any benefits from third parties that were either promised
or granted in view of their position as members of the Managing Board.
GOVERNANCE
Supervisory Board
General
The Supervisory Board supervises the policies of the Managing Board, the general course of QIAGEN’s affairs and
the manner in which the Management Board implements the long-term value creation strategy and the business
enterprises which we operate. The Supervisory Board assists the Managing Board by providing advice relating to the
business activities of QIAGEN. In 2017, the Supervisory Board had five regular meetings that were held with the
attendance of the Managing Board, while certain agenda items were discussed exclusively between the Supervisory
Board members. In discharging its duties, the Supervisory Board takes into account the interests of QIAGEN, its
enterprise and all parties involved in QIAGEN, including shareholders and other stakeholders. The Supervisory
Board is responsible for the quality of its own performance. In this respect, the Supervisory Board conducts a self-
evaluation on an annual basis. Our Supervisory Board has specified matters requiring its approval, including
decisions and actions which would fundamentally change the company’s assets, financial position or results of
operations. The Supervisory Board has appointed an Audit Committee, a Compensation Committee, a Selection and
Appointment (Nomination) Committee and a Science and Technology Committee from among its members and can
appoint other committees as deemed beneficial. The Supervisory Board has approved charters pursuant to which
each of the committees operates.
Composition and Appointment
The Supervisory Board consists of at least three members, or a larger number as determined by the Joint Meeting.
Members of the Supervisory Board are appointed by the General Meeting upon the Joint Meeting having made a
binding nomination for each vacancy. However, the General Meeting may at all times overrule the binding nature of
such a nomination by a resolution adopted by at least a two-thirds majority of the votes cast, if such majority
represents more than half the issued share capital.
The Supervisory Board shall be composed in a way that enables it to carry out its duties properly and enables its
members to act critically and independently of one another and of the Managing Board and any particular interests.
To that effect, the Supervisory Board has adopted a profile of its size and composition that takes into account the
nature of our business, our activities and the desired diversity, expertise and background of the members of the
Supervisory Board. The current profile of the Supervisory Board can be found on our website. The Supervisory Board
has appointed a chairman from its members who has the duties assigned to him by the Articles of Association and
the Dutch Code.
Members of the Supervisory Board are appointed annually for the period beginning on the date following the
General Meeting up to and including the date of the General Meeting held in the following year. Members of the
Supervisory Board may be suspended and dismissed by the General Meeting by a resolution adopted by a two-
thirds majority of the votes cast, if such majority represents more than half of the issued share capital, unless the
proposal was made by the Managing Board and the Supervisory Board in which case a simple majority of votes cast
is sufficient.
Our Supervisory Directors for the year ended December 31, 2017 and their ages as of January 31, 2018, are as
follows:
Supervisory Directors
Name
Stéphane Bancel
Age Nationality Gender Position
45
French
Male Supervisory Director, Member of the Compensation Committee,
Audit Committee and Science and Technology Committee
Dr. Håkan Björklund
61
Swedish
Male Supervisory Director, Member of the Compensation Committee and Selection
and Appointment Committee
Dr. Metin Colpan
63
German
Male Supervisory Director, Chairman of the Science and Technology Committee and
Prof. Dr. Manfred Karobath
77
Austrian
Member of the Selection and Appointment Committee
Male Chairman of the Supervisory Board, Supervisory Director, Chairman of the
Selection and Appointment Committee, Member of the Compensation
Committee and Member of the Science and Technology Committee
Dr. Ross L. Levine
Dr. Elaine Mardis
Lawrence A. Rosen
Elizabeth E. Tallett
46
55
60
68
U.S.
Male Supervisory Director and Member of the Science and Technology Committee
U.S. Female Supervisory Director and Member of the Science and Technology Committee
U.S.
Male Supervisory Director and Chairman of the Audit Committee
U.S. Female Supervisory Director, Chairwoman of the Compensation Committee, Member of
the Audit Committee and Member of the Selection and Appointment Committee
The following is a brief summary of the background of each of the Supervisory Directors and Managing Directors.
References to “QIAGEN” and the “Company” in relation to periods prior to April 29, 1996 mean QIAGEN GmbH
and its consolidated subsidiaries:
Stéphane Bancel, 45, joined the Company's Supervisory Board as well as the Compensation Committee in 2013
and joined the Audit Committee and Science and Technology Committee in 2014. He is Chief Executive Officer of
Moderna Therapeutics, Inc., a clinical-stage biotechnology company based in Cambridge, Massachusetts, which is
advancing multiple drug development programs involving messenger RNA therapeutics. Before joining Moderna,
Mr. Bancel served for five years as Chief Executive Officer of the French diagnostics company bioMérieux SA. Prior
to bioMérieux, he was Managing Director of Eli Lilly in Belgium and Executive Director of Global Manufacturing
Strategy and Supply Chain at Eli Lilly in Indianapolis, Indiana, after having started at Lilly in Great Britain. Before
joining Eli Lilly, Mr. Bancel served as Asia-Pacific Sales and Marketing Director for bioMérieux while based in Tokyo,
Japan. He holds a Master of Engineering degree from École Centrale Paris (ECP), a Master of Science in Chemical
Engineering from the University of Minnesota and an M.B.A. from Harvard Business School.
Dr. Håkan Björklund, 61, was appointed as a new Supervisory Board Member in March 2017. He is a member of
the Compensation Committee and the Selection and Appointment Committee. Dr. Björklund brings an extensive
international background in the life science industry to QIAGEN, through his current role as Operating Executive at
Avista Capital Partners, as well as through previous roles as CEO of the global pharmaceutical company Nycomed,
Regional Director at Astra (now AstraZeneca) and President of Astra Draco. Under Mr. Björklund’s leadership,
Nycomed grew from a predominantly Scandinavian business into a global pharmaceutical company. In addition to
QIAGEN, he currently serves as Chairman of the Board of Directors at Acino International AG, Swedish Orphan
Biovitrum AB (Sobi), BONESUPPORT AB and Trimb Healthcare AB. Dr. Björklund earlier served as Chairman of the
Board of Directors of Lundbeck A/S, and was also a Member of the Board of Directors of several international life
science companies, including Alere, Atos, Coloplast and Danisco. Dr. Björklund has a Ph.D. in Neuroscience from
Karolinska Institutet in Sweden.
Dr. Metin Colpan, 63, is a co-founder of QIAGEN and was the Company's Chief Executive Officer and a Managing
Director from 1985 through 2003. Dr. Colpan has been a member of the Supervisory Board since 2004 and has
served as Chairman of the Science and Technology Committee since 2014. He has been a member of the Selection
and Appointment Committee since 2015. Dr. Colpan obtained his Ph.D. and M.S. in Organic Chemistry and
Chemical Engineering from the Darmstadt Institute of Technology in 1983. Prior to founding QIAGEN, Dr. Colpan
was an Assistant Investigator at the Institute for Biophysics at the University of Düsseldorf. Dr. Colpan has had wide
experience in separation techniques and in the separation and purification of nucleic acids in particular, and has
filed many patents in the field. Dr. Colpan also serves as a Supervisory Board member of Qalovis Farmer Automatic
Energy GmbH, Laer, Germany. Dr. Colpan previously served as a Supervisory Board member of Ingenium
Pharmaceuticals AG, GenPat77 Pharmacogenetics AG, GPC Biotech AG and Morphosys AG, each in Munich,
Germany.
Professor Dr. Manfred Karobath, 77, has been a member of the Supervisory Board since 2000 and joined the
Compensation Committee in 2005. In 2016, Prof. Karobath was appointed as Chairman of the Supervisory Board.
He joined the Science and Technology Committee in 2014 and the Compensation Committee in 2016. He is also
the Chairman of the Selection and Appointment Committee. Prof. Dr. Karobath studied medicine, and from 1967 to
1980 he worked first in the Dept. of Biochemistry of the University of Vienna and, after a stage as postdoctoral
fellow, he joined the Dept. of Psychiatry where he became Professor of Biological Psychiatry. In 1980, he joined
Sandoz Pharma in Basel, first in drug discovery, and later becoming Senior Vice President and head of R&D. In
1992, Prof. Dr. Karobath joined Rhone Poulenc Rorer (RPR) as President of R&D and Executive Vice President, and
later, he became a member of the boards of directors of RPR, Pasteur Mérieux Connought, Centeon and Rhone
Poulenc Pharma. He has received several scientific awards and has published 92 scientific papers.
Dr. Ross L. Levine, 46, joined the Supervisory Board and its Science and Technology Committee in 2016. He is a
physician-scientist focused on researching and treating blood and bone marrow cancers as the Laurence Joseph
Dineen Chair in Leukemia Research, the Director of the Center for Hematologic Malignancies, and an Attending
Physician at Memorial Sloan Kettering Cancer Center, as well as Professor of Medicine at Weill Cornell Medical
College. He leads a research lab investigating genetics and targeted therapies in myeloid malignancies and is
interested in application of next-generation sequencing technology in the practice of medicine in hematologic
cancers. He trained in internal medicine at Massachusetts General Hospital and in hematology-oncology at the
Dana-Farber Cancer Institute, earning board certification in these specialties. He received his M.D. from the Johns
Hopkins University School of Medicine and his A.B. degree from Harvard College.
Dr. Elaine Mardis, 55, joined the Company’s Supervisory Board and its Science and Technology Committee in
2014. Dr. Mardis is the Co-Executive Director of the Institute for Genomic Medicine at Nationwide Children’s
Hospital in Columbus, OH. She also is Professor of Pediatrics at the Ohio State University College of Medicine. Dr.
Mardis has research interests in the application of genomic technologies to improving our understanding of human
disease, and toward improving the precision of medical diagnosis, prognosis and treatment. Dr. Mardis is the former
Robert E. and Louise F. Dunn Distinguished Professor of Medicine at Washington University School of Medicine in St.
Louis, MO, where she was on the faculty for 22 years. As Co-Director of the McDonnell Genome Institute, she
devised methods and automation that contributed to the Human Genome Project and has since played key roles in
the 1000 Genomes Project, The Cancer Genome Atlas, and the Pediatric Cancer Genome Project. Prior to joining
the Washington University faculty, she was a senior research scientist at BioRad Laboratories in Hercules, CA. Dr.
Mardis is a board member of the American Association for Cancer Research, and has scientific advisory roles at the
Regeneron Genomics Center, Caperna LLC, and Interpreta LLC. She also serves the U.S. government as a scientific
advisor to the Veteran’s Administration for the Million Veterans Program. Dr. Mardis received her Bachelor of
Science degree in Zoology in 1984 and her Ph.D. in Chemistry and Biochemistry in 1989, both from the University
of Oklahoma.
Lawrence A. Rosen, 60, joined the Company's Supervisory Board as well as the Audit Committee in 2013 and has
served as the committee's chairman since 2014. Mr. Rosen was a member of the Board of Management and Chief
Financial Officer of Deutsche Post DHL until September 2016. Holding this position since 2009, Mr. Rosen was in
charge of controlling, corporate accounting and reporting, investor relations, corporate finance, corporate internal
audit and security, taxes, as well as the group’s global business services. Prior to joining Deutsche Post DHL, Mr.
Rosen served as Chief Financial Officer of Fresenius Medical Care AG & Co. KGaA in Germany from 2003 to
2009. Prior to that, he was Senior Vice President and Treasurer for Aventis SA in Strasbourg, France. Between 1984
and 2000, Mr. Rosen held different positions at the Aventis predecessor companies Hoechst AG and American
Hoechst/Hoechst Celanese Inc. Mr. Rosen, who is a U.S. citizen, holds a Bachelor's degree in Economics from the
State University of New York and an M.B.A. from the University of Michigan.
Elizabeth E. Tallett, 68, joined the Company's Supervisory Board as well as the Audit Committee and Compensation
Committee in 2011 and since 2016 has served as Chairwoman of the Compensation Committee. She is a member
of the Selection and Appointment Committee. Ms. Tallett was a Principal of Hunter Partners, LLC, a management
company for early to mid-stage pharmaceutical, biotechnology and medical device companies, from 2002 until
February 2015. Ms. Tallett continues to consult with early stage health care companies. Her senior management
experience includes President and CEO of Transcell Technologies Inc., President of Centocor Pharmaceuticals,
member of the Parke-Davis Executive Committee, and Director of Worldwide Strategic Planning for Warner-Lambert
Company. Ms. Tallett graduated from Nottingham University, England with dual Bachelor's degrees with honors in
mathematics and economics. She is a member of the board of directors of Principal Financial Group, Inc. (where she
is currently the Lead Director), Anthem, Inc. and Meredith Corp. She is a former director of Coventry Health Care,
Inc. Ms. Tallett was a founding board member of the Biotechnology Council of New Jersey and is a Trustee of
Solebury School in Pennsylvania.
Conflicts of Interest, Loans or Similar Benefits
Resolutions to enter into transactions under which members of the Supervisory Board could have a conflict of interest
with QIAGEN, and which are of material significance to QIAGEN and/or the relevant member of the Supervisory
Board, must be reported and require the approval of the Supervisory Board plenum. A Supervisory Director that has
a personal conflict of interest will not participate in the decision making process regarding such item. In 2017 neither
QIAGEN nor its Supervisory Board members have entered into any such transactions. No credit, loans or similar
benefits were granted to members of the Supervisory Board. Additionally, the Supervisory Board Members did not
receive any benefits from third parties that were either promised or granted in view of their position as members of
the Supervisory Board.
Committees of the Supervisory Board
The Supervisory Board has established an Audit Committee, a Compensation Committee, a Selection and
Appointment Committee and a Science and Technology Committee from among its members and can establish other
committees as deemed beneficial. The Supervisory Board has approved charters under which each of the committees
operates. These charters are published on our website www.qiagen.com. The committees are comprised of the
following members:
Name of Supervisory Director(1)
Member of Audit
Committee
Member of
Compensation Committee
ember of Selection and
Appointment
Member of Science and
Technology Committee
Stéphane Bancel
Dr. Håkan Björklund
Dr. Metin Colpan
Prof. Dr. Manfred Karobath
Dr. Ross L. Levine
Dr. Elaine Mardis
Lawrence A. Rosen
Stéphane Bancel
*
*
(Chairman)
*
*
*
*
*
*
*
(Chairman)
*
(Chairman)
*
*
*
(Chairman)
*
*
*
We believe that all of our Supervisory Directors meet the independence requirements set forth in the Dutch Corporate
Governance Code (the Dutch Code). We further believe that all Supervisory Board Directors qualify as independent
under the independence standards set forth in the New York Stock Exchange (NYSE) Listed Company Manual.
Pursuant to the NYSE rules, a majority of the Supervisory Directors must qualify as independent, as defined in the
Rules.
Audit Committee
The Audit Committee currently consists of three members, Mr. Rosen (Chairman), Ms. Tallett and Mr. Bancel, and
meets at least quarterly. The Audit Committee members are appointed by the Supervisory Board and serve for a term
of one year. We believe that all members of our Audit Committee meet the independence requirements as set forth in
Rule 10A-3 of the Securities Exchange Act of 1934, as amended, and the New York Stock Exchange Listed
Company Manual. The Board has designated Mr. Rosen as an “audit committee financial expert” as that term is
defined in the United States Securities and Exchange Commission rules adopted pursuant to the Sarbanes-Oxley Act
of 2002 and as defined in provisions III.3.2 and III.5.7 of the Dutch Code. The Audit Committee performs a self-
evaluation of its activities on an annual basis.
The Audit Committee's primary duties and responsibilities include, among other things, to serve as an independent
and objective party to monitor QIAGEN's accounting and financial reporting process and internal risk management,
control and compliance systems. The Audit Committee also is directly responsible for proposing the external auditor
to the Supervisory Board, which then proposes the appointment of the external auditor to the General Meeting.
Further, the Audit Committee is responsible for the compensation and oversight of QIAGEN’s external auditor and for
providing an open avenue of communication among the external auditor as well as the Management Board and the
Supervisory Board. Our Internal Audit department operates under the direct responsibility of the Audit Committee.
Further, the Audit Committee is responsible to establish procedures to allow for the confidential and or anonymous
submission by employees of concerns. Additionally, this includes the receipt, retention and treatment of submissions
received regarding accounting, internal accounting controls, or auditing matters. The Audit Committee discusses our
financial accounting and reporting principles and policies and the adequacy of our internal accounting, financial
and operating controls and procedures with the external auditor and management; considers and approves any
recommendations regarding changes to our accounting policies and processes; reviews with management and the
external auditor our quarterly earnings reports prior to their release to the press; and reviews the quarterly and
annual reports (reported on Forms 6-K and 20-F) to be furnished to or filed with the Securities and Exchange
Commission and the Deutsche Boerse. The Audit Committee met seven times in 2017 and met with the external
auditor excluding members of the Managing Board in July 2017. The Audit Committee reviews major financial risk
exposures, pre-approves related-party transactions between the Company and Supervisory Board or Managing
Board, and reviews any legal matter including compliance topics that could have a significant impact on the
financial statements.
Compensation Committee
The Compensation Committee’s primary duties and responsibilities include, among other things, the preparation of a
proposal for the Supervisory Board concerning the Remuneration Policy for the Managing Board to be adopted by
the General Meeting, the preparation of a proposal concerning the individual compensation of Managing Board
members to be adopted by the Supervisory Board and the preparation of the Remuneration Report on compensation
policies for the Managing Board to be adopted by the Supervisory Board. The Compensation Committee reviews
and approves all equity-based compensation, reviews and approves the annual salaries, bonuses and other benefits
of executive officers, and reviews general policies relating to employee compensation and benefits. The
Remuneration Report reviews the implementation of the Remuneration Policy in the most recent year and provides an
outline of the Remuneration Policy for the future. The Compensation Committee engages external consultants to
ensure that the overall remuneration levels are benchmarked regularly, against a selected group of companies and
key markets in which QIAGEN operates. The Compensation Committee currently consists of four members, Ms.
Tallett (Chairwoman), Professor Karobath, Mr. Bancel and Dr. Björklund. Members are appointed by the Supervisory
Board and serve for a term of one year. The Compensation Committee met five times in 2017.
Selection and Appointment Committee
The Selection and Appointment (Nomination) Committee is primarily responsible for the preparation of selection
criteria and appointment procedures for members of the Supervisory Board and Managing Board as well as the
periodic evaluation of the scope and composition of the Managing Board and the Supervisory Board, including the
profile of the Supervisory Board. Additionally, the Selection and Appointment Committee periodically evaluates the
functioning of individual members of the Managing Board and Supervisory Board, reporting these results to our
Supervisory Board. It also proposes the (re-)appointments of members of our Managing Board and Supervisory
Board and supervises the policy of our Managing Board in relation to selection and appointment criteria for senior
management. Current members of the Selection and Appointment Committee are Professor Karobath (Chairman), Dr.
Colpan, Ms. Tallett and Dr. Björklund. Members are appointed by the Supervisory Board and serve for a one-year
term. The Selection and Appointment Committee did not meet in 2017.
Science and Technology Committee
The Science and Technology Committee is primarily responsible for reviewing and monitoring research and
development projects, programs, budgets, infrastructure management and overseeing the management risks related
to the Company's portfolio and information technology platforms. The Science and Technology Committee provides
understanding, clarification and validation of the fundamental technical basis of the Company's businesses in order
to enable the Supervisory Board to make informed, strategic business decisions and vote on related matters, and to
guide the Managing Board to ensure that powerful, global, world-class science is developed, practiced and
leveraged throughout the Company to create shareholder value. The current members of the Science and Technology
Committee are Dr. Colpan (Chairman), Professor Karobath, Dr. Levine, Mr. Bancel and Dr. Mardis. Members are
appointed by the Supervisory Board and serve for a term of one year. The Science and Technology Committee met
six times in 2017.
Diversity within the Management Board and Supervisory Board
The Dutch Civil Code provided for statutory provisions to ensure a balanced representation of men and women on
the Management Board and Supervisory Boards until January 1, 2016. These statutory rules have expired, but a new
bill entered into force on April 13, 2017, extending the provision on gender balance to December 31, 2019.
Balanced representation of men and women is deemed to exist if at least 30 percent of the seats were filled by men
and at least 30 percent are filled by women. Within the meaning of the new legislation, our Management Board and
Supervisory Board currently do not qualify as balanced. QIAGEN recognizes the benefits of diversity, including
gender balance. In nominating candidates for these boards, QIAGEN supports the trend toward higher participation
of women. QIAGEN feels that gender is only one part of diversity and strives for a diverse composition in the
Managing Board and Supervisory Board also in terms of other factors such as age, nationality, public reputation,
industry or academic background. QIAGEN is committed to expanding diversity while pursuing individuals for these
boards with a unique blend of scientific and commercial expertise and experience that will contribute to the future
success of its business. Management development programs support the career advancement of leaders regardless of
gender and other factors. As a result a number of women are in key leadership roles, particularly in leading
commercial and operational positions around the world. In 2017, almost 31% of our management positions in the
four leadership levels below the Executive Committee were held by women. In line with this long-standing
commitment, QIAGEN's Selection and Appointment committee will continue selecting future members of the
Managing Board and Supervisory Board with due observance of its aim to have a diverse leadership team on the
basis of gender, but also on the basis of age, wide ranging experience, backgrounds, skills, knowledge and insight.
This all without compromising QIAGEN's commitment to hiring the best individuals for those positions. More
information about diversity within the Board other than gender, can be found in below under the section Dutch
Corporate Governance Code - Comply or explain.
Compensation of Managing Board Members and Supervisory Directors
Remuneration policy
The objective of our remuneration policy is to attract and retain the talented, highly qualified international leaders
and skilled individuals, who enable QIAGEN to achieve its short and long-term strategic initiatives and operational
excellence. Our remuneration policy aligns remuneration with individual performance, corporate performance and
fosters sustainable growth and long-term value creation in the context of QIAGEN’s social responsibility and
stakeholders’ interest.
The remuneration policy and overall remuneration levels are benchmarked regularly, against a selected group of
companies and key markets in which QIAGEN operates, to ensure overall competitiveness. QIAGEN participates in
various compensation benchmarking surveys that provide information on the level, as well as the structure, of
compensation awarded by various companies and industries for a broad range of positions around the world. The
companies in the peer group are selected on the basis of market capitalization, competitors for talent, similar
complexity and international spread, operating in similar industries.
The performance of the Managing Board members is measured annually against a written set of goals. The
remuneration of the Managing Board members is linked to the achievement of QIAGEN’s strategic and financial
goals. To ensure that remuneration is linked to performance, a significant proportion of the remuneration package is
variable and contingent on performance of the individual and the company. These goals are set at ambitious levels
each year to motivate and drive performance, with a focus on achieving both long-term strategic initiatives and short-
term objectives based on the annual operative planning. Performance metrics used for these goals include the
achievement of financial and non-financial targets.
The remuneration package of the Managing Board members consists of a combination of base salary, short term
variable cash award and several elements of long term incentives (together, ‘total direct compensation’). In addition,
the members of the Managing Board receive a pension arrangement and other benefits that are standard in our
industry, such as a company car.
The total target remuneration package of the Managing Board members is appropriately set against a variety of
factors which includes external and internal equity, experience, complexity of the position, scope and
responsibilities. We aim to provide the members of the Managing Board a total direct compensation at market
median level.
The structure of the remuneration package for the Managing Board is designed to balance short-term operational
excellence with long-term sustainable value creation while taking into account the interests of its stakeholders. As
such a significant part of the total remuneration of the Managing Board members consist of variable remuneration
which can differ substantially from year to year depending on our corporate results and individual performance and
may include equity-based compensation which may be subject to vesting conditions over a period of 10 years.
The remuneration policies for the Managing Board and for other senior management members of QIAGEN are
generally aligned and consistent.
Managing Board compensation
The compensation granted to the members of the Managing Board in 2017 consisted of a fixed salary and variable
components, with the significant majority of compensation awarded in the form of QIAGEN stock units that are
restricted for a long multi-year period to align management with the interests of shareholders and other stakeholders.
Variable compensation included annual payments linked to business performance (annual bonus), as well as long-
term equity incentives that were awarded based on individual performance.
In 2014, the General Meeting of Shareholders approved a new remuneration policy for the Managing Board which
provides that future annual regular equity-based compensation grants to members of the Managing Board will
primarily consist of performance stock units. Grants of stock options and restricted stock units which are based on
time vesting only shall no longer be granted on a regular basis and shall be reserved for use as special equity
incentive rewards in certain situations.
Stock options granted to the Managing Board members must have an exercise price that is higher than the market
price at the time of grant. Restricted Stock Units granted to the Managing Board members, vest over a 10-year
period. Performance Stock Units are subject to long-term vesting periods and contingent upon the achievement of
several financial goals over a multi-year period.
In 2016, a grant of Performance Stock Units with mandatory minimum holding levels of QIAGEN shares was made
under the Commitment Program linked to achievement of a two-year plan covering 2017 and 2018 including
quantitative goals for net sales, earnings before interest and taxes (EBIT), QIAGEN Value Added (QVA), a steering
metric that measures the ability of QIAGEN to generate returns and exceed its cost of capital and share price
development as compared to peer companies. Under the Commitment Program, the financial targets for vesting are
based on two-year goals as defined within QIAGEN’s five-year business plan covering the period from 2017 until
the end of 2022. The targets for vesting were set and approved by the Supervisory Board.
The table below state the amounts earned on an accrual basis by our Managing Board members in 2017.
For the year ended December 31, 2017 (in US$ thousands, except for number of award grants)
Peer M. Schatz
Roland Sackers
Fixed Salary
Other(1)
Total fixed income 2017
Short-term variable cash bonus
Total short-term income 2017
Defined contribution on benefit plan
Number of performance stock units granted 2017(2)
Related recognized compensation expense
$ 1,192
5
$ 1,197
671
$ 1,868
$ 74
445,000
$ 1,764
$ 535
38
$ 573
237
$ 810
$ 76
186,075
$ 439
(
) A
l d
h
l
d
b
d
l
h
l
W l
(1) Amounts include, among others, car lease and reimbursed personal expenses such as tax consulting. We also
occasionally reimburse our Managing Directors' personal expenses related to attending out-of-town meetings but not directly
related to their attendance. Amounts do not include the reimbursement of certain expenses relating to travel incurred at the
request of QIAGEN, other reimbursements or payments that in total did not exceed $10,000 or tax amounts paid by the
Company to tax authorities in order to avoid double-taxation under multi-tax jurisdiction employment agreements.
