DELAWARE | 001-36156 | 20-5455398 | ||
(State or other jurisdiction of incorporation) | Commission File Number | (IRS Employer Identification No.) |
6000 Shoreline Court, Suite 300, South San Francisco, California | 94080 | |
(Address of principal executive offices) | (Zip Code) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: | |
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934. |
Emerging growth company x |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x |
Exhibit No. | Description | |
Dated: | May 1, 2018 | ||
VERACYTE, INC. | |||
By: | /s/ Keith Kennedy | ||
Name: | Keith Kennedy | ||
Title: | Chief Financial Officer | ||
(Principal Financial and Accounting Officer) |
• | Revenue was $20.0 million, an increase of 22%; |
• | Genomic Volume was 6,864, an increase of 18%; |
• | Gross Margin was 61%, a decline of 1%; |
• | Operating Expenses, Excluding Cost of Revenue were $21.1 million, an increase of 20%; |
• | Net Loss and Comprehensive Loss was ($9.2) million, an increase of 12%; |
• | Basic and Diluted Net Loss Per Common Share was ($0.27), an increase of 13%; |
• | Cash Burn1 was $7.6 million, an improvement of 8%; and |
• | Cash and Cash Equivalents was $27.2 million at March 31, 2018. |
• | Reported 6,864 genomic tests in the first quarter of 2018, representing 18% growth as compared to the first quarter of 2017, and transitioned approximately 70% of the company’s thyroid business to the next-generation Afirma Genomic Sequencing Classifier (GSC), ahead of plan; and |
• | Doubled the number of institutions that submitted samples for Percepta testing in the first quarter of 2018, compared to the fourth quarter of 2017. |
• | Executed an in-network contract with Anthem, an independent Blues plan and one of the nation’s largest health benefits companies. This achievement nearly completes Veracyte’s contracting efforts to make the Afirma classifier available to patients nationally as an in-network service. |
• | Presented the first real-world clinical utility data for the Afirma GSC at ENDO 2018 demonstrating that the genomic test enabled significantly more patients to avoid unnecessary thyroid surgery, compared to the original Afirma test; |
• | Published the INTENSITY study in BMC Pulmonary Medicine, quantifying the challenges of obtaining an IPF diagnosis and the resulting negative impact on patients - and underscoring the clinical need for the Envisia classifier; and |
• | Received acceptance of an abstract for a validation study demonstrating the performance of the Afirma Xpression Atlas to be presented at the American Association of Clinical Endocrinologists’ (AACE) 27th Annual Scientific & Clinical Congress in May 2018. |
• | Unveiled the Afirma Xpression Atlas, an extension of the Afirma GSC, at ENDO 2018 in an oral presentation detailing the RNA sequencing-based platform’s ability to derive rich genomic content - 761 DNA variants and 130 RNA fusions in over 500 genes that are associated with thyroid cancer - from thyroid fine needle aspiration samples; and |
• | Entered into a research collaboration with Loxo Oncology, which will leverage Veracyte’s Afirma Xpression Atlas platform to advance Loxo Oncology’s development of therapies for patients with genetically defined cancers, including thyroid cancer. |
Veracyte First Quarter 2018 Conference Call 4:30 p.m. ET Today | |
Website: | http://investor.veracyte.com |
Dial-in number (U.S.): | (855) 541-0980 |
International Number: | (970) 315-0440 |
Conference ID: | 8389069 |
VERACYTE, INC. | |||||||
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||
(Unaudited) | |||||||
(In thousands of dollars, except share and per share amounts) | |||||||
Three Months Ended March 31, | |||||||
2018 | 2017 | ||||||
Revenue | $ | 20,041 | $ | 16,432 | |||
Operating expenses: | |||||||
Cost of revenue | 7,867 | 6,297 | |||||
Research and development | 3,675 | 4,030 | |||||
Selling and marketing | 11,543 | 7,336 | |||||
General and administrative | 5,644 | 6,019 | |||||
Intangible asset amortization | 267 | 267 | |||||
Total operating expenses | 28,996 | 23,949 | |||||
Loss from operations | (8,955 | ) | (7,517 | ) | |||
Interest expense | (448 | ) | (800 | ) | |||
Other income, net | 226 | 100 | |||||
Net loss and comprehensive loss | $ | (9,177 | ) | $ | (8,217 | ) | |
Net loss per common share, basic and diluted | $ | (0.27 | ) | $ | (0.24 | ) | |
Shares used to compute net loss per common share, basic and diluted | 34,271,254 | 33,823,889 |
