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 first quarter ended March 31, 2021.
First Quarter 2021 Highlights
- Total revenue increased 115% to $375.3 million, from $174.7
million in the first quarter of 2020.
- Total sales of COVID-19 products were $280.3 million, as
compared to $1.0 million in the first quarter of 2020.
- Total sales of Influenza products were $5.2 million, as
compared to $79.6 million in the first quarter of 2020.
- Cardiometabolic Immunoassay sales increased 23% to $66.6
million.
- Reported GAAP EPS of $4.09 per diluted share in the first
quarter of 2021, as compared to $0.93 per diluted share in the
first quarter of 2020.
- Reported non-GAAP EPS of $4.38 per diluted share in the first
quarter of 2021, as compared to $1.22 per diluted share in the
first quarter of 2020.
- Received EUA from the FDA for QuickVue® At-Home COVID-19 Test
for prescription use and for QuickVue® At-Home OTC COVID-19 Test
for serial at-home use without prescription and among asymptomatic
persons.
First Quarter 2021 Results
Total revenue for the first quarter of 2021 was $375.3 million,
versus $174.7 million for the first quarter of 2020. The 115%
increase in sales from the first quarter of 2020 was driven by
growth in Rapid Immunoassay and Molecular Diagnostic Solutions
product categories, the result of strong demand for both rapid
antigen and PCR COVID-19 tests. To a lesser extent, growth also
came from our Cardiometabolic Immunoassay products. Revenue growth
in the quarter was minimally offset by a decline in Specialized
Diagnostic Solutions revenues. Currency exchange had a favorable
impact of $2.1 million. Excluding COVID-19 and influenza products,
revenue for the core business was $89.9 million, as compared to
$94.1 million in the first quarter of 2020.
Rapid Immunoassay product revenue increased by $141.7 million in
the first quarter of 2021 to $237.7 million, primarily due to
$212.1 million in revenue for our Sofia® SARS Antigen test.
Cardiometabolic Immunoassay revenue totaled $66.6 million in the
first quarter of 2021, an increase of 23% from the first quarter of
2020. Molecular Diagnostic Solutions revenue increased $51.9
million to $60.3 million mostly due to sales of Lyra® PCR assays
for COVID-19 diagnosis, as well as, to a lesser extent, sales of
Solana® SARS-CoV-2 assays. Specialized Diagnostic Solutions revenue
decreased 34% from the first quarter of 2020 to $10.9 million,
driven by lower demand for respiratory testing.
“The first quarter of 2021 was both a commercial and operational
success, as well as a foundation forming period for the
transformational opportunities in the quarters and years ahead. Our
team continued to deliver extraordinary performance with the
introduction of breakthrough new products, expanded manufacturing
capabilities, regulatory approvals and capital discipline. As a
result, we delivered a 115% increase in revenues and an
approximately 340% increase in net income and earnings per share
year-over-year,” said Douglas Bryant, president and CEO of Quidel
Corporation.
“We see tremendous opportunities ahead to leverage our rapidly
expanding installed base of Sofia® analyzers leveraging the
exponential rise of telemedicine to drive sales of our full array
of Sofia® assays for flu, Strep and a host of other conditions. In
addition, late in the quarter, we received pathbreaking EUAs from
the FDA for serial screening with our Sofia® SARS and QuickVue®
At-Home OTC COVID-19 Test technologies, which we believe represents
a regulatory shift that extends well beyond the immediate
addressable markets for OTC at-home and re-opening testing,” Mr.
Bryant continued.
“Looking ahead, Quidel is exceptionally well positioned to grow
its share across multiple platforms and channels. We are poised to
introduce Savanna®, a multiplex molecular analyzer that enables
professional customers to analyze up to 12 pathogens or targets,
plus controls, in a single assay run in less than 25 minutes, which
promises to disrupt and decentralize multiplex molecular testing.
Further, we recently established crucial strategic partnerships
with global distribution and retail leaders including McKesson and
Walgreens that will give us unprecedented exposure to the OTC
segment and fulfillment pathways to serve employers seeking a path
to safely re-opening. Taken together, this powerful mix of
products, partnerships and macro trends provide an exciting roadmap
for Quidel’s continued growth and success in advancing diagnostics
to improve human health,” Mr. Bryant concluded.
Gross Profit in the first quarter of 2021 increased by 163% from
the first quarter of 2020 to $302.0 million, driven by the demand
for both rapid antigen and molecular COVID-19 products. Increased
spend, required to expedite the production ramp, was offset by
higher absorption related to the increased production volumes.
Gross margin improvement versus last year was due to the same
factors. R&D expense increased by $6.9 million in the first
quarter as compared to the same period last year, due primarily to
increased spending on the Savanna instrument development project.
