• Adaptive Biotechnologies Reports Third Quarter 2024 Financial Results

    المصدر: Nasdaq GlobeNewswire / 07 نوفمبر 2024 15:05:01   America/Chicago

    SEATTLE, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (“Adaptive Biotechnologies”) (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today reported financial results for the quarter ended September 30, 2024.

    “Our focus on execution and disciplined capital allocation are driving MRD growth with a clear path to profitability while we continue to advance our targeted Immune Medicine programs,” said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. “The increased clonoSEQ® Medicare Gapfill rate and the extension of coverage to Mantle Cell Lymphoma underscore clonoSEQ’s value to patients. I look forward to a strong finish to the year and continued progress toward our strategic goals.” 

    Recent Highlights

    • Revenue for the third quarter of 2024 was $46.4 million. The MRD business, which contributed 81% of revenue, grew 52% versus the third quarter of 2023.
    • clonoSEQ test volume in the third quarter of 2024 grew 30% to 19,600 tests delivered versus the third quarter of 2023.
    • Obtained updated Medicare Clinical Laboratory Fee Schedule (CLFS) Gapfill Determination for clonoSEQ of $2,007 per test, a 17% increase from the previous implied rate under the episode structure.
    • Received expanded Medicare coverage of clonoSEQ for assessing measurable residual disease in Mantle Cell Lymphoma.
    • Recognized $5.0 million in MRD pharma regulatory milestone revenue.
    • Updated full year guidance to reflect an increase to the bottom end of the previous MRD revenue range, a decrease in operating spend and a reduction in annual cash burn.

    Third Quarter 2024 Financial Results

    Revenue was $46.4 million for the quarter ended September 30, 2024, representing a 22% increase from the third quarter in the prior year. MRD revenue was $37.5 million for the quarter, representing a 52% increase from the third quarter in the prior year. Immune Medicine revenue was $9.0 million for the quarter, representing a 32% decrease from the third quarter in the prior year.

    Operating expenses for the third quarter of 2024 were $79.1 million, compared to $88.9 million in the third quarter of the prior year, representing a decrease of 11%. MRD operating expenses for the third quarter of 2024 were $52.5 million, representing a 6% decrease from the third quarter in the prior year. Immune Medicine operating expenses for the third quarter of 2024 were $20.7 million, representing a 22% decrease from the third quarter in the prior year.

    Interest and other income, net was $3.5 million for the third quarter of 2024, compared to $4.3 million in the third quarter of the prior year. Interest expense from our revenue interest purchase agreement was $2.9 million in the third quarter of 2024, compared to $3.7 million in the third quarter of the prior year.

    Net loss was $32.1 million for the third quarter of 2024, compared to $50.3 million for the same period in 2023.

    Adjusted EBITDA (non-GAAP) was a loss of $14.3 million for the third quarter of 2024, compared to a loss of $29.8 million for the third quarter of the prior year. MRD Adjusted EBITDA (non-GAAP) was a loss of $6.1 million for the quarter, compared to a loss of $21.6 million for the third quarter of the prior year. Immune Medicine Adjusted EBITDA (non-GAAP) was a loss of $5.2 million for the quarter, compared to a loss of $5.0 million for the third quarter of the prior year.

    Cash, cash equivalents and marketable securities was $267.2 million as of September 30, 2024.

    2024 Updated Financial Guidance

    Adaptive Biotechnologies expects full year revenue for the MRD business to be between $143 million and $145 million, updated from the previous range between $140 million and $145 million. No revenue guidance is provided for the Immune Medicine business.

    We expect full year total company operating expenses, including cost of revenue and excluding one-time costs from asset impairments and other restructuring charges, to be between $335 million and $340 million, updated from the previous range between $340 million and $350 million.

    Management will provide further details on the outlook during the conference call.

    Webcast and Conference Call Information

    Adaptive Biotechnologies will host a conference call to discuss its third quarter 2024 financial results after market close on Thursday, November 7, 2024 at 4:30 PM Eastern Time. The conference call can be accessed at http://investors.adaptivebiotech.com. The webcast will be archived and available for replay at least 90 days after the event.

