UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K/A
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities and Exchange Act of 1934
Date of Report: November 6, 2017 (November 7, 2017)
(Date of earliest event reported)
Invitae Corporation
(Exact name of registrant as specified in its charter)
Delaware | 001-36847 | 27-1701898 | ||
(State or other jurisdiction of | (Commission File Number) | (I.R.S. employer | ||
incorporation or organization) | identification number) |
1400 16th Street, San Francisco, California 94103
(Address of principal executive offices, including zip code)
(415) 374-7782 (Registrants telephone number, including area code)
N/A (Former Name or Former Address, if Changed Since Last Report) |
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 (see General Instruction A.2. below):
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
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 ☒
Item 2.02 | Results of Operations and Financial Condition. |
Explanatory Note: This amended Current Report on Form 8-K/A is being filed to replace Exhibit 99.1 furnished with the original Current Report on Form 8-K filed with the Securities and Exchange Commission on November 6, 2017, which exhibit inadvertently omitted two graphics. Other than the graphics, there are no changes to Exhibit 99.1.
On November 6, 2017, Invitae Corporation (the Company) issued a press release announcing financial results for its fiscal quarter ended September 30, 2017. The full text of the press release is furnished as Exhibit 99.1 to this report.
The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the Exchange Act), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit No. |
Description | |
99.1 | Press release issued by Invitae Corporation dated November 6, 2017. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: November 7, 2017
INVITAE CORPORATION | ||
By: | /s/ SHELLY D. GUYER | |
Name: | Shelly D. Guyer | |
Title: | Chief Financial Officer |
Exhibit 99.1
Invitae Reports Double-Digit Sequential Volume and Revenue Growth
in Third Quarter 2017
-- Momentum in base business complemented by strategic expansion
into family health genetics
-- Hosting conference call today at 4:30 pm ET / 1:30 pm PT
SAN FRANCISCO, November 6, 2017 Invitae Corporation (NYSE: NVTA), one of the fastest growing genetic information companies, today announced financial and operating results for the quarter ended September 30, 2017, including continued business momentum, double-digit sequential volume and revenue growth, and a strengthened financial position.
Third Quarter 2017 Operational Highlights
| Strategic expansion into reproductive health creates comprehensive platform offering genetic information through every stage of life: |
| Significantly strengthened balance sheet to support strategic growth opportunities, accelerate integration and fund company to anticipated breakeven by year-end 2018: |
| Raised $73.5 million in gross proceeds from a private placement. |
| Led by existing investors with significant participation from multiple new investors. |
Our results this quarter demonstrate strong growth in our base business in the increasingly competitive field of adult inherited genetics, even as we undertook two significant acquisitions to propel us into family health genetics. We believe we are on track to deliver our annual volume and revenue guidance, which is expected to be double our volume from the prior year, said Sean George, chief executive officer of Invitae. As we work to better serve the needs of clinicians and their patients with high-quality, affordable testing through all stages of life, we are well positioned to successfully launch a fully integrated platform in 2018 that leverages the reproductive health portfolio from Good Start Genetics, as well as the anticipated addition of products from CombiMatrix. Our comprehensive platform will help us drive genetic information ever-further into mainstream medical practice.
Third Quarter 2017 Financial Results
| Accessioned more than 40,000 samples on a consolidated basis. |
| Base Invitae business accessioned more than 34,400 samples in the third quarter of 2017, representing a 13% increase over the second quarter of 2017 and a 122% increase over the third quarter of 2016. |
| Achieved positive gross profit of nearly $5.0 million total on a consolidated basis. |
| Base Invitae business achieved positive gross profit of nearly $4.7 million in the third quarter of 2017 compared to a negative gross profit of $1.0 million in the comparable period in 2016. |
| Reduced cost of goods sold (COGS) per sample accessioned from approximately $450 in the third quarter of 2016 to approximately $330 in the third quarter of 2017. |
| Base Invitae business also achieved COGS per sample accessioned of approximately $330. |
Total operating expenses for the third quarter of 2017, excluding cost of goods sold, were $35.9 million compared to $23.9 million in the third quarter of 2016. For the third quarter of 2017, Invitae reported a net loss of $27.4 million, or a $0.57 loss per share, compared to a net loss of $25.0 million in the third quarter of 2016, or a $0.77 loss per share.
Cash used in operating activities in the nine months ended September 30, 2017 was $66.7 million, compared to $59.3 million in the same period in 2016. At September 30, 2017, cash, cash equivalents, restricted cash and marketable securities totaled $106.5 million.
