Veracyte Announces Fourth Quarter and Full-Year 2017 Financial Results, Provides 2018 Financial Outlook
Full-Year Revenue Grew 11%, to
Announces Upcoming Launch of Afirma Xpression Atlas Platform
Conference Call and Webcast Today at
“We delivered a solid year of growth in 2017,” said
“In pulmonology, we built a strong foundation to advance market uptake
of the Percepta classifier in lung cancer screening and diagnosis and
moved our Envisia Genomic Classifier for the diagnosis of idiopathic
pulmonary fibrosis toward
Fourth Quarter and Full-Year 2017 Financial Results
For the three- and twelve-month periods ended
- Revenue was
$19.6 millionand $72.0 million, respectively, an increase of 7% and 11%;
- Genomic Volume was 7,153 and 26,026 reported tests, respectively, an increase of 13% and 12%;
- Gross Margin was 60% and 61%, respectively, a decline of 4% and flat to prior year;
- Operating Expenses, Excluding Cost of Revenue, were
$17.9 millionand $70.3 million, respectively, an increase of 16% and 3%;
- Net Loss and Comprehensive Loss was
($8.4) millionand ($31.0) million, respectively, an increase of 92% and decrease of 1%;
- Basic and Diluted Net Loss Per Common Share was
($0.24)and ($0.91), respectively, an increase of 71% and decrease of 17%;
- Cash Burn1was
$6.1 millionand $25.2 million, respectively, an increase of 31% and improvement of 22%; and
- Cash and Cash Equivalents was
$33.9 millionat December 31, 2017.
1 A reconciliation of net cash used in operating activities to cash burn has been provided in the financial statement tables included in this press release. An explanation of cash burn is also included below under the heading “Non-GAAP Financial Measures.”
2017 and Recent Business Highlights
January 2018, achieved the milestone of 100,000 Afirma tests performed to date, with an estimated 40,000 unnecessary thyroid surgeries saved, penetrating the market by an estimated 35%.
- Launched the next-generation Afirma Genomic Sequencing Classifier on our RNA sequencing platform, further improving the test’s performance and expanding our comprehensive biorepository of genomic content to fuel future product innovation.
- Announced upcoming launch of the Afirma Xpression Atlas platform, providing physicians the most comprehensive genomic data available in a single assay to further inform surgery and treatment decisions for patients with suspected thyroid cancer.
- During the year, structured and significantly expanded our multi-product sales team by over 40% during the year, in preparation for driving Percepta growth in 2018.
Expanded the number of covered lives for Afirma by 70 million during
2017, bringing the total number of patients covered for the genomic
test through their health insurers to over 275 million, including
nearly 120 million Blues plan members, as of
December 31, 2017.
Expanded the number of contracted lives for Afirma by nearly 20
million during 2017, making the test an in-network covered benefit for
over 175 million people, including nearly 45 million Blues plan
members, as of
December 31, 2017.
Medicarecoverage for Percepta through the MolDX program in May 2017, making it the first genomic test to be covered for use in lung cancer screening and diagnosis. The test is now available as a covered benefit for the nearly 60 million Medicareenrollees nationwide.
Medicarepricing stability and transparency for Afirma through the Protecting Access to Medicare Act of 2014 (PAMA) implementation in January 2018, resulting in an increased reimbursement rate of approximately $3,600per test from approximately $3,200per test.
Completed the package of clinical evidence needed to target
Medicarecoverage for the Envisia Genomic Classifier in 2018.
- Afirma – Presented 14 Afirma abstracts at four medical conferences, including four clinical utility studies demonstrating the long-term durability of a benign genomic test result during up to six years of follow-up and seven studies showing the enhanced Afirma GSC’s ability to identify significantly more benign thyroid nodules than the original Afirma test.
Percepta – Presented three studies at major medical meetings
demonstrating the clinical utility of the Percepta classifier and
published a study in the
Journal of Thoracic Oncologydemonstrating the genomic test’s cost-effectiveness.
- Envisia – Presented five abstracts at leading pulmonology meetings and published three studies demonstrating the clinical validity, clinical utility and/or analytical verification of the Envisia classifier.
The above guidance for the full year of 2018 includes the adoption of
ASC 606, which is effective
Conference Call and Webcast Details
Veracyte Fourth Quarter 2017 Conference Call
4:30 p.m. ET Today
|Dial-in number (U.S.):||(855) 541-0980|
|International number:||(970) 315-0440|
The webcast replay will be available on the company’s website approximately two hours following completion of the call.
