SOUTH SAN FRANCISCO, Calif., March 10, 2016 /PRNewswire/ -- Veracyte, Inc. (NASDAQ: VCYT) today announced financial results and business progress for the quarter and full year ended December 31, 2015, and provided financial guidance for 2016.
"We had an excellent year in 2015, driving the growth of our Afirma Gene Expression Classifier (GEC), gaining payer coverage and reimbursement, and advancing our pulmonology program," said Bonnie Anderson, president and chief executive officer of Veracyte. "We are firmly establishing Afirma as a new standard of care that helps patients avoid unnecessary surgery in thyroid cancer diagnosis. We are also creating a growing body of long-term clinical utility evidence and are well-positioned to further drive market penetration for our test.
"We also believe that the substantial clinical data now supporting our Percepta® Bronchial Genomic Classifier to improve diagnosis of lung nodules that are potentially cancerous will strengthen reimbursement and commercialization efforts for the new test. Additionally, we are advancing our pipeline with clinical studies underway to support the launch of our test to help diagnose idiopathic pulmonary fibrosis, or IPF, without the need for surgery. We are targeting launch of our IPF product during the fourth quarter of 2016."
Fourth Quarter and Full-Year 2015 Financial Results
- Revenue was $14.0 million for the fourth quarter of 2015, an increase of 15%, compared to $12.2 million in the fourth quarter of 2014. Excluding a one-time revenue pick-up and cash receipts in the fourth quarter of 2014, the revenue increase was 23% for the fourth quarter of 2015, compared to the same quarter of the prior year. 2015 revenue was $49.5 million, an increase of 30%, compared to 2014 revenue of $38.2 million.
- Afirma GEC test volume grew to 5,609 during the fourth quarter of 2015, an increase of 38%, compared to the same period in 2014. Total GECs performed for 2015 also increased by 38% to 19,421, compared to 14,061 GEC tests for 2014.
- Operating expense for the fourth quarter of 2015 was $22.0 million, compared to $20.3 million for the comparable period in 2014. Operating expense for 2015 was $83.0 million compared to operating expense of $67.2 million for 2014.
- Net loss for the fourth quarter of 2015 was $8.0 million, or $0.29 per common share, compared to a net loss of $8.1 million, or $0.36 per common share, for the same period in 2014. Net loss for 2015 was $33.7 million, or $1.30 per common share, compared to a net loss of $29.4 million, or $1.36 per common share, for 2014.
- Cash and cash equivalents as of December 31, 2015 totaled $39.1 million.
2015 and Recent Business Highlights
- Expanded the total number of covered lives for the Afirma GEC to nearly 180 million today, including more than 45 million Blues plan members, compared to approximately 140 million total and 20 million Blues covered lives at the beginning of 2015, with new coverage from HCSC in December.
- Grew the total number of contracted lives for the Afirma GEC to nearly 130 million today from 90 million at the beginning of 2015.
- Significantly expanded the clinical utility evidence for the Afirma GEC, with more than a dozen such studies now published, including two long-term clinical outcome studies published in peer-reviewed journals, and another study, conducted by Anthem, Inc. subsidiary HealthCore, presented at a major medical conference in October.
- Concluding U.S. co-promotion agreement with Sanofi Genzyme, effective mid-September 2016, when Veracyte will assume full sales and marketing responsibility for Afirma. This will allow us to end payments to Sanofi Genzyme of 15% of all U.S. Afirma sales.
- Launched the Percepta Bronchial Genomic Classifier ahead of schedule in April, followed by strong clinical validation data published in The New England Journal of Medicine in July and BMC Medical Genomics in May, clinical utility data published in CHEST in February 2016 and analytical verification data published in BMC Cancer in February 2016.
- Presented new data for Veracyte's IPF classifier, which was developed and cross-validated on bronchoscopy samples the same type of patient sample that will be used upon commercialization at the Pulmonary Fibrosis Foundation Summit in November 2015.
- Strengthened the Board with the appointments of Robert S. Epstein, M.D., M.S., and Tina S. Nova, Ph.D., and the management team with the addition of Neil M. Barth, M.D., as chief medical officer during 2015.
2016 Financial Outlook
Veracyte's guidance for 2016 is to achieve Afirma GEC test volume in the range of 24,000 to 25,500, and annual 2016 revenue in the range of $59 million to $63 million.
Conference Call and Webcast Details
Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company's financial results and provide a general business update. The live webcast and subsequent replay may be accessed by visiting Veracyte's website at http://investor.veracyte.com. Alternatively, please call (855) 541-0980 (U.S.) or (970) 315-0440 (international) to listen to the live conference call. The conference ID number is 49854042. The webcast replay will be available on the company's website approximately two hours following completion of the call.
About Veracyte
Veracyte (NASDAQ: VCYT) is pioneering the field of molecular cytology, offering genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte's Afirma Thyroid FNA Analysis centers on the proprietary Afirma Gene Expression Classifier (GEC) and is becoming a new standard of care in thyroid nodule assessment. The Afirma test is recommended in leading practice guidelines and is covered for nearly 180 million lives in the United States, including through Medicare and many commercial insurance plans. Veracyte is expanding its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. In April 2015, the company launched the Percepta Bronchial Genomic Classifier, a test to evaluate patients with lung nodules that are suspicious for cancer.
To read full press release, please click here.
