On April 30, 2019 Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, reported financial results for the first quarter ended March 31, 2019 and provided an update on recent business progress (Press release, Veracyte, APR 30, 2019, View Source [SID1234535475]).
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"We delivered excellent results in the first quarter of 2019," said Bonnie Anderson, chairman and chief executive officer of Veracyte. "Product revenue and genomic volume both grew significantly in the quarter, and our biopharmaceutical service revenue exceeded our expectations. We also demonstrated financial discipline, improving our cash used in operating activities by 86%."
Anderson continued, "In addition, we received a final Medicare coverage decision for our Envisia Genomic Classifier and published clinical validation and clinical utility data in The Lancet Respiratory Medicine, positioning the test for commercial expansion nationwide. With this continued strong momentum, we believe we remain well-positioned for both near- and long-term growth."
First Quarter 2019 Financial Results
For the first quarter of 2019, as compared with the first quarter of 2018:
Revenue was $29.5 million, an increase of 47%; excluding biopharmaceutical services revenue, revenue was $25.4 million, an increase of 27%;
Gross Margin was 71%, an improvement of 1,000 basis points or 10 percentage points;
Operating Expenses, Excluding Cost of Revenue, were $23.1 million, an increase of 9%;
Net Loss and Comprehensive Loss was $1.9 million, an improvement of 79%;
Basic and Diluted Net Loss Per Common Share was $0.05, an improvement of 81%;
Net Cash Used in Operating Activities was $1.0 million, an improvement of 86%; and
Cash and Cash Equivalents were $67.8 million at March 31, 2019.
First Quarter 2019 and Recent Business Highlights
Recognized revenue for the first time for the Envisia classifier in the first quarter of 2019.
Grew genomic test volume to 9,162 tests in the first quarter of 2019, an increase of 33% compared with the first quarter of 2018.
Received a final Medicare coverage determination for the Envisia classifier through the MolDX program effective April 1, 2019, making the test a covered service for nearly 60 million Medicare beneficiaries nationwide.
Received coverage for the Afirma Genomic Sequencing Classifier (GSC) under the U.S. Department of Defense TRICARE program for approximately 9.4 million uniformed service members, retirees and their families around the world.
Received regulatory approval for the Envisia classifier from the New York State Department of Health, making the test available to patients in the state effective immediately.
Strengthened Library of Clinical Evidence:
Published clinical validation and utility study findings for the Envisia classifier in The Lancet Respiratory Medicine, demonstrating that the test can identify more than two-thirds of patients (70% sensitivity) with the hallmark pattern of idiopathic pulmonary fibrosis (IPF), with high accuracy (88% specificity), thus improving diagnosis – without the need for surgery.
An independent real-world study on the Afirma GSC was published in Thyroid showing that at Brigham and Women’s Hospital use of the test identified benign thyroid nodules nearly 40% more often than the original Afirma test. This improved performance was due to the test’s enhanced ability to distinguish benign from cancerous Hürthle cells, a common but hard-to-diagnose thyroid nodule subtype.
Published a manuscript on the Afirma GSC in BMS Systems Biology showcasing the development of the classifier using RNA whole-transcriptome sequencing and machine learning, enabling improved diagnosis of Hürthle cell benign adenoma from carcinoma within this subtype of thyroid nodules.
Presented Afirma Xpression Atlas data at the ENDO 2019, revealing new insights into the genomic underpinning of medullary thyroid cancer (MTC). This variant and fusion information may help guide physicians in the preoperative evaluation, surgical planning and targeted therapy selections for patients diagnosed with this rare, but aggressive, form of thyroid cancer.
Updated 2019 Financial Outlook
Veracyte is increasing its 2019 annual revenue guidance to a range of $117 million to $121 million from its prior guidance range of $113 million to $117 million. The company continues to expect full-year 2019 net cash used in operating activities to be in the range of $4 million to $6 million and to achieve operating cash flow breakeven before the end of this year.
Conference Call and Webcast Details
Veracyte will host a conference call and webcast today at 5:00 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link View Source
The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source
The conference call can be accessed as follows:
U.S./Canada participant dial-in number (toll-free): (855) 541-0980
International participant dial-in number: (970) 315-0440
Conference I.D.: 9289499