Quidel Corporation (NASDAQ: QDEL), a provider of rapid
diagnostic testing solutions, cellular-based virology assays and
molecular diagnostic systems, announced today financial results for
the fourth quarter and year ended December 31, 2020.
Fourth Quarter 2020 Highlights
- Total revenue increased 432% to $809.2 million, from $152.2
million in the fourth quarter of 2019.
- Revenue for COVID-19 products was $678.7 million.
- Reported GAAP EPS of $10.78 per diluted share in the fourth
quarter of 2020, compared with $0.71 per diluted share in the
fourth quarter of 2019.
- Reported non-GAAP EPS of $11.07 per diluted share in the fourth
quarter of 2020, compared with $1.00 per diluted share in the
fourth quarter of 2019.
- Received Emergency Use Authorization (EUA) for Sofia® 2 Flu +
SARS Antigen FIA rapid test.
- Received EUA for QuickVue® SARS Antigen test for the
professional point-of-care segment.
- Received EUA for Solana® SARS-CoV-2 Assay for use with the
Solana® molecular diagnostic system.
Full Year 2020 Highlights
- Total revenue increased 211% to $1,661.7 million, from $534.9
million in 2019.
- Revenue for COVID-19 products was $1,164.4 million.
- Reported GAAP EPS of $18.60 per diluted share in the 2020,
compared with $1.73 per diluted share in 2019.
- Reported non-GAAP EPS of $19.92 per diluted share in 2020,
compared with $2.97 per diluted share in 2019.
- Received EUA for 6 different COVID-19 diagnostic products,
ranging from PCR to isothermal molecular to rapid antigen
technologies.
Fourth Quarter 2020 Results
Total revenue for the fourth quarter of 2020 was $809.2 million,
versus $152.2 million for the fourth quarter of 2019. The 432%
increase in sales from the fourth quarter of 2019 was driven by
growth in Rapid Immunoassay and Molecular Diagnostic Solutions
product categories, the result of strong demand for the newly
launched Sofia® SARS Antigen and Lyra® SARS-CoV-2 tests.
Additionally, Cardiometabolic Immunoassay revenues were higher
compared with the fourth quarter of 2019. This growth in revenue
was minimally offset by a decline in Specialized Diagnostic
Solutions revenues. Currency exchange had a favorable impact of
$1.4 million.
Rapid Immunoassay product revenue increased by $566.3 million in
the fourth quarter of 2020 to $631.3 million, primarily due to
$587.6 million in revenue for our Sofia® SARS Antigen and Sofia® 2
Flu + SARS Antigen tests. Cardiometabolic Immunoassay revenue
totaled $70.0 million in the fourth quarter of 2020, an increase of
6% from the fourth quarter of 2019. Molecular Diagnostic Solutions
revenue increased $89.4 million to $96.4 million due to incremental
Lyra® SARS-CoV-2 assay revenue of $87.2 million. Specialized
Diagnostic Solutions revenue decreased 20% from the fourth quarter
of 2019 to $11.5 million.
“Looking back on Q4 and the full year of 2020, it is hard to
overstate how the ingenuity and resilience of our people -- their
dedication and sheer force of will to make a difference in fighting
the pandemic -- has transformed our company and benefited our
customers,” said Douglas Bryant, president and CEO of Quidel
Corporation. “In the quarter, our R&D teams developed six
COVID-19 diagnostic assays across multiple technologies, our
regulatory affairs teams secured EUAs to bring them to market and
our operations teams built manufacturing lines and managed complex
supply chains to vastly scale our production. Our tests have saved
countless lives, allowed athletic seasons to resume and empowered
people to take charge of their own health and safeguard others. It
has been a privilege to witness and work alongside the Quidel Team,
and our numbers for the year reflect the intensity and efficiency
of the effort. The net result is our strongest balance sheet ever
and an excellent competitive position entering 2021.
“We will soon be launching two exciting new products: Savanna, a
multiplex molecular analyzer that we believe will be another
flagship product in the history of the company; and the Sofia Q
analyzer, a tiny product with the potential to eventually serve
several 'new markets,' including the telemedicine and OTC markets.
The addition of these products to our core portfolio positions us
well for future growth," Mr. Bryant noted.
