Bonnie Anderson
Analyst · Piper Jaffray
Thank you, Keith, and thanks everyone, again, for joining us today. We delivered very strong results this quarter with revenue of $20 million, which was a 22% growth over prior year and the highest revenue in any quarter since we launched our first product seven years ago. We also entered the second quarter with momentum across the business, strong test volume growth driven by the reacceleration of the Afirma GSC and in-network contract with Anthem and a significant uptick in Percepta orders. Other important highlights include, the introduction of our Afirma Xpression Atlas platform; our research collaboration with Loxo Oncology, which provides a strong validation of our technology depth; and our continued progress with our Envisia classifier, as we initiate an early access program and progress toward Medicare reimbursement. We are excited about our progress and believe we are realizing the upside from the significant foundation we have built for our business. I'll walk you through the highlights of the quarter using the key metrics by which we measure our success. The first is commercial growth. We saw renewed growth this quarter with our reported genomic test volumes increasing to 6,864 tests, marking an 18% increase over the same period last year. We attribute a significant amount of this growth to the previously anticipated reacceleration from our next-generation Afirma GSC, which our customers are quite excited about. We have now converted approximately 70% of our volume to the Afirma GSC, which is ahead of plan, and expect to have all accounts converted, with the potential exception of those in New York State, by the end of the second quarter. The Afirma GSC has been positively received by the physician community because of its ability to keep potentially 70% of benign patients from unnecessary surgery and its improved performance on more difficult cases, such as those of with Hurthle cell lesions. Further, we are pleased to report that our data confirm that our expanded multi-product sales strategy is working. In fact, most of our sales specialists representing our portfolio of products converted at least 1 Percepta account in the quarter. While the vast majority of the genomic test volume was a result of strong Afirma growth, we are also seeing a significant increase in Percepta orders. For example, the number of institutions that sent us samples in the first quarter doubled compared to the fourth quarter of 2017. And nearly 100 physicians ordered at least 1 Percepta during the quarter. While we expect Percepta's contribution to our revenue to be modest in 2018, we are on track to build to a fourth quarter run rate of 500 to 1,000 Percepta test results as we communicated on our last call. And lastly, due to demand from physicians, who would like to integrate our Envisia classifier into their clinical workup of patients with suspected idiopathic pulmonary fibrosis, or IPF, we have begun efforts to establish an early access program for the test. Our market research suggests that pulmonologists are excited about having a tool that will give them more confidence in diagnosing patients with IPF versus other types of interstitial lung disease. Given the significant differences in how these patients would be treated, our early access program will give a few select institutions the opportunity to begin offering the test to their patients, while helping to assure we are well prepared to ramp commercialization next year following anticipated Medicare coverage by the end of 2018. Our second major of success is reimbursement expansion. We had a big win on this front during the first quarter by signing an in-network contract with Anthem. We are excited to work through all the Anthem plans to get this fully executed and establish Afirma as an in-network benefit for all of the plans approximately 40 million members. This was largely -- this will largely complete the reimbursement journey for Afirma, and we have begun to turn our attention to bringing Percepta through this process. Our third major of success is evidence development, and we continue to execute well in this important area. We presented the first real-world user experience data on the Afirma GSC in March at ENDO 2018, the annual meeting of the Endocrine Society, which confirmed the test's strong clinical utility. The findings from a multicenter prospective study demonstrate that the Afirma GSC enabled significantly more patients to avoid unnecessary surgery compared to the original Afirma test. While we have presented clinical validation study results for the Afirma GSC, we anticipate the study will be published in the coming weeks. We also expect several customers to share their own user experience data at the American Association of Clinical Endocrinologists, or AACE, meeting later this month. Also, later this month, at the American Thoracic Society, or ATS, meeting, we look forward to meeting with our study investigators in which we will update them on the final results of the Percepta registry clinical utility trial. We plan to unveil this information publicly in a peer review form in the second half of the year. And finally, we were pleased that findings from the Pulmonary Fibrosis Foundation's INTENSITY study were published in BMC Pulmonary Medicine. These data quantified the extensive diagnostic odyssey invasive procedures and costs that patients with IPF and other interstitial lung disease patients endure just to get a confident diagnosis. Moreover, they strongly reinforce the need for our Envisia genomic classifier to help provide a more confident diagnosis in IPF. The fourth metric is scientific innovation. We were excited during the quarter to unveil the Afirma Xpression Atlas, which is our new platform for using RNA sequencing to extract extensive, rich genomic content, including gene expression, DNA variance and RNA fusions in over 500 genes that are associated with thyroid cancer from thyroid FNA samples. We are launching the Afirma Xpression Atlas as an extension of the Afirma GSC and believe it will provide clinicians with valuable genomic information that may inform surgery strategy and treatment options for patients with suspected thyroid cancer. In tandem with the Afirma GSC, this new offering will uniquely enable us to offer physicians a single source comprehensive solution for their patients with thyroid nodules. We look forward to sharing more details of the Afirma Xpression Atlas, including performance data at the upcoming AACE meeting. Further, we believe our novel Afirma Xpression Atlas platform, combined with our leadership in thyroid cancer diagnosis, where we have performed genomic testing for more than 100,000 patients, uniquely positions us to provide valuable information and insights on thyroid cancers to developers of targeted therapies. We were pleased recently to announce the first such research collaboration with Loxo Oncology through which we will leverage our RNA sequencing-based Afirma Xpression Atlas platform to advance Loxo's development of therapies for patients with genetically defined cancers, including thyroid cancer. Specifically, we will provide Loxo with genomic information and insights regarding thyroid cancers with TRK fusions and RET alterations. While our initial focus on thyroid -- will be on thyroid cancer for the Xpression Atlas platform, it provided a great opportunity for this collaboration with Loxo Oncology, we believe that, over time, we can also extend this platform to both lung cancer and IPF. And the final metric is financial discipline. Our cash burn for the quarter -- for the first quarter of 2018 was $7.6 million, which was an 8% improvement compared to the first quarter of last year. This progress reflects our continued focus on efficient use of resources, while investing strategically to grow our business as we move closer to our goal of achieving sustained profitability. I will now turn the call over to Keith to review our financial results for the first quarter of 2018.