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☒
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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QUIDEL CORPORATION
(Exact name of registrant as specified in its charter)
|
Delaware
|
94-2573850
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common stock, $0.001 par value
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QDEL
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The Nasdaq Stock Market
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Large accelerated filer
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☒
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Accelerated filer
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☐
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Non-accelerated filer
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☐
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Smaller reporting company
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☐
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Emerging growth company
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☐
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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☐
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Page
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Part I
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Part II
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Part III
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Part IV
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•
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rapid immunoassay tests for use in physician offices, hospital laboratories and emergency departments, retail clinics, eye health settings, pharmacies and other urgent care or alternative site settings;
|
•
|
cardiac immunoassay tests for use in physician offices, hospital laboratories and emergency departments, and other urgent care or alternative site settings;
|
•
|
specialized diagnostic solutions, including direct fluorescent assays (“DFA”) and culture-based tests for the clinical virology laboratory and other products serving the bone health, autoimmune and complement research communities; and
|
•
|
molecular diagnostic tests for use in hospitals, moderately complex physician offices, laboratories and other settings.
|
•
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leveraging our current infrastructure to develop and launch new Rapid Immunoassays and Cardiac Immunoassays such as additional assays for our Sofia® and Sofia® 2 analyzers and Triage® MeterPro® systems;
|
•
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developing a molecular diagnostics franchise that incorporates distinct testing platforms, including Solana® and Savanna®, that leverages our molecular assay development competencies; and
|
•
|
strengthening our position with distribution partners and our end-user customers to gain more emphasis on our products.
|
•
|
provide products that can compete effectively in the healthcare market where cost and quality are important;
|
•
|
focus our research and development efforts on three areas:
|
•
|
new proprietary product platform development;
|
•
|
the creation of improved products and new products for existing markets and unmet clinical needs; and
|
•
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pursuit of collaborations with, or acquisitions of, other companies for new and existing products and markets that advance our strategy to develop differentiated technologies and products;
|
•
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leverage our international infrastructure and enhance our global footprint to support our international operations and future growth;
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•
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strengthen our market and brand leadership in current markets by acquiring and/or developing and introducing clinically superior diagnostic solutions;
|
•
|
strengthen our direct sales force to enhance relationships with integrated delivery networks, laboratories and hospitals, with a goal of driving growth through improved physician and laboratorian satisfaction;
|
•
|
leverage our wireless connectivity and data management systems, including cloud-based tools;
|
•
|
support payer evaluation of diagnostic tests and establishment of favorable reimbursement rates;
|
•
|
provide clinicians with validated studies that encompass the clinical efficacy and economic efficiency of our diagnostic tests for the professional market;
|
•
|
pursue potential acquisitions and create strong global alliances to support our efforts to achieve leadership in key markets and expand our presence in emerging markets;
|
•
|
further refine our manufacturing efficiencies and productivity improvements to increase profit; and
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•
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focus on innovative products and markets and leverage our core competency in new product development.
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•
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Out-of-hospital testing sites consist of physicians’ office laboratories, nursing homes, pharmacies, eye health offices, retail clinics and other non-institutional, ambulatory settings in which healthcare providers perform diagnostic tests.
|
•
|
Hospital POC testing is accepted and growing and is generally an extension of the hospital’s central laboratory. Hospitals in the U.S. have progressively sought to reduce the length of patient stays and, consequently, the proportion of cases seen as outpatients has increased. If the U.S. experience is representative of future trends,
|
•
|
new proprietary product platform development,
|
•
|
the creation of improved products and new products for existing markets and unmet clinical needs, and
|
•
|
pursuit of collaborations with, or acquisitions of, other companies for new and existing products and markets that advance our differentiated strategy.
|
•
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timing of the onset, length and severity of the cold and flu seasons;
|
•
|
seasonal fluctuations in our sales of influenza disease tests, which are generally highest in fall and winter, thus resulting in generally lower operating results in the second and third calendar quarters and higher operating results in the first and fourth calendar quarters;
|
•
|
government and media attention focused on influenza and the related potential impact on humans from novel influenza viruses, such as H1N1 and avian flu;
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•
|
changes in the level of competition, such as would occur if one of our competitors introduced a new, better performing or lower priced product to compete with one or more of our products;
|
•
|
changes in the reimbursement systems or reimbursement amounts that end-users may rely upon in choosing to use our products;
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•
|
changes in economic conditions in our domestic and international markets, such as economic downturns, decreased healthcare spending, reduced consumer demand, inflation and currency fluctuations and changes in government laws and regulations affecting our business;
|
•
|
lower than anticipated market penetration of our new or more recently introduced products;
|
•
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significant quantities of our products or those of our competitors in our distributors’ inventories or distribution channels;
|
•
|
changes in distributor buying patterns; and
|
•
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changes in the healthcare market, including consolidation in our customer base.
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•
|
We have issued patents both in the U.S. and internationally, with expiration dates ranging from the present through approximately 2036. In addition to our patents in the U.S., we have patents issued in various other countries including, among others, Australia, Canada, Japan, various European countries, including France, Germany, Italy, Spain and the United Kingdom, and South Africa. Additionally, we have patent applications pending in the U.S. and various foreign jurisdictions. These pending patent applications may not result in the issuance of any patents, or if issued, may not have priority over others’ applications or may not offer meaningful protection against competitors with similar technology or may not otherwise provide commercial value. Moreover, any patents
|
•
|
We also license the right to use our products to our customers under label licenses that are for research purposes only. These licenses could be contested and, because we cannot monitor all potential unauthorized uses of our proprietary technology around the world, we might not be aware of an unauthorized use or might not be able to enforce the license restrictions in a cost-effective manner.
|
•
|
Our current and future licenses may not be adequate for the operation of our business. In the future, we expect that we will require or desire additional licenses from other parties in order to refine our products further and to allow us to develop, manufacture and market commercially viable or superior products. We may not be able to obtain licenses for technology patented by others and required to produce our products on commercially reasonable terms, if at all.
|
•
|
it may of itself cause our distributors or end-users to reduce or terminate purchases of our products;
|
•
|
it may consume a substantial portion of our managerial and financial resources;
|
•
|
the outcome of such litigation would be uncertain and a court may find any third-party patent claims valid and infringed by our products (issuing a preliminary or permanent injunction) that would require us to procure costly licensing arrangements from third parties or withdraw or recall such products from the market, redesign such products offered for sale or under development or restrict employees from performing work in their areas of expertise;
|
•
|
governmental agencies may commence investigations or criminal proceedings against our employees, former employees and us relating to claims of misappropriation or misuse of another party’s proprietary rights;
|
•
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an adverse outcome could subject us to significant liability in the form of past royalty payments, penalties, special and punitive damages, the opposing party’s attorneys’ fees, and future royalty payments significantly affecting our future earnings; and
|
•
|
failure to obtain a necessary license (upon commercially reasonable terms, if at all) upon an adverse outcome could prevent us from selling our current products or other products we may develop.
|
•
|
our competitors’ products are more effective than ours or take market share from our products through more effective marketing or competitive pricing;
|
•
|
our competitors obtain patent protection or other intellectual property rights that prevent us from offering competing products or services; or
|
•
|
our competitors are able to obtain regulatory approvals for products or services or otherwise bring competing products to market earlier than us.
|
•
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compliance with multiple different registration requirements and new and changing product registration requirements, our inability to benefit from registration for our products inasmuch as registrations may be controlled by a distributor, and the difficulty in transitioning our product registrations;
|
•
|
compliance with complex foreign and U.S. laws and regulations that apply to our international operations, including U.S. laws such as import/export limitations, the Foreign Corrupt Practices Act, and local laws prohibiting corrupt payments to governmental officials, could expose us or our employees to fines and criminal sanctions and damage our reputation;
|
•
|
tariffs or other barriers as we continue to expand into new countries and geographic regions;
|
•
|
exposure to currency exchange fluctuations against the U.S. dollar;
|
•
|
longer payment cycles, generally lower average selling prices and greater difficulty in accounts receivable collection and enforcing agreements with foreign entities;
|
•
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reduced, or lack of, protection for, and enforcement of, intellectual property rights;
|
•
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social, political and economic instability in some of the regions where we currently sell our products or that we may expand into in the future, including as a result of acts of terrorism, health pandemics, natural disasters and disruptions in global transportation;
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•
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increased financial accounting and reporting burdens and complexities;
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•
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complex and potentially adverse tax consequences; and
|
•
|
diversion to the U.S. of our products sold into international markets at lower prices.
|
•
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inability to obtain financing for acquisitions on satisfactory terms, or at all;
|
•
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difficulties transitioning and integrating the operations of companies or technologies that we acquire with our own operations, including difficulties integrating personnel, information systems, and internal control systems;
|
•
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diversion of the attention of management and key personnel from our core business and other potential beneficial opportunities;
|
•
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adverse effects on our existing business relationships;
|
•
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potential loss of management and other key employees of the acquired businesses and inability to attract new employees;
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•
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potential litigation arising from the acquired business’s operations;
|
•
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potential contractual, regulatory, compliance, intellectual property or employment issues;
|
•
|
increased exposure to international operations and sales, including fluctuations in foreign currency; and other economic, political and regulatory risks;
|
•
|
write-downs of goodwill, intangible assets or other assets associated with the acquisitions; and
|
•
|
we may not realize our anticipated benefits and cost savings within our expected time frame, or at all, or may experience unexpected costs and expenditures.
