QDEL

Quidel Corporation (QDEL)

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Quidel Corp. (QDEL)

Q4 2012 Results Earnings Call

February 12, 2013 5:00 PM ET

Executives

Randy Steward - Chief Financial Officer

Doug Bryant - President and CEO

Ruben Argueta - Investor Relations Manager

Analysts

Shaun Rodriguez - Cowen and Company

David Clair - Piper Jaffray

Matthew O’Brien - William Blair

Ross Taylor - CL King

Jeff Frelick - Canaccord

Zarak Khurshid - Wedbush

Ramesh Donthamsetty - JPMorgan

Presentation

Operator

Ladies and gentlemen, thank you for standing by. And welcome to the Quidel Corporation’s Fourth Quarter and Full Year 2012 Earnings Conference Call. At this time, all participants are in listen-only mode. Later, instructions will be given for the question-and-answer session. (Operator Instructions)

I’d now like to turn the call over to Mr. Randy Steward, Quidel’s Chief Financial Officer. Please go ahead.

Randy Steward

Thank you, Operator. Good afternoon, everyone, and thank you for joining today’s call. With me today is our President and Chief Executive Officer, Doug Bryant; and Ruben Argueta, Investor Relations Manager.

Please note that this conference call will include forward-looking statements within the meaning of Federal Securities Laws. It is possible that actual results and performance could differ materially from these stated expectations.

For a discussion of risk factors, please review Quidel’s annual report on Form 10-K, registration statements and subsequent quarterly reports on Form 10-Q as filed with the SEC.

Furthermore, this conference call contains time sensitive information that is accurate only as of the date of the live broadcast today February 12, 2013. Quidel undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call, except as required by law.

Today, Quidel released financial results for the fourth quarter and full year ended December 31, 2012, if you have not received our news release or if you would like to be added to the company’s distribution list, please call Ruben at 858-646-8023.

For today’s call, Doug will report on the highlights of the fourth quarter and provide updates on our product development pipeline. I will then briefly discuss our financial results and we’ll open the call for your questions.

I’ll now hand the call over to Doug for his comment.

Doug Bryant

Thank you, Randy. Total revenues for the fourth quarter of 2012 were $53.9 million, a 40% increase over fourth quarter 2011 revenues of $38.4 million, consistent with our early January pre-announcement revenue estimate of $53 million to $54 million.

The increase in revenue was driven primarily by a sudden and early start to this year’s influenza season and our ability to respond to the demand for our flu tests, particularly given very low product inventories at our distribution partners warehouses and with physicians, offices and hospital labs.

While sales of QuickVue Influenza A+B benefited most, the Sofia, D3 Ultra, and Quidel Molecular PCR products were a contributor to the increase in revenues in the quarter as well.

Overall, we had a good quarter from our revenue perspective, but more importantly, our product development teams achieved several key milestones during the period and we are now poised to introduce a number of new products over the next several quarters.

I’d now like to update you on some of our near-term product development and commercial plans.

Let start with Sofia, our automated fluorescent immunoassay analyzer. We said many times before that success with Sofia was critical to our ability to reach $250 million in revenues by 2015 and that our objective was to have a full year impact 10,000 analyzers online and operational at that time.

In the pre-announcement, we mentioned that we had surpassed 3000 instrument placements and we’re ahead of our original internal projection forecast that had assumed more than just one assay in 2012.

At this point, given our placement proficiency to date, I will add that we remain confident that we can given further product development success reach the 10,000 instrument hurdle and that we see little technical risk with respect to introducing assays for Group A Strept, RSV and hCG, and a number of women’s health assays over the next few quarters.

Also an important part of incremental revenue in 2015 the success with our two near-term molecular programs Quidel Molecular, which refers to our PCR-based assays for use on established FDA cleared thermocyclers, and AmpliVue a handheld disposable molecular platform that combines isothermal amplification with traditional lateral flow detection.

To date, we are FDA cleared to market two PCR assays, Quidel Molecular Influenza A+B and Quidel Molecular hMPV. In development or already submitted to the FDA are several other PCR assays, seven of which we hope to introduce in 2013.

At this point our menu is focused on assays for respiratory pathogens and stool-based antigens market segments where we believe we have both technical and commercial expertise.

And as of December, we are now FDA cleared to market our first AmpliVue assays for C. difficile, a product that has received a moderate complexity CLIA designation. In development are three additional AmpliVue assays and a next-generation cartridge platform that we hope to roll out at the end of October.

Finally, the third aspect of our molecular program is Project Wildcat, a durable, low-cost, fully-integrated instrument that we will make available for use in limited resource settings for the purpose of providing through the Northwestern Global Health Foundation affordable access to HIV viral load and TB testing.

As was noted in our fourth quarter press release, we’ll be receiving some help from the Bill and Melinda Gates Foundation for the HIV portion of this endeavor. Program remains very much on track and we hope to provide further detail on our progress during our Analyst Day, which will be held on March 7th.

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