This story has been updated to include information from a conference call to discuss Quidel's earnings.
NEW YORK (GenomeWeb) – Diagnostics manufacturer Quidel reported after the close of the market on Wednesday that its fourth quarter revenues rose approximately 1 percent year over year, due largely to higher sales of immunoassay, molecular, and specialty products.
For the three months ended Dec. 31, Quidel reported revenues of $52.8 million, up from $52.4 million in Q4 2015, but missing the consensus analyst estimate of $57.5 million. Reported revenues were consistent with preliminary results the firm announced in January.
The firm also said in January that it was changing the way it reported results. Revenues for the QuickVue and Sofia businesses are now reported within Quidel's immunoassay category, while Solana AmpliVue and Lyra products are reported in its molecular category. Certain categories such as infectious disease and women's health have been eliminated. Quidel's Thyretain and diagnostic hybrids revenues will be reported in the virology category, and the specialty products group will be reported in the specialty products category.
During the quarter, immunoassay product revenue increased 5 percent, led by a 17 percent rise in revenues from the Sofia business that was partially offset by a 4 percent decline in QuickVue sales. Virology revenues, meanwhile, fell 12 percent, while the molecular category grew 72 percent to $2.7 million. Specialty products grew 23 percent.
"Our fourth quarter results were softened by two factors. First, although states like Florida, North Carolina and some others saw earlier starts to the influenza season than last year, many did not," Quidel President and CEO Douglas Bryant said in a statement. "And second, while data in our Virena cloud indicated increasing Sofia influenza test usage and positivity rates in many states in December, distributors consumed their inventories to levels that were roughly two-thirds of what they were at the end of 2015. On the positive side, Sofia placements were significant, as anticipated, and our molecular franchise grew nicely, driven by the launch of multiple Solana assays earlier in the year."
Molecular sales were driven by the launch of multiple Solana assays earlier in the year, the firm said, including a test for HSV-1, HSV-2, and VZV, influenza A and B, Trichomonas vaginalis, and the Solana Strep Complete Assay.
Quidel's Q4 net loss widened to $2.0 million, or $.06 per share, from a loss of $377,000, or $.01 per share, in Q4 2015. On an adjusted basis, Quidel's Q4 EPS was $.17, beating the consensus analyst estimate of $.10 per share.
Quidel's Q4 R&D expenses fell 24 percent to $7.5 million from $9.9 million in the year-ago period due to reduced spend on Savanna and Sofia instruments. SG&A expenses fell 8 percent to $17.9 million from $19.5 million.
For full-year 2016, Quidel reported total revenues of $191.6 million, down 2 percent from $196.1 million in 2015, and below of the consensus analyst estimate of $196.3 million. This decrease was driven primarily by weaker immunoassay and virology sales and a less-than-average influenza season, the company said.
Immunoassay revenue in 2016 declined 7 percent to $121.4 million. Sofia revenue accounted for 42 percent of the total immunoassay revenues, and QuickVue revenue accounted for 58 percent of the total, the firm said. Virology revenues fell 8 percent over the same period to $40.1 million, while molecular revenue for the year grew 75 percent to $9.5 million. Specialty product revenue grew 25 percent to $11.2 million due to the acquisition of Immutopics in the first quarter of 2016. Other revenues grew 23 percent to $9.4 million.
On a conference call with analysts following the release of the earnings, Bryant noted that Quidel expects FDA clearance and CLIA waiver for the Sofia 2 immunoassay platform soon, and will train its sales force at a global sales meeting next week.
"We anticipate having the instrument inventory needed to do the cut over from Sofia to Sofia 2 this quarter," Bryant said, adding that the instrument will initially run the existing influenza, respiratory syncytial virus, and Strep A cartridges, with other assays to follow. Quidel also expects to launch its Sofia Lyme and Vitamin D assays this year, pending FDA clearance.
There are four assays in development for the Solana molecular platform, and the firm anticipates two will receive FDA clearance this summer. With the Savanna molecular platform, Byrant said, "We continue to finalize adjustments to the cartridge to enable high volume manufacturing, and have begun the development of assays in a mini-panel format, so that we can deliver 20 or more analytes at or near instrument launch in 2018."
Quidel's net loss in 2016 widened to $13.8 million, or $.42 per share, from $6.1 million, or $.18 per share, in 2015. On an adjusted basis, Quidel reported earnings per share of $.19, handily beating the average analysts estimate for a net loss of $.27 per share for the year.
In 2016, Quidel's R&D expenses rose 9 percent to $38.7 million from $35.5 million a year earlier due to an increase in development spending for the Savanna platform and the next generation Sofia instrument, and an increase in clinical trials spending for Solana and Sofia products. Meanwhile, SG&A expenses fell 3 percent to $74.9 million from $77.3 million.
Quidel ended the year with $169.5 million in cash, cash equivalents, and restricted cash.
The firm's shares fell 3 percent to $19.10 in Thursday morning trading on the Nasdaq.