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HYPERION DEFI, INC.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
HYPERION DEFI, INC.
Response Received
1 company response(s)
High - file number match
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HYPERION DEFI, INC.
Response Received
1 company response(s)
High - file number match
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HYPERION DEFI, INC.
Response Received
1 company response(s)
Medium - date proximity
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HYPERION DEFI, INC.
Awaiting Response
0 company response(s)
High
HYPERION DEFI, INC.
Response Received
1 company response(s)
High - file number match
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Company responded
2022-01-19
HYPERION DEFI, INC.
Summary
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HYPERION DEFI, INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-12-20
HYPERION DEFI, INC.
Summary
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Company responded
2021-12-20
HYPERION DEFI, INC.
Summary
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HYPERION DEFI, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2020-05-05
HYPERION DEFI, INC.
Summary
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Company responded
2020-05-08
HYPERION DEFI, INC.
References: May 5, 2020
Summary
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Company responded
2020-05-11
HYPERION DEFI, INC.
Summary
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HYPERION DEFI, INC.
Response Received
1 company response(s)
High - file number match
Company responded
2019-02-08
HYPERION DEFI, INC.
Summary
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SEC wrote to company
2019-02-11
HYPERION DEFI, INC.
Summary
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HYPERION DEFI, INC.
Response Received
3 company response(s)
Medium - date proximity
SEC wrote to company
2018-12-04
HYPERION DEFI, INC.
Summary
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Company responded
2018-12-12
HYPERION DEFI, INC.
References: December 4, 2018
Summary
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Company responded
2018-12-14
HYPERION DEFI, INC.
Summary
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Company responded
2018-12-14
HYPERION DEFI, INC.
Summary
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HYPERION DEFI, INC.
Response Received
3 company response(s)
Medium - date proximity
SEC wrote to company
2018-01-05
HYPERION DEFI, INC.
Summary
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Company responded
2018-01-05
HYPERION DEFI, INC.
Summary
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Company responded
2018-01-22
HYPERION DEFI, INC.
Summary
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Company responded
2018-01-22
HYPERION DEFI, INC.
Summary
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HYPERION DEFI, INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-12-14
HYPERION DEFI, INC.
Summary
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Company responded
2017-12-19
HYPERION DEFI, INC.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-08 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2025-04-24 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2025-04-23 | SEC Comment Letter | HYPERION DEFI, INC. | DE | 333-286617 | Read Filing View |
| 2024-10-04 | SEC Comment Letter | HYPERION DEFI, INC. | DE | 333-282458 | Read Filing View |
| 2024-10-04 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2022-12-21 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2022-12-20 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2022-02-22 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2022-01-19 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2021-12-22 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2021-12-20 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2021-12-20 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2020-05-11 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2020-05-08 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2020-05-05 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2019-02-11 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2019-02-08 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-12-14 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-12-14 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-12-12 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-12-04 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-01-22 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-01-22 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-01-05 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-01-05 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2017-12-19 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2017-12-14 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-23 | SEC Comment Letter | HYPERION DEFI, INC. | DE | 333-286617 | Read Filing View |
| 2024-10-04 | SEC Comment Letter | HYPERION DEFI, INC. | DE | 333-282458 | Read Filing View |
| 2022-12-20 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2022-02-22 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2021-12-22 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2021-12-20 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2020-05-05 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2019-02-11 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-12-04 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-01-05 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2017-12-14 | SEC Comment Letter | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-08 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2025-04-24 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2024-10-04 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2022-12-21 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2022-01-19 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2021-12-20 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2020-05-11 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2020-05-08 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2019-02-08 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-12-14 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-12-14 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-12-12 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-01-22 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-01-22 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2018-01-05 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
| 2017-12-19 | Company Response | HYPERION DEFI, INC. | DE | N/A | Read Filing View |
2025-12-08 - CORRESP - HYPERION DEFI, INC.
CORRESP 1 filename1.htm December 8, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Jimmy MacNamara Re: Hyperion DeFi, Inc. (the "Company") Registration Statement Filed on Form S-3 (the "Registration Statement") File No. 333-291570 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, the Company hereby respectfully requests that the effective date for the above-referenced Registration Statement be accelerated to 8:00 a.m., Eastern Time, on December 9, 2025, or as soon as practicable thereafter. Please contact Megan Gates of Covington & Burling LLP at (617) 785-4653 or mgates@cov.com with any questions you may have regarding this request. In addition, please notify Ms. Gates by telephone when this request for acceleration has been granted. Respectfully, Hyperion DeFi, Inc. By: /s/ Hyunsu Jung Name: Hyunsu Jung Title: Interim Chief Executive Officer cc: Megan Gates, Covington & Burling LLP
2025-04-24 - CORRESP - HYPERION DEFI, INC.
