Message from the CEO

November 2013

CEO Profile
Patrick J. Balthrop, President and CEO. Click here for bio.

Luminex generated good performance for the quarter, although we experienced some one-time events which impacted revenue in the third quarter. Some of our customers are facing external market headwinds due to uncertainty and changes in reimbursement guidelines, which impacted the timing and placement of assay orders. We view these headwinds as transient and are encouraged by the recent progress that has been made.

Outside of assays, our other product lines showed continued strong growth. Our products and technology continue to be in high demand. We shipped 280 multiplexing analyzers, higher than our historical quarterly average range of 200-250 shipments, and royalty revenue grew 17% over the prior year period. Our direct sales initiative continues to gain momentum with the addition of new xTAG® Gastrointestinal Pathogen Panel customers. Additionally, during the third quarter, we received FDA and European clearance for both an updated Cytochrome P450 2D6 assay and for a new comprehensive genotyping assay, Cytochrome P450 2C19. Finally, we are very excited by our strategic development program, Project ARIES, which will represent a new standard for sample-to-answer testing when we launch this groundbreaking product in 2014.

Third Quarter 2013 Financial Highlights

Luminex’s financial and operating highlights from the third quarter ended Sept. 30, 2013 include:

  • Consolidated third quarter revenue of $50.8 million
  • Third quarter assay revenue of $16.1 million. Infectious disease sales comprised approximately 64 percent of total assay sales, with genetic testing representing 36 percent
  • Shipments of 280 multiplexing analyzers, which included 135 MAGPIX® systems, 128 LX systems, and 17 FLEXMAP 3D® systems
  • Cumulative life-to-date multiplexing analyzer shipments of 10,410
  • Received FDA and European clearance for an updated version of comprehensive genotyping assay, xTAG® CYP2D6 in July
  • Received FDA and European clearance for a new personalized medicine genotyping assay, xTAG® CYP2C19 in September

MDx External Environment

Luminex and other companies in the molecular diagnostic market segment continue to face challenges in the U.S. due to our customers facing reimbursement disruption. While we are disappointed that the reimbursement issues concerning certain tests included in the new molecular diagnostic code system in the U.S have not been resolved, we agree with our customers' public comments that this is a transient issue and we expect to see resolution in the near future.

Update on Strategic Initiatives

We strongly believe in our strategic initiatives and that Luminex is well-positioned for continued long-term growth across our entire portfolio. Among these initiatives is the development of our unique sample-to-answer system, Project ARIES, which will be a major growth catalyst. Project ARIES will be unveiled at the upcoming Association for Molecular Pathology Annual Meeting in Phoenix on November 14-16th. In addition, we are pleased with the progress our direct sales force continues to make serving our customers and selling our family of diagnostic tests including GPP, RVP, and our recently cleared genotyping assays.

Looking Ahead

We remain dedicated, determined, and focused on our strategic initiatives and executing our long-term growth strategy. Our diversified business model, strategic investments and ever-growing product portfolio put Luminex in a position for long-term, profitable growth.

Sincerely,

Patrick J. Balthrop, Sr.
President and Chief Executive Officer

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