Invitae Reports $68.7 Million in Revenue Driven by 170,000 Samples Accessioned in the Third Quarter of 2020
SAN FRANCISCO, Nov. 5, 2020 /PRNewswire/ -- Invitae Corporation (NYSE: NVTA), a leading medical genetics company, today announced financial and operating results for the third quarter ended September 30, 2020.
"Strategic, commercial and operating results in the third quarter continued to demonstrate the value and leverage available from our global, diversified business. These strong results are a testament to our unique combination of comprehensive menu, durable customer relationships and ability to execute," said Sean George, Ph.D., co-founder and chief executive officer of Invitae. "We further advanced clinical understanding of the importance of genetic information with the publication of several studies, including a collaboration supporting universal testing for cancer patients. Looking ahead, we believe recent acquisitions and integrations, coupled with our internal development efforts, will provide access to new and developing markets and improve ease-of-use for customers, enhancing our ability to meet the needs of patients and clinicians as the use of genetics in healthcare continues to accelerate."
Third Quarter 2020 Financial Results
-- Accessioned approximately 170,000 samples in the third quarter of 2020 compared to 129,000 samples in the third quarter of 2019. Billable volume was approximately 157,000 in the third quarter of 2020 -- Generated revenue of $68.7 million in the third quarter of 2020 compared to $56.5 million in revenue in the third quarter of 2019 -- Reported average cost per sample of $274 in the third quarter of 2020 compared to $249 average cost per sample in the third quarter of 2019. Non-GAAP average cost per sample was $247 in the third quarter of 2020 -- Achieved gross profit of $22.1 million in the third quarter of 2020 compared to $24.4 million of gross profit in the third quarter of 2019. Non-GAAP gross profit was $26.8 million in the third quarter of 2020
Total operating expense, excluding cost of revenue, for the third quarter of 2020 was $102.9 million. Non-GAAP operating expense was $102.6 million in the third quarter of 2020.
Net loss for the third quarter of 2020 was $102.9 million, or $0.78 net loss per share, compared to a net loss of $78.7 million in the third quarter of 2019, or $0.82 net loss per share. Non-GAAP net loss was $81.7 million, or $0.62 non-GAAP net loss per share, in the third quarter of 2020.
At September 30, 2020, cash, cash equivalents, restricted cash and marketable securities totaled $368.0 million. Net decrease in cash, cash equivalents and restricted cash for the quarter was $61.4 million. Cash burn was $64.9 million for the quarter.
Corporate and Scientific Highlights
-- Completed the transaction to bring ArcherDX, a leading genomics analysis company, into Invitae to create a global leader in comprehensive cancer genetics and precision oncology, bringing germline and somatic testing, liquid biopsy and tissue genomic profiling onto a single platform. With both centralized and distributed capabilities, Invitae is now uniquely positioned to provide flexibility in meeting customers' needs. -- Published significant studies underscoring the use of both germline and somatic sequencing in oncology: -- A multi-year collaboration with researchers at Mayo Clinic published in JAMA Oncology evaluated universal germline genetic testing for solid tumor cancer patients. The study found one in eight patients with cancer had an inherited, cancer-related gene mutation, half of whom would not have been detected using a standard guidelines based approach and one-third of whom had their therapy changed as a result of their genetics. The data support changing the standard of care to include germline genetic testing for all solid tumor cancer patients. -- A study published in JAMA Network Open showing tumor-only genetic sequencing misses medically actionable genetic variants in cancer patients that germline genetic tests identify, suggesting the use of both tumor and germline testing to provide the most complete and actionable genetic profiling to inform cancer treatment. -- Data presented at the American Society of Human Genetics annual meeting, showed one in ten men with prostate cancer harbored genetic changes linked to hereditary cancer syndromes and three-quarters of those patients met criteria for changes in their cancer management or treatment based on their genetic findings. Study findings suggest common criteria used to restrict testing would miss clinically important changes for many patients and their families. -- Began enrollment in a nationwide study to better understand the role of current genetic testing guidelines in ensuring prostate cancer patients receive testing to identify clinically relevant genetic variants that can inform prognosis and support access to targeted therapies. -- Signed 32 biopharma partnership deals in the quarter. -- Partnered with Pfizer to offer the BRCA Care genetic testing program, which provides sponsored, no-charge germline BRCA testing for patients diagnosed with HER2-negative locally advanced or metastatic breast cancer in different countries, beginning in Hong Kong, Oman, Qatar, Saudi Arabia, Taiwan and United Arab Emirates. -- Signed two new partners to the Behind the Seizure program, bringing the total number of biopharma partners in this program to 10. -- Added two additional partners to Invitae's Detect programs providing no-charge genetic testing for conditions in which testing is underutilized and can improve diagnosis and treatment. -- Announced the appointment of tech entrepreneur Kimber Lockhart to the company's Board of Directors, noting her expertise and leadership in scaling engineering and digital tools.