(2) The Performance Stock Units Granted amount includes a special incentive grant of 100,000 PSUs which was not
achieved.
The total recognized compensation expense in accordance with IFRS 2 in the year 2017 (2016) for stock units
including recognized expenses for equity awards granted in previous years as well as for any non-periodical share-
based payments in kind of a bonus amounted to $10.7 million ($9.2 million) for Mr. Schatz and $3.2 million ($2.7
million) for Mr. Sackers.
Based on such valuations the total compensation including recognized compensation expenses in the year 2017
(2016) for members of the Managing Board was $16.7 million ($14.0 million), and amounts $12.6 million ($10.6
million) for Mr. Schatz and $4.1 million ($3.4 million) for Mr. Sackers. Total non-periodical remuneration according
Dutch Civil Code included in total compensation for the Managing Board was $3.1 million ($2.8 million) and
amounts $2.4 million ($2.3 million) for Mr. Schatz and $0.7 million ($0.6 million) for Mr. Sackers.
Further details on the composition of remuneration for the Managing Board, and the implementation of the
Remuneration Policy during 2017, are disclosed in the Remuneration Report of the Compensation Committee as
published on our website at www.qiagen.com.
Supervisory Board compensation
In early 2014, we conducted a board remuneration benchmark review of 36 peer companies of similar size and
complexity in similar industries, including biotechnology, life science supplies, diagnostics and pharmaceuticals.
Based on the results of this review, the Supervisory Board remuneration was aligned to the applicable market
standards to reflect our nexus to the European Markets as a Dutch company as well as our U.S. focus as a NYSE
listed company subject to U.S. regulations and the fact that five of the eight Supervisory Board members are residing
in the United States.
The Supervisory Board compensation for 2017 consists of fixed retainer compensation and additional retainer
amounts for Chairman and Vice Chairman. Annual remuneration of the Supervisory Board members is as follows:
Fee payable to the Chairman of the Supervisory Board
Fee payable to the Vice Chairman of the Supervisory Board
Fee payable to each member of the Supervisory Board
Additional compensation payable to members holding the following positions:
Chairman of the Audit Committee
Chairman of the Compensation Committee
Chairman of the Selection and Appointment Committee and other board committees
Fee payable to each member of the Audit Committee
Fee payable to each member of the Compensation Committee
Fee payable to each member of the Selection and Appointment Committee and other
$ 150,000
$ 90,000
$ 57,500
$ 25,000
$ 18,000
$ 12,000
$ 15,000
$ 11,000
$ 6,000
Further, the Supervisory Board members will be reimbursed for tax consulting costs incurred in connection with the
preparation of their tax returns up to an amount of €5,000 per person per fiscal year.
Supervisory Board members also receive a variable component, in the form of share-based compensation. We did
not pay any agency or advisory service fees to members of the Supervisory Board.
The following table summarizes the total compensation paid to the members of the Supervisory Board in 2017:
For the year ended December 31, 2017 (in US$
thousands, except for number of share grants)
Fixed
remuneration
Chairman /
Chairwoman
Committee
membership
Total(1)
Number of restricted stock
units granted
Stéphane Bancel
Dr. Håkan Björklund
Dr. Metin Colpan
Prof. Dr. Manfred Karobath
Dr. Ross L. Levine
Dr. Elaine Mardis
Lawrence A. Rosen
Elizabeth E. Tallett
$ 57.5
$ 43.1
$ 57.5
$ 150.0
$ 57.5
$ 57.5
$ 57.5
$ 57.5
—
—
12.0
12.0
—
—
25.0
18.0
32.0
$ 89.5
12.8
$ 55.9
6.0
$ 75.5
17.0 $ 179.0
6.0
$ 63.5
6.0
$ 63.5
— $ 82.5
21.0
$ 96.5
10,732
—
10,732
10,732
10,732
10,732
10,732
10,732
(1) Supervisory Directors are reimbursed for travel costs and for any value-added tax to be paid on their remuneration. These
reimbursements are excluded from the amounts presented herein.
The total recognized compensation expense in accordance with IFRS 2 in the year 2017 (2016) for long-term
compensation of restricted stock units including recognized expenses for equity awards granted in previous years as
well as for any non-periodical share-based payments in kind of a bonus amounted to $1.6 million ($1.3 million) and
includes $269.0 thousand ($160.2 thousand) for Mr. Bancel, no amounts for Mr. Björklund, $339.4 thousand
($244.1 thousand) for Mr. Colpan, $201.9 thousand ($239.3 thousand) for Mr. Karobath, $55.4 thousand ($0) for
Mr. Levine, $218.8 thousand ($92.6 thousand) for Ms. Mardis, $268.9 thousand ($160.2 thousand) for Mr. Rosen
and $201.9 thousand ($239.3 thousand) for Ms. Tallett.
The total recognized compensation expenses for members of the Supervisory Board in 2017 (2016) for short-term
and long-term compensation totaled $2.3 million ($2.0 million) and includes amounts of $358.5 thousand ($249.7
thousand) for Mr. Bancel, $55.9 thousand ($0) for Mr. Björklund, $414.9 thousand ($319.6 thousand) for Mr.
Colpan, $380.9 thousand ($388.8 thousand) for Mr. Karobath, $118.9 thousand ($31.8 thousand) for Mr. Levine,
$282.3 thousand ($156.1 thousand) for Ms. Mardis, $351.4 thousand ($242.7 thousand) for Mr. Rosen, and
$298.4 thousand ($329.3 thousand) for Ms. Tallett.
Total non-periodical remuneration according Dutch Civil Code included in total compensation in 2017 (2016),
which includes the expense related to the short-term variable cash bonus and the expense related to the long-term
compensation of equity awards granted in 2017 (2016), totaled $0.6 million ($0.3 million) and includes amounts of
$55.4 thousand ($14.4 thousand) for Mr. Bancel, $55.4 thousand ($29.4 thousand) for Mr. Colpan, $147.0
thousand ($102.3 thousand) for Mr. Karobath, $55.4 thousand ($0) for Mr. Levine, $55.4 thousand ($29.4
thousand) for Ms. Mardis, $55.4 thousand ($29.4 thousand) for Mr. Rosen, and $147.0 thousand ($102.3
thousand) for Ms. Tallett.
GOVERNANCE
Share Ownership
The following table sets forth certain information as of January 31, 2018 concerning the ownership of Common
Shares by our directors and officers. In preparing the following table, we have relied on information furnished by
such persons.
Name and Country of Residence
Peer M. Schatz, Germany
Roland Sackers, Germany
Stéphane Bancel, United States
Dr. Metin Colpan, Germany
Prof. Dr. Manfred Karobath, Austria
Dr. Ross L. Levine, United States
Dr. Elaine Mardis, United States
Lawrence A. Rosen, United States
Elizabeth Tallett, United States
Shares Beneficially Owned(1)
Number(2)
Percent Ownership
2,681,395
(3)
1.18%
40,000
(4)
2,081
(5)
*
*
3,529,123
(6)
1.56%
22,631
(7)
—
— (8)
— (9)
10,130 (10)
*
—
—
—
*
* Indicates that the person beneficially owns less than 0.5% of the Common Shares issued and outstanding as of January 31,
2018.
(1) The number of Common Shares outstanding as of January 31, 2018 was 226,556,855. The persons and entities named
in the table have sole voting and investment power with respect to all shares shown as beneficially owned by them and have
the same voting rights as shareholders with respect to Common Shares.
(2) Does not include Common Shares subject to options or awards held by such persons at January 31, 2018. See footnotes
below for information regarding options now exercisable or that could become exercisable within 60 days of the date of this
table.
(3) Does not include 628,045 shares issuable upon the exercise of options now exercisable having exercise prices ranging
from $15.59 to $22.25 per share. Options expire in increments during the period between February 2019 and February
2023. Does not include 387,518 shares issuable upon the release of unvested stock awards that could become releasable
within 60 days from the date of this table.
(4) Does not include 162,483 shares issuable upon the exercise of options now exercisable having exercise prices ranging
from $15.59 to $22.25 per share. Options expire in increments during the period between February 2019 and February
2023. Does not include 117,966 shares issuable upon the release of unvested stock awards that could become releasable
within 60 days from the date of this table.
(5) Does not include 4,496 shares issuable upon the release of unvested stock awards that could become releasable within
60 days from the date of this table.
(6) Does not include 7,893 shares issuable upon the exercise of options now exercisable having exercise prices ranging from
$15.59 to $22.43 per share. Options expire in increments during the period between April 2018 and February 2022.
Includes 2,741,579 shares held by CC Verwaltungs GmbH, of which Dr. Colpan is the sole stockholder and 770,370 shares
held by Colpan GbR. Does not include 10,496 shares issuable upon the release of unvested stock awards that could become
releasable within 60 days from the date of this table.
(
bl h
l d
bl
h
h
)
f
f
(7) Does not include 7,893 shares issuable upon the exercise of options now exercisable having exercise prices ranging from
$15.59 to $22.43 per share. Options expire in increments during the period between April 2018 and February 2022. Does
not include 10,496 shares issuable upon the release of unvested stock awards that could become releasable within 60 days
from the date of this table.
(8) Does not include 4,496 shares issuable upon the release of unvested stock awards that could become releasable within
60 days from the date of this table.
(9) Does not include 4,496 shares issuable upon the release of unvested stock awards that could become releasable within
60 days from the date of this table.
(10) Does not include 1,563 shares issuable upon the exercise of options now exercisable having exercise prices of $15.59
per share. Options expire on February 2022. Does not include 10,496 shares issuable upon the release of unvested stock
awards that could become releasable within 60 days from the date of this table.
The following table sets forth the options of our officers and directors as of January 31, 2018:
Name
Peer M. Schatz
Roland Sackers
Dr. Metin Colpan
Prof. Dr. Manfred Karobath
Elizabeth E. Tallett
Total Vested Options
Expiration Dates
Exercise Prices
628,045
2/27/2019 to 2/28/2023
$ 15.59 to $ 22.25
162,483
2/27/2019 to 2/28/2023
$ 15.59 to $ 22.25
7,893
7,893
1,563
4/29/2018 to 2/28/2022
$ 15.59 to $ 22.43
4/29/2018 to 2/28/2022
$ 15.59 to $ 22.43
2/28/2022
$ 15.59
GOVERNANCE
Additional Information
Shareholders
Our shareholders exercise their voting rights through Annual and Extraordinary General Meetings. Resolutions of the
General Meeting are adopted by an absolute majority of votes cast, unless a different majority of votes or quorum is
required by Dutch law or the Articles of Association. Each common share confers the right to cast one vote.
Furthermore, the Managing Board, or where appropriate, the Supervisory Board, shall provide all shareholders and
other parties in the financial markets with equal and simultaneous information about matters that may influence
QIAGEN's share price.
QIAGEN is required to convene an Annual General Meeting in The Netherlands no later than six months following
the end of each year. The agenda for the Annual General Meeting must contain certain matters as specified in
QIAGEN's Articles of Association and under Dutch law, including, among other things, the adoption of QIAGEN's
annual financial statements.
Additional Extraordinary General Meetings may be requested and/or convened at any time by the Managing
Board, the Supervisory Board or by one or more shareholders jointly representing at least 40% of QIAGEN's issued
share capital. Furthermore, one or more shareholders, who jointly represent at least 10% of QIAGEN's issued share
capital may, on their application, be authorized by the district court judge having applications for interim relief, to
convene a General Meeting. Shareholders are entitled to propose items for the agenda of the General Meeting
provided that they hold at least 3% of the issued share capital. Proposals for agenda items for the General Meeting
must be submitted at least 60 days prior to the meeting date. The notice convening a General Meeting,
accompanied by the agenda, shall be sent no later than 42 days prior to the meeting. QIAGEN informs the General
Meeting by means of explanatory notes to the agenda, providing all facts and circumstances relevant to the
proposed resolutions.
Pursuant to the Dutch Code, all transactions between the company and legal or natural persons who hold at least ten
percent of the shares in the company shall be agreed on terms that are customary in the sector concerned. Decisions
to enter into transactions in which there are conflicts of interest with such persons that are of material significance to
the company and/or to such persons require the approval of the Supervisory Board. QIAGEN has not entered into
any such transactions in 2017.
Stock Plans
We adopted the QIAGEN N.V. Amended and Restated 2005 Stock Plan (the 2005 Plan) which was approved by
our shareholders on June 14, 2005. The 2005 Plan expired by its terms in April 2015 and no further awards will be
granted under the 2005 Plan. On June 25, 2014, our shareholders approved the QIAGEN N.V. 2014 Stock Plan
(the 2014 Plan), which replaced the 2005 Plan in April 2015. An aggregate of 16.7 million Common Shares were
reserved for issuance pursuant to the 2014 Plan, subject to certain antidilution adjustments. We issue Treasury
Shares to satisfy option exercises and award releases and had approximately 22 million Common Shares reserved
and available for issuance under the 2005 and 2014 Plans at December 31, 2017.
Pursuant to the 2014 Plan, stock rights, which include options to purchase our Common Shares, stock grants and
stock-based awards, may be granted to employees and consultants of QIAGEN and its subsidiaries and to
Supervisory Directors. Options granted pursuant to the 2014 Plan may either be incentive stock options within the
meaning of Section 422 of the United States Internal Revenue Code of 1986, as amended (the Code), or non-
qualified stock options. Options granted to members of the Supervisory Board and the Managing Board must have
an exercise price that is higher than the market price at the time of grant. Generally, each of the options has a term
of ten years, subject to earlier termination in the event of death, disability or other termination of employment. The
vesting and exercisability of certain stock rights will be accelerated in the event of a Change of Control, as defined
in the agreements under the 2014 Plan.
The Plan is administered by the Compensation Committee of the Supervisory Board, which selects participants from
among eligible employees, consultants and directors and determines the number of shares subject to the stock-based
award, the length of time the award will remain outstanding, the manner and time of the award's vesting, the price
per share subject to the award and other terms and conditions of the award consistent with the Plan. The
Compensation Committee's decisions are subject to the approval of the Supervisory Board.
The Compensation Committee has the power, subject to Supervisory Board approval, to interpret the plans and to
adopt such rules and regulations (including the adoption of “sub plans” applicable to participants in specified
jurisdictions) as it may deem necessary or appropriate. The Compensation Committee or the Supervisory Board may
at any time amend the plans in any respect, subject to Supervisory Board approval, and except that (i) no
amendment that would adversely affect the rights of any participant under any option previously granted may be
made without such participant's consent and (ii) no amendment shall be effective prior to shareholder approval to the
extent such approval is required to ensure favorable tax treatment for incentive stock options or to ensure compliance
with Rule 16b-3 under the United States Securities Exchange Act of 1934, as amended (the Exchange Act) at such
times as any participants are subject to Section 16 of the Exchange Act.
As of January 31, 2018, there were 1.1 million options outstanding with exercise prices ranging between $14.91
and $23.16 and expiring between April 29, 2018 and October 31, 2023. The exercise price of the options is the
fair market value of the Common Shares as of the date of grant or a premium above fair market value. Additionally,
there were 8.1 million stock unit awards outstanding as of January 31, 2018. These awards will be released
between February 15, 2018 and February 28, 2027. As of January 31, 2018, options to purchase 0.8 million
Common Shares and 3.4 million stock unit awards were held by the officers and directors of QIAGEN, as a group.
Further detailed information regarding stock options and awards granted under the plan can be found in Note 20
included in the Consolidated Financial Statements.
Independence
Unlike the New York Stock Exchange listing standards which require a majority of the Supervisory Board members to
be independent, the Dutch Corporate Governance Code distinguishes between certain independence criteria which
may be fulfilled by not more than one Supervisory Board Members (as e.g. prior employment with the Company,
receiving personal financial an important business relationship with the Company) and other criteria which may not
be fulfilled by more than the majority of the Supervisory Board members. In some cases the Dutch independence
requirement is more stringent, such as by requiring a longer “look back” period (five years) for former executive
directors. In other cases, the New York Stock Exchange rules are more stringent, such as a broader definition of
disqualifying affiliations. Currently, all members of our Supervisory Board are “independent” under both the New
York Stock Exchange and Dutch definitions.
Risk Management
Reference is made to the discussion in the section "Principle Risks and Uncertainties" above.
Disclosure Controls and Procedures
Our Managing Directors, with the assistance of other members of management, performed an evaluation of the
effectiveness of the design and operation of our disclosure controls and procedures. Based on that evaluation, they
concluded that as of December 31, 2017, our disclosure controls and procedures were effective to ensure that
information required to be disclosed by us in the reports that we file is recorded, processed, summarized and
reported in a timely manner, and is accumulated and communicated to our management, including our Managing
Directors, as appropriate to allow timely decisions regarding required disclosure.
There are inherent limitations to the effectiveness of any system of disclosure controls and procedures, no matter how
well designed, such as the possibility of human error and the circumvention or overriding of the controls and
procedures. Therefore, even those systems determined to be effective may not prevent or detect misstatements and
can provide only reasonable assurance of achieving their control objectives. In addition, any determination of
effectiveness of controls is not a projection of any effectiveness of those controls to future periods, as those controls
may become inadequate because of changes in conditions or the degree of compliance with the policies or
procedures may deteriorate.
Report of Management on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting.
The Company’s system of internal controls over financial reporting is designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of the consolidated financial statements in
accordance with generally accepted accounting principles.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements
and even when determined to be effective can provide only reasonable assurance with respect to financial statement
preparation and presentation. Projections of any evaluation of effectiveness to future periods are subject to the risk
that controls may become inadequate because of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate.
Our management assessed the effectiveness of the Company’s internal control over financial reporting as of
December 31, 2017. In making this assessment, management used the updated criteria set forth in 2013 by the
Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated
Framework.
Based on our assessment under the COSO Internal Control-Integrated Framework, management believes that, as of
December 31, 2017, our internal control over financial reporting is effective.
Changes in Internal Control over Financial Reporting
There has been no change in our internal control over financial reporting during 2017 that has materially affected,
or is reasonably likely to materially affect, our internal control over financial reporting.
Independent Auditors
In accordance with the requirements of Dutch law, our independent registered public accounting firm for our statutory
consolidated financial statements prepared in accordance with International Financial Reporting Standards and filed
with the Netherlands Authority for the Financial Markets (AFM), is appointed, and may be removed by, the General
Meeting. The Supervisory Board nominates a candidate for the appointment as external auditor, for which purpose
both the Audit Committee and the Managing Board advise the Supervisory Board. At the Annual General Meeting in
2017, KPMG Accountants N.V. was appointed as external auditor for the Company for 2017 year. The external
auditor is invited to attend the meeting of the Supervisory Board at which the statutory financial statements prepared
in accordance with International Financial Reporting Standards and filed with the AFM shall be approved and is
furthermore invited to attend the General Meeting at which the statutory financial statements are adopted and may
be questioned by the General Meeting on its statement on the fairness of our annual accounts prepared in
accordance with International Financial Reporting Standards.
The remuneration of the external auditor, and instructions to the external auditor to provide non-audit services, shall
be approved by the Supervisory Board on the recommendation of the Audit Committee and after consultation with
the Managing Board. At least once every four years, the Supervisory Board and the Audit Committee shall conduct a
thorough assessment of the functioning of the external auditor. The main conclusions of this assessment shall be
communicated to the General Meeting for the purposes of assessing the nomination for the appointment of the
external auditor. The external auditor is invited to attend the meeting of the Supervisory Board at which the financial
statements shall be approved and is furthermore invited to attend the General Meeting at which the financial
statements are adopted and may be questioned by the General Meeting on its statement on the fairness of our
annual accounts.
Whistleblower Policy and Code of Conduct
We have a formal Whistleblower Policy concerning the reporting of alleged irregularities within QIAGEN of a
general, operational or financial nature. Furthermore, we have a published Code of Conduct that outlines business
principles for our employees and rules of conduct. The Code of Conduct can be found on our website at
www.qiagen.com.
Anti-Takeover Measures
In 2004, the Supervisory Board granted an option to the Dutch Foundation Stichting Preferente Aandelen QIAGEN
that allows the Foundation to acquire preference shares from QIAGEN if (i) a person has (directly or indirectly)
acquired or has expressed a desire to acquire more than 20% of our issued share capital, or (ii) a person holding at
least a 10% interest in the share capital has been designated as a hostile person by our Supervisory Board. The
option enables the Foundation to acquire preference shares equal to the number of our outstanding common shares
at the time of the relevant exercise of the right, less one share. When exercising the option and exercising its voting
rights on these shares, the Foundation must act in the interest of QIAGEN and the interests of our stakeholders. No
preference shares are currently outstanding.
Dutch Corporate Governance Code - Comply or Explain
The corporate governance structure and compliance with the Dutch Code is the joint responsibility of the Managing
Board and the Supervisory Board. They are accountable for this responsibility to the General Meeting. We continue
to seek ways to improve our corporate governance by measuring itself against international best practice. The Dutch
Code was last amended on December 8, 2016, and applicable as of the financial year 2017 and can be found at
www.commissiecorporategovernance.nl.
Non-application of a specific best practice provision is not in itself considered objectionable by the Dutch Code and
may well be justified because of particular circumstances relevant to a company. In accordance with Dutch law, we
disclose in our Annual Report the application of the Dutch Code's principles and best practice provisions.
To the extent that we do not apply certain principles and best practice provisions, or do not intend to apply these in
the current or the subsequent year, we state the reasons.
We take a positive view of the Dutch Code and apply nearly all of the best practice provisions. However, we prefer
not to apply some provisions due to the international character of our business as well as the fact - acknowledged by
the Commission that drafted the Dutch Code - that existing contractual agreements between QIAGEN and individual
members of the Managing Board cannot be set aside at will.
The following provides an overview of exceptions that we have identified:
1. Best practice provision 2.2.2 recommends that a supervisory board member is appointed for a period of four
years. A member may be reappointed for a term of additional two years, which appointment may be extended by at
most two years. Best practice provision 2.2.2 does not apply to supervisory board members, who as of the date of
the entry into force of this Code, have already held office for more than eight years, provided that best practice
provision III.3.5 of the Dutch Code adopted in 2008, that is replaced by the Dutch Code 2016 is being complied
with. Best practice provision III.3.5. of the Dutch Code 2008 recommends that a supervisory board member is
appointed for a maximum of three 4-year terms.
Members of the Supervisory Board are appointed annually for a one-year period beginning on the day following the
General Meeting up to and including the day of the General Meeting held in the following year. Further, Dr. Metin
Colpan has joined the Supervisory Board in 2004 and Prof. Dr. Manfred Karobath in 2000. While Prof. Karobath
has announced not to stand for re-election in 2018, we value the profound industry experience of Dr. Colpan and
his in-depth knowledge of QIAGEN. QIAGEN therefore supports the reappointment of Dr. Colpan beyond the
twelve-year term as recommended by the Dutch Code.
2. Best practice provision 2.1.5 recommends that the Supervisory Board should draw up a diversity policy for the
composition of the Management Board, the Supervisory Board and, if applicable, the Executive Committee. The
policy should address concrete targets relating to diversity and the diversity aspects to the Company, such as
nationality, age, gender and education and work background.
While QIAGEN strives for a diverse composition of the Supervisory Board, Managing Board, Executive Committee
and in all other management levels of the Company, we do not consider the definition of concrete targets relating to
diversity useful, We are committed to create an environment where all individuals have the opportunity to grow and
contribute to our progress, regardless of their age, educational background, gender, nationality, physical abilities,
race and ethical background, religion, or sexual orientation. We consider it to be a key success factor on the path to
achieving our mission and goals. Individuals and teams alike understand the diverse needs of our customers, identify
and realize cross-functional opportunities for our business areas, can quickly adapt to a fast changing environment.
In 2017, our multicultural workforce was composed of 71 nationalities with an average age of 40.3 With 49.2%
women we are well balanced in terms of gender on an aggregate level. We also have significantly increased the
diversity of our senior leadership team and will continue to do so in the future. In 2017, almost 31% of our
management positions in the four leadership levels below the Executive Committee were held by women. Information
on the composition of our Managing and Supervisory Boards can be found above and more information on gender
diversity within the Managing and Supervisory Board can be found about under the section "Diversity within the
Management Board and Supervisory Board."
3. Best practice provision 3.1.2 vi. recommends that when formulating the remuneration policy, it should be
considered that shares awarded to management board should be held for a period of at least five years.
Pursuant to the Company’s Remuneration Policy, long-term equity-based grants to members of the Managing Board
under the 2014 Plan primarily consist of an award of performance stock units, i.e. long-term incentive awards which
are dependent upon the achievement of pre-defined performance goals. Grants of restricted stock units, which are
based on time vesting only, are no longer to be granted on a regular basis and shall be reserved for use as special
equity incentive rewards in certain situations. Performance stock units and restricted stock units are basically
structured so that 40% of a grant vests after three years, 50% after five years and the remaining 10% after ten years.
In 2015 and 2016, the members of the Managing Board elected to receive in lieu of their cash bonus the value
earned in these years in performance stock units and restricted stock units respectively which vested over two years
from the grant date.
4. Best practice provision 3.2.3 recommends that the maximum remuneration in the event of dismissal of a
management board member may not exceed one year's salary (the "fixed" remuneration component).
Our Managing Board members have entered into employment agreements with QIAGEN N.V. and some QIAGEN
affiliates for which they hold managing positions. In case of termination of an agreement without serious cause as
defined by the applicable law, the respective affiliate would remain obliged to compensate the Managing Board
member for the remaining term of the employment agreement. QIAGEN believes that these contractual arrangements
are well justified due to the long tenures of the Managing Board members.