Gross Profit in the fourth quarter of 2020 increased to $701.5
million, driven by the demand for the new Sofia® SARS Antigen,
Sofia® 2 Flu + SARS Antigen and Lyra SARS-CoV-2 products, which
drove improved product mix and increased sales volume. These
increases were only partially offset by increased indirect costs
across all plants. Gross margin improved to 87% versus last year's
62% due to the introduction of high-margin Coronavirus products
which resulted in significantly more volume running through the
manufacturing facilities with relatively fixed overhead. R&D
expense increased by $10.6 million in the fourth quarter as
compared to the same period last year, due primarily to increased
spending on SARS-CoV-2 diagnostic assay development, as well as
development for Savanna and Sofia Q projects. We also incurred
incremental labor and material costs associated with COVID-19
product development. Sales and Marketing expense increased by $10.2
million in the quarter, due primarily to increased freight costs as
well as higher compensation costs driven by increased headcount and
improved performance in the quarter. G&A expense increased by
$5.9 million in the quarter due to increased headcount and higher
compensation costs. Acquisition and integration costs of $0.5
million for the three months ended December 31, 2020 related to
professional service fees.
In the fourth quarter of 2020, the Company recorded an income
tax expense of $145.4 million, as compared with $1.9 million in the
same quarter last year. The higher tax expense for the three months
ended December 31, 2020 compared to the same period in the prior
year is a result of higher pre-tax profits and lower proportional
discrete tax benefits recorded in 2020 for excess tax benefits of
stock-based compensation.
Net income for the fourth quarter was $470.1 million, or $10.78
per diluted share, as compared to a net income of $30.6 million, or
$0.71 per diluted share, for the fourth quarter of 2019. On a
non-GAAP basis, net income for the fourth quarter of 2020 was
$482.8 million, or $11.07 per diluted share, as compared to net
income of $43.5 million, or $1.00 per diluted share, for the same
period in 2019.
Results for the Twelve Months Ended December 31, 2020
Total revenue for the twelve months ended December 31, 2020 was
$1,661.7 million, versus $534.9 million for the same period in
2019. The 211% increase in sales was driven by greater Rapid
Immunoassay and Molecular Diagnostics Solutions revenue associated
with COVID-19. This was partially offset by lower Cardiometabolic
Immunoassay revenue. Foreign exchange had a positive impact of $0.7
million for the twelve months ended December 31, 2020. The majority
of the foreign currency tailwind impacted the Cardiometabolic
Immunoassay business.
Rapid Immunoassay product revenue increased 497% in the twelve
months ended December 31, 2020 to $1,144.8 million. This was led by
a 742% growth in Sofia revenue to $1,092.7 million, while QuickVue
sales decreased 15% to $48.3 million as compared to 2019.
Cardiometabolic Immunoassay revenue totaled $242.9 million in the
twelve months ended December 31, 2020, representing a 9% decline
from 2019. Molecular Diagnostic Solutions revenue increased $201.2
million to $223.0 million, led by $203.2 million in revenue growth
from Lyra. Specialized Diagnostic Solutions revenue for the twelve
months ended December 31, 2020 was $50.9 million, down 7% from
prior year.
Gross Profit in the twelve months ended December 31, 2020
increased to $1,348.9 million, driven by the demand for the new
Sofia® SARS Antigen, Sofia® 2 Flu + SARS Antigen and Lyra
SARS-CoV-2 products, which drove improved product mix. In addition,
higher production volumes contributed to increased manufacturing
overhead absorption, which offset increases in spend required to
expedite the production ramp. Gross margin improved to 81% due to
the same factors. R&D expense increased by $31.7 million in the
twelve months ended December 31, 2020 as compared to the same
period last year, due primarily to increased spending on Sofia,
Savanna and next-generation instrument development projects. We
also incurred higher labor, material and clinical trials spend
associated with COVID-19 product development. Sales and Marketing
expense increased by $22.8 million in the twelve months ended
December 31, 2020, as compared to the same period in 2019,
primarily due to higher employee-related costs, freight and bad
debt expense. G&A expense increased by $13.8 million, primarily
due to increased compensation costs from increased headcount to
support the growth experienced in 2020 as well as improved
performance in the period. Acquisition and integration costs of
$3.7 million for the twelve months ended December 31, 2020
primarily related to the evaluation of new business development
opportunities. Acquisition and integration costs of $11.7 million
for the twelve months ended December 31, 2019 consisted primarily
of global operation integration costs.
Net income for the twelve months ended December 31, 2020 was
$810.3 million, or $18.60 per diluted share, as compared to net
income of $72.9 million, or $1.73 per diluted share, for the same
period in 2019. On a non-GAAP basis, net income for the twelve
months ended December 31, 2020 was $868.4 million, or $19.92 per
diluted share, as compared to net income of $127.8 million, or
$2.97 per diluted share, for the same period in 2019.
