United States securities and exchange commission logo
October 9, 2020
Scott Hutton
President and Chief Executive Officer
Biodesix, Inc.
2970 Wilderness Place, Suite 100
Boulder, CO 80301
Re: Biodesix, Inc.
Registration
Statement on Form S-1
Filed October 2,
2020
File No. 333-249260
Dear Mr. Hutton:
We have reviewed your 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 amending your registration
statement and providing the
requested information. 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 any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Amendment 1 to Draft Registration Statement on Form S-1
Business Overview, page 2
1. We note your response
to prior comment 4 and your revised disclosures; however it
remains unclear what
basis you have to refer to the two tests as your products as opposed
to Bio-Rad's products.
More specifically, your disclosures indicate that you may be
packaging and marketing
Bio-Rad's products as part of a program branded under your
name. Please revise or
explain in detail how you have "utilized" Bio-Rad's technology
and intellectual
property and whether you performed material research and development.
Please note that we may
also have additional comment once you file your agreements with
Bio-Rad as exhibits to
the registration statement.
Scott Hutton
FirstName LastNameScott Hutton
Biodesix, Inc.
Comapany
October NameBiodesix, Inc.
9, 2020
October
Page 2 9, 2020 Page 2
FirstName LastName
Some intellectual property that we in-license may have been developed through
government
funded programs..., page 63
2. Please revise your disclosure on page 63 to include your response to
prior comment 7.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Revenue, page 91
3. Please expand your disclosures to quantify the decrease in diagnostic
test revenue due to
impacts from the COVID-19 pandemic and the increase in revenue related
to the release
of two COVID-19 diagnostic tests.
Research and Development , page 92
4. Please quantify the amount of costs incurred for internal costs versus
external costs and
provide further breakout of those types of costs.
Bio-Rad SARS-CoV-2 ddPCR Test, page 127
5. We note your response to our prior comment 11. Please further revise
your disclosure
here to reflect your response and more plainly state that the
publication did not report
results from testing of Bio-Rad's SARS-CoV-2 ddPCR and that the report
was from
testing of another ddPCR testing product.
Platelia SARS-CoV-2 Total Ab Test , page 127
6. We note your response to our prior comment 12. Please revise to
disclosure the n value.
In light of your response that the p-value is not known to you, please
disclose
whether uncertainty exists as to whether the results are statistically
significant, or advise.
Intellectual Property, page 136
7. We note your response to our prior comment 16. Please expand your
disclosure to clarify
whether Bio-Rad has patent protections covering the COVID-19
diagnostic and antibody
tests that you sell as part of your program.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
Scott Hutton
Biodesix, Inc.
October 9, 2020
Page 3
You may contact David Burton at (202) 551-3626 or Jeanne Baker at (202)
551-3691 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Courtney Lindsay at (202) 551-7237 or Joe McCann at (202) 551-6262 with
any other
questions.
FirstName LastNameScott Hutton Sincerely,
Comapany NameBiodesix, Inc.
Division of
Corporation Finance
October 9, 2020 Page 3 Office of Life
Sciences
FirstName LastName