5. Best practice provision 2.2.4 recommends that the supervisory board should draw up a retirement schedule in
order to avoid, as far as possible, a situation in which many supervisory board members retire simultaneously. The
retirement schedule should be made generally available and should be posted on the company’s website.
The Supervisory Board follows the practice to discuss retirement plans of individual members early to proactively
manage continuity within the Supervisory Board. QIAGEN believes that this practice provides a more flexible and
better succession planning than a fixed retirement schedule.
6. Best practice provision 3.3.2 recommends that a supervisory board member may not be granted any shares
and/or rights to shares by way of remuneration.
QIAGEN has granted stock options to the members of the Supervisory Board as a remuneration component since its
establishment. Since 2007, Supervisory Board members have also been granted restricted stock units. We believe
that the reasonable level of equity based compensation which we practice allows a positive alignment of shareholder
interests with the other duties of the Supervisory Board and that this practice is necessary to attract and retain
Supervisory Board members as the granting of share-based compensation to Supervisory Board members is a
common practice in our industry.
NYSE Exemptions
Exemptions from the NYSE corporate governance standards are available to foreign private issuers, such as
QIAGEN when those standards are contrary to a law, rule or regulation of any public authority exercising
jurisdiction over such issuer or contrary to generally accepted business practices in the issuer’s country of domicile. In
connection with QIAGEN’s listing on the NYSE, the NYSE accepted QIAGEN's exemptions from certain corporate
governance standards that are contrary to the laws, rules, regulations or generally accepted business practices of
The Netherlands. These exemptions and the practices followed by QIAGEN are described below:
QIAGEN is exempt from NYSE’s quorum requirements applicable to meetings of ordinary shareholders. In keeping
with the law of The Netherlands and generally accepted business practices in The Netherlands, QIAGEN’s Articles
of Association provide that there are no quorum requirements generally applicable to meetings of the General
Meeting.
QIAGEN is exempt from NYSE’s requirements that shareholder approval be obtained prior to the establishment of,
or material amendments to, stock option or purchase plans and other equity compensation arrangements pursuant
to which options or stock may be acquired by directors, officers, employees or consultants. QIAGEN is also
exempt from NYSE’s requirements that shareholder approval be obtained prior to certain issuances of stock
resulting in a change of control, occurring in connection with acquisitions of stock or assets of another company or
issued at a price less than the greater of book or market value other than in a public offering. QIAGEN’s Articles
of Association do not require approval of the General Meeting prior to the establishment of a stock plan. The
Articles of Association also permit the General Meeting to grant the Supervisory Board general authority to issue
shares without further approval of the General Meeting. QIAGEN’s General Meeting has granted the Supervisory
Board general authority to issue up to a maximum of our authorized capital without further approval of the
General Meeting. QIAGEN plans to seek approval of the General Meetings for stock plans and stock issuances
only where required under the law of The Netherlands or under QIAGEN’s Articles of Association.
FINANCIAL RESULTS
Financial Results
QIAGEN N.V. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (in thousands)
Assets
Current assets:
Cash and cash equivalents
Short-term investments
Accounts receivable, net of allowance for doubtful accounts of $8,008 and $7,614 in 2017 and
2016, respectively
Income taxes receivable
Inventories, net
Prepaid expenses and other current assets
Total current assets
Long-term assets:
As of December 31,
Note
2017
2016
(3)
(7)
$ 657,714
$ 439,180
359,198
92,999
(3, 22)
329,138
278,244
39,509
23,795
(3)
(8)
155,927
136,552
106,487
66,799
1,647,973
1,037,569
Property, plant and equipment, net of accumulated depreciation of $564,588 and $451,160 in
2017 and 2016, respectively
(9)
494,321
436,655
Goodwill
Intangible assets, net of accumulated amortization of $1,117,423 and $948,072 in 2017 and
2016, respectively
Deferred income taxes
Other long-term assets (of which $17,713 and $13,067 in 2017 and 2016 due from related
parties, respectively)
Total long-term assets
Total assets
(11)
2,012,904
1,925,518
(11)
499,318
557,159
(16)
39,353
68,384
(10, 13, 22)
344,647
282,909
3,390,543
$ 3,270,625
5,038,516
$ 4,308,194
The accompanying notes are an integral part of these consolidated financial statements.
QIAGEN N.V. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (in thousands,
except par value)
Liabilities and equity
Current liabilities:
Accounts payable
Accrued and other current liabilities (of which $9,028 and $3,926 due to related parties in 2017
and 2016, respectively)
Income taxes payable
Total current liabilities
Long-term liabilities:
Long-term debt, net of current portion
Deferred income taxes
As of December 31,
Note
2017
2016
(22)
$ 59,205
$ 51,218
(10, 22)
244,114
230,305
21,473
26,906
324,792
308,429
(15)
(16)
1,758,258
1,067,096
76,727
40,621
Other long-term liabilities (of which $3,075 and $5,889 due to related parties in 2017 and 2016,
respectively)
(10, 13, 22)
337,743
284,952
Total long-term liabilities
Commitments and contingencies
Equity:
Preference shares, 0.01 EUR par value, authorized — 450,000 shares, no shares issued and
outstanding
Financing preference shares, 0.01 EUR par value, authorized — 40,000 shares, no shares issued
and outstanding
Common Shares, 0.01 EUR par value, authorized — 410,000 shares, issued — 230,829 and
239,707 shares in 2017 and 2016, respectively
Additional paid-in capital
Retained earnings
Accumulated other comprehensive loss
Less treasury shares, at cost — 4,272 and 5,147 shares in 2017 and 2016, respectively
Total equity
Total liabilities and equity
The accompanying notes are an integral part of these consolidated financial statements.
2,172,728
1,392,669
(19)
—
—
—
—
2,702
2,812
1,630,095
1,794,665
1,247,945
1,263,464
(17)
(17)
(220,759)
(333,839)
(118,987)
(120,006)
2,540,996
2,607,096
$ 5,038,516
$ 4,38,194
QIAGEN N.V. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF INCOME (in
thousands, except per share data)
Net sales
Cost of sales
Gross profit
Operating expenses:
Research and development
Sales and marketing
Years ended December 31,
Note
2017
2016
2015
(3, 4, 22) $ 1,417,536 $ 1,337,991
$ 1,280,986
494,975
493,338
454,328
922,561
844,653
826,658
(3)
154,084
149,841
146,830
375,562
376,321
359,598
General and administrative, restructuring, integration and other
(3)
200,098
180,573
102,066
Acquisition-related intangible amortization
Total operating expenses
Income from operations
Other income (expense):
Interest income
Interest expense
Other expense, net
Total other expense, net
Income before income taxes
Income taxes
Net income
Net loss attributable to noncontrolling interest
39,398
39,091
38,666
769,142
745,826
647,160
153,419
98,827
179,498
10,645
6,776
4,753
(49,685)
(39,022)
(37,396)
(6)
(4)
(9,673)
(10,552)
(39,044)
(41,919)
(43,195)
114,375
56,908
136,303
(3, 16)
73,981
(23,395)
6,401
40,394
80,303
129,902
—
(101)
(246)
Net income attributable to the owners of QIAGEN N.V.
$ 40,394
$ 80,404
$130,148
Basic net income per common share attributable to the owners of QIAGEN N.V.
$ 0.18
$ 0.34
$ 0.56
Diluted net income per common share attributable to the owners of QIAGEN N.V.
$ 0.17
$ 0.34
$ 0.55
Weighted-average common shares outstanding
Basic
Diluted
(18)
(18)
228,074
234,800
233,483
233,009
238,993
238,647
The accompanying notes are an integral part of these consolidated financial statements.
QIAGEN N.V. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF COMPREHENSIVE
INCOME (in thousands)
Net income
Other comprehensive income (loss) to be reclassified to profit or loss in subsequent
periods:
Years ended December 31,
Note
2017
2016
2015
$ 40,394
$ 80,303
$ 129,902
(Losses) Gains on cash flow hedges, before tax
Reclassification adjustments on cash flow hedges, before tax
(13)
(13)
(50,067)
(3,969)
5,337
26,136
(6,228)
(5,273)
Cash flow hedges, before tax
(Losses) gains on marketable securities, before tax
Gains (losses) on pensions, before tax
(23,931)
(10,197)
64
(854)
(1,421)
1,215
886
929
(1,809)
Foreign currency translation adjustments, before tax
135,945
(65,910)
(124,639)
Other comprehensive income (loss), before tax
112,046
(76,599)
(125,169)
Income tax relating to components of other comprehensive income (loss)
1,034
2,562
1,140
Total other comprehensive income (loss), after tax
Comprehensive income
Comprehensive (income) attributable to noncontrolling interest
113,080
(74,037)
(124,029)
153,474
—
6,266
(545)
5,873
(146)
Comprehensive income attributable to the owners of QIAGEN N.V.
$ 153,474
$ 5,721
$ 5,727
The accompanying notes are an integral part of these consolidated financial statements.
QIAGEN N.V. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CHANGES IN
EQUITY
Note
Common Shares
Additional
Paid-In Capital
Retained
Earnings
Accumulated Other
Comprehensive Income
(Loss)
Treasury Shares
Equity Attributable to
the Owners of
QIAGEN N.V.
Non-
controlling
Interest
Total Equity
(in thousands)
Shares
Amount
Shares
Amount
BALANCE AT DECEMBER 31, 2014
239,707 $ 2,812
$ 1,851,404 $ 1,104,329
$ (134,735)
(7,684) $ (167,190)
$ 2,656,620
$ 8,255 $ 2,664,875
Acquisition of QIAGEN Marseille S.A.
shares from noncontrolling interests
Net income
Unrealized loss, net on pension
(17)
Unrealized gain, net on hedging contracts
(13)
Realized gain, net on hedging contracts
(13)
Unrealized gain, net on marketable
securities
Translation adjustment, net
Purchase of treasury shares
Issuance of common shares in connection
with stock plan
Excess tax benefit of employee stock plans
(17)
(17)
(20)
Share-based compensation
(20)
Proceeds from subscription receivables
Redemption of subscription receivables
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
130,148
—
—
—
—
—
—
—
—
(1,266)
4,003
(3,955)
1,215
(124,418)
—
—
—
—
—
—
—
—
—
—
—
—
—
—
— (842)
(20,818)
(25,280)
— 1,824
35,596
3,328
23,761
97
(112,995)
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
(6,367)
(6,367)
130,148
(246)
129,902
(1,266)
4,003
(3,955)
1,215
—
—
—
—
(1,266)
4,003
(3,955)
1,215
(124,418)
392
(124,026)
(20,818)
10,316
3,328
23,761
97
(112,995)
—
—
—
—
—
—
(20,818)
10,316
3,328
23,761
97
(112,995)
BALANCE AT
DECEMBER 31, 2015
239,707 $ 2,812
$ 1,765,595 $ 1,209,197
$ (259,156)
(6,702) $ (152,412)
$ 2,566,036
$ 2,034 $ 2,568,070
Acquisition of QIAGEN Marseille S.A.
shares from noncontrolling interests
Acquisition of Exiqon A/S
Acquisition of Exiqon A/S shares from
noncontrolling
(5)
(5)
Net income
Unrealized gain, net on pension
(17)
Unrealized loss, net on hedging contracts
(13)
Realized gain, net on hedging contracts
(13)
Unrealized loss, net on marketable
securities
Translation adjustment, net
Issuance of common shares in connection
with stock plan
Excess tax benefit of employee stock plans
(10)
(17)
(20)
Share-based compensation
(20)
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Issuance of warrants
(17)
Net income
Unrealized gain, net on pension
(17)
Unrealized loss, net on hedging contracts
(13)
Realized loss, net on hedging contracts
Unrealized loss, net on marketable
securities
Translation adjustment, net
Purchase of treasury shares
Issuance of common shares in connection
with stock plan
Share-based compensation
(13)
(10)
(17)
(17)
(20)
(20)
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
80,404
—
—
—
—
—
—
—
—
—
650
(2,977)
(4,671)
(1,371)
(66,314)
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
(2,624)
(2,624)
—
—
5,519
5,519
(5,474)
(5,474)
80,404
(101)
80,303
650
(2,977)
(4,671)
(1,371)
—
—
—
—
650
(2,977)
(4,671)
(1,371)
(66,314)
646
(65,668)
(26,137)
— 1,555
32,406
6,269
782
28,288
—
—
—
—
—
—
—
—
782
28,288
—
—
40,394
—
—
—
—
—
—
—
—
—
620
(42,489)
19,602
(786)
136,133
191
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
— (1,909)
(60,970)
(55,913)
— 2,593
61,989
(244,429)
45,307
40,394
620
(42,489)
19,602
(786)
136,133
(60,970)
6,076
45,307
—
—
—
—
—
—
—
—
34,442
—
—
—
—
34,442
—
—
—
6,269
782
28,288
—
—
—
—
—
—
—
—
—
—
—
(244,429)
45,307
40,394
620
(42,489)
19,602
(786)
136,133
(60,970)
6,076
34,442
BALANCE AT
DECEMBER 31, 2016
239,707 $ 2,812
$ 1,794,665 $ 1,263,464
$ (333,839 (5,147) $ (120,006)
$ 2,607,096
$ — $ 2,607,096
Capital repayment
(17)
(8,878)
(110)
(244,319)
BALANCE AT DECEMBER 31, 2017
230,829 $ 2,702
$ 1,630,095 $ 1,247,945
$ (220,759)
(4,272) $ (118,987)
$ 2,540,996
$ — $ 2,540,996
h
l
f h
l d
d f
l
The accompanying notes are an integral part of these consolidated financial statements.
QIAGEN N.V. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Cash flows from operating activities:
Net income
Adjustments to reconcile net income to net cash provided by operating activities, net of effects of
businesses acquired:
Depreciation and amortization
Non-cash impairments
Amortization of debt discount and issuance costs
Share-based compensation expense
Years ended December 31,
Note
2017
2016
2015
$ 40,394
$ 80,303
129,902
216,448
213,056
191,473
(6)
5,137
44,399
5,471
24,773
20,451
19,955
(20)
34,442
28,288
23,760
Excess tax benefits from share-based compensation
—
(782)
(3,328)
Deferred income taxes
Loss on early redemption of debt
Loss (gain) on marketable securities
Reversals of contingent consideration
(16)
60,176
(63,981)
(32,280)
(15)
—
—
7,564
1,055
(1,360)
6,039
(14)
(3,269)
(6,501)
(5,225)
Other items, net including fair value changes in derivatives
(4,521)
19,435
2,609
Net changes in operating assets and liabilities:
Accounts receivable
Inventories
Prepaid expenses and other current assets
Other long-term assets
Accounts payable
Accrued and other current liabilities
Income taxes
Other long-term liabilities
Net cash provided by operating activities
Cash flows from investing activities:
Purchases of property, plant and equipment
Proceeds from sale of equipment
Purchases of intangible assets
Purchases of investments
Cash paid for acquisitions, net of cash acquired
Purchases of short-term investments
Proceeds from sales of short-term investments
Cash paid for collateral asset
Other investing activities
Net cash used in investing activities
Cash flows from financing activities:
(3)
(3)
(8)
(34,165)
(12,238)
(24,764)
(21,633)
(20,346)
(33,194)
(5,245)
6,640
52,315
(16,786)
3,549
2,730
4,321
(1,466)
7,732
(12)
2,828
10,618
(25,570)
(16)
(41,266)
13,483
(4,242)
24,090
8,054
(3,450)
286,779
341,602
317,497
(90,081)
(74,536)
(97,778)
42
63
103
(34,324)
(19,388)
(19,703)
(4,777)
(23,448)
(6,053)
(5)
(50,549)
(90,490)
(66,930)
(7)
(450,564)
(496,304)
(317,570)
(7)
189,006
533,847
367,714
(13)
(20,707)
(1,200)
—
(2,310)
(7,600)
(5,983)
(464,264)
(179,056)
(146,200)
Proceeds from long-term debt, net of issuance costs
(15)
329,875
—
—
Proceeds from issuance of cash convertible notes, net of
Purchase of call option related to cash convertible notes
Proceeds from issuance of warrants, net of issuance costs
Capital repayment
Repayment of long-term debt
Principal payments on capital leases
Excess tax benefits from share-based compensation
Proceeds from issuance of common shares
Purchase of treasury shares
Other financing activities
Net cash provided by (used in) financing activities
Effect of exchange rate changes on cash and cash equivalents
Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents, beginning of period
Cash and cash equivalents, end of period
Supplemental cash flow disclosures:
Cash paid for interest
Cash paid for income taxes
Supplemental disclosure of non-cash investing and financing activities:
Equipment purchased through capital lease
Intangible assets acquired in non-monetary exchange
(15)
394,391
(15)
(73,646)
(17)
45,396
(17)
(243,945)
—
—
—
—
(86)
—
—
—
(15)
—
(6,738)
(251,868)
(1,402)
(1,322)
(1,079)
—
782
3,328
6,075
6,269
10,316
(17)
(60,970)
— (20,818)
(8,587)
(9,595)
1,594
387,187
(10,604)
(258,613)
8,832
(2,773)
(15,340)
218,534
149,169 (102,656)
439,180
290,011
392,667
$ 657,714 $ 439,180 $ 290,011
$ 20,252
$ 18,227
$ 20,799
$ 40,499
$ 22,670
$ 34,441
$ 88
$ 113
$ 231
$ —
$ —
$ 5,900
FINANCIAL RESULTS
Notes to consolidated financial statements December
31, 2017
1. Corporate Information and Basis of Presentation
Corporate Information
QIAGEN N.V. is a public limited liability company ('naamloze vennootschap') under Dutch law with registered office
at Hulsterweg 82, 5912 PL Venlo, The Netherlands. QIAGEN N.V., a Netherlands holding company, and
subsidiaries (we, our or the Company) is the leading global provider of Sample to Insight solutions to transform
biological materials into valuable molecular insights. Our sample technologies isolate and process DNA, RNA and
proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for
analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights.
Automation solutions tie these together in seamless and cost-effective molecular testing workflows. We provide these
workflows to four major customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics,
veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life
sciences research). We market our products in more than 130 countries.
Basis of Presentation
The accompanying consolidated financial statements were prepared in accordance with U.S. generally accepted
accounting principles (GAAP) and all amounts are presented in U.S. dollars rounded to the nearest thousand, unless
otherwise indicated. The consolidated financial statements have been prepared on a historical cost basis, except for
derivative financial instruments, contingent consideration and available-for-sale financial instruments that have been
measured at fair value.
On January 6, 2017, we acquired OmicSoft Corporation, located in Cary, North Carolina (U.S.). On June 28,
2016, we acquired Exiqon A/S, located in Vedbaek, Denmark and on November 20, 2015, we acquired MO BIO
Laboratories, Inc., located in Carlsbad, California. Accordingly, at the acquisition dates, all of the assets acquired
and liabilities assumed were recorded at their respective fair values and our consolidated results of operations
include the operating results from the acquired companies from the acquisition dates.
Certain prior year amounts related to deferred taxes have been reclassified in Note 16 Income Taxes and the
Consolidated Statements of Cash Flows. Certain prior year amounts related to restructuring costs have been
reclassified to conform to the current year presentation. For the year ended December 31, 2016, $26.3 million and
$25.0 million costs were reclassified out of research and development and sales and marketing, respectively, to
general and administrative, restructuring, integration and other. These reclassifications had no effect on income from
operations.
2. Effects of New Accounting Pronouncements
Adoption of New Accounting Standards
The following new FASB Accounting Standards Updates (ASU) were effective for the year ended December 31,
2017.
ASU 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory requires in scope inventory,
including inventory measured using first-in, first out (FIFO) or average cost, to be measured at the lower of cost and
net realizable value. Net realizable value is the estimated selling price in the ordinary course of business, less
reasonably predictable costs of completion, disposal, and transportation. The adoption of ASU 2015-11 did not
have a material impact on our consolidated financial statements.
ASU 2016-07, Investments - Equity Method and Joint Ventures (Topic 323): Simplifying the Transition to the Equity
Method of Accounting eliminates the requirement to retroactively adopt the equity method of accounting when an
investment qualifies for use of the equity method as a result of an increase in the level of ownership or degree of
influence. The new guidance had no impact on our consolidated financial statements.
ASU 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment
Accounting is intended to simplify several aspects of the accounting for share-based payment transactions, including
the income tax consequences, classification of awards as either equity or liabilities, and classification on the
statement of cash flows. The new guidance became effective for us on January 1, 2017. The impact of the adoption
of ASU 2016-09 is limited to the recording of any windfall or shortfall benefit directly to the tax provision and the
reclassification of certain items in our statement of cash flows. We will continue estimating stock-based compensation
award forfeitures in determining the amount of compensation cost to be recognized each period. As a result of this
adoption, we expect volatility in our effective tax rate as any windfall or shortfall tax benefits related to our share-
based compensation will be recorded directly into our results of operations. Additionally, excess tax benefits after
adoption are classified as cash flows from operating activities instead of cash flows from financing activities. We
adopted this standard on a prospective basis and during 2017, $5.2 million of excess tax benefit was recognized
directly to the tax provision and classified as cash flows from operating activities.
New Accounting Standards Not Yet Adopted
The following new FASB Accounting Standards Updates, which are not yet adopted, have been grouped by their
required effective dates:
First Quarter of 2018
ASU 2014-09, Revenue from Contracts with Customers (Topic 606) affects any entity that either enters into contracts
with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets unless those
contracts are within the scope of other standards (e.g., insurance contracts or lease contracts). In August 2015, the
FASB issued Accounting Standards Update No. 2015-14 (ASU 2015-14), Revenue from Contracts with Customers
(Topic 606): Deferral of the Effective Date which defers the effective date of ASU 2014-09 to interim and annual
reporting periods beginning after December 15, 2017. The FASB has continued to issue accounting standards
updates to clarify and provide implementation guidance related to Revenue from Contracts with Customers, including
ASU 2016-08 Revenue from Contract with Customers: Principal versus Agent Considerations, ASU 2016-10 Revenue
from Contracts with Customers: Identifying Performance Obligations and Licensing, and ASU 2016-12 Revenue from
Contracts with Customers: Narrow-Scope Improvements and Practical Expedients. An entity should apply the
amendments either retrospectively to each prior reporting period presented and the entity may elect certain practical
expedients (the full retrospective method of adoption); or, retrospectively with the cumulative effect of initially
applying this ASU recognized at the date of initial application (the modified retrospective method of adoption).
We will adopt this standard on its effective date, January 1, 2018 using the modified retrospective method. The new
standard is largely consistent with the existing guidance and current practices applied by our business and we do
not expect a material impact on our existing revenue accounting policies. The new standard also requires additional
disclosures including quantitative and qualitative disclosures about the nature, amount, timing and uncertainty of
revenue and cash flows from customer contracts. The Company is in the process of finalizing changes to support
recognition and disclosure under the new revenue standard.
ASU 2016-01, Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets
and Financial Liabilities will impact certain aspects of recognition, measurement, presentation and disclosure of
financial instruments. The new guidance makes targeted improvements to existing U.S. GAAP by:
requiring equity investments (except those accounted for under the equity method of accounting, or those that result
in consolidation of the investee) to be measured at fair value with changes in fair value recognized in net income;
requiring public business entities to use the exit price notion when measuring the fair value of financial instruments
for disclosure purposes;
requiring separate presentation of financial assets and financial liabilities by measurement category and form of
financial asset (i.e., securities or loans and receivables) on the balance sheet or the accompanying notes to the
financial statements;
eliminating the requirement for public business entities to disclose the method(s) and significant assumptions used
to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost on
the balance sheet; and
requiring a reporting organization to present separately in other comprehensive income the portion of the total
change in the fair value of a liability resulting from a change in the instrument-specific credit risk (also referred to
as “own credit”) when the organization has elected to measure the liability at fair value in accordance with the
fair value option for financial instruments.
The amendments will become effective for our financial statements beginning in the first quarter of 2018 and require
adoption using a cumulative-effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption.
The implementation of the amendments is expected to increase the volatility of net income as gains or losses in future
periods will be recognized in net income; however the extent of any volatility will be dependent upon the
significance of the equity investments at the time of adoption. At December 31, 2017, we had a net unrealized loss
of $0.9 million net of tax, and at December 31, 2016, we had a net unrealized loss, net of tax, of $0.2 million from
equity investments recorded in equity, respectively.
ASU No. 2016-15, Statement of Cash Flows (Topic 320): Classification of Certain Cash Receipts and Cash
Payments (a consensus of the FASB Emerging Issues Task Force), addresses eight classification issues related to the
statement of cash flows:
debt prepayment or debt extinguishment costs;
settlement of zero-coupon bonds;
contingent consideration payments made after a business combination;
proceeds from the settlement of insurance claims;
proceeds from the settlement of corporate-owned life insurance policies, including bank-owned life insurance
policies;
distributions received from equity method investees;
beneficial interests in securitization transactions; and
separately identifiable cash flows and application of the predominance principle.
We will adopt ASU 2016-15 on January 1, 2018. We will be required to apply this ASU using a retrospective
transition method to each period presented other than for issues where application would be impracticable in which
case we will be permitted to apply the amendments for those issues prospectively as of the earliest date practicable.
We do not expect any material impact from the adoption of ASU 2016-15 on our consolidated financial statements.
ASU 2016-16, Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory, aims to improve the
accounting for the income tax consequences of intra-entity transfers of assets other than inventory. This amendment
requires an entity to recognize the income tax consequences of an intra-entity transfer of an asset other than
inventory when the transfer occurs. The amendments in this update should be applied on a modified retrospective
basis through a cumulative-effect adjustment directly to retained earnings as of the beginning of the period of
adoption. We will adopt ASU 2016-16 on January 1, 2018 without material impact.
