Natera Reports Second Quarter 2020 Financial Results

SAN CARLOS, Calif., Aug. 5, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today reported financial results for the second quarter ended June 30, 2020 and provided an update on recent business progress.

Recent Accomplishments & Highlights

    --  Processed approximately 234,100 tests in the second quarter of 2020
        compared to approximately 194,200 tests processed in the second quarter
        of 2019, an increase of 21%.
    --  Generated total revenues of $86.5 million in the second quarter of 2020
        compared to $74.4 million in the second quarter of 2019.
    --  Published Signatera(TM) study in Nature Cancer validating ability to
        monitor tumor response to immune therapy in 25 different types of solid
        cancer.
    --  Launched the PEDAL study designed to demonstrate Prospera test
        enhancements at the American Transplant Conference.
    --  Presented four abstracts, including one oral presentation and three
        poster presentations, at the American Society for Clinical Oncology
        conference demonstrating the performance of Signatera in areas including
        colorectal cancer and hepatocellular carcinoma.
    --  Enrolled first patients in both CIRCULATE-Japan and BESPOKE CRC for
        Signatera in colorectal cancer, and in PROACTIVE for Prospera.
    --  Received positive coverage from Noridian for Prospera; commenced full
        commercial launch.
    --  Received the Force for Change Illuminator Award from Leading Women
        Entrepreneurs.

"The business was very resilient in the second quarter," said Steve Chapman, Natera's Chief Executive Officer. "We posted another very strong volume and revenue result despite the COVID-19 impact, and we achieved major milestones across the oncology and transplant businesses. We are very proud of the team's performance during this challenging time."

Second Quarter Ended June 30, 2020 Financial Results

Total revenues were $86.5 million in the second quarter of 2020 compared to $74.4 million for the second quarter of 2019. The increase in total revenues was driven primarily by sales of Natera's Panorama and Horizon tests. Natera processed 234,100 tests in the second quarter of 2020, including approximately 221,600 tests accessioned in its laboratory, compared to 194,200 tests processed in the second quarter of 2019, including approximately 181,600 tests accessioned in its laboratory.

In the three months ended June 30, 2020, Natera recognized revenue on approximately 220,000 tests for which results were reported to customers in the period (tests reported), including approximately 208,400 tests reported in its laboratory, compared to approximately 187,600 tests reported, including approximately 174,800 tests reported in its laboratory, in the second quarter of 2019.

Gross profit* for the three months ended June 30, 2020 and 2019 was $39.5 million and $30.5 million, respectively, representing approximately 46% and 41% gross margin*, respectively. The company was able to achieve higher margins in the second quarter of 2020 primarily because of improved cost of goods sold per test and increased revenues.

Total operating expenses, representing research and development expenses and selling, general and administrative expenses, for the second quarter of 2020 were $91.2 million, compared to $59.2 million in the same period of the prior year. The increases were primarily driven by headcount growth to support new product offerings.

Loss from operations for the second quarter of 2020 was $51.6 million compared to $28.6 million for the same period of the prior year.

Net loss for the second quarter of 2020 was $59.6 million, or ($0.75) per diluted share, compared to net loss of $32.4 million, or ($0.48) per diluted share, for the same period in 2019. Weighted average shares outstanding were approximately 79.0 million in the second quarter of 2020.

At June 30, 2020, Natera held $571.2 million in cash, cash equivalents, short-term investments and restricted cash, compared to $441.0 million as of December 31, 2019. As of June 30, 2020, Natera had a total outstanding debt balance of $247.5 million, comprised of $50.1 million with accrued interest under its $50.0 million line of credit with UBS at a variable interest rate of 30-day LIBOR plus 110 bps and a net carrying amount of $197.5 million under its seven-year convertible senior notes. The convertible senior notes were issued in April 2020 for net proceeds of $278.9 million, of which a portion was used to repay the $79.2 million obligations under the company's 2017 term loan with OrbiMed Advisors. The gross principal balance outstanding for the convertible senior notes was $287.5 million for the second quarter of 2020.

2020 Financial Outlook

Natera anticipates 2020 total revenue of $345 million to $365 million; 2020 cost of revenues to be approximately 51% to 55% of revenues; selling, general and administrative costs to be approximately $260 million to $280 million; research and development costs to be $85 million to $95 million, and net cash burn to be $125 million to $155 million**.

* Gross profit is calculated as GAAP total revenues less GAAP cost of revenues. Gross margin is calculated as gross profit divided by GAAP total revenues.

** Cash burn is calculated as the sum of GAAP net cash used by operating activities (estimated for 2020 to be between $117 million and $147 million) and GAAP net purchases of property and equipment (estimated for 2020 to be approximately $8 million).


