Exact Sciences Corp. (Nasdaq: EXAS) today announced that the company continued its strong performance during the third quarter ended Sept. 30, 2015, completing 34,000 Cologuard tests, an increase of 60 percent from the second quarter, which resulted in $12.6 million in revenues. The cumulative number of ordering physicians grew to 21,000 during the quarter, an increase of 42 percent.
“We remain pleased with the growing traction that Cologuard is gaining in the colon cancer screening market,” said Kevin T. Conroy, chairman and CEO of Exact Sciences in prepared remarks and the company’s investor call today. “Cologuard’s continued growth is built on its outstanding performance characteristics, our sales and marketing strategy, physician awareness, patient preference and accessibility.”
The patient compliance rate at the end of the third quarter remained strong at 73 percent. The compliance rate is derived from the number of valid test results generated from collection kits shipped to patients 60 or more days prior to Sept. 30, 2015. Exact Sciences Laboratories, through its customer care center, is helping to drive patient compliance by systematically contacting patients for whom Cologuard has been ordered and encouraging them to complete their screening.
Cologuard’s strong patient compliance is having an impact on people who previously had not been screened for colon cancer. Data presented this month at the American College of Gastroenterology’s annual scientific meeting showed that 42 percent of initial Cologuard users between 50-74 years of age, the primary targets for screening, reported no previous colorectal cancer screening.
An independently-conducted, peer-reviewed study published this month in Family Medicine and Community Health showed that 75 percent of the prospectively-recruited patients found Cologuard “more suitable” than a colonoscopy. The self-administered study, conducted by the Case Western Reserve University School of Medicine, evaluated perceptions of patients undergoing both a colonoscopy and a Cologuard test. Eighty-four percent of patients said they’d be likely or somewhat likely to repeat Cologuard testing, if recommended.
A recently-published, peer-reviewed study of Cologuard use among Alaska Native people also confirms its performance across all stages of colorectal cancer and showcased how the at-home test can improve access to screening. In the study of 661 average-risk Alaska Native people,
Cologuard detected 100 percent (10/10) of colorectal cancers and 52 percent (24/46) of significant premalignant lesions (adenomas >1cm) in people between the ages of 40-85. The detection rate of Cologuard increased to 80 percent for the largest pre-cancers (>3cm), which are most likely to progress to cancer. The study, “Stool DNA Testing for Screening Detection of Colorectal Neoplasia in Alaska Native People,” is published in the Mayo Clinic Proceedings .
As part of the study, which mirrored a previously-published (New Engl J Med April 2014 10,000-patient prospective study of Cologuard, patients underwent both Cologuard and fecal immunochemical testing (FIT) prior to a pre-scheduled screening colonoscopy. The Alaska Native people study results improved on the previously-published results, showing a higher rate of sensitivity for colorectal cancer and pre-cancer, and an increased specificity. FIT detected 80 percent (8/10) of colorectal cancers and only 30 percent of significant premalignant lesions (adenomas >1 cm). Cologuard achieved a specificity of 93 percent and FIT achieved a specificity of 96 percent.
Exact Sciences reported total revenues of $12.6 million for the third quarter of 2015 and total revenues of $25.0 million for the nine months ended Sept. 30, 2015. Cologuard received approval from the U.S. Food and Drug Administration in August 2014 and a final National Coverage Decision from the Center for Medicare and Medicaid Services in October 2014.
For the third quarter of 2015, Exact Sciences reported a net loss of ($42.9) million, or ($0.45) a share. The company had a net loss of ($32.1) million, or ($0.39) a share, for the same period of 2014. The company’s net loss for the first nine months of 2015 was ($117.8) million, or ($1.30) a share. The company had a net loss of ($67.6) million, or ($0.86) a share, for the same period of 2014.
Operating expenses for the quarter ending Sept. 30, 2015, were $48.4 million, compared to $31.3 million for the third quarter of 2014. Operating expenses for the nine months ended Sept. 30, 2015 were $126.8 million. The company had operating expenses of $67.3 million for the same period of 2014.
Exact Sciences ended the third quarter of 2015 with cash, cash equivalents and marketable securities of $343.5 million, compared to $282.8 million at Dec. 31, 2014.