Bonnie Anderson
Analyst · William Blair. Your line is open
Thanks Keith. And thanks again everyone for joining us today. We delivered another outstanding quarter of growth, stemming from solid execution. Revenue for the second quarter was $22.8 million, which marks a 24% increase over prior year and reflects the strong momentum we see across the business. Let's review the highlights driving our results. I'll begin with commercial growth. Our reported genomic test volume for the quarter was 7,686, an 18% increase over the same period last year. The strong growth was fueled largely by our nearly complete transition to the next generation Afirma GSC, which is enabling us to grow business among existing clients and attract new customers who are sold on the ability to prevent significantly more surgeries compared to the original GEC. This transition is punctuated by regulatory approval from the New York State Department of Health, which we received earlier this month making the Afirma GSC nationally available to 100% of customers. We launched our Afirma Xpression Atlas in May, which enables us to extract deep RNA sequencing data across the genome for every sample we run with the GSC. The Xpression Atlas is garnering growing interest from physicians due to its ability to inform surgery strategy and treatment decisions for patients with suspected thyroid cancer. This rich genomic content, as well as our market-leading access to large numbers of diverse thyroid samples is also of significant interest to developers of precision medicine therapies. To that end, we are pleased to report that we booked our first biopharmaceutical service revenue based on the Xpression Atlas platform. We are also extremely pleased with the market reaction to an early traction of our Percepta Bronchial Genomic Classifier, which is resonating with physicians because of its ability to improve the performance of bronchoscopy in lung cancer diagnosis and thus reduce the need for more invasive procedures. During the second quarter, we tripled our Percepta revenue compared to the first quarter, and increased the number of physicians ordering the test by over 50%. This includes physicians from some of the nation's leading institutions. We believe we are well on track to achieve our Percepta test volume goals for the year. In May, we launched our early access program for the Envisia Genomic Classifier with a select and highly engaged group of institutions around the country. The goal is to address physician and patient demand for the test and to further our readiness for broad commercialization which we expect in 2019. Such sites as UCLA, Jefferson, and Keck Medicine of the USC, are already up and running and beginning to submit samples, and we are moving through the process with other target institutions that are interested in participating. In fact, I'm delighted to report that we delivered our first five Envisia patient reports this quarter. I’d like to share a few observations we've made in the short time since we launched the Envisia early access program. First, there has been multiple instances in which physicians have adopted Percepta and Envisia together. In one case, interestingly, a physician interested in Envisia, helped us also get a foot in the door for Percepta. These findings, while anecdotal, reflects the value of our integrated sales team and our strategy of leveraging synergies in the pulmonology market. More broadly, it speaks to the trust that physicians and other decision makers have in the value and quality of the Veracyte brand. We are also already seeing real world evidence of Envisia's value for payers. In one instance for example, physicians in an early access site were able to help overturn the health plan’s denial of coverage for a patient who needed an IPF drug, only after the Envisia Classifiers results provided a more confident diagnosis of IPF. Needless to say, we are excited about the opportunity for Envisia and believe it will play a significant role in helping ILD patients who are being evaluated for IPF, get the treatment they need while avoiding unnecessary and potentially harmful treatment. These results all underscore the foundation of our success in the first half of 2018, and are the bases of our confidence in delivering a very solid full year of commercial growth. Our second success metric is reimbursement expansion. We nearly completed contracting with the remaining Anthem plans during the quarter, establishing Afirma as an in-network offering for most of the health plan’s estimate of 40 million members. Veracyte is now a preferred provider for over 210 million Americans through their health plans. We believe this in-network status will facilitate coverage and reimbursement for Percepta, which we have begun moving through the private payer process and Envisia, which will follow. We continue to work toward Medicare reimbursement for Envisia and believe we are in a good position to achieve that milestone before the end of the year. Next, is evidence development and we made significant strides in this area over the quarter as well. We published strong clinical validation data for the Afirma GSC in JAMA surgery, which shows that the RNA sequencing base test can keep nearly 70% of patients with benign thyroid nodules that are classified as indeterminate by cytopathology out of surgery. These findings along with the clinical rigor behind them are helping to further cement our leadership in thyroid cancer diagnosis. Interestingly, our market research shows that the JAMA surgery article yielded an impact factor in the top 5% compared to other articles published around the same time or in the same journal based on mentions in social media, news sites, and other channels. Clearly, there is interest in what we're doing to improve patient care. Additionally, at the American Association of Clinical Endocrinologists or AACE annual meeting in May, researchers presented findings from three independent studies demonstrating the real-world value of the Afirma GSC. In each study, the institution compared the performance of the next generation test with that of the original version, and found that the GSC's results were even stronger than those in our clinical validation study. Also at the AACE meeting, data for the Afirma Xpression Atlas represented and demonstrate the test high accuracy in identifying 761 DNA variants and 130 RNA fusion partners in over 500 genes that are associated with thyroid cancer. For Percepta, we shared new interim results from our Percepta registry clinical utility trial with study investigators at the American Thoracic Society Annual Meeting in May, and as a poster at the World Congress for Bronchoscopy and Interventional Pulmonology Meeting in June. Our findings from the ongoing study which now includes over 700 enrollment patients at 40 sites, continue to show the use of Percepta Classifier significantly reduces the number of unnecessary surgeries in lung cancer diagnosis. We look forward to unveiling more data in a peer-reviewed form later this year. Our fourth success metric is scientific innovation. I want to just mention for a moment the incredible innovation that we have already delivered in the 10 years of our existence, this includes the Afirma GEC, Second-Generation GSC, Malignancy Classifiers, Xpression Atlas, and the Percepta and Envisia Classifiers, along with a pipeline of truly exciting advancements. We made incredible progress this quarter, analyzing literally thousands samples towards the discovery effort of a nasal swab test that will enable early detection of lung cancer when it is more treatable. This exciting test will use the same field of injury technology platform that powers our Percepta classifier. We look forward to unveiling early data on the proof-of-concept classifier for the nose later this year. As you know, we recently launched the RNA-based Xpression Atlas in thyroid cancer, and believe we can extend this capability to our other indications. I'd like to share some thoughts on the power of our RNA sequencing capabilities. Currently, we are extracting vast amounts of rich transcriptome data from across the genome for every sample we run with our Afirma and Envisia test. While today, we leverage this data using our powerful algorithms to redevelop diagnostic uncertainty, we believe this capability will one day open the door to answering important clinical questions at other points in the continuum of care. More broadly, we believe it will enable us to unlock new insights into the genomic underpinnings of complex diseases to help advance precision medicine. Our industry is in very early stages of realizing the potential of precision medicine, and we believe that we are well-positioned to push the boundaries of what is possible in this exciting frontier in medicine. We'll do this by focusing in on the transcriptome, which gives us far richer and informative data to work with than just DNA, as we seek to answer ever more challenging clinical questions. Our final metric is financial discipline, and we excelled in this area as well this quarter. Our cash burn for the second quarter of 2018 was $3.6 million, which was a 28% improvement compared to the prior year quarter. Clearly, our results show that our careful management of spending and our strategic investment in growing the business are paying off. With that, I will now turn the call over to Keith, to review our financial results for the second quarter of 2018.