United States securities and exchange commission logo
October 20, 2023
Melker Nilsson
Chief Executive Officer
Capstone Dental Pubco, Inc.
154 Middlesex Turnpike
Burlington, MA 01803
Re: Capstone Dental
Pubco, Inc.
Amendment No. 1 to
Registration Statement on Form S-4
Filed October 5,
2023
File No. 333-274297
Dear Melker Nilsson:
We have reviewed your amended registration statement and have the
following
comments.
Please respond to this letter by amending your registration
statement and providing the
requested information. If you do not believe a comment applies 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 this letter, we may have additional comments.
Unless we note otherwise,
any references to prior comments are to comments in our September 29,
2023 letter.
Amendment No. 2 to Registration Statement on Form S-4
Summary, page 8
1. We note your revised
disclosure in response to prior comment 7 and reissue. Please revise
these and all similar
statements in your registration statement to eliminate conclusions,
predictions, or
opinions that your devices are effective or accurate, whether implicitly or
impliedly. In this
regard, we note your statements that "Keystone develops and offers
technologies it
believes are effective...," the products "significantly reduce treatment time
for practitioners and
patients, while delivering high accuracy..." and "accurately record"
patient information,
and that mapping technology allows practitioners to "accurately scan"
a patient's mouth. We
do not object to the presentation of objective data without efficacy
determinations.
Melker Nilsson
FirstName LastNameMelker
Capstone Dental Pubco, Inc. Nilsson
Comapany
October 20,NameCapstone
2023 Dental Pubco, Inc.
October
Page 2 20, 2023 Page 2
FirstName LastName
2. We note your revised disclosure in response to prior comment 8. We
also note that the
language remains on pages F-60 and F-95. Please remove or provide
support for these
statements.
Background of the Business Combination, page 109
3. We note your response to prior comment 10 and reissue in part. With
respect to the
negotiations between Keystone and Check-Cap, please enhance your
disclosure in this
section by explaining how the parties determined the relative initial
valuations of the
companies and how these valuations evolved during the negotiations to
arrive at the final
terms. For example, you disclose that between June 12 and June 15,
2023 the parties
exchanged drafts of non-binding term sheets and that while the
proposed changes differed
from term sheet to term sheet, they primarily focused on relative
valuations, net cash
requirements and other closing conditions, and the treatment of legacy
assets. Please
explain which party proposed certain valuations and further explain
how the terms
changed throughout the negotiations.
4. We note your response to prior comment 14 and reissue. Please revise
to clarify whether
Check-Cap received any non-binding offers from the four candidates
after receipt of the
draft term sheets.
5. We note the disclosure on page 122 that the Check-Cap board considered
as
a countervailing factor the likelihood that Check-Cap shareholders may
not receive any
value for the C-Scan assets. Please disclose whether the valuation of
the C-Scan assets
was discussed during the negotiations between Check-Cap and Keystone.
Discounted Cash Flow Analysis, page 131
6. Please address the following relating to the revenue forecasts
provided by Keystone:
For revenue forecasts in North America, please disclose the
current number of sales
representatives and the number of sales representatives they
plan to have in each of
the next ten years. Explain the basis for assuming they achieve
specific increases in
the number of sales representatives and discuss the limitations
specific to basing
revenue projections on this assumption.
Disclose the specific limitations of assuming a historical average
revenues per sales
representative will remain constant.
Please quantify the amount of revenue assumed for Israel and
Australia by providing
a range or similar disclosure so investors can understand how much
of the projected
revenue resulted from these less objective assumptions.
Please explain how and to what extent Check-Cap independently
verified
information provided by Keystone.
Please explain how Keystone determined the potential market for
the Keystone
portfolio in Israel and Australia and how they used it to project
revenue.
Explain what an analysis of the competitive landscape
entails, the significant
material assumptions underlying revenue projections and the
limitations specific to
Melker Nilsson
Capstone Dental Pubco, Inc.
October 20, 2023
Page 3
this analysis.
Describe the specific regulatory approval assumed in making the
projections and the
impact on the projections if it is not obtained.
Explain what assumptions were made with regard to Keystone s
ability to scale the
production and distribution to assumed increased sales levels and
the related costs.
7. Clarify which elements of the projections were provided by Keystone
and which were
prepared by Check-Cap.
8. Clarify how you determined the percentage of net sales used to
calculate COGS and
discuss the limitations specific to these assumptions. Define net
sales in this context.
