Quidel

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Quidel Anticipates Record Quarterly Results Driven by Strong Demand for Flu Tests

SAN DIEGO--(BUSINESS WIRE)--Sep. 10, 2009-- Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid point-of-care diagnostic tests, announced today that it currently anticipates its highest quarterly revenue and operating income in its history, driven by global shipments of its QuickVue® Influenza A+B tests in the third quarter of 2009. Demand for its market-leading tests accelerated during the third quarter, consistent with reports of escalating influenza-like illness in the U.S. Since the end of April 2009, the company has continued to manufacture flu tests seven days a week at its facility in San Diego and has the capacity to produce millions of additional tests per month to accommodate customer orders.

Quidel attributes the early demand for its rapid flu tests to a number of factors, as widely reported across the country:

  • The U.S. Centers for Disease Control and Prevention’s (CDC) Week 34 Influenza Surveillance Report (for August 23-29, 2009) documented elevated levels of influenza-like illness in several Southeastern states, with all jurisdictions reporting regional or widespread flu activity.
  • The American College Health Association (ACHA) reported last week that 54 percent of the 189 colleges and universities that are tracking influenza say they have students with the flu.
  • Schools and universities across the country are seeing spikes in the number of students with influenza-like illness as classes begin and students return to dormitories. Washington State University, with approximately 19,000 students, announced it is experiencing the nation’s largest flu outbreak, with 2,000 students impacted just before classes started. The ACHA reported several universities in Georgia combined had the second-highest attack rate or spread of flu-like illness.
  • According to the CDC’s Week 34 Influenza Report, the percentage of specimens testing positive for influenza by collaborating laboratories remained unusually higher during the week than is typically seen at this time of year. This may be due to a combination of factors including higher than normal circulation of influenza in the summer with the emergence of the 2009 H1N1 virus, changes in testing practices by healthcare providers, triaging of specimens by public health laboratories, and an increase in the number of specimens collected from outbreaks.

“Quidel has experienced an unprecedented volume of orders by hospital and physician office labs for the QuickVue tests in the third quarter of 2009, coinciding with the start of school. Previously we had anticipated that third quarter flu sales would be solely a factor of physicians initially stocking shelves in preparation for the traditional October through May flu season, but we are already receiving reorders for influenza products, which is activity that we usually see in the fourth and first quarters of the year,” said Douglas Bryant, president and chief executive officer of Quidel. “Despite having delivered a record level of flu tests to customers, we continue to manufacture at high levels given notable increases in non-seasonal demand.”

Bryant continued, “As the incidence of influenza-like illness increased globally earlier this year and awareness of the availability of rapid flu tests increased, we are now seeing widespread use of our rapid flu tests in the management of influenza outbreaks. As we demonstrated in our clinical studies, in 10 minutes or less with a simple nasal swab, our QuickVue Influenza A+B test can detect seasonal influenza A with 94 percent clinical sensitivity and 90 percent specificity compared with culture. This type of product performance is tremendously valuable, aiding physicians in their diagnosis and treatment decisions while helping to diminish the spread of flu.”

About Quidel

Quidel Corporation serves to enhance the health and well being of people around the globe through the discovery, development, manufacturing and marketing of rapid diagnostic solutions at the point-of-care in infectious diseases and reproductive health. Marketed under the leading brand name of QuickVue®, Quidel’s portfolio of products currently includes tests that aid in the diagnosis of several disease or condition states, including influenza, respiratory syncytial virus, Fecal Occult Blood, Strep A, pregnancy, H. pylori and Chlamydia. Quidel's products are sold to healthcare professionals with a focus on the physician office lab and acute care markets through leading medical distribution partners on a worldwide basis. Quidel's Specialty Products Group (SPG) develops research products in the fields of oncology and bone health with potential future point-of-care applications. By building value in rapid diagnostic tests, Quidel provides leadership to the industry and among healthcare professionals allowing for the movement of patient testing out of the central laboratory setting and into the physician office, urgent care and other outpatient settings where rapid testing and treatment have an impact on clinical outcomes and provide an economic benefit. For more information, visit www.quidel.com, www.colorectal-test.com, www.rsvtesting.com and www.flutest.com.

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. 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, seasonality, the timing of onset, length and severity of cold and flu seasons, the level of success in executing our strategic initiatives, uncertainty surrounding the detection of novel influenza viruses involving human specimens, adverse changes in the competitive and economic conditions in domestic and international markets, actions of our major distributors, technological changes and uncertainty with research and technology development, including any future molecular-based technology, the reimbursement system currently in place and future changes to that system, manufacturing and production delays or difficulties, adverse actions or delays in product reviews by the U.S. Food and Drug Administration, intellectual property, product liability, environmental or other litigation, required patent license fee payments not currently reflected in our costs, potential inadequacy of booked reserves and possible impairment of goodwill, and lower-than-anticipated sales or market penetration of our new products. Forward-looking statements typically are identified by the use of terms such as “may,” “will,” “should,” “might,” “expect,” “anticipate,” “estimate,” and similar words, although some forward-looking statements are expressed differently. The risks described under “Risk Factors” in reports and registration statements that we file with 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. We undertake no obligation to publicly release the results of any revision or update of the forward-looking statements, except as required by law.

Source: Quidel Corporation

Quidel Corporation
John M. Radak, Chief Financial Officer
858-646-8032
or
Porter Novelli Life Sciences
Pam Lord
619-849-6003
plord@pnlifesciences.com