Strategic Advancements
| Made significant progress integrating newly acquired Good Start Genetics, combining day-to-day operations, systems and policies. |
| Integration of operations proceeding on schedule with full-integration of personnel completed within 10 weeks of acquisition. |
| Former Good Start Genetics sales reps who call on fertility clinics are able to cross sell select CombiMatrix testing services as of September 27, 2017. |
| Transfer of lab operations to our San Francisco headquarters anticipated by mid-2018. |
| Completed integration of CancerGene Connect technology into Invitae platform making one of the most efficient, end-to-end platforms available for collecting and managing genetic family histories more broadly available to clinicians. |
Scientific Presence
| Published a detailed and transparent approach for classifying variants at scale in Genetics in Medicine. Sherloc, a comprehensive analytic framework, refines existing genetic variant classification guidelines, resulting in more than 100 refinements to the 2015 American College of Medical Genetics (ACMG)-Association of Molecular Pathologists (AMP) guidelines to ensure confident and consistent variant classifications with the goal of increasing consistency in classification industry-wide. |
| Presented over 36 posters and 10 platform presentations at a variety of scientific conferences, including at the Southeastern Regional Genetics Group (SERGG) Annual Meeting, at the National Society of Genetic Counselors (NSGC) 36th Annual Conference, at the 2017 Child Neurology Society (CNS) Annual Meeting, at the American Society of Human Genetics (ASHG) Annual Meeting, at the 2017 Collaborative Group of the Americas on Inherited Colorectal Cancer (CGA) Annual Meeting, and at the American Society for Reproductive Medicine (ASRM) 2017 Scientific Congress and Expo. Data highlighted include: |
| Utility of proactive genetic testing: Retrospective analysis of 120 patients tested with a genetic screening panel for healthy adults found pathogenic or likely pathogenic results in 18 percent of patients, predominantly in genes associated with an elevated risk for cancer or cardiovascular disease, underscoring utility of proactive genetic screening in healthy adults. |
| Unique sequencing plus copy number variant (CNV) approach increases neurology diagnosis rates: Studies in both neuromuscular disorders and childhood epilepsy each demonstrated Invitaes unique approach to genetic sequencing plus CNV detection performed together using expert-curated panels offers better diagnosis rates over sequencing alone. |
| Improving preimplantation screening through next generation sequencing: Validation of Good Start Genetics novel NGS-based preimplantation genetic screening technology to comprehensively identify the most frequent chromosomal causes of miscarriage, which are missed by most other PGS tests. |
| New technique to increase embryos available for transfer: Analysis demonstrating that 97% of repeat PGS embryo biopsies yield actionable results and can dramatically increase the number of embryos identified as suitable for transfer. |
Webinar and Conference Call Details
Management will host a webinar and conference call today at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss financial results and recent developments. The dial-in numbers for the conference call are (844) 579-6824 for domestic callers and (763) 488-9145 for international callers, and the reservation number for both is 99386744.
The live webinar and conference call may be accessed by visiting the investors section of the companys website at ir.invitae.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the companys website.
About Invitae
Invitae Corporation (NYSE: NVTA) is one of the fastest growing genetic information companies in the United States. Invitae Corporations mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. Invitaes goal is to aggregate the worlds genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit our website at invitae.com.
Safe Harbor Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the companys increasing momentum in its base business; the timing and/or completion of the proposed acquisition of CombiMatrix; that the companys strengthened balance sheet will support strategic growth opportunities, accelerate integration and fund the company to anticipated breakeven by year-end 2018; the companys expectations that it will meet annual test volume and revenue guidance, and that annual volume will be double from the prior year; the expected benefits of the companys products and services; the expected benefits of the companys comprehensive platform, including that it will deliver better services and pricing and that it will help drive genetic information into mainstream medical practice; the expected benefits of completed and proposed acquisitions; and that the company is well positioned to launch a fully integrated platform in 2018. 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 companys history of losses; the ability to consummate the proposed CombiMatrix acquisition and unanticipated difficulties or expenditures relating thereto; risks associated with the companys limited experience with respect to acquisitions; the companys ability to compete; the companys failure to manage growth effectively; the companys need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the companys ability to develop and commercialize new tests and expand into new markets; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; the companys inability to raise additional capital on acceptable terms; risks associated with the companys ability to use rapidly changing genetic data to interpret test results accurately, consistently, and quickly; security breaches, loss of data and other disruptions; laws and regulations applicable to the companys business; and the other risks set forth in the companys filings with the Securities and Exchange Commission, including the risks set forth in the companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2017. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.
