GeneDx Holdings Corp. (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic and clinical insights, today reported its financial results for the fourth quarter and full year of 2023.

“Our strong fourth quarter results were a product of our relentless focus on exome and genome revenue growth, uplift from gross margin expansion, and continued efforts to meaningfully reduce our cash burn,” said Katherine Stueland, Chief Executive Officer of GeneDx. “With our focus and disciplined approach to delivering on our goals in 2024, we are confident in our ability to continue to execute and reach profitability in 2025.”

Fourth Quarter and Full Year 2023 Financial Results (Unaudited)1,2,3

Revenues

Fourth quarter 2023:

  • Revenues from continuing operations grew to $58.1 million, an increase of 27% year-over-year and 15% sequentially.
    • Total company revenues were $57.4 million.
  • Exome and genome test revenue grew to $39.2 million, an increase of 68% year-over-year and 15% sequentially.

Full year 2023:

  • Revenues from continuing operations grew to $194.4 million, an increase of 59% year-over-year and 14% year-over-year on a pro-forma basis3.
    • Total company revenues were $202.6 million.
  • Exome and genome test revenue grew to $124.3 million, an increase of 43% year-over-year on a pro-forma basis3.

Exome and genome volume

Fourth quarter 2023:

  • Exome and genome test results volume grew to 15,663, an increase of 99% year-over-year and 19% sequentially.
  • Exome and genome represented 27% of all test results, up from 16% in the fourth quarter of 2022 and up from 23% in the third quarter of 2023.

Full year 2023:

  • Exome and genome test results volume grew to 49,439, an increase of 62% year-over-year on a pro-forma basis3.
  • Exome and genome represented 22% of all test results, up from 17% for the full year 2022 on a pro-forma basis3.

Gross margin

Fourth quarter 2023:

  • Adjusted gross margin from continuing operations expanded to 56%, up from 41% in the fourth quarter of 2022 and up from 48% in the third quarter of 2023.
    • Total company gross margin was 53.6%.
  • Exome and genome adjusted gross margin operated in excess of 60%.

Full year 2023:

  • Adjusted gross margin from continuing operations expanded to 45%, up from 39% for full year 2022.
    • Total company gross margin was 44.4%.
  • Exome and genome adjusted gross margin operated in excess of 60%.

Operating expenses

Fourth quarter 2023:

  • Adjusted total operating expenses reduced to $48.3 million, a decrease of 36% year-over-year.
    • Total GAAP operating expenses were $54.4 million.

Full year 2023:

  • Adjusted total operating expenses reduced to $216.3 million, a decrease of 33% year-over-year.
    • Total GAAP operating expenses were $253.0 million.

Net loss

Fourth quarter 2023:

  • Adjusted net loss narrowed to $17.8 million, an improvement of 76% year-over-year and 16% sequentially.
    • GAAP net loss was $25.8 million.

Full year 2023:

  • Adjusted net loss narrowed to $126.3 million, an improvement of 53% year-over-year.
    • GAAP net loss was $175.8 million.

Cash burn and cash position

  • Excluding one-time items, representative continuing operations cash burn was $23.9 million in the fourth quarter of 2023. Total net use of cash, excluding net financing proceeds, was $32.9 million in the fourth quarter of 2023, an improvement of 51% year-over-year and 22% sequentially. The use of cash in the fourth quarter included $5 million in scheduled payments under the Legacy Sema4 payer settlement entered into in 2022, $3 million to discharge operating payables for the exited reproductive health business and $1 million in severance payments related to the previously announced cost reduction initiative.
  • Cash, cash equivalents, marketable securities and restricted cash was $131.1 million as of December 31, 2023.
  1. Revenue and gross margin results from continuing operations, which we believe are representative of our ongoing business strategy exclude any revenue and cost of goods sold of the exited Legacy Sema4 diagnostic testing business. Total company results include GeneDx’s continuing operations and the financial impacts of exited Legacy Sema4 business activities.
  2. Adjusted gross margin, adjusted total operating expenses and adjusted net loss are non-GAAP financial measures. See appendix for a reconciliation of GAAP to Non-GAAP figures presented.
  3. Volume and revenue comparison for full year 2022 are on a pro forma basis assuming Legacy GeneDx and the Company were combined for the entirety of 2022.

