UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of December 2024

Commission File Number: 001-39316

 

 

BURNING ROCK BIOTECH LIMITED

(Registrant’s Name)

 

 

No.5 Xingdao Ring Road North, International Bio Island

Guangzhou, Guangdong

People’s Republic of China

(Address of principal executive offices)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒   Form 40-F ☐

 

 

 


INCORPORATION BY REFERENCE

Exhibit 99.1 (excluding the paragraphs under the heading “Non-GAAP Measures,” the table under the heading “Burning Rock Biotech Limited Reconciliations of GAAP and Non-GAAP Results,” and other discussions on non-GAAP measures therein) of this current report on Form 6-K (the “Report”) shall be incorporated by reference into the Company’s registration statements on Form F-3, which became effective on September 30, 2022 (File no. 333-264577).

 

2


EXHIBIT INDEX

 

Number

  

Description of Document

Exhibit 99.1    Press release

 

3


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Burning Rock Biotech Limited
By:   /s/ Yusheng Han
Name:   Yusheng Han
Title:   Chief Executive Officer

 

Date: December 4, 2024      

 

4

Exhibit 99.1

Burning Rock Reports Third Quarter 2024 Financial Results

GUANGZHOU, China, December 4, 2024—Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended September 30, 2024.

Recent Business Updates

 

   

Therapy Selection

 

   

Presented study results at the 2024 World Conference on Lung Cancer in September 2024. “Neoadjuvant sintilimab plus chemotherapy could be an optional treatment modality in selected EGFR-mutant NSCLC” and “Distinct Genomic and Immune Microenvironment Features of Solid or Micropapillary Predominant Subtype in Stage I Lung Adenocarcinomas”.

 

   

Signed a strategic cooperation agreement with MGI Tech Co., Ltd in October 2024, aiming to fully complement each other’s platform and technological advantages to further promote the clinical application progress and global business of precision oncology.

 

   

Pharma Services

 

   

The companion diagnostic (CDx) for EGFR exon 20 insertion mutation (exon20ins) for sunvozertinib, developed through the collaboration of Burning Rock and Dizal, has been approved by the National Medical Products Administration (NMPA) of China, which marks the first co-developed NGS-based CDx for lung cancer approved by NMPA since the release of the CDx guideline in China.

Third Quarter 2024 Financial Results

Total revenues were RMB128.6 million (US$18.3 million) for the three months ended September 30, 2024, representing a 0.8% increase from RMB127.6 million for the same period in 2023, the increased revenue of in-hospital business was offset by the decrease of central-lab business, as we transition from central-lab to more in-hospital based testing.

 

   

Revenue generated from in-hospital business was RMB63.8 million (US$9.1 million) for the three months ended September 30, 2024, representing a 17.0% increase from RMB54.5 million for the same period in 2023, driven by an increase in sales volume.

 

   

Revenue generated from central laboratory business was RMB40.0 million (US$5.7 million) for the three months ended September 30, 2024, representing a 25.2% decrease from RMB53.5 million for the same period in 2023, primarily attributable to a decrease in the number of tests, as we continued our transition towards in-hospital testing.

 

   

Revenue generated from pharma research and development services was RMB24.9 million (US$3.5 million) for the three months ended September 30, 2024, representing a 27.1% increase from RMB19.6 million for the same period in 2023, primarily attributable to an increased development and testing services performed for our pharma customers.

Cost of revenues was RMB36.8 million (US$5.2 million) for the three months ended September 30, 2024, representing an 11.6% decrease from RMB41.6 million for the same period in 2023, primarily due to (i) a decrease in cost of central laboratory business, which was in line with the decrease in revenue generated from this business; (ii) a decrease in amortization expense for all kinds of business; and (iii) the receipt of a government grant for Guangzhou headquarters building.

Gross profit was RMB91.8 million (US$13.1 million) for the three months ended September 30, 2024, representing a 6.9% increase from RMB85.9 million for the same period in 2023. Gross margin was 71.4% for the three months ended September 30, 2024, compared to 67.4% for the same period in 2023. By channel, gross margin of central laboratory business was 83.2% for the three months ended September 30, 2024, compared to 77.6% during the same period in 2023, primarily due to the decreased depreciation and rental cost in relation to our laboratory of Guangzhou headquarters; gross margin of in-hospital business was 73.0% for the three months ended September 30, 2024, compared to 65.1% during the same period in 2023, primarily due to the same reason; gross margin of pharma research and development services was 48.2% for the three months ended September 30, 2024, compared to 45.8% during the same period of 2023.

