Invitae Reports $53.5 Million in Quarterly Revenue Driven by More Than 111,000 Samples in Quarterly Volume

SAN FRANCISCO, Aug. 6, 2019 /PRNewswire/ -- Invitae Corporation (NYSE: NVTA), a leading medical genetics company, today announced financial and operating results for the second quarter ended June 30, 2019.

"We have now delivered our 25th quarter of impressive growth in both revenue and volume, while continuing to invest in new technologies that further our position as a leader in the rapidly evolving genetics industry," said Sean George, co-founder and chief executive officer of Invitae. "We are beginning to stand out to our customers as the company that offers the most comprehensive menu of high-quality, affordable genetic testing to everyone who can benefit, enabling us to bring genetics more broadly into mainstream medicine. With the success we've had in the first half of the year, we are confident in our ability to achieve our 2019 guidance."

Second Quarter 2019 Financial Results

    --  Accessioned more than 111,000 samples in the second quarter of 2019,
        representing a 52% increase over the more than 73,000 samples in the
        second quarter of 2018. Billable volume was nearly 111,000 in the second
        quarter of 2019
    --  Generated revenue of $53.5 million in the second quarter of 2019,
        representing a 43% increase over the second quarter of 2018 revenue of
        $37.3 million
    --  Reported the average cost per sample at $252 in the second quarter of
        2019, representing a 10% reduction from a $279 average cost per sample
        in the second quarter of 2018
    --  Achieved gross profit of $25.5 million in the second quarter of 2019
        compared to $16.9 million in gross profit in the second quarter of 2018

Total operating expenses, which exclude cost of revenue, for the second quarter of 2019 were $77.4 million, which includes $25.3 million in research and development, $21.3 million in general and administrative and $30.8 million in sales and marketing expenses for the quarter. Comparatively, total operating expenses for the second quarter of 2018 was $46.9 million. Contributing to the increase in operating expense was acquisition-related costs.

For the second quarter of 2019, Invitae reported a net loss of $48.7 million, or a $0.54 loss per share, compared to a net loss of $31.7 million in the second quarter of 2018, or a $0.47 net loss per share. Excluding acquisition-related expenses and income tax benefit, our non-GAAP net loss was $46.8 million in the second quarter of 2019, or a $0.52 non-GAAP net loss per share.

As of June 30, 2019, cash, cash equivalents, restricted cash, and marketable securities totaled $254.0 million. Net decrease in cash, cash equivalents and restricted cash for the quarter was $5.1 million. Cash burn for the quarter was $33.2 million.

Invitae's Corporate and Scientific Highlights

    --  Reduced patient-pay pricing for its non-invasive prenatal screening
        (NIPS) to $99, increasing access to testing for women in early pregnancy
    --  Announced the addition of supplemental RNA testing for variants of
        uncertain significance (VUS), beginning with patients undergoing cancer
        testing, to contribute to research and further reduce the uncertainty
        inherent in genetic testing results
    --  Launched Invitae's direct channel to make it easier for customers to
        order and receive the same high-quality, medical genetic testing from
        Invitae that experts use and trust
    --  Continued progress with payers, as Invitae was named one of seven labs
        in UnitedHealthcare's (UHC) Preferred Lab Network (PLN), effective as of
        July 1, 2019j. The PLN was designed to make it easier for providers to
        choose from UHC's broader network of more than 300 labs, based on a
        rigorous quality review process. Services accessed through the PLN are
        at a lower average cost than other lab providers
    --  Presented various studies at The American College of Medical Genetics
        and Genomics (ACMG) Annual Clinical Genetics Meeting generated by
        researchers from Invitae
        --  Shared data on the limitations of a direct-to-consumer strategy
            testing that detects only three of the thousands of genetic variants
            in BRCA1 and BRCA2 associated with hereditary breast and ovarian
            cancer (HBOC) risk, showing this strategy results in a clinical
            false negative rate of approximately 90% of those at risk for HBOC
        --  Shared data from more than 113,000 patients that support broadening
            genetic testing guidelines to include patients with potentially
            actionable germline variants that are missed when clinicians adhere
            to current guidelines
    --  Presented research at the American Society of Clinical Oncology (ASCO)
        Annual Meeting demonstrating the importance of germline multigene panel
        testing in guiding therapy for expanding groups of cancer patients can
        impact patient outcomes and inform surgical strategy, treatments, and
        clinical trial eligibility
    --  Continued investment in M&A to drive technologies to scale the business
        and improve quality
        --  Acquired Singular Bio, Inc., a privately held company developing
            single molecule detection technology enabling lower costs and
            expanded use of high-quality cell-free, nucleic acid analysis,
            initially for application in NIPS
        --  Acquired Jungla Inc., a privately held company funded by Andreessen
            Horowitz (a16z) that has developed a cloud-based platform that
            further enhances Invitae's genetic variant interpretation and
            ability to deliver high-quality, more affordable genetic testing
    --  Extended Invitae's genome network with the addition of 12 new biopharma
        partnership programs in the second quarter of 2019
        --  Launched ID YOUR IRD, an initiative with Spark Therapeutics, to
            offer genetic testing at no charge to patients suspected by their
            healthcare providers of having an inherited retinal disease (IRD), a
            group of rare, progressive eye disorders that may result in vision
            loss or blindness caused by inherited genetic changes
        --  Announced the availability of its Detect programs to provide
            no-charge genetic testing to improve diagnosis and treatment in four
            conditions: muscular dystrophy, hereditary prostate cancer,
            cardiomyopathy and arrhythmia and lysosomal storage diseases
    --  Announced the appointment of Sean George as the new chairman of the
        board of directors and the retirement of executive chairman Randy Scott,
        effective September 1, 2019