    About Adaptive Biotechnologies

    Adaptive Biotechnologies (“we” or “our”) is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient.

    Forward-Looking Statements

    This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts and other matters regarding our business strategies, use of capital, results of operations and financial position and plans and objectives for future operations.

    In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

    Use of Non-GAAP Financial Measure

    To supplement our unaudited condensed consolidated statements of operations and unaudited condensed consolidated balance sheets, which are prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”), this press release also includes references to Adjusted EBITDA, which is a non-GAAP financial measure that we define as net loss attributable to Adaptive Biotechnologies Corporation adjusted for interest and other income, net, interest expense, income tax (expense) benefit, depreciation and amortization expense, impairment costs for long-lived assets, restructuring expense and share-based compensation expense. We define our segment Adjusted EBITDA in the same way to the extent the net loss attributable to Adaptive Biotechnologies Corporation and adjustments are allocable to each segment. We have provided reconciliations of net loss attributable to Adaptive Biotechnologies Corporation, the most directly comparable GAAP financial measure, to Adjusted EBITDA at the end of this press release.

    Management uses Adjusted EBITDA, including segment Adjusted EBITDA, to evaluate the financial performance of our business and segments and to evaluate the effectiveness of our strategies. We present these figures because we believe it is frequently used by analysts, investors and other interested parties to evaluate companies in our industry and it facilitates comparisons on a consistent basis across reporting periods. Further, we believe it is helpful in highlighting trends in our operating results because it excludes items that are not indicative of our core operating performance.

    Adjusted EBITDA, including segment Adjusted EBITDA, has limitations as an analytical tool and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP. We may in the future incur expenses similar to the adjustments we make. In particular, we expect to incur meaningful share-based compensation expense in the future. Other limitations include that Adjusted EBITDA, including segment Adjusted EBITDA, does not reflect:

    • all expenditures or future requirements for capital expenditures or contractual commitments;
    • changes in our working capital needs;
    • interest expense, which is an ongoing element of our costs to operate;
    • income tax (expense) benefit, which may be a necessary element of our costs and ability to operate;
    • the costs of replacing the assets being depreciated and amortized, which will often have to be replaced in the future;
    • the noncash component of employee compensation expense;
    • long-lived assets impairment costs; and
    • the impact of earnings or charges resulting from matters we consider not to be reflective, on a recurring basis, of our ongoing operations, such as our restructuring activities and reductions in workforce.

    In addition, Adjusted EBITDA may not be comparable to similarly titled measures used by other companies in our industry or across different industries.

    ADAPTIVE INVESTORS
    Karina Calzadilla, Vice President, Investor Relations
    201-396-1687
    investors@adaptivebiotech.com

    ADAPTIVE MEDIA
    Erica Jones, Associate Corporate Communications Director
    206-279-2423
    media@adaptivebiotech.com

     
    Adaptive Biotechnologies
    Condensed Consolidated Statements of Operations
    (in thousands, except share and per share amounts)
    (unaudited)
           
      Three Months Ended September 30,  Nine Months Ended September 30, 
      2024  2023  2024  2023 
    Revenue $46,435  $37,919  $131,498  $124,492 
    Operating expenses            
    Cost of revenue  16,667   19,346   54,035   55,937 
    Research and development  24,163   28,533   79,761   93,371 
    Sales and marketing  20,551   20,493   63,184   66,673 
    General and administrative  17,258   20,075   54,750   63,208 
    Amortization of intangible assets  428   428   1,275   1,270 
    Impairment of long-lived assets        7,205    
    Total operating expenses  79,067   88,875   260,210   280,459 
    Loss from operations  (32,632)  (50,956)  (128,712)  (155,967)
    Interest and other income, net  3,474   4,282   11,462   10,918 
    Interest expense  (2,939)  (3,652)  (8,628)  (10,788)
    Net loss  (32,097)  (50,326)  (125,878)  (155,837)
    Add: Net loss attributable to noncontrolling interest  26   26   78   28 
    Net loss attributable to Adaptive Biotechnologies Corporation $(32,071) $(50,300) $(125,800) $(155,809)
    Net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted $(0.22) $(0.35) $(0.86) $(1.08)
    Weighted-average shares used in computing net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted  147,516,398   144,704,868   146,908,234   144,208,940 
                     