|
•
|
we may experience business interruptions during and after the transition and integration process
|
•
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we may not realize the anticipated benefits of the acquisitions, including those anticipated to arise from making product and process improvements and developing new products;
|
•
|
we may incur substantial unexpected integration or transition related costs;
|
•
|
the deferred consideration payable to Alere for the BNP Business will be payable even if BNP sales are significantly reduced, or even terminate, whether as a result of the introduction of a competing product, a determination that provisions of the contractual arrangement with Beckman are unenforceable or otherwise, and such payment obligations may significantly exceed the revenues from such business;
|
•
|
we may not be able to successfully or efficiently manage our foreign expansion, and the acquired businesses will increase our exposure and risks related to foreign markets;
|
•
|
we may be subject to claims, litigation, other legal proceedings and liabilities and damages in connection with the businesses and assets acquired in the acquisition, which may not be covered in full, if at all, by the indemnification provisions provided for in the acquisition agreements, and even if indemnified, may be disruptive to our business;
|
•
|
in certain international markets, the marketing authorizations to sell the acquired products are being held by Alere post-closing until the authorizations can be transferred to us or new ones issued through the applicable regulatory process, and such markets have additional risks, including:
|
◦
|
we may not timely receive such authorizations, if at all, or may encounter unexpected difficulties and costs in receiving the authorizations or required regulatory approvals or clearances relating to the acquired businesses, or may lose previously received regulatory approvals or clearances; and
|
◦
|
Alere may be unable or unwilling to satisfy its performance obligations under these arrangements.
|
•
|
our ability to obtain additional financing in the future for working capital, capital expenditures, acquisitions and general corporate purposes may be impaired;
|
•
|
a significant portion of our cash flow from operating activities must be dedicated to the payment of our deferred and contingent payment obligations, which reduces the funds available to us for our operations and may limit our ability to engage in acts that may be in our long-term best interests;
|
•
|
our debt agreements contain, and any agreements to refinance our debt likely will contain, financial and other restrictive covenants, and our failure to comply with them may result in an event of default, which, if not cured or waived, could have a material adverse effect on us;
|
•
|
our level of indebtedness and deferred and contingent payment obligations may increase our vulnerability to, and reduce our flexibility to respond to, general economic downturns and adverse industry and business conditions;
|
•
|
to the extent the debt we incur requires collateral to secure such indebtedness, our assets could be at risk and our flexibility related to such assets could be limited
|
•
|
our debt service and deferred and contingent payment obligations could limit our flexibility in planning for, or reacting to, changes in our business and industry; and
|
•
|
any borrowings under our Revolving Credit Facility will be at variable rates of interest, which may result in higher interest expense in the event of market interest rates.
|
•
|
requiring us to dedicate a substantial portion of our cash flows from operations to payments on our debt;
|
•
|
limiting our ability to obtain future financing for working capital, capital expenditures, acquisitions, debt obligations and other general corporate requirements;
|
•
|
making us more vulnerable to adverse conditions in the general economy or our industry and to fluctuations in our operating results, including affecting our ability to comply with and maintain any financial tests and ratios required under our indebtedness;
|
•
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limiting our flexibility to engage in certain transactions or to plan for, or react to, changes in our business and the diagnostics industry;
|
•
|
putting us at a disadvantage compared to competitors that have less relative and/or less restrictive debt; and
|
•
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subjecting us to additional restrictive financial and other covenants.
|
•
|
incur additional debt, including guarantees;
|
•
|
allow other liens on our property;
|
•
|
make certain investments and acquisitions;
|
•
|
sell or otherwise dispose of assets;
|
•
|
engage in mergers or consolidations or allow a change in control to occur;
|
•
|
make distributions to our stockholders;
|
•
|
engage in restructuring activities;
|
•
|
enter into transaction with affiliates;
|
•
|
prepay or amend other indebtedness;
|
•
|
engage in certain sale and leaseback transactions; and
|
•
|
issue or repurchase stock or other securities.
|
•
|
announcements by us or our competitors concerning technological innovations;
|
•
|
introductions of new products;
|
•
|
FDA and foreign regulatory actions;
|
•
|
adverse litigation developments;
|
•
|
developments or disputes relating to patents or proprietary rights;
|
•
|
failure to meet the expectations of stock market analysts and investors;
|
•
|
changes in stock market analyst recommendations regarding our common stock;
|
•
|
changes in healthcare policy in the U.S. or other countries; and
|
•
|
general stock market conditions and other factors unrelated to our operating performance.
|
Location
|
|
Status
|
|
Lease term
|
|
Square
Footage
|
|
Primary Use
|
|
San Diego, CA (Summers Ridge)
|
|
Leased
|
(1)
|
2033 - options to extend for two additional 5-year periods
|
|
246,000
|
|
|
Administrative offices, sales and marketing, research and development and manufacturing (principal executive offices)
|
San Diego, CA (McKellar)
|
|
Leased
|
|
2020 - options to extend for three additional 5-year periods
|
|
78,000
|
|
|
Administrative offices, research and development and manufacturing
|
San Diego, CA (High Bluff)
|
|
Leased
|
|
2022 - options to extend for two additional 5-year periods
|
|
30,000
|
|
|
This facility was vacated in 2019 and sublet to a third party in 2020.
|
Athens, OH
|
|
Leased
|
|
2022 - option to extend for one additional 5-year period
|
|
94,000
|
|
|
Administrative offices, sales and marketing, research and development and manufacturing
|
Beverly, MA
|
|
Leased
|
|
2023 - option to extend for one additional 3-year period
|
|
9,700
|
|
|
Administrative offices, research and development and manufacturing
|
Shanghai, China
|
|
Leased
|
|
2021 - option to extend for one additional 2-year period
|
|
8,500
|
|
|
Administrative offices, sales and marketing
|
Galway, Ireland
|
|
Leased
|
|
2028
|
|
3,900
|
|
|
Administrative offices, sales and marketing
|
(1)
|
The Summers Ridge lease is subject to certain must-take provisions related to one additional building, consisting of approximately 71,000 square feet. See Note 8 in the Consolidated Financial Statements in Part II, Item 8 of this Annual Report.
|
Period
|
|
Total number of shares purchased (1)
|
|
Average price paid per share
|
|
Total number of shares purchased as part of publicly announced plans or programs
|
|
Approximate dollar value of shares that may yet be purchased under the plans or programs (2)
|
||||||
September 30, 2019 - October 27, 2019
|
|
8,384
|
|
|
$
|
57.72
|
|
|
—
|
|
|
$
|
50,000,000
|
|
October 28, 2019 - November 24, 2019
|
|
3,253
|
|
|
62.91
|
|
|
—
|
|
|
50,000,000
|
|
||
November 25, 2019 - December 29, 2019
|
|
252,342
|
|
|
65.82
|
|
|
—
|
|
|
50,000,000
|
|
||
Total
|
|
263,979
|
|
|
$
|
65.53
|
|
|
—
|
|
|
$
|
50,000,000
|
|
|
Base Period
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Company/Index
|
12/31/2014
|
|
12/31/2015
|
|
12/31/2016
|
|
12/31/2017
|
|
12/31/2018
|
|
12/31/2019
|
||||||||||||
Quidel Corporation
|
$
|
100.00
|
|
|
$
|
73.31
|
|
|
$
|
74.07
|
|
|
$
|
149.90
|
|
|
$
|
168.81
|
|
|
$
|
259.44
|
|
NASDAQ Composite
|
$
|
100.00
|
|
|
$
|
105.73
|
|
|
$
|
113.66
|
|
|
$
|
145.76
|
|
|
$
|
140.10
|
|
|
$
|
189.45
|
|
NASDAQ US Benchmark Medical Supplies
|
$
|
100.00
|
|
|
$
|
109.57
|
|
|
$
|
123.86
|
|
|
$
|
161.69
|
|
|
$
|
153.18
|
|
|
$
|
226.34
|
|
NASDAQ Health Care
|
$
|
100.00
|
|
|
$
|
106.86
|
|
|
$
|
88.78
|
|
|
$
|
107.70
|
|
|
$
|
103.21
|
|
|
$
|
129.87
|
|
Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
|
||||||||||
|
Year ended December 31,
|
||||||||||||||||||
|
2019
|
|
2018
|
|
2017 (1)
|
|
2016 (1)
|
|
2015
|
||||||||||
|
|
|
(in thousands, except per share data)
|
||||||||||||||||
Total revenues
|
$
|
534,890
|
|
|
$
