Invitae Reports $216.8 Million in Annual Revenue Driven by More Than 482,000 Samples in 2019

SAN FRANCISCO, Feb. 19, 2020 /PRNewswire/ -- Invitae Corporation (NYSE: NVTA), a leading medical genetics company, today announced financial and operating results for the fourth quarter and full year ended December 31, 2019.

"In 2019, we delivered another year of extraordinary growth, both in the U.S. and internationally. We expanded our customer base and saw strong re-order rates among new accounts. We also made it easier to access our testing, both through traditional payers and via unique partnership programs," said Sean George, co-founder and chief executive officer of Invitae. "We enter 2020 with momentum and a unique business model that we believe is well-positioned to deliver genetics-informed healthcare to patients. As we continue to scale our business, we are confident our approach and the investments we are making will further strengthen our ability to bring affordable, accessible genetic information to billions of people worldwide."

Full Year and Fourth Quarter 2019 Financial Results

    --  Increased test volume by nearly 60% year-over-year, driven by an
        expanding customer base with approximately 3,500 new accounts added to
        previous base of 4,900 and strong re-order rates of 80% across new
        accounts in 2019
        --  Accessioned more than 482,000 samples in 2019, including
            approximately 148,000 samples in the fourth quarter
        --  Reported approximately 469,000 billable reports in 2019, including
            147,000 billable reports in the fourth quarter
    --  Increased revenue by approximately 47% year-over-year
        --  Generated revenue of $216.8 million in 2019, including $66.3 million
            in the fourth quarter
    --  Decreased average cost per sample 7% year-over-year
        --  Reported average cost per sample of $245 during 2019, and $248 in
            the fourth quarter
    --  Improved gross profit by 46% year-over-year
        --  Achieved gross profit of $98.7 million in 2019, including $29.6
            million in the fourth quarter
    --  Reported 46% gross margins in 2019, including 45% gross margins in the
        fourth quarter

Total operating expense, excluding cost of revenue, for the full year 2019 was $342.8 million compared to $190.2 million in 2018. Operating expense for the fourth quarter of 2019 was $108.6 million. Non-GAAP operating expense, which excludes amortization of acquired intangible assets and acquisition-related stock-based compensation and post-combination expense, was $293.6 million for the full year 2019 compared to $185.1 million in 2018, and $89.2 million in the fourth quarter of 2019.

For the full year 2019, net loss was $242.0 million, or a $2.66 net loss per share compared to a net loss of $129.4 million, or a $1.94 net loss per share, for the full year 2018. For the fourth quarter of 2019, Invitae reported a net loss of $76.9 million, or a $0.79 net loss per share, compared to a net loss of $29.8 million in the fourth quarter of 2018, or a $0.40 net loss per share.

At December 31, 2019, cash, cash equivalents, restricted cash, and marketable securities totaled $398.0 million. Net increase in cash, cash equivalents and restricted cash was $39.4 million in 2019 and $315.6 million for the fourth quarter. Cash burn, including various financing and acquisition-related expenses, was $278.3 million in 2019, including $75.5 million in the fourth quarter. The annual cash burn was approximately $153 million when various financing and acquisition-related expenses are excluded (such as $85.6 million cash paid to settle obligations under the 2018 Note Purchase Agreement (which includes $1.3 million of accrued interest on the third quarter 2019 quarterly interest payment) and $41 million in acquisition-related payments).

Looking ahead to 2020, Invitae has guided to more than 725,000 samples accessioned generating more than $330 million in revenue, reflecting a more than 50% annual growth rate in both volume and revenue.

This press release contains non-GAAP financial measures. Investors are encouraged to review the non-GAAP reconciliations provided in the tables below.

Corporate & Scientific Highlights

Invitae's network of biopharma partnerships continued to grow throughout the year and now includes more than 80 agreements with more than 45 companies:

    --  Invitae's first sponsored testing partnership program, Behind the
        Seizure(®), expanded access to testing for pediatric epilepsy to
        children under eight who experience an unprovoked seizure. With eight
        partners now supporting the program, it has been shown that participants
        in the program were diagnosed one to two years sooner than historic
        averages.
    --  Five Invitae Detect programs were launched in 2019, creating
        multi-partner programs that increase access to genetic testing in
        therapeutic areas where it is under-utilized. The company announced
        Amicus Therapeutics, Enzyvant and Orchard have joined as partners in the
        Detect Lysosomal Disorders program in January 2020.

