Invitae Reports 47% Growth in Quarterly Revenue and Volume Year-Over-Year

SAN FRANCISCO, May 7, 2019 /PRNewswire/ -- Invitae Corporation (NYSE: NVTA), the leader in advanced medical genetics, today announced financial and operating results for the first quarter ended March 31, 2019.

"We've seen another first quarter of foundational growth across all of our customer segments, with strong momentum putting us well on our way to exceed our 2019 guidance and in 2020 to serve more than one million patients with more than $500 million in revenue," said Sean George, co-founder and chief executive officer of Invitae. "Invitae is rapidly becoming the preferred provider of genetic information for clinicians and biopharma partners and increasingly the partner of choice for third party commercial payers seeking to improve patient outcomes and lower healthcare costs. We intend to continue driving the transformation of the genetics industry as we further extend our leadership position in bringing genetics into mainstream medicine, improving patient outcomes and lowering costs for everyone."

First Quarter 2019 Financial Results

    --  Accessioned more than 94,000 samples in the first quarter of 2019,
        representing a 47% increase over the more than 64,000 samples in the
        first quarter of 2018. Billable volume was approximately 87,000 in the
        first quarter of 2019
    --  Generated revenue of $40.6 million in the first quarter of 2019,
        representing a 47% increase over the first quarter of 2018 revenue of
        $27.7 million
    --  Reduced the average cost per sample to $226 in the first quarter of
        2019, representing a 19% reduction from a $279 average cost per sample
        in the first quarter of 2018
    --  Achieved gross profit of $19.3 million in the first quarter of 2019
        which is double the $9.6 million gross profit in the first quarter of
        2018

Total operating expenses, which exclude cost of revenue, for the first quarter of 2019 were $55.5 million compared to $46.1 million in the first quarter of 2018. For the first quarter of 2019, Invitae reported a net loss of $37.7 million, or a $0.47 loss per share, compared to a net loss of $36.1 million in the first quarter of 2018, or a $0.66 net loss per share.

In the first quarter of 2019, Invitae completed a public offering of common stock, resulting in gross proceeds of $196.7 million and net proceeds of $184.5 million.

As of March 31, 2019, cash, cash equivalents, restricted cash, and marketable securities totaled $287.1 million. Net increase in cash, cash equivalents and restricted cash for the quarter was $140.2 million, with cash burn for the quarter at $29.6 million.

"We are committed to making the investments necessary to meet our 2020 goals," said Shelly Guyer, chief financial officer of Invitae. "To that end, we have capital totaling nearly $300 million, which we will invest in advancing the development of our total cancer care offering, accelerating the development and commercialization of our new direct channel for patients, and continuing to invest in further engineering capabilities to reduce costs, add content and enhance the quality of our offering overall."

Invitae's Corporate and Scientific Highlights

    --  Announced the availability of non-invasive prenatal screening (NIPS)
        using maternal cell-free DNA, rounding out Invitae's comprehensive
        women's health genetic testing services
    --  Named as one of seven labs in UnitedHealthcare's (UHC) Preferred Lab
        Network 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
    --  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
    --  Published data in the Journal of Clinical Oncology by Invitae scientists
        in collaboration with researchers from the TME Breast Care Network
        showing that current guidelines for genetic testing of breast cancer
        patients miss as many patients with pathogenic variants as they find.
        The American Society of Breast Surgeons (ASBS) revised its genetic
        testing guidelines for hereditary breast cancer to include all patients
        with a personal history of breast cancer
    --  Collaborated with investigators at Tulane Cancer Center on the largest
        study to date on the genetics of prostate cancer. The study, published
        in JAMA Oncology, found that guidelines for genetic testing of prostate
        cancer patients excluded a substantial number of patients with disease
        causing genetic variants from having genetic testing done and concluded
        that broader genetic testing of patients with prostate cancer is
        warranted
    --  Extended Invitae's genome network by signing eight new biopharma
        partnership contracts since the beginning of the year
        --  Expanded its Behind the Seizure program with BioMarin to include two
            additional partners, Stoke Therapeutics and Xenon Pharmaceuticals,
            to help speed the diagnosis of genetic epilepsy in children
            experiencing unprovoked seizures from birth up to age five
        --  Partnered with Ultragenyx Pharmaceutical on a new testing program to
            offer sponsored genetic testing to accurately diagnose more patients
            suspected of having a genetic hypophosphatemia disorder, or provide
            confirmatory testing for those who have been clinically diagnosed
            with X-linked hypophosphatemia (XLH)