GeneDx Full Year 2024 Guidance

Management expects GeneDx to:

  • Drive full year 2024 revenues between $220 and $230 million;
  • Expand full year 2024 adjusted gross margin profile to at least 50%;
  • Use $75 to $80 million of net cash for full year 2024;
  • Turn profitable in 2025.

2023 Business Highlights

Driving sustainable growth and market leadership

  • Presented new data at the American Epilepsy Society Annual Meeting demonstrating that exome sequencing outperforms multi-gene panels for patients with epilepsy
  • Announced that Genetics in Medicine, the official journal of the American College of Medical Genetics and Genomics (ACMG), published a peer-reviewed research analysis involving GeneDx that concluded that variants of unknown significance (VUS) are reported more frequently on multi-gene panels than exome and genome sequencing
  • Reached a milestone of over 1,000 publications in peer-reviewed journals, demonstrating GeneDx’s leadership in furthering scientific discoveries and innovation in the commercial laboratory space
  • Worked closely with state Medicaid programs, including Florida, Arizona, and Utah, to expand coverage of rapid genetic testing in the NICU
  • Announced partnership program with the New York Center for Rare Diseases (NYCRD) at Montefiore, PacBio and Google Health to deliver genetic diagnoses for Bronx families living with rare diseases
  • Continued to support the GUARDIAN study, which continued to offer data and insights on the benefits and potential for genetic diagnoses through newborn screening – a retrospective analysis of GeneDx data showed that more than 20% of individuals could have identified their genetic disease, on average, 7 to 11 years sooner had they received genome sequencing at birth
  • Launched research collaboration with the University of Washington and PacBio to study the capabilities of long-read whole genome sequencing (WGS) to increase diagnostic rates in pediatric patients with genetic conditions
  • Refined the strategic direction for biopharma and partnerships efforts and aligned the team within the Commercial organization, offering enhanced integration between our testing and data businesses
  • Evolved the management team to include Melanie Duquette as Chief Growth Officer and Eric Olivares as Chief Product Officer

Strengthening our financial health and path to profitability

  • On October 30, 2023, the Company announced a continued strategic realignment of its organization to key priorities which included the elimination of approximately 50 positions impacted on August 23, 2023 and approximately 35 positions impacted on October 30, 2023. Together these actions reduced the size of the Company’s workforce by 10% from the total number that existed at the time of the August reduction in force. In total, the Company announced cost saving initiatives, including but not limited to these reductions in force, that are expected to amount to approximately $40 million in annual cost reduction.
  • Entered into a new, five-year senior secured credit facility with Perceptive Advisors. The agreement provides access of up to $75 million, consisting of an initial tranche of $50 million, and a subsequent tranche for an additional $25 million, subject to certain timelines and other defined criteria.
    • Interest is payable in cash on the outstanding principal amount at a rate per annum equal to the sum of the applicable secured overnight financing rate (SOFR), plus 7.5%.
    • Under the terms of the agreement, Perceptive was issued warrants to purchase 800,000 shares of the Company’s Class A common stock on the closing date, with an exercise price equal to $3.18. Upon the borrowing of the subsequent tranche, Perceptive will be issued warrants to purchase an additional 400,000 shares of Class A common stock.

Webcast and Conference Call Details

GeneDx will host a conference call today, February 20, 2024, at 4:30 p.m. Eastern Time. Investors interested in listening to the conference call are required to register online. A live and archived webcast of the event will be available on the “Events” section of the GeneDx investor relations website at https://ir.genedx.com/.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding our future performance and our market opportunity, including our expected full year 2024 reported revenue guidance, our expectations regarding our adjusted gross margin profile in 2024, our use of net cash in 2024 and our turning profitable in 2025, the expected annual cost reduction from our cost savings initiatives. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) our ability to implement business plans, goals and forecasts, and identify and realize additional opportunities, (ii) the risk of downturns and a changing regulatory landscape in the highly competitive healthcare industry, (iii) the size and growth of the market in which we operate, (iv) our ability to pursue our new strategic direction, and (vi) our ability to enhance our artificial intelligence tools that we use in our clinical interpretation platform. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 16, 2023 and other documents filed by us from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and we assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. We do not give any assurance that we will achieve our expectations.