ASU 2016-18, Statement of Cash Flows (Topic 320): Restricted Cash, requires entities to show the changes in the
total of cash, cash equivalents, restricted cash and restricted cash equivalents in the statement of cash flows. As a
result, entities will no longer present transfers between cash and cash equivalents and restricted cash and restricted
cash equivalents in the statement of cash flows. The amendments in this update should be applied using a
retrospective transition method to each period presented. This update is effective for us on January 1, 2018. There is
no impact from the adoption of ASU 2016-18 on our consolidated financial statements other than the effect of a
retrospective adjustment for the $6.3 million restricted cash balance held as of January 1, 2016 in the comparative
Consolidated Statements of Cash Flows.
ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, clarifies and provides a
more robust framework to use in determining when a set of assets and activities is a business. The amendments in this
update should be applied prospectively on or after the effective date. We adopted this update beginning January 1,
2018.
ASU 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting, clarifies when to
account for a change to the terms or conditions of a share-based payment award as a modification. Under the new
guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the
award (as equity or liability) changes as a result of the change in terms or conditions. The guidance is effective for us
prospectively for annual periods beginning on January 1, 2018.
First Quarter of 2019
ASU 2016-02, Leases (Topic 842) aims to increase transparency and comparability among organizations by
recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing
arrangements. ASU 2016-02 will become effective for us beginning in the first quarter of 2019 and requires
modified retrospective application for leases that exist or are entered into after the beginning of the earliest
comparative period in the financial statements. We do not plan to early adopt this standard and we anticipate that
the adoption of this standard will require changes to our systems and processes. We expect this standard to increase
total assets and total liabilities, however, we are currently evaluating the potential size of the impact that ASU 2016-
02 may have on our consolidated financial statements.
ASU 2017-12, Derivatives and Hedging (Topic 815): Targeted Improvements to Accounting for Hedging Activities,
will make more financial and nonfinancial hedging strategies eligible for hedge accounting. It also amends the
presentation and disclosure requirements and changes how companies assess effectiveness. It is intended to more
closely align hedge accounting with companies’ risk management strategies, simplify the application of hedge
accounting, and increase transparency as to the scope and results of hedging programs. The new guidance will
become effective for us beginning on January 1, 2019 by applying a modified retrospective approach to existing
hedging relationship as of the adoption date. Under the modified retrospective approach, entities with cash flow or
net investment hedges will make (1) a cumulative-effect adjustment to accumulated other comprehensive income so
that the adjusted amount represents the cumulative change in the hedging instruments’ fair value since hedge
inception (less any amounts that should have been recognized in earnings under the new accounting model) and (2)
a corresponding adjustment to opening retained earnings as of the most recent period presented on the date of
adoption. We are currently evaluating the potential impact ASU 2017-12 may have on our consolidated financial
statements.
First Quarter of 2020
ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments. provides financial statement users with more decision-useful information about the expected credit losses
on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. To
achieve this objective, the amendments in ASU 2016-13 replace the incurred loss impairment methodology in current
GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of
reasonable and supportable information to inform credit loss estimates. The new guidance will become effective for
us by applying the standard's provisions as a cumulative-effect adjustment to retained earnings beginning on January
1, 2020. We are currently evaluating the potential impact ASU 2016-13 may have on our consolidated financial
statements.
ASU 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment, removes
Step 2 of the goodwill impairment test. A goodwill impairment will now be the amount by which a reporting unit’s
carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. ASU 2017-04 is effective for us
for annual periods beginning January 1, 2020 and early adoption is permitted. The new guidance is required to be
applied on a prospective basis. We are currently evaluating the impact the adoption of this new standard will have
on our financial position and results of operations.
3. Summary of Significant Accounting Policies and Critical Accounting
Estimates
Principles of Consolidation
The consolidated financial statements include the accounts of QIAGEN N.V. and its wholly-owned subsidiaries. All
significant intercompany accounts and transactions have been eliminated. Investments in either common stock or in-
substance common stock of companies where we exercise significant influence over the operations but do not have
control, and where we are not the primary beneficiary, are accounted for using the equity method. All other
investments are accounted for under the cost method. When there is a portion of equity in an acquired subsidiary not
attributable, directly or indirectly, to the Company, we record the fair value of the noncontrolling interests at the
acquisition date and classify the amounts attributable to noncontrolling interests separately in equity in the
consolidated financial statements. Any subsequent changes in the Company's ownership interest while the Company
retains its controlling financial interest in its subsidiary are accounted for as equity transactions.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United
States requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities
and disclosure of contingencies at the date of the financial statements as well as the reported amounts of revenues
and expenses during the reporting period. Actual results could differ from those estimates.
Concentrations of Risk
We buy materials for products from many suppliers, and are not dependent on any one supplier or group of
suppliers for the business as a whole. However, key components of certain products, including certain
instrumentation components and chemicals, are available only from a single source. If supplies from these vendors
were delayed or interrupted for any reason, we may not be able to obtain these materials timely or in sufficient
quantities in order to produce certain products and sales levels could be negatively affected. Additionally, our
customers include researchers at pharmaceutical and biotechnology companies, academic institutions, and
government and private laboratories. Fluctuations in the research and development budgets of these researchers and
their organizations for applications in which our products are used could have a significant effect on the demand for
our products.
The financial instruments used in managing our foreign currency, equity and interest rate exposures have an element
of risk in that the counterparties may be unable to meet the terms of the agreements. We attempt to minimize this risk
by limiting the counterparties to a diverse group of highly-rated international financial institutions. The carrying values
of our financial instruments incorporate the non-performance risk by using market pricing for credit risk. However, we
have no reason to believe that any counterparties will default on their obligations and therefore do not expect to
record any losses as a result of counterparty default. In order to minimize our exposure with any single counterparty,
we have entered into master agreements which allow us to manage the exposure with the respective counterparty on
a net basis.
Other financial instruments that potentially subject us to concentrations of credit risk are cash and cash equivalents,
short-term investments, and accounts receivable. We attempt to minimize the risks related to cash and cash
equivalents and short-term investments by dealing with highly-rated financial institutions and investing in a broad and
diverse range of financial instruments. We have established guidelines related to credit quality and maturities of
investments intended to maintain safety and liquidity.
Concentration of credit risk with respect to accounts receivable is limited due to a large and diverse customer base,
which is dispersed over different geographic areas. Allowances are maintained for potential credit losses and such
losses have historically been within expected ranges.
Foreign Currency Translation
Our reporting currency is the U.S. dollar and our subsidiaries’ functional currencies are generally the local currency
of the respective countries in which they are headquartered. All amounts in the financial statements of entities whose
functional currency is not the U.S. dollar are translated into U.S. dollar equivalents at exchange rates as follows: (1)
assets and liabilities at period-end rates, (2) income statement accounts at average exchange rates for the period,
and (3) components of equity at historical rates. Translation gains or losses are recorded in equity, and transaction
gains and losses are reflected in net income as a component of other expense, net. Realized gains or losses on the
value of derivative contracts entered into to hedge the exchange rate exposure of receivables and payables are also
included in net income as a component of other expense, net. The net (loss) gain on foreign currency transactions
was $(3.3) million, less than $0.1 million, and $(0.5) million in 2017, 2016 and 2015, respectively, and is
included in other expense, net.
The exchange rates of key currencies were as follows:
(US$ equivalent for one)
Euro (EUR)
Pound Sterling (GBP)
Swiss Franc (CHF)
Australian Dollar (AUD)
Canadian Dollar (CAD)
Japanese Yen (JPY)
Chinese Yuan (CNY)
Closing rate at December 31,
Annual average rate
2017
2016
2017
2016
2015
1.1993
1.0541
1.1292
1.1068
1.1100
1.3517
1.2312
1.2882
1.3560
1.5286
1.0249
0.9816
1.0156
1.0153
1.0406
0.7815
0.7222
0.7666
0.7439
0.7522
0.7975
0.7430
0.7710
0.7552
0.7836
0.0089
0.0085
0.0089
0.0092
0.0083
0.1537
0.1440
0.1480
0.1506
0.1592
Segment Information
We determined that we operate as one operating segment in accordance with the Financial Accounting Standards
Board (FASB) Accounting Standards Codification (ASC) Topic 280, Segment Reporting. Our chief operating decision
maker (CODM) makes decisions based on the Company as a whole. In addition, we have a common basis of
organization and types of products and services which derive revenues and consistent product margins. Accordingly,
we operate and make decisions as one reporting unit.
Revenue Recognition
Our revenues are reported net of sales and value added taxes, discounts and sales allowances, and are derived
primarily from the sale of consumable and instrumentation products, and to a much lesser extent, from the sale of
services, intellectual property and technology. We recognize revenue when four basic criteria are met: (1)
persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee
is fixed or determinable; and (4) collectability is reasonably assured.
Consumable and Related Products: In the last three years, revenue from consumable product sales has accounted for
approximately 79%-80% of our net sales and is generally recognized upon transfer of title consistent with the
shipping terms. We maintain a small amount, on average less than $2.0 million in total, of consignment inventory at
certain customer locations. Revenues for the consumable products which are consigned in this manner are
recognized upon consumption. We generally allow returns of consumable products if the product is returned in a
timely manner and in good condition. Allowances for returns are provided for based upon the historical pattern of
returns and management’s evaluation of specific factors that impact the risk of returns.
Revenues from related products include software-as-a-service (SaaS), license fees, intellectual property and patent
sales, royalties and milestone payments and over the last three years has accounted for approximately 7%-8% of our
net sales. Revenue from SaaS arrangements is recognized ratably over the duration of the agreement unless the
terms of the agreement indicate that revenue should be recognized in a different pattern, for example based on
usage. License fees from research collaborations include payments for technology transfer and access rights. Non-
refundable, up-front payments received in connection with collaborative research and development agreements are
generally deferred and recognized on a straight-line basis over the contract period during which there is any
continuing obligation. Revenue from intellectual property and patent sales is recognized when earned, either at the
time of sale, or over the contract period when licensed. Payments for milestones, generally based on the achievement
of substantive and at-risk performance criteria, are recognized in full at such time as the specified milestone has been
achieved according to the terms of the agreement. Royalties from licensees are based on reported sales of licensed
products and revenues are calculated based on contract terms when reported sales are reliably measurable, fees are
fixed or determinable and collectability is reasonably assured.
Instrumentation: Revenue from instrumentation includes the instrumentation equipment, installation, training and other
instrumentation services, such as extended warranty services or product maintenance contracts and over the last
three years has accounted for approximately 12%-13% of net sales. Revenue from instrumentation equipment is
recognized when title passes to the customer, upon either shipment or written customer acceptance after satisfying
any installation and training requirements.
We offer our customers access to our instrumentation via reagent rental agreements which place instrumentation with
customers without requiring them to purchase the equipment. Instead, we recover the cost of providing the
instrumentation in the amount charged for consumable products. The instruments placed with customers under a
reagent rental agreement are depreciated and charged to cost of sales on a straight-line basis over the estimated life
of the instrument, typically 3 to 5 years. The costs to maintain these instruments in the field are charged to cost of
sales as incurred. Revenue from these reagent rental agreements is allocated to the elements within the arrangement
(the lease, the sale of consumables and/or services) in accordance with ASC 605-25, Revenue Recognition—
Multiple-Element Arrangements and recognized for each unit of accounting as appropriate.
We have contracts with multiple elements which include instrumentation equipment, either leased under a reagent
rental agreement or sold directly, together with other elements such as installation, training, extended warranty
services or product maintenance contracts or consumable products. These contracts are accounted for under ASC
605-25, Revenue Recognition—Multiple-Element Arrangements. Multiple-element arrangements are assessed to
determine whether there is more than one unit of accounting. In order for a deliverable to qualify as a separate unit
of accounting, both of the following criteria must be met:
The delivered items have value to the client on a stand-alone basis;
If the arrangement includes a general right of return relative to the delivered item, delivery or performance of the
undelivered item or items is considered probable and substantially in the control of the Company.
Arrangement consideration is allocated at the inception of the arrangement to all deliverables on the basis of their
relative selling price. When applying the relative selling price method, the selling price for each deliverable is
determined using (a) vendor-specific objective evidence (VSOE) of selling price, if it exists; or otherwise (b) third-party
evidence of selling price. If neither VSOE nor third-party evidence of selling price exists for a deliverable, then the
best estimated selling price for the deliverable is used. The arrangement consideration is allocated to the separate
units of accounting based on each unit’s relative fair value. If these criteria are not met, deliverables included in an
arrangement are accounted for as a single unit of accounting and revenues and costs are deferred until the period or
periods in which the final deliverable is provided.
We have evaluated the deliverables in our multiple-element arrangements and concluded that they are separate units
of accounting because the delivered item or items have value to the customer on a standalone basis and for an
arrangement that includes a general right of return relative to the delivered item(s), delivery or performance of the
undelivered item(s) is considered probable and substantially in our control. Revenues from installation and training
are recognized as services are completed, based on VSOE, which is determined by reference to the price customers
pay when the services are sold separately. Revenues from extended warranty services or product maintenance
contracts are recognized on a straight-line basis over the term of the contract, typically one year. VSOE of fair value
of extended warranty services or product maintenance is determined based on the price charged for the
maintenance and support when sold separately. Revenues from the instrumentation equipment and consumable
products are recognized when the products are delivered and there are no further performance obligations. VSOE of
fair value of instrumentation equipment and consumable products is determined based on the price charged for the
instrument and consumables when sold separately. Certain of our reagent rental arrangements include termination
provisions for breach of contract. However, these termination provisions would not impact recognized revenues. Our
other arrangements do not include any provisions for cancellation or refunds.
Warranty
We provide warranties on our products against defects in materials and workmanship for a period of 1 year. A
provision for estimated future warranty costs is recorded in cost of sales at the time product revenue is recognized.
Product warranty obligations are included in accrued and other current liabilities in the accompanying consolidated
balance sheets. The changes in the carrying amount of warranty obligations are as follows:
(in thousands)
BALANCE AT DECEMBER 31, 2015
Provision charged to cost of sales
Usage
Adjustments to previously provided warranties, net
Currency translation
BALANCE AT DECEMBER 31, 2016
Provision charged to cost of sales
Usage
Adjustments to previously provided warranties, net
Currency translation
BALANCE AT DECEMBER 31, 2017
Total
$ 2,637
3,562
(2,936)
(424)
(60)
$ 2,779
3,024
(2,859)
(54)
161
$ 3,051
Research and Development
Research and product development costs are expensed as incurred. Research and development expenses consist
primarily of salaries and related expenses, facility costs and amounts paid to contract research organizations, and
laboratories for the provision of services and materials as well as costs for internal use or clinical trials.
Government Grants
We recognize government grants when there is reasonable assurance that all conditions will be complied with and
the grant will be received. Our government grants generally represent subsidies for specified activities and are
therefore recognized when earned as a reduction of the expenses recorded for the activity that the grants are
intended to compensate. Thus, when the grant relates to research and development expense, the grant is recognized
over the same period that the related costs are incurred. Otherwise, amounts received under government grants are
recorded as liabilities in the balance sheet. When the grant relates to an asset, the nominal amount of the grant is
deducted from the carrying amount of the asset and recognized over the same period that the related asset is
depreciated.
Borrowing Costs
Borrowing costs directly attributable to the acquisition, construction or production of an asset that takes a substantial
period of time to get ready for its intended use or sale are capitalized as part of the cost of the respective assets
(qualifying asset) when such borrowing costs are significant. All other borrowing costs are expensed in the period
they occur.
Shipping and Handling Income and Costs
Shipping and handling costs charged to customers are recorded as revenue in the period that the related product
sale revenue is recorded. Associated costs of shipping and handling are included in sales and marketing expenses.
For the years ended December 31, 2017, 2016 and 2015, shipping and handling costs totaled $28.6 million,
$26.5 million and $26.2 million, respectively.
Advertising Costs
The costs of advertising are expensed as incurred and are included as a component of sales and marketing expense.
Advertising costs for the years ended December 31, 2017, 2016 and 2015 were $7.2 million, $8.4 million and
$7.2 million, respectively.
General and Administrative, Restructuring, Integration and Other
General and administrative expenses primarily represent the costs required to support administrative infrastructure. In
addition, we incur indirect acquisition and business integration costs in connection with business combinations. These
costs represent incremental costs that we believe would not have been incurred absent the business combinations.
Major components of these costs include payroll and related costs for employees remaining with the Company on a
transitional basis; public relations, advertising and media costs for re-branding of the combined organization; and,
consulting and related fees incurred to integrate or restructure the acquired operations.
Restructuring costs include personnel costs (principally termination benefits), facility closure and contract termination
costs. Termination benefits are accounted for in accordance with FASB ASC Topic 712, Compensation -
Nonretirement Postemployment Benefits, and are recorded when it is probable that employees will be entitled to
benefits and the amounts can be reasonably estimated. Estimates of termination benefits are based on the frequency
of past termination benefits, the similarity of benefits under the current plan and prior plans, and the existence of
statutory required minimum benefits. Facility closure, some termination benefits and other costs are accounted for in
accordance with FASB ASC Topic 420, Exit or Disposal Cost Obligations and are recorded when the liability is
incurred. The specific restructuring measures and associated estimated costs are based on management's best
business judgment under the existing circumstances at the time the estimates are made. If future events require
changes to these estimates, such adjustments will be reflected in the period of the revised estimate.
Income Taxes
We account for income taxes under the liability method. Under this method, total income tax expense is the amount
of income taxes expected to be payable for the current year plus the change from the beginning of the year for
deferred income tax assets and liabilities established for the expected further tax consequences resulting from
differences in the financial reporting and tax basis of assets and liabilities. Deferred tax assets and/or liabilities are
determined by multiplying the differences between the financial reporting and tax reporting bases for assets and
liabilities by the enacted tax rates expected to be in effect when such differences are recovered or settled. Deferred
tax assets are reduced by a valuation allowance to the amount more likely than not to be realized. The effect on
deferred taxes of a change in tax rates is recognized in income in the period that includes the enactment date.
Tax benefits are initially recognized in the financial statements when it is more likely than not that the position will be
sustained upon examination by the tax authorities. Such tax positions are initially and subsequently measured as the
largest amount of tax benefit that is greater than 50 percent likely of being realized upon settlement with the taxing
authority using the cumulative probability method, assuming the tax authority has full knowledge of the position and
all relevant facts. Our policy is to recognize interest accrued related to unrecognized tax benefits in interest expense
and penalties within the income tax expense.
Derivative Instruments
We enter into derivative financial instrument contracts to minimize the variability of cash flows or income statement
impact associated with the anticipated transactions being hedged or to hedge fluctuating interest rates. As changes
in foreign currency or interest rate impact the value of anticipated transactions, the fair value of the forward or swap
contracts also changes, offsetting foreign currency or interest rate fluctuations. Derivative instruments are recorded on
the balance sheet at fair value. Changes in fair value of derivatives are recorded in current earnings or other
comprehensive income, depending on whether a derivative is designated as part of a hedge transaction.
Share-Based Payments
Compensation cost for all share-based payments is recorded based on the grant date fair value, less an estimate for
pre-vesting forfeitures, recognized in expense over the service period. During 2016 we made a change in
accounting principle to move from a straight-line attribution method for expense recognition to an accelerated
attribution method.
Forfeiture Rate—This is the estimated percentage of grants that are expected to be forfeited or cancelled on an
annual basis before becoming fully vested. We estimated the forfeiture rate based on historical forfeiture experience.
Restricted Stock Units and Performance Stock Units: Restricted stock units and performance stock units represent rights
to receive Common Shares at a future date. The fair market value of restricted and performance stock units is
determined based on the number of stock units granted and the fair market value of our shares on the grant date.
The fair market value at the time of the grant, less an estimate for pre-vesting forfeitures, is recognized in expense
over the vesting period. At each reporting period, the estimated performance achievement of the performance stock
units is assessed and any change in the estimated achievement is recorded on a cumulative basis in the period of
adjustment.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash on deposit in banks and other cash invested temporarily in various
instruments that are short-term and highly liquid, and having an original maturity of less than 90 days at the date of
purchase.
(in thousands)
Cash at bank and on hand
Short-term bank deposits
Cash and Cash Equivalents
2017
2016
$ 139,597
$ 137,615
518,117
301,565
$ 657,714
$ 439,180
Short-Term Investments
Short-term investments are classified as “available for sale” and stated at fair value in the accompanying balance
sheet. Interest income is accrued when earned and changes in fair market values are reflected as unrealized gains
and losses, calculated on the specific identification method, as a component of accumulated other comprehensive
income (loss) in equity. The amortization of premiums and accretion of discounts to maturity arising from acquisition
is included in interest income. A decline in fair value that is judged to be other-than-temporary is accounted for as a
realized loss and the write-down is included in the consolidated statements of income. Realized gains and losses,
determined on a specific identification basis, on the sale of short-term investments are included in income.
Fair Value of Financial Instruments
The carrying amount of cash and cash equivalents, notes receivable, accounts receivable, accounts payable and
accrued liabilities approximate their fair values because of the short maturities of those instruments. The carrying
value of our variable rate debt and capital leases approximates their fair values because of the short maturities
and/or interest rates which are comparable to those available to us on similar terms. The fair values of the Cash
Convertible Notes are based on an estimation using available over-the-counter market information. The fair values of
the Private Placement Senior Notes further described in Note 15 were estimated using the changes in the U.S.
Treasury rates.
Accounts Receivable
Our accounts receivable are unsecured and we are at risk to the extent such amounts become uncollectible. We
continually monitor accounts receivable balances, and provide for an allowance for doubtful accounts at the time
collection becomes questionable based on payment history or age of the receivable. Amounts determined to be
uncollectible are written off against the reserve. For the years ended December 31, 2017, 2016 and 2015, write-
offs of accounts receivable totaled $3.2 million, $1.6 million and $2.0 million, respectively, while provisions for
doubtful accounts which were charged to expense totaled $3.1 million, $2.1 million and $2.1 million, respectively.
For all years presented, no single customer represented more than ten percent of accounts receivable or consolidated
net sales.
Inventories
Inventories are stated at the lower of cost or net realizable value, determined on either a weighted average cost
basis or a standard cost basis which is regularly adjusted to actual. Inventories include material, direct labor and
overhead costs and are reduced for estimated obsolescence. Inventories consisted of the following as of December
31, 2017 and 2016:
(in thousands)
Raw materials
Work in process
Finished goods
Total inventories, net
2017
2016
$ 23,717
$ 29,402
33,153
28,123
99,057
$ 79,027
$ 155,927
$ 136,552
Property, Plant and Equipment
Property, plant and equipment, including equipment acquired under capital lease obligations, are stated at cost less
accumulated amortization. Capitalized internal-use software costs include only those direct costs associated with the
actual development or acquisition of computer software for internal use, including costs associated with the design,
coding, installation and testing of the system. Costs associated with preliminary development, such as the evaluation
and selection of alternatives, as well as training, maintenance and support are expensed as incurred. Costs for
software to be sold, leased or otherwise marketed that are related to the conceptual formulation and design are
expensed as incurred. Costs incurred to produce the product after technological feasibility is established are
capitalized and amortized in accordance with the accounting standards for the costs of software to be sold, leased,
or otherwise marketed. All other depreciation is computed using the straight-line method over the estimated useful
lives of the assets (3 to 40 years). Amortization of leasehold improvements is computed on a straight-line basis over
the lesser of the remaining life of the lease or the estimated useful life of the improvement asset. We have a policy of
capitalizing expenditures that materially increase assets’ useful lives and charging ordinary maintenance and repairs
to operations as incurred. When property or equipment is disposed of, the cost and related accumulated
depreciation and amortization are removed from the accounts and any gain or loss is included in earnings.
Acquired Intangibles and Goodwill
Acquired intangibles with alternative future uses are carried at cost less accumulated amortization and consist of
licenses to technology held by third parties and other acquired intangible assets. Amortization is computed over the
estimated useful life of the underlying patents, which has historically ranged from one to twenty years. Purchased
intangible assets acquired in business combinations, other than goodwill, are amortized over their estimated useful
lives unless these lives are determined to be indefinite. Intangibles are assessed for recoverability considering the
contract life and the period of time over which the intangible will contribute to future cash flow. The unamortized cost
of intangible assets, where cash flows are independent and identifiable from other assets, is evaluated periodically
and adjusted, if necessary, if events and circumstances indicate that a decline in value below the carrying amount
has occurred. For the years ended December 31, 2016 and 2015, we recorded intangible asset impairments of
$21.4 million and $0.2 million, respectively. Intangible asset impairments recorded during the year ended
December 31, 2016 are further discussed in Note 6 Restructuring.
Amortization expense related to developed technology and patent and license rights which have been acquired in a
business combination is included in cost of sales. Amortization of trademarks, customer base and non-compete
agreements which have been acquired in a business combination is recorded in operating expense under the
caption 'acquisition-related intangible amortization'. Amortization expenses of intangible assets not acquired in a
business combination are recorded within either the cost of sales, research and development or sales and marketing
line items based on the use of the asset.
Goodwill represents the difference between the purchase price and the estimated fair value of the net assets acquired
arising from business combinations. Goodwill is subject to impairment tests annually or earlier if indicators of
potential impairment exist, using a fair-value-based approach. We have elected to perform our annual test for
indications of impairment as of October 1st of each year. Following the annual impairment tests for the years ended
December 31, 2017, 2016 and 2015, goodwill has not been impaired. As discussed in Note 6 Restructuring, in
2016 we recorded a $2.6 million disposal of goodwill associated to the 2016 restructuring initiative.
Investments
We have investments in non-marketable securities issued by privately held companies. These investments are
included in other long-term assets in the accompanying consolidated balance sheets and are accounted for using the
equity or cost method of accounting.
Investments are evaluated periodically, or when impairment indicators are noted, to determine if declines in value
are other-than-temporary. In making that determination, we consider all available evidence relating to the realizable
value of a security. This evidence includes, but is not limited to, the following:
adverse financial conditions of a specific issuer, segment, industry, region or other variables;
the length of time and the extent to which the fair value has been less than cost; and
the financial condition and near-term prospects of the issuer.