Invitae enhanced its technologies and services and advanced medical research to deepen understanding of the use of genetics in clinical care:

    --  Acquired three companies that are intended to further enhance Invitae's
        clinical variant interpretation capabilities, meaningfully reduce the
        cost of testing and provide superior customer workflows and patient
        support.
    --  Presented and published clinical research demonstrating the frequency of
        actionable genetic variants in large patient populations and supporting
        the expansion of guidelines for patients with ovarian, breast,
        pancreatic, prostate and colorectal cancer.
    --  Launched Invitae Discover, a clinical research platform that leverages
        biometric data available through Apple Watch to provide better
        understanding of the genetic causes of disease, with the first study in
        cardiovascular disease.

Invitae expanded access to its high-quality, in-depth medical genetic testing via insurers and health systems in the United States and internationally:

    --  Supported the finalized National Coverage Determination (NCD) issued by
        Centers for Medicare and Medicaid Services (CMS), which allows for more
        flexible Medicare coverage for Next Generation Sequencing (NGS).
    --  Partnered with the University of Vermont Health Network on a population
        health testing program to offer proactive genetic screening as part of
        routine clinical care for patients in Vermont.
    --  Announced in-network status with Cigna. Invitae is now in contract with
        all national commercial health plans and has approximately 295 million
        covered lives in network.
    --  Named one of seven labs in UnitedHealthcare's (UHC) Preferred Lab
        Network (PLN), based on a rigorous quality and affordability review out
        of a broader network of more than 300 labs.
    --  Launched Invitae's direct channel to make it easier for consumers to
        receive the same high-quality, affordable medical genetic testing from
        Invitae that experts use and trust.
    --  Established plans to increase international presence with local
        laboratory and/or fulfillment infrastructure in five countries. Invitae
        served customers in more than 95 ex-U.S. countries, accounting for more
        than 10% of 2019 volume.

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. The dial-in numbers for the conference call are (866) 393-4306 for domestic callers and (734) 385-2616 for international callers, and the reservation number for both is 2782984. Following prepared remarks, management will respond to questions from investors and analysts, subject to time limitations.

The live webcast of the call and slide deck may be accessed 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 financial results for the quarter and year ended December 31, 2019; the company's beliefs regarding estimated guidance for 2020 and future financial performance; the impact of the company's acquisitions, partnerships and product offerings; and the company's beliefs regarding the growth of its business, its position and impact on the genetic testing industry, its success in executing on its mission and achieving its goals, and the benefits of genetic testing. 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 actual results for the quarter and year ended December 31, 2019; 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; 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 September 30, 2019. 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 cost of revenue, non-GAAP operating expense, including non-GAAP research and development, non-GAAP selling and marketing and non-GAAP general and administrative, as well as non-GAAP net loss and 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 related to inducement grants, (3) post-combination expense related to the acceleration of equity grants in connection with business combinations, and (4) 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 other than investments made in privately held companies, (2) cash received from equity financings, (3) net cash received from proceeds from term debt or convertible senior notes, and (4) 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 non-GAAP cost of revenue, non-GAAP research and development, non-GAAP selling and marketing, non-GAAP general and administrative expense, non-GAAP operating expense, non-GAAP net loss and net loss per share, or cash burn 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)




                                                      
            
              December 31,


                                                     2019                                  2018



     
              Assets



     Current assets:


      Cash and cash equivalents                             $
            151,389                     $
       112,158



     Marketable securities                       240,436                                  13,727



     Accounts receivable                          32,541                                  26,296


      Prepaid expenses and other
       current assets                              18,032                                  13,258



     Total current assets                        442,398                                 165,439


      Property and equipment, net                  37,747                                  27,886



     Operating lease assets                       36,640



     Restricted cash                               6,183                                   6,006



     Intangible assets, net                      125,175                                  30,469



     Goodwill                                    126,777                                  50,095



     Other assets                                  6,681                                   3,064



     Total assets                                          $
            781,601                     $
       282,959


                 Liabilities and stockholders' equity



     Current liabilities:



     Accounts payable                                       $
            10,321                       $
       7,812



     Accrued liabilities                          64,814                                  26,563


      Operating lease obligation                    4,870


      Finance lease obligation                      1,855                                   1,937