     
    Adaptive Biotechnologies
    Condensed Consolidated Balance Sheets
    (in thousands, except share and per share amounts)
           
      September 30, 2024  December 31,
    2023
     
      (unaudited)    
    Assets      
    Current assets      
    Cash and cash equivalents $38,084  $65,064 
    Short-term marketable securities (amortized cost of $204,757 and $281,122, respectively)  205,245   281,337 
    Accounts receivable, net  40,814   37,969 
    Inventory  11,955   14,448 
    Prepaid expenses and other current assets  12,247   11,370 
    Total current assets  308,345   410,188 
    Long-term assets      
    Property and equipment, net  51,314   68,227 
    Operating lease right-of-use assets  46,530   52,096 
    Long-term marketable securities (amortized cost of $23,857)  23,866    
    Restricted cash  2,978   2,932 
    Intangible assets, net  3,853   5,128 
    Goodwill  118,972   118,972 
    Other assets  2,648   3,591 
    Total assets $558,506  $661,134 
    Liabilities and shareholders’ equity      
    Current liabilities      
    Accounts payable $7,351  $7,719 
    Accrued liabilities  6,062   8,597 
    Accrued compensation and benefits  12,337   13,685 
    Current portion of operating lease liabilities  10,021   9,384 
    Current portion of deferred revenue  51,856   48,630 
    Total current liabilities  87,627   88,015 
    Long-term liabilities      
    Operating lease liabilities, less current portion  81,804   89,388 
    Deferred revenue, less current portion  32,781   44,793 
    Revenue interest liability, net  132,700   130,660 
    Other long-term liabilities  20    
    Total liabilities  334,932   352,856 
    Commitments and contingencies      
    Shareholders’ equity      
    Preferred stock: $0.0001 par value, 10,000,000 shares authorized at September 30, 2024 and December 31, 2023; no shares issued and outstanding at September 30, 2024 and December 31, 2023      
    Common stock: $0.0001 par value, 340,000,000 shares authorized at September 30, 2024 and December 31, 2023; 147,561,586 and 145,082,271 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively  14   14 
    Additional paid-in capital  1,493,394   1,452,502 
    Accumulated other comprehensive gain  497   215 
    Accumulated deficit  (1,270,132)  (1,144,332)
    Total Adaptive Biotechnologies Corporation shareholders’ equity  223,773   308,399 
    Noncontrolling interest  (199)  (121)
    Total shareholders’ equity  223,574   308,278 
    Total liabilities and shareholders’ equity $558,506  $661,134 
             

    Adjusted EBITDA

    The following is a reconciliation of net loss attributable to Adaptive Biotechnologies Corporation, the most directly comparable GAAP financial measure, to Adjusted EBITDA for the periods presented (in thousands, unaudited):

      Three Months Ended September 30,  Nine Months Ended
    September 30,
     
      2024  2023  2024  2023 
    Net loss attributable to Adaptive Biotechnologies Corporation $(32,071) $(50,300) $(125,800) $(155,809)
    Interest and other income, net  (3,474)  (4,282)  (11,462)  (10,918)
    Interest expense  2,939   3,652   8,628   10,788 
    Depreciation and amortization expense  4,591   5,763   14,808   16,839 
    Impairment of long-lived assets        7,205    
    Restructuring expense  193      1,917    
    Share-based compensation expense  13,522   15,336   40,778   47,352 
    Adjusted EBITDA $(14,300) $(29,831) $(63,926) $(91,748)
                     

    Segment Information (Including Segment Adjusted EBITDA)

    The following tables set forth our segment information for the three and nine months ended September 30, 2024 and 2023, respectively (in thousands, unaudited):

