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United States securities and exchange commission logo
September 9, 2020
Scott Hutton
President and Chief Executive Officer
Biodesix, Inc.
2970 Wilderness Place, Suite 100
Boulder, CO 80301
Re: Biodesix, Inc.
Draft Registration
Statement on Form S-1
Submitted August
12, 2020
CIK No. 0001439725
Dear Mr. Hutton:
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 S-1
Business Overview, page 1
1. With reference to your
disclosures on pages 83-85, revise to highlight the impact of the
COVID-19 pandemic on
your business, including with respect to product mix, costs and
revenues.
2. With reference to your
disclosure in the third full paragraph on page 134, please revise
your Summary discussion
of the Biodesix WorkSafe testing program to explain
briefly what the
Emergency Use Authorization allows and the uncertain nature of its
duration. Also, revise
to clarify when the two products received this authorization and
when they were
commercialized.
Scott Hutton
FirstName LastNameScott Hutton
Biodesix, Inc.
Comapany 9,
September NameBiodesix,
2020 Inc.
September
Page 2 9, 2020 Page 2
FirstName LastName
3. With regard to the July 23 announcement, please revise to clarify the
importance of this
arrangement so that it is clear why you are highlighting this
announcement in your
Summary. For instance, indicate whether you have derived material
revenues to date from
the arrangement and whether it is exclusive in nature. Also file the
agreement as a
material contract or advise. As applicable, refer to Compliance
Disclosure Interpretations,
Regulation S-K, Question 146.04 for additional guidance.
4. Your Summary disclosure suggests that you developed the two COVID-19
tests, that you
own the technology, and that you hold the relevant EUAs; however, your
disclosures on
pages 34-35, 37 indicate that Bio-Rad developed the tests and that
they own the
technology and hold the relevant EUAs. We further note that your March
20, 2020
and May 19, 2020 press releases indicate that you and Bio-Rad are
partners and
collaborators with respect to these tests and that your disclosure on
page 129 indicates that
Bio-Rad is your supplier. Please revise to clarify or advise.
Our Market Opportunity, page 2
5. With reference to your disclosure on page 86, please revise the
Summary to explain that
your revenues have historically derived primarily from your diagnostic
testing business as
opposed to your services business.
We are exposed to significant future payments and other obligations associated
with our
acquisitions, page 25
6. Please disclose here and at page 146 to clarify whether you have made
any payments in
connection with the acquisition agreements you reference.
Some intellectual property that we in-license may have been developed through
government
funded programs..., page 60
7. Please revise to identify the commercialized products that are or may
be subject to march-
in rights.
Our amended and restated certificate of incorporation provides that the Court
of Chancery of the
State of Delaware will be the exclusive..., page 68
8. We note that your amended and restated certificate of incorporation
will provide that the
Court of Chancery of the State of Delaware will be the exclusive forum
for "substantially
all" shareholder claims, including "any derivative action." Please
disclose whether this
provision applies to actions arising under the Securities Act or
Exchange Act. In that
regard, we note that Section 27 of the Exchange Act creates exclusive
federal jurisdiction
over all suits brought to enforce any duty or liability created by the
Exchange Act or the
rules and regulations thereunder, and Section 22 of the Securities Act
creates concurrent
jurisdiction for federal and state courts over all suits brought to
enforce any duty or
liability created by the Securities Act or the rules and regulations
thereunder. If the
provision applies to Securities Act claims, please also revise your
prospectus to state that
Scott Hutton
FirstName LastNameScott Hutton
Biodesix, Inc.
Comapany 9,
September NameBiodesix,
2020 Inc.
September
Page 3 9, 2020 Page 3
FirstName LastName
there is uncertainty as to whether a court would enforce such
provision and that investors
cannot waive compliance with the federal securities laws and the rules
and regulations
thereunder.
Use of Proceeds, page 73
9. Expand your disclosure here and on page 6 to specify how much of the
proceeds you
intend to allocate to each of the four purposes you list. Also revise
your disclosure
concerning the second use to indicate, as applicable, whether material
proceeds
are intended to be allocated towards specific pipeline products or
research efforts, such as
those described on pages 123-124.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Research and Development, page 90
10. We note the increase in your research and development expenses and
that you are
currently engaged in clinical studies for certain product candidates
and as well as
ongoing product innovation. Please expand your disclosure to provide
more detail for
your research and development expenses for each period presented,
including but not
limited to by product candidate as well as by the nature of the
expenses. To the extent that
you do not track expenses by product candidate, please disclose as
such.
Bio-Rad SARS-CoV-2 ddPCR Test, page 120
11. Please revise the disclosure at the top of page 121 to clarify whether
the publication
reported results from testing of Bio-Rad's SARS-CoV-2 ddPCR or from
testing of another
ddPCR testing product.
Platelia SARS-CoV-2 Total Ab Test, page 121
12. Please revise to disclose the p and n values applicable to the test.
Coverage and Reimbursement, page 125
13. Please revise to discuss coverage and reimbursement as it pertains to
the two COVID-19
diagnostic tests.
Clinical Laboratory Operations, page 128
14. In light of your disclosure on page 85 indicating that your recently
introduced COVID-19
tests will comprise a significant portion of your revenue for the
remainder of 2020 and the
first quarter of 2021, please revise to clarify whether existing
workflows are adequate
to delivery tests within the same 3-day and 5-day timeframes you
disclose in this section.
Intellectual Property, page 129
15. Please revise to disclose the material terms of your agreements with
Bio-Rad concerning
Scott Hutton
Biodesix, Inc.
September 9, 2020
Page 4
the two diagnostic tests for COVID-19. Also, file these agreements as
exhibits to the
registration statement.
16. Discuss, as applicable, whether you hold patents that cover the
COVID-19 diagnostic and
antibody tests.
Acquisition of Integrated Diagnostics, page 146
17. We note your disclosure that you may be required to pay up to $37
million in contingent
consideration to Integrated Diagnostics, Inc. and IND Funding, LLC.
Please revise to
disclose the applicable milestones or advise.
Financial Statements
Note 3 - Business Combination
Integrated Diagnostics, Inc., page F-19
18. Given the significance of the developed technology acquired, please
expand your
disclosures herein or elsewhere to identify the nature of the
technology and how you
determined its fair value. Please also disclose how you assess this
technology for
impairment.
19. Please disclose a qualitative description of the factors that make up
the
goodwill recognized in this transaction in accordance with ASC
805-30-50-1(a).
General
20. 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.
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
September 9, 2020 Page 4 Office of Life
Sciences
FirstName LastName