 

1


Non-GAAP gross profit, which excludes depreciation and amortization expenses, was RMB97.8 million (US$13.9million) for the three months ended September 30, 2024, representing a 2.8% increase from RMB95.1 million for the same period in 2023. Non-GAAP gross margin was 76.0% for the three months ended September 30, 2024, compared to 74.5% for the same period in 2023.

Operating expenses were RMB130.4 million (US$18.6 million) for the three months ended September 30, 2024, representing a 50.7% decrease from RMB264.7 million for the same period in 2023. The decrease was primarily driven by decreases in amortized expense on share-based compensation, budget control measures and headcount reduction to improve the Company’s operating efficiency.

 

   

Research and development expenses were RMB49.2 million (US$7.0 million) for the three months ended September 30, 2024, representing a 41.3% decrease from RMB83.7 million for the same period in 2023, primarily due to (i) a decrease in staff cost resulted from the reorganization of our research and development department to improve operating efficiency; (ii) a decrease in the expenditure for research projects; (iii) a decrease in amortized expense on share-based compensation; and (iv) a decrease in amortized expenses for office building decoration.

 

   

Selling and marketing expenses were RMB48.4 million (US$6.9 million) for the three months ended September 30, 2024, representing a 22.3% decrease from RMB62.3 million for the same period in 2023, primarily due to (i) a decrease in staff cost resulted from the reorganization of the sales department and improvement in operating efficiency; (ii) a decrease in conference fee; and (iii) a decrease in entertainment expense.

 

   

General and administrative expenses were RMB32.9 million (US$4.7 million) for the three months ended September 30, 2024, representing a 72.3% decrease from RMB118.7 million for the same period in 2023, primarily due to (i) a decrease in amortized expense on share-based compensation; (ii) a decrease in amortized expenses for office building decoration; (iii) a decrease in operating lease; and (iv) a decrease in general and administrative personnel’s staff cost.

Net loss was RMB35.7 million (US$5.10 million) for the three months ended September 30, 2024, compared to RMB175.0 million for the same period in 2023.

Cash, cash equivalents, restricted cash and short-term investments were RMB498.2 million (US$71.0 million) as of September 30, 2024.

About Burning Rock

Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, and ii) cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.

For more information about Burning Rock, please visit: ir.brbiotech.com.

Safe Harbor Statement

This press release contains forward-looking statements. These statements constitute “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “target,” “confident” and similar statements. Burning Rock may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about Burning Rock’s beliefs and expectations, are forward-looking statements. Such statements are based upon management’s current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond Burning Rock’s control. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. All information provided in this press release is as of the date of this press release, and Burning Rock does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.

 

2


Non-GAAP Measures

In evaluating the business, the Company considers and uses non-GAAP measures, such as non-GAAP gross profit and non-GAAP gross margin, as supplemental measures to review and assess operating performance. The presentation of these non-GAAP financial measures is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The company defines non-GAAP gross profit as gross profit excluding depreciation and amortization. The company defines non-GAAP gross margin as gross margin excluding depreciation and amortization.

The company presents these non-GAAP financial measures because they are used by management to evaluate operating performance and formulate business plans. The company believe non-GAAP gross profit and non-GAAP gross margin excluding non-cash impact of depreciation and amortization reflect the company’s ongoing business operations in a manner that allows more meaningful period-to-period comparisons.

Contact: IR@brbiotech.com

 

3


Selected Operating Data

 

     As of  
     September 30,
2023
     December 31,
2023
     March 31,
2024
     June 30,
2024
     September 30,
2024
 

In-hospital Channel:

              

Pipeline partner hospitals(1)

     29        28        28        29        30  

Contracted partner hospitals(2)

     55        59        59        59        61  

Total number of partner hospitals

     84        87        87        88        91  

 

(1) 

Refers to hospitals that are in the process of establishing in-hospital laboratories, laboratory equipment procurement or installation, staff training or pilot testing using the Company’s products.

(2) 

Refers to hospitals that have entered into contracts to purchase the Company’s products for use on a recurring basis in their respective in-hospital laboratories the Company helped them establish. Kit revenue is generated from contracted hospitals.