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 3435689. Following prepared remarks, management will respond to questions from investors and analysts, subject to time limitations.

The live webcast of the call may be accessed by visiting the investors section of the company's website at ir.invitae.com. A replay of the webcast 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 March 31, 2019; estimated guidance for 2019 and future financial performance; the timing and impact of the company's partnerships, product offerings and distribution channels; investment plans; 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 March 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 Annual Report on Form 10-K for the year ended December 31, 2018. 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 monitors and considers cash burn, which is a non-GAAP financial measure. This non-GAAP financial measure is not based on any standardized methodology prescribed by GAAP and is not necessarily comparable to similarly-titled measures presented by other companies. 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 its operating, investing and financing activities in the statements of cash flows in its consolidated financial statements in its 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 its reconciliation of cash burn. In addition, other companies, including companies in the same industry, may not use cash burn, may calculate cash burn in a different manner than management or may use other financial measures to evaluate their performance, all of which could reduce the usefulness of cash burn as a comparative measure.

Because of these limitations, cash burn 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 reconciliation of net increase in cash, cash equivalents and restricted cash to cash burn provided in the table below.


                                                            
        
          INVITAE CORPORATION




                                                          
       
         Consolidated Balance Sheets


                                                                
        (in thousands)


                                                                  
        (unaudited)




                                                                                         March 31,              December 31,
                                                                                              2019                       2018

                                                                                                                         ---


     
              Assets



     Current assets:



     Cash and cash equivalents                                                                    $
       252,502                          $
       112,158



     Marketable securities                                                                 28,714                                13,727



     Accounts receivable                                                                   23,700                                26,296



     Prepaid expenses and other current assets                                             16,569                                13,258




     Total current assets                                                                 321,485                               165,439



     Property and equipment, net                                                           25,757                                27,886



     Operating lease assets                                                                37,290



     Restricted cash                                                                        5,871                                 6,006



     Intangible assets, net                                                                29,156                                30,469



     Goodwill                                                                              50,095                                50,095



     Other assets                                                                           6,845                                 3,064




     Total assets                                                                                 $
       476,499                          $
       282,959




     
              Liabilities and stockholders' equity



     Current liabilities:



     Accounts payable                                                                               $
       9,867                            $
       7,812



     Accrued liabilities                                                                   25,354                                26,563



     Operating lease obligations                                                            4,419



     Finance lease obligations                                                              1,960                                 1,937



     Total current liabilities                                                             41,600                                36,312



     Operating lease obligations, net of current portion                                   42,634



     Finance lease obligations, net of current portion                                        875                                 1,375



     Debt                                                                                  74,828                                74,477



     Other long-term liabilities                                                              150                                 8,956




     Total liabilities                                                                    160,087                               121,120



     Stockholders' equity:



     Common stock                                                                               9                                     8



     Accumulated other comprehensive income (loss)                                              8                                   (5)



     Additional paid-in capital                                                           870,784                               678,548



     Accumulated deficit                                                                (554,389)                            (516,712)




     Total stockholders' equity                                                           316,412                               161,839




     Total liabilities and stockholders' equity                                                   $
       476,499                          $
       282,959


                                                                         
          
                INVITAE CORPORATION




                                                                     
         
            Consolidated Statements of Operations


                                                                       
         (in thousands, except per share data)


                                                                               
              (unaudited)




                                                                                                                                           Three Months Ended
                                                                                                                                     
         March 31,


                                                                                                                              2019                               2018




     Revenue:



     Test revenue                                                                                                                   $
       39,619                           $
        27,053



     Other revenue                                                                                                            934                                  618




     Total revenue                                                                                                         40,553                               27,671



     Cost of revenue                                                                                                       21,254                               18,076



     Research and development                                                                                              17,994                               15,366



     Selling and marketing                                                                                                 24,193                               18,924



     General and administrative                                                                                            13,319                               11,780




     Loss from operations                                                                                                (36,207)                            (36,475)



     Other income, net                                                                                                        638                                1,647



     Interest expense                                                                                                     (2,108)                             (1,292)




     Net loss                                                                                                                     $
       (37,677)                        $
        (36,120)




     Net loss per share, basic and diluted                                                                                          $
       (0.47)                          $
        (0.66)




     Shares used in computing net loss per share, basic and diluted                                                        79,369                               54,382


                                           
              
                INVITAE CORPORATION




                                  
              
                Consolidated Statements of Cash Flows


                                                    
              (in thousands)


                                                      
              (unaudited)




                                                                               Three Months Ended March 31,


                                                             2019                                         2018

                                                                                                          ---

                   Cash flows from operating activities:



     Net loss                                                      $
              (37,677)                         $
        (36,120)


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


      Depreciation and amortization                         3,286                                          3,433


      Stock-based compensation                              5,223                                          4,393


      Remeasurements of liabilities
       associated with business
       combinations                                         (130)                                         1,093



     Other                                                   388                                             32


      Changes in operating assets and liabilities:



     Accounts receivable                                   2,596                                          (224)


      Prepaid expenses and other
       current assets                                     (3,365)                                       (1,156)



     Other assets                                          1,019                                        (2,548)



     Accounts payable                                      (307)                                       (1,574)


      Accrued expenses and other
       liabilities                                            601                                          (231)



      Net cash used in operating
       activities                                        (28,366)                                      (32,902)





                   Cash flows from investing activities:


      Purchases of marketable
       securities                                        (20,781)                                         (225)


      Proceeds from sales of
       marketable securities                                    -                                        19,965


      Proceeds from maturities of
       marketable securities                                6,000                                          2,078


      Purchases of property and
       equipment                                          (2,764)                                       (1,871)


      Net cash provided by (used in)
       in investing activities                           (17,545)                                        19,947





                   Cash flows from financing activities:


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


      Proceeds from issuance of common
       stock                                                2,107                                            191


      Proceeds from debt financing                              -                                        19,792


      Finance lease principal payments                      (477)                                         (638)


      Net cash provided by financing
       activities                                         186,120                                         19,345





                   Net increase in cash, cash
                    equivalents and restricted cash       140,209                                          6,390


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



                   Cash, cash equivalents and
                    restricted cash at end of
                    period                                           $
              258,373                            $
        23,849


                                                                       
              
                INVITAE CORPORATION




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


                                                                                
              (in thousands)


                                                                              
              (unaudited)




                                                                                                                                                               Three Months Ended March 31,


                                                                                                                                                          2019      2018

                                                                                                                                                                    ---


     Net cash used in operating activities                                                                                                           (28,366)             (32,902)



     Net cash provided by (used in) investing activities                                                                                             (17,545)               19,947



     Net cash provided by financing activities                                                                                                        186,120                19,345




     Net increase in cash, cash equivalents and restricted cash                                                                                       140,209                 6,390





     Adjustments:



     Purchases of investments                                                                                                                          20,781                   225



     Sales of investments                                                                                                                                                 (19,965)



     Maturities of investments                                                                                                                        (6,000)              (2,078)



     Purchases of investments in privately held companies                                                                                                                    (225)



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



     Net proceeds from issuance of debt                                                                                                                                   (19,792)



     Proceeds from exercises of warrants                                                                                                                 (88)                (191)



     Cash burn                                                                                                                                       (29,588)             (35,636)

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

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SOURCE Invitae Corporation