"During my 35 years in the biotech industry, it has been amazing to watch the genomics field emerge from the early days of the human genome project to now affecting millions of lives around the world," said Randy Scott, executive chairman. "I couldn't be more proud to be a part of the Invitae story, and I look forward to following the progress of a great team on a great mission to make genetic information more affordable and accessible for all. I plan to continue to support the Invitae team as a private investor and look forward to the tremendous growth that lies ahead."

"Given the stage of growth we're in, we are confident in our ability to scale as we bring genetics to mainstream medicine, and Randy's leadership and vision have been central to getting us here," said Sean George. "We're deeply grateful to Randy for his passion for Invitae's success and for his role as a pioneer and innovator in the genetics industry."

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 6153749. 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 the leading advanced 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 ended June 30, 2019; estimated guidance for 2019 and future financial performance; the impact of the company's acquisitions, product offerings and distribution channels; the retirement plans of the company's executive chairman, appointment of a new chairman, and the timing thereof; 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 ended June 30, 2019 and the year ending December 31, 2019; the company's ability to continue to grow its business; 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 March 31, 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 non-GAAP research and development expense, non-GAAP general and administrative expense, non-GAAP net loss and net loss per share, and cash burn, which are non-GAAP financial measures. 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 evaluation the company's ongoing operating results and trends.

Non-GAAP research and development expense, non-GAAP general and administrative expense and non-GAAP net loss exclude acquisition-related stock-based compensation related to inducement grants, post-combination expense related to the acceleration of equity grants in connection with the company's business combinations, and 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, including proceeds from a public offering of common stock in March 2019, (3) cash received from loan proceeds, 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 in cash, cash equivalents and restricted cash in reconciliation of cash burn.

In addition, other companies, including companies in the same industry, may not use cash burn, non-GAAP research and development and general and administrative expense, or non-GAAP net loss 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 table below.


                                                        
           
              INVITAE CORPORATION




                                                      
         
              Consolidated Balance Sheets
                                                                    (in thousands)
                                                                     (unaudited)




                                                           June 30,                                December 31,

                                                               2019                                         2018

                                                                                                            ---


     
              Assets



     Current assets:


      Cash and cash equivalents                                       $
            247,000                                     $
       112,158


      Marketable securities                                     800                                                  13,727


      Accounts receivable                                    23,143                                                  26,296


      Prepaid expenses and other
       current assets                                        16,976                                                  13,258



      Total current assets                                  287,919                                                 165,439


      Property and equipment,
       net                                                   29,021                                                  27,886


      Operating lease assets                                 40,228



     Restricted cash                                         6,243                                                   6,006


      Intangible assets, net                                 57,832                                                  30,469



     Goodwill                                               76,556                                                  50,095