We consider whether the fair values of any of our cost or equity method investments have declined below their
carrying value whenever adverse events or changes in circumstances indicate that recorded values may not be
recoverable. If any such decline is considered to be other than temporary (based on various factors, including
historical financial results, product development activities and the overall health of the affiliate’s industry), then a
write-down of the investment would be recorded in operating expense to its estimated fair value. For the year ended
December 31, 2017 and 2015, we recorded total impairments to cost method investments of $5.1 million and $2.2
million, respectively, in other expense, net. In 2016, we recorded an impairment to an equity method investment of
$8.3 million in other expense, net.
Impairment of Long-Lived Assets
We review our long-lived assets for impairment whenever events or changes in circumstances indicate that the
carrying amount of an asset or a group of assets may not be recoverable. We consider, amongst other indicators, a
history of operating losses or a change in expected sales levels to be indicators of potential impairment. Assets are
grouped and evaluated for impairment at the lowest level for which there are identifiable cash flows that are largely
independent of the cash flows of other groups of assets. If an asset is determined to be impaired, the loss is
measured as the amount by which the carrying amount of the asset exceeds fair value which is determined by
applicable market prices, when available. When market prices are not available, we generally measure fair value
by discounting projected future cash flows of the asset. Considerable judgment is necessary to estimate discounted
future cash flows. Accordingly, actual results could differ from such estimates. During the year ended 2016, in
connection with the restructuring discussed in Note 6, we recorded asset impairment charges of $10.9 million, of
which $10.8 million is recorded in general and administrative, restructuring, integration and other expense and
$0.1 million is recorded in cost of sales. In 2015, we recorded asset impairment charges of $3.1 million in general
and administrative, restructuring, integration and other expenses in the accompanying consolidated statements of
income related to the abandonment of certain software projects following the acquisition of MO BIO.
4. Segment Information
Considering the acquisition made during 2017, we determined that we still operate as one business segment in
accordance with FASB ASC Topic 280, Segment Reporting. As a result of our continued restructuring and
streamlining of the growing organization, our chief operating decision maker (CODM) continues to make decisions
with regards to business operations and resource allocation based on evaluations of QIAGEN as a whole.
Accordingly, we operate as one business segment. Summarized product category and geographic information is
shown in the tables below.
Product Category Information
Net sales for the product categories are attributed based on those revenues related to sample and assay products
and similarly related revenues including bioinformatics solutions, and revenues derived from instrumentation sales.
(in thousands)
Net Sales
2017
2016
2015
Consumables and related revenues
$ 1,242,715
$ 1,166,131
$ 1,114,580
Instrumentation
Total
174,821
171,860
166,406
$ 1,417,536
$ 1,337,991
$ 1,280,986
Geographical Information
Net sales are attributed to countries based on the location of the customer. QIAGEN operates manufacturing
facilities in Germany, China, and the United States that supply products to customers as well as QIAGEN
subsidiaries in other countries. The intersegment portions of such net sales are excluded to derive consolidated net
sales. No single customer represents more than ten percent of consolidated net sales. Our country of domicile is the
Netherlands, which reported net sales of $15.0 million, $12.4 million and $11.3 million for the years ended 2017,
2016 and 2015, respectively, and these amounts are included in the line item Europe, Middle East and Africa as
shown in the table below.
(in thousands)
Net Sales
Americas:
United States
Other Americas
Total Americas
Europe, Middle East and Africa
Asia Pacific and Rest of World
Total
2017
2016
2015
$ 579,906
$ 555,676
$ 525,532
73,478
71,797
79,578
653,384
627,473
605,110
462,980
428,055
409,955
301,172
282,463
265,921
$ 1,417,536
$ 1,337,991
$ 1,280,986
Long-lived assets include property, plant and equipment. The Netherlands, which is included in the balances for
Europe, reported long-lived assets of $1.7 million and $1.4 million as of December 31, 2017 and 2016,
respectively.
(in thousands)
Long-lived assets
Americas:
United States
Other Americas
Total Americas
Germany
Other Europe
Asia Pacific and Rest of World
Total
5. Acquisitions
2017
2016
$ 148,694
$ 145,813
4,488
153,182
286,567
41,188
13,384
4,544
150,357
237,190
37,057
12,051
$ 494,321
$ 436,655
Acquisitions have been accounted for as business combinations, and the acquired companies’ results have been
included in the accompanying consolidated statements of income from their respective dates of acquisition. Our
acquisitions have historically been made at prices above the fair value of the acquired net assets, resulting in
goodwill, due to expectations of synergies of combining the businesses. These synergies include use of our existing
infrastructure, such as sales force, shared service centers, distribution channels and customer relations, to expand
sales of the acquired businesses’ products; use of the infrastructure of the acquired businesses to cost-effectively
expand sales of our products; and elimination of duplicative facilities, functions and staffing.
2017 Acquisition
On January 6, 2017, we acquired OmicSoft Corporation, a leading provider of omics data management solutions
located in Cary, North Carolina (U.S.). This acquisition was not significant to the overall consolidated financial
statements and as of December 31, 2017, the allocation of the purchase price was final. The acquisition did not
have a material impact to net sales, net income or earnings per share and therefore no pro forma information has
been provided herein.
2016 Acquisitions
During the second quarter of 2016, we acquired a majority shareholding in Exiqon A/S (Exiqon), a publicly traded
Danish company headquartered in Vedbaek, Denmark, which is a leading provider of RNA analysis solutions with a
proprietary Locked Nucleic Acid (LNA) technology. The acquisition expands our leadership position in Sample to
Insight solutions for RNA analysis. On June 28, 2016, we paid DKK 627.4 million ($95.2 million) for approximately
94.52% of the outstanding Exiqon common shares. On the acquisition date, the fair value of the remaining shares
was $5.5 million. The fair value of this noncontrolling share was based on reference to quoted market values of
Exiqon stock. During the year ended December 31, 2016, we acquired the remaining Exiqon shares for $5.5 million
in cash, which is included in other financing activities in the accompanying consolidated statements of cash flows
and as of December 31, 2016 we held 100% of Exiqon's shares. For the year ended December 31, 2016,
acquisition-related costs of $6.3 million are included in general and administrative, restructuring, integration and
other in the accompanying consolidated statements of income.
The final purchase price allocation as of December 31, 2017 did not differ from the preliminary purchase price
allocation as of June 30, 2016 other than a $9.4 million increase in developed technology, a $9.2 million increase
in deferred tax asset on tax loss carry forwards, a $2.8 million decrease in customer relationships, a $1.2 million
increase of long-term deferred tax liability, a $0.4 million increase in prepaid expenses and other current assets and
an additional $0.3 million increase of other opening balance sheet liabilities. The corresponding impact for these
adjustments was a decrease to goodwill of $14.7 million.
(in thousands)
Purchase Price:
Cash consideration
Fair value of remaining shares
Final Allocation:
Cash and cash equivalents
Accounts receivable
Inventory
Prepaid expenses and other current assets
Accounts payable
Accruals and other current liabilities
Debt assumed
Other long-term liabilities
Deferred tax asset on tax loss carry forwards
Fixed and other long-term assets
Developed technology
Customer relationships
Tradenames
Goodwill
Deferred tax liability on fair value of identifiable intangible assets acquired
Exiqon acquisition
$ 95,163
5,519
$ 100,682
$ 4,824
3,581
1,553
1,853
(1,289)
(11,587)
(6,068)
(197)
10,016
2,870
18,500
3,800
1,400
76,807
(5,381)
$ 100,682
The weighted average amortization period for the intangible assets is 11.1 years. The goodwill acquired is not
deductible for tax purposes.
Revenue and earnings in the reporting periods since the acquisition date have not been significant. No pro forma
financial information has been provided herein as the acquisition of Exiqon did not have a material impact to net
sales, net income or earnings per share on a pro forma basis.
2015 Acquisitions
During 2015, we completed three acquisitions, including the acquisition of MO BIO Laboratories, Inc., a privately-
held U.S. company, that is considered a leader in sample technologies for metagenomics and microbiome analysis.
Purchase consideration for these acquisitions totaled $66.9 million in cash, net of cash acquired, and as of
December 31, 2016, the purchase price allocations are final. Each of these acquisitions did not have a material
impact to net sales, net income or earnings per share and therefore no pro forma information has been provided
herein.
6. Restructuring
2017 Restructuring
During the fourth quarter of 2017, we initiated restructuring initiatives to mitigate the negative impacts stemming from
the U.S. tax legislation as further discussed in Note 16. Total pre-tax costs are expected to be between $22.8 million
and $24.8 million, of which $13.8 million was incurred in 2017. Future pre-tax costs between $9.0 million to
$11.0 million are expected to be incurred in 2018 primarily related to personnel and other costs.
The following table summarizes the cash components of the restructuring activity.
(in thousands)
Costs incurred in 2017
Foreign currency translation adjustment
Liability at December 31, 2017
Personnel Related
Consulting Costs
Total
$ 6,174
$ 4,583
$ 10,757
48
2
50
$ 6,222
$ 4,585
$ 10,807
The Personnel Related and Consulting Costs are included within general and administrative, restructuring, integration
and other and an additional $3.0 million of inventory write-offs is included in cost of sales in the accompanying
consolidated statement of income for the year ended December 31, 2017. The liability of $10.8 million is included
in accrued and other current liabilities in the accompanying consolidated balance sheet at December 31, 2017.
2016 Restructuring
During the fourth quarter of 2016, we initiated a series of targeted actions to support faster sales momentum and
improve efficiency and accountability. The objective with these actions is to ensure that we grow sustainably and
consistently in the coming years. Measures include simplifying our geographic presence with site reductions, focusing
resources to shared service centers, and streamlining selected organizational structures. No additional costs will be
incurred related to this program. Cumulative costs for this program are as follows:
(in thousands)
Cost of sales
General and administrative, restructuring,
integration and other
Other expense, net
Total 2016 costs
Cost of sales
General and administrative, restructuring,
integration and other
Total 2017 costs
Total cumulative costs
Personnel Related
Facility Related
Contract and Other
Costs
Asset Impairments &
Disposals
Total
$ 1,222
17,998
—
$ 205
6,960
—
$ 19,220
$ 7,165
$ 1,141
$ 8,399
$ —
$ 350
$ 43
8,272
$ 10,490
$ 11,960
22,963
56,193
—
10,946
10,946
$ 8,315
$ 238
$ 9,612
$ 44,399
$ 79,099
$ —
$ —
$ 1,379
$ 18,361
$ 9,540
$ 350
$ 9,850
$ —
$ 19,740
$ 28,760
$ 7,515
$ 18,165
$ 44,399
$ 98,839
Personnel Related expenses during 2017 and 2016 includes reductions in costs of $0.7 million and $2.0 million,
respectively, as a result of forfeitures of share-based compensation in connection with terminations. During the year
ended December 31, 2016, Asset Impairments and Disposals include $21.4 million for intangible asset impairments,
$10.9 million for fixed asset abandonments, and $1.1 million primarily in connection with the write-off of prepaid
contract costs. The total $10.9 million of expense included in other expense, net in the accompanying consolidated
statements of income is composed of $8.3 million associated with an impairment of an equity method investment and
a disposal of goodwill of $2.6 million.
The following table summarizes the cash components of the restructuring activity.
(in thousands)
Costs incurred in 2016
Payments
Facility deferred rent reclassified to restructuring
Foreign currency translation adjustment
Liability at December 31, 2016
Additional costs in 2017
Release of excess accrual
Payments
Facility deferred rent reclassified to restructuring
Foreign currency translation adjustment
Personnel Related
Facility Related
Contract and Other
Costs
$ 21,252
(2,742)
—
(30)
$ 18,480
13,357
(3,083)
(25,586)
—
1,126
$ 7,165
(601)
1,326
(8)
$ 7,882
1,798
(1,448)
(7,478)
241
57
$ 8,315
(2,391)
—
19
Total
$ 36,732
(5,734)
1,326
(19)
$ 5,943
$ 32,305
9,883
(30)
(14,887)
—
157
25,038
(4,561)
(47,951)
241
1,340
Liability at December 31, 2017
$ 4,294
$ 1,052
$ 1,066
$ 6,412
At December 31, 2017, $5.6 million of the liability is included in accrued and other current liabilities and $0.8
million is included in other-long term liabilities in the accompanying consolidated balance sheet. At December 31,
2016, $27.6 million of the liability is included in accrued and other current liabilities and $4.7 million is included in
other long-term liabilities in the accompanying consolidated balance sheet.
2014 Restructuring
During the fourth quarter of 2014, we recorded restructuring charges in connection with the acquisition of
Enzymatics and from the implementation of headcount reductions and facility consolidations to further streamline
operations and various measures as part of a commitment to continuous improvement and related to QIAGEN's
strategic focus on its five growth drivers. No additional costs were incurred subsequent to 2014 related to this
program.
The following table summarizes the components of the restructuring costs.
(in thousands)
Personnel Related
Facility Related
Contract and Other
Costs
Balance at December 31, 2014
Payments
Release of excess accrual
Foreign currency translation adjustment
Balance at December 31, 2015
Payments
Release of excess accrual
Foreign currency translation adjustment
Balance at December 31, 2016
$ 6,341
(4,789)
(453)
(630)
$ 469
(143)
(325)
(1)
$ —
$ 7,627
(4,199)
—
—
$ 3,428
(3,428)
—
—
$ —
$ 652
(418)
(20)
—
$ 214
(214)
—
—
$ —
Total
$ 14,620
(9,406)
(473)
(630)
$ 4,111
(3,785)
(325)
(1)
$ —
7. Short-Term Investments
At December 31, 2017 and 2016, we had $359.2 million and $89.3 million, respectively, of loan receivables and
commercial paper due from financial institutions. These loan receivables and commercial paper are non-derivative
financial assets with fixed or determinable payments that are not quoted in an active market and are carried at fair
market value, which is equal to the cost. At December 31, 2017, these loans consist of $308.2 million and €42.5
million ($51.0 million as of December 31, 2017) which mature at various dates through December 2018. All
instruments that have an original tenor of more than 12 months include redemption rights on at least a quarterly
basis. Interest income is determined using the effective interest rate method. These loans are classified as current
assets in the accompanying consolidated balance sheets since we may redeem the loans at our discretion.
At December 31, 2016, we had €3.5 million ($3.7 million) in term deposits which matured in August 2017. The
deposits could be withdrawn at the end of each quarter without penalty and were therefore classified as current
assets in the accompanying consolidated balance sheets.
For the years ended December 31, 2017, 2016 and 2015, proceeds from sales of short term investments totaled
$189.0 million, $533.8 million and $367.7 million, respectively. During the years ended December 31, 2017 and
2016, realized gains totaled $1.1 million and $1.4 million, respectively. During the year ended December 31,
2015, realized losses totaled $6.0 million.
8. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets are summarized as follows as of December 31, 2017 and 2016:
(in thousands)
Prepaid expenses
Cash collateral
Value added tax
Other receivables
Fair value of derivative instruments
2017
$ 41,775
21,907
17,870
15,902
9,033
2016
$ 35,529
1,200
14,985
9,699
5,386
Total prepaid expenses and other current assets
$ 106,487
$ 66,799
9. Property, Plant and Equipment
Property, plant and equipment, including equipment acquired under capital lease obligations, are summarized as
follows as of December 31, 2017 and 2016:
(in thousands)
Land
Buildings and improvements
Machinery and equipment
Computer software
Furniture and office equipment
Construction in progress
Less: Accumulated depreciation and amortization
Property, plant and equipment, net
Estimated useful life
—
5-40
3-10
3-7
3-10
—
2017
$ 18,188
328,938
299,175
243,809
103,257
65,542
1,058,909
(564,588)
$ 494,321
2016
$ 16,327
301,092
257,349
176,227
89,560
47,260
887,815
(451,160)
$ 436,655
Amortization of assets acquired under capital lease obligations is included within accumulated depreciation and
amortization above for the years ended December 31, 2017 and 2016, respectively. For the years ended
December 31, 2017, 2016 and 2015 depreciation and amortization expense totaled $82.5 million, $75.1 million
and $59.5 million, respectively. For the years ended December 31, 2017, 2016 and 2015 amortization related to
computer software to be sold, leased or marketed totaled $13.9 million, $9.3 million and $5.1 million, respectively.
In 2016, we recorded asset impairment charges of $10.9 million related to the restructuring charge discussed in
Note 6. Impairments included $7.5 million of computer software to be sold, leased or marketed, $1.7 million in
machinery and equipment, $1.5 million in internal-use software, $0.1 million in furniture and office equipment and
$0.1 million in buildings and improvements. In 2015, we recorded asset impairment charges of $3.1 million, of
which $1.0 million related to computer software to be sold, leased or marketed related to the abandonment of
certain projects following the acquisition of MO BIO.
Repairs and maintenance expense was $12.7 million, $13.0 million and $15.4 million in 2017, 2016 and 2015,
respectively. For the year ended December 31, 2017 and 2016, construction in progress primarily includes amounts
related to ongoing software development projects. For the years ended December 31, 2017, 2016 and 2015,
interest capitalized in connection with construction projects was not significant.
10. Investments
We have made strategic investments in certain companies that are accounted for using the equity or cost method of
accounting. The method of accounting for an investment depends on the level of influence. We monitor changes in
circumstances that may require a reassessment of the level of influence. We periodically review the carrying value of
these investments for impairment, considering factors such as the most recent stock transactions and book values from
the recent financial statements. The fair value of cost and equity-method investments is estimated when there are
identified events or changes in circumstances that may have an impact on the fair value of the investment.
Additionally, we have investments in marketable equity securities that have readily determinable fair values that are
classified as available-for-sale. These investments are reported at fair value, with unrealized gains and losses
recorded in accumulated other comprehensive income (loss) in equity.
Equity Method Investments
A summary of these equity method investments, which are included in other long-term assets in the consolidated
balance sheets, is as follows:
($ in thousands)
PreAnalytiX GmbH
Biotype Innovation GmbH
MAQGEN Biotechnology Co., Ltd
Pyrobett
Hombrechtikon Systems Engineering AG
QIAGEN (Suzhou) Institute of Translation
Research Co., Ltd.
QIAGEN Finance
100.00 %
Equity investments
as of December 31,
Share of income
(loss)for the years ended December 31,
Ownership
Percentage
2017
2016
2017
2016
2015
50.00 %
$ 7,562
$ 3,519
$ 3,818
$ 3,067
$ 1,878
24.90 %
40.00 %
19.00 %
19.00 %
0.00 %
3,821
3,285
2,639
1,155
—
—
3,339
—
2,444
1,524
—
—
39
(542)
195
(346)
—
—
(335)
—
333
—
(244)
(595)
—
(600)
—
(107)
—
85
$ 18,462
$ 10,826
$ 3,164
$ 2,821
$ 661
During 2017, we acquired a 40% interest in MAQGEN Biotechnology Co., Ltd. for $4.0 million and a commitment
to contribute an additional $8.0 million in future periods. Also, during 2017, we sold our interest in QIAGEN
(Suzhou) Institute of Translation Research Co., Ltd., which had no book value at the time of sale, for $3.5 million and
recorded a corresponding gain in other expense, net in the accompanying statement of income.
In connection with the 2016 restructuring activities discussed in Note 6, in 2016 we transferred the research and
development activities of our instrumentation business to a new company, Hombrechtikon Systems Engineering AG
(HSE), in which we acquired a 19.0% interest for a total obligation of $9.8 million payable over three years. As of
December 31, 2017 and 2016, $3.1 million and $3.9 million, respectively, were included in accrued and other
current liabilities and $3.1 million and $5.9 million, respectively, were included in other long-term liabilities in the
accompanying consolidated balance sheet. HSE is a variable interest entity and we are not the primary beneficiary
as we do not hold the power to direct the activities that most significantly impact the economic performance of HSE.
Therefore, HSE is not consolidated. In 2016, we recorded an impairment of the investment in HSE of $8.3 million in
other expense, net. As of December 31, 2017 and 2016, the investment had a carrying value of $1.2 million and
$1.5 million, respectively, which is included in other long-term assets in the consolidated balance sheets,
representing our maximum exposure to loss.
We had a 100% interest in QIAGEN Finance (Luxembourg) S.A. (QIAGEN Finance) which was established for the
purpose of issuing convertible debt in 2004. The proceeds of the 2004 Notes were loaned to subsidiaries within the
consolidated QIAGEN N.V. group. QIAGEN N.V. had guaranteed the 2004 Notes, and had agreements with
QIAGEN Finance to issue common shares to the investors in the event of conversion of the 2004 Notes. QIAGEN
Finance was a variable interest entity. We did not hold any variable interests in QIAGEN Finance, and we were not
the primary beneficiary, therefore QIAGEN Finance was not consolidated. Accordingly, the 2004 convertible debt
was not included in the consolidated statements of QIAGEN N.V., though QIAGEN N.V. did report the full
obligation of the debt through its liabilities to QIAGEN Finance. QIAGEN N.V. accounted for its investment in
QIAGEN Finance as an equity investment until the first quarter of 2015 and accordingly recorded 100% of the profit
or loss of QIAGEN Finance in the gain or loss from equity method investees. During the first quarter of 2015, we
repaid the $250.9 million loan to QIAGEN Finance and repurchased the warrant agreement with QIAGEN Finance.
Cost Method Investments
At December 31, 2017 and 2016, we had a total of cost-method investments in non-publicly traded companies with
carrying amounts of $33.6 million and $38.2 million, respectively, which are included in other long-term assets in
the consolidated balance sheets. The fair-value of these cost-method investments are not estimated unless there are
identified events or changes in circumstances that may have a significant adverse effect on the fair value of the
investment. During the years ended December 31, 2017, and 2016, we made cost-method investments totaling $0.3
million, and $20.5 million, respectively. In 2017 and 2015, we recorded total impairments to cost method
investments of $5.1 million and $2.2 million, respectively, in other expense, net. In 2016, we converted a $0.6
million short-term loan into additional ownership interest of a cost-method investment.
Marketable Equity Securities
During 2016, we made an investment in HTG Molecular Diagnostics, Inc. (HTGM), a publicly traded company. At
December 31, 2017, we held 833,333 shares with a cost basis of $2.0 million. As of December 31, 2017 and
2016, the fair market value of these shares was $1.7 million and $1.9 million, respectively. During 2017, we
purchased a convertible loan from HTGM as further discussed in Note 22. Additionally, our former cost-method
investment in Curetis AG was reclassified as a long-term marketable security during 2015 upon the completed IPO of
its Dutch holding company, Curetis N.V. At December 31, 2017, we hold 320,424 shares of Curetis N.V. with a
cost basis of $2.3 million and a fair market value of $1.5 million. We held 320,712 shares with a cost basis of
$2.3 million and a fair value of $2.2 million as of December 31, 2016. These marketable securities are included in
other long-term assets in the accompanying consolidated balance sheets.
11. Goodwill and Intangible Assets
The following sets forth the intangible assets by major asset class as of December 31, 2017 and 2016:
($ in thousands)
Amortized Intangible Assets:
Patent and license rights
Developed technology
Customer base, trademarks, and non-compete
agreements
Unamortized Intangible Assets:
Goodwill
2017
2016
Weighted
Average Life
Gross Carrying
Amount
Accumulated
Amortization
Gross Carrying
Amount
Accumulated
Amortization
9.41
$ 407,635
$ (280,434)
$ 373,609
$ (233,406)
11.82
10.28
771,893
(544,633)
708,825
(469,312)
437,213
(292,356)
422,797
(245,354)
10.76
$ 1,616,741
$ (1,117,423)
$ 1,505,231
$ (948,072)
$ 2,012,904
$ 1,925,518
The changes in intangible assets for the years ended December 31, 2017 and 2016 are as follows:
(in thousands)
BALANCE AT DECEMBER 31, 2015
Additions
Purchase adjustments
Additions from acquisitions
Amortization
Disposals
Impairment losses
Foreign currency translation adjustments
BALANCE AT DECEMBER 31, 2016
Additions
Additions from acquisitions
Amortization
Disposals
Foreign currency translation adjustments
BALANCE AT DECEMBER 31, 2017
Intangibles
$ 636,421
70,937
(321)
23,700
(137,949)
(29)
(21,423)
(14,177)
Goodwill
$ 1,875,698
—
316
76,807
—
(2,650)
—
(24,653)
$ 557,159
$ 1,925,518
15,527
28,700
(133,797)
(897)
32,626
—
26,934
—
—
60,452
$ 499,318
$ 2,012,904
Amortization expense on intangible assets totaled approximately $133.8 million, $137.9 million and $132.0
million, respectively, for the years ended December 31, 2017, 2016 and 2015.
In 2016, we recorded an intangible asset abandonment charge of $21.4 million related to the discontinuation of
existing technologies in connection with the 2016 restructuring discussed more fully in Note 6. Of this abandonment
charge, $10.3 million is included in cost of sales and $11.1 million is included in general and administrative,
restructuring, integration and other in the accompanying consolidated statements of income.
Cash paid for purchases of intangible assets during the year ended December 31, 2017 totaled $34.3 million, of
which $16.5 million is related to current year payments for licenses that were accrued as of December 31, 2016
and $5.8 million is related to prepayments recorded in other long-term assets in the accompanying consolidated
balance sheet. Intangible asset additions of $15.5 million includes $12.0 million of cash paid during the year ended
December 31, 2017, together with $3.5 million of additions which were previously recorded as prepayments. Cash
paid for intangible assets during the year ended December 31, 2016 totaled $19.4 million of which $3.9 million is
related to prepayments recorded in other long-term assets in accompanying consolidated balance sheet. Intangible
asset additions of $70.9 million includes $15.5 million of cash paid during the year ended December 31, 2016,
together with $7.1 million of additions which were previously recorded as prepayments and $48.4 million of
additions which were accrued as of December 31, 2016. Of the accrued additions in 2016, $46.3 million related
to licenses for which fixed payments are expected to occur through the end of the license term in 2024.
The changes in the carrying amount of goodwill during the years ended December 31, 2017 and 2016 resulted
primarily from changes in foreign currency translation together with acquired goodwill from the 2017 acquisition of
OmicSoft and the 2016 acquisition of Exiqon discussed in Note 5. Additionally, $2.6 million of goodwill was
disposed of in connection with the transfer of the research and development activities of our instrumentation business
as part of the 2016 restructuring program discussed in Note 6.