 

4


Selected Financial Data

 

     For the three months ended  
Revenues    September 30,
2023
     December 31,
2023
     March 31,
2024
     June 30,
2024
     September 30,
2024
 
     (RMB in thousands)  

Central laboratory channel

     53,481        51,288        47,614        48,773        39,984  

In-hospital channel

     54,496        28,809        57,387        59,872        63,769  

Pharma research and development channel

     19,589        40,988        20,622        26,888        24,891  

Total revenues

     127,566        121,085        125,623        135,533        128,644  
     For the three months ended  
Gross profit    September 30,
2023
     December 31,
2023
     March 31,
2024
     June 30,
2024
     September 30,
2024
 
     (RMB in thousands)  

Central laboratory channel

     41,487        41,886        37,002        38,424        33,262  

In-hospital channel

     35,459        12,910        39,192        44,058        46,580  

Pharma research and development channel

     8,974        23,317        9,500        12,956        12,004  

Total gross profit

     85,920        78,113        85,694        95,438        91,846  
     For the three months ended  
Share-based compensation expenses    September 30,
2023
     December 31,
2023
     March 31,
2024
     June 30,
2024
     September 30,
2024
 
     (RMB in thousands)  

Cost of revenues

     680        654        596        464        289  

Research and development expenses

     12,161        12,401        12,287        12,008        3,180  

Selling and marketing expenses

     2,848        1,816        508        1,232        1,917  

General and administrative expenses

     57,704        56,472        55,990        54,407        4,732  

Total share-based compensation expenses

     73,393        71,343        69,381        68,111        10,118  

 

5


Burning Rock Biotech Limited

Unaudited Condensed Statements of Comprehensive Loss

(in thousands, except for number of shares and per share data)

 

     For the three months ended  
     September 30,
2023
    December 31,
2023
    March 31,
2024
    June 30,
2024
    September 30,
2024
    September 30,
2024
 
     RMB     RMB     RMB     RMB     RMB     US$  

Revenues

     127,566       121,085       125,623       135,533       128,644       18,331  

Cost of revenues

     (41,646     (42,972     (39,929     (40,095     (36,798     (5,243
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     85,920       78,113       85,694       95,438       91,846       13,088  

Operating expenses:

            

Research and development expenses

     (83,701     (73,119     (65,985     (64,952     (49,150     (7,004

Selling and marketing expenses

     (62,310     (49,785     (46,856     (48,907     (48,411     (6,899

General and administrative expenses

     (118,724     (121,533     (98,681     (92,794     (32,874     (4,685
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (264,735     (244,437     (211,522     (206,653     (130,435     (18,588
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (178,815     (166,324     (125,828     (111,215     (38,589     (5,500

Interest income

     4,018       5,539       4,038       3,187       3,173       452  

Other income (expense), net

     (157     160       434       (82     1       —   

Foreign exchange (loss) gain, net

     423       (517     (13     262       (129     (18
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income tax

     (174,531     (161,142     (121,369     (107,848     (35,544     (5,066

Income tax expenses

     (450     (1,071     (180     (190     (201     (29
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

     (174,981     (162,213     (121,549     (108,038     (35,745     (5,095
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to Burning Rock Biotech Limited’s shareholders

     (174,981     (162,213     (121,549     (108,038     (35,745     (5,095

Net loss attributable to ordinary shareholders

     (174,981     (162,213     (121,549     (108,038     (35,745     (5,095

Loss per share for class A and class B ordinary shares:

            

Class A ordinary shares - basic and diluted

     (1.71     (1.58     (1.19     (1.05     (0.35     (0.05

Class B ordinary shares - basic and diluted

     (1.71     (1.58     (1.19     (1.05     (0.35     (0.05

Weighted average shares outstanding used in loss per share computation:

            

Class A ordinary shares - basic and diluted

     85,000,869       85,071,360       85,219,188       85,271,858       85,902,670       85,902,670  

Class B ordinary shares - basic and diluted

     17,324,848       17,324,848       17,324,848       17,324,848       17,324,848       17,324,848  

Other comprehensive income (loss), net of tax of nil:

            

Foreign currency translation adjustments

     (1,955     (3,026     590       940       (4,054     (578

Total comprehensive loss

     (176,936     (165,239     (120,959     (107,098     (39,799     (5,673

Total comprehensive loss attributable to Burning Rock Biotech Limited’s shareholders

     (176,936     (165,239     (120,959     (107,098     (39,799     (5,673

 

6


Burning Rock Biotech Limited

Unaudited Condensed Statements of Comprehensive Loss

(in thousands, except for number of shares and per share data)

