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At JP Morgan Conference, Quidel CEO Discusses Plan to Enter OTC Infectious Disease Test Market

NEW YORK – In a virtual presentation at the JP Morgan Healthcare Conference on Wednesday, Quidel CEO Doug Bryant punctuated $1.66 billion in projected full-year 2020 revenues with signaling a strategic move for the firm into a nascent over-the-counter infectious disease testing market.

Last week, Quidel announced a fivefold increase in its fourth quarter revenues. And today, the San Diego-based firm said it anticipates full year 2020 revenues of $1.66 billion, up more than threefold from $534.9 million in 2019, but just below analysts' consensus forecast of $1.67 billion. Quidel shares on the Nasdaq closed down nearly 3 percent at $197.94 following Bryant's presentation.   

The revenue jump was led by $1.0 billion in sales of SARS-CoV-2 antigen tests on the Sofia system, with a $200 million contribution from Lyra PCR test revenues.

Although the firm is placing all the SARS-CoV-2 tests it can manufacture into the professional market, Bryant said the firm is now confidently anticipating regulatory clearance for an at-home, non-prescription, over-the-counter version of its rapid lateral flow QuickVue COVID-19 test.

"The future for our company will include a very significant contribution from an emerging OTC and at-home testing market," Bryant said.

Being among the first to market in the OTC space will help build the brand for the long term, but more importantly, creating an affordable at-home test to "democratize" testing and potentially reduce the spread of SARS-CoV-2 is also "the right thing to do," he said.

Quidel is building inventory of the visually read lateral flow test in order to supply large enough volumes for a launch with as-yet-to-be-determined retail partners. But, Bryant noted that any tests not used in the OTC roll-out can be easily redirected to the professional market, if required.

"If indeed this leads to an over-the-counter infectious disease market for all of the things that we do, we will have greatly expanded our market size," Bryant said. Being involved early in the OTC space and being seen as a leader will also be "far more valuable in the longer term," than supplying additional volume to current customers.

In addition to this splashy news, Bryant also debuted the updated, smartphone-connected Sofia instrument, now called the Sofia Q.

The firm also expects to position this instrument in the at-home OTC market at some point, such that customers would keep the instrument at home and purchase diagnostic test cartridges as needed. Quidel expects to manufacture the first 100,000 Sofia Q's in the first quarter.

The firm is awaiting installation of additional "spotting, laminating, and cutting" equipment to further ramp production of its Sofia and QuickVue assays from the current rate of 3 million tests per week. It also ramped monthly production capacity for its Sofia 2 instrument to 10,000 instruments, and with 23,000 recent new placements Quidel now claims an installed base of 65,000 Sofias, Bryant said.

The firm obtained Emergency Use Authorization from the US Food and Drug Administration for its Solana isothermal molecular diagnostic SARS-CoV-2 test late last year, and Bryant said the installed base is now 1,350 instruments. And, the long-awaited multiplex molecular diagnostic instrument, called Savanna, is expected to launch in the second half of this year. Bryant referred to it as "probably the most important flagship product in the history of the company."

Going forward, Quidel expects the first half of 2021 to resemble Q4 in terms of production rates as it pivots toward building inventory in anticipation of the OTC launch. 

Quidel has no debt and expects to double its revenues in 2021. The firm also anticipates an 18 percent revenue growth rate through 2024, primarily from expanding Savanna revenues, according to a slide in Bryant's presentation. It will deploy its capital in strengthening the supply chain and increasing production, with potential M&A if the right opportunity arises, Bryant said.