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Luminex Q3 Revenues Jump 12 Percent on Assay Sales

NEW YORK (GenomeWeb) — Luminex reported after the close of the market Monday a 12 percent spike in third quarter revenues driven primarily by growth in assay sales across all major product categories.

The company also pushed back the commercialization timeline for Aries, its sample-to-answer molecular diagnostics system.

For the three months ended Sept. 30, the Austin, Texas-based molecular diagnostics firm tallied $56.7 million in revenues, compared to $50.8 million in the year-ago period, and edging the average analyst estimate of $56.6 million.

Luminex's system sales rose 1 percent to just over $7.6 million from just under $7.6 million a year ago, while its consumable sales deteriorated 6 percent to $12.1 million from $12.8 million.

Meantime, royalty revenue at the company increased 8 percent to $9.7 million from $9.0 million, while assay revenue shot up 37 percent to $22.1 million from $16.1 million. Luminex said that infectious disease assay sales comprised approximately 65 percent of total assay sales, while genetic testing assays represented 35 percent. All other revenue dropped 1 percent to $5.2 million.

During the quarter Luminex shipped 269 multiplexing analyzers, including 115 LX systems, 122 MagPix systems, and 32 FlexMap platforms. The company also received US Food and Drug Administration clearance to add three new clinical targets and additional sample types to its xTAG Gastrointestinal Pathogen Panel.

"We completed a strong quarter, driven primarily by growth in assay revenues that was well-balanced across our major product categories," Harriss Currie, senior vice president and CFO, said in a statement. "This resulted in improved results at the net profit line. Cash flow also was positive for the quarter notwithstanding substantial capital investments in our innovative pipeline."

Elaborating on these items during a conference call following release of the company's earnings, Currie noted that Luminex has previously underscored its assay business as a primary growth engine.

"Over the last couple of years we've taken a number of steps to support this business, including multiple strategic acquisitions, taking control of the sale channel by building a direct sales force, and making considerable R&D investments," Currie said. "With the headwinds from 2013 largely behind us, we believe our strategic investments are beginning to pay off, as is reflected in the performance of our assay business during the quarter, which experienced balanced growth across all of our major assay product lines."

Also, in regards to the new FDA clearances for the GPP panel, Currie noted that the panel's 11 original targets provided coverage for more than 90 percent of the causes of infectious gastroenteritis.

"Now with a total of 14 targets, GPP provides even more comprehensive coverage to labs," Currie said. "But more importantly, from a reimbursement perspective, beginning in 2015, this configuration will put GPP in the highest reimbursement tier for tests of this nature. In addition, the clearance of the new sample type provides our customers with additional flexibility based on the sample types they receive. Moving forward, we're optimistic that these enhancements to GPP will be well-received by our laboratory customers."

Also during the quarter, Patrick Balthrop retired as president and CEO, and will be succeeded by Nachum Shamir.

"With the recent appointment of Nachum 'Homi' Shamir as president and CEO, we believe we are well positioned to continue executing our vision to deliver innovative diagnostic solutions to simplify and speed the delivery of health care," Wally Loewenbaum, chairman of the company, said in a statement. "As we prepare for the launch of several key pipeline products in the near future, we are very pleased to have a talented and accomplished executive to lead the company into the next stage of growth."

During the call, Shamir updated investors on Aries, a sample-to-answer molecular diagnostics system that Luminex has been developing as a higher-throughput, target-specific complement to its relatively lower-throughput but highly multiplexed infectious disease panels, which use xTAG chemistry and run on the company's MagPix or Lumninex 100/200 analyzers.

"We anticipate beginning clinical trials over the end of the first quarter of 2015, following by a standard 510(k) submission in late summer, which coincides with RUO availability in the US," Shamir said. "Therefore, we are targeting IVD clearance in the US of the system and [the herpes simplex virus] assay during the fourth quarter of 2015, pending the review of the submission by the FDA."

Luminex had originally been targeting a European launch of Aries in the latter half of this year and a US launch in early 2015.

Luminex's net income for the quarter was $5.6 million, or $.13 per share, compared to $796,000, or $.02 per share, in the year-ago period. On a non-GAAP basis, net income was $11.5 million, or $.27 per share, compared to $2.3 million, or $.06 per share, besting the Wall Street estimate of $.10 per share.

The company spent $10.3 million on R&D in the quarter, essentially flat compared to the year-ago period. Meantime, SG&A expenses were also flat at $21.4 million.

Luminex finished the quarter with $89.1 million in cash and cash equivalents.

The firm revised its full-year 2014 revenue guidance to between $225 million and $228 million from a previous range of $225 million to $240 million.

In Tuesday morning trade on the Nasdaq, shares of Luminex were down 11 percent at $18.49.