Bonnie Anderson
Analyst · Leerink Partners. Your line is open
Thanks, Keith. Good afternoon, everyone and thanks for joining us today. We are excited to recap a year of exceptional execution in 2016 and highlight the momentum, plans and expectations for our business in 2017. We have just completed our fourth quarter consecutive year of at least 30% annual revenue growth since becoming a public company. And as you have seen from our recent press releases, we have made significant progress in advancing our thyroid and pulmonology franchises, which we would expand upon today. At the beginning of 2016, we committed to our investors that we would measure our success for the year using three key metrics: Afirma growth and reimbursement expansion; Percepta coverage decision by Medicare; and the launch of our third commercial test for idiopathic pulmonary fibrosis, or IPF. Here is our scorecard. First, Afirma growth and reimbursement expansion, our original 2016 annual revenue goal was $59 million to $63 million. We exceeded our expectations closing the year at $65 million in revenue, a 31% year-over-year increase. We set out to achieve 2016 Afirma Gene Expression Classifier, or GEC volume in the range of 24,000 to 25,500. We reported 23,237 Afirma GEC tests for the year, 3% below our range, but resulting in solid volume growth of 20% year over prior year. In terms of reimbursement expansion for the Afirma GEC, we believe our execution and progress were exceptional. We expanded the total number of covered lives by $15 million to nearly $225 million as of March 1, 2017 and the total number of people covered through in-network contracts by $25 million to over $155 million today. In April 2016, we secured an agreement with Blue Cross and Blue Shield Association’s internal group purchasing organization, CareSource to accelerate in-network contracts and overall reimbursement for the Afirma GEC among Blues plans across the country. Our strategy worked. We now have more than 70 million Blues covered lives for the Afirma GEC, including over 20 million gained in the first two months of 2017 as well as 20 million Blues lives now under contract. Lastly, in September 2016, our scientists presented data at the American Thyroid Association Meeting showing the potential for our next generation Afirma GEC, which combines RNA sequencing and machine learning to significantly increase the number of patients with benign thyroid nodules who could avoid unnecessary diagnostic surgery. Data revealed at the meeting showed our ability to maintain the Afirma GEC’s high sensitivity and negative predictive value, while increasing the test specificity above the 50% mark today. We are excited to transition this enhanced Afirma GEC in 2017. Second, Percepta coverage, we aim to achieve a Medicare coverage decision for Percepta by the end of 2016 and we exceeded our goal. In September and October of 2016, Veracyte received three draft Medicare coverage decisions through the MolDx programs for Percepta’s use in lung cancer screening and diagnosis. Two of these policies are now final and scheduled to go into effect this month. Upon finalization of the third draft policy, Percepta will be covered for over 35 million or nearly two-thirds of the 57 million Medicare beneficiaries in the United States. We also made significant progress in building our library of clinical evidence for the Percepta classifier with data demonstrating that our test in fact helps change clinical decision-making and reduce healthcare costs. Data presented at key medical conferences in 2016 included two clinical utility studies at the CHEST Annual Meeting in 2016 showing that use of the Percepta classifier led to a significant decrease in physician’s decisions to perform diagnostic surgery or other invasive procedures in patients being evaluated for potential lung cancer. And data presented at the American Thoracic Society, or ATS meeting, which suggested the Percepta classifier’s ability to both be cost savings and cost effective to the healthcare system at a reimbursed rate estimated at $3,200. Third, the launch of the Envisia Bronchial Genomic Classifier, are tests for IPF. In October 2016, we launch the Envisia classifier at the CHEST Annual Meeting. The Envisia classifier helps improve the diagnosis of IPF among the 200,000 patients who present each year in the United States and Europe with a potential interstitial lung disease, or ILD. We believe the Envisia test is the first commercially available test to help patients with suspected IPF securing accurate diagnosis more quickly and through currently available processes and without the need for invasive surgery. We also made significant progress in building the clinical evidence for Envisia. At the International Colloquium for Lung Airway Fibrosis and at a private event at the CHEST Annual Meeting in October, we unveiled clinical validation data from our prospective 30-site double-blinded BRAVE study, which demonstrated the ability of the Envisia classifier to accurately identify with an 88% specificity usual interstitial pneumonia, a classic diagnostic pattern whose presence is essential to IPF diagnosis. We closed out 2016 with great momentum. We have got three commercial genomic tests now that targeted $2 billion market and an expanding pipeline for sustained growth. We exited our co-promotion agreement with Genzyme in 2016 and expanded and began integrating our sales team to sell across our Afirma and Percepta product lines in 2017. At this time, I would like to address two important executive leadership promotions, which we announced yesterday and which we believe will best align our business to meet the growth objectives, transition our business to profitability and importantly allow me more time to work with the leadership team in pursuit of the continued evolution and growth of our company. First, we have appointed Chris Hall as President and Chief Operating Officer with expanded responsibility for Veracyte’s day-to-day business and operations. Most of you know Chris and are familiar with the critical leadership role he has played in developing and guiding our commercial enterprise and operations since joining the company in 2010 as Chief Commercial Officer and being promoted in 2014 to Chief Operating Officer. As we enter our next phase, I am focused on sustained profitable growth I can imagine no better person to lead the execution of that corporate strategy. Additionally, we promoted John Hanna to Chief Commercial Officer. He will oversee sales, marketing and managed care for Veracyte reporting to Chris. John joined Veracyte in 2011 leading a very successful managed care strategy and has served most recently as Vice President of Marketing. He has been the key driver of our efforts to build clear value proposition for our genomic tests which is leading to broad physician adoption and health plan reimbursement. I am thrilled to have John leading our commercial efforts and look forward to introducing him to many of you. Finally, at the corporate level, we have recruited Kevin Gordon, the former Chief Operating Officer of Quintiles Transnational Holdings to our Board of Directors. I would like to thank Brian Atwood for his incredible service to the company as Director and Chairman of the Board since Veracyte’s founding. Now, Brian stepped down in December of 2016. His significant positive impact on the company will continue for years to come. I would now like to turn the call over to Keith to review our financial results for the fourth quarter and for the full year of 2016.