UPLOAD Filing
YD Bio Ltd
Date: May 15, 2025 · CIK: 0002011674 · Accession: 0000000000-25-005222
AI Filing Summary & Sentiment
File numbers found in text: 333-283428
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May 15, 2025
J. Douglas Ramsey, Ph.D
Chief Executive Officer
YD Bio Limited
955 West John Carpenter Freeway
Suite 100-929
Irving, TX, 75039
Ethan Shen, Ph.D
Chief Executive Officer
YD Biopharma Limited
12F., No. 3, Xingnan St.
Nangang Dist.
Taipei City 115001, Taiwan
Re: YD Bio Limited
Amendment No. 5 to Registration Statement on Form F-4
Filed April 30, 2025
File No. 333-283428
Dear J. Douglas Ramsey Ph.D and Ethan Shen Ph.D:
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 April 3,
2025 letter.
May 15, 2025
Page 2
Amendment No. 5 to Registration Statement on Form F-4 filed April 30, 2025
The Business Combination
Breeze's Board of Directors' Reasons for the Approval of the Business
Combination, page
107
1. We refer to your disclosure on page 121 that CIAA used the Market
Approach to
calculate YD Biopharma s enterprise valuation as ranging from $826.8
million and
$978.38 million. You also state that YD Biopharma's enterprise value
based on the
Income Approach was based on updated projections provided by YD
Biopharma.
Please revise your disclosure to provide greater detail of how CIAA used
its Income
Approach, which provided a final valuation of $1.14 billion, in
calculating the final
enterprise valuation.
2. We note your disclosure on page 121 that CIAA s determination of YD
Biopharma s
enterprise value in January 2025 was based on prospective information
provided by
YD Biopharma, which represented "updated projections from those used in
connection with the CIAA Breast Cancer License Valuation." Please revise
to clearly
specify the material differences in the projections and prospective
information
provided by YD Biopharma in connection with CIAA's Breast Cancer License
Valuation and the CIAA Enterprise Valuation.
3. We note your disclosure on page 116 that YD Biopharma management s
assumptions
rely on the expectation that cooperative pharmaceutical factories will
enter the breast
cancer diagnostics market beginning in 2025. Please expand your
disclosure, where
appropriate, to discuss the cooperative pharmaceutical factories in
greater detail and
clarify whether YD Biopharma has entered into any agreements with such
pharmaceutical factories to date, and if so, please file such agreements
as exhibits to
the registration statement or explain to us why you believe you are not
required to do
so. Refer to Item 601(b)(10) of Regulation S-K.
4. We note your disclosure on page 122 relating to the assumptions
underlying YD
Biopharma s management s projections with respect to CIAA's
Enterprise Valuation.
Please revise your disclosure to address the following comments:
Describe why you include assumptions regarding "Health Food" and
how this fits
into YD Biopharma's current or planned operations (or specify that
this relates to
your supplement business, if true), and clarify how "Drugs and
Medical Devices"
is separate from the individual drugs and medical devices detailed
separately.
We note that the assumptions underlying the projections provided
by YD
Biopharma s management include projected market sizes and
anticipated
compound annual growth rates. You also state that the projected
revenue growth
rates are derived from market studies in the oncology and
ophthalmology sectors
that "reflect growing demand for early cancer detection technologies
and
ophthalmic treatments." Please revise to discuss any material
assumptions
underlying these projections, as well as disclose the discount rate
used for the
Enterprise Valuation. Please also expand your disclosure to specify
the sources
and citations that support the statements, including the market
studies referenced
in your disclosure; and
May 15, 2025
Page 3
When referring to estimated market sizes for each industry
referenced, please
revise to specify the year and jurisdiction for each such market
valuation. By way
of example only, we note your disclosure on page 117 that "the U.S.
breast cancer
testing market size is $2.79 billion, while the major global markets,
including the
Americas, the European Union and Asia, have a total market size of
approximately $4.07 billion ".
5. We note your response to prior comments 7 and 8. Please address the
following
comments:
We note discussions of comparable companies for both the Breast
Cancer License
Valuation, but it appears only Grail's data was used for the Market
Approach
valuation. In this regard, we note statements like the following on
page 114 with
respect to the Breast Cancer License Valuation: "Specifically, CIAA
looked at
Grail s valuation CIAA applied a market size adjustment of 145.85%
($4.07
billion/$2.79 billion) to Grail s valuation when determining a
global market
valuation range for YD Biopharma of between $747 million and $884
million." Explain how CIAA considered these other comparable companies
and
revise to clarify that their data did not factor into the valuation
conclusion reached
by CIAA in this Report, if true; and
Similarly, we note your statement that "the CIAA Breast Cancer
License
Valuation compared the detection technology capabilities of EG BioMed
with
those of other comparable companies. The analysis evaluated factors
such as the
methodology employed by each detection method, its intended use (e.g.
tracking
versus screening), clinical data sensitivity, product specifications,
and pricing."