Webcast and Conference Call Details
Management will host a conference call and webcast today at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss financial results and recent developments. To register for the conference call and webcast, please use one of the methods below. Upon registering, each participant will be provided with call details and a registrant ID.
Online registration: http://www.directeventreg.com/registration/event/7916067
Phone registration: (888) 869-1189 or (706) 643-5902
The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company's website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company's website.
About Invitae
Invitae Corporation (NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company's website at invitae.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's belief regarding the value and leverage of its global, diversified business; the company's belief regarding the impact of its unique combination of comprehensive menu, durable customer relationships and ability to execute; the importance of the company's recent studies and collaborations; the company's belief regarding the momentum of its business and ability to continue to deliver on its mission to bring genetic information into mainstream medicine; the impact of the company's acquisitions, including its completed merger with ArcherDX, as well as its internal development efforts, partnerships and product offerings; and the company's beliefs regarding its ability to access new and developing markets, improve ease-of-use for customers, and meet the needs of patients and clinicians. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the impact of COVID-19 on the company, and the effectiveness of the efforts it has taken or may take in the future in response thereto; the company's ability to continue to grow its business, including internationally; the company's history of losses; the company's ability to compete; the company's failure to manage growth effectively; the company's need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; the company's failure to successfully integrate or fully realize the anticipated benefits of acquired businesses; risks associated with litigation; the company's ability to use rapidly changing genetic data to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to the company's business; and the other risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.
Non-GAAP Financial Measures
To supplement Invitae's consolidated financial statements prepared in accordance with generally accepted accounting principles in the United States (GAAP), the company is providing several non-GAAP measures, including non-GAAP gross profit, non-GAAP cost of revenue, non-GAAP operating expense, including non-GAAP research and development, non-GAAP selling and marketing, non-GAAP general and administrative and non-GAAP other income (expense), net, as well as non-GAAP net loss and non-GAAP net loss per share and non-GAAP cash burn. These non-GAAP financial measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similarly-titled measures presented by other companies. Management believes these non-GAAP financial measures are useful to investors in evaluating the company's ongoing operating results and trends.
Management is excluding from some or all of its non-GAAP operating results (1) amortization of acquired intangible assets, (2) acquisition-related stock-based compensation, (3) post-combination expense related to the acceleration of equity grants or bonus payments in connection with the company's business combinations, (4) adjustments to the fair value of acquisition-related liabilities and (5) acquisition-related income tax benefits. These non-GAAP financial measures are limited in value because they exclude certain items that may have a material impact on the reported financial results. Management accounts for this limitation by analyzing results on a GAAP basis as well as a non-GAAP basis and also by providing GAAP measures in the company's public disclosures.
Cash burn excludes (1) changes in marketable securities, (2) cash received from equity financings and (3) cash received from exercises of warrants. Management believes cash burn is a liquidity measure that provides useful information to management and investors about the amount of cash consumed by the operations of the business. A limitation of using this non-GAAP measure is that cash burn does not represent the total change in cash, cash equivalents, and restricted cash for the period because it excludes cash provided by or used for other operating, investing or financing activities. Management accounts for this limitation by providing information about the company's operating, investing and financing activities in the statements of cash flows in the consolidated financial statements in the company's most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and by presenting net cash provided by (used in) operating, investing and financing activities as well as the net increase or decrease in cash, cash equivalents and restricted cash in its reconciliation of cash burn.
In addition, other companies, including companies in the same industry, may not use the same non-GAAP measures or may calculate these metrics in a different manner than management or may use other financial measures to evaluate their performance, all of which could reduce the usefulness of these non-GAAP measures as comparative measures. Because of these limitations, the company's non-GAAP financial measures 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 non-GAAP reconciliations provided in the tables below.