|
522,285
|
|
|
$
|
277,743
|
|
|
$
|
191,603
|
|
|
$
|
196,129
|
|
Cost of sales
|
214,085
|
|
|
206,572
|
|
|
121,601
|
|
|
79,872
|
|
|
78,029
|
|
|||||
Gross profit
|
320,805
|
|
|
315,713
|
|
|
156,142
|
|
|
111,731
|
|
|
118,100
|
|
|||||
Research and development
|
52,553
|
|
|
51,649
|
|
|
33,644
|
|
|
38,672
|
|
|
35,514
|
|
|||||
Sales and marketing
|
111,114
|
|
|
108,987
|
|
|
67,248
|
|
|
50,436
|
|
|
50,401
|
|
|||||
General and administrative
|
52,755
|
|
|
44,951
|
|
|
29,192
|
|
|
26,351
|
|
|
27,057
|
|
|||||
Acquisition and integration costs
|
11,667
|
|
|
14,197
|
|
|
16,506
|
|
|
711
|
|
|
2,390
|
|
|||||
Total operating expenses
|
228,089
|
|
|
219,784
|
|
|
146,590
|
|
|
116,170
|
|
|
115,362
|
|
|||||
Operating income (loss)
|
92,716
|
|
|
95,929
|
|
|
9,552
|
|
|
(4,439
|
)
|
|
2,738
|
|
|||||
Other expense, net
|
|
|
|
|
|
|
|
|
|
||||||||||
Interest expense, net
|
(14,790
|
)
|
|
(24,283
|
)
|
|
(17,588
|
)
|
|
(12,181
|
)
|
|
(12,035
|
)
|
|||||
Loss on extinguishment of debt
|
(748
|
)
|
|
(8,262
|
)
|
|
—
|
|
|
421
|
|
|
—
|
|
|||||
Total other expense, net
|
(15,538
|
)
|
|
(32,545
|
)
|
|
(17,588
|
)
|
|
(11,760
|
)
|
|
(12,035
|
)
|
|||||
Income (loss) before income taxes
|
77,178
|
|
|
63,384
|
|
|
(8,036
|
)
|
|
(16,199
|
)
|
|
(9,297
|
)
|
|||||
Provision (Benefit) for income taxes
|
4,257
|
|
|
(10,799
|
)
|
|
129
|
|
|
(2,391
|
)
|
|
(3,218
|
)
|
|||||
Net income (loss)
|
$
|
72,921
|
|
|
$
|
74,183
|
|
|
$
|
(8,165
|
)
|
|
$
|
(13,808
|
)
|
|
$
|
(6,079
|
)
|
Basic earnings (loss) per share
|
$
|
1.78
|
|
|
$
|
1.95
|
|
|
$
|
(0.24
|
)
|
|
$
|
(0.42
|
)
|
|
$
|
(0.18
|
)
|
Diluted earnings (loss) per share
|
$
|
1.73
|
|
|
$
|
1.86
|
|
|
$
|
(0.24
|
)
|
|
$
|
(0.42
|
)
|
|
$
|
(0.18
|
)
|
Shares used in basic per share calculation
|
40,860
|
|
|
37,995
|
|
|
33,734
|
|
|
32,708
|
|
|
34,104
|
|
|||||
Shares used in diluted per share calculation
|
43,111
|
|
|
42,554
|
|
|
33,734
|
|
|
32,708
|
|
|
34,104
|
|
Balance Sheet Data
|
|
|
|
|
|
|
|
|
|
||||||||||
|
December 31,
|
||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||||
|
2019
|
|
2018
|
|
2017 (1)
|
|
2016 (1)
|
|
2015
|
||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||||
|
|
|
(in thousands)
|
||||||||||||||||
Cash and cash equivalents
|
$
|
52,775
|
|
|
$
|
43,695
|
|
|
$
|
36,086
|
|
|
$
|
169,508
|
|
|
$
|
191,471
|
|
Working capital
|
$
|
96,336
|
|
|
$
|
33,662
|
|
|
$
|
202,881
|
|
|
$
|
191,782
|
|
|
$
|
209,834
|
|
Adjusted working capital (2)
|
$
|
108,997
|
|
|
$
|
88,041
|
|
|
$
|
202,881
|
|
|
$
|
191,782
|
|
|
$
|
209,834
|
|
Total assets
|
$
|
910,867
|
|
|
$
|
806,371
|
|
|
$
|
935,251
|
|
|
$
|
388,250
|
|
|
$
|
406,505
|
|
Long-term debt and lease obligation, net of current portions
|
$
|
4,375
|
|
|
$
|
56,865
|
|
|
$
|
381,110
|
|
|
$
|
148,319
|
|
|
$
|
147,329
|
|
Stockholders’ equity
|
$
|
559,820
|
|
|
$
|
425,584
|
|
|
$
|
227,104
|
|
|
$
|
200,630
|
|
|
$
|
218,676
|
|
Common shares outstanding
|
41,868
|
|
|
39,386
|
|
|
34,540
|
|
|
32,897
|
|
|
33,323
|
|
(1)
|
Includes the results of operations of the Immutopics, Inc., RPS Diagnostics and Triage and BNP Businesses, from dates of acquisition, March 18, 2016, May 16, 2017 and October 6, 2017, respectively.
|
(2)
|
Adjusted working capital as of December 31, 2019 and December 31, 2018 excludes the current portion of the Convertible Senior Notes of $12.7 million and $54.4 million, respectively, as such notes may be settled at the Company’s option in cash or a combination of cash and shares of common stock.
|
•
|
rapid immunoassay tests for use in physician offices, hospital laboratories and emergency departments, retail clinics, eye health settings, pharmacies and other urgent care or alternative site settings;
|
•
|
cardiac immunoassay tests for use in physician offices, hospital laboratories and emergency departments, and other urgent care or alternative site settings;
|
•
|
specialized diagnostic solutions, including DFA and culture-based tests for the clinical virology laboratory and other products serving the bone health, autoimmune and complement research communities; and
|
•
|
molecular diagnostic tests for use in hospitals, moderately complex physician offices, laboratories and other settings.
|
•
|
leveraging our current infrastructure to develop and launch new Rapid Immunoassays and Cardiac Immunoassays such as additional assays for our Sofia® and Sofia® 2 analyzers and Triage® MeterPro® systems;
|
•
|
developing a molecular diagnostics franchise that incorporates distinct testing platforms, including Solana® and Savanna®, that leverages our molecular assay development competencies; and
|
•
|
strengthening our position with distribution partners and our end-user customers to gain more emphasis on our products.
|
•
|
provide products that can compete effectively in the healthcare market where cost and quality are important;
|
•
|
focus our research and development efforts on three areas:
|
•
|
new proprietary product platform development;
|
•
|
the creation of improved products and new products for existing markets and unmet clinical needs; and
|
•
|
pursuit of collaborations with, or acquisitions of, other companies for new and existing products and markets that advance our strategy to develop differentiated technologies and products;
|
•
|
leverage our international infrastructure and enhance our global footprint to support our international operations and future growth;
|
•
|
strengthen our market and brand leadership in current markets by acquiring and/or developing and introducing clinically superior diagnostic solutions;
|
•
|
strengthen our direct sales force to enhance relationships with integrated delivery networks, laboratories and hospitals, with a goal of driving growth through improved physician and laboratorian satisfaction;
|
•
|
leverage our wireless connectivity and data management systems, including cloud-based tools;
|
•
|
support payer evaluation of diagnostic tests and establishment of favorable reimbursement rates;
|
•
|
provide clinicians with validated studies that encompass the clinical efficacy and economic efficiency of our diagnostic tests for the professional market;
|
•
|
create strong global alliances to support our efforts to achieve leadership in key markets and expand our presence in emerging markets;
|
•
|
further refine our manufacturing efficiencies and productivity improvements to increase profit; and
|
•
|
focus on innovative products and markets and leverage our core competency in new product development.
|
|
|
For the year ended December 31,
|
|
Increase (decrease)
|
|||||||||||
|
|
2019
|
|
2018
|
|
$
|
|
%
|
|||||||
Rapid Immunoassay
|
|
$
|
191,736
|
|
|
$
|
183,160
|
|
|
$
|
8,576
|
|
|
5
|
%
|
Cardiac Immunoassay
|
|
266,505
|
|
|
266,524
|
|
|
(19
|
)
|
|
0
|
%
|
|||
Specialized Diagnostic Solutions
|
|
54,933
|
|
|
53,243
|
|
|
1,690
|
|
|
3
|
%
|
|||
Molecular Diagnostic Solutions
|
|
21,716
|
|
|
19,358
|
|
|
2,358
|
|
|
12
|
%
|
|||
Total revenues
|
|
$
|
534,890
|
|
|
$
|
522,285
|
|
|
$
|
12,605
|
|
|
2
|
%
|
|
For the year ended December 31,
|
|
Increase (decrease)
|
|||||||||||
|
2019
|
|
2018
|
|
$
|
|
%
|
|||||||
Interest and other expense, net
|
$
|
14,790
|
|
|
$
|
24,283
|
|
|
$
|
(9,493
|
)
|
|
(39
|
)%
|
Loss on extinguishment of debt
|
748
|
|
|
8,262
|
|
|
(7,514
|
)
|
|
(91
|
)%
|
|||
Total other expense, net
|
$
|
15,538
|
|
|
$
|
32,545
|
|
|
$
|
(17,007
|
)
|
|
(52
|
)%
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Cash, cash equivalents, and restricted cash
|
$
|
52,775
|
|
|
$
|
43,695
|
|
Amount available to borrow under the Revolving Credit Facility
|
$
|
175,000
|
|
|
$
|
121,812
|
|
Working capital including cash, cash equivalents, and restricted cash
|
$
|
96,336
|
|
|
$
|
33,662
|
|
Adjusted working capital (1)
|
$
|
108,997
|
|
|
$
|
88,041
|
|
•
|
support of commercialization efforts related to our current and future products, including support of our direct sales force and field support resources;
|
•
|
interest on and repayments of our Convertible Senior Notes, deferred consideration, contingent consideration and lease obligations;
|
•
|
the continued advancement of research and development efforts;
|
•
|
acquisitions of equipment and other fixed assets for use in our current and future manufacturing and research and development facilities; and
|
•
|
potential strategic acquisitions and investments.
|
•
|
our ability to realize revenue growth from our new technologies and create innovative products in our markets;
|
•
|
our outstanding debt and covenant restrictions;
|
•
|
our ability to leverage our operating expenses to realize operating profits as we grow revenue;
|
•
|
competing technological and market developments; and
|
•
|
the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement our product and service offerings.