      Total current liabilities                    81,860                                  36,312


      Operating lease obligation, net
       of current portion                          42,191


      Finance lease obligation, net
       of current portion                           1,155                                   1,375



     Debt                                              -                                 74,477


      Convertible senior notes, net               268,755


      Other long-term liabilities                   8,000                                   8,956



     Total liabilities                           401,961                                 121,120



     Stockholders' equity:



     Preferred stock                                   -



     Common stock                                     10                                       8


      Accumulated other comprehensive
       loss                                           (9)                                    (5)


      Additional paid-in capital                1,138,316                                 678,548



     Accumulated deficit                       (758,677)                              (516,712)


      Total stockholders' equity                  379,640                                 161,839


      Total liabilities and
       stockholders' equity                                 $
            781,601                     $
       282,959


                                                                        
              
                INVITAE CORPORATION




                                                               
              
                Consolidated Statements of Operations


                                                                     
              (in thousands, except per share data)


                                                                                  
              (unaudited)




                                                      Three Months Ended December 31,                                         Year Ended December 31,


                                            2019                               2018                                           2019                    2018



     Revenue:



     Test revenue                                 $
        65,050                                        $
              44,546                                      $
         212,473       $
          144,560



     Other revenue                        1,235                                  810                                            4,351                                   3,139



     Total revenue                       66,285                               45,356                                          216,824                                 147,699


      Costs and operating expenses:



     Cost of revenue                     36,723                               21,141                                          118,103                                  80,105


      Research and development            51,279                               16,570                                          141,526                                  63,496



     Selling and marketing               34,575                               19,206                                          122,237                                  74,428


      General and administrative          22,744                               14,343                                           79,070                                  52,227


      Total costs and operating
       expenses                          145,321                               71,260                                          460,936                                 270,256



     Loss from operations              (79,036)                            (25,904)                                        (244,112)                               (122,557)



     Other expense, net                   1,681                              (4,634)                                         (3,891)                                (2,568)



     Interest expense                   (5,350)                             (2,103)                                        (12,412)                                (7,030)



     Net loss before taxes             (82,705)                            (32,641)                                        (260,415)                               (132,155)



     Income tax benefit                 (5,800)                             (2,800)                                        (18,450)                                (2,800)



     Net loss                                   $
        (76,905)                                     $
              (29,841)                                   $
         (241,965)    $
          (129,355)


      Net loss per share, basic and
       diluted                                     $
        (0.79)                                       $
              (0.40)                                      $
         (2.66)       $
          (1.94)


      Shares used in computing net loss
       per share, basic and diluted       97,374                               75,092                                           90,859                                  66,747


                                                                  
              
                INVITAE CORPORATION




                                                         
              
                Consolidated Statements of Cash Flows


                                                                           
              (in thousands)


                                                                             
              (unaudited)




                                                                    
              
                Year Ended December 31,


                                                        2019                                        2018                          2017


                   Cash flows from operating activities:



     Net loss                                                 $
              (241,965)                                   $
        (129,355)              $
        (123,380)



     Adjustments to reconcile net loss to net cash used in operating activities:


      Depreciation and
       amortization                                   16,206                                        13,540                                    9,181


      Stock-based compensation                        75,948                                        20,850                                   19,221


      Amortization of debt
       discount and issuance costs                     4,416



     Impairment losses                                    -                                        2,925


      Benefit from income taxes                     (18,450)                                      (2,862)                                 (1,856)


      Debt extinguishment costs                        8,926                                         5,266



     Other                                            1,095                                         1,168                                    2,214



     Changes in operating assets and liabilities, net of businesses acquired:


      Accounts receivable                            (6,131)                                      (5,291)                                 (1,963)


      Prepaid expenses and other
       current assets                                (4,979)                                      (1,445)                                   (641)



     Other assets                                     2,026                                         (163)                                   (185)



     Accounts payable                                 1,558                                         (417)                                   (535)


      Accrued expenses and other
       liabilities                                    16,297                                         3,564                                     (37)


      Net cash used in operating
       activities                                  (145,053)                                     (92,220)                                 (97,981)


                   Cash flows from investing activities:


      Purchases of marketable
       securities                                  (260,917)                                      (9,680)                               (101,867)


      Proceeds from sales of
       marketable securities                               -                                       19,965