     Other assets                                            5,103                                                   3,064




     Total assets                                                    $
            502,902                                     $
       282,959



                 Liabilities and stockholders' equity



     Current liabilities:



     Accounts payable                                                  $
            5,255                                       $
       7,812


      Accrued liabilities                                    27,801                                                  26,563


      Operating lease
       obligations                                            5,102


      Finance lease obligations                               1,934                                                   1,937


      Total current liabilities                              40,092                                                  36,312


      Operating lease
       obligations, net of
       current portion                                       45,694


      Finance lease obligations,
       net of current portion                                   429                                                   1,375



     Debt                                                   75,184                                                  74,477


      Other long-term
       liabilities                                                -                                                  8,956




     Total liabilities                                     161,399                                                 121,120




     Stockholders' equity:



     Common stock                                                9                                                       8


      Accumulated other
       comprehensive income
       (loss)                                                     -                                                    (5)


      Additional paid-in
       capital                                              944,559                                                 678,548


      Accumulated deficit                                 (603,065)                                              (516,712)



      Total stockholders' equity                            341,503                                                 161,839



      Total liabilities and
       stockholders' equity                                           $
            502,902                                     $
       282,959


                                                                            
              
                INVITAE CORPORATION




                                                                   
              
                Consolidated Statements of Operations
                                                                               (in thousands, except per share data)
                                                                                            (unaudited)




                                                            Three Months Ended                                            Six Months Ended

                                                
          
              June 30,                            
              
                June 30,


                                            2019                                   2018                                 2019               2018




     Revenue:



     Test revenue                                  $
         52,302                                          $
              36,350                       $
         91,921       $
          63,403



     Other revenue                        1,173                                      956                                            2,107                   1,574




     Total revenue                       53,475                                   37,306                                           94,028                  64,977



     Cost of revenue                     28,006                                   20,447                                           49,260                  38,523


      Research and development            25,302                                   15,784                                           43,296                  31,150



     Selling and marketing               30,779                                   18,707                                           54,972                  37,631


      General and administrative          21,274                                   12,436                                           34,593                  24,216




     Loss from operations              (51,886)                                (30,068)                                         (88,093)               (66,543)



     Other income, net                    1,381                                      188                                            2,019                   1,835



     Interest expense                   (2,121)                                 (1,791)                                         (4,229)                (3,083)




     Net loss before taxes             (52,626)                                (31,671)                                         (90,303)               (67,791)



     Income tax benefit                 (3,950)                                                                                 (3,950)




     Net loss                                    $
         (48,676)                                       $
              (31,671)                    $
         (86,353)    $
          (67,791)



      Net loss per share, basic and
       diluted                                      $
         (0.54)                                         $
              (0.47)                      $
         (1.01)      $
          (1.12)



      Shares used in computing net loss
       per share, basic and diluted       90,863                                   67,807                                           85,148                  60,775


                                           
              
                INVITAE CORPORATION




                                  
              
                Consolidated Statements of Cash Flows
                                                          (in thousands)
                                                           (unaudited)




                                                                               Six Months Ended June 30,


                                                             2019                                         2018

                                                                                                          ---

                   Cash flows from operating activities:



     Net loss                                                      $
              (86,353)                         $
        (67,791)


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


      Depreciation and amortization                         6,725                                          6,927


      Stock-based compensation                             19,540                                         10,505


      Remeasurements of liabilities
       associated with business
       combinations                                         (286)                                           709


      Benefit from income taxes                           (3,950)



     Other                                                 1,182                                            462


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



     Accounts receivable                                   3,153                                        (4,037)


      Prepaid expenses and other
       current assets                                     (3,825)                                         (512)



     Other assets                                          2,410                                        (1,428)



     Accounts payable                                    (3,954)                                       (3,106)


      Accrued expenses and other
       liabilities                                          4,267                                          (396)



      Net cash used in operating
       activities                                        (61,091)                                      (58,667)





                   Cash flows from investing activities:


      Purchases of marketable
       securities                                        (20,781)                                         (900)


      Proceeds from sales of
       marketable securities                                    -                                        19,965


      Proceeds from maturities of
       marketable securities                               34,000                                          2,078


      Acquisition of business, net of
       cash acquired                                        3,193