|
|
Year ended December 31,
|
||||||
(in thousands)
|
2019
|
|
2018
|
||||
Net cash provided by operating activities
|
$
|
134,485
|
|
|
$
|
136,345
|
|
Net cash (used for) provided by investing activities
|
(27,229
|
)
|
|
114,955
|
|
||
Net cash used for financing activities
|
(98,282
|
)
|
|
(244,058
|
)
|
||
Effect of exchange rate changes on cash
|
106
|
|
|
367
|
|
||
Net increase in cash and cash equivalents
|
$
|
9,080
|
|
|
$
|
7,609
|
|
|
Payment due by period
|
||||||||||||||||||
|
Total
|
|
Less than
1 year
|
|
1-3
Years
|
|
3-5
Years
|
|
More than
5 years
|
||||||||||
Convertible Senior Notes (1)
|
$
|
13,558
|
|
|
$
|
13,558
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Deferred consideration (2)
|
166,000
|
|
|
42,000
|
|
|
84,000
|
|
|
40,000
|
|
|
—
|
|
|||||
Finance lease obligation (3)
|
8,314
|
|
|
1,264
|
|
|
2,554
|
|
|
2,399
|
|
|
2,097
|
|
|||||
Operating lease obligations (4)
|
130,455
|
|
|
10,603
|
|
|
20,648
|
|
|
18,904
|
|
|
80,300
|
|
|||||
Non-cancelable purchase commitment (5)
|
15,079
|
|
|
13,464
|
|
|
453
|
|
|
327
|
|
|
835
|
|
|||||
Total contractual obligations
|
$
|
333,406
|
|
|
$
|
80,889
|
|
|
$
|
107,655
|
|
|
$
|
61,630
|
|
|
$
|
83,232
|
|
(1)
|
Includes the principal amount of our Convertible Senior Notes due in December 2020, as well as interest payments to be made semi-annually.
|
(2)
|
Reflects the deferred consideration payments related to the acquisition of the BNP Business.
|
(3)
|
Reflects our finance lease obligation primarily on the approximately 78,000 square-foot McKellar San Diego facility. The lease expires in December 2020 with options to extend for three additional 5-year periods. Finance lease obligations include payments through December 2025.
|
(4)
|
Reflects future minimum lease obligations on facilities and equipment under operating leases in place as of December 31, 2019. The lease for the Summers Ridge facility is subject to certain must-take provisions related to one additional building that is not included in the operating lease obligations.
|
(5)
|
Reflects our $15.1 million of non-cancelable commitments for planned inventory purchases under contractual arrangements.
|
•
|
the asset’s ability to continue to generate income from operations and positive cash flow in future periods;
|
•
|
any volatility or significant decline in our stock price and market capitalization compared to our net book value;
|
•
|
loss of legal ownership or title to an asset;
|
•
|
significant changes in our strategic business objectives and utilization of our assets; and
|
•
|
the impact of significant negative industry or economic trends.
|
Currency
|
|
Year ended December 31, 2019
|
||
Chinese Renminbi
|
|
$
|
615
|
|
Euro
|
|
$
|
381
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
52,775
|
|
|
$
|
43,695
|
|
Accounts receivable, net
|
94,496
|
|
|
58,677
|
|
||
Inventories
|
58,086
|
|
|
67,379
|
|
||
Prepaid expenses and other current assets
|
16,870
|
|
|
23,646
|
|
||
Total current assets
|
222,227
|
|
|
193,397
|
|
||
Property, plant and equipment, net
|
79,762
|
|
|
73,901
|
|
||
Right-of-use assets
|
92,119
|
|
|
—
|
|
||
Goodwill
|
337,018
|
|
|
337,021
|
|
||
Intangible assets, net
|
148,112
|
|
|
175,029
|
|
||
Deferred tax asset
|
24,502
|
|
|
22,192
|
|
||
Other non-current assets
|
7,127
|
|
|
4,831
|
|
||
Total assets
|
$
|
910,867
|
|
|
$
|
806,371
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
26,701
|
|
|
$
|
25,171
|
|
Accrued payroll and related expenses
|
17,286
|
|
|
19,210
|
|
||
Operating lease liabilities
|
6,412
|
|
|
—
|
|
||
Contingent consideration
|
5,969
|
|
|
3,983
|
|
||
Deferred consideration
|
42,000
|
|
|
44,000
|
|
||
Convertible Senior Notes
|
12,661
|
|
|
54,379
|
|
||
Other current liabilities
|
14,862
|
|
|
12,992
|
|
||
Total current liabilities
|
125,891
|
|
|
159,735
|
|
||
Operating lease liabilities - non-current
|
93,227
|
|
|
—
|
|
||
Revolving Credit Facility - non-current
|
—
|
|
|
53,188
|
|
||
Deferred consideration - non-current
|
109,382
|
|
|
143,158
|
|
||
Contingent consideration - non-current
|
10,566
|
|
|
15,129
|
|
||
Other non-current liabilities
|
11,981
|
|
|
9,577
|
|
||
Commitments and contingencies (Note 8)
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, $.001 par value per share; 5,000 shares authorized; none issued or outstanding at December 31, 2019 and 2018
|
—
|
|
|
—
|
|
||
Common stock, $.001 par value per share; 97,500 shares authorized; 41,868 and 39,386 shares issued and outstanding at December 31, 2019 and 2018, respectively
|
42
|
|
|
39
|
|
||
Additional paid-in capital
|
425,557
|
|
|
363,921
|
|
||
Accumulated other comprehensive loss
|
(463
|
)
|
|
(139
|
)
|
||
Retained earnings
|
134,684
|
|
|
61,763
|
|
||
Total stockholders’ equity
|
559,820
|
|
|
425,584
|
|
||
Total liabilities and stockholders’ equity
|
$
|
910,867
|
|
|
$
|
806,371
|
|
|
Year ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Total revenues
|
$
|
534,890
|
|
|
$
|
522,285
|
|
|
$
|
277,743
|
|
Cost of sales
|
214,085
|
|
|
206,572
|
|
|
121,601
|
|
|||
Gross profit
|
320,805
|
|
|
315,713
|
|
|
156,142
|
|
|||
Research and development
|
52,553
|
|
|
51,649
|
|
|
33,644
|
|
|||
Sales and marketing
|
111,114
|
|
|
108,987
|
|
|
67,248
|
|
|||
General and administrative
|
52,755
|
|
|
44,951
|
|
|
29,192
|
|
|||
Acquisition and integration costs
|
11,667
|
|
|
14,197
|
|
|
16,506
|
|
|||
Total operating expenses
|
228,089
|
|
|
219,784
|
|
|
146,590
|
|
|||
Operating income
|
92,716
|
|
|
95,929
|
|
|
9,552
|
|
|||
Other expense, net
|
|
|
|
|
|
||||||
Interest and other expense, net
|
(14,790
|
)
|
|
(24,283
|
)
|
|
(17,588
|
)
|
|||
Loss on extinguishment of debt
|
(748
|
)
|
|
(8,262
|
)
|
|
—
|
|
|||
Total other expense, net
|
(15,538
|
)
|
|
(32,545
|
)
|
|
(17,588
|
)
|
|||
Income (loss) before income taxes
|
77,178
|
|
|
63,384
|
|
|
(8,036
|
)
|
|||
Provision (benefit) for income taxes
|
4,257
|
|
|
(10,799
|
)
|
|
129
|
|
|||
Net income (loss)
|
$
|
72,921
|
|
|
$
|
74,183
|
|
|
$
|
(8,165
|
)
|
Basic earnings (loss) per share
|
$
|
1.78
|
|
|
$
|
1.95
|
|
|
$
|
(0.24
|
)
|
Diluted earnings (loss) per share
|
$
|
1.73
|
|
|
$
|
1.86
|
|
|
$
|
(0.24
|
)
|
Shares used in basic per share calculation
|
40,860
|
|
|
37,995
|
|
|
33,734
|
|
|||
Shares used in diluted per share calculation
|
43,111
|
|
|
42,554
|
|
|
33,734
|
|
|
Year ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Net income (loss)
|
$
|
72,921
|
|
|
$
|
74,183
|
|
|
$
|
(8,165
|
)
|
Other comprehensive income (loss)
|
|
|
|
|
|
||||||
Changes in cumulative translation adjustment, net of tax
|
(322
|
)
|
|
(139
|
)
|
|
53
|
|
|||
Changes in unrealized gains (losses) from cash flow hedges:
|
|
|
|
|
|
||||||
Net unrealized gains on derivative instruments
|
716
|
|
|
—
|
|
|
—
|
|
|||
Reclassification of net realized gains on derivative instruments included in net income
|
(718
|
)
|
|
—
|
|
|
—
