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SEC Comment Letter for Burning Rock Biotech Ltd (BNR) (CIK 0001792267) (BNR) — Dec 4, 2019

Burning Rock Biotech Ltd (BNR) (CIK 0001792267)
Date: Dec. 4, 2019 · CIK: 0001792267 · Accession: 0000000000-19-016120

AI Filing Summary & Sentiment

Date
December 4, 2019
Author
Not clearly detected
Form
UPLOAD
Company
Burning Rock Biotech Ltd (BNR) (CIK 0001792267)

Letter

December 4, 2019 Yusheng Han Director and Chief Executive Officer Burning Rock Biotech Ltd 601, 6/F, Building 3, Standard Industrial Unit 2 No. 7, Luoxuan 4th Road International Bio Island, Guangzhou, 510005 Peoples Republic of China Re:Burning Rock Biotech Ltd Draft Registration Statement on Form F-1 Submitted November 4, 2019 CIK No. 0001792267 Dear Mr. Han: We have reviewed your draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Draft Registration Statement on Form F-1 submitted on November 4, 2019 Prospectus Summary Overview, page 1 1.We note your reference to findings by China Insights Consultancy. Please provide us with a copy of the report. 2.The prospectus summary should include a balanced presentation of your business, including your competitive position in the industry. In the presentation of your business, you present your organization as a "China's number one cancer diagnostics company" and your platform technologies as "unrivaled" and "world-class." Please revise to state the

FirstName LastNameYusheng Han Comapany NameBurning Rock Biotech Ltd December 4, 2019 Page 2 FirstName LastNameYusheng Han Burning Rock Biotech Ltd December 4, 2019 Page 2 basis for your performance claims or revise to state such claims are management's belief. Additionally, please balance your summary presentation by providing equally prominent disclosure about the competitive, regulatory and technical challenges you face. 3.We note your statement that your "products are validated by the medical, pharmaceutical and scientific communities...." Please clarify what you mean by "validated" in your disclosure. 4.We note that you currently offer 13 NGS-based cancer genotyping tests applicable to a broad range of cancer types. Please revise your disclosure to identify in the Summary the specific cancer types. 5.Where you reference your collaborations on clinical trials, please revise your disclosure to indicate you primarily provide central laboratory services and companion diagnostics development services, as discussed on page 119. Please also expand your disclosure in the Business section to include any compensation arrangements with oncology key opinion leaders. Our Addressable Markets, page 3 6.Please revise your references here and throughout your registration statement to your "addressable" market to remove any implication you have captured or are likely to capture the stated market potential. Implication of Being an Emerging Growth Company, page 5 7.Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. Risks Related to Our Business and Industry If we were to be sued for product liability or professional liability….., page 16 8.We note your disclosure that similar to other Chinese companies, you do not carry product liability or professional liability insurance. Please briefly explain the relevant features of the China market that impact this decision. We rely on a limited number of suppliers, or in some cases, sole suppliers, for some of our laboratory equipment and supplies, page 19 9.We note your disclosure that you source sequencers, reagents and certain other laboratory supplies used in your laboratory operations from several sole suppliers. Your supply agreements appear to be material contracts. Please expand your disclosure in the Business section to provide the material terms of your material supply agreements, including each parties’ rights and obligations, financial terms, term and termination provisions.

FirstName LastNameYusheng Han Comapany NameBurning Rock Biotech Ltd December 4, 2019 Page 3 FirstName LastNameYusheng Han Burning Rock Biotech Ltd December 4, 2019 Page 3 Please also file your supply agreements as exhibits to your registration statement or tell us why you believe such filing is not required. Refer to Item 601(b)(10) of Regulation S-K.

Risks Relating to Our ADSs and This Offering Our dual-class structure with different voting rights will limit your ability to influence corporate matters…., page 53 10.We note your disclosure that each Class B ordinary share will be entitled to six votes. Please expand your disclosure to discuss the risk that future issuance of Class B shares may be dilutive to holders of Class A shares and that your dual-class structure may render your shares ineligible for inclusion in certain stock market indices and the potential impact on the market price and liquidity of your ordinary shares.