9. Clarify how you determined the percentage of revenue used to calculate
sales and
marketing costs and discuss the limitations specific to these
assumptions.
10. Define other expenses and if it includes expenses other than
sales and marketing costs,
clarify how the amounts were determined.
11. Clarify how projected R&D amounts were determined and discuss
significant underlying
assumptions and their limitations.
12. Explain the significant assumptions underlying the components of
unlevered free cash
flow and their limitations.
13. Explain the basis for projecting amounts more than three years out and
if the sales
forecasts reflect more than simple growth rates. Explain why these
rates are reasonable
and disclose the limitations presented by the difficulty in sustaining
significant growth
rates over long periods of time. As part of your response, specially
address how you
considered the guidance in Item 10(b)(2) of Regulation S-K.
Fairness Opinion of Variance, page 134
14. Please clarify the various assumptions made by Variance based on
Keystone s forecast
and clarify whether this forecast is the same as that presented on
earlier pages.
15. Explain the significant assumptions underlying operating profit and
explain why it is
reasonable to assume significant growth rates more than three years out.
Refer to Item
10(b)(2) of Regulation S-K.
FirstName LastNameMelker Nilsson
16. Please explain how you determined the identified companies were
appropriate for the
Comapany NameCapstone
multiple method givenDental
mostPubco,
of the Inc.
companies have much greater revenues
and are not
Octoberreporting
20, 2023the large
Page 3 recurring losses reported by Keystone Dental.
FirstName LastName
Melker Nilsson
FirstName LastNameMelker
Capstone Dental Pubco, Inc. Nilsson
Comapany
October 20,NameCapstone
2023 Dental Pubco, Inc.
October
Page 4 20, 2023 Page 4
FirstName LastName
Keystone's Products, page 196
17. We note your revised disclosure in response to prior comment 31. On
page 197, you
state that Keystone's existing annual market opportunity, including
opportunities for
expansion, is approximately $9 billion and, on page 203, you state
that Keystone operates
in "high-growth subsectors with an approximate size of $11.3 billion."
Please provide
additional disclosure to reconcile these figures or provide further
details to explain the
different markets and how Keystone operates within each.
Industry Background and Market Overview, page 203
18. We note your revised disclosure, citing your market estimates, in
response to prior
comments 32 and 34 and reissue in part. Please cite the source of the
CAGR expectations
and include the specific expected CAGR. If the exact figures are not
available, please tell
us why. Please provide the foundation for the dental biomaterials
global market estimate
of $1.5 billion. Further, please revise to state that the Company's
projections are the
opinion of the Company and unsupported by external sources, or provide
further citations.
For example, on page 203, you state that "based on management
calculations using
information from i-data, by 2027 it is projected that value-based
solutions will represent
roughly 38% of the global market share." Please briefly explain the
i-data source and tell
us whether you commissioned any information or study. Refer to Rule
436 and Section 7
of the Securities Act.
Exhibits
19. We note that certain exhibits within your exhibit index are indicated
as having portions of
the exhibit omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
We further note
that not all of these exhibits contain omitted material and that some
of the omissions may
not be applicable under the Item 601(b)(10)(iv). Please revise the
exhibits index, file all
redacted exhibits, as indicated, or remove indicators of omitted
materials from certain
exhibits. If you are seeking to redact information pursuant to Item
601(b)(10)(iv), please
include a prominent statement on the first page of the redacted
exhibit that certain
identified information has been excluded from the exhibit because it
is both not material
and is the type that the company treats as private or confidential.
Please also refer to Item
601(a)(5) and Item 601(b)(10)(iv) of Regulation S-K.
General
20. We note numerous citations related to information from third-party
sources throughout
your registration statement. Please tell us whether you commissioned
any of the
information for use in the registration statement, and, if so, analyze
whether you are
required to file a consent pursuant to Rule 436 of the Securities Act.
Melker Nilsson
FirstName LastNameMelker
Capstone Dental Pubco, Inc. Nilsson
Comapany
October 20,NameCapstone
2023 Dental Pubco, Inc.
October
Page 5 20, 2023 Page 5
FirstName LastName
Please contact Julie Sherman at 202-551-3640 or Terence O'Brien at
202-551-3355 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Benjamin Richie at 202-551-7857 or Lauren Nguyen at 202-551-3642 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Industrial
Applications and
Services
cc: Mark Rosenstein