|
|
|||
Total change in unrealized losses realized from cash flow hedges, net of tax
|
(2
|
)
|
|
—
|
|
|
—
|
|
|||
Comprehensive income (loss)
|
$
|
72,597
|
|
|
$
|
74,044
|
|
|
$
|
(8,112
|
)
|
|
Common Stock
|
|
|
|
|
|
|
|
|
|||||||||||||
|
Shares
|
|
Par
|
|
Additional
paid-in
capital
|
|
Accumulated
other
comprehensive loss
|
|
Retained
earnings (accumulated
deficit)
|
|
Total
stockholders’
equity
|
|||||||||||
Balance at January 1, 2017
|
32,897
|
|
|
$
|
33
|
|
|
$
|
204,905
|
|
|
$
|
(53
|
)
|
|
$
|
(4,255
|
)
|
|
$
|
200,630
|
|
Issuance of common stock under equity compensation plans
|
1,669
|
|
|
2
|
|
|
26,077
|
|
|
—
|
|
|
—
|
|
|
26,079
|
|
|||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
9,048
|
|
|
—
|
|
|
—
|
|
|
9,048
|
|
|||||
Repurchases of common stock
|
(26
|
)
|
|
—
|
|
|
(541
|
)
|
|
—
|
|
|
—
|
|
|
(541
|
)
|
|||||
Changes in cumulative translation adjustment, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
53
|
|
|
—
|
|
|
53
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(8,165
|
)
|
|
(8,165
|
)
|
|||||
Balance at December 31, 2017
|
34,540
|
|
|
35
|
|
|
239,489
|
|
|
—
|
|
|
(12,420
|
)
|
|
227,104
|
|
|||||
Issuance of common stock under equity compensation plans
|
1,237
|
|
|
—
|
|
|
17,047
|
|
|
—
|
|
|
—
|
|
|
17,047
|
|
|||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
10,078
|
|
|
—
|
|
|
—
|
|
|
10,078
|
|
|||||
Issuance of shares in exchange for Convertible Senior Notes
|
3,699
|
|
|
4
|
|
|
200,215
|
|
|
—
|
|
|
—
|
|
|
200,219
|
|
|||||
Tax impact from the conversion of Convertible Senior Notes
|
—
|
|
|
—
|
|
|
2,162
|
|
|
—
|
|
|
—
|
|
|
2,162
|
|
|||||
Reduction for equity component of Convertible Senior Notes exchanged
|
—
|
|
|
—
|
|
|
(100,726
|
)
|
|
—
|
|
|
—
|
|
|
(100,726
|
)
|
|||||
Repurchases of common stock
|
(90
|
)
|
|
—
|
|
|
(4,344
|
)
|
|
—
|
|
|
—
|
|
|
(4,344
|
)
|
|||||
Changes in cumulative translation adjustment, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
(139
|
)
|
|
—
|
|
|
(139
|
)
|
|||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
74,183
|
|
|
74,183
|
|
|||||
Balance at December 31, 2018
|
39,386
|
|
|
39
|
|
|
363,921
|
|
|
(139
|
)
|
|
61,763
|
|
|
425,584
|
|
|||||
Issuance of common stock under equity compensation plans
|
1,152
|
|
|
2
|
|
|
16,797
|
|
|
—
|
|
|
—
|
|
|
16,799
|
|
|||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
12,088
|
|
|
—
|
|
|
—
|
|
|
12,088
|
|
|||||
Issuance of shares in exchange for Convertible Senior Notes
|
1,497
|
|
|
1
|
|
|
86,427
|
|
|
—
|
|
|
—
|
|
|
86,428
|
|
|||||
Tax impact from the conversion of Convertible Senior Notes
|
—
|
|
|
—
|
|
|
568
|
|
|
—
|
|
|
—
|
|
|
568
|
|
|||||
Reduction for equity component of Convertible Senior Notes exchanged
|
—
|
|
|
—
|
|
|
(43,516
|
)
|
|
—
|
|
|
—
|
|
|
(43,516
|
)
|
|||||
Repurchases of common stock
|
(167
|
)
|
|
—
|
|
|
(10,728
|
)
|
|
—
|
|
|
—
|
|
|
(10,728
|
)
|
|||||
Other comprehensive loss, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
(324
|
)
|
|
—
|
|
|
(324
|
)
|
|||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
72,921
|
|
|
72,921
|
|
|||||
Balance at December 31, 2019
|
41,868
|
|
|
$
|
42
|
|
|
$
|
425,557
|
|
|
$
|
(463
|
)
|
|
$
|
134,684
|
|
|
$
|
559,820
|
|
|
Year ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
OPERATING ACTIVITIES
|
|
|
|
|
|
||||||
Net income (loss)
|
$
|
72,921
|
|
|
$
|
74,183
|
|
|
$
|
(8,165
|
)
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
|||||||||||
Depreciation, amortization and other
|
51,791
|
|
|
46,266
|
|
|
30,762
|
|
|||
Stock-based compensation expense
|
13,252
|
|
|
11,709
|
|
|
9,061
|
|
|||
Impairment loss
|
1,481
|
|
|
—
|
|
|
—
|
|
|||
Amortization of debt discount and deferred issuance costs
|
1,582
|
|
|
3,952
|
|
|
6,022
|
|
|||
Change in fair value of acquisition contingencies
|
1,467
|
|
|
1,114
|
|
|
(81
|
)
|
|||
Accretion of interest on deferred consideration
|
8,224
|
|
|
10,000
|
|
|
2,608
|
|
|||
Amortization of inventory step-up to fair value
|
—
|
|
|
3,650
|
|
|
10,950
|
|
|||
Change in deferred tax assets and liabilities
|
(1,742
|
)
|
|
(20,458
|
)
|
|
365
|
|
|||
Loss on extinguishment of debt
|
748
|
|
|
8,262
|
|
|
—
|
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable
|
(36,059
|
)
|
|
8,236
|
|
|
(42,052
|
)
|
|||
Inventories
|
9,143
|
|
|
(3,974
|
)
|
|
362
|
|
|||
Prepaid expenses and other current and non-current assets
|
4,314
|
|
|
(12,681
|
)
|
|
(9,113
|
)
|
|||
Accounts payable
|
2,434
|
|
|
(331
|
)
|
|
12,956
|
|
|||
Accrued payroll and related expenses
|
(1,037
|
)
|
|
1,674
|
|
|
7,130
|
|
|||
Other current and non-current liabilities
|
5,966
|
|
|
4,743
|
|
|
6,904
|
|
|||
Net cash provided by operating activities
|
134,485
|
|
|
136,345
|
|
|
27,709
|
|
|||
INVESTING ACTIVITIES
|
|
|
|
|
|
||||||
Acquisitions of property, equipment
|
(27,229
|
)
|
|
(31,689
|
)
|
|
(17,510
|
)
|
|||
Acquisition of other businesses, net of cash acquired
|
—
|
|
|
—
|
|
|
(14,451
|
)
|
|||
Acquisition of Triage and BNP Businesses
|
—
|
|
|
—
|
|
|
(399,798
|
)
|
|||
Proceeds from sale of Summers Ridge Property
|
—
|
|
|
146,644
|
|
|
—
|
|
|||
Net cash (used for) provided by investing activities
|
(27,229
|
)
|
|
114,955
|
|
|
(431,759
|
)
|
|||
FINANCING ACTIVITIES
|
|
|
|
|
|
||||||
Proceeds from issuance of Term Loan
|
—
|
|
|
—
|
|
|
245,000
|
|
|||
Proceeds from issuance of Revolving Credit Facility
|
—
|
|
|
—
|
|
|
10,000
|
|
|||
Proceeds from issuance of common stock
|
14,782
|
|
|
17,047
|
|
|
25,426
|
|
|||
Payments of debt issuance costs
|
—
|
|
|
(513
|
)
|
|
(8,682
|
)
|
|||
Payments on finance lease obligation
|
(371
|
)
|
|
(130
|
)
|
|
(98
|
)
|
|||
Payments on Revolving Credit Facility
|
(53,188
|
)
|
|
(40,000
|
)
|
|
—
|
|
|||
Repurchases of common stock
|
(10,728
|
)
|
|
(4,344
|
)
|
|
(541
|
)
|
|||
Payments on acquisition contingent consideration
|
(4,044
|
)
|
|
(6,303
|
)
|
|
(497
|
)
|
|||
Payments of deferred consideration
|
(44,000
|
)
|
|
(46,000
|
)
|
|
—
|
|
|||
Payments of Term Loan
|
—
|
|
|
(161,813
|
)
|
|
—
|
|
|||
Transaction costs related to debt exchange
|
(733
|
)
|
|
(2,002
|
)
|
|
—
|
|
|||
Net cash (used for) provided by financing activities
|
(98,282
|
)
|
|
(244,058
|
)
|
|
270,608
|
|
|||
Effect of exchange rate changes on cash
|
106
|
|
|
367
|
|
|
20
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
9,080
|
|
|
7,609
|
|
|
(133,422
|
)
|
|||
Cash and cash equivalents, beginning of period
|
43,695
|
|
|
36,086
|
|
|
169,508
|
|
|||
Cash and cash equivalents, at end of period
|
$
|
52,775
|
|
|
$
|
43,695
|
|
|
$
|
36,086
|
|
Consolidated Balance Sheets (in thousands)
|
January 1,
2019 |
|
Effect of Change in Accounting Principle
|
|
After change in Accounting Principle
|
||||||
ASSETS
|
|
|
|
|
|
||||||
Right-of-use assets
|
$
|
—
|
|
|
$
|
87,086
|
|
|
$
|
87,086
|
|
Total assets
|
$
|
806,371
|
|
|
$
|
87,086
|
|
|
$
|
893,457
|
|
|
|