      Proceeds from maturities of
       marketable securities                          34,500                                        32,458                                   68,768


      Acquisition of businesses,
       net of cash acquired                         (33,846)                                                                                2,821


      Purchases of property and
       equipment                                    (20,047)                                      (5,970)                                 (6,675)



     Other                                                -                                      (1,000)


      Net cash provided by (used
       in) investing activities                    (280,310)                                       35,773                                 (36,953)


                   Cash flows from financing activities:


      Proceeds from public
       offerings of common stock,
       net of issuance costs                         204,024                                       112,441


      Proceeds from issuance of
       common stock, net                               9,470                                        17,511                                   74,619


      Proceeds from issuance of
       convertible senior notes,
       net                                           339,900


      Proceeds from issuance of
       debt, net                                           -                                       93,909                                   39,661


      Payments of debt
       extinguishment costs                         (10,638)                                      (4,609)



     Loan payments                                 (75,000)                                     (60,000)                                 (30,457)


      Finance lease principal
       payments                                      (2,075)                                      (2,100)                                 (2,952)



     Other                                            (910)


      Net cash provided by
       financing activities                          464,771                                       157,152                                   80,871


                   Net increase (decrease) in
                    cash, cash equivalents and
                    restricted cash                   39,408                                       100,705                                 (54,063)


                   Cash, cash equivalents and
                    restricted cash at
                    beginning of period              118,164                                        17,459                                   71,522


                   Cash, cash equivalents and
                    restricted cash at end of
                    period                                       $
              157,572                                      $
        118,164                $
          17,459


                                                                          
              
                INVITAE CORPORATION




                                                           
              
                Reconciliation of GAAP to Non-GAAP Cost of Revenue


                                                                                   
              (in thousands)


                                                                                     
              (unaudited)




                                                          Three Months Ended December 31,                                        Year Ended December 31,


                                            2019                                  2018                                          2019                    2018



     Cost of revenue                              $
            36,723                                       $
              21,141                                     $
          118,103        $
           80,105


      Amortization of acquired
       intangible assets                 (2,038)                                                                               (4,435)


      Non-GAAP cost of revenue                     $
            34,685                                       $
              21,141                                     $
          113,668        $
           80,105







                                                    
            
                Reconciliation of GAAP to Non-GAAP Research and Development Expense


                                                                                   
              (in thousands)


                                                                                     
              (unaudited)




                                                          Three Months Ended December 31,                                        Year Ended December 31,


                                            2019                                  2018                                          2019                    2018


      Research and development                     $
            51,279                                       $
              16,570                                     $
          141,526        $
           63,496


      Amortization of acquired
       intangible assets                   (117)                                  (609)                                          (467)                                 (2,437)


      Acquisition-related stock-based
       compensation                     (17,907)                                                                              (39,106)


      Non-GAAP research and development            $
            33,255                                       $
              15,961                                     $
          101,953        $
           61,059







                                                      
            
                Reconciliation of GAAP to Non-GAAP Selling and Marketing Expense


                                                                                   
              (in thousands)


                                                                                     
              (unaudited)




                                                          Three Months Ended December 31,                                        Year Ended December 31,


                                            2019                                  2018                                          2019                    2018



     Selling and marketing                        $
            34,575                                       $
              19,206                                     $
          122,237        $
           74,428


      Amortization of acquired
       intangible assets                   (675)                                  (619)                                        (2,699)                                 (2,496)


      Non-GAAP selling and marketing               $
            33,900                                       $
              18,587                                     $
          119,538        $
           71,932







                                                   
            
                Reconciliation of GAAP to Non-GAAP General and Administrative Expense


                                                                                   
              (in thousands)


                                                                                     
              (unaudited)




                                                          Three Months Ended December 31,                                        Year Ended December 31,


                                            2019                                  2018                                          2019                    2018


      General and administrative                   $
            22,744                                       $
              14,343                                      $
          79,070        $
           52,227


      Amortization of acquired
       intangible assets                    (29)                                   (29)                                          (114)                                   (114)


      Acquisition-related post-
       combination expense                 (640)                                                                               (6,798)


      Non-GAAP general and
       administrative                              $
            22,075                                       $
              14,314                                      $
          72,158        $
           52,113







                                                     
            
                Reconciliation of Operating Expense to Non-GAAP Operating Expense


                                                                        
              (in thousands, except per share data)