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements can be identified by words such as:
"anticipate," "intend," "plan," "expect," "believe," "should," "may,"
"will" and similar references to future periods. Examples of
forward-looking statements include, among others, statements we make
regarding our belief that we have a strong foundation in place to drive
revenue growth, our beliefs regarding momentum in our business and
potential drivers of future growth, our expectations regarding full-year
2018 revenue and cash burn, our introduction of our Afirma Xpression
Atlas platform, our expectations regarding our ability to receive
Non-GAAP Financial Measures
To supplement our financial statements prepared in accordance with
generally accepted accounting principles in
Because of these limitations, cash burn should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. Investors are encouraged to review the reconciliation of cash burn to net cash used in operating activities provided in the tables below.
|CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(In thousands of dollars, except share and per share amounts)|
Three Months Ended
|Year Ended December 31,|
|Cost of revenue||7,769||6,515||28,195||25,462|
|Research and development||3,202||3,590||13,881||15,324|
|Selling and marketing||9,045||5,832||32,260||28,248|
|General and administrative||5,357||5,725||23,088||23,787|
|Intangible asset amortization||267||267||1,067||1,067|
|Total operating expenses||25,640||21,929||98,491||93,888|
|Loss from operations||(6,044||)||(3,672||)||(26,538||)||(28,803||)|
|Other income, net||123||75||476||202|
|Net loss and comprehensive loss||$||(8,439||)||$||(4,403||)||$||(31,003||)||$||(31,358||)|
|Net loss per common share, basic and diluted||$||(0.24||)||$||(0.14||)||$||(0.91||)||$||(1.09||)|
|Shares used to compute net loss per common share, basic and diluted||34,055,524||31,705,603||33,925,617||28,830,472|
|CONDENSED BALANCE SHEETS|
|December 31,||December 31,|
|Cash and cash equivalents||$||33,891||$||59,219|
|Prepaid expenses and other current assets||1,997||2,057|
|Total current assets||53,928||73,627|
|Property and equipment, net||9,688||11,480|
|Finite-lived intangible assets, net||13,067||14,133|
|Liabilities and Stockholders’ Equity|
|Total current liabilities||12,028||11,534|
|Capital lease liability, net of current portion||308||599|
|Deferred rent, net of current portion||4,170||4,402|
|Total stockholders’ equity||37,225||59,581|
|Total liabilities and stockholders’ equity||$||78,669||$||101,034|
(1) The condensed balance sheet at December 31, 2016 has been derived from the audited financial statements at that date included in the Company's Form 10-K filed with the Securities and Exchange Commission dated March 1, 2017.
|CONDENSED STATEMENT OF CASH FLOWS|
|(in thousands of dollars)|
|Year Ended December 31,|
|Adjustments to reconcile net loss to net cash used in operating activities:|
|Depreciation and amortization||3,841||3,511|
|Bad debt expense||-||68|
|Loss on disposal of property and equipment||12||12|
|Genzyme co-promotion fee amortization||-||(948||)|
|Conversion of accrued interest on long-term debt||-||385|
|Amortization and write-off of debt discount and issuance costs||472||173|
|Interest on end-of-term debt obligation and prepayment penalty||1,589||206|
|Changes in operating assets and liabilities:|
|Prepaid expenses and other current assets||(7||)||(415||)|
|Accrued liabilities and deferred rent||(1,163||)||451|
|Net cash used in operating activities||(23,915||)||(27,982||)|
|Purchases of property and equipment||(1,755||)||(4,210||)|
|Proceeds from sale of property and equipment||440||-|
|Change in restricted cash||120||(2||)|
|Net cash used in investing activities||(1,195||)||(4,212||)|
|Proceeds from the issuance of long-term debt, net of debt issuance costs||24,880||24,452|
|Proceeds from issuance of common stock in a public offering, net of issuance costs||200||31,949|
|Payment of long-term debt||(25,385||)||(5,000||)|
|Payment of end-of-term debt obligation and prepayment penalty||(1,536||)||(288||)|
|Payment of capital lease liability||(274||)||-|
|Proceeds from the exercise of common stock options and employee stock purchases||1,897||1,216|
|Net cash (used in) provided by financing activities||(218||)||52,329|
|Net (decrease) increase in cash and cash equivalents||(25,328||)||20,135|
|Cash and cash equivalents at beginning of year||59,219||39,084|
|Cash and cash equivalents at end of year||$||33,891||$||59,219|
|Supplementary cash flow information of non-cash investing and financing activities:|
|Net receivable for reimbursement of public offering issuance costs||$||-||$||144|
|Purchases of property and equipment included in accounts payable and accrued liabilities||$||42||$||363|
|Supplementary cash flow information:|
|Cash paid for interest on debt||$||2,718||$||2,149|
|Cash paid for tax||$||21||$||7|
Reconciliation of net cash used in operating activities to cash burn:
(Unaudited, in thousands of dollars)
Three Months Ended
|Year Ended December 31,|
|Net cash used in operating activities||$||(5,816||)||$||(4,232||)||$||(23,915||)||$||(27,982||)|
|Plus purchases of property and equipment||(300||)||(450||)||(1,755||)||(4,210||)|
|Less proceeds from the sale of property and equipment||-||-||440||-|
|Net cash used in investing activities||$||(300||)||$||(450||)||$||(1,195||)||$||(4,212||)|
|Net cash (used in) provided by financing activities||$||(1,188||)||$||32,202||$||(218||)||$||52,329|