We also incurred incremental labor and material costs associated
with COVID-19 product development. Sales and Marketing expense
increased by $3.5 million in the quarter, due primarily to higher
compensation costs driven by increased headcount as well as product
promotions. This was partially offset by reduced travel, meeting
and trade show costs due to the COVID-19 travel restrictions.
G&A expense increased by $5.2 million in the quarter due to
higher compensation costs. Acquisition and integration costs of
$0.7 million and $1.9 million for the three months ended March 31,
2021 and 2020, respectively, primarily related to the evaluation of
new business development opportunities.
In the first quarter of 2021, the Company recorded an income tax
expense of $43.7 million, as compared with $8.6 million in the same
quarter last year. The higher tax expense for the three months
ended March 31, 2021 as compared to the same period in the prior
year is a result of higher pre-tax profits.
Net income for the first quarter was $178.1 million, or $4.09
per diluted share, as compared to a net income of $40.2 million, or
$0.93 per diluted share, for the first quarter of 2020. On a
non-GAAP basis, net income for the first quarter of 2021 was $190.5
million, or $4.38 per diluted share, as compared to net income of
$52.7 million, or $1.22 per diluted share, for the same period in
2020.
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
first quarter 2021 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.
To join the live webcast, participants may click the following
link directly:
https://event.on24.com/wcc/r/3079598/CE0CADA8C76940432131766161A25083,
or access the event 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 May 6th, 2021 by dialing
800-585-8367 from the U.S., or by dialing 416-621-4642 for
international callers, and entering pass code 684-7708.
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, 2020 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 March
31,
Consolidated Statements of
Operations:
2021
2020
Total revenues
$
375,338
$
174,653
Cost of sales
73,379
59,662
Gross profit
301,959
114,991
Research and development
23,304
16,379
Sales and marketing
34,233
30,738
General and administrative
19,507
14,332
Acquisition and integration costs
726
1,914
Total operating expenses
77,770
63,363
Operating income
224,189
51,628
Interest and other expense, net
(2,382
)
(2,807
)
Income before income taxes
221,807
48,821
Provision for income taxes
43,723
8,584
Net income
$
178,084
$
40,237
Basic earnings per share
$
4.19
$
0.96
Diluted earnings per share
$
4.09
$
0.93
Shares used in basic per share
calculation
42,510
42,056
Shares used in diluted per share
calculation
43,533
43,403
Gross profit as a % of total revenues
80
%
66
%
Research and development as a % of total
revenues
6
%
9
%
Sales and marketing as a % of total
revenues
9
%
18
%
General and administrative as a % of total
revenues
5
%
8
%
Consolidated net revenues by product
category are as follows:
Rapid Immunoassay
$
237,670
$
95,930
Cardiometabolic Immunoassay
66,552
53,901
Specialized Diagnostic Solutions
10,853
16,459
Molecular Diagnostic Solutions
60,263
8,363
Total revenues
$
375,338
$
174,653
Condensed balance sheet data:
3/31/2021
12/31/2020
Cash and cash equivalents
$
981,052
$
489,941
Accounts receivable, net
$
70,170
$
497,688
Inventories
$
174,669
$
113,798
Total assets
$
2,097,369
$
1,871,164
Short-term debt
$
266
$
238
Long-term debt
$
4,206
$
4,100
Stockholders’ equity
$
1,489,714
$
1,332,703
QUIDEL CORPORATION
Reconciliation of Non-GAAP
Financial Information
(In thousands, except per share
data; unaudited)
Three months ended March
31,
Gross Profit
Operating Income
Net Income
Diluted EPS
2021
2020
2021
2020
2021
2020
2021
2020
GAAP Financial Results
$
301,959
$
114,991
$
224,189
$
51,628
$
178,084
$
40,237
Interest expense on Convertible Senior
Notes, net of tax
—
181
Net income used for diluted earnings per
share, if-converted method
178,084
40,418
$
4.09
$
0.93
Adjustments:
Non-cash stock compensation expense
516
258
5,828
3,878
5,828
3,878
Amortization of intangibles
1,959
1,958
7,503
7,062
7,503
7,062
Amortization of debt issuance costs on
credit facility
101
101
Non-cash interest expense for deferred
consideration
1,451
1,895
Acquisition and integration costs
726
1,914
726
1,914
Foreign exchange loss
369
360
Income tax impact of adjustments (a)
(3,515
)
(2,890
)
Adjusted
$
304,434
$
117,207
$
238,246
$
64,482
$
190,547
$
52,738
$
4.38
$
1.22
(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 22% for 2021 and
19% for 2020.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210506006113/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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