                                                                                     
              (unaudited)




                                                          Three Months Ended December 31,                                        Year Ended December 31,


                                            2019                                  2018                                          2019                    2018


      Research and development                     $
            51,279                                       $
              16,570                                     $
          141,526        $
           63,496



     Selling and marketing               34,575                                  19,206                                         122,237                                   74,428


      General and administrative          22,744                                  14,343                                          79,070                                   52,227



     Operating expense                  108,598                                  50,119                                         342,833                                  190,151


      Amortization of acquired
       intangible assets                   (821)                                (1,257)                                         (3,280)                                 (5,047)


      Acquisition-related stock-based
       compensation                     (17,907)                                                                              (39,106)


      Acquisition-related post-
       combination expense                 (640)                                                                               (6,798)


      Non-GAAP operating expense                   $
            89,230                                       $
              48,862                                     $
          293,649       $
           185,104







                                                        
             
                Reconciliation of Net Loss to Non-GAAP Net Loss Per Share


                                                                        
              (in thousands, except per share data)


                                                                                     
              (unaudited)




                                                          Three Months Ended December 31,                                        Year Ended December 31,


                                            2019                                  2018                                          2019                    2018



     Net loss                                   $
            (76,905)                                    $
              (29,841)                                  $
          (241,965)    $
           (129,355)


      Amortization of acquired
       intangible assets                   2,859                                   1,257                                           7,715                                    5,047


      Acquisition-related stock-based
       compensation                       17,907                                                                                 39,106


      Acquisition-related post-
       combination expense                   640                                                                                  6,798


      Acquisition-related income tax
       benefit                           (5,800)                                (2,800)                                        (18,450)                                  (2,800)



     Non-GAAP net loss                          $
            (61,299)                                    $
              (31,384)                                  $
          (206,796)    $
           (127,108)




      Non-GAAP net loss per share,
       basic and diluted                           $
            (0.63)                                      $
              (0.42)                                     $
          (2.28)       $
           (1.90)


      Shares used in computing net loss
       per share, basic and diluted       97,374                                  75,092                                          90,859                                   66,747


                                                                                          
              
                INVITAE CORPORATION




                                                  
              
                Reconciliation of Net Increase (Decrease) in Cash, Cash Equivalents and Restricted Cash to Cash Burn


                                                                                                   
              (in thousands)


                                                                                                     
              (unaudited)




                                       
        
          Three Months Ended                                                                                                         Year Ended


                          March 31,                                   June 30,                                        September 30,                                     December 31,                                      December 31,
                               2019                        2019                                           2019                                              2019                                      2019


      Net cash used in
       operating
       activities                   $
       (28,366)                               $
              (32,725)                                                                              $
          (36,696)                     $
       (47,266)   $
     (145,053)


      Net cash provided
       by (used in)
       investing
       activities          (17,545)                       25,133                                         (17,200)                                                                         (270,698)         (280,310)


      Net cash provided
       by financing
       activities           186,120                         2,462                                          273,848                                                                              2,341            464,771


      Net increase
       (decrease) in
       cash, cash
       equivalents and
       restricted cash      140,209                       (5,130)                                         219,952                                                                          (315,623)            39,408



     Adjustments:


      Purchases of
       investments           20,781                                                                                                                                                         240,136            260,917


      Maturities of
       investments          (6,000)                     (28,000)                                            (500)                                                                                            (34,500)


      Proceeds from
       public offering of
       common stock, net
       of issuance costs  (184,490)                                                                     (19,534)                                                                                           (204,024)


      Proceeds from
       issuance of
       convertible senior
       notes, net                 -                                                                    (339,900)                                                                                            (339,900)


      Proceeds from
       exercises of
       warrants                (88)                         (25)                                            (58)                                                                              (10)             (181)


      Cash burn                     $
       (29,588)                               $
              (33,155)                                                                             $
          (140,040)                     $
       (75,497)   $
     (278,280)



     -Cash burn for the year ended December 31, 2019 includes $85.6
      million of cash paid to settle our obligations under the 2018
      Note Purchase Agreement (which includes $1.3 million of accrued
      interest on the third quarter 2019 quarterly interest payment)
      and $41 million paid in connection with acquisitions during 2019.

Contact:
Laura D'Angelo
ir@invitae.com
(628) 213-3369

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