 

     For the nine months ended  
     September 30,
2023
    September 30,
2024
    September 30,
2024
 
     RMB     RMB     US$  

Revenues

     416,350       389,800       55,546  

Cost of revenues

     (131,236     (116,822     (16,648
  

 

 

   

 

 

   

 

 

 

Gross profit

     285,114       272,978       38,898  

Operating expenses:

      

Research and development expenses

     (273,897     (180,087     (25,662

Selling and marketing expenses

     (197,926     (144,174     (20,545

General and administrative expenses

     (316,288     (224,349     (31,969
  

 

 

   

 

 

   

 

 

 

Total operating expenses

     (788,111     (548,610     (78,176
  

 

 

   

 

 

   

 

 

 

Loss from operations

     (502,997     (275,632     (39,278

Interest income

     12,417       10,398       1,482  

Other income, net

     324       353       50  

Foreign exchange gain, net

     97       120       17  
  

 

 

   

 

 

   

 

 

 

Loss before income tax

     (490,159     (264,761     (37,729

Income tax expenses

     (1,317     (571     (81
  

 

 

   

 

 

   

 

 

 

Net loss

     (491,476     (265,332     (37,810
  

 

 

   

 

 

   

 

 

 

Net loss attributable to Burning Rock Biotech Limited’s shareholders

     (491,476     (265,332     (37,810

Net loss attributable to ordinary shareholders

     (491,476     (265,332     (37,810

Loss per share for class A and class B ordinary shares:

      

Class A ordinary shares - basic and diluted

     (4.80     (2.58     (0.37

Class B ordinary shares - basic and diluted

     (4.80     (2.58     (0.37

Weighted average shares outstanding used in loss per share computation:

      

Class A ordinary shares - basic and diluted

     85,070,921       85,467,131       85,467,131  

Class B ordinary shares - basic and diluted

     17,324,848       17,324,848       17,324,848  

Other comprehensive income (loss), net of tax of nil:

      

Foreign currency translation adjustments

     7,215       (2,524     (360

Total comprehensive loss

     (484,261     (267,856     (38,170

Total comprehensive loss attributable to Burning Rock Biotech Limited’s shareholders

     (484,261     (267,856     (38,170

 

7


Burning Rock Biotech Limited

Unaudited Condensed Consolidated Balance Sheets

(In thousands)

 

     As of  
     December 31,
2023
     September 30,
2024
     September 30,
2024
 
     RMB      RMB      US$  

ASSETS

        

Current assets:

        

Cash and cash equivalents

     615,096        497,969        70,960  

Restricted cash

     120        278        40  

Accounts receivable, net

     126,858        166,491        23,725  

Contract assets, net

     22,748        17,750        2,529  

Inventories, net

     69,020        66,444        9,468  

Prepayments and other current assets, net

     50,254        30,623        4,364  

Convertible note receivable

     —         5,320        758  
  

 

 

    

 

 

    

 

 

 

Total current assets

     884,096        784,875        111,844  
  

 

 

    

 

 

    

 

 

 

Non-current assets:

        

Equity method investment

     337        243        35  

Convertible note receivable

     5,320        —         —   

Property and equipment, net

     131,912        90,139        12,845  

Operating right-of-use assets

     12,284        99,301        14,150  

Intangible assets, net

     964        525        75  

Other non-current assets

     5,088        9,722        1,385  
  

 

 

    

 

 

    

 

 

 

Total non-current assets

     155,905        199,930        28,490  
  

 

 

    

 

 

    

 

 

 

TOTAL ASSETS

     1,040,001        984,805        140,334  
  

 

 

    

 

 

    

 

 

 

 

8


Burning Rock Biotech Limited

Unaudited Condensed Consolidated Balance Sheets (Continued)

(in thousands)

 

     As of  
     December 31,
2023
    September 30,
2024
    September 30,
2024
 
     RMB     RMB     US$  

LIABILITIES AND SHAREHOLDERS’ EQUITY

      

Current liabilities:

      

Accounts payable

     18,061       25,213       3,593  

Deferred revenue

     130,537       110,748       15,781  

Accrued liabilities and other current liabilities

     104,935       94,110       13,411  

Customer deposits

     1,197       567       81  

Current portion of operating lease liabilities

     8,634       27,842       3,967  
  

 

 

   

 

 

   

 

 

 

