Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider
of rapid diagnostic testing solutions, cellular-based virology
assays and molecular diagnostic systems, announced today the
following business update in advance of today’s presentation and
investor meetings at the 13th Annual Piper Sandler Med-Tech and
Diagnostic California Bus Tour.
Quidel Corporation, an industry leader in the introduction of
FDA-authorized rapid tests for a wide range of diseases and medical
conditions, remains in the forefront of the battle against the
COVID-19 pandemic.
Abbott’s entry into the SARS antigen testing market was fully
anticipated, as was the potential scale of visually read lateral
flow assays. The assay performance described in the package insert
is unsurprising as well and is very encouraging as it further
validates the utility of rapid immunoassay technology in addressing
the critical testing needs of our nation. The suggestion of lower
product pricing was also expected, given how the Alere BinaxNOW
Influenza A+B Card had been previously priced relative to other
rapid influenza products, including Sofia Influenza A+B, the
premier product and market leader in rapid influenza testing.
Quidel’s Sofia has an installed base of over 50,000 Sofia
instruments in the United States. The Sofia system has features
that customers find attractive, such as an objectively read result,
internal controls that ensure testing accuracy, and the Virena®
data management system, which provides aggregated, de-identified
testing data in near real-time to thousands of hospital systems,
urgent care networks and public health officials. These
differentiating features are valuable to customers and help to
explain the price difference between Sofia assays -- like Influenza
A+B, Strep A and RSV – and visually read products.
“Another SARS Antigen product from a high-quality company with
scale like Abbott is welcome. The validity of rapid antigen testing
has been questioned by some, including state public health
officials, and together with Abbott, BD and perhaps others, we can
begin to change this mindset and to expand the utility and demand
for this technology,” said Douglas Bryant, president and CEO Quidel
Corporation. “Another entrant into the segment doesn’t change our
plans to develop or manufacture any of the products in our
pipeline, doesn’t change our marketing plans, and has no impact on
our financial forecast at this time.”
Quidel’s new product development engine is what has historically
fueled its growth. Quidel plans to introduce a Sofia Flu + COVID
Antigen combination assay, a Sofia Serology assay, and a Solana
molecular SARS assay in September. Quidel is also developing SARS
and SARS combination assays in its QuickVue format.
Quidel to Present Today at 13th Annual Piper Sandler Med-Tech
and Diagnostics California Bus Tour
Douglas Bryant, president and chief executive officer, and Randy
Steward, chief financial officer, will present today at 3:00 p.m.
Eastern time (12:00 p.m. Pacific time) with a question and answer
session scheduled immediately following the presentation. During
the presentation, the company will discuss business and financial
developments and trends. The company's statements may contain or
constitute material information that has not been previously
disclosed.
A live webcast and audio archive of each presentation will be
available via the Investor Relations section of the company’s
website at http://ir.quidel.com or by clicking on the link
below:
https://event.on24.com/wcc/r/2470021/02FE2E0F9F708F783AFABC0E56013B47
Participants should allow approximately five to ten minutes
prior to the presentation's start time to visit the site and
download any streaming media software needed to listen to the
Internet webcast. A replay of the webcast will also be available on
the company’s website for 14 days.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being
of people around the globe through the development of diagnostic
solutions that can lead to improved patient outcomes and provide
economic benefits to the healthcare system. Marketed under the
Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and
InflammaDry® leading brand names, as well as under the new Solana®,
AmpliVue® and Lyra® molecular diagnostic brands, Quidel’s products
aid in the detection and diagnosis of many critical diseases and
conditions, including, among others, influenza, respiratory
syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease
and fecal occult blood. Quidel's Triage® system of tests comprises
a comprehensive test menu that provides rapid, cost-effective
treatment decisions at the point-of-care (POC), offering a diverse
immunoassay menu in a variety of tests to provide diagnostic
answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I
and qualitative TOX Drug Screen. Quidel’s research and development
engine is also developing a continuum of diagnostic solutions from
advanced immunoassay to molecular diagnostic tests to further
improve the quality of healthcare in physicians’ offices and
hospital and reference laboratories. For more information about
Quidel’s comprehensive product portfolio and to explore exciting
employment opportunities, visit quidel.com.
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 financial 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; an
inability to agree on a definitive agreement or meet key
deliverables and milestones under the NIH’s RADx-ATP contract;
adverse changes in competitive conditions, the reimbursement system
currently in place and future changes to that system, changes in
economic conditions in our domestic and international markets,
lower than anticipated market penetration of our products, our
reliance on sales of our influenza and COVID-19 diagnostic tests,
fluctuations in our operating results resulting from the timing of
the onset, length and severity of cold and flu seasons,
seasonality, government and media attention focused on influenza
and other respiratory or novel viruses and the related potential
impact on humans from such viruses, the quantity of our product in
our distributors’ inventory or distribution channels, changes in
the buying patterns of our distributors, and changes in the
healthcare market and consolidation of our customer base; our
development, acquisition and protection of proprietary technology
rights; our development of new technologies, products and markets;
our reliance on a limited number of key distributors; 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.; intellectual property risks, including but not limited to,
infringement litigation; our need for additional funds to finance
our capital or operating needs; the financial soundness of our
customers and suppliers; acceptance of our products among
physicians and other healthcare providers; competition with other
providers of diagnostic products; failures or delays in receipt of
new product reviews 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 or clearances or other adverse actions by
regulatory authorities; changes in government policies; costs of
and adverse operational impact from failure to comply with
government regulations in addition to FDA regulations; compliance
with government regulations relating to the handling, storage and
disposal of hazardous substances; third-party reimbursement
policies and potential cost constraints; our failure to comply with
laws and regulations relating to billing and payment for healthcare
services; our ability to meet demand for our products;
interruptions or shortages in our supply of raw materials and other
components; product defects; business risks not covered by
insurance; costs and disruptions from failures in our information
technology and storage systems; our exposure to data corruption,
cyber-based attacks, security breaches and privacy violations;
competition for and loss of management and key personnel;
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. markets;
changes in tax rates and exposure to additional tax liabilities or
assessments; risks relating to our acquisition and integration of
the Triage MeterPro Cardiovascular and toxicology business and
B-type Natriuretic Peptide assay business; that we may have to
write off goodwill relating to our acquisitions; our ability to
manage our growth strategy and identify and integrate acquired
companies or technologies and our ability to obtain financing; the
level of our indebtedness and deferred payment obligations; our
ability to generate sufficient cash to meet our debt service and
deferred and contingent payment obligations; that our Revolving
Credit Facility is secured by substantially all of our assets; the
agreements for our indebtedness place operating and financial
restrictions on us and our ability to operate our business; that an
event of default could trigger acceleration of our outstanding
indebtedness; that we may incur additional indebtedness; increases
in interest rate relating to our variable rate debt; dilution
resulting from future sales of our equity; volatility in our stock
price; provisions in our charter documents, Delaware law and the
indenture governing our Convertible Senior Notes that might delay
or impede stockholder actions with respect to business combinations
or similar transactions; our intention of not paying dividends; and
our ability to identify and successfully acquire and integrate
potential acquisition targets. 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 (the “SEC”) from
time to time, should be carefully considered. 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 the results of 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/20200827005663/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@quidelcom
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