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 second quarter ended June 30, 2021.
Second Quarter 2021 Highlights
- Total revenue decreased 12% to $176.6 million, from $201.8
million in the second quarter of 2020.
- Total sales of COVID-19 products were $83.4 million, as
compared to $109.0 million in the second quarter of 2020.
- Total sales of Influenza products were $1.6 million, as
compared to $18.7 million in the second quarter of 2020.
- Reported GAAP EPS of $0.45 per diluted share in the second
quarter of 2021, as compared to $1.55 per diluted share in the
second quarter of 2020.
- Reported non-GAAP EPS of $0.75 per diluted share in the second
quarter of 2021, as compared to $1.86 per diluted share in the
second quarter of 2020.
- Sofia® SARS Antigen test received Emergency Use Authorization
(EUA) for screening use with serial testing.
- Received amended EUA for new Sofia® Q Rapid Antigen test
device.
Second Quarter 2021 Results
Total revenue for the second quarter of 2021 was $176.6 million,
versus $201.8 million for the second quarter of 2020. The 12%
decrease in sales from the second quarter of 2020 was driven by
decreased demand for Sofia and PCR COVID-19 assays that was
partially offset by increased demand for QuickVue COVID-19 tests,
as well as lower demand for influenza products. This decrease was
partially offset by 32% growth from our Cardiometabolic Immunoassay
product. Currency exchange impact was favorable by $2.8 million
dollars. Excluding COVID-19 and influenza products, revenue for the
core business grew 24% to $91.5 million, as compared to $74.0
million in the second quarter of 2020.
Rapid Immunoassay product revenue decreased by $20.5 million in
the second quarter of 2021 to $60.1 million, due to lower revenue
for our Sofia® SARS Antigen and influenza products that were
partially offset by $28.6 million in incremental QuickVue SARS
Antigen product sales. Cardiometabolic Immunoassay revenue totaled
$71.7 million in the second quarter of 2021, an increase of 32%
from the second quarter of 2020. Molecular Diagnostic Solutions
revenue decreased $20.7 million to $34.5 million, due to a $25.5
million decline in sales of Lyra® PCR assays for COVID-19 diagnosis
that was partially offset by incremental revenue from our Solana®
SARS-CoV-2 assay. Specialized Diagnostic Solutions revenue
decreased 12% from the second quarter of 2020 to $10.4 million,
driven by lower demand for respiratory testing.
“During the second quarter of 2021, we made great progress
advancing our product portfolio, while continuing to position
Quidel for long-term growth. In the quarter, we delivered solid 24%
growth in our core business, further broadened our installed base
of Sofia® analyzers and established a strong beachhead for COVID
testing in the retail segment,” said Douglas Bryant, president and
CEO of Quidel Corporation.
“We also made great strides in our R&D and Clinical efforts
during the quarter, which set us up to execute on our multi-faceted
growth strategy. Although the landscape of COVID testing continues
to evolve daily, the highly transmissible COVID-19 Delta variant is
starting to drive demand in both the professional and OTC
segments,” continued Mr. Bryant. “Further, the recent EUA for our
miniaturized Sofia® Q device will make access to our Sofia® tests
more affordable for professional and point-of-care customers.
Longer-term, it could create a retail pathway for our full
portfolio of Sofia® tests for influenza, RSV, Strep and other
conditions. This positions us favorably to address the coming flu
and respiratory disease seasons.”
“Looking ahead, we believe our Savanna® multiplex molecular
analyzer will be our next flagship product. We recently received CE
Mark for the European market. When approved in the U.S., Savanna®
will enable professional customers to analyze up to 12 pathogens or
targets, plus controls, in a single assay run in less than 25
minutes,” Mr. Bryant added. “While the environment remains
incredibly fluid, we have made tremendous progress to date, and are
very pleased with both the performance of our Quidel team and the
outlook for the company.”
Gross profit decreased to $106.2 million, or 60% of revenue for
the three months ended June 30, 2021, compared to $148.8 million,
or 74% of revenue for the three months ended June 30, 2020. The
decreased gross profit was driven by lower selling prices for our
SARS products and unfavorable product mix due to lower demand for
SARS products and increased demand for Cardiometabolic Immunoassay
products. Increases in supply chain and other indirect
manufacturing costs also contributed to lower gross profit in the
period. Gross margin declined as compared to last year due to the
same factors. R&D expense increased by $1.6 million in the
second quarter as compared to the same period last year, due
primarily to increased spending on Savanna instrument and cartridge
development in preparation for clinical trials. Sales and Marketing
expense increased by $10.5 million in the quarter, due primarily to
higher product promotional spend associated with the launch of our
QuickVue At-Home OTC COVID-19 Test as well as increased travel and
meetings as COVID-19-related travel restrictions ease. G&A
expense increased by $5.5 million in the quarter due to increased
spend on IT projects and higher compensation costs driven by
increased headcount to support the growth of the business.