Total current liabilities

     263,364       258,480       36,833  
  

 

 

   

 

 

   

 

 

 

Non-current liabilities:

      

Non-current portion of operating lease liabilities

     3,690       73,055       10,410  

Other non-current liabilities

     4,537       5,104       728  
  

 

 

   

 

 

   

 

 

 

Total non-current liabilities

     8,227       78,159       11,138  
  

 

 

   

 

 

   

 

 

 

TOTAL LIABILITIES

     271,591       336,639       47,971  
  

 

 

   

 

 

   

 

 

 

Shareholders’ equity:

      

Class A ordinary shares

     116       118       17  

Class B ordinary shares

     21       21       3  

Additional paid-in capital

     4,849,337       4,996,947       712,059  

Treasury stock

     (65,896     (65,896     (9,390

Accumulated deficits

     (3,853,635     (4,118,967     (586,948

Accumulated other comprehensive loss

     (161,533     (164,057     (23,378
  

 

 

   

 

 

   

 

 

 

Total shareholders’ equity

     768,410       648,166       92,363  
  

 

 

   

 

 

   

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

     1,040,001       984,805       140,334  
  

 

 

   

 

 

   

 

 

 

 

9


Burning Rock Biotech Limited

Unaudited Condensed Statements of Cash Flows

(in thousands)

 

     For the three months ended  
     September 30,
2023
    September 30,
2024
    September 30,
2024
 
     RMB     RMB     US$  

Net cash used in operating activities

     (47,417     (30,278     (4,315

Net cash used in investing activities

     (1,985     (987     (141

Net cash (used in)/generated from financing activities

     (45,888     2       —   

Effect of exchange rate on cash, cash equivalents and restricted cash

     (1,239     (3,537     (503

Net decrease in cash, cash equivalents and restricted cash

     (96,529     (34,800     (4,959

Cash, cash equivalents and restricted cash at the beginning of period

     733,278       533,047       75,959  

Cash, cash equivalents and restricted cash at the end of period

     636,749       498,247       71,000  
     For the nine months ended  
     September 30,
2023
    September 30,
2024
    September 30,
2024
 
     RMB     RMB     US$  

Net cash used in operating activities

     (239,764     (111,323     (15,863

Net cash used in investing activities

     (8,972     (3,600     (513

Net cash (used in)/generated from financing activities

     (46,923     2       —   

Effect of exchange rate on cash, cash equivalents and restricted cash

     7,140       (2,048     (292

Net decrease in cash, cash equivalents and restricted cash

     (288,519     (116,969     (16,668

Cash, cash equivalents and restricted cash at the beginning of period

     925,268       615,216       87,668  

Cash, cash equivalents and restricted cash at the end of period

     636,749       498,247       71,000  

 

10


Burning Rock Biotech Limited

Reconciliations of GAAP and Non-GAAP Results

 

     For the three months ended  
     September 30,
2023
    December 31,
2023
    March 31,
2024
    June 30,
2024
    September 30,
2024
 
     (RMB in thousands)  

Gross profit:

    

Central laboratory channel

     41,487       41,886       37,002       38,424       33,262  

In-hospital channel

     35,459       12,910       39,192       44,058       46,580  

Pharma research and development channel

     8,974       23,317       9,500       12,956       12,004  

Total gross profit

     85,920       78,113       85,694       95,438       91,846  

Add: depreciation and amortization:

          

Central laboratory channel

     2,550       2,414       1,919       1,226       1,277  

In-hospital channel

     2,751       2,728       1,524       824       798  

Pharma research and development channel

     3,863       3,808       3,856       4,417       3,846  

Total depreciation and amortization included in cost of revenues

     9,164       8,950       7,299       6,467       5,921  

Non-GAAP gross profit:

          

Central laboratory channel

     44,037       44,300       38,921       39,650       34,539  

In-hospital channel

     38,210       15,638       40,716       44,882       47,378  

Pharma research and development channel

     12,837       27,125       13,356       17,373       15,850  

Total non-GAAP gross profit

     95,084       87,063       92,993       101,905       97,767  

Non-GAAP gross margin:

          

Central laboratory channel

     82.3     86.4     81.7     81.3     86.4

In-hospital channel

     70.1     54.3     70.9     75.0     74.3

Pharma research and development channel

     65.5     66.2     64.8     64.6     63.7

Total non-GAAP gross margin

     74.5     71.9     74.0     75.2     76.0

 

11


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