Quidel Comments on California Court Ruling
December 07 2018 - 3:00PM
Business Wire
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider
of rapid diagnostic testing solutions, cellular-based virology
assays and molecular diagnostic systems, announced today that the
San Diego Superior Court (the “Court”) stated that it intends to
enter an order granting Beckman’s motion for summary adjudication
relating to the agreement for the supply of antibodies and other
inputs related to, and distribution of, the Triage® BNP Test for
the Beckman Coulter Access Family of Immunoassay Systems, between
Quidel and Beckman (the “Beckman Agreement”). Specifically, the
Court stated that it intends to rule that a provision of the
Beckman Agreement restricting Beckman from manufacturing or selling
another BNP or NT-proBNP assay is void as a matter of law. The
remainder of the Beckman Agreement remains in effect. Beckman will
continue to supply Quidel, and Quidel will continue to sell, the
underlying BNP assay.
“The ruling does not end the litigation, as it concerns only one
aspect of the case. Quidel intends to promptly request that the
Court stay its order, and it intends to request that the Fourth
District Court of Appeal immediately review the decision,” said
Douglas Bryant, president and chief executive officer of Quidel
Corporation. “Our overall view of the litigation remains unchanged,
and we continue to believe that Beckman's position is meritless, in
opposition to Beckman’s long-standing strategy over the last 15
years of honoring the Beckman Agreement with its previous partners
– Alere and Biosite. The Court’s ruling today does not change our
view that Quidel will ultimately prevail in the litigation on the
merits through motion, or at trial, which is currently scheduled
for August 30, 2019.”
Conference Call Information
Quidel management will host a conference call to discuss the
matter on Monday morning, December 10, 2018 beginning at 8:30 a.m.
Eastern Time (5:30 a.m. Pacific Time). During the conference call,
management may answer questions regarding the intended ruling.
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.
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, herpes, pregnancy, thyroid disease and
fecal occult blood. Quidel's recently acquired 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,
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. These forward-looking
statements include statements about our legal positions and
strategies and the expected outcome of the legal proceeding between
the Company and Beckman Coulter. 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, a
determination that some of the provisions of our contractual
arrangement with Beckman Coulter are unenforceable or otherwise not
valid; our reliance on sales of our influenza 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 the related potential impact on humans from novel influenza
viruses, adverse changes in competitive conditions in domestic and
international markets, 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, 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 and protection of proprietary technology rights; our
development of new technologies, products and markets; our reliance
on a limited number of key distributors; 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;
adverse actions or delays in 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;
changes in government policies; our exposure to claims and
litigation, including litigation currently pending against us;
costs of or our 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; 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 in our supply of raw materials; product
defects; business risks not covered by insurance; our exposure to
cyber-based attacks and security breaches; competition for and loss
of management and key personnel; international risks, including but
not limited to, compliance with product registration requirements,
exposure to currency exchange fluctuations and foreign currency
exchange risk sharing arrangements, longer payment cycles, lower
selling prices and greater difficulty in collecting accounts
receivable, reduced protection of intellectual property rights,
political and economic instability, 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 the acquisition and integration of the Triage and
BNP Businesses; Alere’s failure to perform under various transition
agreements relating to our acquisition of the Triage and BNP
Businesses; that we may incur substantial costs to build our
information technology infrastructure to transition the Triage and
BNP Businesses; that we may have to write off goodwill relating to
our acquisition of the Triage and BNP Businesses; that we our
ability to manage our growth strategy; the level of our
indebtedness; the amount of, and our ability to repay, renew or
extend, our outstanding debt and its impact on our operations and
our ability to obtain financing; that substantially the Senior
Credit Facility is secured by substantially all of our assets; our
prepayment requirements under the Senior Credit Facility; the
agreements for our indebtedness place operating and financial
restrictions on the Company; that an event of default could trigger
acceleration of our outstanding indebtedness; our inability to
settle conversions of our Convertible Senior Notes in cash; the
effect on our operating results from the trigger of the conditional
conversion feature of our Convertible Senior Notes; 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; and our intention of not paying dividends.
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/20181207005511/en/
Quidel Contact:Quidel CorporationRandy StewardChief Financial
Officer(858) 552-7931
Media and Investors Contact:Quidel CorporationRuben Argueta(858)
646-8023rargueta@quidel.com
QuidelOrtho (NASDAQ:QDEL)
Historical Stock Chart
From Aug 2024 to Sep 2024
QuidelOrtho (NASDAQ:QDEL)
Historical Stock Chart
From Sep 2023 to Sep 2024