SEC Comment Letter for HYPERION DEFI, INC. (HYPD) (CIK 0001682639) (HYPD) — Dec 14, 2017
HYPERION DEFI, INC. (HYPD) (CIK 0001682639)
Date: Dec. 14, 2017 · CIK: 0001682639 · Accession: 0000000000-17-043681
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December 14, 2017
Tsontcho Ianchulev
Chief Executive Officer
Eyenovia, Inc.
501 Fifth Avenue, Suite 1404
New York, NY 10017
Re:Eyenovia, Inc.
Draft Registration Statement on Form S-1
Submitted November 15, 2017
CIK No. 0001682639
Dear Dr. Ianchulev:
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.
Form DRS Submitted November, 15, 2017
Prospectus Summary
Our Solution, page 3
1.Please balance the stated advantages you believe your micro-therapeutic solution by
expanding the discussion of the "Risks Associated with our Business" to provide a
similar level of detail and relocating the discussion to immediately follow "Our
Strategy."
2.Your product candidates appear to require a device for administering. Please clarify
FirstName LastNameTsontcho Ianchulev
Comapany NameEyenovia, Inc.
June 16, 2017 Page 2
FirstName LastNameTsontcho Ianchulev
Eyenovia, Inc.
December 14, 2017
Page 2
whether you have FDA approval for the device used for administration and the electronic
system used to track administration. If you have not yet obtained FDA approval, please
describe your plans to obtain approval. Additionally, expand your Business discussion to
describe applicable government regulation of medical devices. If you believe you do not
need FDA approval for the devices, please provide us with an analysis supporting your
determination.
Results of Operations
Nine Months Ended September 30, 2017 Compared with Nine Months Ended September 30,
2016
Research and Development Expenses, page 54
3.Please disclose the research and development expenses incurred by project for the
periods presented. If you do not separately track certain costs (e.g. internal costs) by
projects, disclose that fact and disclose those costs by type of costs (e.g. facilities,
personnel, etc.).
Critical Accounting Policies
Stock-Based Compensation, page 57
4.Please revise to disclose the following information. You may cross-reference to the
extent that this, or other material information relevant to share-based compensation, is
provided elsewhere in the preliminary prospectus.
•The methods that management used to determine the fair value of the company’s
shares and the nature of the material assumptions involved.
•The extent to which the estimates are considered highly complex and subjective; and
•The estimates will not be necessary to determine the fair value of new awards once
the underlying shares begin trading.
5.We may have additional comments on your accounting for equity issuances including
stock based compensation and convertible instruments. Once you have an estimated
offering price, please provide us an analysis explaining the reasons for the differences
between the recent valuations of your common stock leading up to the IPO and the
estimated offering price. Include the following in your analysis:
•The issuance dates and the fair value of the underlying stock at each date; and
•The significant factors, assumptions, methodologies used for each grant date.
In addition, to the extent the common stock fair value significantly varies from the
preferred stock issuance price, tell us the factors that contributed to the difference and
explain how you considered the fact that the preferred stocks are convertible at a 1-for-1
ratio and are not redeemable.
FirstName LastNameTsontcho Ianchulev
Comapany NameEyenovia, Inc.
June 16, 2017 Page 3
FirstName LastNameTsontcho Ianchulev
Eyenovia, Inc.
December 14, 2017
Page 3
Sales and Marketing, page 72
6.Please expand your discussion regarding your license agreement with the Senju
Pharmaceuticals Co., Ltd. with respect to your MicroStat program to disclose the
material terms, including the term, any royalty term and termination provisions, as well
as any royalty or other material payment provisions.
Intellectual Property
Patents, page 73
7.We note that your licensing partnership with Senju Pharmaceuticals is for Asia, including
China. To the extent material to your business, please disclose the jurisdictions where
you have been issued patents or pending patent applications.
Management, page 89
8.Please revise to clarify the description of the business experience for Jennifer Clasby,
Luke Clauson, and Shuhei Yoshida so that it covers each person´s principal occupations
and employment during the past five years and provides all the information required by
Item 401(e) of Regulation S-K.
Note 7 – Commitments and Contingencies
License Agreement, page F-16
9.Please confirm to us that you have no outstanding obligations and are not eligible to
receive any milestones under the Senju license agreement. Otherwise, please disclose
these terms.
General
10.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.
11.Please provide us proofs of any additional graphics, visual, or photographic information
you will provide in the printed prospectus prior to its use, for example in a preliminary
prospectus. Please note that we may have comments regarding this material.
FirstName LastNameTsontcho Ianchulev
Comapany NameEyenovia, Inc.
June 16, 2017 Page 4
FirstName LastName
Tsontcho Ianchulev
Eyenovia, Inc.
December 14, 2017
Page 4
You may contact Keira Nakada at 202-551-3659 or Sharon Blume at 202-551-3474 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jeffrey Gabor at 202-551-2544 or Suzanne Hayes at 202-551-3675 with any other
questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Benjamin Reichel