INVITAE CORPORATION Consolidated Balance Sheets (in thousands) (unaudited) September 30, December 31, 2020 2019 --- Assets Current assets: Cash and cash equivalents $ 106,436 $ 151,389 Marketable securities 254,848 240,436 Accounts receivable 27,328 32,541 Prepaid expenses and other current assets 26,492 18,032 Total current assets 415,104 442,398 Property and equipment, net 46,130 37,747 Operating lease assets 39,007 36,640 Restricted cash 6,685 6,183 Intangible assets, net 187,060 125,175 Goodwill 211,225 126,777 Other assets 7,961 6,681 Total assets $ 913,172 $ 781,601 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 15,589 $ 10,321 Accrued liabilities 77,986 64,814 Operating lease obligations 6,628 4,870 Finance lease obligations 1,237 1,855 Total current liabilities 101,440 81,860 Operating lease obligations, net of current portion 42,363 42,191 Finance lease obligations, net of current portion 1,834 1,155 Convertible senior notes, net 279,870 268,755 Deferred tax liability 10,250 Other long-term liabilities 60,864 8,000 Total liabilities 496,621 401,961 Stockholders' equity: Common stock 13 10 Accumulated other comprehensive income (loss) 199 (9) Additional paid-in capital 1,542,848 1,138,316 Accumulated deficit (1,126,509) (758,677) Total stockholders' equity 416,551 379,640 Total liabilities and stockholders' equity $ 913,172 $ 781,601
INVITAE CORPORATION Consolidated Statements of Operations (in thousands, except per share data) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Revenue: Test revenue $ 67,326 $ 55,502 $ 175,503 $ 147,423 Other revenue 1,402 1,009 3,664 3,116 Total revenue 68,728 56,511 179,167 150,539 Cost of revenue 46,643 32,120 130,017 81,380 Research and development 37,802 46,951 168,433 90,247 Selling and marketing 37,800 32,690 119,440 87,662 General and administrative 27,306 21,733 81,966 56,326 Loss from operations (80,823) (76,983) (320,689) (165,076) Other expense, net (15,771) (7,591) (32,499) (5,572) Interest expense (6,308) (2,833) (17,244) (7,062) Net loss before taxes (102,902) (87,407) (370,432) (177,710) Income tax benefit (8,700) (2,600) (12,650) Net loss $ (102,902) $ (78,707) $ (367,832) $ (165,060) Net loss per share, basic and diluted $ (0.78) $ (0.82) $ (3.08) $ (1.86) Shares used in computing net loss per share, basic and diluted 132,484 95,577 119,386 88,663
INVITAE CORPORATION Consolidated Statements of Cash Flows (in thousands) (unaudited) Nine Months Ended September 30, 2020 2019 --- Cash flows from operating activities: Net loss $ (367,832) $ (165,060) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 22,964 11,135 Stock-based compensation 102,329 47,826 Amortization of debt discount and issuance costs 11,115 855 Remeasurements of liabilities associated with business combinations 42,448 Benefit from income taxes (2,600) (12,650) Debt extinguishment costs - 8,926 Other (570) 901 Changes in operating assets and liabilities, net of businesses acquired: Accounts receivable 5,516 (444) Prepaid expenses and other current assets (8,460) (1,424) Other assets 1,387 2,369 Accounts payable 3,118 87 Accrued expenses and other liabilities 5,665 9,692 Net cash used in operating activities (184,920) (97,787) Cash flows from investing activities: Purchases of marketable securities (180,021) (20,781) Proceeds from sales of marketable securities 12,832 Proceeds from maturities of marketable securities 152,465 34,500 Acquisition of businesses, net of cash acquired (57,576) (9,801) Purchases of property and equipment (13,991) (13,530) Other (2,000) Net cash provided by (used in) investing activities (88,291) (9,612) Cash flows from financing activities: Proceeds from public offerings of common stock, net 217,489 204,024 Proceeds from issuance of common stock, net 9,076 5,734 Proceeds from issuance of convertible senior notes, net - 339,900 Payments of debt extinguishment costs - (10,638) Loan payments - (75,000) Finance lease principal payments (1,543) (1,590) Other 3,738 Net cash provided by financing activities 228,760 462,430 Net increase in cash, cash equivalents and restricted cash (44,451) 355,031 Cash, cash equivalents and restricted cash at beginning of period 157,572 118,164 Cash, cash equivalents and restricted cash at end of period $ 113,121 $ 473,195
INVITAE CORPORATION Reconciliation of GAAP to Non-GAAP Cost of Revenue (in thousands) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Cost of revenue $ 46,643 $ 32,120 $ 130,017 $ 81,380 Amortization of acquired intangible assets (4,708) (1,412) (12,138) (2,397) Non-GAAP cost of revenue $ 41,935 $ 30,708 $ 117,879 $ 78,983
Reconciliation of GAAP to Non-GAAP Gross Profit (in thousands) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Revenue $ 68,728 $ 56,511 $ 179,167 $ 150,539 Cost of revenue 46,643 32,120 130,017 81,380 Gross profit 22,085 24,391 49,150 69,159 Amortization of acquired intangible assets -cost of revenue 4,708 1,412 12,138 2,397 Non-GAAP gross profit $ 26,793 $ 25,803 $ 61,288 $ 71,556