|
|
|
|
||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
||||||
Operating lease liabilities
|
$
|
—
|
|
|
$
|
5,290
|
|
|
$
|
5,290
|
|
Other current liabilities
|
12,992
|
|
|
(448
|
)
|
|
12,544
|
|
|||
Total current liabilities
|
159,735
|
|
|
4,842
|
|
|
164,577
|
|
|||
Operating lease liability
|
—
|
|
|
84,866
|
|
|
84,866
|
|
|||
Other non-current liabilities
|
9,577
|
|
|
(2,622
|
)
|
|
6,955
|
|
|||
Total liabilities and stockholders’ equity
|
$
|
806,371
|
|
|
$
|
87,086
|
|
|
$
|
893,457
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Other receivables
|
$
|
7,857
|
|
|
$
|
15,507
|
|
Prepaid expenses
|
4,568
|
|
|
4,508
|
|
||
Income taxes receivable
|
2,560
|
|
|
2,703
|
|
||
Other
|
1,885
|
|
|
928
|
|
||
Total prepaid expenses and other current assets
|
$
|
16,870
|
|
|
$
|
23,646
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Raw materials
|
$
|
23,294
|
|
|
$
|
24,292
|
|
Work-in-process (materials, labor and overhead)
|
20,514
|
|
|
21,280
|
|
||
Finished goods (materials, labor and overhead)
|
14,278
|
|
|
21,807
|
|
||
Total inventories
|
$
|
58,086
|
|
|
$
|
67,379
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Equipment, furniture and fixtures
|
$
|
96,347
|
|
|
$
|
89,285
|
|
Building and improvements
|
46,878
|
|
|
37,335
|
|
||
Leased instruments
|
47,656
|
|
|
42,647
|
|
||
Land
|
1,080
|
|
|
1,080
|
|
||
Total property, plant and equipment, gross
|
191,961
|
|
|
170,347
|
|
||
Less: accumulated depreciation and amortization
|
(112,199
|
)
|
|
(96,446
|
)
|
||
Total property, plant and equipment, net
|
$
|
79,762
|
|
|
$
|
73,901
|
|
|
|
December 31, 2019
|
|
December 31, 2018
|
||||||||||||||||||||
Description
|
Weighted-average
useful life
(years)
|
Gross
assets
|
|
Accumulated
amortization
|
|
Net
|
|
Gross
assets
|
|
Accumulated
amortization
|
|
Net
|
||||||||||||
Purchased technology
|
9.1
|
$
|
112,100
|
|
|
$
|
(64,632
|
)
|
|
$
|
47,468
|
|
|
$
|
112,100
|
|
|
$
|
(57,495
|
)
|
|
$
|
54,605
|
|
Customer relationships
|
7.0
|
122,178
|
|
|
(44,045
|
)
|
|
78,133
|
|
|
122,389
|
|
|
(27,561
|
)
|
|
94,828
|
|
||||||
License agreements
|
9.9
|
6,509
|
|
|
(4,931
|
)
|
|
1,578
|
|
|
6,511
|
|
|
(4,530
|
)
|
|
1,981
|
|
||||||
Patent and trademark costs
|
10.8
|
28,740
|
|
|
(10,331
|
)
|
|
18,409
|
|
|
28,740
|
|
|
(7,624
|
)
|
|
21,116
|
|
||||||
Software development costs
|
5.0
|
7,432
|
|
|
(4,908
|
)
|
|
2,524
|
|
|
6,629
|
|
|
(4,130
|
)
|
|
2,499
|
|
||||||
Total finite-lived intangible assets
|
|
$
|
276,959
|
|
|
$
|
(128,847
|
)
|
|
$
|
148,112
|
|
|
$
|
276,369
|
|
|
$
|
(101,340
|
)
|
|
$
|
175,029
|
|
For the years ending December 31,
|
|
Amortization expense
|
||
2020
|
|
$
|
27,258
|
|
2021
|
|
27,124
|
|
|
2022
|
|
26,593
|
|
|
2023
|
|
25,882
|
|
|
2024
|
|
21,322
|
|
|
Thereafter
|
|
19,933
|
|
|
Total
|
|
$
|
148,112
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Customer incentives
|
$
|
7,369
|
|
|
$
|
7,516
|
|
Income and other taxes payable
|
1,214
|
|
|
1,962
|
|
||
Customer deposits
|
1,500
|
|
|
—
|
|
||
Other
|
4,779
|
|
|
3,514
|
|
||
Total other current liabilities
|
$
|
14,862
|
|
|
$
|
12,992
|
|
|
Year ended December 31, 2019
|
||
Principal amount settled
|
$
|
45,372
|
|
Number of shares of common stock issued
|
1,497
|
|
|
Loss on extinguishment of debt
|
$
|
748
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Principal amount of Convertible Senior Notes outstanding
|
$
|
13,131
|
|
|
$
|
58,503
|
|
Unamortized discount of liability component
|
(415
|
)
|
|
(3,637
|
)
|
||
Unamortized deferred issuance costs
|
(55
|
)
|
|
(487
|
)
|
||
Net carrying amount of liability component
|
12,661
|
|
|
54,379
|
|
||
Carrying value of equity component, net of issuance costs
|
$
|
2,265
|
|
|
$
|
10,092
|
|
Fair value of outstanding Convertible Senior Notes
|
$
|
30,991
|
|
|
$
|
85,999
|
|
Remaining amortization period of discount on the liability component
|
1 year
|
|
|
2 years
|
|
|
December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Current:
|
|
|
|
|
|
||||||
Federal
|
$
|
1,559
|
|
|
$
|
—
|
|
|
$
|
(615
|
)
|
State
|
746
|
|
|
755
|
|
|
314
|
|
|||
Foreign
|
2,007
|
|
|
6,575
|
|
|
57
|
|
|||
Total current provision (benefit)
|
4,312
|
|
|
7,330
|
|
|
(244
|
)
|
|||
Deferred:
|
|
|
|
|
|
||||||
Federal
|
1,234
|
|
|
(9,970
|
)
|
|
131
|
|
|||
State
|
(1,186
|
)
|
|
(7,944
|
)
|
|
238
|
|
|||
Foreign
|
(103
|
)
|
|
(215
|
)
|
|
4
|
|
|||
Total deferred (benefit) provision
|
(55
|
)
|
|
(18,129
|
)
|
|
373
|
|
|||
Provision (benefit) for income taxes
|
$
|
4,257
|
|
|
$
|
(10,799
|
)
|
|
$
|
129
|
|
|
December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
United States
|
$
|
70,606
|
|
|
$
|
46,592
|
|
|
$
|
(8,198
|
)
|
Foreign
|
6,572
|
|
|
16,792
|
|
|
162
|
|
|||
Income (loss) before income taxes
|
$
|
77,178
|
|
|
$
|
63,384
|
|
|
$
|
(8,036
|
)
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Deferred tax assets:
|
|
|
|
||||
Lease liability
|
$
|
22,009
|
|
|
$
|
—
|
|
Net operating loss carryforwards
|
591
|
|
|
711
|
|
||
Intangible assets
|
3,951
|
|
|
3,502
|
|
||
Sale-leaseback, net
|
593
|
|
|
617
|
|
||
Allowance for returns and discounts
|
5,266
|
|
|
4,541
|
|
||
Stock-based compensation
|
5,197
|
|
|
5,333
|
|
||
Tax credit carryforwards
|
13,846
|
|
|
12,246
|
|
||
Other, net
|
5,426
|
|
|
6,883
|
|
||
Total deferred tax assets
|
56,879
|
|
|
33,833
|
|
||
Valuation allowance for deferred tax assets
|
(2,353
|
)
|
|
(1,830
|
)
|
||
Total deferred tax assets, net of valuation allowance
|
54,526
|
|
|
32,003
|
|
||
Deferred tax liabilities:
|
|
|
|
||||
Convertible Senior Notes
|
—
|
|
|
(636
|
)
|
||
Right-of-use assets
|
(20,334
|
)
|
|
—
|
|
||
Intangible assets
|
(1,633
|
)
|
|
(2,165
|
)
|
||
Property, plant and equipment
|
(8,057
|
)
|
|
(7,010
|
)
|
||
Total deferred tax liabilities
|
(30,024
|
)
|
|
(9,811
|
)
|
||
Net deferred tax assets
|
$
|
24,502
|
|
|
$
|
22,192
|
|
|
Year ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Tax expense (benefit) at statutory tax rate
|
$
|
16,207
|
|
|
$
|
13,311
|
|
|
$
|
(2,812
|
)
|
State tax (benefits), net of federal tax
|
1,061
|
|
|
1,526
|
|
|
(239
|
)
|
|||
Permanent differences
|
611
|
|
|
635
|
|
|
327
|
|
|||
Federal and state research credits—current year
|
(4,269
|
)
|
|
(3,628
|
)
|
|
(484
|
)
|
|||
Accrual of uncertain tax positions
|
—
|
|
|
—
|
|
|
142
|
|
|||
Stock-based compensation
|
(10,408
|
)
|
|
(9,286
|
)
|
|
(5,851
|
)
|
|||
Impact of change in federal and state tax rate on revaluing deferred tax assets
|
—
|
|
|
—
|
|
|
3,357
|
|
|||
Change in valuation allowance
|
523
|
|
|
(13,374
|
)
|
|
5,799
|
|
|||
Foreign Derived Intangible Income Deduction (FDII)
|
(159
|
)
|
|
(786
|
)
|
|
—
|
|
|||
Other
|
691
|
|
|
803
|
|
|
(110
|
)
|
|||
Provision (benefit) for income taxes
|
$
|
4,257
|
|
|
$
|
(10,799
|
)
|
|
$
|
129
|
|
|
Year ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Beginning balance