Use of Proceeds, page 58 11.Please revise the discussion to disclose the estimated net amount of the proceeds broken down into each principal intended use, (i) research and development of our early cancer detection technologies, (ii) obtaining NMPA approvals for additional cancer genotyping products, including completing related clinical trials; and (iii) other general and administrative matters. If the anticipated proceeds will not be sufficient to fund all the proposed purposes, please disclose the order of priority of such purposes. To the extent material amounts of other funds are necessary to accomplish the specified purposes, state the amounts and sources of such other funds needed for each specified purpose. Refer to Item 3.C.1 of Form 20-F. Capitalization, page 60 12.We note on pages F-24 and F-36 that all of your outstanding preferred shares will convert automatically into ordinary shares in the event of a "Qualified IPO". Please revise your disclosures to clarify all of the stipulations of a "Qualified IPO" and explain why you believe that it is factually supportable that the outstanding preferred shares will automatically convert into ordinary shares. Management's Discussion and Analysis of Financial Condition and Results of Operations Key Components of Results of Operations Operating Expenses Selling and Marketing Expenses , page 76 13.We note your disclosure that selling and marketing expenses primarily consist of staff costs for personnel engaged in sales and marketing functions, travel and entertainment expenses and convention expenses. We further note your disclosure on page 80 that your selling and marketing expenses as a percentage of total revenues decreased in 2018 primarily due to economies of scale. Please expand your disclosure to discuss your

FirstName LastNameYusheng Han Comapany NameBurning Rock Biotech Ltd December 4, 2019 Page 4 FirstName LastNameYusheng Han Burning Rock Biotech Ltd December 4, 2019 Page 4 compensation structure with your sales force. Refer to Item 5.A of Form 20-F. Additionally, please reconcile the description of selling and marketing expenses with your statement on page 80 that your general and administrative expenses increased in 2018 in part due to an increase in travel and entertainment expenses. Fair Value of Share Options, page 88 14.We note that the estimated fair market value per ordinary share is a significant assumption in your share option grant valuation. Accordingly, please bridge for us the fair value per share determinations used for each option grant subsequent to December 31, 2018 to the current estimated IPO price per share. We will delay our assessment of your response pending inclusion of the estimated IPO price in the filing. Business Overview, page 106 15.With respect to your early detection technologies, please briefly explain what you mean by "specificities of 96%." Similarly, please revise the graphics and expand your disclosure as appropriate on page 112 to provide appropriate context for an investor to evaluate the graphics. Please also briefly explain what you mean by a "capture-based" fully automated NGS library preparation system on page 106. Additionally, please revise your statement on page 123 that the testing success rate of your LungPlasma is 99.5%, on par with world- class genomic testing companies to indicate how testing success rate is measured and the basis for your competitive claim. Intellectual Property, page 124 16.We note your disclosure regarding your patent rights. For each of your material patents, please clearly disclose: •applicable jurisdictions where patents are issued or where patent applications are pending; •type of patent protection (e.g. composition of matter, use, or process); and •the specific NGS-based cancer genotyping test or technology to which the patent relates and the patent expiration date or expected expiration date for patent application. Note 1. Organization and Basis of Presentation , page F-10 17.We note here and throughout the filing that you consolidate Burning Rock (Beijing) Biotechnology Co., Ltd. ("VIE") and the VIE's subsidiaries within your financial statements as of each balance sheet date and that those VIE agreements were amended on October 21, 2019. Please revise the filing to disclose the process by which you formed the VIE structure, including relevant chronological dates. Also, revise the filing to explain why you are consolidating this VIE and the VIE's subsidiaries as of each balance sheet

FirstName LastNameYusheng Han Comapany NameBurning Rock Biotech Ltd December 4, 2019 Page 5 FirstName LastName Yusheng Han Burning Rock Biotech Ltd December 4, 2019 Page 5 date and how the amended agreements signed on October 21, 2019 impacted your consolidation conclusions. Note 2. Summary of Significant Accounting Policies Revenue Recognition Revenue from central laboratory business, page F-20 18.We note that when you are expected to be entitled to a breakage amount, it is recognized as revenue in proportion to the pattern of rights exercised by the patient. Please revise the filing to explain how you estimate breakage in these situations and the significant judgments underlying those estimates. Refer to ASC 606-10-50-17. Revenue from in-hospital business, page F-21 19.We note that you recognize revenue on a net basis related to the provision of the facilitation services for the laboratory equipment sales to hospitals since you have determined that you are an agent. We also note that you purchase this laboratory equipment from third-party suppliers when the hospital makes a purchase request and resell the laboratory equipment to the hospital. Please explain in more detail how you have considered all of the requirements in ASC 606-10-55-36 through 55-40 to conclude that you are the agent in these transactions. 20.Please revise the filing to disclose if you have any warranty obligations or customer rights of return from the sales of reagent kits to hospitals. Refer to ASC 606-10-55-22 thru 55- 35. General 21.Please provide us proofs of all graphics, visual, or photographic information you will provide in the printed prospectus prior to its use, for example in a preliminary prospectus. Please note that we may have comments regarding this material. You may contact Tara Harkins at 202-551-3639 or Kevin Kuhar at 202-551-3662 if you have questions regarding comments on the financial statements and related matters. Please contact Jeffrey Gabor at 202-551-2544 or Christine Westbrook at 202-551-5019 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Shuang Zhao , Esq.

