October 15, 2018
George Yeh
President
Taiwan Liposome Company, Ltd.
11F-1, No. 3 Yuanqu Street
Nangang District
Taipei City, Taiwan 11503
Republic of China
Re: Taiwan Liposome Company, Ltd.
Amendment No. 2 to Registration Statement on Form F-1
Filed September 17, 2018
File No. 333-223090
Dear Mr. Yeh:
We have reviewed your amended 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 amending your registration statement
and providing the
requested information. 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 any amendment to your registration statement and the
information you
provide in response to these comments, we may have additional comments. Unless
we note
otherwise, our references to prior comments are to comments in our April 24,
2018 letter.
Form F-1 Filed September 17, 2018
Prospectus Summary
Overview, page 1
1. Please balance your disclosure regarding the ability of TLC399 to
maintain therapeutic
drug levels for at least six months with the fact that you have not been
able to show
similar results beyond three months in your current Phase II trial.
George Yeh
FirstName LastNameGeorge Yeh
Taiwan Liposome Company, Ltd.
Comapany NameTaiwan Liposome Company, Ltd.
October 15, 2018
October 15, 2018 Page 2
Page 2
FirstName LastName
Pipeline, page 4
2. We note your response to prior comment 2. The table of your product
candidate pipeline
on pages 4 and 84 should reflect the actual, and not the anticipated,
status of your pipeline
candidates as of the latest practicable date. The table currently
suggests that TLC590 has
completed Phase I trials but your disclosure indicates that you are
currently recruiting and
dosing patients for a Phase I/II trial, and expect to report data in
2019. Additionally, the
table suggests that TLC178 is in the midst of Phase I trials but your
disclosure indicates
that you filed an IND application in June 2018 and have not initiated
clinical trials. Please
revise the table to reflect the actual status of TLC590 and TLC178.
Risk Factors
The terms of our loan and security agreement, page 15
3. We note that your loan and security agreement with Cathay Bank will be
in default if you
do not issue $50 million in equity by December 31, 2018 and receive,
by October 31,
2018, either (1) $20 million from the sale or issuance of equity
securities of TLCHK or (2)
at least a $15 million royalty payment from a license in China. Please
disclose the current
amount outstanding under this agreement here and elsewhere that you
discuss the loan.
Please also tell us if you have any immediate plan to issue equity
securities of TLCHK
and/or receive a royalty payment pursuant to a license agreement,
including the particular
license agreement. If not, please tell us how you intend to meet these
requirements.
Please also disclose the existence of this agreement in the summary,
including the
obligations due October 31, 2018 and December 31, 2018 and the
potential default if you
do not meet these obligations. Please also tell us whether you will
use any proceeds of the
offering to repay this loan.
Use of Proceeds, page 58
4. We note that you only list TLC590 and TLC178 in this section. Please
revise to indicate
the amount of proceeds you will allocate to each of your product
candidates and stage of
development you expect to achieve for each. We note your disclosure
elsewhere that you
intend to begin U.S. trials for TLC599 in the first half of 2019 and
that you have ongoing
Phase I and Phase II trials for TLC399. If you do not plan to use any
proceeds of this
offering for either product candidate, please state this fact.
TLC599 Phase II Data, page 92
5. Efficacy is assessed throughout all stages of clinical trials and the
determinations are
within the sole authority of the FDA or comparable foreign regulatory
entities. Please
remove all references to your product candidates being effective. We
note the following
examples:
- "TLC599 also met a series of key secondary endpoints including
efficacy..." (p. 81);
--"data showed statistically significant efficacy..." (p. 94 and 96);
George Yeh
FirstName LastNameGeorge Yeh
Taiwan Liposome Company, Ltd.
Comapany NameTaiwan Liposome Company, Ltd.
October 15, 2018
October 15, 2018 Page 3
Page 3
FirstName LastName
"TLC599 showed rapid onset of pain relief....data from these trials
indicated that 12mg
dose provided the best efficacy" (p. 96);
- "TLC599 demonstrated a sustained duration of pain relief...." (p.
97); and
- "TLC599 has potential efficacy through 24 weeks...."
You can describe the results observed during the study but drawing
conclusions related to
efficacy is not appropriate.
6. We note your statement on page 97, and the related Figure 11, that
TLC599 demonstrated
a sustained duration of pain relief twice as long as observed in a
separate Phase 3 clinical
trial of a currently available long-acting steroid. Given that you
have not conducted a
head-to-head trial of TLC599 and the referenced steroid, it is not
appropriate to make this
comparison. Please revise your disclosure accordingly.
Governing Law, Submission to Jurisdiction and Arbitration, page 184
7. Please revise your disclosure in this section to state that the
federal securities law violation
aspects of such claims brought by a Holder against the Company and/or
the Depositary
may, at the option of the Holder, remain in state or federal court in
New York as
referenced in Section 22 of the Form of Deposit Agreement filed as
Exhibit 4.1.
Notes to Consolidated Financial Statements
3. Application of New Standards, Amendments and Interpretations
Adoption and Impact of IFRS 15 Revenue from Contracts with Customers and
Amendments,
page F-63
8. Tell us:
confirm that you had no authorization collaboration and development
revenue for
2017. All revenue for 2017 is described as royalty revenue on page
F-38.
how you determined the amount of NT$5.6 million of revenue
recognized in 2018
under IFRS 15 when no revenue would have been recognized under
previous
accounting policies per page F-96. Ensure the disclosure is
adequate so that a reader
can understand the impact of adoption of IFRS 15.
your consideration of disclosing on page F-38 and F-82:
o the amount of the up-front payment received from Sandoz, the
date received, and
the period over which you recognize the up-front payment and
o a description of the milestones stated in the contract, the
amount of any milestones
that have been received and when milestones were received.
if revenue from SciClone and SamChumDang is only recognized in 2016
as these two
customers are referenced on page F-38 and do not appear on page
F-82. If revenue
from the SciClone and SamChumDang agreements is recognized in 2017
and/or 2018
tell us your consideration of disclosing the amount of up-front and
milestone payments
received.
George Yeh
Taiwan Liposome Company, Ltd.
October 15, 2018
Page 4
Exhibits
9. We note that Section 24 of the Deposit Agreement filed as Exhibit 4.1
includes a waiver
of jury trial provision with respect to claims arising out of the Deposit
Agreement, any
ADR, or any transaction contemplated therein. Please clarify whether the
waiver of the
right to a jury trial applies to claims under the U.S. federal securities
laws. To the extent
that the provision applies to securities law claims, please include: (i)
a risk factor
regarding the impact of this provision as to holders and (ii) a statement
in the registration
statement and the Deposit Agreement that, by agreeing to the provision,
investors will not
be deemed to have waived the company s compliance with the federal
securities laws and
the rules and regulations thereunder. Additionally, please specifically
describe the basis
for your belief that this provision is enforceable under federal law and
the laws of the
State of New York.
You may contact Franklin Wyman at 202-551-3660 or Lisa Vanjoske at
202-551-3614 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jeffrey Gabor at 202-551-2544 or Erin Jaskot at 202-551-3442 with any
other questions.
Sincerely,
FirstName LastNameGeorge Yeh
Division of
Corporation Finance
Comapany NameTaiwan Liposome Company, Ltd.
Office of
Healthcare & Insurance
October 15, 2018 Page 4
cc: Charlie Kim, Esq.
FirstName LastName