|
$
|
15,245
|
|
|
$
|
9,565
|
|
|
$
|
8,604
|
|
Increases (decreases) related to prior year tax positions
|
287
|
|
|
(558
|
)
|
|
10
|
|
|||
Increases related to current year tax positions
|
2,209
|
|
|
6,238
|
|
|
951
|
|
|||
Expiration of the statute of limitations for the assessment of taxes
|
(505
|
)
|
|
—
|
|
|
—
|
|
|||
Ending balance
|
$
|
17,236
|
|
|
$
|
15,245
|
|
|
$
|
9,565
|
|
|
Year ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Cost of sales
|
$
|
1,162
|
|
|
$
|
763
|
|
|
$
|
579
|
|
Research and development
|
2,332
|
|
|
2,266
|
|
|
1,886
|
|
|||
Sales and marketing
|
3,497
|
|
|
2,843
|
|
|
2,129
|
|
|||
General and administrative
|
6,261
|
|
|
5,837
|
|
|
4,467
|
|
|||
Total stock-based compensation expense
|
$
|
13,252
|
|
|
$
|
11,709
|
|
|
$
|
9,061
|
|
|
Year ended December 31,
|
|||||||
|
2019
|
|
2018
|
|
2017
|
|||
Risk-free interest rate
|
2.51
|
%
|
|
2.49
|
%
|
|
2.30
|
%
|
Expected option life (in years)
|
5.68
|
|
|
6.29
|
|
|
6.63
|
|
Volatility rate
|
39
|
%
|
|
36
|
%
|
|
36
|
%
|
Dividend rate
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
|
Number
of Shares
|
|
Weighted-
average exercise
price per
share
|
|
Weighted-
average remaining
contractual
term (in years)
|
|
Aggregate
intrinsic
value
|
|||||
Outstanding at January 1, 2017
|
3,941
|
|
|
$
|
17.49
|
|
|
|
|
|
||
Granted
|
263
|
|
|
22.21
|
|
|
|
|
|
|||
Exercised
|
(1,527
|
)
|
|
16.38
|
|
|
|
|
|
|||
Forfeited
|
(18
|
)
|
|
24.91
|
|
|
|
|
|
|||
Outstanding at December 31, 2017
|
2,659
|
|
|
18.54
|
|
|
|
|
|
|||
Granted
|
159
|
|
|
46.50
|
|
|
|
|
|
|||
Exercised
|
(891
|
)
|
|
17.07
|
|
|
|
|
|
|||
Forfeited
|
(50
|
)
|
|
21.19
|
|
|
|
|
|
|||
Outstanding at December 31, 2018
|
1,877
|
|
|
21.53
|
|
|
|
|
|
|||
Granted
|
169
|
|
|
59.18
|
|
|
|
|
|
|||
Exercised
|
(1,091
|
)
|
|
19.22
|
|
|
|
|
|
|||
Forfeited
|
(11
|
)
|
|
49.71
|
|
|
|
|
|
|||
Outstanding at December 31, 2019
|
944
|
|
|
$
|
30.63
|
|
|
6.77
|
|
$
|
41,185
|
|
Vested and expected to vest at December 31, 2019
|
919
|
|
|
$
|
30.12
|
|
|
6.73
|
|
$
|
40,560
|
|
Exercisable at December 31, 2019
|
388
|
|
|
$
|
20.12
|
|
|
5.41
|
|
$
|
21,030
|
|
|
Shares
|
|
Weighted-average
grant date
fair value
|
|||
Non-vested at January 1, 2017
|
501
|
|
|
$
|
20.37
|
|
Granted
|
349
|
|
|
22.34
|
|
|
Vested
|
(100
|
)
|
|
23.49
|
|
|
Forfeited
|
(4
|
)
|
|
18.69
|
|
|
Non-vested at December 31, 2017
|
746
|
|
|
20.88
|
|
|
Granted
|
242
|
|
|
49.97
|
|
|
Vested
|
(296
|
)
|
|
21.70
|
|
|
Forfeited
|
(16
|
)
|
|
28.40
|
|
|
Non-vested at December 31, 2018
|
676
|
|
|
30.75
|
|
|
Granted
|
279
|
|
|
59.75
|
|
|
Vested
|
(148
|
)
|
|
24.26
|
|
|
Forfeited
|
(21
|
)
|
|
43.90
|
|
|
Non-vested at December 31, 2019
|
786
|
|
|
$
|
41.88
|
|
|
Year ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Numerator:
|
|
|
|
|
|
||||||
Net income (loss) used for basic earnings per share
|
$
|
72,921
|
|
|
$
|
74,183
|
|
|
$
|
(8,165
|
)
|
Interest expense on Convertible Senior Notes, net of tax
|
1,848
|
|
|
4,927
|
|
|
—
|
|
|||
Net income (loss) used for diluted earnings per share, if-converted method
|
$
|
74,769
|
|
|
$
|
79,110
|
|
|
$
|
(8,165
|
)
|
|
|
|
|
|
|
||||||
Basic weighted-average common shares outstanding
|
40,860
|
|
|
37,995
|
|
|
33,734
|
|
|||
Potentially dilutive shares issuable from Convertible Senior Notes
|
1,062
|
|
|
2,850
|
|
|
—
|
|
|||
Potentially dilutive shares issuable from stock options and unvested RSUs
|
1,189
|
|
|
1,709
|
|
|
—
|
|
|||
Diluted weighted-average common shares outstanding, if-converted
|
43,111
|
|
|
42,554
|
|
|
33,734
|
|
|||
Potentially dilutive shares excluded from calculation due to anti-dilutive effect
|
199
|
|
|
161
|
|
|
37
|
|
|
Year ended December 31,
|
||
|
2019
|
||
Finance lease ROU asset amortization
|
$
|
314
|
|
Finance lease interest expense
|
835
|
|
|
Total finance lease costs
|
1,149
|
|
|
Operating lease costs
|
10,130
|
|
|
Total lease costs
|
$
|
11,279
|
|
|
|
||
Cash paid for amounts included in the measurement of operating lease liabilities
|
|
||
Operating cash flows from operating leases
|
$
|
9,385
|
|
Operating cash flows from finance leases
|
$
|
835
|
|
ROU assets obtained in exchange for new lease liabilities
|
|
||
Operating leases
|
$
|
12,231
|
|
Finance leases
|
$
|
1,369
|
|
Years ending December 31,
|
|
Operating
|
|
Finance
|
||||
2020
|
|
$
|
10,603
|
|
|
$
|
1,264
|
|
2021
|
|
10,812
|
|
|
1,272
|
|
||
2022
|
|
9,836
|
|
|
1,282
|
|
||
2023
|
|
9,458
|
|
|
1,293
|
|
||
2024
|
|
9,446
|
|
|
1,106
|
|
||
Thereafter
|
|
80,300
|
|
|
2,097
|
|
||
Total lease payments
|
|
130,455
|
|
|
8,314
|
|
||
Less: imputed interest
|
|
(30,816
|
)
|
|
(3,465
|
)
|
||
Total
|
|
99,639
|
|
|
4,849
|
|
||
Less: current portion
|
|
(6,412
|
)
|
|
(474
|
)
|
||
Non-current portion
|
|
$
|
93,227
|
|
|
$
|
4,375
|
|
|
|
|
|
|
||||
Weighted average remaining lease term
|
|
12.2 years
|
|
|
5.6 years
|
|
||
Weighted average discount rate
|
|
4
|
%
|
|
18
|
%
|
|
Year ended December 31,
|
|||||||
|
2019
|
|
2018
|
|
2017
|
|||
Customer:
|
|
|
|
|
|
|||
A
|
18
|
%
|
|
19
|
%
|
|
20
|
%
|
B
|
15
|
%
|
|
13
|
%
|
|
13
|
%
|
C
|
13
|
%
|
|
12
|
%
|
|
21
|
%
|
|
46
|
%
|
|
44
|
%
|
|
54
|
%
|
|
Long-lived assets as of December 31,
|
|
Total revenue
for the years ended December 31,
|
||||||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
2017
|
||||||||||
Domestic
|
$
|
78,254
|
|
|
$
|
72,569
|
|
|
$
|
358,381
|
|
|
$
|
354,895
|
|
|
$
|
227,611
|
|
Foreign
|
1,508
|
|
|
1,332
|
|
|
176,509
|
|
|
167,390
|
|
|
50,132
|
|
|||||
Total
|
$
|
79,762
|
|
|
$
|
73,901
|
|
|
$
|
534,890
|
|
|
$
|
522,285
|
|
|
$
|
277,743
|
|
|
Year ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Rapid Immunoassay
|
$
|
191,736
|
|
|
$
|
183,160
|
|
|
$
|
165,099
|
|
Cardiac Immunoassay
|
266,505
|
|
|
266,524
|
|
|
47,030
|
|
|||
Specialized Diagnostic Solutions
|
54,933
|
|
|
53,243
|
|
|
51,978
|
|
|||
Molecular Diagnostic Solutions
|
21,716
|
|
|
19,358
|
|
|
13,636
|
|
|||
Total revenues
|
$
|
534,890
|
|
|
$
|
522,285
|
|
|
$
|
277,743
|
|
|
December 31, 2019
|
|
December 31, 2018
|
||||||||||||||||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Derivative assets
|
$
|
—
|
|
|
$
|
321
|
|
|
$
|
—
|
|
|
$
|
321
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets measured at fair value
|
$
|
—
|
|
|
$
|
321
|
|
|
$
|
—
|
|
|
$
|
321
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Derivative liabilities
|
$
|
—
|
|
|
$
|
433
|
|
|
$
|
—
|
|
|
$
|
433
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Contingent consideration
|
—
|
|
|
—
|
|
|
16,535
|
|
|
16,535
|
|
|
—
|
|
|
—
|
|
|
19,112
|
|
|
19,112
|
|
||||||||
Deferred consideration
|
—
|
|
|
151,382
|
|
|
—
|
|
|
151,382
|
|
|
—
|
|
|
187,158
|
|
|
—
|
|
|
187,158
|
|
||||||||
Total liabilities measured at fair value
|
$
|
—
|
|
|
$
|
151,815
|
|
|
$
|
16,535
|
|
|
$
|
168,350
|
|
|
$
|
—
|
|
|
$
|
187,158
|
|
|
$
|
