Genomic Health (GHDX) reported an EPS of 8 cents in the fourth quarter of fiscal 2011, a penny below the Zacks Consensus Estimate, but higher than 6 cents earned in the year-ago period. For the full year, EPS came in at 26 cents, missing the Zacks Consensus Estimate of 27 cents and way above 14 cents recorded in the previous year.

Total revenue in the reported quarter climbed 13.4% year over year to $53.4 million, marginally missing the Zacks Consensus Estimate of $54 million. Product revenues (primarily from the Oncotype DX breast cancer test) climbed approximately 15% to $53.2 million in the quarter. Contract revenues accounted for the balance. During 2011, revenues increased 16% to $206.1 million lagging behind the Zacks Consensus Estimate of $207 million.

In the reported quarter, Genomic provided more than 17,080 Oncotype DX test results (taking the total number of tests during the year to 66,000), as against 15,180 in the comparable period of 2010 (57,270 for 2010), representing a growth of 13%.

Operating expenses during the quarter climbed 16.8% year over year to $43.3 million driven by higher research and development (10.9% to $10.3 million), selling and marketing (20.8% to $22.4 million) and general and administrative (14.6% to $10.6 million) expenses. Despite higher operating expenses, operating margin improved 230 basis points year over year to $5.1%.

Viewing the huge market opportunity in DNA sequencing, Genomic announced the setting up of a wholly owned genetics subsidiary by March this year that will strive to provide clinically relevant genetic information to physicians and patients from 2013. This decision will involve $20 million of investment over the next two years, the impact of which has been considered in the financial outlook for 2012.

Outlook

Genomic Health revealed its outlook for fiscal 2012. The company expects to report revenues of $230-$240 million and tests numbering 75,000-77,000. Moreover, the net income guidance of $5-$8 million is before an incremental loss of up to $8 million for the new subsidiary. The current Zacks Consensus Estimate of $237 million in revenues is in sync with the company’s guided range.

Recommendation

At present, Genomic Health is highly dependent on the success of the Oncotype DX breast cancer test. Recent achievements made by the company in this regard include the launch of Oncotype DX DCIS Score and some development on the reimbursement front for both node-negative and node-positive breast cancer patients. The company also established distribution agreements to provide Oncotype DX in Hungary, Romania and Peru.

Meanwhile, the colon cancer test, launched in January 2010, is yet to make a significant contribution to the top line. However, the situation could improve gradually as the company tries to get reimbursement for this test, which should lead to increased adoption.

Adoption of the test should also benefit from the publication of QUASAR clinical validation study in the Journal of Clinical Oncology. Genomic is also providing mismatch repair (“MMR”) testing for recurrence risk, presented results of the first clinical decision making study of the Oncotype DX colon cancer test and progressed on the reimbursement front as well. We are also encouraged by the company’s increasing focus on the international market. The stock retains a Zacks # 2 Rank (“Buy”) in the short term.

However, the several studies that would expand Genomic Health’s portfolio are still in their initial stages. Though encouraged by the company’s decision to form a subsidiary solely focused on genetic sequencing, we also see a lot of activity in the market targeting this specified niche. Notable among these is Roche‘s (RHHBY) recent hostile bid for Illumina (ILMN). Life Technologies (LIFE) is another significant player in this business. For the long term, we have a Neutral rating on Genomic Health.

To read this article on Zacks.com click here.

Zacks Investment Research