Rosetta Genomics (ROSG) Reports Q3 EPS of $0.27

Rosetta Genomics (NASDAQ: ROSG) reported Q3 EPS of $0.27, versus $0.29 reported last year. Revenue for the quarter came in at $2.43 million, versus $273 thousand reported last year.

Management Commentary

“During recent months we continued to make meaningful progress integrating the PersonalizeDx acquisition, growing top-line results, expanding our high-value molecular diagnostics offerings with important product launches, upgrading our sales and reimbursement infrastructure and strengthening our balance sheet,” stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.

“The third quarter of 2015 was the first full quarter of PersonalizeDx being part of Rosetta Genomics and we had strong revenue growth from our two lines of business, namely solid tumor testing services and urologic cancer testing services.

“Throughout the third quarter and recent weeks we have been focused on the preparation and launch of RosettaGX Reveal, our microRNA-based assay for the classification of indeterminate thyroid nodules. We are particularly excited about the positive performance data from our blinded validation study of RosettaGX Reveal as these data demonstrate exceptional clinical performance when compared with the current market leader. The ability to run RosettaGX Reveal on cytology slides is important because working off the same slides created to perform the initial diagnoses eliminates the inconvenience and risks associated with additional fine needle passages into the patient’s neck that are required by other assays. We have already begun to receive and process commercial samples at our Philadelphia laboratory and have reported our results on these first orders with very positive feedback from clinicians. Moving forward, our plan is to leverage our solid tumor sales force as well as a dedicated group of thyroid sales specialists to call on endocrinologists and cytopathologists to form a third business segment with high-growth potential. Given its high negative predictive value, health economic benefit and added convenience of working on cytology slides, we expect RosettaGX Reveal to gain significant traction into a market valued at $350 million annually in the U.S.

“When issued, our new U.S. patent in prostate cancer will fortify our leadership in microRNA technology and expand our footprint in urological cancers. Through PersonalizeDx we offer FISH, IHC and PCR-based testing capabilities in urologic and other cancers, which provide content and platforms that complement our microRNA offerings to provide clinicians with valuable information to guide treatment decisions. This patent is important as this biomarker, which is over-expressed in primary prostate tumors, could be used as both a prognostic tool and as a therapeutic target for prostate cancer. We continue to explore opportunities to monetize our broad intellectual property portfolio in microRNA-based diagnostics and therapeutics.

“We were particularly pleased with the recent Clinical Lab Fee Schedule (CLFS) posted by the Centers for Medicare and Medicaid Services (CMS) for 2016, which reverses some of the unfavorable features of the original CLFS draft proposal. Importantly, the final fees provide a long overdue correction to FISH reimbursement, which includes a 92% increase in allowable reimbursement for our most common solid tumor FISH procedures, which account for approximately 20% of our current testing revenue. These and other favorable fee schedules are encouraging and should continue to enhance both the amount and timing of payments for our testing services in 2016.

“As we look toward 2016, Rosetta Genomics is fundamentally stronger and better positioned for success, and we look forward to achieving a series of value-creating milestones,” concluded Mr. Berlin.

For earnings history and earnings-related data on Rosetta Genomics (ROSG) click here.

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