On July 29, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the second quarter ended June 30, 2021, and provided an update on recent business progress (Press release, Veracyte, JUL 29, 2021, View Source [SID1234585366]).
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"Our business demonstrated significant momentum in the second quarter, with particularly strong growth in our thyroid and urologic cancer product lines," said Marc Stapley, Veracyte’s chief executive officer. "The pending HalioDx acquisition is expected to further fuel our global cancer diagnostics growth and leadership. Importantly, we also added key new hires to the executive team and are well-positioned to execute on our compelling vision of improving outcomes for patients all over the world at every step of their journey."
Second Quarter 2021 Financial Results
For the second quarter of 2021, as compared with the second quarter of 2020:
Total Revenue was $55.1 million, an increase of 166%;
Gross Margin was 68%, an increase of 500 basis points;
Operating Expenses, Excluding Cost of Revenue, were $45.1 million, an increase of 87%;
Net Loss and Comprehensive Loss was $9.0 million, an improvement of 18%;
Basic and Diluted Net Loss Per Common Share was $0.13, an improvement of 41%;
Net Cash Provided by Operating Activities was $1.9 million, an improvement of 122%; and
Cash and Cash Equivalents were $327.5 million at June 30, 2021.
For the six months ended June 30, 2021, compared to the prior year:
Total Revenue was $91.8 million, comprising $89.6 million in testing and product revenue and $2.2 million in biopharmaceutical partnership and collaboration revenue, an increase of 77%;
Gross Margin was 67%, an increase of 500 basis points;
Operating Expenses, Excluding Cost of Revenue, were $114.8 million, including $39.5 million of acquisition-related expenses, an increase of 108%;
Net Loss and Comprehensive Loss was $50.9 million, including $39.5 million of acquisition-related expenses, an increase of 124%;
Basic and Diluted Net Loss Per Common Share was $0.78, including $0.60 per share attributable to the acquisition-related expenses recorded in general and administrative expenses, an increase of 73%; and
Net Cash Used in Operating Activities was $38.7 million.
Second Quarter 2021 and Recent Business Highlights
Commercial Growth:
Grew total volume to 20,856 genomic tests, an increase of 215% compared to the same period in 2020 and 44% compared to the first quarter of 2021.
Achieved key managed care milestones for our genomic tests:
Received final Medicare coverage policy for the Decipher Bladder test from Noridian, our Medicare Administrative Contractor, through the MolDX program.
Signed a managed care contract with a major health plan, making the Decipher Prostate test an in-network benefit for eligible patients among the plan’s approximately 20 million members nationally.
Granted reimbursement for the Prosigna breast cancer test in Germany for eligible patients with HR+/HER2- early-stage breast cancer, enabling hospitals and laboratories in Germany to perform the test locally.
Evidence Development and Pipeline Advancement:
Presented 14 abstracts demonstrating the performance and utility of our current and pipeline genomic tests at the American Thoracic Society (ATS), American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer annual meetings. This included the presentation of pivotal clinical validation data at the ASCO (Free ASCO Whitepaper) meeting demonstrating the ability of the Percepta Nasal Swab test to improve the early assessment of lung cancer.
Published data demonstrating the prognostic utility of Veracyte’s Decipher Prostate genomic classifier:
Data published in JAMA Oncology suggest that, among men with non-metastatic castration-resistant prostate cancer (nmCRPC), the Decipher test can help identify those patients most likely to benefit from treatment with apalutamide, a second-generation androgen receptor signaling inhibitor (ARSi), in addition to androgen-deprivation therapy (ADT).
Findings from a study published in Prostate Cancer and Prostatic Diseases suggest the Decipher test may help guide treatment decisions for men with early-stage prostate cancer who are candidates for active surveillance.
Global Expansion Progress:
Announced the planned acquisition of HalioDx to further accelerate growth and strengthen Veracyte’s global leadership in cancer diagnostics. The acquisition is intended to provide three strategic benefits to Veracyte:
Accelerate IVD test development and manufacturing operations in Europe;
Expand the company’s scientific expertise into the emerging immuno-oncology field; and
Broaden Veracyte’s cancer diagnostics scope into eight of the top 10 cancers by U.S. incidence.
Added key new hires to further strengthen the executive team and position the company to scale globally:
Rebecca Chambers as executive vice president and chief financial officer;
Rob Brainin as executive vice president and chief business officer; and
Bill Zondler as senior vice president and chief information officer.
2021 Financial Outlook
Veracyte is increasing its 2021 annual total revenue guidance to a range of $200 million to $208 million from its previous guidance range of $190 million to $200 million. This range represents 69% to 76% total revenue growth for fiscal 2021 compared to fiscal 2020, and increased from Veracyte’s prior estimate of 61% to 69% total revenue growth.
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 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