VERACYTE, INC. | |||||||
CONDENSED BALANCE SHEETS | |||||||
(In thousands) | |||||||
March 31, 2018 | December 31, 2017 | ||||||
(Unaudited) | (1) | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 27,152 | $ | 33,891 | |||
Accounts receivable | 13,198 | 12,716 | |||||
Supplies inventory | 4,557 | 5,324 | |||||
Prepaid expenses and other current assets | 2,142 | 1,997 | |||||
Total current assets | 47,049 | 53,928 | |||||
Property and equipment, net | 9,215 | 9,688 | |||||
Finite-lived intangible assets, net | 12,800 | 13,067 | |||||
Goodwill | 1,057 | 1,057 | |||||
Restricted cash | 603 | 603 | |||||
Other assets | 466 | 326 | |||||
Total assets | $ | 71,190 | $ | 78,669 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,356 | $ | 3,853 | |||
Accrued liabilities | 8,483 | 8,175 | |||||
Total current liabilities | 11,839 | 12,028 | |||||
Long-term debt | 25,016 | 24,938 | |||||
Capital lease liability, net of current portion | 233 | 308 | |||||
Deferred rent, net of current portion | 4,094 | 4,170 | |||||
Total liabilities | 41,182 | 41,444 | |||||
Total stockholders’ equity | 30,008 | 37,225 | |||||
Total liabilities and stockholders’ equity | $ | 71,190 | $ | 78,669 | |||
(1) The condensed balance sheet at December 31, 2017 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 February 27, 2018. |
VERACYTE, INC. | |||||||
Condensed Statements of Cash Flows | |||||||
(Unaudited) | |||||||
(In thousands of dollars) | |||||||
Three Months Ended March 31, | |||||||
2018 | 2017 | ||||||
Operating activities | |||||||
Net loss | $ | (9,177 | ) | $ | (8,217 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization | 980 | 902 | |||||
Stock-based compensation | 1,175 | 1,572 | |||||
Other income | (93 | ) | — | ||||
Amortization of debt issuance costs | 8 | 26 | |||||
Interest on end-of-term debt obligations | 70 | — | |||||
Changes in operating assets and liabilities: | |||||||
Accounts receivable | (482 | ) | (369 | ) | |||
Supplies inventory | 767 | 32 | |||||
Prepaid expenses and current other assets | (239 | ) | (244 | ) | |||
Other assets | (140 | ) | 7 | ||||
Accounts payable | (510 | ) | 528 | ||||
Accrued liabilities and deferred rent | 228 | (2,323 | ) | ||||
Net cash used in operating activities | (7,413 | ) | (8,086 | ) | |||
Investing activities | |||||||
Purchases of property and equipment | (227 | ) | (615 | ) | |||
Proceeds from sale of property and equipment | — | 440 | |||||
Net cash used in investing activities | (227 | ) | (175 | ) | |||
Financing activities | |||||||
Proceeds from the issuance of common stock in a public offering, net of costs | — | 200 | |||||
Proceeds from legal settlement regard short swing profits | 403 | — | |||||
Payment of capital lease liability | (71 | ) | (66 | ) | |||
Proceeds from the exercise of common stock options and employee stock purchases | 569 | 414 | |||||
Net cash provided by financing activities | 901 | 548 | |||||
Net decrease in cash, cash equivalents and restricted cash | (6,739 | ) | (7,713 | ) | |||
Cash, cash equivalents and restricted cash at beginning of period | 34,494 | 59,942 | |||||
Cash, cash equivalents and restricted cash at end of period | $ | 27,755 | $ | 52,229 | |||
Supplementary cash flow information of non-cash investing and financing activities: | |||||||
Purchases of property and equipment included in accounts payable and accrued liabilities | $ | 56 | $ | — | |||
Interest paid on debt | $ | 356 | $ | 770 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH | |||||||
(Unaudited) | |||||||
(In thousands of dollars) | |||||||
March 31, 2018 | December 31, 2017 | ||||||
Cash and cash equivalents | $ | 27,152 | $ | 33,891 | |||
Restricted cash in long term assets, deposit for lease security | 603 | 603 | |||||
Total cash, cash equivalents and restricted cash | $ | 27,755 | $ | 34,494 |
RECONCILIATION OF NET CASH USED IN OPERATING ACTIVITIES TO CASH BURN | |||||||
(Unaudited) | |||||||
(In thousands of dollars) | |||||||
Three Months Ended March 31, | |||||||
2018 | 2017 | ||||||
Net cash used in operating activities | $ | (7,413 | ) | $ | (8,086 | ) | |
Plus purchases of property and equipment | (227 | ) | (615 | ) | |||
Less proceeds from the sale of property and equipment | — | 440 | |||||
Cash burn | $ | (7,640 | ) | $ | (8,261 | ) | |
Net cash used in investing activities | $ | (227 | ) | $ | (175 | ) | |
Net cash provided by financing activities | $ | 901 | $ | 548 | |||