                                   
       
              Test Volume Summary





            
              Unit           Q2 2020                        Q2 2019         
     
     Definition

    ---


            Tests processed                       234,000                    194,200                Tests accessioned in our
                                                                                                    laboratory plus units processed
                                                                                                    outside of our laboratory



            Tests accessioned                     221,600                    181,600                Test accessioned in our
                                                                                                    laboratory


                                     Total tests reported in our
                                                                                                    laboratory less units reported
                                                                                                    outside of our laboratory
                                                                                                    including Evercord units in

            Tests reported in our                 208,400                    174,800                 prior periods
    laboratory

About Natera

Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform.

Conference Call Information


     Event:       Natera's Second Quarter 2020 Financial Results Conference Call


     Date:      
     Wednesday, August 5, 2020


     Time:      
     1:30 p.m. PT (4:30 p.m. ET)


     Live Dial-
      In:       
     (800) 708-4540, Domestic


                
     (847) 619-6397, International


     Conference
      Password:                                                         49854736


     Webcast:   
     https://edge.media-server.com/mmc/p/mh4xc5b8

A webcast replay will be available at investor.natera.com.

Forward-Looking Statements

This release contains forward-looking statements, including regarding the company's business operations in light of the COVID-19 pandemic. Any forward-looking statements contained in this release are based upon Natera's current plans, estimates, and expectations, as of the date of this release, and are not a representation that such plans, estimates, or expectations will be achieved. Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements in the future.

These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including: we face numerous uncertainties and challenges in operating our business in light of the COVID-19 pandemic; we may be unable to further increase the use and adoption of Panorama and Horizon, through our direct sales efforts or through our laboratory partners, or to develop and successfully commercialize new products, including Signatera and Prospera; we have incurred losses since our inception and we anticipate that we will continue to incur losses for the foreseeable future; our quarterly results may fluctuate from period to period; our estimates of market opportunity and forecasts of market growth may prove to be inaccurate; we may be unable to compete successfully with existing or future products or services offered by our competitors; we may not be successful in commercializing our cloud-based distribution model; our products may not perform as expected; the results of our clinical studies may not be compelling to professional societies or payors as supporting the use of our tests, particularly in the average-risk pregnancy population or for microdeletions screening, or may not be able to be replicated in later studies required for regulatory approvals or clearances; if our primary CLIA-certified laboratory facility becomes inoperable, we will be unable to perform our tests and our business will be harmed; we rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials and may not be able to find replacements or immediately transition to alternative suppliers; if we are unable to successfully scale our operations, our business could suffer; the marketing, sale, and use of Panorama and our other products could result in substantial damages arising from product liability or professional liability claims that exceed our resources; we may be unable to expand third-party payer coverage and reimbursement for Panorama, Horizon and our other tests, and we may be required to refund reimbursements already received; third-party payers may withdraw coverage or provide lower levels of reimbursement due to changing policies, billing complexities or other factors, such as the increased focus by third-party payers on requiring that prior authorization be obtained prior to conducting a test; if the FDA were to begin actively regulating our tests, we could incur substantial costs and delays associated with trying to obtain premarket clearance or approval and incur costs associated with complying with post-market controls; litigation or other proceedings, resulting from either third party claims of intellectual property infringement or third party infringement of our technology, is costly, time-consuming and could limit our ability to commercialize our products or services; any inability to effectively protect our proprietary technology could harm our competitive position or our brand; and we cannot guarantee that we will be able to service and comply with our outstanding debt obligations or achieve our expectations regarding the conversion of our outstanding convertible notes.

Additional risks and uncertainties that could affect our financial results are included under the captions, "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our most recent filings on Forms 10-K and 10-Q and in other filings that we make with the SEC from time to time. These documents are available on our website at www.natera.com under the Investor Relations section and on the SEC's website at www.sec.gov

Natera assumes no obligation to, and does not currently intend to, update any such forward-looking statements after the date of this release.

Contacts

Natera, Inc.

Investor Relations
Mike Brophy, CFO, Natera, Inc., 650-249-9090

Media
Paul Greenland, VP of Corporate Marketing, Natera, Inc., pr@natera.com


                                                                                  
       
                Natera, Inc.