However, it appears based in Annex D, page 26 that the valuation that
was
quantified using the Market Approach was based solely on Grail's
valuation,
without considering these other factors from comparable companies
(noted
in Annex D, page 16). If true, please revise to state such or advise.
6. We note the revenue forecast on page 116 related to the CIAA Breast
Cancer License
Valuation includes revenues from 2025 through 2031 and the related
assumptions
refer to the breast cancer diagnostic test being launched in 2032. Please
revise to
clarify the source of the revenues for the periods before 2032. In
addition, we note
you assume that the Breast Cancer Diagnostics figures for Europe and Asia
each
represent a 20% market share in 2032, and the 2032 market size equals the
2032
revenues included in the table. However, for the U.S. market the revenues
per the
assumptions equals $878 million, not $1,040 million. Please clarify the
difference.
7. As it relates to the CIAA Market Approach and Income Approach for the
Breast
Cancer License Valuation, please expand your disclosure to provide the
following:
Greater detail regarding the specific regulatory approvals;
Greater detail explaining the ratio of the number of breast cancer
diagnostics to
the number of all cancer tests and how the ratio was determined; and
Greater detail showing in tabular form the calculations underlying
and supporting
the market valuations for the Income Approach.
May 15, 2025
Page 4
8. As it relates to the CIAA Enterprise Valuation, please expand your
disclosure to
provide the following:
Greater detail regarding the specific regulatory approvals;
Greater detail explaining the ratio of the number of breast cancer
diagnostics to
the number of all cancer tests and how the ratio was determined, as
well as an
explanation of why a similar analysis is not shown with respect to
pancreatic
cancer diagnostics; and
Greater detail showing in tabular form the calculations underlying
and supporting
the enterprise value under the Market Approach and the Income
Approach.
9. We note your references to Grail s 2019 and 2020 valuations for both
the Breast
Cancer License Valuation and the Enterprise Valuation. Please explain to
us and
provide a related analysis of how GRAIL s current stock market
valuation would
impact these valuations and describe to us any other considerations you
have related
to its current stock market capitalization and the valuations.
Information about YD Biopharma
The Business
Industry Background and Market Trends, page 191
10. Given your disclosure that you are seeking to sell your products in
Taiwan and have
sold your products to date in Taiwan, please revise your disclosure in
this section to
disclose the industry background and market trends in Taiwan.
Advancing Noninvasive Cancer Detection with Circulating Cell-Free DNA ("cfDNA")
Methylation Technology, page 193
11. We note your disclosure on page 197: "EG BioMed intends to seek approval
for a
version of this [pancreatic blood cancer] test that does not strictly
fall within the
definition of an LDT .if approval is obtained, YD Biopharma intends to
market (1)
the approved version of the pancreatic cancer diagnostic test and (2)
the LDT version
of the pancreatic cancer diagnostic test (in compliance with the
requirements for the
test to be deemed an LDT). This is because certain markets and entities
may prefer to
utilize the product as an FDA approved test, while others may prefer to
utilize the
product as an LDT." A similar statement with respect to the breast
cancer diagnostic
test appears on pages 216-217. Please revise to specify the
characteristics that would
require these tests to have FDA approval as opposed to being marketed as
an LDT.
Exhibits
12. We note your response to prior comment 2. We note your disclosure that
"Subscription Agreements for an aggregate of $10,000,000 in PIPE
Financing have
been signed" and "[t]he YD Stock will be issued and sold pursuant to a
stock purchase
agreement" and "[a]s of the date of this filing, there are no remaining
open items to be
negotiated for the PIPE Financing, except with respect to the
registration rights
agreement." Please revise to file these agreements, or forms thereof, as
exhibits to the
Registration Statement. We understand the registration rights agreement
may not yet
be available.
May 15, 2025
Page 5
Please contact Christie Wong at 202-551-3684 or Michael Fay at
202-551-3812 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jane Park at 202-551-7439 or Margaret Sawicki at 202-551-7153 with any
other
questions.
Sincerely,
Division of Corporation
Finance
Office of Industrial
Applications and
Services
cc: Mathew J. Saur, Esq.
Marc Rivera, Esq.
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