Amortization of intangibles for the next five years is expected to be approximately:
(in thousands)
Years ended December 31:
2018
2019
2020
2021
2022
12. Accrued and Other Current Liabilities
Accrued and other current liabilities at December 31, 2017 and 2016 consist of the following:
(in thousands)
Accrued expenses and other liabilities
Payroll and related accruals
Deferred revenue
Restructuring
Accrued contingent consideration and milestone payments
Accrued royalties
Accrued interest on long-term debt
Cash collateral
Fair value of derivative instruments
Current portion of capital lease obligations
Total accrued and other current liabilities
13. Derivatives and Hedging
Amortization
$ 114,009
$ 92,717
$ 65,503
$ 56,214
$ 40,692
2016
$ 74,245
54,772
44,629
27,590
2,957
7,801
4,239
6,984
6,089
999
2017
$ 85,986
63,525
49,357
14,667
11,539
6,714
5,543
3,000
2,424
1,359
$ 244,114
$ 230,305
In the ordinary course of business, we use derivative instruments, including swaps, forwards and/or options, to
manage potential losses from foreign currency exposures and interest bearing assets or liabilities. The principal
objective of such derivative instruments is to minimize the risks and/or costs associated with our global financial and
operating activities. We do not utilize derivative or other financial instruments for trading or other speculative
purposes. We recognize all derivatives as either assets or liabilities on the balance sheet on a gross basis, measure
those instruments at fair value and recognize the change in fair value in earnings in the period of change, unless the
derivative qualifies as an effective hedge that offsets certain exposures. We have agreed with almost all of our
counterparties with whom we had entered into cross-currency swaps, interest rate swaps or foreign exchange
contracts, to enter into bilateral collateralization contracts under which we will receive or provide cash collateral, as
the case may be, for the net position with each of these counterparties. As of December 31, 2017, cash collateral
positions consisted of $3.0 million recorded in accrued and other current liabilities and $21.9 million recorded in
prepaid and other current assets in the accompanying consolidated balance sheet. As of December 31, 2016, we
had a liability position of $7.0 million recorded in accrued and other current liabilities and $1.2 million recorded in
prepaid expenses and other current assets in the accompanying consolidated balance sheet.
In 2017, we entered into a foreign currency non-derivative hedging instrument that is designated and qualifies as net
investment hedge. The objective of the hedge is to protect part of the net investment in foreign operations against
adverse changes in the exchange rate between the Euro and the functional currency of the U.S. dollar. The non-
derivative hedging instrument is the German private corporate bond ("Schuldschein") which was issued in the total
amount of $331.1 million as described in Note 15. Of the $331.1 million, which is held in both U.S. dollars and
Euro, €255.0 million is designated as the hedging instrument against a portion of our Euro net investments in our
foreign operations. The relative changes in both the hedged item and hedging instrument are calculated by applying
the change in spot rate between two assessment dates against the respective notional amount. The effective portion
of the hedge is recorded in the cumulative translation adjustment account within other accumulated comprehensive
income (loss). Based on the spot rate method, the unrealized loss recorded in equity as of December 31, 2017 is
$19.8 million. Since we are using the debt as the hedging instrument, which is also remeasured based on the spot
rate method, there is no hedge ineffectiveness related to the net investment hedge as of December 31, 2017.
As of December 31, 2017 and 2016, we held derivative instruments that are designated and qualify as cash flow
hedges where the effective portion of the gain or loss on the derivative is reported as a component of other
comprehensive income (loss) and reclassified into earnings in the same period or periods during which the hedged
transaction affects earnings. Gains and losses on the derivative representing either hedge ineffectiveness or hedge
components excluded from the assessment of effectiveness are recognized in current earnings. In 2017 and in 2016,
we did not record any hedge ineffectiveness related to any cash-flow hedges in earnings. Based on their valuation as
of December 31, 2017, we expect approximately $10.7 million of derivative losses included in accumulated other
comprehensive loss will be reclassified into income during the next 12 months. The cash flows derived from
derivatives are classified in the consolidated statements of cash flows in the same category as the consolidated
balance sheet account of the underlying item.
As of December 31, 2017 and 2016, we held derivative instruments that qualify for hedge accounting as fair value
hedges. For derivative instruments that are designated and qualify as a fair value hedge, the effective portion of the
gain or loss on the derivative is reflected in earnings. This earnings effect is offset by the change in the fair value of
the hedged item attributable to the risk being hedged that is also recorded in earnings. In 2017 and 2016, we
concluded there was no ineffectiveness. The cash flows derived from derivatives are classified in the consolidated
statements of cash flows in the same category as the consolidated balance sheet account of the underlying item.
Interest Rate Derivatives
We use interest rate derivative contracts to align our portfolio of interest bearing assets and liabilities with our risk
management objectives. During 2015, we entered into five cross currency interest rate swaps through 2025 for a
total notional amount of $180.0 million which qualify for hedge accounting as cash flow hedges. We determined
that no ineffectiveness exists related to these swaps. As of December 31, 2017, the €180.0 million notional swap
amount had a fair value of $28.9 million recorded in other-long term liabilities and a related interest receivable of
$1.2 million recorded in prepaid and other current assets, respectively, in the accompanying consolidated balance
sheet. As of December 31, 2016, this swap had a fair value of $1.4 million and accrued and unpaid interest of
$1.7 million which recorded in other long-term assets and prepaid expenses and other current assets, respectively, in
the accompanying consolidated balance sheet.
During 2014, we entered into interest rate swaps, which effectively fixed the fair value of $200.0 million of our fixed
rate private placement debt and qualify for hedge accounting as fair value hedges. We determined that no
ineffectiveness exists related to these swaps. As of December 31, 2017, the $200.0 million notional swap amount
had a fair value of $0.9 million and accrued and unpaid interest of $0.3 million which are recorded in other long-
term assets and prepaid and other current assets, respectively, in the accompanying consolidated balance sheet. As
of December 31, 2016, this swap had a fair value of $3.1 million and accrued and unpaid interest of $0.6 million
which are recorded in other long-term assets and prepaid expenses and other current assets, respectively, in the
accompanying balance sheet.
Call Options
We entered into Call Options in 2014 which, along with the sale of the Warrants, represent the Call Spread
Overlay entered in connection with the 2019 and 2021 Cash Convertible Notes, which are more fully described in
Note 15. We used $105.2 million of the proceeds from the issuance of the 2019 and 2021 Cash Convertible Notes
to pay the premium for the Call Options, and simultaneously received $68.9 million (net of issuance costs) from the
sale of the Warrants, for a net cash outlay of $36.3 million for the Call Spread Overlay.
During 2017, we used $73.6 million of the proceeds from the from the issuance of the 2023 Cash Convertible
Notes to pay for the premium for the Call Option, and simultaneously received $45.4 million from the sale of
Warrants, for a net cash outlay of $28.3 million for the Call Spread Overlay. Issuance costs incurred in connection
with the Warrant and the Call Option were $0.3 million and $0.1 million respectively, which $0.1 million was
accrued as of December 31, 2017.
In both transactions, the Call Options are intended to address the equity price risk inherent in the cash conversion
feature of each instrument by offsetting cash payments in excess of the principal amount due upon any conversion of
the Cash Convertible Notes.
Aside from the initial payment of a premium of $105.2 million (2019 and 2021 Notes) and $73.6 million (2023
notes) for the Call Options, we will not be required to make any cash payments under the Call Options. We will,
however, be entitled to receive under the terms of the Call Options an amount of cash generally equal to the amount
by which the market price per share of our common stock exceeds the exercise price of the Call Options during the
relevant valuation period. The exercise price under the Call Options is equal to the conversion price of the Cash
Convertible Notes.
The Call Options, for which our common stock is the underlying security, are a derivative asset that requires mark-to-
market accounting treatment due to the cash settlement features until the Call Options settle or expire. The Call
Options are measured and reported at fair value on a recurring basis, within Level 2 of the fair value hierarchy. For
further discussion of the inputs used to determine the fair value of the Call Options, refer to Note 14. The fair value of
the Call Options at December 31, 2017 and 2016 was approximately $223.2 million and $185.8 million,
respectively which is recorded in other long-term assets in the accompanying consolidated balance sheet.
The Call Options do not qualify for hedge accounting treatment. Therefore, the change in fair value of these
instruments is recognized immediately in our consolidated statements of income in other expense, net. For the years
ended December 31, 2017 and 2016, the changes in the fair value of the Call Options resulted in gains of $37.4
million and $16.7 million, respectively. Because the terms of the Call Options are substantially similar to those of the
Cash Convertible Notes' embedded cash conversion option, discussed below, we expect the effect on earnings from
those two derivative instruments to mostly offset each other.
Cash Convertible Notes Embedded Cash Conversion Option
The embedded cash conversion option within the Cash Convertible Notes is required to be separated from the Cash
Convertible Notes and accounted for separately as a derivative liability, with changes in fair value reported in our
consolidated statements of income in other expense, net until the cash conversion option settles or expires. For further
discussion of the Cash Convertible Notes, refer to Note 15. The initial fair value liability of the embedded cash
conversion option for the 2019 and 2021 Notes was $105.2 million and for the 2023 Notes was $74.5 million,
which simultaneously reduced the carrying value of the Cash Convertible Notes (effectively an original issuance
discount). The embedded cash conversion option is measured and reported at fair value on a recurring basis, within
Level 2 of the fair value hierarchy. For further discussion of the inputs used to determine the fair value of the
embedded cash conversion options, refer to Note 14. The fair value of the embedded cash conversion options at
December 31, 2017 and 2016 was approximately $224.3 million and $187.5 million, respectively, which is
recorded in other long-term liabilities in the accompanying balance sheet. For the years ended December 31, 2017
and 2016 the change in the fair value of the embedded cash conversion options resulted in losses of $36.7 million
and $16.6 million, respectively, recognized in our consolidated statements of income in other expense, net.
Foreign Currency Derivatives
As a globally active enterprise, we are subject to risks associated with fluctuations in foreign currencies in our
ordinary operations. This includes foreign currency-denominated receivables, payables, debt, and other balance
sheet positions including intercompany items. We manage balance sheet exposure on a group-wide basis using
foreign exchange forward contracts, foreign exchange options and cross-currency swaps.
Undesignated Derivative Instruments
We are party to various foreign exchange forward, option and swap arrangements which had, at December 31,
2017, an aggregate notional value of $587.3 million and fair values of $7.5 million and $2.4 million included in
prepaid and other current assets and accrued and other current liabilities, respectively, which expire at various dates
through March 2018. We were party to various foreign exchange forward and swap arrangements which had, at
December 31, 2016, an aggregate notional value of $347.6 million and fair values of $3.2 million and $6.1
million included in prepaid and other current assets and accrued and other current liabilities, respectively, which
expired at various dates through December 2017. The transactions have been entered into to offset the effects from
short-term balance sheet exposure to foreign currency exchange risk. Changes in the fair value of these arrangements
have been recognized in other expense, net.
Fair Values of Derivative Instruments
The following table summarizes the fair value amounts of derivative instruments reported in the consolidated balance
sheets as of December 31, 2017 and 2016:
($ in thousands)
Derivatives in Asset Positions Fair value
Derivatives in Liability Positions Fair value
2017
2016
2017
2016
Derivative instruments designated as hedges
Interest rate contracts
Total derivative instruments designated as hedges
Undesignated derivative instruments
Call spread overlay
Foreign exchange contracts
Total derivative instruments
$ 2,409
$ 2,409
$ 6,655
$ (28,942)
$ 6,655
$ (28,942)
$ —
$ —
$ 223,164
$ 185,750
$ (224,286)
$ (187,546)
7,480
3,154
(2,424)
(6,089)
$ 230,644
$ 188,904
$ (226,710)
$ (193,635)
The following tables summarize the classification and gains and losses on derivative instruments for the years ended
December 31, 2017, 2016 and 2015:
Year-Ended December 31, 2017 (in thousands)
Non-derivative instruments
Net investment hedge
Gain/(loss)
recognized in
AOCI
Location of (gain) loss
in income statement
(Gain) loss reclassified
from AOCI into income
Gain (loss)
recognized in
income
$ (19,757)
Other expense, net
$ —
n/a
Year-Ended December 31, 2016 (in thousands)
Gain/(loss)
recognized in
AOCI
Location of (gain) loss
in income statement
(Gain) loss reclassified
from AOCI into income
Cash flow hedges
Interest rate contracts
Fair value hedges
Interest rate contracts
Undesignated derivative instruments
Call spread overlay
Foreign exchange contracts
Cash flow hedges
Interest rate contracts
Fair value hedges
Interest rate contracts
Undesignated derivative instruments
Call spread overlay
Foreign exchange contracts
$ (30,310)
Other expense, net
$ 26,136
n/a
$ —
Other expense, net
$ —
$ (2,199)
n/a
n/a
Other expense, net
Other expense, net
n/a
n/a
$ (3,969)
Other expense, net
$ (6,228)
n/a
$ —
Other expense, net
$ —
$ (1,930)
n/a
n/a
Other expense, net
Other expense, net
n/a
n/a
$ 1,573
11,813
$ 13,386
Gain (loss)
recognized in
income
$ 118
(6,072)
$ (5,954)
Gain (loss)
recognized in
income
Year-Ended December 31, 2015 (in thousands)
Gain/(loss)
recognized in
AOCI
Location of (gain) loss
in income statement
(Gain) loss reclassified
from AOCI into income
Cash flow hedges
Interest rate contracts
Fair value hedges
Interest rate contracts
Undesignated derivative instruments
Call spread overlay
Foreign exchange contracts
$ 5,337
Other expense, net
$ (5,273)
n/a
$ —
Other expense, net
$ —
$ 1,691
n/a
n/a
Other expense, net
Other expense, net
n/a
n/a
$ (171)
$ 21,434
$ 21,263
The amounts noted in the table above for accumulated other comprehensive income (AOCI) do not include any
adjustment for the impact of deferred income taxes.
14. Fair Value Measurements
Assets and liabilities are measured at fair value according to a three-tier fair value hierarchy which prioritizes the
inputs used in measuring fair value as follows:
Level 1. Observable inputs, such as quoted prices in active markets;
Level 2. Inputs, other than the quoted price in active markets, that are observable either directly or indirectly; and
Level 3. Unobservable inputs in which there is little or no market data, which require the reporting entity to develop
its own assumptions.
Our assets and liabilities measured at fair value on a recurring basis consist of short-term investments, which are
classified in Level 1 and Level 2 of the fair value hierarchy, marketable securities discussed in Note 10, which are
classified in Level 1, derivative contracts used to hedge currency and interest rate risk and derivative financial
instruments entered into in connection with the Cash Convertible Notes discussed in Note 15, which are classified in
Level 2 of the fair value hierarchy, and contingent consideration accruals which are classified in Level 3 of the fair
value hierarchy, and are shown in the tables below. There have been no transfers between levels.
In determining fair value for Level 2 instruments, we apply a market approach, using quoted active market prices
relevant to the particular instrument under valuation, giving consideration to the credit risk of both the respective
counterparty to the contract and the Company. To determine our credit risk, we estimated our credit rating by
benchmarking the price of outstanding debt to publicly-available comparable data from rated companies. Using the
estimated rating, our credit risk was quantified by reference to publicly-traded debt with a corresponding rating. The
Level 2 derivative financial instruments include the Call Options asset and the embedded conversion option liability.
See Note 15, "Lines of Credit and Debt", and Note 13, "Derivatives and Hedging", for further information. The
derivatives are not actively traded and are valued based on an option pricing model that uses observable market
data for inputs. Significant market data inputs used to determine fair values included our common stock price, the
risk-free interest rate, and the implied volatility of our common stock. The Call Options asset and the embedded cash
conversion option liability were designed with the intent that changes in their fair values would substantially offset,
with limited net impact to our earnings. Therefore, the sensitivity of changes in the unobservable inputs to the option
pricing model for such instruments is substantially mitigated.
Our Level 3 instruments include contingent consideration liabilities. We value contingent consideration liabilities
using unobservable inputs, applying the income approach, such as the discounted cash flow technique, or the
probability-weighted scenario method. Contingent consideration arrangements obligate us to pay the sellers of an
acquired entity if specified future events occur or conditions are met such as the achievement of technological or
revenue milestones. We use various key assumptions, such as the probability of achievement of the milestones (0% to
100%) and the discount rate (between 2.2% and 7.7%), to represent the non-performing risk factors and time value
when applying the income approach. We regularly review the fair value of the contingent consideration, and reflect
any change in the accrual in the consolidated statements of income in the line items commensurate with the
underlying nature of milestone arrangements.
The following table presents our fair value hierarchy for our financial assets and liabilities measured at fair value on
a recurring basis:
As of December 31, 2017
As of December 31, 2016
(in thousands)
Level 1
Level 2
Level 3
Total
Level 1
Level 2
Level 3
Total
Assets:
Short-term investments
$ —
$ 359,198
$ —
$ 359,198
$ 3,699
$ 89,300
$ —
$ 92,999
Marketable securities
3,208
—
—
—
—
223,164
7,480
2,409
—
—
—
—
3,208
4,064
—
223,164
7,480
2,409
—
—
—
185,750
3,154
6,655
—
—
—
—
4,064
185,750
3,154
6,655
$ 3,208
$ 592,251
$ —
$ 595,459
$ 7,763
$ 284,859
$ —
$ 292,622
Call option
Foreign exchange
Interest rate contracts
Liabilities:
Foreign exchange
$ —
$ (2,424)
$ —
$ (2,424)
$ —
$ (6,089)
$ —
$ (6,089)
Interest rate contracts
Cash conversion option
Contingent consideration
—
—
—
(28,942)
(224,286)
—
—
(28,942)
(224,286)
—
(11,539)
(11,539)
$ —
$ (255,652)
$ (11,539)
$ (267,191)
—
—
—
—
—
(187,546)
—
—
—
(187,546)
—
(8,754)
(8,754)
$ (193,635)
$ (8,754)
$ (202,389)
For liabilities with Level 3 inputs, the following table summarizes the activity for the years ended December 31, 2017
and 2016:
(in thousands)
BALANCE AT DECEMBER 31, 2015
Additions from acquisitions
Payments
Gain included in earnings
Foreign currency translation adjustments
BALANCE AT DECEMBER 31, 2016
Additions
Payments
Gain included in earnings
BALANCE AT DECEMBER 31, 2017
Contingent Consideration
$ (17,678)
(692)
3,120
6,501
(5)
$ (8,754)
(10,954)
4,900
3,269
$ (11,539)
For the year ended December 31, 2017, the total $11.5 million accrued for contingent consideration is accrued and
other current liabilities. During 2017 and 2016, gains for the reduction in the fair value of contingent consideration
related to unmet milestones of $3.3 million and $6.5 million were recognized in general and administrative,
restructuring, integration and other in the accompanying consolidated statements of income.
The carrying values of financial instruments, including cash and cash equivalents, accounts receivable, accounts
payable and other accrued liabilities, approximate their fair values due to their short-term maturities. The estimated
fair value of long-term debt as disclosed in Note 15 was based on current interest rates for similar types of
borrowings. The estimated fair values may not represent actual values of the financial instruments that could be
realized as of the balance sheet date or that will be realized in the future. There were no fair value differences in the
years ended December 31, 2017 and 2016 for nonfinancial assets or liabilities required to be measured at fair
value on a nonrecurring basis other than the impairment of cost-method investments as discussed in Note 10.
15. Lines of Credit and Debt
Our credit facilities available and undrawn at December 31, 2017 total €426.6 million (approximately $511.6
million). This includes a €400.0 million syndicated multi-currency revolving credit facility expiring December 2021 of
which no amounts were utilized at December 31, 2017 or at December 31, 2016, and four other lines of credit
amounting to €26.6 million with no expiration date, none of which were utilized as of December 31, 2017 or as of
December 31, 2016. The €400.0 million facility can be utilized in Euro, British pounds sterling, Swiss franc or U.S.
dollar and bears interest of 0.4% to 1.2% above three months EURIBOR, or LIBOR in relation to any loan not in euro,
and is offered with interest periods of one, two, three or six months. The commitment fee is calculated based on 35%
of the applicable margin. In 2017 and 2016, $0.9 million and $1.0 million of commitment fees were paid,
respectively. The revolving facility agreement contains certain financial and non-financial covenants, including but
not limited to, restrictions on the encumbrance of assets and the maintenance of certain financial ratios. We were in
compliance with these covenants at December 31, 2017. The credit facilities are for general corporate purposes.
At December 31, 2017 and December 31, 2016, total long-term debt, net of debt issuance costs of $12.4 million
and $8.1 million, respectively, consists of the following:
(in thousands)
0.375% Senior Unsecured Cash Convertible Notes due
2019
0.875% Senior Unsecured Cash Convertible Notes due
2021
0.500% Senior Unsecured Cash Convertible Notes due
2023
3.19% Series A Senior Notes due October 16, 2019
3.75% Series B Senior Notes due October 16, 2022
3.90% Series C Senior Notes due October 16, 2024
Schuldschein Private Placement
Total long-term debt
2017
2016
$ 414,843
$ 402,806
270,762
322,902
72,742
300,276
26,921
349,812
262,371
—
73,408
301,601
26,910
—
$ 1,758,258
$ 1,067,096
The notes are all unsecured obligations that rank pari passu. Interest expense on long-term debt was $43.6 million,
$35.8 million and $34.5 million for the years ended December 31, 2017, 2016 and 2015, respectively.
Future maturities (stated at the carrying values) of long-term debt as of December 31, 2017 are as follows:
Year ending December 31,
2018
2019
2020
2021
2022
thereafter
(in thousands)
$ —
487,585
—
311,743
479,070
479,860
$ 1,758,258
Cash Convertible Notes due 2019, 2021 and 2023
On March 19, 2014, we issued $730.0 million aggregate principal amount of Cash Convertible Senior Notes of
which $430.0 million is due in 2019 (2019 Notes) and $300.0 million is due in 2021 (2021 Notes). The
aggregate net proceeds of the 2019 and 2021 Convertible Notes were $680.7 million, after payment of the net
cost of the Call Spread Overlay described below and transaction costs. Additionally, we used $372.5 million of the
net proceeds to repay other debt.
On September 13, 2017, we issued $400.0 million aggregate principal amount of Cash Convertible Senior Notes
which is due in 2023 (2023 Notes). The net proceeds of the 2023 Notes were $365.9 million, after payment of the
net cost of the Call Spread Overlay described below and transaction costs paid through December 31, 2017.
We refer to the 2019 Notes, 2021 Notes and 2023 Notes, collectively as the “Cash Convertible Notes”. Interest on
the Cash Convertible Notes is payable semi-annually in arrears on March 19 and September 19 of each year, at
rates of 0.375%, 0.875% and 0.500% per annum for the 2019 Notes, 2021 Notes and 2023 Notes respectively,
commencing on September 19, 2014 for the 2019 Notes and 2021 Notes and March 13, 2018 for the 2023
Notes. The 2019 Notes will mature on March 19, 2019, the 2021 Notes will mature on March 19, 2021 and the
2023 Notes will mature on September 13, 2023 unless repurchased or converted in accordance with their terms
prior to such date.
The Cash Convertible Notes are solely convertible into cash in whole, but not in part, at the option of noteholders in
the following circumstances: (a) from April 29, 2014 through September 18, 2018 for the 2019 Notes, and
September 18, 2020 for the 2021 Notes and from October 24, 2017 through March 13, 2023 for the 2023 Notes
(Contingent Conversion Period), under any of the Contingent Conversion Conditions and (b) at any time following
the Contingent Conversion Period through the fifth business day immediately preceding the applicable maturity Date.
Upon conversion, noteholders will receive an amount in cash equal to the Cash Settlement Amount, calculated as
described below. The Cash Convertible Notes are not convertible into shares of our common stock or any other
securities.
Noteholders may convert their 2019 and 2021 Cash Convertible Notes into cash at their option at any time during
the Contingent Conversion Period only under the following circumstances (Contingent Conversion Conditions):
during any calendar quarter commencing after the calendar quarter ending on March 31, 2014 (and only during
such calendar quarter), if the last reported sale price of our common stock for at least 20 trading days (whether or
not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately
preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading
day;
if we undergo certain fundamental changes as defined in the agreement;
during the 5 business day period immediately after any 10 consecutive trading day period in which the quoted
price for the 2019 Notes or the 2021 Notes for each trading day of the measurement period was less than 98%
of the product of the last reported sale price of our common stock and the conversion rate on each such trading
day;
if we elect to distribute assets or property to all or substantially all of the holders of our common stock and those
assets or other property have a value of more than 25% of the average daily volume-weighted average trading
price of our common stock for the prior 20 consecutive trading days;
if we elect to redeem the Cash Convertible Notes; or
if we experience certain customary events of default, including defaults under certain other indebtedness.