19,112
|
|
|
$
|
206,270
|
|
|
Contingent consideration
liability
(Level 3 measurement)
|
||
Balance at December 31, 2016
|
$
|
5,175
|
|
Cash payments
|
(498
|
)
|
|
Change in estimated fair value, recorded in cost of sales
|
(81
|
)
|
|
Additional liability recorded for the BNP Business
|
19,700
|
|
|
Unrealized loss on foreign currency translation
|
5
|
|
|
Balance at December 31, 2017
|
24,301
|
|
|
Cash payments
|
(6,303
|
)
|
|
Change in estimated fair value, recorded in general and administrative expenses
|
1,114
|
|
|
Balance at December 31, 2018
|
19,112
|
|
|
Cash payments
|
(4,044
|
)
|
|
Change in estimated fair value recorded in general and administrative expenses
|
1,467
|
|
|
Balance at December 31, 2019
|
$
|
16,535
|
|
|
December 31, 2019
|
||||||
|
Notional Amount
|
|
Fair Value, Net
|
||||
Prepaid expenses and other current assets
|
$
|
27,944
|
|
|
$
|
321
|
|
Other current liabilities
|
$
|
6,219
|
|
|
$
|
433
|
|
|
First Quarter
|
|
Second Quarter
|
|
Third Quarter
|
|
Fourth Quarter
|
||||||||
|
(in thousands, except per share data)
|
||||||||||||||
2019
|
|||||||||||||||
Total revenues
|
$
|
147,968
|
|
|
$
|
108,252
|
|
|
$
|
126,492
|
|
|
$
|
152,178
|
|
Gross profit
|
$
|
90,927
|
|
|
$
|
59,179
|
|
|
$
|
75,859
|
|
|
$
|
94,840
|
|
Operating income
|
$
|
31,153
|
|
|
$
|
5,818
|
|
|
$
|
20,682
|
|
|
$
|
35,063
|
|
Net income
|
$
|
24,844
|
|
|
$
|
1,270
|
|
|
$
|
16,181
|
|
|
$
|
30,626
|
|
Basic income per share
|
$
|
0.63
|
|
|
$
|
0.03
|
|
|
$
|
0.39
|
|
|
$
|
0.73
|
|
Diluted income per share
|
$
|
0.60
|
|
|
$
|
0.03
|
|
|
$
|
0.38
|
|
|
$
|
0.71
|
|
2018
|
|||||||||||||||
Total revenues
|
$
|
169,143
|
|
|
$
|
103,155
|
|
|
$
|
117,399
|
|
|
$
|
132,588
|
|
Gross profit
|
$
|
106,271
|
|
|
$
|
57,668
|
|
|
$
|
69,642
|
|
|
$
|
82,132
|
|
Operating income
|
$
|
51,093
|
|
|
$
|
404
|
|
|
$
|
16,894
|
|
|
$
|
27,538
|
|
Net income (loss)
|
$
|
33,958
|
|
|
$
|
(3,076
|
)
|
|
$
|
10,822
|
|
|
$
|
32,479
|
|
Basic income (loss) per share
|
$
|
0.96
|
|
|
$
|
(0.08
|
)
|
|
$
|
0.28
|
|
|
$
|
0.82
|
|
Diluted income (loss) per share
|
$
|
0.86
|
|
|
$
|
(0.08
|
)
|
|
$
|
0.27
|
|
|
$
|
0.78
|
|
|
|
|
|
|
|
|
|
|
||||||||
Description
|
|
Balance at
beginning of
period
|
|
Additions charged to expense or as reductions to revenue (1)
|
|
Deductions (2)
|
|
Balance at end of
period
|
||||||||
|
|
|
|
|
|
|
|
|
||||||||
|
|
(in thousands)
|
||||||||||||||
Year ended December 31, 2019:
|
|
|
|
|
|
|
|
|
||||||||
Accounts receivable allowance
|
|
$
|
11,979
|
|
|
$
|
65,649
|
|
|
$
|
(61,668
|
)
|
|
$
|
15,960
|
|
Year ended December 31, 2018:
|
|
|
|
|
|
|
|
|
||||||||
Accounts receivable allowance
|
|
$
|
12,309
|
|
|
$
|
65,142
|
|
|
$
|
(65,472
|
)
|
|
$
|
11,979
|
|
Year ended December 31, 2017:
|
|
|
|
|
|
|
|
|
||||||||
Accounts receivable allowance
|
|
$
|
7,165
|
|
|
$
|
36,449
|
|
|
$
|
(31,305
|
)
|
|
$
|
12,309
|
|
(1)
|
Represents charges associated primarily to allowances for contracts rebates recorded as reductions to revenue. Additions to allowance for doubtful accounts are recorded to sales and marketing expense.
|
(2)
|
The deductions represent actual charges against the accrual described above.
|
(a)
|
(1) Financial Statements
|
(b)
|
Exhibits
|
(c)
|
Financial Statements required by Regulation S-X which are excluded from this Annual Report on Form 10-K by Rule 14(a)-3(b).
|
|
|
|
Exhibit
Number
|
|
Description
|
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
101
|
|
The following financial statements from the Company's Annual Report on Form 10-K for the year ended December 31, 2019, formatted in Inline XBRL: (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations, (iii) Consolidated Statements of Comprehensive Income (Loss), (v) Consolidated Statements of Stockholders’ Equity (v) Consolidated Statements of Cash Flows, and (vi) Notes to Consolidated Financial Statements, tagged as blocks of text and including detailed tags.
|
|
|
|
104
|
|
The cover page from the Company's Annual Report on Form 10-K for the year ended December 31, 2019, formatted in Inline XBRL (included as Exhibit 101).
|
*
|
Filed / furnished herewith
|
(1)
|
Indicates a management plan or compensatory plan or arrangement.
|
|
QUIDEL CORPORATION
|
|
|
By
|
/s/ DOUGLAS C. BRYANT
|
Date: February 13, 2020
|
|
Douglas C. Bryant
President, Chief Executive Officer
(Principal Executive Officer)
|
Signature
|
|
Title
|
|
Date
|
/s/ DOUGLAS C. BRYANT
|
|
Director, President, Chief Executive Officer (Principal Executive Officer)
|
|
February 13, 2020
|
Douglas C. Bryant
|
|
|||
|
|
|
|
|
/s/ RANDALL J. STEWARD
|
|
Chief Financial Officer, (Principal Financial and Accounting Officer)
|
|
February 13, 2020
|
Randall J. Steward
|
|
|||
|
|
|
|
|
/s/ KENNETH F. BUECHLER
|
|
Chairman of the Board
|
|
February 13, 2020
|
Kenneth F. Buechler
|
|
|||
|
|
|
|
|
/s/ EDWARD L. MICHAEL
|
|
Director
|
|
February 13, 2020
|
Edward L. Michael
|
|
|
||
|
|
|
|
|
/s/ KATHY P. ORDOÑEZ
|
|
Director
|
|
February 13, 2020
|
Kathy P. Ordoñez
|
|
|
||
|
|
|
|
|
/s/ MARY LAKE POLAN
|
|
Director
|
|
February 13, 2020
|
Mary Lake Polan
|
|
|||
|
|
|
|
|
/s/ JACK W. SCHULER
|
|
Director
|
|
February 13, 2020
|
Jack W. Schuler
|
|
|||
|
|
|
|
|
/s/ CHARLES P. SLACIK
|
|
Director
|
|
February 13, 2020
|
Charles P. Slacik
|
|
|||
|
|
|
|
|
/s/ MATTHEW W. STROBECK
|
|
Director
|
|
February 13, 2020
|
Matthew W. Strobeck
|
|
|
||
|
|
|
|
|
/s/ KENNETH J. WIDDER
|
|
Director
|
|
February 13, 2020
|
Kenneth J. Widder
|
|
|
•
|
decrease the amount of earnings and assets available for distribution to existing common stockholders;
|
•
|
make removal of the present management more difficult;
|
•
|
result in restrictions upon the payment of dividends and other distributions to the existing common stockholders;
|
•
|
delay or prevent a change in control of our company; and
|
•
|
limit the price that investors are willing to pay in the future for our existing common stock.
|
1.
|
I have reviewed this annual report on Form 10-K of Quidel Corporation;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
/s/ DOUGLAS C. BRYANT
|
|
Douglas C. Bryant
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
1.
|
I have reviewed this annual report on Form 10-K of Quidel Corporation;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
/s/ RANDALL J. STEWARD
|
|
Randall J. Steward
|
|
Chief Financial Officer
|
|
(Principal Financial Officer)
|
•
|
the Company’s Annual Report on Form 10-K for the period ended December 31, 2019 (the “Report”), as filed with the Securities and Exchange Commission on the date hereof, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
•
|
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
/s/ DOUGLAS C. BRYANT
|
Douglas C. Bryant
|
President and Chief Executive Officer
|
(Principal Executive Officer)
|
|
/s/ RANDALL J. STEWARD
|
Randall J. Steward
|
Chief Financial Officer
|
(Principal Financial Officer)
|