Acquisition and integration costs of $1.0 million and $0.9 million
for the three months ended June 30, 2021 and 2020, respectively,
primarily related to the evaluation of new business development
opportunities and litigation costs.
In the second quarter of 2021, the Company recorded an income
tax expense of $2.6 million, as compared with $12.5 million in the
same quarter last year. The lower tax expense for the three months
ended June 30, 2021 as compared to the same period in the prior
year is a result of lower pre-tax profits.
Net income for the second quarter was $19.1 million, or $0.45
per diluted share, as compared to a net income of $67.7 million, or
$1.55 per diluted share, for the second quarter of 2020. On a
non-GAAP basis, net income for the second quarter of 2021 was $31.8
million, or $0.75 per diluted share, as compared to net income of
$81.6 million, or $1.86 per diluted share, for the same period in
2020.
Results for the Six Months Ended June 30, 2021
Total revenue for the six months ended June 30, 2021 was $551.9
million, versus $376.4 million for the six months ended June 30,
2020. The 47% increase in sales from the six months ended June 30,
2020 was driven by growth in Rapid Immunoassay and Molecular
Diagnostic Solutions product categories, the result of relatively
strong demand for both rapid antigen and PCR COVID-19 tests in the
beginning of 2021 versus the same period in 2020. Revenue growth in
the first half of the year also came from our Cardiometabolic
Immunoassay products, increasing 28% over the same period in 2020,
as COVID-19 restrictions have begun to lift and sales return to
pre-pandemic levels. Specialized Diagnostic Solutions revenues
decreased 25%, driven primarily by a decline in demand for cell
culture respiratory products. Currency exchange had a favorable
impact of $4.8 million. Excluding COVID-19 and influenza products,
revenue for the core business was $181.4 million for the six months
ended June 30, 2021, as compared to $168.1 million for the six
months ended June 30, 2020.
Rapid Immunoassay product revenue increased by $121.2 million in
the six months ended June 30, 2021 to $297.7 million, primarily due
to $224.6 million in revenue for our Sofia® SARS Antigen test and
$41.0 million in revenue for our QuickVue SARS products.
Cardiometabolic Immunoassay revenue totaled $138.2 million in the
six months ended June 30, 2021, an increase of 28% from the six
months ended June 30, 2020. Molecular Diagnostic Solutions revenue
increased $31.2 million to $94.7 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 25% from the six months ended June 30,
2020 to $21.3 million, driven by lower demand for respiratory
testing.
Gross profit increased to $408.1 million, or 74% of revenue for
the six months ended June 30, 2021, compared to $263.7 million, or
70% of revenue for the six months ended June 30, 2020. The
increased gross profit was due to higher sales volumes in the
current period as well as improved product mix driven by continued
demand for our SARS assays. The gains were partially offset by
higher indirect manufacturing costs. Gross margin improved as
compared to the same period in the prior year driven primarily by
improved product mix. R&D expense increased by $8.6 million in
the six months ended June 30, 2021 as compared to the same period
last year, due primarily to increased spending on the Savanna
instrument and cartridge development in preparation for
commercialization. Sales and Marketing expense increased by $14.0
million for the six months ended June 30, 2021, as compared to the
same period in 2020, due primarily to product promotional spend
associated with the launch of QuickVue At-Home OTC COVID-19 Test,
higher compensation costs driven by increased headcount and
increased travel, meeting and trade show costs as COVID-19-related
restrictions ease. G&A expense increased by $10.6 million for
the six months ended June 30, 2021 due to increased spend on IT
projects and higher compensation costs driven by increased
headcount to support the growth of the business. Acquisition and
integration costs of $1.8 million and $2.8 million for the six
months ended June 30, 2021 and 2020, respectively, primarily
related to the evaluation of new business development
opportunities.
For the six months ended June 30, 2021, the Company recorded an
income tax expense of $46.3 million, as compared with $21.1 million
in the same period last year. The higher tax expense for the six
months ended June 30, 2021 as compared to the same period in the
prior year is a result of higher pre-tax profits, as well as a
proportional decrease in tax deductions from stock based
compensation to pre-tax profits.
