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Despite Continued Genotyping Growth, Weak Expression Sales Force Affymetrix to Suspend Guidance

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This article was originally posted on May 1.

An unanticipated decline in demand for gene expression microarrays has thwarted Affymetrix's return to growth and profitability and caused the firm to suspend its 2013 guidance, executives said last week.

The Santa Clara, Calif.-based array vendor reported that its first-quarter revenues increased around 19 percent to $77.9 million from 65.2 million in the first quarter of 2012. Affymetrix in April said that it would report about $78 million in Q1, missing a consensus Wall Street estimate of $83.3 million for the quarter.

Tim Barabe, the firm's chief financial officer, noted in an earnings call that Affymetrix's Q1 revenues included a $19 million contribution from eBioscience, the San Diego flow cytometry reagents provider the company bought last year. Excluding eBioscience, Affymetrix's revenues actually decreased by $6.3 million, or about 10 percent, primarily due to lower revenue from gene expression array sales, Barabe said.

Since the eBioscience acquisition, Affymetrix has operated with four business units: Gene Expression, which consists of its legacy gene expression array products, as well as newer expression array products and Panomics branched DNA assays; Genetic Analysis, which includes its genotyping arrays for cytogenetics and other research applications; Life Science Reagents, mainly products gained through its 2008 buy of reagent firm USB; and eBioscience.

According to Barabe, all of Affymetrix's business units are growing except for Gene Expression, which has been shrinking for years due to pressure from next-generation sequencing and a constrained environment for academic funding. Still, in Q1 2013, the company's Gene Expression losses were about 30 percent, roughly double the decline that Affymetrix had anticipated.

CEO Frank Witney said on the call that Affymetrix's $23 million in Q1 Gene Expression revenues were "negatively impacted by uncharacteristically weak sales of array-based gene expression products, particularly in Japan." Witney said that Japanese researchers continue to be heavily dependent on the firm's expression array products, and that the slowdown in sales in that country was unexpected, making it difficult for the firm to predict gene expression array sales for the rest of the year, and prompting it to suspend its financial guidance.

In addition, Witney said that Affymetrix's attempts to stem its Gene Expression losses by offering new expression products have "simply not been significant enough to offset the declines" in its legacy IVT expression array products. On a more positive note, Witney said that since the eBioscience acquisition, the company has become less dependent on gene expression array sales than it used to be.

"Our Gene Expression business accounted for 29 percent of our revenue in the first quarter of 2013 as compared to 50 percent of our revenue in the first quarter of 2012," said Witney. "As expression becomes a smaller percentage of total revenue, [we will] reach the point where our realigned portfolio will enable us to return the overall business to growth."

Genetic Analysis

While Affymetrix's Gene Expression business declines, its Genetic Analysis business continues to grow.

Witney said that Genetic Analysis had revenues of approximately $22 million in Q1, up 16 percent year over year, "driven by strong growth in cytogenetics and increased momentum in genotyping." He noted that the company's cytogenetic product line, led by its flagship CytoScan product, grew by 40 percent compared to the first quarter of 2012, and now contributes more than a tenth of the company's revenues.

During the quarter, Affymetrix submitted CytoScan to the US Food and Drug Administration, seeking to sell the platform to clinicians for use in identifying genetic abnormalities in postnatal patients (BAN 2/19/2013). Witney said that the company has been "tracking well and interacting well" with the agency, but did not elaborate on when such clearance could come.

While Affymetrix awaits word from the FDA, it is also keen to see CytoScan adopted in cancer cytogenetics research.

"Numerous research studies have documented the value of cytogenetic analysis in the diagnosis and prognosis of leukemia and lymphoma and it is increasingly clear that high-resolution arrays are an important tool for clinicians," Witney said. "We expect that the increased resolution, enabled by arrays, will create new growth opportunities in oncology."

In regards to its Axiom genotyping arrays, the company signed an agreement with UK Biobank to genotype its 500,000-sample collection in coming years (BAN 3/26/2013). Barabe said that the deal, which he called the "largest genotyping study that's ever been undertaken," will have its primary impact on the firm's revenues in 2014.

Witney said that the study will first rely on Affymetrix's service lab to provide the genotyping, but that UK Biobank eventually intends to install Affymetrix's Axiom platform in its own facility to support future studies.

With the UK Biobank project underway, Affymetrix is in the process of looking for opportunities with biobanks in other countries, Barabe said. "While we're extremely excited about the revenue opportunity from the UK Biobank, we also feel that it portends very well for the future that there's additional biobank deals out there that will be very competitive for us," he said.

Looking ahead, Barabe said that Affymetrix expects its Genetic Analysis business to grow by between 15 percent and 20 percent this year.

eBioscience and Life Science Reagents

In the first quarter, Affymetrix's eBioscience business contributed about 25 percent of overall revenue and is expected to grow in the low- to mid-single-digit range for the rest of the year, Witney said. He added that Affymetrix intends to drive this growth via new product launches and selling eBioscience's products through the company's global sales channels, especially in Europe and Asia, regions where eBioscience had a limited presence prior to its acquisition.

"We remain confident that we can increase eBioscience's global market share to drive long-term growth," said Witney.

Company representatives recently told BioArray News that eBioscience is moving its menu of FlowCytomix multi-analyte, bead-based immunoassays to the Luminex xMAP platform (BAN 9/2/2013). These assays enable the simultaneous quantitative detection of up to 20 different analytes from blood, serum, and tissue samples using a flow cytometer. But given the number of existing Affymetrix QuantiGene and Procarta assays that run on Luminex's platform, the company decided that it would make sense to offer the FlowCytomix assays on the Luminex platform.

During the call, Witney commented on the move.

"We intend to grow our multiplex amino assay revenues by utilizing our Luminex partnership to leverage eBioscience's expertise in antibody immunoassay development," he said.

He also discussed QuantiGene FlowRNA, a new product in early access that marries Affymetrix's QuantiGene ViewRNA, in situ hybridization assays that enable the localization and visualization of RNA in cells or tissues, with eBioscience's flow cytometry capabilities.

Witney said that the roll out of QuantiGene FlowRNA is "progressing on schedule" and that the "feedback from our beta sites is very positive."

With regards to the company's Life Science Reagents business, Witney said that the unit generated revenue of approximately $8 million in the first quarter, in line with the same period in 2012. "This business continues to generate healthy operating margins and should grow in the low single digits in 2013," he said.

Affymetrix is predicting low- to mid-single-digit growth for its eBioscience and Life Science Reagents business units this year.

Elsewhere in Q1

Barabe said that first quarter product revenue was $71.6 million compared to $58.5 million for 2012.

Instrument sales for the quarter were $3.5 million compared to approximately $4.7 million in the prior year's quarter.

Affy posted a net loss of $15.4 million compared to a net loss of $4.2 million for the first quarter of 2012.

Its R&D spending declined 8 percent to $12.2 million from $13.3 million, while SG&A spending increased 26 percent to $35.1 million from $27.9 million. Affy also reported restructuring charges of $4.8 million for the most recent quarter.

Affy finished the quarter with $38.2 million in cash, cash equivalents, and restricted cash.

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