      Purchases of property and
       equipment                                          (8,824)                                       (3,084)


      Net cash provided by investing
       activities                                           7,588                                         18,059





                   Cash flows from financing activities:


      Proceeds from public offerings
       of common stock, net of
       issuance costs                                     184,490                                         53,480


      Proceeds from issuance of common
       stock                                                5,123                                          4,933


      Proceeds from debt financing                              -                                        19,781


      Finance lease principal payments                    (1,031)                                       (1,170)


      Net cash provided by financing
       activities                                         188,582                                         77,024





                   Net increase in cash, cash
                    equivalents and restricted cash       135,079                                         36,416


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



                   Cash, cash equivalents and
                    restricted cash at end of
                    period                                           $
              253,243                            $
        53,875


                                                          
              
                INVITAE CORPORATION




                                         
       
                Reconciliation of GAAP to Non-GAAP Research and Development Expense
                                                                         (in thousands)
                                                                          (unaudited)




                                            Three Months Ended                                     Six Months Ended

                                 
            
         June 30,                   
              
                June 30,


                                   2019                     2018                    2019                            2018


     Research and development           $
       25,302                                       $
              15,784                  $
     43,296 $
     31,150


     Acquisition-related stock-
      based compensation        (2,586)                                                                       (2,586)



     Non-GAAP research and
      development                       $
       22,716                                       $
              15,784                  $
     40,710 $
     31,150


                                          
       
                Reconciliation of GAAP to Non-GAAP General and Administrative Expense
                                                                          (in thousands)
                                                                            (unaudited)




                                            Three Months Ended                                     Six Months Ended

                                
            
         June 30,                    
              
                June 30,


                                   2019                     2018                    2019                            2018


     General and administrative         $
       21,274                                       $
              12,436                     $
     34,593 $
     24,216


     Acquisition-related post-
      combination expense       (3,212)                                                                       (3,212)



     Non-GAAP general and
      administrative                    $
       18,062                                       $
              12,436                     $
     31,381 $
     24,216


                                                    
              
                Reconciliation of Net Loss to Non-GAAP Net Loss Per Share
                                                                          (in thousands, except per share data)
                                                                                       (unaudited)




                                                       Three Months Ended                                            Six Months Ended

                                           
          
              June 30,                            
              
                June 30,


                                        2019                                  2018                                 2019               2018




     Net loss                               $
          (48,676)                                      $
              (31,671)                    $
       (86,353)    $
       (67,791)


      Acquisition-related stock-
       based compensation              2,586                                                                                   2,586


      Acquisition-related post-
       combination expense             3,212                                                                                   3,212


      Acquisition-related income tax
       benefit                       (3,950)                                                                                (3,950)




     Non-GAAP net loss                      $
          (46,828)                                      $
              (31,671)                    $
       (84,505)    $
       (67,791)





      Non-GAAP net loss per share,
       basic and diluted                       $
          (0.52)                                        $
              (0.47)                      $
       (0.99)      $
       (1.12)



      Shares used in computing net
       loss per share, basic and
       diluted                        90,863                                  67,807                                           85,148                60,775


                                               
              
                INVITAE CORPORATION




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




                                      Three Months                                       Three Months                                       Six Months
                           Ended March                                         Ended June                                      Ended June 30,
                            31, 2019                                            30, 2019                                            2019

                                                                                                                                                   ---



      Net cash used in
       operating
       activities                         (28,366)                                                       (32,725)                                       (61,091)


      Net cash provided
       by (used in)
       investing
       activities                         (17,545)                                                         25,133                                           7,588


      Net cash provided
       by (used in)
       financing
       activities                          186,120                                                           2,462                                         188,582



      Net increase
       (decrease) in
       cash, cash
       equivalents and
       restricted cash                     140,209                                                         (5,130)                                        135,079





     Adjustments:


      Purchases of
       investments                          20,781                                                                                                         20,781


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


      Proceeds from
       public offering
       of common stock,
       net of issuance
       costs                             (184,490)                                                                                                     (184,490)


      Proceeds from
       exercises of
       warrants                               (88)                                                           (25)                                          (113)


      Cash burn                           (29,588)                                                       (33,155)                                       (62,743)

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

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