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 March 31, 2022.

“We started the year strong and completed a strategic reorganization of our company around two key business areas: MRD and Immune Medicine,” said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. “I am encouraged by the solid momentum across both business areas as we optimize our resource allocation to capitalize on the multiple opportunities ahead.”

Recent Highlights

  • Revenue of $38.6 million for the first quarter 2022, representing a 0.5% increase from the first quarter 2021.
  • clonoSEQ test volume in the first quarter 2022 grew 45% versus the first quarter of prior year and 12% over the fourth quarter of 2021. 
  • Signed expanded MRD pan-portfolio agreement with major partner in MM and CLL for the use of MRD status as a clinical endpoint.
  • Recognized $3.0 million in MRD regulatory milestone revenue resulting from a biopharmaceutical partner who used data from our MRD assay to support its drug approval. 
  • Completed analysis from immuneSense Lyme blinded data from 990 participants, confirming T-Detect Lyme is nearly twice as sensitive as the current standard of care (54% T-Detect Lyme vs 30% STTT sensitivity, both at 99% specificity). T-Detect Lyme offering to be made available during 2022 Lyme season. 
  • Entered a new T-MAP collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson to map T cell responses to RSV to support Janssen’s RSV vaccine program. 
  • Announced the appointment of Tycho Peterson as chief financial officer, who brings several decades of financial leadership and experience within the life science and diagnostic industries.

First Quarter 2022 Financial Results

Revenue was $38.6 million for the quarter ended March 31, 2022, representing a 0.5% increase from the first quarter in the prior year. Immune Medicine revenue was $20.8 million for the quarter, representing a 4% increase from the first quarter in the prior year. MRD revenue was $17.8 million for the quarter, representing a 3% decrease from the first quarter in the prior year.

Operating expenses were $101.7 million for the first quarter of 2022, compared to $79.7 million in the first quarter of the prior year, representing an increase of 28%.

Net loss was $62.8 million for the first quarter of 2022, compared to $40.6 million for the same period in 2021.

Cash, cash equivalents and marketable securities was $500.7 million as of March 31, 2022.

2022 Financial Guidance

Adaptive Biotechnologies reiterates full year 2022 revenue to be in the range of $185 million to $195 million.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its first quarter 2022 financial results after market close on Wednesday, May 4, 2022 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 to develop products in life sciences research, clinical diagnostics and drug discovery. We have three commercial products and a robust clinical pipeline to diagnose, monitor and enable the 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.

ADAPTIVE MEDIALaura Cooper205-908-5603media@adaptivebiotech.com

ADAPTIVE INVESTORSKarina Calzadilla, Vice President, Investor Relations201-396-1687Carrie Mendivil, Gilmartin Groupinvestors@adaptivebiotech.com

Adaptive BiotechnologiesCondensed Consolidated Statements of Operations(in thousands, except share and per share amounts)(unaudited)
 
    Three Months Ended March 31,  
    2022     2021  
Revenue   $ 38,620     $ 38,442  
Operating expenses                
Cost of revenue     13,192       9,991  
Research and development     37,839       33,772  
Sales and marketing     26,093       20,604  
General and administrative     24,144       14,936  
Amortization of intangible assets     419       419  
Total operating expenses     101,687       79,722  
Loss from operations     (63,067 )     (41,280 )
Interest and other income, net     271       638  
Net loss     (62,796 )     (40,642 )
Add: Net loss attributable to noncontrolling interest     60        
Net loss attributable to Adaptive Biotechnologies Corporation   $ (62,736 )   $ (40,642 )
Net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted   $ (0.44 )   $ (0.29 )
Weighted-average shares used in computing net loss per share attributable to Adaptive Biotechnologies Corporation common shareholders, basic and diluted     141,697,252       138,967,754  
                 