Show Raw Text
December 4, 2019
Yusheng Han
Director and Chief Executive Officer
Burning Rock Biotech Ltd
601, 6/F, Building 3, Standard Industrial Unit 2
No. 7, Luoxuan 4th Road
International Bio Island, Guangzhou, 510005
Peoples Republic of China
Re:Burning Rock Biotech Ltd
Draft Registration Statement on Form F-1
Submitted November 4, 2019
CIK No. 0001792267
Dear Mr. Han:
            We have reviewed your draft registration statement and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
            Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR.  If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
            After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form F-1 submitted on November 4, 2019
Prospectus Summary
Overview, page 1
1.We note your reference to findings by China Insights Consultancy.  Please provide us with
a copy of the report.
2.The prospectus summary should include a balanced presentation of your business,
including your competitive position in the industry.  In the presentation of your business,
you present your organization as a "China's number one cancer diagnostics company" and
your platform technologies as "unrivaled" and "world-class."  Please revise to state the

 FirstName LastNameYusheng Han
 Comapany NameBurning Rock Biotech Ltd
 December 4, 2019 Page 2
 FirstName LastNameYusheng Han
Burning Rock Biotech Ltd
December 4, 2019
Page 2
basis for your performance claims or revise to state such claims are management's belief.
Additionally, please balance your summary presentation by providing equally prominent
disclosure about the competitive, regulatory and technical challenges you face.
3.We note your statement that your "products are validated by the medical, pharmaceutical
and scientific communities...."  Please clarify what you mean by "validated" in your
disclosure.
4.We note that you currently offer 13 NGS-based cancer genotyping tests applicable to a
broad range of cancer types.  Please revise your disclosure to identify in the Summary the
specific cancer types.
5.Where you reference your collaborations on clinical trials, please revise your disclosure to
indicate you primarily provide central laboratory services and companion diagnostics
development services, as discussed on page 119. Please also expand your disclosure in the
Business section to include any compensation arrangements with oncology key opinion
leaders.
Our Addressable Markets, page 3
6.Please revise your references here and throughout your registration statement to your
"addressable" market to remove any implication you have captured or are likely to capture
the stated market potential.
Implication of Being an Emerging Growth Company, page 5
7.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
Risks Related to Our Business and Industry
If we were to be sued for product liability or professional liability….., page 16
8.We note your disclosure that similar to other Chinese companies, you do not carry product
liability or professional liability insurance. Please briefly explain the relevant features of
the China market that impact this decision.
We rely on a limited number of suppliers, or in some cases, sole suppliers, for some of our
laboratory equipment and supplies, page 19
9.We note your disclosure that you source sequencers, reagents and certain other laboratory
supplies used in your laboratory operations from several sole suppliers. Your supply
agreements appear to be material contracts. Please expand your disclosure in the Business
section to provide the material terms of your material supply agreements, including each
parties’ rights and obligations, financial terms, term and termination provisions.

 FirstName LastNameYusheng Han
 Comapany NameBurning Rock Biotech Ltd
 December 4, 2019 Page 3
 FirstName LastNameYusheng Han
Burning Rock Biotech Ltd
December 4, 2019
Page 3
Please also file your supply agreements as exhibits to your registration statement or tell us
why you believe such filing is not required. Refer to Item 601(b)(10) of Regulation S-K.

Risks Relating to Our ADSs and This Offering
Our dual-class structure with different voting rights will limit your ability to influence corporate
matters…., page 53
10.We note your disclosure that each Class B ordinary share will be entitled to six votes.
Please expand your disclosure to discuss the risk that future issuance of Class B shares
may be dilutive to holders of Class A shares and that your dual-class structure may render
your shares ineligible for inclusion in certain stock market indices and the potential impact
on the market price and liquidity of your ordinary shares.

Use of Proceeds, page 58
11.Please revise the discussion to disclose the estimated net amount of the proceeds broken
down into each principal intended use, (i) research and development of our early cancer
detection technologies, (ii) obtaining NMPA approvals for additional cancer genotyping
products, including completing related clinical trials; and (iii) other general and
administrative matters.  If the anticipated proceeds will not be sufficient to fund all the
proposed purposes, please disclose the order of priority of such purposes. To the extent
material amounts of other funds are necessary to accomplish the specified purposes, state
the amounts and sources of such other funds needed for each specified purpose. Refer to
Item 3.C.1 of Form 20-F.
Capitalization, page 60
12.We note on pages F-24 and F-36 that all of your outstanding preferred shares will convert
automatically into ordinary shares in the event of a "Qualified IPO".  Please revise your
disclosures to clarify all of the stipulations of a "Qualified IPO" and explain why you
believe that it is factually supportable that the outstanding preferred shares will
automatically convert into ordinary shares.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Key Components of Results of Operations
Operating Expenses
Selling and Marketing Expenses , page 76
13.We note your disclosure that selling and marketing expenses primarily consist of staff
costs for personnel engaged in sales and marketing functions, travel and entertainment
expenses and convention expenses. We further note your disclosure on page 80 that your
selling and marketing expenses as a percentage of total revenues decreased in 2018
primarily due to economies of scale. Please expand your disclosure to discuss your