About GeneDx

GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation, fueled by one of the world’s largest rare disease data sets. For more information, please visit genedx.com and connect with us on LinkedIn, Facebook, Twitter and Instagram.

Investor Relations Contact:Investors@GeneDx.com

Media Contact:Press@GeneDx.com

Volume and revenue in the table below include the combination of the Legacy GeneDx diagnostic business with the data and information business of Legacy Sema4.

Volume & Revenue

  4Q23   3Q23   2Q23   1Q23   4Q22   2023 YTD   2022 YTD1
Volumes                          
Whole exome, whole genome   15,663     13,216     11,855     8,705     7,862     49,439     30,560
Exome based panels   2,606     2,922     3,472     3,136     3,013     12,136     11,767
Hereditary cancer   8,240     8,556     7,142     7,120     6,069     31,058     25,334
Other individual gene tests and multi-gene disease panels   31,086     32,939     32,459     33,817     31,891     130,301     112,711
Total   57,595     57,633     54,928     52,778     48,835     222,934     180,372
                           
Revenue ($ millions)                          
Whole exome, whole genome $ 39.2   $ 34.0   $ 28.7   $ 22.4   $ 23.3   $ 124.3   $ 86.8
Exome based panels   1.7     1.7     2.0     2.1     2.0     7.5     9.1
Hereditary cancer   5.5     4.5     3.8     4.3     4.4     18.1     14.4
Other individual gene tests and multi-gene disease panels   9.5     8.9     8.6     10.6     14.2     37.6     53.0
Data information   2.2     1.3     2.1     1.3     1.9     6.9     7.7
Total $ 58.1   $ 50.4   $ 45.2   $ 40.7   $ 45.8   $ 194.4   $ 171.0

1 Volume and revenue comparison for full year 2022 are on a pro forma basis as if Legacy GeneDx and the Company were combined for the entirety of 2022.

Unaudited Select Financial Information (in thousands)

  Three months ended December 31, 2023   Three months ended December 31, 2022
  GeneDx   Legacy Sema4   Total   GeneDx   Legacy Sema4   Total
Revenue $58,107     $(689 )   $57,418     $45,824     $15,526     $61,350  
Adjusted cost of services   25,626             25,626       27,000       30,153       57,153  
Adjusted gross profit (loss) $32,481     $(689 )   $31,792     $18,824     $(14,627 )   $4,197  
Adjusted gross margin %   55.9 %     (100.0 )%     55.4 %     41.1 %     (94.2 )%     6.8 %
  Year ended December 31, 2023   Year ended December 31, 2022
  GeneDx   Legacy Sema4   Total   GeneDx   Legacy Sema4   Total
Revenue $194,376     $8,190     $202,566     $122,234     $112,460     $234,694  
Adjusted cost of services   106,983       2,305       109,288       74,213       148,897       223,110  
Adjusted gross profit (loss) $87,393     $5,885     $93,278     $48,021     $(36,437 )   $11,584  
Adjusted gross margin %   45.0 %     71.9 %     46.0 %     39.3 %     (32.4 )%     4.9 %
  Three months ended September 30, 2023    
  GeneDx   Legacy Sema4   Total    
Revenue $50,350     $2,953     $53,303    
Adjusted cost of services   26,079       225       26,304    
Adjusted gross profit (loss) $24,271     $2,728     $26,999    
Adjusted gross margin %   48.2 %     92.4 %     50.7 %  
  For the three months ended December 31, 2023
  Reported   Depreciation and amortization   Stock-based compensation expense   Restructuring costs   Change in FV of financial liabilities   Charges related to business exit   Other   Adjusted
Diagnostic test revenue $ 55,214     $     $     $     $     $     $   $ 55,214  
Other revenue   2,204                                         2,204  
Total revenue   57,418                                         57,418  
Cost of services   26,664       (915 )     (123 )                           25,626  
Gross profit (loss)   30,754       915       123                             31,792  
Gross margin   53.6 %                             55.4 %
                               