      Three Months Ended September 30, 2024 
      MRD  Immune Medicine  Unallocated Corporate  Total 
    Revenue $37,470  $8,965  $  $46,435 
    Operating expenses  52,538   20,689   5,840   79,067 
    Adjusted EBITDA  (6,120)  (5,212)  (2,968)  (14,300)
    Reconciliation of Net Loss to Adjusted EBITDA:            
    Net loss $(15,068) $(11,724) $(5,305) $(32,097)
    Net loss attributable to noncontrolling interest        26   26 
    Net loss attributable to Adaptive Biotechnologies Corporation  (15,068)  (11,724)  (5,279)  (32,071)
    Interest and other income, net        (3,474)  (3,474)
    Interest expense        2,939   2,939 
    Depreciation and amortization expense  2,428   1,728   435   4,591 
    Restructuring expense  167   26      193 
    Share-based compensation expense  6,353   4,758   2,411   13,522 
    Adjusted EBITDA $(6,120) $(5,212) $(2,968) $(14,300)


      Three Months Ended September 30, 2023 
      MRD  Immune Medicine  Unallocated Corporate  Total 
    Revenue $24,668  $13,251  $  $37,919 
    Operating expenses  55,977   26,400   6,498   88,875 
    Adjusted EBITDA  (21,616)  (4,986)  (3,229)  (29,831)
    Reconciliation of Net Loss to Adjusted EBITDA:            
    Net loss $(31,309) $(13,148) $(5,869) $(50,326)
    Net loss attributable to noncontrolling interest        26   26 
    Net loss attributable to Adaptive Biotechnologies Corporation  (31,309)  (13,148)  (5,843)  (50,300)
    Interest and other income, net        (4,282)  (4,282)
    Interest expense        3,652   3,652 
    Depreciation and amortization expense  2,489   2,546   728   5,763 
    Share-based compensation expense  7,204   5,616   2,516   15,336 
    Adjusted EBITDA $(21,616) $(4,986) $(3,229) $(29,831)


      Nine Months Ended September 30, 2024 
      MRD  Immune Medicine  Unallocated Corporate  Total 
    Revenue $105,380  $26,118  $  $131,498 
    Operating expenses  170,785   70,663   18,762   260,210 
    Adjusted EBITDA  (34,668)  (19,172)  (10,086)  (63,926)
    Reconciliation of Net Loss to Adjusted EBITDA:            
    Net loss $(65,405) $(44,545) $(15,928) $(125,878)
    Net loss attributable to noncontrolling interest        78   78 
    Net loss attributable to Adaptive Biotechnologies Corporation  (65,405)  (44,545)  (15,850)  (125,800)
    Interest and other income, net        (11,462)  (11,462)
    Interest expense        8,628   8,628 
    Depreciation and amortization expense  7,733   5,777   1,298   14,808 
    Impairment of long-lived assets  2,819   4,386      7,205 
    Restructuring expense  1,195   722      1,917 
    Share-based compensation expense  18,990   14,488   7,300   40,778 
    Adjusted EBITDA $(34,668) $(19,172) $(10,086) $(63,926)


      Nine Months Ended September 30, 2023 
      MRD  Immune Medicine  Unallocated Corporate  Total 
    Revenue $71,977  $52,515  $  $124,492 
    Operating expenses  170,946   88,753   20,760   280,459 
    Adjusted EBITDA  (71,081)  (11,149)  (9,518)  (91,748)
    Reconciliation of Net Loss to Adjusted EBITDA:            
    Net loss $(98,969) $(36,236) $(20,632) $(155,837)
    Net loss attributable to noncontrolling interest        28   28 
    Net loss attributable to Adaptive Biotechnologies Corporation  (98,969)  (36,236)  (20,604)  (155,809)
    Interest and other income, net        (10,918)  (10,918)
    Interest expense        10,788   10,788 
    Depreciation and amortization expense  6,812   7,907   2,120   16,839 
    Share-based compensation expense  21,076   17,180   9,096   47,352 
    Adjusted EBITDA $(71,081) $(11,149) $(9,518) $(91,748)
                     

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