Non-GAAP Financial Information
The Company is providing non-GAAP financial information to
exclude the effect of stock-based compensation, amortization of
intangibles, non-cash interest expense, foreign exchange gains and
losses and certain non-recurring items on net income and earnings
per share as a supplement to its consolidated financial statements,
which are presented in accordance with generally accepted
accounting principles in the U.S., or GAAP.
Management is providing the adjusted gross profit, adjusted
operating income, adjusted net income, adjusted net earnings per
share, and constant currency revenue information for the periods
presented because it believes this enhances the comparison of the
Company’s financial performance from period-to-period, and to that
of its competitors. Constant currency revenue is calculated by
translating current period revenues using prior period exchange
rates, net of any hedging effect recognized in the current period.
Constant currency revenue growth (expressed as a percentage) is
calculated by determining the change in current period constant
currency revenues over prior period revenues. This press release is
not meant to be considered in isolation, or as a substitute for
results prepared in accordance with GAAP. A reconciliation of the
non-GAAP financial measures to the comparable GAAP measures is
included in this press release as part of the attached financial
tables.
Conference Call Information
Quidel management will host a conference call to discuss the
fiscal fourth quarter and full year 2020 results as well as other
business matters today beginning at 5:00 p.m. Eastern Time (2:00
p.m. Pacific Time). During the conference call, management may
answer questions concerning business and financial developments and
trends. Quidel’s responses to these questions, as well as other
matters discussed during the conference call, may contain or
constitute material information that has not been previously
disclosed.
Investors may either join the live call by telephone, or join
via webcast:
- To participate in the live call by telephone from the U.S.,
please dial 833-968-2118, or from outside the U.S. dial
778-560-2849, and request either the “Quidel Q4 and FY 2020
Earnings Call” when prompted by the conference call operator, or
dial conference ID 339-3433.
- To join the live webcast, participants may click on the
following link directly:
https://event.on24.com/wcc/r/2948384/3C5838A0099F31657278AD32E3BDD754,
or via the Investor Relations section of the Quidel website
(http://ir.quidel.com).
The website replay will be available for 1 year. The telephone
replay will be available for 14 days beginning at 8:00 p.m. Eastern
Time (5:00 p.m. Pacific Time) on February 18th, 2020 by dialing
800-585-8367 from the U.S., or by dialing 416-621-4642 for
international callers, and entering pass code 339-3433.
About Quidel Corporation
Quidel Corporation (Nasdaq: QDEL) is a leading manufacturer of
diagnostic solutions at the point of care, delivering a continuum
of rapid testing technologies that further improve the quality of
health care throughout the globe. An innovator for over 40 years in
the medical device industry, Quidel pioneered the first FDA-cleared
point-of-care test for influenza in 1999 and was the first to
market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted
brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s
comprehensive product portfolio includes tests for a wide range of
infectious diseases, cardiac and autoimmune biomarkers, as well as
a host of products to detect COVID-19. With products made in
America, Quidel’s mission is to provide patients with immediate and
frequent access to highly accurate, affordable testing for the good
of our families, our communities and the world. For more
information about Quidel, visit quidel.com.
View our story told by our people at
www.quidel.com/ourstory.
Forward-looking Statements
This press release contains forward-looking statements within
the meaning of the federal securities laws that involve material
risks, assumptions and uncertainties. Many possible events or
factors could affect our future results and performance, such that
our actual results and performance may differ materially from those
that may be described or implied in the forward-looking statements.
As such, no forward-looking statement can be guaranteed.