Net income for the six months ended June 30, 2021 was $197.2
million, or $4.64 per diluted share, as compared to a net income of
$107.9 million, or $2.48 per diluted share, for the six months
ended June 30, 2020. On a non-GAAP basis, net income for the six
months ended June 30, 2021 was $222.4 million, or $5.24 per diluted
share, as compared to net income of $134.3 million, or $3.08 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
second 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/3196433/B5D63E95E34F79DE5D13425B35E75377,
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 August 5th, 2021 by dialing
929-458-6194 from the U.S., or by dialing +44-204-525-0658 for
international callers, and entering pass code 080478.
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 of
the novel virus (COVID-19) global pandemic; competition; our
development of new technologies, products and markets; our reliance
on sales of our influenza and COVID-19 diagnostic tests; our
reliance on a limited number of key distributors; the financial
soundness of our customers and suppliers; acceptance of our
products among physicians and other healthcare providers and other
targeted customers; the reimbursement system currently in place and
future changes to that system; our ability to meet demand for our
products; interruptions or shortages in our supply of raw materials
and other components; costs and disruptions from failures in our
information technology and storage systems and our exposure to data
corruption, cyber-based attacks, security breaches and privacy
violations; international risks, including but not limited to,
compliance with product registration requirements, compliance with
legal requirements, tariffs, exposure to currency exchange
fluctuations and foreign currency exchange risk, longer payment
cycles, lower selling prices and greater difficulty in collecting
accounts receivable, reduced protection of intellectual property
rights, social, political and economic instability, increased
financial accounting and reporting burdens and complexities, taxes,
and diversion of lower priced international products into U.S.
market; worldwide political and social uncertainty, including
tariffs, trade wars or social tensions; our development,
acquisition and protection of proprietary technology rights;
intellectual property risks, including but not limited to,
infringement litigation, loss of our Emergency Use Authorization
from the U.S. Food and Drug Administration (the “FDA”) for our
COVID-19 products; failures or delays in receipt of new product
reviews or related to currently-marketed products by FDA or other
regulatory authorities or loss of any previously received
regulatory approvals, clearances or authorizations or other adverse
actions by regulatory authorities; funding and compliance risks
relating to government contracts, including the ability to meet key
deliverables and milestones under our NIH RADx-ATP contract;
product defects; compliance with government regulations relating to
the handling, storage and disposal of hazardous substances; our
ability to identify and successfully acquire and integrate
potential acquisition targets; risks relating to our acquisition of
Alere’s Triage and BNP Businesses; our need for additional funds to
finance our capital or operating needs; the level of our
indebtedness and deferred payment obligations; competition for and
loss of management and key personnel; our exposure to claims and
litigation that could result in significant expenses and could
ultimately result in an unfavorable outcome for us; 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 June
30,
Consolidated Statements of
Operations:
2021
2020
Total revenues
$
176,610
$
201,754
Cost of sales
70,424
53,003
Gross profit
106,186
148,751
Research and development
22,614
20,970
Sales and marketing
38,100
27,567
General and administrative
21,138
15,679
Acquisition and integration costs
1,028
872
Total operating expenses
82,880
65,088
Operating income
23,306
83,663
Interest and other expense, net
(1,623
)
(3,467
)
Income before income taxes
21,683
80,196
Provision for income taxes
2,610
12,544
Net income
$
19,073
$
67,652
Basic earnings per share
$
0.46
$
1.61
Diluted earnings per share
$
0.45
$
1.55
Shares used in basic per share
calculation
41,691
42,117
Shares used in diluted per share
calculation
42,374
43,746
Gross profit as a % of total revenues
60
%
74
%
Research and development as a % of total
revenues
13
%
10
%
Sales and marketing as a % of total
revenues
22
%
14
%
General and administrative as a % of total
revenues
12