INVITAE CORPORATION
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Revenue: |
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Test revenue |
$ | 17,310 | $ | 6,259 | $ | 40,597 | $ | 15,747 | ||||||||
Other revenue |
838 | 17 | 2,225 | 65 | ||||||||||||
Total revenue |
18,148 | 6,276 | 42,822 | 15,812 | ||||||||||||
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Costs and operating expenses: |
||||||||||||||||
Cost of test revenue |
13,274 | 7,242 | 33,093 | 19,705 | ||||||||||||
Research and development |
11,502 | 11,482 | 32,864 | 32,855 | ||||||||||||
Selling and marketing |
13,246 | 6,803 | 37,338 | 20,689 | ||||||||||||
General and administrative |
11,102 | 5,655 | 25,915 | 17,794 | ||||||||||||
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Total costs and operating expenses |
49,124 | 31,182 | 129,210 | 91,043 | ||||||||||||
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Loss from operations |
(30,976 | ) | (24,906 | ) | (86,388 | ) | (75,231 | ) | ||||||||
Interest and other income (expense), net |
(56 | ) | 50 | (596 | ) | 122 | ||||||||||
Interest expense |
(1,128 | ) | (115 | ) | (2,517 | ) | (299 | ) | ||||||||
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Net loss before taxes |
(32,160 | ) | (24,971 | ) | (89,501 | ) | (75,408 | ) | ||||||||
Income tax benefit |
(4,758 | ) | | (6,614 | ) | | ||||||||||
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Net loss |
$ | (27,402 | ) | $ | (24,971 | ) | $ | (82,887 | ) | $ | (75,408 | ) | ||||
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Net loss per share, basic and diluted |
$ | (0.57 | ) | $ | (0.77 | ) | $ | (1.86 | ) | $ | (2.35 | ) | ||||
Shares used in computing net loss per share, basic and diluted |
48,221,896 | 32,315,038 | 44,639,416 | 32,145,806 |
INVITAE CORPORATION
Condensed Consolidated Balance Sheets
(In thousands)
September 30, | December 31, | |||||||
2017 | 2016 | |||||||
(Unaudited) | ||||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 33,858 | $ | 66,825 | ||||
Marketable securities |
43,049 | 25,798 | ||||||
Accounts receivable |
6,142 | 1,153 | ||||||
Prepaid expenses and other current assets |
7,898 | 8,024 | ||||||
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Total current assets |
90,947 | 101,800 | ||||||
Property and equipment, net |
29,308 | 23,793 | ||||||
Restricted cash |
5,405 | 4,697 | ||||||
Marketable securities, non-current |
24,229 | | ||||||
Intangible assets, net |
20,100 | | ||||||
Goodwill |
42,843 | | ||||||
Other assets |
406 | 361 | ||||||
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Total assets |
$ | 213,238 | $ | 130,651 | ||||
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Liabilities and stockholders equity |
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Current liabilities: |
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Accounts payable |
$ | 10,683 | $ | 3,352 | ||||
Accrued liabilities |
22,267 | 6,711 | ||||||
Capital lease obligation, current portion |
1,851 | 1,309 | ||||||
Debt, current portion |
| 3,381 | ||||||
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Total current liabilities |
34,801 | 14,753 | ||||||
Capital lease obligation, net of current portion |
2,420 | 266 | ||||||
Debt, net of current portion |
39,030 | 8,721 | ||||||
Other long-term liabilities |
11,593 | 7,837 | ||||||
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Total liabilities |
87,844 | 31,577 | ||||||
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Stockholders equity: |
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Common stock |
5 | 4 | ||||||
Accumulated other comprehensive loss |
(57 | ) | | |||||
Additional paid-in capital |
483,551 | 374,288 | ||||||
Accumulated deficit |
(358,105 | ) | (275,218 | ) | ||||
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Total stockholders equity |
125,394 | 99,074 | ||||||
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Total liabilities and stockholders equity |
$ | 213,238 | $ | 130,651 | ||||
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The condensed, consolidated balance sheet at December 31, 2016 has been derived from the audited consolidated financial statements at that date included in the companys annual report on Form 10-K for the year ended December 31, 2016.
Source: Invitae Corporation
Contact:
Kate McNeil
ir@invitae.com
347-204-4226
###
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