Adaptive BiotechnologiesCondensed Consolidated Balance Sheets(in thousands, except share and per share amounts)
    March 31, 2022     December 31, 2021  
    (unaudited)          
Assets                
Current assets                
Cash and cash equivalents   $ 114,805     $ 139,065  
Short-term marketable securities (amortized cost of $250,448 and $214,115, respectively)     248,757       213,996  
Accounts receivable, net     22,518       17,409  
Inventory     21,002       19,263  
Prepaid expenses and other current assets     12,038       13,015  
Total current assets     419,120       402,748  
Long-term assets                
Property and equipment, net     85,994       85,262  
Operating lease right-of-use assets     85,634       87,678  
Long-term marketable securities (amortized cost of $140,202 and $218,163, respectively)     137,110       217,145  
Restricted cash     2,382       2,138  
Intangible assets, net     8,107       8,526  
Goodwill     118,972       118,972  
Other assets     874       875  
Total assets   $ 858,193     $ 923,344  
Liabilities and shareholders’ equity                
Current liabilities                
Accounts payable   $ 5,959     $ 3,307  
Accrued liabilities     10,407       9,343  
Accrued compensation and benefits     6,651       15,642  
Current portion of operating lease liabilities     8,545       5,055  
Current portion of deferred revenue     83,504       80,460  
Total current liabilities     115,066       113,807  
Long-term liabilities                
Operating lease liabilities, less current portion     104,978       106,685  
Deferred revenue, less current portion     84,894       98,750  
Total liabilities     304,938       319,242  
Commitments and contingencies                
Shareholders’ equity                
Preferred stock: $0.0001 par value, 10,000,000 shares authorized at March 31, 2022 and December 31, 2021; no shares issued and outstanding at March 31, 2022 and December 31, 2021            
Common stock: $0.0001 par value, 340,000,000 shares authorized at March 31, 2022 and December 31, 2021; 142,183,258 and 141,393,865 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively     14       14  
Additional paid-in capital     1,339,601       1,324,006  
Accumulated other comprehensive loss     (4,783 )     (1,137 )
Accumulated deficit     (781,627 )     (718,891 )
Total Adaptive Biotechnologies Corporation shareholders’ equity     553,205       603,992  
Noncontrolling interest     50       110  
Total shareholders’ equity     553,255       604,102  
Total liabilities and shareholders’ equity   $ 858,193     $ 923,344  
                 

Revenue Reclassification and clonoSEQ Test Volume

We previously disclosed revenue bifurcated into sequencing and development financial statement captions and now present total revenue on our unaudited condensed consolidated statements of operations.

The following table presents the amount of sequencing revenue and development revenue recognized under our Immune Medicine and MRD market opportunities for the periods presented (in thousands, unaudited):

    Three Months Ended  
    December 31,2021     September 30,2021     June 30,2021     March 31,2021  
Immune Medicine revenue                                
Sequencing revenue   $ 6,860     $ 8,170     $ 5,404     $ 4,048  
Development revenue     14,514       15,445       17,635       16,057  
Total Immune Medicine revenue     21,374       23,615       23,039       20,105  
MRD revenue                                
Sequencing revenue     16,201       13,936       13,151       11,126  
Development revenue     355       1,916       2,315       7,211  
Total MRD revenue     16,556       15,852       15,466       18,337  
Total revenue   $ 37,930     $ 39,467     $ 38,505     $ 38,442  
    Three Months Ended  
    December 31,2020     September 30,2020     June 30,2020     March 31,2020  
Immune Medicine revenue                                
Sequencing revenue   $ 3,310     $ 3,691     $ 2,036     $ 3,170  
Development revenue     17,155       12,438       12,856       11,077  
Total Immune Medicine revenue     20,465       16,129       14,892       14,247  
MRD revenue                                
Sequencing revenue     9,399       7,585       5,949       6,299  
Development revenue     321       2,585       147       364  
Total MRD revenue     9,720       10,170       6,096       6,663  
Total revenue   $ 30,185     $ 26,299     $ 20,988     $ 20,910  

We also previously disclosed the number of clonoSEQ reports provided to ordering physicians in the United States, referred to as “clinical sequencing volume” or “clinical sequencing volume, excluding T-Detect COVID volume” in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of certain of our SEC filings. We now present the number of clonoSEQ reports and results we have provided to ordering physicians in the United States and international technology transfer sites, collectively referred to as “clonoSEQ test volume.” Our clonoSEQ test volume does not include sample results from our biopharmaceutical customers or academic institutions utilizing our MRD services.

The following table presents our clonoSEQ test volume for the periods presented:

    Three Months Ended  
    December 31,2021     September 30,2021     June 30,2021     March 31,2021  
Clinical sequencing volume, excluding T-Detect COVID volume     6,356       5,928       5,475       4,757  
clonoSEQ reports or results provided to international technology transfer sites     494       413       422       543  
clonoSEQ test volume     6,850       6,341       5,897       5,300  
    Three Months Ended  
    December 31,2020     September 30,2020     June 30,2020     March 31,2020  
Clinical sequencing volume     4,509       4,023       3,136       3,518  
clonoSEQ reports or results provided to international technology transfer sites     704       375       310       238  
clonoSEQ test volume     5,213       4,398       3,446       3,756  
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