%
8
%
Consolidated net revenues by product
category are as follows:
Rapid Immunoassay
$
60,070
$
80,606
Cardiometabolic Immunoassay
71,666
54,191
Molecular Diagnostic Solutions
34,456
55,177
Specialized Diagnostic Solutions
10,418
11,780
Total revenues
$
176,610
$
201,754
Condensed balance sheet data:
6/30/2021
12/31/2020
Cash and cash equivalents
$
593,224
$
489,941
Accounts receivable, net
$
46,216
$
497,688
Inventories
$
218,506
$
113,798
Total assets
$
1,807,652
$
1,871,164
Short-term debt
$
269
$
238
Long-term debt
$
4,051
$
4,100
Stockholders’ equity
$
1,411,079
$
1,332,703
QUIDEL CORPORATION
(In thousands, except per share
data; unaudited)
Six months ended June
30,
Consolidated Statements of
Operations:
2021
2020
Total revenues
$
551,948
$
376,407
Cost of sales
143,803
112,665
Gross profit
408,145
263,742
Research and development
45,918
37,349
Sales and marketing
72,333
58,305
General and administrative
40,645
30,011
Acquisition and integration costs
1,754
2,786
Total operating expenses
160,650
128,451
Operating income
247,495
135,291
Interest and other expense, net
(4,005
)
(6,274
)
Income before income taxes
243,490
129,017
Provision for income taxes
46,333
21,128
Net income
$
197,157
$
107,889
Basic earnings per share
$
4.74
$
2.56
Diluted earnings per share
$
4.64
$
2.48
Shares used in basic per share
calculation
41,622
42,086
Shares used in diluted per share
calculation
42,475
43,574
Gross profit as a % of total revenues
74
%
70
%
Research and development as a % of total
revenues
8
%
10
%
Sales and marketing as a % of total
revenues
13
%
15
%
General and administrative as a % of total
revenues
7
%
8
%
Consolidated net revenues by product
category are as follows:
Rapid Immunoassay
$
297,740
$
176,536
Cardiometabolic Immunoassay
138,218
108,092
Molecular Diagnostic Solutions
94,719
63,540
Specialized Diagnostic Solutions
21,271
28,239
Total revenues
$
551,948
$
376,407
QUIDEL CORPORATION
Reconciliation of Non-GAAP
Financial Information
(In thousands, except per share
data; unaudited)
Three months ended June
30,
Gross Profit
Operating Income
Net Income
Diluted EPS
2021
2020
2021
2020
2021
2020
2021
2020
GAAP Financial Results
$
106,186
$
148,751
$
23,306
$
83,663
$
19,073
$
67,652
Interest expense on Convertible Senior
Notes, net of tax
—
179
Net income used for diluted earnings per
share, if-converted method
19,073
67,831
$
0.45
$
1.55
Adjustments:
Non-cash stock compensation expense
643
435
5,846
5,130
5,846
5,130
Amortization of intangibles
2,073
1,905
8,005
7,041
8,005
7,041
Amortization of debt issuance costs on
credit facility
101
101
Non-cash interest expense for deferred
consideration
1,107
1,717
Change in fair value of acquisition
contingencies
101
848
101
848
Change in fair value of derivative
liabilities - Convertible Senior Note
—
1,084
Acquisition and integration costs
1,028
872
1,028
872
Foreign exchange loss
164
146
Income tax impact of adjustments (a)
(3,597
)
(3,218
)
Adjusted
$
108,902
$
151,091
$
38,286
$
97,554
$
31,828
$
81,552
$
0.75
$
1.86
_________________________________________________________
(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.
QUIDEL CORPORATION
Reconciliation of Non-GAAP
Financial Information
(In thousands, except per share
data; unaudited)
Six months ended June
30,
Gross Profit
Operating Income
Net Income
Diluted EPS
2021
2020
2021
2020
2021
2020
2021
2020
GAAP Financial Results
$
408,145
$
263,742
$
247,495
$
135,291
$
197,157
$
107,889
Interest expense on Convertible Senior
Notes, net of tax
—
360
Net income used for diluted earnings per
share, if-converted method
197,157
108,249
$
4.64
$
2.48
Adjustments:
Non-cash stock compensation expense
1,159
693
11,674
9,008
11,674
9,008
Amortization of intangibles
4,032
3,863
15,508
14,103
15,508
14,103
Amortization of debt issuance costs on
credit facility
202
202
Non-cash interest expense for deferred
consideration
2,558
3,612
Change in fair value of acquisition
contingencies
101
848
101
848
Change in fair value of derivative
liabilities - Convertible Senior Note
—
.
1,084
Acquisition and integration costs
1,754
2,786
1,754
2,786
Foreign exchange loss
533
506
Income tax impact of adjustments (a)
(7,112
)
(6,108
)
Adjusted
$
413,336
$
268,298
$
276,532
$
162,036
$
222,375
$
134,290
$
5.24
$
3.08
_________________________________________________________
(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/20210805006080/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
QuidelOrtho (NASDAQ:QDEL)
Historical Stock Chart
From May 2024 to Jun 2024
QuidelOrtho (NASDAQ:QDEL)
Historical Stock Chart
From Jun 2023 to Jun 2024