0000353569-19-000004.txt : 20190107 0000353569-19-000004.hdr.sgml : 20190107 20190107162126 ACCESSION NUMBER: 0000353569-19-000004 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20190107 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20190107 DATE AS OF CHANGE: 20190107 FILER: COMPANY DATA: COMPANY CONFORMED NAME: QUIDEL CORP /DE/ CENTRAL INDEX KEY: 0000353569 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 942573850 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-10961 FILM NUMBER: 19513555 BUSINESS ADDRESS: STREET 1: 12544 HIGH BLUFF DRIVE STREET 2: SUITE 200 CITY: SAN DIEGO STATE: CA ZIP: 92130 BUSINESS PHONE: 8585521100 MAIL ADDRESS: STREET 1: 12544 HIGH BLUFF DRIVE STREET 2: SUITE 200 CITY: SAN DIEGO STATE: CA ZIP: 92130 FORMER COMPANY: FORMER CONFORMED NAME: MONOCLONAL ANTIBODIES INC /DE/ DATE OF NAME CHANGE: 19910210 8-K 1 qdelpreliminaryq42018resul.htm 8-K Document


 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
 
FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): January 7, 2019
 
 
 
QUIDEL CORPORATION
(Exact name of Registrant as specified in its Charter)

 
 
 
 
Delaware (State or Other Jurisdiction
of Incorporation)
0-10961 (Commission
File Number)
94-2573850 (IRS Employer
Identification No.)
 
 
 
12544 High Bluff Drive, Suite 200
San Diego, California
(Address of Principal Executive Offices)
92130
(Zip Code)
Registrant's telephone number, including area code: (858) 552-1100
 
 
 
 
Not Applicable
 
(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions (see General Instruction A.2. below):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
 





Item 2.02    Results of Operations and Financial Condition.
In connection with Quidel Corporation's participation at the 37th Annual J.P. Morgan Healthcare Conference to be held on Wednesday, January 9, 2019, the company is providing preliminary unaudited revenue results for its fourth quarter of 2018. Based on preliminary financial information, Quidel expects revenues in the fourth quarter of 2018 to be between $132 million and $133 million.
    
These preliminary results are based on management’s initial analysis of operations for the quarter ended December 31, 2018. The company expects to issue full financial results for the fourth quarter and fiscal year 2018 in February.

The Company issued a press release announcing its preliminary revenue results for the quarter ended December 31, 2018 on January 7, 2019. A copy of the press release is attached as Exhibit 99.1 to this current report on Form 8-K.

Forward Looking Statements: The financial information set forth in this Form 8-K reflects the company’s current preliminary revenue estimates, is subject to the completion of its audit process, and is subject to change. The company’s full fourth quarter and year 2018 results could differ materially from the preliminary estimates provided in this Form 8-K. 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 Form 8-K. We undertake no obligation to publicly release the results of any revision or update of the forward-looking statements, except as required by law.

Item 7.01    Regulation FD Disclosure.
As referenced above, in connection with the company’s participation at the 37th Annual J.P. Morgan Healthcare Conference to be held on January 9, 2019, the company is reporting cumulative worldwide Sofia instrument placements of over 35,000 at customer sites as of December 31, 2018.

Item 9.01    Financial Statements and Exhibits.
 
 
 
 
 
 
 
(d)    Exhibits.
 
 
 
 
 
The following exhibit is furnished with this current report on Form 8-K:
 
 
 
 
 
Exhibit Number
Description of Exhibit
 
 
 
 
 
 
 
 
 
 
 
 
 






















SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 7, 2019
 
 
 
 
 
 
 
QUIDEL CORPORATION
 
 
By:
/s/ Randall Steward
 
Name:
Randall J. Steward
 
Its:
Chief Financial Officer
 



EX-99.1 2 ex-991qdelq42018prexannoun.htm EXHIBIT 99.1 Exhibit


Exhibit 99.1
 qdelcorplogoa01a01.jpg
 
 
 
Quidel Contact:
 
Media and Investors Contact:
Quidel Corporation
 
Quidel Corporation
Randy Steward
 
Ruben Argueta
Chief Financial Officer
 
858.646.8023
858.552.7931
 
ruben.argueta@quidel.com


QUIDEL ANNOUNCES PRELIMINARY REVENUE FOR FOURTH QUARTER 2018

SAN DIEGO--(BUSINESS WIRE)-Jan 7, 2019-- Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, it announced today that it expects revenues in the fourth quarter of 2018 to be in the range of $132 million to $133 million.

“We had another great quarter, and a remarkable year, a year in which our efforts and excellent performance were driven significantly by the integration of the acquired Triage assets. We unlocked synergies, brought most international businesses within our control, and aggressively paid down debt,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “And we did all that without taking our eye off the ball. Notably, Sofia placements, which for the year were nearly 10,000, were higher than in any prior year since launch by far, further demonstrating the competitiveness and resilience of the Sofia instrument system, as well as the global commercial organization’s proficiency in ‘selling the entire bag’,” added Mr. Bryant.

These preliminary results are based on management’s initial analysis of operations for the quarter ended December 31, 2018. The company expects to issue full financial results for the fourth quarter and fiscal year 2018 in February.

Quidel to Present at 37th Annual J.P. Morgan Healthcare Conference
Quidel will present at the 37th Annual J.P. Morgan Healthcare Conference to be held at The Westin St. Francis hotel in San Francisco, California on Wednesday, January 9, 2019.

Douglas Bryant, president and chief executive officer, and Randy Steward, chief financial officer, will present that day at 5:30 p.m. Eastern time (2:30 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 the presentation will be available via the Investor Relations section of the company’s Web site at www.quidel.com. 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 Web site 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, influenzarespiratory 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. 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 final 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.





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