Originally published Feb. 12.
After growing its revenues in 2012 by 14 percent from the previous year to $235 million, Genomic Health is focusing on further penetrating the markets for its breast and colon cancer recurrence tests and on launching a new prostate cancer diagnostic.
"The majority of the planned operating expense in 2013 will be directed towards our international opportunity in breast and colon and our entrance into the large US prostate market," Genomic Health COO Bradley Cole said during a call with analysts held last week to discuss the company's fourth quarter and 2012 full-year financial results.
The company is awaiting the publication of a validation study using Oncotype DX to predict whether women with a non-invasive form of ductal carcinoma in situ are at risk of recurrence of DCIS in the same breast or are at risk of developing new invasive disease. Cole highlighted that the Oncotype DX DCIS score identifies up to 75 percent of women who have low-risk disease, may be treated with surgery, and can avoid radiation.
Genomic Health's Oncotype DX breast cancer recurrence test is the company's top-selling product and is used most readily in node-negative women. The test has also been validated to gauge recurrence in women whose disease has spread to the lymph nodes.
The company launched Oncotype DX DCIS at the end of 2011 and estimates that the market opportunity for Oncotype DX in DCIS is 50,000 patients in the US. Publication of the validation study for Oncotype DX in the DCIS population will drive further adoption of the test in this market, the company is hoping.
Steve Shak, Genomic Health's chief medical officer, noted during the earnings call that the company is planning to conduct another large DCIS clinical study to confirm and extend the findings of the first validation trial, ECOG E5194.
The Oncotype DX colon cancer test, launched in early 2012, assesses whether stage II patients after surgery will experience a recurrence and therefore need to be treated with chemotheprapy. According to the company, the Journal of Clinical Oncology has accepted for publication the QUASAR study, which validated the ability of the colon cancer test to differentiate high- and low- recurrence risk colon cancer patients. Publication of this study will likely help bolster reimbursement for the colon cancer recurrence test.
Additionally, Genomic Health is continuing to invest in clinical utility and cost-effectiveness studies for its marketed tests to help spur reimbursement. In January, the company presented data from a clinical utility study demonstrating that physicians using the colon cancer test changed their treatment decisions 45 percent of the time resulting in a 22 percent reduction in chemotherapy use. Another analysis suggested that the decision to avoid chemotherapy following the Oncotype DX colon test results was associated with direct medical care cost savings of $4,200 per patient.
Shak added during the call that Genomic Health will conduct a study to gauge whether the Oncotype DX test can predict whether patients with Stage III colon cancer will benefit from oxaliplatin treatment.
Genomic Health is planning to launch in the second quarter of 2013 its third Oncotype DX franchise in the prostate cancer market. The company has said it has conducted six feasibility and development studies in partnership with the Cleveland Clinic to evaluate more than 700 patients and 700 candidate genes in order to select the multi-gene set for the prostate cancer test.
Upon launching the molecular diagnostic, Genomic Health will market it as a tool that doctors can use in conjunction with the Gleason grading system, the prostate specific antigen test, and patients' other clinical data in order to personalize prostate cancer treatment. That test, according to Genomic Health, can differentiate which patients have aggressive or indolent disease.
Highlighting that nearly 240,000 men are diagnosed with prostate cancer annually, Cole said that the prostate cancer market represents the "largest opportunity to date" for the company. In readying for the launch of the prostate cancer test, Cole said that Genomic Health has hired a national sales director and senior director of urology medical affairs to help drive test adoption by physicians and reimbursement among payors.
"Capturing this opportunity will require publication of validation study results, completion of additional clinical studies, and reimbursement success to broaden patient access," Cole added. "We are developing patient websites and online tools that will not only educate but encourage prostate cancer patients and their loved ones to ask their physicians about the test." Genomic Health plans to present positive data from the first clinical validation study for the prostate cancer test at an American Urological Association meeting in May.
Finally, Genomic Health is also planning to conduct a large clinical study using next-generation sequencing to examine tumor expression and mutations in fixed paraffin embedded tissue.
For the full year, Genomic Health posted product revenues of $233.5 million, a 14 percent jump from the previous year. The company reported that it delivered 74,520 Oncotype DX test results – including results for breast and colon cancer -- in 2012, compared to 66,600 test results in 2011.
Genomic Health posted a profit of $8.2 million in 2012, compared to $7.8 million in 2011. R&D spend grew 23 percent during the year to $49.1 million, compared to $39.9 million. The firm posted SG&A costs of $140.6 million, a 13 percent increase from $124.2 million in 2011.
The company completed 2012 with $18.0 million in cash and cash equivalents and $81.1 million in short-term marketable securities.
In 2013, Genomic Health said it expects to bring in between $258 million and $266 million in revenues. Due to investments in launching the prostate cancer test and efforts to grow existing test franchises, CFO Dean Schorno said he anticipated a net loss during the first two quarters of the year.
Additionally, Schorno projected that research and development and sales and marketing expenses would increase as a percent of total revenue compared to last year. "We expect to spend approximately $15 million on capital expenditures in 2013 to increase capacity, enhance laboratory automation, and expand IT infrastructure and equipment for the development of next generation products," he said.