Research and development   12,248       (919 )     2,320       (1,300 )                     12,349  
Selling and marketing   15,559       (1,225 )     1,071       (487 )                     14,918  
General and administrative   26,626       (3,035 )     (2,356 )     (197 )                     21,038  
Impairment loss                                            
Other, net   1,964                               (1,277 )         687  
                               
Loss from operations   (25,643 )     6,094       (912 )     1,984             1,277           (17,200 )
                               
Interest income (expense), net   (978 )                                       (978 )
Other income (expense), net   437                         (485 )           48      
Income tax benefit   411                                         411  
Net loss $ (25,773 )   $ 6,094     $ (912 )   $ 1,984     $ (485 )   $ 1,277     $ 48   $ (17,767 )
  For the three months ended December 31, 2022
  Reported   Depreciation and amortization   Stock-based compensation expense   Restructuring costs   Change in FV of financial liabilities   Charges related to business exit   Adjusted
Diagnostic test revenue $ 59,345     $     $     $     $     $     $ 59,345  
Other revenue   2,005                                     2,005  
Total revenue   61,350                                     61,350  
Cost of services   77,676       (19,993 )     (412 )     (118 )                 57,153  
Gross profit (loss)   (16,326 )     19,993       412       118                   4,197  
Gross margin (26.6 )%                         6.8 %
                           
Research and development   24,366       (9,149 )     937       (892 )                 15,262  
Selling and marketing   29,236       (1,226 )     324       (3,476 )                 24,858  
General and administrative   43,209       (3,672 )     (1,271 )     (2,770 )                 35,496  
Impairment loss   210,145                               (210,145 )      
Other, net   1,600                                     1,600  
                           
Loss from operations   (324,882 )     34,040       422       7,256             210,145       (73,019 )
                           
Interest income (expense), net   333                                     333  
Other income (expense), net   15,878                         (15,878 )            
Income tax benefit   (90 )                                   (90 )
Net loss $ (308,761 )   $ 34,040     $ 422     $ 7,256     $ (15,878 )   $ 210,145     $ (72,776 )
  For the year ended December 31, 2023
  Reported   Depreciation and amortization   Stock-based compensation expense   Restructuring costs   Change in FV of financial liabilities   Charges related to business exit   Other   Adjusted
Diagnostic test revenue $ 195,654     $     $     $     $     $     $     $ 195,654  
Other revenue   6,912                                           6,912  
Total revenue   202,566                                           202,566  
Cost of services   112,560       (4,350 )     1,217       (139 )                       109,288  
Gross profit (loss)   90,006       4,350       (1,217 )     139                         93,278  
Gross margin   44.4 %                             46.0 %
                               
Research and development   58,266       (6,710 )     2,585       (3,176 )                       50,965  
Selling and marketing   60,956       (4,902 )     1,266       (1,371 )                       55,949  
General and administrative   133,755       (17,772 )     (4,742 )     (1,846 )                       109,395  
Impairment loss   10,402                               (10,402 )            
Other, net   7,223                               (1,957 )           5,266  
                               
Loss from operations   (180,596 )     33,734       (326 )     6,532             12,359             (128,297 )
                               