Noteholders may convert their 2023 Notes into cash at their option at any time during the Contingent Conversion
Period only under the following circumstances (Contingent Conversion Conditions)
during any fiscal quarter ending after September 30, 2017, if the arithmetic mean of the last reported sale prices
of the Common Stock during a period of 20 consecutive trading days selected from the 30 consecutive trading
days ending on and including the final trading day of the immediately preceding quarter is equal to or more than
130% of the conversion price (i.e., USD 200,000 minimum denomination divided by the applicable Conversion
Ratio) applicable on the last day of such preceding quarter;
in the event of early redemption at the option of the Issuer of all the outstanding Notes, where the conversion date
falls in the period from (and including) the date on which the notice of redemption is published up to the 10th
calendar day preceding the date of such early redemption;
in the event of a planned distribution by the Issuer of cash, assets, securities or other property, which has a per
share value greater than 25% of the arithmetic mean of the volume weighted average price (VWAP) of the
Common Stock during the 20 consecutive trading day period immediately preceding the date on which the
planned distribution is announced by the Issuer, at any time following such notice, which shall be at least 20
scheduled trading days prior to the ex-dividend date for such distribution, until the earlier of (i) the fifth business
day immediately preceding the ex-dividend date for such distribution and (ii) the Issuer's announcement that such
planned distribution will not take place;
in the event of certain Fundamental Changes or Make-Whole Fundamental Changes (each as described below),
where the conversion date falls in the period from the 60th scheduled trading day prior to the anticipated effective
date of such Fundamental Change or Make-Whole Fundamental Change (or, if later, public announcement of the
same by the Issuer), until (i) the fifth business day immediately preceding the related Fundamental Change
Repurchase Date, or (ii) in the case of a Make-Whole Fundamental Change that does not constitute a Fundamental
Change, the 60th trading day immediately following such effective date (or, if later in either case, the 60th
calendar day following the notification of such Fundamental Change or Make-Whole Fundamental Change);
at any time from and after the occurrence of an event of default, until such event of default has been cured or
waived or the principal amount of the Notes shall have been accelerated; or
if a Parity Event or a Trading Price Unavailability Event, as the case may be, occurs, the period of 10 Business
Days from and including the first Business Day following the relevant Trading Price Notification Date.
The Contingent Conversion Conditions in the 2019, 2021 and 2023 Notes noted above have been analyzed under
ASC 815, Derivatives and Hedging, and, based on our analysis, we determined that each of the embedded features
listed above are clearly and closely related to the 2019, 2021 and 2023 Notes (i.e., the host contract). As a result,
pursuant to the accounting provisions of ASC 815, Derivatives and Hedging, these features noted above are not
required to be bifurcated as separate instruments. As of December 31, 2017, no contingent conversion condition
was triggered.
For the 2023 Notes, the initial conversion rate is 4,829.7279 shares of our common stock per $200,000 principal
amount of the 2023 Notes (reflecting an initial conversion price of approximately $41.4102 per share of common
stock). As adjusted by the synthetic share repurchase discussed in Note 17, the conversion rate for the 2019 Notes
and 2021 Notes is 7,063.1647 shares of our common stock per $200,000 principal amount of Cash Convertible
Notes (reflecting an adjusted conversion price of approximately $28.32 per share of common stock). Upon
conversion, holders are entitled to a cash payment (Cash Settlement Amount) equal to the average of the conversion
rate multiplied by the daily volume-weighted average trading price for our common stock over a 50-day period. The
conversion rate is subject to adjustment in certain instances but will not be adjusted for any accrued and unpaid
interest. In addition, following the occurrence of certain corporate events that may occur prior to the applicable
maturity date, we may be required to pay a cash make-whole premium by increasing the conversion rate for any
holder who elects to convert Cash Convertible Notes in connection with the occurrence of such a corporate event,
but in no event will the Conversion Ratio exceed 6,728.6463 per $200,000 principal amount of Notes.
We may redeem the 2019, 2021 or 2023 Notes in their entirety at a price equal to 100% of the principal amount
of the applicable Cash Convertible Notes plus accrued interest at any time when 20% or less of the aggregate
principal amount of the applicable Cash Convertible Notes originally issued remain outstanding.
Because the Cash Convertible Notes contain an embedded cash conversion option, we have determined that the
embedded cash conversion option is a derivative financial instrument, which is required to be separated from the
Cash Convertible Notes and accounted for separately as a derivative liability, with changes in fair value reported in
our consolidated statements of income until the cash conversion option transaction settles or expires. The initial fair
value liability of the embedded cash conversion option was $105.2 million and for the 2023 Notes was $74.5
million, which simultaneously reduced the carrying value of the Cash Convertible Notes (effectively an original
issuance discount). For further discussion of the derivative financial instruments relating to the Cash Convertible
Notes, refer to Note 13.
As noted above, the reduced carrying value on the Cash Convertible Notes resulted in a debt discount that is
amortized to the principal amount through the recognition of non-cash interest expense using the effective interest
method over the expected life of the debt, which is five, seven and six years for the 2019 Notes, 2021 Notes and
2023 Notes, respectively. This resulted in our recognition of interest expense on the Cash Convertible Notes at an
effective rate approximating what we would have incurred had nonconvertible debt with otherwise similar terms
been issued. The effective interest rate of the 2019 Notes, 2021 Notes and 2023 Notes is 2.937%, 3.809% and
3.997%, respectively, which is imputed based on the amortization of the fair value of the embedded cash conversion
option over the remaining term of the Cash Convertible Notes. As of December 31, 2017, we expect the 2019
Notes, 2021 Notes and 2023 Notes to be outstanding until their respective maturity dates. Based on an estimation
using available over-the-counter market information on the Cash Convertible Notes, the Level 2 fair value of the 2019
Notes, 2021 Notes and 2023 Notes was $498.8 million, $366.0 million and $404.8 million at December 31,
2017. Based on an estimation using available over-the-counter market information on the Cash Convertible Notes,
the Level 2 fair value of the 2019 Notes and 2021 Notes was $485.9 million and $346.6 million, at December 31,
2016.
In connection with the issuance of the 2019 and 2021 Cash Convertible Notes, we incurred approximately $13.1
million in transaction costs. We incurred approximately $6.2 million in transaction costs for the 2023 Cash
Convertible Notes of which $0.6 million was accrued as of December 31, 2017. Such costs have been allocated to
the Cash Convertible Notes and deferred as a long-term asset and are being amortized to interest expense over the
terms of the Cash Convertible Notes using the effective interest method.
Interest expense related to the Cash Convertible Notes was comprised of the following:
(in thousands)
Coupon interest
Amortization of original issuance discount
Amortization of debt issuance costs
Total interest expense related to the Cash Convertible Notes
2017
$ 4,832
21,377
2,615
$ 28,824
Year-Ended December 31
2016
$ 4,238
17,503
2,279
$ 24,020
Cash Convertible Notes Call Spread Overlay
Concurrent with the issuance of the Cash Convertible Notes, we entered into privately negotiated hedge transactions
(Call Options) with, and issued warrants to purchase shares of our common stock (Warrants) to, certain financial
institutions. We refer to the Call Options and Warrants collectively as the “Call Spread Overlay”. The Call Options
are intended to offset any cash payments payable by us in excess of the principal amount due upon any conversion
of the Cash Convertible Notes. During 2014, we used $105.2 million of the proceeds from the issuance of the 2019
and 2021 Cash Convertible Notes to pay for the Call Options, and simultaneously received $69.4 million from the
sale of the Warrants, for a net cash outlay of $35.8 million for the Call Spread Overlay.
During 2017, we used $73.6 million of the proceeds from the from the issuance of the 2023 Cash Convertible
Notes to pay for the premium for the Call Option, and simultaneously received $45.4 million from the sale of
Warrants, for a net cash outlay of $28.3 million for the Call Spread Overlay. Issuance costs incurred in connection
with the Warrant and the Call Option were $0.3 million and $0.1 million respectively, which $0.1 million was
accrued as of December 31, 2017.
The Call Options are derivative financial instruments and are discussed further in Note 13. The Warrants are equity
instruments and are further discussed in Note 17.
Aside from the initial payment of a premium of $105.2 million (2019 and 2021 Notes) and $73.6 million (2023
Notes) for the Call Option, we will not be required to make any cash payments under the Call Options, and will be
entitled to receive an amount of cash, generally equal to the amount by which the market price per share of our
common stock exceeds the exercise price of the Call Options during the relevant valuation period. The exercise price
under the Call Options is initially equal to the conversion price of the Cash Convertible Notes.
The Warrants cover an aggregate of 25.8 million shares in connection with the 2019 and 2021 Notes of our
common stock (subject to anti-dilution adjustments under certain circumstances) and have an initial exercise price of
$32.085 per share, subject to customary adjustments. The Warrants expire as follows: Warrants to purchase 15.2
million shares expire over a period of 50 trading days beginning on December 27, 2018 and Warrants to purchase
10.6 million shares expire over a period of 50 trading days beginning on December 29, 2020. The Warrants are
European-style (exercisable only upon expiration).
Concurrent with the 2023 Notes, we issued Warrants which cover 9.7 million shares of our common stock (subject
to anti-dilution adjustments under certain circumstances) and have an initial exercise price of $50.9664 per share,
subject to customary adjustments. The Warrants expire as follows: Warrants to purchase 9.7 million shares expire
over a period of 50 trading days beginning on June 26, 2023. The Warrants are European-style (exercisable only
upon expiration).
The Warrants that were issued with our Cash Convertible Notes discussed above, could have a dilutive effect to the
extent that the price of our common stock exceeds the applicable strike price of the Warrants. For each Warrant that
is exercised, we will deliver to the holder a number of shares of our common stock equal to the amount by which the
settlement price exceeds the exercise price, plus cash in lieu of any fractional shares. We will not receive any
proceeds if the Warrants are exercised.
Private Placement
In October 2012, we completed a private placement through the issuance of new senior unsecured notes at a total
amount of $400 million with a weighted average interest rate of 3.66% (settled on October 16, 2012). The notes
were issued in three series: (1) $73 million 7-year term due in 2019 (3.19%); (2) $300 million 10-year term due in
2022 (3.75%); and (3) $27 million 12-year term due in 2024 (3.90%). We paid $2.1 million in debt issue costs
which will be amortized through interest expense using the effective interest method over the lifetime of the notes. The
note purchase agreement contains certain financial and non-financial covenants, including but not limited to,
restrictions on priority indebtedness and the maintenance of certain financial ratios. We were in compliance with
these covenants at December 31, 2017. Based on an estimation using the changes in the U.S. Treasury rates, the
Level 2 fair value of these senior notes as of December 31, 2017 and December 31, 2016 was approximately
$394.7 million and $397.1 million, respectively. During 2014, we entered into interest rate swaps, which effectively
fixed the fair value of $200.0 million of this debt and qualify for hedge accounting as fair value hedges as
described in Note 13.
German Private Placement (Schuldschein)
In 2017, we completed a German private placement bond ("Schuldschein") which was issued in several tranches
totaling $331.1 million due in various periods through 2027. The Schuldschein consists of U.S. dollar and Euro
denominated tranches. The Euro tranches are designated as a foreign currency non-derivative hedging instrument
that qualifies as a net investment hedge as described in Note 13 "Derivatives and Hedging". Based on the spot rate
method, the change in the carrying value of the Euro denominated tranches attributed to the net investment hedge as
of December 31, 2017 totaled $19.8 million of unrealized loss and is recorded in equity. We paid $1.2 million in
debt issuance costs which are being amortized through interest expense over the lifetime of the notes. A summary of
the tranches as of December 31, 2017 is as follows:
Currency
Notional Amount
Interest Rate
Maturity
Carrying Value as of December 31, 2017 (in thousands)
EUR
EUR
EUR
EUR
USD
EUR
EUR
EUR
EUR
€11.5 million
Fixed 0.4%
March 2021
€23.0 million
Floating EURIBOR + 0.4%
March 2021
€21.5 million
Fixed 0.68% October 2022
€64.5 million
Floating EURIBOR + 0.5% October 2022
$45.0 million
Floating LIBOR + 1.2% October 2022
€25.0 million
Floating EURIBOR + 0.5% October 2022
€64.0 million
Fixed 1.09%
June 2024
€31.0 million
Floating EURIBOR + 0.7%
June 2024
€14.5 million
Fixed 1.61%
June 2027
$ 13,660
27,320
25,535
76,605
44,862
31,792
76,005
36,815
17,218
$ 349,812
2004 Notes
In August 2004, we completed the sale of $150 million of 1.5% Senior Convertible Notes due in 2024 (2004
Notes), through our unconsolidated subsidiary QIAGEN Finance. The net proceeds of the 2004 Notes were loaned
by QIAGEN Finance to consolidated subsidiaries with an effective interest rate of 1.8% were due in February 2024.
Interest was payable semi-annually in February and August. The 2004 Notes were issued at 100% of principal
value, and were convertible into 11.5 million common shares at the option of the holders upon the occurrence of
certain events at a price of $12.6449 per share, subject to adjustment. QIAGEN N.V. had an agreement with
QIAGEN Finance to issue shares to the investors in the event of conversion. The subscription right, along with the
related receivable, was recorded at fair value in the equity of QIAGEN N.V. as paid-in capital. In 2014, 1.2 million
common shares were issued in connection with the conversions. During 2015, we repaid the loan to QIAGEN
Finance and repurchased the warrant agreement with QIAGEN Finance for $250.9 million and recognized a loss of
$7.6 million in other expense, net. The repayment amount was allocated to the loan and warrants on a relative fair
value basis with $113.0 million recorded against additional paid in capital for the redemption of the warrant
subscription receivable. Subsequent to these transactions QIAGEN Finance was liquidated.
16. Income Taxes
On December 22, 2017, President Trump signed into law the Tax Cuts and Jobs Act (H.R.1) (the “2017 Tax Act”).
The 2017 Tax Act includes a number of changes to existing U.S. tax laws that impact us, most notably a reduction of
the U.S. corporate income tax rate from 35% to 21% effective as of January 1, 2018 and a new net interest expense
deduction limitation, which limits the deduction of net interest expense to 30% of the taxpayer’s adjusted taxable
income (ATI). The 2017 Tax Act also provides the acceleration of depreciation for certain assets placed into service
after September 27, 2017 as well as prospective changes including repeal of the domestic manufacturing deduction
beginning in 2018 and capitalization of research and development expenditures beginning in 2022.
In December 2017, the SEC staff issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of
the Tax Cuts and Jobs Act (“SAB 118”), which allows us to record provisional amounts during a measurement period
not to extend beyond one year of the enactment date. For those specific income tax effects of the 2017 Tax Act for
which the accounting under ASC Topic 740 is incomplete, a reasonable estimate was determined. We have
recognized the provisional tax impacts related to the interest expense deduction limitation and the revaluation of
deferred tax assets and liabilities and included these amounts in our consolidated financial statements for the year
ended December 31, 2017. The ultimate impact may differ from these provisional amounts due to additional
analysis, changes in interpretations and assumptions that we have made, additional regulatory guidance that may
be issued, and actions we may take because of the 2017 Tax Act. We did not identify items for which the income
tax effects of the 2017 Tax Act have not been completed and a reasonable estimate could not be determined as of
December 31, 2017. We expect to complete our analysis within the measurement period in accordance with
SAB118.
Income before income taxes for the years ended December 31, 2017, 2016 and 2015 consisted of:
(in thousands)
Pretax income in The Netherlands
Pretax income from foreign operations
2017
$ 42,220
72,155
$ 114,375
2016
$ 20,695
36,213
$ 56,908
2015
$ 1,310
134,993
$ 136,303
Income taxes for the years ended December 31, 2017, 2016 and 2015 are as follows:
(in thousands)
Current—The Netherlands
—Foreign
Deferred—The Netherlands
—Foreign
2017
$ 3,430
10,375
13,805
151
60,025
60,176
2016
$ 6,043
34,543
40,586
188
(64,169)
(63,981)
Total income tax expense (benefit)
$ 73,981
$ (23,395)
2015
$ 973
37,708
38,681
250
(32,530)
(32,280)
$ 6,401
The Netherlands statutory income tax rate was 25% for the years ended December 31, 2017, 2016 and 2015.
Income from foreign subsidiaries is generally taxed at the statutory income tax rates applicable in the respective
countries of domicile. The principal items comprising the differences between income taxes computed at The
Netherlands statutory rate and our reported income taxes and effective tax rate for the years ended December 31,
2017, 2016 and 2015 are as follows:
2017
2016
2015
(in thousands)
Amount
Percent
Amount
Percent
Amount
Percent
Income taxes at The Netherlands statutory
$ 28,594
25.0 %
$ 14,227
25.0 %
$ 34,076
25.0 %
Taxation of foreign operations, net(1)
(38,635)
(33.8)
(43,265)
(76.0)
(36,407)
(26.7)
Tax impact from permanent items
Tax impact from tax-exempt income
Tax contingencies, net(2)
Taxes due to changes in tax rates(3)
Stock Compensation(4)
Government incentives and other
Prior year taxes
Valuation allowance(3)
Other items, net
(1,586)
(1,558)
23,189
12,958
(5,237)
(4,949)
(2,319)
62,644
880
(1.4)
(1.4)
20.3
11.3
(4.6)
(4.3)
(2.0)
54.8
0.8
5,938
(3,331)
1,761
399
—
10.4
(5.9)
3.1
0.7
—
14,219
(5,810)
1,163
(836)
—
(2,543)
(4.5)
(2,754)
1,411
1,521
487
2.5
2.7
0.9
(1,201)
3,450
501
10.4
(4.3)
0.9
(0.6)
—
(2.0)
(0.9)
2.5
0.4
Total income tax expense (benefit)
$ 73,981
64.7 %
$ (23,395)
(41.1)%
$ 6,401
4.7 %
(1) Our effective tax rate reflects the benefit of our global operations where certain income or loss is taxed at rates higher or
lower than The Netherlands’ statutory rate of 25% as well as the benefit of some income being partially exempt from income
taxes due to various intercompany operating and financing activities. The most significant tax benefits from these foreign
operations and financing activities are attributable to subsidiaries in Germany, Singapore, Switzerland, Ireland and
Luxembourg. These foreign tax benefits are due to a combination of favorable tax laws, regulations, rulings, and exemptions
in these jurisdictions. Additionally in 2016, in certain foreign jurisdictions (primarily Germany and the U.S.), we recorded
acquisition related and impairment charges which reduced pretax income in these higher tax jurisdictions.
(2) During 2017, we increased accruals for tax contingencies, primarily related to ongoing income tax audits.
(3) During 2017, we revalued our U.S. deferred tax assets and liabilities to reflect the corporate income tax rate change from
35% to 21% as a result of U.S. tax reform. Additionally, we recorded a full valuation allowance of $60.8 million against
deferred tax assets related to U.S. interest carry forwards. Based on the current debt level in the U.S., along with the new
restrictive interest limitation enacted with the new U.S. tax reform, it is highly unlikely that the historic U.S. interest carry
forward will ever be utilized. We also recorded full valuation allowances against other deferred tax assets on tax losses due
to unlikely future profits in other jurisdictions.
(4)
h
b
f
f
h
b
d
fl
d
d
f h
(4) Beginning in 2017, the excess tax benefits from share-based compensation activity are reflected as a reduction of the
provision for income taxes, whereas previously they were recognized in equity.
(5) Government incentives include favorable tax regulations in the U.S. and the U.K. and relating to research and
development expense as well as the U.S. Internal Revenue Code Section 199 domestic production activities deduction.
We conduct business globally and, as a result, file numerous consolidated and separate income tax returns in The
Netherlands, Germany, Switzerland and the U.S. federal jurisdiction, as well as in various other state and foreign
jurisdictions. In the normal course of business, we are subject to examination by taxing authorities throughout the
world. Tax years in The Netherlands are open since 2005 for income tax examinations by tax authorities. Our
subsidiaries, with few exceptions, are no longer subject to income tax examinations by tax authorities for years
before 2013. The U.S. consolidated group is subject to federal and most state income tax examinations by tax
authorities beginning with the year ending December 31, 2014 through the current period.
Starting in February 2014, the U.S. tax authorities (Internal Revenue Service) have been auditing our U.S. federal tax
returns for 2011 and 2012. The audit was closed in 2016 without any tax adjustments. As a result, we released
$6.6 million of unrecognized tax benefit due to closure of the tax audit. Additionally, in February 2016 German tax
authorities began the audit of the German tax returns for the 2010-2013 tax years. This audit is currently in process
and we expect the audit to close during 2018.
Changes in the amount of unrecognized tax benefits are as follows:
(in thousands)
BALANCE AT DECEMBER 31, 2015
Additions based on tax positions related to the current year
Additions for tax positions of prior years
Decrease for tax position of prior years
Reductions due to lapse of statute of limitations
Decrease from currency translation
BALANCE AT DECEMBER 31, 2016
Additions based on tax positions related to the current year
Additions for tax positions of prior years
Increase from currency translation
BALANCE AT DECEMBER 31, 2017
Unrecognized Tax Benefits
$ 16,735
4,218
5,162
(6,796)
(288)
(737)
$ 18,294
12,212
9,933
3,594
$ 44,033
At December 31, 2017 and 2016, our net unrecognized tax benefits totaled approximately $44.0 million and
$18.3 million, respectively, of which $44.0 million and $18.3 million in benefits, if recognized, would favorably
affect our effective tax rate in any future period. It is reasonably possible that approximately $11.6 million of the
unrecognized tax benefits may be released during the next 12 months due to lapse of statute of limitations or
settlements with tax authorities; however, various events could cause our current expectations to change in the future.
The above unrecognized tax benefits, if ever recognized in the financial statements, would be recorded in the
statement of income as part of the income tax expense.
Our policy is to recognize interest accrued related to unrecognized tax benefits in interest expense and penalties
within income tax expense. For the years ended December 31, 2017, 2016 and 2015, we have net interest
(income) expense and penalties of $1.5 million, $0.1 million and $0.3 million, respectively. At December 31, 2017
and 2016, we have accrued interest of $3.0 million and $1.4 million, respectively, which are not included in the
table above.
We have recorded net deferred tax liabilities of $37.4 million and deferred tax assets of $27.8 million at December
31, 2017 and 2016, respectively. The components of the net deferred tax asset and liability at December 31, 2017
and 2016 are as follows:
(in thousands)
Deferred
Deferred
2017
Net operating loss carryforwards
Accrued and other current liabilities
Inventories
Allowance for bad debts
Currency revaluation
Property, plant and equipment
Capital lease
Tax credit carryforwards
Unremitted profits and earnings
Intangible assets
Share-based compensation
Deferred interest deductions
Convertible debt
Other
Valuation allowance
$ 30,966
15,748
4,163
739
4,095
1,103
531
1,563
—
1,289
18,143
60,790
10,865
2,632
152,627
(67,849)
$ —
—
(778)
(475)
(167)
(23,649)
—
—
(998)
(93,771)
—
—
—
(2,315)
(122,153)
—
2016
Deferred
$ —
—
(1,567)
(451)
(73)
(19,733)
—
—
(923)
(137,682)
—
—
—
(1,507)
(161,936)
—
Deferred
$ 46,627
24,663
2,919
1,060
3,474
2,096
830
915
—
586
20,282
76,793
12,313
2,652
195,210
(5,511)
Net deferred tax assets (liabilities)
$ (37,375)
$ 27,763
$ 84,778
$ (122,153)
$ 189,699
$ (161,936)
At December 31, 2017 and 2016, we had $432.7 million and $380.7 million in total foreign net operating loss
(NOL) carryforwards. Included in these amounts at December 31, 2017 and 2016, were $108.5 million and
$109.2 million of U.S. federal (NOL) carryforwards. At December 31, 2017, the entire NOL in the U.S. is subject to
limitations under Section 382 of the U.S. Internal Revenue Code. The NOLs in the U.S. will expire beginning
December 31, 2023 through December 31, 2033. Also included in the above amount as of December 31, 2017
and 2016, were other foreign NOL carryforwards totaling approximately $324.1 million and $271.5 million,
respectively, with $41.5 million added due to German trade tax loss generated in 2017. As of December 31, 2017,
we had NOL carryforwards in Germany of $225.0 million predominantly trade tax NOLs. Of the total $324.1
million foreign NOL carryforwards, $253.8 million does not expire with the balance expiring beginning December
2018 through 2032. The valuation allowance amounts related to net operating losses as of the years ended
December 31, 2017 and December 31, 2016 are $7.1 million and $5.5 million. In 2017, we recorded a valuation
allowance of $60.8 million related to U.S. interest carryforwards. Based on the current debt level in the U.S., along
with the new restrictive interest limitation enacted with the new U.S. tax reform, it is highly unlikely that the historic
U.S. interest carry forward will ever be utilized. We believe it is more likely than not that the deferred tax assets, net
of the valuation allowances, as shown above will be realized.
As of December 31, 2017, a deferred tax liability has not been recognized for residual income taxes in The
Netherlands on the undistributed earnings of the majority of our foreign subsidiaries as these earnings are
considered to be either indefinitely reinvested or can be repatriated tax free under the Dutch participation exemption.
The indefinitely reinvested earnings retained by subsidiaries amounted to $381.9 million at December 31, 2017.
Estimating the amount of the unrecognized deferred tax liability on indefinitely reinvested foreign earnings is not
practicable. Should the earnings be remitted as dividends, we may be subject to taxes including withholding tax.
We have $22.9 million of undistributed earnings that we do not consider indefinitely reinvested and have recorded
deferred taxes or withholding taxes at December 31, 2017 and December 31, 2016, of $1.0 million and $0.9
million, respectively.
17. Equity
Issuance of Warrants
In March 2014, in connection with the issuance of our Cash Convertible Notes, we issued Warrants (as described in
Note 15) for approximately 25.8 million shares of our common stock (subject to antidilution adjustments under
certain circumstances) with an exercise price of $32.085 per share, subject to customary adjustments. Following the
synthetic share repurchase discussed below, the adjusted exercise price is $32.056. The proceeds, net of issuance
costs, from the sale of the Warrants of approximately $68.9 million are included as additional paid in capital in the
accompanying consolidated balance sheets. The Warrants expire as follows: Warrants to purchase 15.2 million
shares expire over a period of 50 trading days beginning on December 27, 2018 and Warrants to purchase 10.6
million shares expire over a period of 50 trading days beginning on December 29, 2020.
In September 2017, concurrent with the issuance of our 2023 Cash Convertible Notes, we issued Warrants (as
described in Note 15) for approximately 9.7 million shares of our common stock (subject to anti-dilution adjustments
under certain circumstances) with an exercise price of $50.9664 per share, subject to customary adjustments. The
proceeds from the sale of the Warrants, net of issuance costs, of approximately $45.3 million are included as
additional paid in capital in the accompanying consolidated balance sheets. The warrants to purchase
approximately 9.7 million shares expire over a period of 50 trading days beginning on June 26, 2023.
