Establishes distribution partnership agreement
to increase access to At-Home COVID-19 testing
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider
of rapid diagnostic testing solutions, cellular-based virology
assays and molecular diagnostic systems, announced today
preliminary results for the first quarter of 2021.
The Company expects revenues in the first quarter of 2021 to be
in the range of $374 million to $376 million, up approximately 114%
from $174.7 million in the prior year quarter. In the quarter,
Quidel shipped nearly 15 million SARS tests, which compares
favorably to the performance of our industry colleagues. COVID-19
revenues for the first quarter of 2021 are expected to be over $280
million, compared with $1.0 million for the first quarter of 2020.
The first quarter of 2021 was marked by the lack of a respiratory
season, resulting in lower sales of influenza and other respiratory
disease products. Influenza revenues for the first quarter of 2021
are expected to be $5 million, compared with $79.6 million in the
first quarter of 2020. Additionally, gross margins are expected to
be approximately 80% for the period, with earnings growth over the
prior year quarter in excess of 300%.
Douglas Bryant, president and
chief executive officer of Quidel Corporation, said: “Over the past
year, we have transformed our business through innovative new
product introductions and strong operational execution. By all
measures, the first quarter of 2021 reflected demand-side and
manufacturing strength as we more than doubled our revenues
year-over-year, with even greater growth in gross profit and net
income. Still, as the COVID-19 pandemic response evolved, the
operating environment was fluid, making it difficult to predict
testing demand with certainty. In combination with the COVID-19
volatility, there was no circulating influenza in the community,
and as a result, revenues came in well below our previous
expectations.”
Mr. Bryant added: “While the COVID-19 scenario continues to
evolve, we believe Quidel remains incredibly well-positioned given
our robust portfolio and recent regulatory indications for serial
asymptomatic screening with both our QuickVue® OTC and Sofia® rapid
antigen tests. There are three macro trends that we are tracking
and expect to be material to both market demand and revenues going
forward.
“First, there is ongoing demand for testing symptomatic
patients, which we believe is likely to persist at least through
the first half of 2022. Therefore, for this type of testing, the
underlying run rate is somewhat predictable and is trending upward
as COVID-19 cases in the U.S. have risen more than 22 percent since
March.
“Second, customer inquiries and market research suggest strong
demand for at-home testing through pharmacies, employers and
schools. In fact, today we announced a new distribution partnership
agreement with McKesson in the retail space to increase access to
At-Home COVID-19 testing and expect to be entering into direct
partnerships with a number of major national retailers, several
state school programs, and a major global employer group.
“Third, global demand for asymptomatic SARS testing appears to
be larger than what the IVD industry can support at this time. For
Quidel, while we are early in the transition to on-site and at-home
testing for asymptomatic and pre-symptomatic individuals, the
demand for QuickVue SARS antigen tests appears to be well above
what we can supply, at least until our new plant in Carlsbad is up
and running,” continued Mr. Bryant.
Mr. Bryant concluded: “While
we will not be providing an updated financial outlook for the full
year 2021, given the volatility in the market and the impact on our
results, we do look forward to discussing the important revenue
growth drivers we have in front of us in more detail during our
scheduled first quarter 2021 earnings call on May 6,
2021.”
These preliminary results are based on management’s initial
analysis of operations for the quarter ended March 31, 2021. The
company expects to issue full financial results for the fiscal
first quarter 2021 on May 6, 2021.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210422006099/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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