Interest income (expense), net   1,114                                           1,114  
Other income (expense), net   2,789                         (1,170 )           (1,619 )      
Income tax benefit   926                                           926  
Net loss $ (175,767 )   $ 33,734     $ (326 )   $ 6,532     $ (1,170 )   $ 12,359     $ (1,619 )   $ (126,257 )
  For the year ended December 31, 2022
  Reported   Depreciation and amortization   Stock-based compensation expense   Restructuring costs   Change in FV of financial liabilities   Charges related to business exit   Other   Adjusted
Diagnostic test revenue $ 227,334     $     $     $     $     $         $ 227,334  
Other revenue   7,360                                           7,360  
Total revenue   234,694                                           234,694  
Cost of services   261,444       (31,328 )     (5,080 )     (1,926 )                       223,110  
Gross profit (loss)   (26,750 )     31,328       5,080       1,926                         11,584  
Gross margin (11.4 )%                             4.9 %
                               
Research and development   86,203       (14,960 )     (1,755 )     (3,260 )                       66,228  
Selling and marketing   122,075       (3,271 )     (5,390 )     (7,979 )                       105,435  
General and administrative   216,167       (9,750 )     (29,750 )     (12,645 )                 (13,436 )     150,586  
Impairment loss   210,145                               (210,145 )            
Other, net   6,312                                           6,312  
                               
Loss from operations   (667,652 )     59,309       41,975       25,810             210,145       13,436       (316,977 )
                               
Interest income (expense), net   (666 )                                         (666 )
Other income (expense), net   70,286                         (70,229 )           (57 )      
Income tax benefit   49,052                                           49,052  
Net loss $ (548,980 )   $ 59,309     $ 41,975     $ 25,810     $ (70,229 )   $ 210,145     $ 13,379     $ (268,591 )
  For the three months ended September 30, 2023
  Reported   Depreciation and amortization   Stock-based compensation expense   Restructuring costs   Change in FV of financial liabilities   Charges related to business exit   Other   Adjusted
Diagnostic test revenue $ 51,955     $     $     $     $     $     $   $ 51,955  
Other revenue   1,348                                         1,348  
Total revenue   53,303                                         53,303  
Cost of services   28,044       (1,613 )     (75 )     (52 )                 26,304  
Gross profit (loss)   25,259       1,613       75       52                       26,999  
Gross margin   47.4 %                             50.7 %
                               
Research and development   14,288       (283 )     533       (970 )                     13,568  
Selling and marketing   16,763       (1,225 )     115       (416 )                     15,237  
General and administrative   26,099       (5,551 )     (1,004 )     (753 )                     18,791  
Impairment loss   8,282                               (8,282 )          
Other, net   2,794                               (1,014 )         1,780  
                               
Loss from operations   (42,967 )     8,672       431       2,191             9,296           (22,377 )
                               
Interest income (expense), net   1,053                                         1,053  
Other income (expense), net   (544 )                       (590 )           1,134      
Income tax benefit   172                                         172  
Net loss $ (42,286 )   $ 8,672     $ 431     $ 2,191     $ (590 )   $ 9,296     $ 1,134   $ (21,152 )

GeneDx Holdings Corp.Consolidated Balance Sheets(in thousands, except share and per share amounts)
  December 31,
    2023       2022  
Assets      
Current assets:      
Cash and cash equivalents $ 99,681     $ 123,933  
Marketable securities   30,467        
Accounts receivable   32,371       42,634  
Due from related parties   445       708  
Inventory, net   8,777       13,665  
Prepaid expenses and other current assets   10,598       31,682  
Total current assets   182,339       212,622  
Operating lease right-of-use assets   26,900       32,758  
Property and equipment, net   32,479       51,527  
Intangible assets, net   172,625       186,650  
Other assets(1)   4,413       7,385  
Total assets $ 418,756     $ 490,942  
Liabilities and Stockholders’ Equity      
Current liabilities:      
Accounts payable and accrued expenses $ 37,456     $ 84,878  
Due to related parties   1,379       3,593  
Short-term lease liabilities   3,647       6,121  
Other current liabilities   16,336       49,705  
Total current liabilities   58,818       144,297  
Long-term debt, net of current portion   52,688       6,250  
Long-term lease liabilities   62,938       60,013  
Other liabilities   14,735       24,018  
Deferred taxes   1,560       2,659  
Total liabilities   190,739       237,237  
       
Stockholders’ Equity:      
Preferred stock          
Class A common stock   2       1  
Additional paid-in capital   1,527,778       1,378,125  
Accumulated deficit   (1,300,188 )     (1,124,421 )
Accumulated other comprehensive income   425        
Total stockholders’ equity   228,017       253,705  
Total liabilities and stockholders’ equity $ 418,756     $ 490,942  

(1)  Other assets includes $987 thousand and $900 thousand of restricted cash as of December 31, 2023 and December 31, 2022, respectively.