The Warrants are exercisable only upon expiration. For each Warrant that is exercised, we will deliver to the holder
a number of shares of our common stock equal to the amount by which the settlement price exceeds the exercise
price, divided by the settlement price, plus cash in lieu of any fractional shares. The Warrants could separately have
a dilutive effect on shares of our common stock to the extent that the market value per share of our common stock
exceeds the applicable exercise price of the Warrants (as measured under the terms of the Warrants).
Share Repurchase Programs
In July 2014, we announced the launch of our third share repurchase program to purchase up to another $100
million of our common shares (excluding transaction costs). In 2014, 2.1 million QIAGEN shares were repurchased
for $49.1 million (excluding transaction costs) and in 2015, 0.8 million QIAGEN shares were repurchased for
$20.8 million.
On April 27, 2016, we announced the launch of our fourth $100 million share repurchase program which was
expected to be completed by the end of 2017. During the third quarter of 2017, 1.9 million QIAGEN shares were
repurchased for $61.0 million (including transaction costs).
On January 31, 2018, we announced our fifth share repurchase program of up to $200 million of our common
shares.
The cost of repurchased shares is included in treasury stock and reported as a reduction in total equity when a
repurchase occurs. Repurchased shares will be held in treasury in order to satisfy various obligations, which include
exchangeable debt instruments, warrants and employee share-based remuneration plans.
Synthetic Share Repurchase
In August 2016, we announced our plan to return approximately $250.0 million to shareholders through a synthetic
share repurchase program that combines a direct capital repayment with a reverse stock split. The synthetic share
repurchase was implemented through a series of amendments to our Articles of Association which were approved by
our shareholders at an Extraordinary General Meeting (EGM) held on October 26, 2016. The first amendment
involved an increase in share capital by an increase in the nominal value per common share from EUR 0.01 to EUR
1.04 and a corresponding reduction in additional paid in capital. The second amendment involved a reduction in
stock whereby 27 existing common shares with a nominal value of EUR 1.04 each were consolidated into 26 new
common shares with a nominal value of EUR 1.08 each. The third amendment was a reduction of the nominal value
per common share from EUR 1.08 to EUR 0.01. As a result of these amendments, which in substance constitute a
synthetic share buyback, $243.9 million was repaid to our shareholders and the outstanding number of common
shares was reduced by 8.9, or 3.7%. The capital repayment program was completed in January 2017. Expenses
incurred related to the capital repayment and share consolidation amounted to $0.5 million and were charged to
equity.
Accumulated Other Comprehensive Loss
The following table is a summary of the components of accumulated other comprehensive loss as of December 31,
2017 and 2016:
(in thousands)
Net unrealized loss on hedging contracts, net of tax
Net unrealized loss on marketable securities, net of tax
Net unrealized loss on pension, net of tax
Foreign currency effects from intercompany long-term
investment transactions, net of tax of $7.9 million and $7.7
million in 2017 and 2016, respectively
Foreign currency translation adjustments
Accumulated other comprehensive loss
18. Earnings per Common Share
2017
$ (30,487)
(942)
(878)
(16,144)
(172,308)
$ (220,759)
2016
$ (7,600)
(156)
(1,498)
(15,901)
(308,684)
$ (333,839)
We present basic and diluted earnings per share. Basic earnings per share is calculated by dividing the net income
attributable to the owners of QIAGEN N.V. by the weighted average number of common shares outstanding. Diluted
earnings per share reflect the potential dilution that would occur if all “in the money” options and warrants to issue
common shares were exercised. The following schedule summarizes the information used to compute earnings per
common share:
(in thousands, except per share data)
Net income attributable to the owners of QIAGEN N.V.
Weighted average number of common shares used to compute basic net
income per common share
Dilutive effect of stock options and restrictive stock units
Dilutive effect of outstanding warrants
Weighted average number of common shares used to compute diluted net
income per common share
Outstanding options and awards having no dilutive effect, not included in
above calculation
Outstanding warrants having no dilutive effect, not included in above
calculation
2017
2016
2015
Years ended December 31,
$ 40,394
228,074
4,760
175
$ 80,404
234,800
4,193
—
$ 130,148
233,483
5,028
136
233,009
238,993
238,647
52
210
37
30,434
25,800
26,071
Basic earnings per common share attributable to the owners of QIAGEN
N.V.
$ 0.18
$ 0.34
Diluted earnings per common share attributable to the owners of QIAGEN
N.V.
$ 0.17
$ 0.34
$ 0.56
$ 0.55
19. Commitments and Contingencies
Lease Commitments
We lease facilities and equipment under operating lease arrangements expiring in various years through 2024.
Certain rental commitments provide for escalating rental payments or have renewal options extending through
various years. Certain facility and equipment leases constitute capital leases expiring in various years through 2020.
The accompanying consolidated balance sheets include the assets and liabilities arising from these capital lease
obligations. Rent expense under operating lease agreements not including facility related costs accrued in
association with the restructuring activities discussed in Note 6 was $24.5 million, $22.4 million and $23.2 million
for the years ended December 31, 2017, 2016 and 2015, respectively.
Minimum future obligations under capital and operating leases at December 31, 2017 are as follows:
Capital Leases
Operating Leases
(in thousands)
2018
2019
2020
2021
2022
Thereafter
Less: Amount representing interest
Less: Current portion
Long-term portion
$ 18,483
16,011
11,762
8,457
6,126
4,038
$ 64,877
$ 1,411
45
14
—
—
—
1,470
(54)
1,416
(1,359)
$ 57
Licensing and Purchase Commitments
We have licensing agreements with companies, universities and individuals, some of which require certain up-front
payments. Royalty payments are required on net product sales ranging from 0.45 percent to 20 percent of covered
products or based on quantities sold. Several of these agreements have minimum royalty requirements. The
accompanying consolidated balance sheets include accrued royalties relating to these agreements in the amount of
$6.7 million and $7.8 million at December 31, 2017 and 2016, respectively. Royalty expense relating to these
agreements amounted to $16.8 million, $35.9 million, and $43.2 million for the years ended December 31, 2017,
2016 and 2015, respectively. Royalty expense is primarily recorded in cost of sales, with a small portion recorded
as research and development expense depending on the use of the technology under license. Some of these
agreements also have minimum raw material purchase requirements and requirements to perform specific types of
research.
At December 31, 2017, we had commitments to purchase goods or services, and for future license and royalty
payments. They are as follows:
Purchase Commitments
License & Royalty Commitments
(in thousands)
2018
2019
2020
2021
2022
Thereafter
$ 65,073
22,556
10,472
943
11
434
$ 99,489
$ 12,907
11,858
11,558
8,860
6,161
3,748
$ 55,092
As of December 31, 2017, future license payments of $11.8 million and $35.3 million are included in accrued and
other current liabilities and other long-term liabilities, respectively.
Contingent Consideration Commitments
Pursuant to the purchase agreements for certain acquisitions we could be required to make additional contingent
cash payments totaling up to $18.5 million based on the achievement of certain revenue and operating results
milestones as follows: $11.5 million in 2018 and $7.0 million, payable in any 12-month period from now until
2029 based on the accomplishment of certain revenue targets. Of the $18.5 million total contingent obligation, we
have assessed the fair value at December 31, 2017, to be $11.5 million which is included in accrued liabilities in
the accompanying consolidated balance sheet.
Employment Agreements
Certain of our employment contracts contain provisions which guarantee the payments of certain amounts in the
event of a change in control, as defined in the agreements, or if the executive is terminated for reasons other than
cause, as defined in the agreements. At December 31, 2017, the commitment under these agreements totaled $16.8
million. The employment agreements with the Managing Directors and the German affiliate include a clause,
whereby the affiliate will compensate the Managing Directors for potential deductions under Dutch law which, since
2014, has introduced a duty to deduct from a Managing Director’s remuneration any increase in the value of shares
or options that were part of his pay to the extent that such increase is based on a public offer, merger or other
identity changing transaction.
Contingencies
In the ordinary course of business, we provide a warranty to customers that our products are free of defects and will
conform to published specifications. Generally, the applicable product warranty period is one year from the date of
delivery of the product to the customer or of site acceptance, if required. Additionally, we typically provide limited
warranties with respect to our services. From time to time, we also make other warranties to customers, including
warranties that our products are manufactured in accordance with applicable laws and not in violation of third-party
rights. We provide for estimated warranty costs at the time of the product sale. We believe our warranty reserves as
of December 31, 2017 and 2016 appropriately reflect the estimated cost of such warranty obligations.
Preacquisition Contingencies
In connection with certain acquisitions, amounts were paid into escrow accounts to cover preacquisition
contingencies assumed in the acquisition. The escrow amounts that are certain to be claimed by QIAGEN are
recorded in prepaid expenses and other current assets and total $2.5 million as of December 31, 2017. As of
December 31, 2016, $2.5 million was recorded in other long-term assets in the accompanying consolidated
balance sheets.
Litigation
From time to time, we may be party to legal proceedings incidental to our business. For the year ended December
31, 2017, we had settlement amounts related to various acquisition-related litigation matters totaling $49.2 million,
primarily related to PCR-based biomarker disputes and patent litigation, which were settled during 2017 of which
$45.3 million was recorded to general and administrative, restructuring, integration and other expense and $3.9
million was recorded as a license right. $44.8 million of the settlement amounts were paid during 2017 and as of
December 31, 2017, $4.4 million was accrued in accrued and other current liabilities.
As of December 31, 2017, certain claims, suits or legal proceedings arising out of the normal course of business
have been filed or were pending against QIAGEN or its subsidiaries. These matters have arisen in the ordinary
course and conduct of business, as well as through acquisition. Although it is not possible to predict the outcome of
such litigation, we assess the degree of probability and evaluate the reasonably possible losses that we could incur
as a result of these matters. We accrue for any estimated loss when it is probable that a liability has been incurred
and that the amount of the probable loss can be estimated. Based on the facts known to QIAGEN and after
consultation with legal counsel, management believes that such litigation will not have a material adverse effect on
QIAGEN’s financial position or results of operations.
20. Share-Based Compensation
We adopted the QIAGEN N.V. Amended and Restated 2005 Stock Plan (the 2005 Plan) in 2005 and the QIAGEN
N.V. 2014 Stock Plan (the 2014 Plan) in 2014. The 2005 Plan expired by its terms in April 2015 and no further
awards will be granted under the 2005 Plan. The plans allow for the granting of stock rights and incentive stock
options, as well as non-qualified options, stock grants and stock-based awards, generally with terms of up to 10
years, subject to earlier termination in certain situations. Generally, options vest over a 3-year period. The vesting
and exercisability of certain stock rights will be accelerated in the event of a Change of Control, as defined in the
plans. To date, all option grants have been at the market value on the grant date or at a premium above the closing
market price on the grant date. We issue Treasury Shares to satisfy option exercises and award releases and had
approximately 22 million Common Shares reserved and available for issuance under the 2005 and 2014 Plans at
December 31, 2017.
Stock Options
We have not granted stock options since 2013. A summary of the status of employee stock options as of December
31, 2017 and changes during the year then ended is presented below:
All Employee Options
Outstanding at January 1, 2017
Exercised
Expired
Outstanding at December 31, 2017
Vested at December 31, 2017
Vested and expected to vest at December 31, 2017
Number of Shares
(in thousands)
Weighted Average
Exercise Price
Weighted Average
Contractual Term (in
years)
Aggregate Intrinsic
Value (in thousands)
1,439
(287)
(3)
1,149
1,149
1,149
$ 19.84
$ 21.08
$ 18.63
19.54
19.54
19.54
3.32
3.32
3.32
13,088
13,088
13,088
The total intrinsic value of options exercised during the years ended December 31, 2017, 2016 and 2015 was
$3.3 million, $3.2 million and $7.0 million, respectively. At December 31, 2017, there was no unrecognized share-
based compensation expense related to employee stock option awards.
At December 31, 2017, 2016 and 2015, 1.1 million, 1.4 million and 1.7 million options were exercisable at a
weighted average price of $19.54, $19.84 and $19.27 per share, respectively. The options outstanding at
December 31, 2017 expire in various years through 2023.
Stock Units
Stock units represent rights to receive Common Shares at a future date and include restricted stock units which are
subject to time-vesting only and performance stock units which include performance conditions in addition to time-
vesting. The final number of performance stock units earned is based on the performance achievement which for
some grants can reach up to 120% of the granted shares. There is no exercise price and the fair market value at the
time of the grant is recognized over the requisite vesting period, generally 3 to 5 years, and in certain grants 10
years. The fair market value is determined based on the number of stock units granted and the market value of our
shares on the grant date. Pre-vesting forfeitures were estimated to be approximately 7.0%. At December 31, 2017,
there was $67.5 million remaining in unrecognized compensation cost including estimated forfeitures related to these
awards, which is expected to be recognized over a weighted average period of 2.35 years. The weighted average
grant date fair value of stock units granted during the years ended December 31, 2017, 2016 and 2015 was
$31.12, $23.81 and $24.91, respectively. The total fair value of stock units that vested during the years ended
December 31, 2017, 2016 and 2015 was $69.2 million, $27.4 million and $28.7 million, respectively.
A summary of stock units as of December 31, 2017 and changes during the year are presented below:
Stock Units (in
thousands)
Weighted Average Contractual
Term (in years)
Aggregate Intrinsic Value (in
thousands)
Stock Units
Outstanding at January 1, 2017
Granted
Vested
Forfeited
Outstanding at December 31, 2017
Vested and expected to vest at December 31, 2017
10,198
1,976
(2,306)
(1,766)
8,102
6,914
2.30
2.15
$ 250,603
$ 213,861
Compensation Expense
Share-based compensation expense before taxes for the years ended December 31, 2017, 2016 and 2015 totaled
approximately $34.4 million, $28.3 million and $23.8 million, respectively, as shown in the table below.
Compensation Expense (in thousands)
Cost of sales
Research and development
Sales and marketing
General and administrative
Share-based compensation expense
Less: income tax benefit(1)
2017
2016
2015
$ 2,641
5,367
6,820
19,614
34,442
7,407
$ 2,553
4,735
4,824
16,176
28,288
6,223
$ 2,177
5,686
4,815
11,083
23,761
5,751
Net share-based compensation expense
$ 27,035
$ 22,065
$ 18,010
(1)
Does not include the excess tax benefit realized for the tax deductions of the share-based payment arrangements totaled
$5.2 million, $0.8 million and $3.3 million, respectively, for the years ended December 31, 2017, 2016 and 2015.
Following the 2016 restructuring program discussed in Note 6, share-based compensation expense in 2017 and
2016 includes forfeitures of $0.7 million and $2.0 million, respectively, in connection with the restructuring
terminations. Total share-based compensation expense in 2015 was lower following a reassessment on stock units
with performance criteria. No share-based compensation cost was capitalized in inventory in December 31, 2017,
2016 or 2015 as the amounts were not material.
21. Employee Benefits
We maintain various benefit plans, including defined contribution and defined benefit plans. Our U.S. defined
contribution plan is qualified under Section 401(k) of the Internal Revenue Code, and covers substantially all U.S.
employees. Participants may contribute a portion of their compensation not exceeding a limit set annually by the
Internal Revenue Service. This plan includes a provision for us to match a portion of employee contributions. Total
expense under the 401(k) plans, including the plans acquired via business acquisitions, was $3.6 million, $2.5
million and $2.4 million for the years ended December 31, 2017, 2016 and 2015, respectively. We also have a
defined contribution plan which covers certain executives. We make matching contributions up to an established
maximum. Matching contributions made to the plan, and expensed, totaled approximately $0.3 million in each year
ended December 31, 2017, 2016 and 2015.
We have five defined benefit, non-contributory retirement or termination plans that cover certain employees in
Germany, France, Japan, Italy and the United Arab Emirates. These defined benefit plans provide benefits to
covered individuals satisfying certain age and/or service requirements. For certain plans, we calculate the vested
benefits to which employees are entitled if they separate immediately. The benefits accrued on a pro-rata basis
during the employees’ employment period are based on the individuals’ salaries, adjusted for inflation. The liability
under the defined benefit plans was $8.0 million at December 31, 2017 and $6.7 million at December 31, 2016,
and is included as a component of other long-term liabilities on the accompanying consolidated balance sheets.
22. Related Party Transactions
From time to time, we have transactions with other companies in which we hold an interest all of which are
individually and in the aggregate immaterial, as summarized in the table below.
As of December 31,
For the years ended December 31,
2017
2016
2017
2016
(in thousands)
Net sales
Reimbursements against research and development
Accounts receivable
Other long-term assets
Accounts payable
—
—
—
—
$ 3,802
$ 1,302
$ 17,713
$ 13,067
$ 1,921
$ 391
Accrued and other current liabilities
$ 9,028
$ 3,926
Other long-term liabilities
$ 3,075
$ 5,889
$ 3,852
$ 1,360
—
—
—
—
—
—
—
—
—
—
—
—
2015
$ 418
$ 2,032
—
—
—
—
—
During 2017, we purchased a convertible note for $3.0 million from a publicly listed company considered a related
party. The note is due in October 2020 and bears interest of 3.0%. As of December 31, 2017, the principal and
accrued interest of this note totals $2.7 million while the remaining $0.2 million is attributable to the embedded
derivative, that is bifurcated and measured at fair value, associated to a convertible feature of this note. Also in
2017, we granted a loan to a member of management totaling €0.6 million ($0.7 million as of December 31,
2017) bearing interest at 2.0% annually. Repayment is forgiven with continued employment at the rate of €0.1
million plus accrued interest annually. These are included in other long-term assets in the accompanying consolidated
balance sheet.
Additionally, we have two loan receivables due from related parties granted prior to 2017. The first loan, with a
balance of $11.3 million including accrued interest at December 31, 2017, was originally granted in 2015 and
subsequently increased during 2016. This loan is due in January 2020 and bears interest of 6%. The second loan,
also granted in 2015, has a principal of €2.0 million and is due in June 2019. This loan bears interest of 7% and
as of December 31, 2017 carries a balance of $2.9 million including accrued interest. The loans were made for
general business purposes and no amounts have been repaid. These loans are included in other long-term assets in
the accompanying consolidated balance sheet as of December 31, 2017.
As discussed in Note 10, during 2016 we acquired a 19.0% interest in Hombrechtikon Systems Engineering AG
(HSE) for a total obligation of $9.8 million payable over three years. As of December 31, 2017, the total remaining
obligation was $6.2 million, of which $3.1 million was included in accrued and other current liabilities and $3.1
million was included in other long-term liabilities in the accompanying consolidated balance sheet. HSE is a variable
interest entity and we are not the primary beneficiary, therefore HSE is not consolidated.
23. Subsequent Events
On January 31, 2018, we announced our fifth share repurchase program of up to $200 million of our common
shares beginning in 2018 as well as the acquisition of STAT-Dx for approximately $147 million in cash and
additional payments of up to approximately $44 million based on the achievement of regulatory and commercial
milestones. The acquisition is expected to be completed in 2018 and funded from existing cash reserves.
In January 2018, a partnership became effective with a Chinese company that has taken over R&D, commercial
distribution, and the related QIAGEN employees and infrastructure of the HPV test franchise in China.
FINANCIAL RESULTS
Auditor’s Report
Report of independent registered public accounting firm
To the Stockholders and Supervisory Board
QIAGEN N.V.:
Opinion on Internal Control Over Financial Reporting
We have audited QIAGEN N.V.’s and subsidiaries (“QIAGEN” or “the Company”) internal control over financial
reporting as of December 31, 2017, based on criteria established in Internal Control - Integrated Framework (2013)
issued by the Committee of Sponsoring Organizations of the Treadway Commission. In our opinion, the Company
maintained, in all material respects, effective internal control over financial reporting as of December 31, 2017,
based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of
Sponsoring Organizations of the Treadway Commission.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United
States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2017 and 2016, the related
consolidated statements of income, comprehensive income, changes in equity, and cash flows for each of the years
in the three-year period ended December 31, 2017, and the related notes and the financial statement schedule as
listed in Item 18 (A) (collectively, the “consolidated financial statements”), and our report dated March 5, 2018
expressed an unqualified opinion on those consolidated financial statements.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for
its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Report of
Management on Internal Control over Financial Reporting’. Our responsibility is to express an opinion on the
Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered
with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.
federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the
PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting
was maintained in all material respects. Our audit of internal control over financial reporting included obtaining an
understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and
testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our
audit also included performing such other procedures as we considered necessary in the circumstances. We believe
that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles. A company’s internal control over financial reporting
includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail,
accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable
assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance
with generally accepted accounting principles, and that receipts and expenditures of the Company are being made
only in accordance with authorizations of management and directors of the company; and (3) provide reasonable
assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s
assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may
deteriorate.
/s/ KPMG AG Wirtschaftsprüfungsgesellschaft
Düsseldorf, Germany
March 5, 2018
Report of independent registered public accounting firm
To the Stockholders and Supervisory Board
QIAGEN N.V.:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of QIAGEN N.V. and subsidiaries (the
“Company”) as of December 31, 2017 and 2016, the related consolidated statements of income, comprehensive
income, changes in equity, and cash flows for each of the years in the three year period ended December 31,
2017, and the related notes and the financial statement schedule as listed in Item 18 (A) (collectively, the
“consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all
material respects, the financial position of the Company as of December 31, 2017 and 2016, and the results of its
operations and its cash flows for each of the years in the three year period ended December 31, 2017, in
conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United
States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2017, based on
criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring
Organizations of the Treadway Commission, and our report dated March 5, 2018 expressed an unqualified opinion
on the effectiveness of the Company’s internal control over financial reporting.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to
express an opinion on these consolidated financial statements based on our audits. We are a public accounting firm
registered with the PCAOB and are required to be independent with respect to the Company in accordance with the
U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and
the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of
material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks
of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing
procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the
amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting
principles used and significant estimates made by management, as well as evaluating the overall presentation of the
consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ KPMG AG Wirtschaftsprüfungsgesellschaft
We have served as the Company’s auditor since 2015.
Düsseldorf, Germany
March 5, 2018
FINANCIAL RESULTS
List of Subsidiaries
The following is a list of the Registrant’s subsidiaries as of December 31,
2017, other than certain subsidiaries that did not in the aggregate constitute a
significant subsidiary.
Company Name
Amnisure International, LLC
Cellestis Ltd.
MO BIO Laboratories, Inc.
QIAGEN Aarhus A/S
QIAGEN AB
QIAGEN AG
QIAGEN Australia Holding Pty. Ltd.
QIAGEN Benelux B.V.
QIAGEN Beverly, Inc.
QIAGEN China (Shanghai) Co. Ltd.
QIAGEN Deutschland Holding GmbH
QIAGEN Finance (Ireland) Ltd.
QIAGEN Finance (Malta) Ltd.
QIAGEN France S.A.S.
QIAGEN Gaithersburg, Inc.
QIAGEN GmbH
QIAGEN Hamburg GmbH
QIAGEN Inc. (Canada)
QIAGEN Inc. (USA)
QIAGEN Instruments AG
QIAGEN K.K.
QIAGEN Lake Constance GmbH
QIAGEN Ltd.
QIAGEN Manchester Ltd.
QIAGEN Marseille SA
QIAGEN North American Holdings Inc.
QIAGEN Pty. Ltd.
QIAGEN Redwood City, Inc.
QIAGEN Sciences, LLC
QIAGEN S.r.l.
QIAGEN U.S. Finance Holdings (Luxembourg) SARL
QIAGEN U.S. Finance, Inc.
QIAGEN Waltham, Inc.
Jurisdiction of Incorporation
USA
Australia
USA
Denmark
Sweden
Switzerland
Australia
Netherlands
USA
China
Germany
Ireland
Malta
France
USA
Germany
Germany
Canada
USA
Switzerland
Japan
Germany
UK
UK
France
USA
Australia
USA
USA
Italy
Luxembourg
USA
USA
APPENDIX
Service
CORPORATE COMMUNICATIONS
For Investors
Phone worldwide: +49 2103 29 11711
Phone U.S.: +1 240 686 2222
Email: IR@QIAGEN.COM
IR.QIAGEN.COM
For Media
Phone worldwide: +49 2103 29 11826
Phone U.S.: +1 240 686 7425
Email: PR@QIAGEN.COM
PR.QIAGEN.COM
QIAGEN on the web
https://corporate.QIAGEN.com
www.facebook.com/QIAGEN
www.twitter.com/QIAGEN
www.linkedin.com/company/QIAGEN
www.youtube.com/QIAGEN
FINANCIAL CALENDAR
First Quarter 2018 Results
May 2, 2018
Annual General Meeting of Shareholders of QIAGEN N.V.
June 19, 2018
Second Quarter 2018 Results
July 31, 2018
Third Quarter 2018 Results
October 29, 2018
Fourth Quarter 2018 Results
January 2019
Publication Date
March 2018
TRADEMARKS
Our name together with our logo is registered as a trademark in the United States and a number of other countries:
QIAGEN®.
For a complete list of QIAGEN’s trademarks and disclaimers, please refer to QIAGEN’s webpage under
www.QIAGEN.com/trademarks_disclaimers.aspx.
In this annual report QIAGEN uses the term molecular diagnostics. The use of this term is in reference to certain
countries, such as the United States, limited to products subject to regulatory requirements. As of February 2018,
QIAGEN molecular diagnostics products included 18 FDA (PMA approved or 510k cleared) products, 16 clinical
sample concentrator products (13 kits and 3 instruments), 62 EU CE IVD assays, 16 EU CE IVD sample preparation
products, 17 EU CE IVD instruments for sample purification or detection, 29 China CFDA IVD assays/sample
preparation and 13 China CFDA IVD instruments.
This Annual Report may also contain trade names or trademarks of companies other than QIAGEN.
© 2018 QIAGEN, all rights reserved.
This document contains detailed financial information about QIAGEN prepared under generally accepted
accounting standards in the U.S. (U.S. GAAP) and included in our Form 20-F annual report filed with the U.S.
Securities and Exchange Commission. QIAGEN also publishes an Annual Report under IFRS accounting standards,
which is available on our website at www.QIAGEN.com.