View:
November 15, 2018
Waleed H. Hassanein, M.D.
President and Chief Executive Officer
TransMedics Group, Inc.
200 Minuteman Road
Andover, MA 01810
Re: TransMedics Group, Inc.
Draft Registration Statement on Form S-1
Submitted on October 19, 2018
CIK No. 0001756262
Dear Dr. Hassanein:
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 Form S-1 submitted on October 19, 2018
Industry and Market Data, page ii
1. Please tell us whether you commissioned any of the third-party data
included in your
registration statement.
Our Business, page 1
2. We note your disclosure that you have developed a "substantial" body of
clinical evidence
supporting effectiveness and safety of your OCS product. Since efficacy
and safety
are determinations within the authority of the FDA, it is not
appropriate to make these
Waleed H. Hassanein, M.D.
FirstName LastNameWaleed H. Hassanein, M.D.
TransMedics Group, Inc.
Comapany 15, 2018
November NameTransMedics Group, Inc.
November 15, 2018 Page 2
Page 2
FirstName LastName
claims to the extent you have not received approval for certain
indications discussed. You
may describe the primary and secondary endpoints of any clinical
trials, provide data
indicating the achievement of the endpoints and any statistical
measures relating to the
significance of the data.
3. Please provide a more detailed discussion of underlying assumptions
used in your
addressable market calculation.
Risks Associated with Our Business, page 7
4. Please revise the first bullet point in this section to quantify your
operating losses for the
most recent period and your total accumulated deficit.
Implications of Being an Emerging Growth Company and Smaller Reporting Company,
page 8
5. 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.
Our existing and any future indebtedness..., page 15
6. Please describe the applicable covenants from your credit agreement
with more specificity
and include a discussion of the potential risks relating to the
financial covenant mentioned
on page 80.
Use of Proceeds, page 55
7. Please provide more specific disclosure regarding the intended
advancements in clinical
trials and the continued development and commercialization of your OCS
products. As
examples only, provide more detail regarding the clinical trials you
plan to pursue,
whether new or existing, whether you believe the proceeds will be
sufficient to complete
the clinical trials, and how you intend to continue developing your
products.
Dilution, page 60
8. Please expand to disclose how the amounts and percentages in the
second table would
change assuming the exercise of all outstanding options and warrants.
Net Revenue, page 72
9. Revise here and on page 75 to provide the relative growth rate in
revenue of consoles
versus disposable sets for each of the three OCS product classes.
Also, quantify the extent
to which change in price for each OCS product class affected your
revenue.
Waleed H. Hassanein, M.D.
FirstName LastNameWaleed H. Hassanein, M.D.
TransMedics Group, Inc.
Comapany 15, 2018
November NameTransMedics Group, Inc.
November 15, 2018 Page 3
Page 3
FirstName LastName
Stock-Based Compensation, page 84
10. We note your disclosure on page 86 related to the stock options
granted between
January 1, 2017 and September 29, 2018. When pricing information for
this offering is
available, please tell us the significant reasons for any material
differences between your
last fair value determination and the mid-point of the estimated IPO
price range.
Clinical Evidence, page 105
11. Please tell us whether your studies or other studies or peer-reviewed
articles have revealed
any material disadvantages of your product.
12. Please tell us when you expect the study mentioned at the bottom of
page 106 to be
published.
Patents and Trademarks, page 115
13. Please distinguish between patents that you own and patents that you
license. Ensure that
the quantification of the patents that you license does not include
patents that have
expired, and tell us the significance to your business of the patents
you license that have
recently expired or will expire in 2018.
FDA Premarket Clearance and Approval Requirements, page 120
14. Please clarify what you mean by "extended" and "standard" criteria.
Underwriting, page 170
15. Please specify the "certain other conditions" to the underwriters'
obligations mentioned in
the second paragraph.
Relationships, page 171
16. Please provide more specific information regarding the past
relationships with the
underwriters mentioned in the last paragraph on page 171.
Note 2. Summary of Significant Accounting Policies
Property and Equipment, page F-12
17. Please tell us how you determined that OCS Consoles have an estimated
useful life of five
years.
Inventory, page F-13
18. You disclose that inventory is valued at the lower of cost or market
value and that you
establish provisions for excess and obsolete inventory. Please revise
the policy to comply
with the lower of cost or net realizable value requirements of ASC
330-10-35-1B.
Waleed H. Hassanein, M.D.
TransMedics Group, Inc.
November 15, 2018
Page 4
Additionally, revise to disclose how your accounting for excess or
obsolete inventory
complies with ASC 330-10-35-14 and SAB Topic 5.BB.
Revenue Recognition, page F-15
19. You disclose that when you loan the OCS Console to customers you do not
require
minimum purchase commitments. Clarify if any of your sales agreements
contain
minimum purchase commitment. Please also tell us how you have determined
the relative
fair value allocated to the OCS Console deliverable in the
multiple-element arrangement
under ASC 605-25-15-3 and 15-3A.
Note 15. Segment Reporting and Geographic Data , page F-46
20. You discuss throughout the filing that you have organ-specific disposable
sets and OCS
Consoles. We also see on page 72 that these classes of disposable sets
have different
selling prices and gross margins. Please revise the filing to provide
product line
disclosures for each class of the organ-specific disposable sets as
required by ASC 280-
10-50-40.
You may contact Tara Harkins at 202-551-3639 or Kevin Kuhar, Accounting
Branch
Chief, at 202-551-3662 if you have questions regarding comments on the
financial statements
and related matters. Please contact Thomas Jones at 202-551-3602 or Heather
Percival, Senior
Attorney, at 202-551-3498 with any other questions.
Sincerely,
FirstName LastNameWaleed H. Hassanein, M.D.
Division of
Corporation Finance
Comapany NameTransMedics Group, Inc.
Office of
Electronics and Machinery
November 15, 2018 Page 4
cc: Tara Fisher
FirstName LastName