Reconciliation of GAAP to Non-GAAP Research and Development Expense (in thousands) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Research and development $ 37,802 $ 46,951 $ 168,433 $ 90,247 Amortization of acquired intangible assets (117) (117) (350) (350) Acquisition-related stock-based compensation 171 (18,613) (52,011) (21,199) Acquisition-related post- combination expense (60) (60) Non-GAAP research and development $ 37,796 $ 28,221 $ 116,012 $ 68,698
Reconciliation of GAAP to Non-GAAP Selling and Marketing Expense (in thousands) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Selling and marketing $ 37,800 $ 32,690 $ 119,440 $ 87,662 Amortization of acquired intangible assets (760) (675) (2,331) (2,024) Acquisition-related post- combination expense (40) (40) Non-GAAP selling and marketing $ 37,000 $ 32,015 $ 117,069 $ 85,638
INVITAE CORPORATION Reconciliation of GAAP to Non-GAAP General and Administrative Expense (in thousands) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 General and administrative $ 27,306 $ 21,733 $ 81,966 $ 56,326 Amortization of acquired intangible assets (29) (10) (86) Acquisition-related post- combination expense (2,946) (500) (6,158) Fair value adjustments to acquisition-related liabilities 504 (4,328) Non-GAAP general and administrative $ 27,810 $ 18,758 $ 77,128 $ 50,082
Reconciliation of Operating Expense to Non-GAAP Operating Expense (in thousands, except per share data) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Research and development $ 37,802 $ 46,951 $ 168,433 $ 90,247 Selling and marketing 37,800 32,690 119,440 87,662 General and administrative 27,306 21,733 81,966 56,326 Operating expense 102,908 101,374 369,839 234,235 Amortization of acquired intangible assets (877) (821) (2,691) (2,460) Acquisition-related stock-based compensation 171 (18,613) (52,011) (21,199) Acquisition-related post- combination expense (100) (2,946) (600) (6,158) Fair value adjustments to acquisition-related liabilities 504 (4,328) Non-GAAP operating expense $ 102,606 $ 78,994 $ 310,209 $ 204,418
Reconciliation of Other Income (Expense), Net to Non-GAAP Other Income (Expense), Net (in thousands, except per share data) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Other expense, net $ (15,771) $ (7,591) $ (32,499) $ (5,572) Fair value adjustments to acquisition-related liabilities 16,208 37,937 Non-GAAP other income (expense), net $ 437 $ (7,591) $ 5,438 $ (5,572)
INVITAE CORPORATION Reconciliation of Net Loss to Non-GAAP Net Loss Per Share (in thousands, except per share data) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Net loss $ (102,902) $ (78,707) $ (367,832) $ (165,060) Amortization of acquired intangible assets 5,585 2,233 14,829 4,857 Acquisition-related stock-based compensation (171) 18,613 52,011 21,199 Acquisition-related post- combination expense 100 2,946 600 6,158 Fair value adjustments to acquisition-related liabilities 15,704 42,265 Acquisition-related income tax benefit (8,700) (2,600) (12,650) Non-GAAP net loss $ (81,684) $ (63,615) $ (260,727) $ (145,496) Non-GAAP net loss per share, basic and diluted $ (0.62) $ (0.67) $ (2.18) $ (1.64) Shares used in computing net loss per share, basic and diluted 132,484 95,577 119,386 88,663
Reconciliation of Net Increase (Decrease) in Cash, Cash Equivalents and Restricted Cash to Cash Burn (in thousands) (unaudited) Three Months Three Months Three Months Nine Months Ended Ended March 31, Ended June 30, Ended September September 30, 2020 2020 30, 2020 2020 Net cash used in operating activities $ (62,361) $ (60,393) (62,166) (184,920) Net cash provided by (used in) investing activities 801 (83,418) (5,674) (88,291) Net cash provided by financing activities 551 221,794 6,415 228,760 Net increase (decrease) in cash, cash equivalents and restricted cash (61,009) 77,983 (61,425) (44,451) Adjustments: Purchases of investments - 115,350 64,671 180,021 Sales of investments (12,532) (300) (12,832) Maturities of investments (24,965) (65,000) (62,500) (152,465) Proceeds from public offering of common stock, net of issuance costs - (217,489) (217,489) Prepayment for private placement - (5,000) (5,000) Proceeds from exercises of warrants (27) (35) (324) (386) Cash burn $ (98,533) $ (89,191) $ (64,878) (252,602) -- Cash burn for the three months ended March 31, 2020 includes $32.3 million of cash paid in connection with the acquisition of Diploid and cash burn for the three months ended June 30, 2020 includes $25.4 million of cash paid in connection with the acquisitions of Genelex and YouScript.
Contact:
Laura D'Angelo
ir@invitae.com
(628) 213-3369
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