                                                                         
           
         Condensed Consolidated Balance Sheets


                                                                                   
       
                (Unaudited)


                                                                                 
       
                (in thousands)




                                                                                                                             June 30,                December 31,


                                                                                                                                 2020                         2019



                                                                                                                                                              (1)



     
                Assets



     Current assets:



     Cash and cash equivalents                                                                                                        $
         77,322                $
          61,926



     Restricted cash                                                                                                                             55                            55



     Short-term investments                                                                                                                 493,852                       379,065



     Accounts receivable, net of allowance of $3,080 in 2020 and $2,919 in 2019                                                              58,706                        53,351



     Inventory                                                                                                                               18,033                        12,394



     Prepaid expenses and other current assets, net                                                                                          15,536                        16,376




     Total current assets                                                                                                                   663,504                       523,167



     Property and equipment, net                                                                                                             25,925                        23,283



     Operating lease right-of-use assets                                                                                                     21,475                        23,730



     Other assets                                                                                                                            12,357                        12,476




     Total assets                                                                                                                    $
         723,261               $
          582,656




     
                Liabilities and Stockholders' Equity



     Current liabilities:



     Accounts payable                                                                                                                  $
         3,450                 $
          8,604



     Accrued compensation                                                                                                                    16,583                        16,088



     Other accrued liabilities                                                                                                               53,082                        49,043



     Deferred revenue, current portion                                                                                                       52,392                        56,016



     Short-term debt financing                                                                                                               50,053                        50,123




     Total current liabilities                                                                                                              175,560                       179,874



     Long-term debt financing                                                                                                               197,476                        73,656



     Deferred revenue, long-term portion                                                                                                     22,533                        23,808



     Operating lease liabilities, long-term portion                                                                                          23,115                        26,297



     Other long-term liabilities                                                                                                                310                           310




     Total liabilities                                                                                                                      418,994                       303,945





     Commitments and contingencies





     Stockholders' equity:



     Common stock (2)                                                                                                                             8                             8



     Additional paid in capital                                                                                                           1,093,072                       976,955



     Accumulated deficit                                                                                                                  (794,583)                    (699,171)



     Accumulated other comprehensive income                                                                                                   5,770                           919




     Total stockholders' equity                                                                                                             304,267                       278,711




     Total liabilities and stockholders' equity                                                                                      $
         723,261               $
          582,656




              (1)              The condensed, consolidated balance
                                  sheet at December 31, 2019 has
                                  been derived from the audited
                                  consolidated financial statements
                                  at that date included in the
                                  company's Annual Report on Form
                                  10-K for the year ended December
                                  31, 2019.



              (2)              As of June 30, 2020, there were
                                  approximately 79,717,000 shares of
                                  common stock issued and
                                  outstanding.


                                                                       
              
                Natera, Inc.


                                                  
         
             Condensed Consolidated Statements of Operations and Comprehensive Loss


                                                                       
              
                (Unaudited)


                                                            
            
                (in thousands, except per share data)




                                                
         
             Three months ended                                                             Six months ended


                                                    
         
              June 30,                                          
              
                June 30,



                                                           2020                         2019                                                 2020               2019






     
                Revenues



     Product revenues                                            $
              80,414                                          $
              65,099                       $
        167,460     $
         128,463



     Licensing and other revenues                                             6,058                                                       9,256                              13,024             12,716




     Total revenues                                                          86,472                                                      74,355                             180,484            141,179



     
                Cost and expenses



     Cost of product revenues                                                42,731                                                      41,382                              84,251             82,987


      Cost of licensing and other revenues                                     4,208                                                       2,443                               7,666              4,141



     Research and development                                                23,005                                                      12,124                              41,230             23,559


      Selling, general and administrative                                     68,188                                                      47,042                             133,869             90,874




     Total cost and expenses                                                138,132                                                     102,991                             267,016            201,561



                   Loss from operations                                     (51,660)                                                   (28,636)                           (86,532)          (60,382)



     Interest expense                                                       (4,038)                                                    (2,721)                            (6,502)           (5,445)



     Interest and other income, net                                           1,924                                                         836                               3,911              1,289



     Loss on debt extinguishment                                            (5,848)                                                                                       (5,848)




     Loss before income taxes                                              (59,622)                                                   (30,521)                           (94,971)          (64,538)



     Income tax expense                                                        (15)                                                    (1,895)                               (38)           (1,969)




     Net loss                                                  $
              (59,637)                                       $
              (32,416)                     $
        (95,009)   $
         (66,507)



      Unrealized gain on available-for-sale
       securities, net of tax                                                    104                                                       1,061                               4,850              1,347




     Comprehensive loss                                        $
              (59,533)                                       $
              (31,355)                     $
        (90,159)   $
         (65,160)






     Net loss per share:



     Basic and diluted                                           $
              (0.75)                                         $
              (0.48)                       $
        (1.21)     $
         (1.01)



      Weighted-average number of shares used in
       computing basic and diluted net loss per
       share:



     Basic and diluted                                                       79,069                                                      68,224                              78,681             65,542

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SOURCE Natera, Inc.