Differences in actual results and performance may arise as a result
of a number of factors including, without limitation: the impact
and duration of the COVID-19 global pandemic; competition from
other providers of diagnostic products; our ability to accurately
forecast demand for our products and products in development,
including in new market segments; our ability to develop new
technologies, products and markets and to commercialize new
products; our reliance on sales of our COVID-19 and influenza
diagnostic tests; our reliance on a limited number of key
distributors; quantity of our product in our distributors’
inventory or distribution channels; changes in the buying patterns
of our distributors; the financial soundness of our customers and
suppliers; lower than anticipated market penetration of our
products; third-party reimbursement policies and potential cost
constraints; our ability to meet demand for our products;
interruptions, delays or shortages in the supply of raw materials,
components and other products and services; failures in our
information technology and storage systems; our exposure to data
corruption, cyber-based attacks, security breaches and privacy
violations; international risks, including but not limited to,
economic, political and regulatory risks; continuing worldwide
political and social uncertainty; our development, acquisition and
protection of proprietary technology rights; intellectual property
risks, including but not limited to, infringement litigation; the
loss of Emergency Use Authorizations for our COVID-19 products and
failures or delays in receipt of reviews or regulatory approvals,
clearances or authorizations for new products or related to
currently-marketed products by the U.S. Food and Drug
Administration (the “FDA”) or other regulatory authorities or loss
of any previously received regulatory approvals, clearances or
authorizations or other adverse actions by regulatory authorities;
our contracts with government entities involve future funding,
compliance and possible sanctions risks; product defects; changes
in government policies and regulations and compliance risks related
thereto; our ability to manage our growth strategy and successfully
identify, acquire and integrate potential acquisition targets or
technologies and our ability to obtain financing; our acquisition
of Alere’s Triage® business presents certain risks to our business
and operations; the level of our deferred payment obligations; our
exposure to claims and litigation that could result in significant
expenses and could ultimately result in an unfavorable outcome for
us, including the ongoing litigation between us and Beckman
Coulter, Inc.; we may need to raise additional funds to finance our
future capital or operating needs; our debt, deferred and
contingent payment obligations; competition for and loss of
management and key personnel; business risks not covered by
insurance; changes in tax rates and exposure to additional tax
liabilities or assessments; and provisions in our charter documents
and Delaware law that might delay or impede stockholder actions
with respect to business combinations or similar transactions.
Forward-looking statements typically are identified by the use of
terms such as “may,” “will,” “should,” “might,” “expect,”
“anticipate,” “estimate,” “plan,” “intend,” “goal,” “project,”
“strategy,” “future,” and similar words, although some
forward-looking statements are expressed differently. The risks
described in reports and registration statements that we file with
the Securities and Exchange Commission from time to time, should be
carefully considered, including those discussed in Item 1A, “Risk
Factors” and elsewhere in our Annual Report on Form 10‑K for the
year ended December 31, 2019 and in our subsequent Quarterly
Reports on Form 10‑Q. You are cautioned not to place undue reliance
on these forward-looking statements, which reflect management’s
analysis only as of the date of this press release. Except as
required by law, we undertake no obligation to publicly release any
revision or update of these forward-looking statements, whether as
a result of new information, future events or otherwise.
QUIDEL CORPORATION
(In thousands, except per share
data; unaudited)
Three months ended December
31,
Consolidated Statements of
Operations:
2020
2019
Total revenues
$
809,203
$
152,178
Cost of sales
107,709
57,338
Gross profit
701,494
94,840
Research and development
25,495
14,924
Sales and marketing
38,239
28,000
General and administrative
20,165
14,302
Acquisition and integration costs
519
2,551
Total operating expenses
84,418
59,777
Operating income
617,076
35,063
Other expense, net
Interest and other expense, net
(1,552
)
(2,551
)
Total other expense, net
(1,552
)
(2,551
)
Income before income taxes
615,524
32,512
Provision for income taxes
145,394
1,886
Net income
$
470,130
$
30,626
Basic earnings per share
$
11.14
$
0.73
Diluted earnings per share
$
10.78
$
0.71
Shares used in basic per share
calculation
42,211
41,875
Shares used in diluted per share
calculation
43,622
43,290
Gross profit as a % of total revenues
87
%
62
%