GeneDx Holdings Corp.Consolidated Statements of Operations(in thousands, except share and per share amounts)
  Year ended December 31,
    2023       2022  
Revenue      
Diagnostic test revenue $ 195,654     $ 227,334  
Other revenue   6,912       7,360  
Total revenue   202,566       234,694  
Cost of services   112,560       261,444  
Gross profit (loss)   90,006       (26,750 )
Research and development   58,266       86,203  
Selling and marketing   60,956       122,075  
General and administrative   133,755       216,167  
Impairment loss   10,402       210,145  
Other operating expenses, net   7,223       6,312  
Loss from operations   (180,596 )     (667,652 )
       
Non-operating income (expenses), net      
Change in fair market value of warrant and earn-out contingent liabilities   1,170       70,229  
Interest income (expense), net   1,114       (666 )
Other income, net   1,619       57  
Total non-operating income, net   3,903       69,620  
Loss before income taxes $ (176,693 )   $ (598,032 )
Income tax benefit   926       49,052  
Net loss $ (175,767 )   $ (548,980 )
       
Weighted average shares outstanding of Class A common stock   24,311,989       10,236,960  
Basic and diluted net loss per share, Class A common stock $ (7.23 )   $ (53.63 )

GeneDx Holdings Corp.Consolidated Statements of Cash Flows(in thousands)
  Year Ended December 31,
    2023       2022  
Operating activities      
Net loss $ (175,767 )   $ (548,980 )
Adjustments to reconcile net loss to net cash used in operating activities:      
Depreciation and amortization expense   33,734       59,309  
Stock-based compensation expense   (326 )     41,975  
Change in fair value of warrant and contingent liabilities   (1,170 )     (70,229 )
Deferred tax benefit   (926 )     (49,124 )
Provision for excess and obsolete inventory   3,913       1,125  
Third-party payor reserve release   (9,745 )      
Gain on sale of assets   (1,677 )      
Gain on debt forgiveness   (2,750 )      
Impairment loss   10,402       210,145  
Other   1,308       2,743  
Change in operating assets and liabilities, net of effects from purchase of business:      
Accounts receivable   10,263       5,527  
Inventory   975       2,350  
Accounts payable and accrued expenses   (46,953 )     34,459  
Other assets and liabilities   (2,526 )     (8,455 )
Net cash used in operating activities   (181,245 )     (319,155 )
Investing activities      
Consideration on escrow paid for GeneDx acquisition   (12,144 )     (127,004 )
Purchases of property and equipment   (5,250 )     (7,156 )
Proceeds from sale of assets   4,034        
Purchases of marketable securities   (47,670 )      
Proceeds from maturities of marketable securities   17,765        
Development of internal-use software assets   (461 )     (7,166 )
Net cash used in investing activities   (43,726 )     (141,326 )
Financing activities      
Proceeds from PIPE issuance, net of issuance costs         197,659  
Proceeds from offerings, net of issuance costs   143,002        
Proceeds from long-term debt, net of issuance costs   48,549        
Exercise of stock options   285       2,948  
Long-term debt principal payments   (2,000 )      
Finance lease payoff and principal payments   (2,500 )     (3,292 )
Net cash provided by financing activities   187,336       197,315  
Net decrease in cash, cash equivalents and restricted cash   (37,635 )     (263,166 )
Cash, cash equivalents and restricted cash, at beginning of year   138,303       401,469  
Cash, cash equivalents and restricted cash, at end of year(1) $ 100,668     $ 138,303  

(1) Cash, cash equivalents and restricted cash at December 31, 2023 excludes marketable securities of $30.5 million.

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