SAN DIEGO--(BUSINESS WIRE)--Dec. 7, 2018--
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/
Source: Quidel Corporation
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