View:
United States securities and exchange commission logo
April 19, 2021
Robert Spignesi
President and Chief Executive Officer
Rapid Micro Biosystems, Inc.
1001 Pawtucket Boulevard West, Suite 280
Lowell, MA 01854
Re: Rapid Micro
Biosystems, Inc.
Draft Registration
Statement on Form S-1
Submitted March 22,
2021
CIK No. 0001380106
Dear Mr. Spignesi:
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
General
1. Please 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.
Prospectus Summary
Overview, page 1
2. Please expand your
disclosure on the top of page 2 to describe what a Form 483 is.
Robert Spignesi
FirstName LastNameRobert
Rapid Micro Biosystems, Inc.Spignesi
Comapany
April NameRapid Micro Biosystems, Inc.
19, 2021
April 219, 2021 Page 2
Page
FirstName LastName
3. We note your disclosure that your Growth Direct platform is the only
fully automated,
high-throughput and secure MQC solution. We further note your
disclosure under
Competition, on page 106, that you compete with companies that have
entered the MQC
testing market with alternative automated solutions, such as
Interscience. Please revise to
reconcile or clarify these disclosures.
Our market, page 6
4. Please expand your disclosure to describe how you developed the
estimates of your total
addressable market, or TAM, where discussed in both the Summary and
Business sections
of the prospectus.
Risk Factors, page 14
5. We note your disclosure on page 16 in the risk factor, "Our revenue
from customers is
highly concentrated," that 45.8% of our revenue was generated from two
customers and
46.1% of our revenue was generated from three customers in the years
ended December
31, 2019 and 2020, respectively. Please expand the Summary and
Business disclosure to
discuss your dependence on a few major customers. See Item
101(h)(4)(vi) of Regulation
S-K.
Market and Industry Data, page 53
6. You state that you have not independently verified market and industry
data from third-
party sources and that the market definitions employed have not been
verified by any
independent source. Please note that you are responsible for the
entire contents of the
registration statement. Please revise your disclosure to remove any
implication that you
are not responsible for assessing the reasonableness and soundness of
the market and
industry data and definitions included in your disclosures.
Capitalization, page 56
7. Please revise the table to include debt as part of your
capitalization.
Critical accounting policies and significant judgments and estimates, page 75
8. We note from page 66 the description of your consumables and LIMS
connection
software, especially that the latter is "optional". Referring to the
revenue recognition
policy on page 76, please clarify herein and in the significant
accounting policy on pages
F-16-F-17 whether your proprietary consumables and/or LIMS software
can be purchased
and/or effectively utilized without the Growth Direct System (as
described on page 5).
Explain how the Growth Direct system can operate as intended without
these products.
Finally, explain why the purchase of the consumables and/or the
installation of the
software would not constitute a separate performance obligation if
there is no binding
agreement or requirement to purchase the consumables and/or the
software and these
products can be used without each other, if true.
Robert Spignesi
Rapid Micro Biosystems, Inc.
April 19, 2021
Page 3
Business
License agreement, page 105
9. Please expand your disclosure regarding the Thermo Fisher license
agreement to disclose
the fees paid to date under the agreement and the royalty rate you are
obligated to pay,
within a ten percent range. In addition, we note the license will remain
in effect until the
last to expire licensed patent right. Please separately disclose the
expiration year of the
licensed patents in the Intellectual Property section.
Intellectual property, page 105
10. Please expand your disclosure to address the following:
disclose the foreign jurisdictions where you have been issued or
granted patents and
where you have patent applications pending; and
disaggregate the number of your owned patents by type of patent or
patent family and
disclose the related expiration dates for each group.
Government Regulation, page 106
11. We note your disclosure in this section that your Growth Direct platform
is not directly
subject to regulation by the FDA. Please expand your disclosure to
explain what
regulations the company adheres to in developing its products, including
the Growth
Direct platform.
Principal stockholders, page 127
12. Please identify the natural person(s) with voting and/or dispositive
power over the shares
owned by Colony Harvest Ltd. and Endeavour Medtech Growth II LP.
You may contact Jenn Do at 202-551-3743 or Daniel Gordon at 202-551-3486
if you
have questions regarding comments on the financial statements and related
matters. Please
contact David Gessert at 202-551-2326 or Laura Crotty at 202-551-7614 with any
other
questions.
Sincerely,
FirstName LastNameRobert Spignesi
Division of
Corporation Finance
Comapany NameRapid Micro Biosystems, Inc.
Office of Life
Sciences
April 19, 2021 Page 3
cc: Wesley C. Holmes
FirstName LastName