Research and development as a % of total
revenues
3
%
10
%
Sales and marketing as a % of total
revenues
5
%
18
%
General and administrative as a % of total
revenues
2
%
9
%
Consolidated net revenues by product
category are as follows:
Rapid Immunoassay
$
631,253
$
64,936
Cardiometabolic Immunoassay
70,031
65,831
Molecular Diagnostic Solutions
96,431
7,073
Specialized Diagnostic Solutions
11,488
14,338
Total revenues
$
809,203
$
152,178
Condensed balance sheet data:
12/31/2020
12/31/2019
Cash and cash equivalents
$
489,941
$
52,775
Accounts receivable, net
$
497,688
$
94,496
Inventories
$
113,798
$
58,086
Total assets
$
1,871,164
$
910,867
Short-term debt
$
238
$
13,135
Long-term debt
$
4,100
$
4,375
Stockholders’ equity
$
1,332,703
$
559,820
QUIDEL CORPORATION
(In thousands, except per share
data; unaudited)
Twelve months ended December
31,
Consolidated Statements of
Operations:
2020
2019
Total revenues
$
1,661,668
$
534,890
Cost of sales
312,813
214,085
Gross profit
1,348,855
320,805
Research and development
84,292
52,553
Sales and marketing
133,957
111,114
General and administrative
66,586
52,755
Acquisition and integration costs
3,694
11,667
Total operating expenses
288,529
228,089
Operating income
1,060,326
92,716
Other expense, net
Interest and other expense, net
(9,623
)
(14,790
)
Loss on extinguishment of debt
(10,384
)
(748
)
Total other expense, net
(20,007
)
(15,538
)
Income before income taxes
1,040,319
77,178
Provision for income taxes
230,032
4,257
Net income
$
810,287
$
72,921
Basic earnings per share
$
19.24
$
1.78
Diluted earnings per share
$
18.60
$
1.73
Shares used in basic per share
calculation
42,124
40,860
Shares used in diluted per share
calculation
43,591
43,111
Gross profit as a % of total revenues
81
%
60
%
Research and development as a % of total
revenues
5
%
10
%
Sales and marketing as a % of total
revenues
8
%
21
%
General and administrative as a % of total
revenues
4
%
10
%
Consolidated net revenues by product
category are as follows:
Rapid Immunoassay
$
1,144,831
$
191,736
Cardiometabolic Immunoassay
242,933
266,505
Molecular Diagnostic Solutions
222,964
21,716
Specialized Diagnostic Solutions
50,940
54,933
Total revenues
$
1,661,668
$
534,890
QUIDEL CORPORATION
Reconciliation of Non-GAAP
Financial Information
(In thousands, except per share
data; unaudited)
Three months ended December
31,
Gross Profit
Operating Income
Net Income
Diluted EPS
2020
2019
2020
2019
2020
2019
2020
2019
GAAP Financial Results
$
701,494
$
94,840
$
617,076
$
35,063
$
470,130
$
30,626
Interest expense on Convertible Senior
Notes, net of tax
(13
)
179
Net income used for diluted earnings per
share, if-converted method
470,117
30,805
$
10.78
$
0.71
Adjustments:
Non-cash stock compensation expense
780
355
6,458
3,168
6,458
3,168
Amortization of intangibles
1,901
1,970
7,166
7,043
7,166
7,043
Amortization of debt issuance costs on
credit facility
100
100
Non-cash interest expense for deferred
consideration
1,543
1,872
Change in fair value of acquisition
contingencies
557
841
557
841
Acquisition and integration costs
519
2,551
519
2,551
Foreign exchange (gain) loss
(307
)
59
Income tax impact of adjustments (a)
(3,368
)
(2,970
)
Adjusted
$
704,175
$
97,165
$
631,776
$
48,666
$
482,785
$
43,469
$
11.07
$
1.00
(a)
Income tax impact of adjustments
represents the tax impact related to the non-GAAP adjustments
listed above and reflects an effective tax rate of 21% for 2020 and
19% for 2019.
QUIDEL CORPORATION
Reconciliation of Non-GAAP
Financial Information
(In thousands, except per share
data; unaudited)
Twelve months ended December
31,
Gross Profit
Operating Income
Net Income
Diluted EPS
2020
2019
2020
2019
2020
2019
2020
2019
GAAP Financial Results
$
1,348,855
$
320,805
$
1,060,326
$
92,716
$
810,287
$
72,921
Interest expense on Convertible Senior
Notes, net of tax
445
1,848
Net income used for diluted earnings per
share, if-converted method
810,732
74,769
$
18.60
$
1.73
Adjustments:
Non-cash stock compensation expense
2,012
1,162
21,019
13,252
21,019
13,252
Amortization of intangibles
7,665
7,746
28,398
27,956
28,398
27,956
Amortization of debt issuance costs on
credit facility
403
403
Non-cash interest expense for deferred
consideration
6,569
8,224
Loss on extinguishment of Convertible
Senior Notes
10,384
748
Change in fair value of acquisition
contingencies
1,405
1,467
1,405
1,467
Change in fair value of derivative
liabilities - Convertible Senior Note
1,084
—
Acquisition and integration costs
3,694
11,667
3,694
11,667
Foreign exchange loss
40
1,794
Income tax impact of adjustments (a)
(15,329
)
(12,447
)
Adjusted
$
1,358,532
$
329,713
$
1,114,842
$
147,058
$
868,399
$
127,833
$
19.92
$
2.97
(a)
Income tax impact of adjustments
represents the tax impact related to the non-GAAP adjustments
listed above and reflects an effective tax rate of 21% for 2020 and
19% for 2019.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210218006003/en/
Quidel Contact: Quidel Corporation Randy Steward Chief Financial
Officer 858.552.7931
Media and Investors Contact: Quidel Corporation Ruben Argueta
858.646.8023 rargueta@quidel.com
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