 FirstName LastNameYusheng Han
 Comapany NameBurning Rock Biotech Ltd
 December 4, 2019 Page 4
 FirstName LastNameYusheng Han
Burning Rock Biotech Ltd
December 4, 2019
Page 4
compensation structure with your sales force. Refer to Item 5.A of Form 20-F.
Additionally, please reconcile the description of selling and marketing expenses with your
statement on page 80 that your general and administrative expenses increased in 2018 in
part due to an increase in travel and entertainment expenses.
Fair Value of Share Options, page 88
14.We note that the estimated fair market value per ordinary share is a significant assumption
in your share option grant valuation.  Accordingly, please bridge for us the fair value per
share determinations used for each option grant subsequent to December 31, 2018 to the
current estimated IPO price per share. We will delay our assessment of your response
pending inclusion of the estimated IPO price in the filing.
Business
Overview, page 106
15.With respect to your early detection technologies, please briefly explain what you mean
by "specificities of 96%." Similarly, please revise the graphics and expand your disclosure
as appropriate on page 112 to provide appropriate context for an investor to evaluate the
graphics. Please also briefly explain what you mean by a "capture-based" fully automated
NGS library preparation system on page 106. Additionally, please revise your statement
on page 123 that the testing success rate of your LungPlasma is 99.5%, on par with world-
class genomic testing companies to indicate how testing success rate is measured and the
basis for your competitive claim.
Intellectual Property, page 124
16.We note your disclosure regarding your patent rights.  For each of your material patents,
please clearly disclose:
•applicable jurisdictions where patents are issued or where patent applications are
pending;
•type of patent protection (e.g. composition of matter, use, or process); and
•the specific NGS-based cancer genotyping test or technology to which the patent
relates and the patent expiration date or expected expiration date for patent
application.
Note 1. Organization and Basis of Presentation , page F-10
17.We note here and throughout the filing that you consolidate Burning Rock (Beijing)
Biotechnology Co., Ltd. ("VIE") and the VIE's subsidiaries within your financial
statements as of each balance sheet date and that those VIE agreements were amended on
October 21, 2019.  Please revise the filing to disclose the process by which you formed
the VIE structure, including relevant chronological dates. Also, revise the filing to explain
why you are consolidating this VIE and the VIE's subsidiaries as of each balance sheet

 FirstName LastNameYusheng Han
 Comapany NameBurning Rock Biotech Ltd
 December 4, 2019 Page 5
 FirstName LastName
Yusheng Han
Burning Rock Biotech Ltd
December 4, 2019
Page 5
date and how the amended agreements signed on October 21, 2019 impacted your
consolidation conclusions.
Note 2. Summary of Significant Accounting Policies
Revenue Recognition
Revenue from central laboratory business, page F-20
18.We note that when you are expected to be entitled to a breakage amount, it is recognized
as revenue in proportion to the pattern of rights exercised by the patient. Please revise the
filing to explain how you estimate breakage in these situations and the significant
judgments underlying those estimates. Refer to ASC 606-10-50-17.
Revenue from in-hospital business, page F-21
19.We note that you recognize revenue on a net basis related to the provision of the
facilitation services for the laboratory equipment sales to hospitals since you have
determined that you are an agent.  We also note that you purchase this laboratory
equipment from third-party suppliers when the hospital makes a purchase request and
resell the laboratory equipment to the hospital.  Please explain in more detail how you
have considered all of the requirements in ASC 606-10-55-36 through 55-40 to conclude
that you are the agent in these transactions.
20.Please revise the filing to disclose if you have any warranty obligations or customer rights
of return from the sales of reagent kits to hospitals. Refer to ASC 606-10-55-22 thru 55-
35.
General
21.Please provide us proofs of all graphics, visual, or photographic information you will
provide in the printed prospectus prior to its use, for example in a preliminary prospectus.
Please note that we may have comments regarding this material.
            You may contact Tara Harkins at 202-551-3639 or Kevin Kuhar at 202-551-3662 if you
have questions regarding comments on the financial statements and related matters.  Please
contact Jeffrey Gabor at 202-551-2544 or Christine Westbrook at 202-551-5019 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Shuang Zhao , Esq.