CORRESP 1 filename1.htm April 24, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Tim Buchmiller Re: Eyenovia, Inc. (the "Company") Registration Statement Filed on Form S-3 (the "Registration Statement") File No. 333-286617 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, the Company hereby respectfully requests that the effective date for the above-referenced Registration Statement be accelerated to 9:00 a.m., Eastern Time, on April 25, 2025, or as soon as practicable thereafter. Please contact Julie Plyler of Covington & Burling LLP at (212) 841-1090 or jplyler@cov.com with any questions you may have regarding this request. In addition, please notify Ms. Plyler by telephone when this request for acceleration has been granted. Respectfully, Eyenovia, Inc. By: /s/ Michael Rowe Name: Michael Rowe Title: Chief Executive Officer cc: Julie Plyler, Covington & Burling LLP
2025-04-23 - UPLOAD - HYPERION DEFI, INC. File: 333-286617
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 23, 2025 Michael Rowe Chief Executive Officer Eyenovia, Inc. 23461 S. Pointe Drive, Suite 390 Laguna Hills, CA 92653 Re: Eyenovia, Inc. Registration Statement on Form S-3 Filed April 18, 2025 File No. 333-286617 Dear Michael Rowe: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Tim Buchmiller at 202-551-3635 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Julie M. Plyler, Esq. </TEXT> </DOCUMENT>
2024-10-04 - UPLOAD - HYPERION DEFI, INC. File: 333-282458
October 4, 2024
Michael Rowe
Chief Executive Officer
Eyenovia, Inc.
295 Madison Avenue, Suite 2400
New York, New York 10017
Re:Eyenovia, Inc.
Registration Statement on Form S-3
Filed October 1, 2024
File No. 333-282458
Dear Michael Rowe:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that
the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Joshua Gorsky at 202-551-7836 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Julie M. Plyler
2024-10-04 - CORRESP - HYPERION DEFI, INC.
CORRESP
1
filename1.htm
October 4, 2024
Via EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Joshua Gorsky
Re: Eyenovia,
Inc. (the “Company”)
Registration Statement Filed on Form S-3 (the “Registration
Statement”)
File No. 333-282458
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of
1933, as amended, the Company hereby respectfully requests that the effective date for the above-referenced Registration Statement be
accelerated to 5:00 p.m., Eastern Time, on October 8, 2024, or as soon as practicable thereafter.
Please contact Julie Plyler of Covington &
Burling LLP at (212) 841-1090 or jplyler@cov.com with any questions you may have regarding this request. In addition, please notify Ms.
Plyler by telephone when this request for acceleration has been granted.
Respectfully,
Eyenovia, Inc.
By:
/s/ Andrew Jones
Name:
Andrew Jones
Title:
Chief Financial Officer
cc:
Julie Plyler, Covington & Burling LLP
2022-12-21 - CORRESP - HYPERION DEFI, INC.
CORRESP
1
filename1.htm
EYENOVIA, INC.
295 Madison Avenue, Suite 2400
New York, New York 10017
December 21, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Tim Buchmiller
RE: Eyenovia, Inc.
Registration Statement on Form S-3
Filed December 16, 2022
File No. 333- 268832
Acceleration Request
Dear Mr. Buchmiller:
With respect to the above-referenced
Registration Statement on Form S-3 (the “Registration Statement”), and pursuant to Rule 461 of Regulation C promulgated
under the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of Eyenovia, Inc. (the “Company”),
that the Securities and Exchange Commission accelerate the effective date of the Registration Statement to December 22, 2022, at
4:00 p.m. Eastern Time, or as soon as practicable thereafter.
The cooperation of the staff in meeting the timetable described
above is very much appreciated.
Please call Megan N. Gates
of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 542-6000, with any comments or questions regarding
the Registration Statement.
Very truly yours,
EYENOVIA, INC.
/s/ Michael Rowe
Michael Rowe
Chief Executive Officer
cc: Michael Rowe, Eyenovia, Inc.
John Gandolfo, Eyenovia, Inc.
Megan N. Gates, Esq., Mintz,
Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2022-12-20 - UPLOAD - HYPERION DEFI, INC.
United States securities and exchange commission logo
December 20, 2022
Michael Rowe
Chief Executive Officer
Eyenovia, Inc.
295 Madison Avenue, Suite 2400
New York, New York 10017
Re:Eyenovia, Inc.
Registration Statement on Form S-3
Filed December 16, 2022
File No. 333-268832
Dear Michael Rowe:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Megan Gates, Esq.
2022-02-22 - UPLOAD - HYPERION DEFI, INC.
United States securities and exchange commission logo
February 22, 2022
John Gandolfo
Chief Financial Officer
Eyenovia, Inc.
295 Madison Avenue, Suite 2400
New York, New York 10017
Re:Eyenovia, Inc.
Form 10-K for the fiscal year ended December 31, 2020
Filed March 30, 2021
File No. 001-38365
Dear Mr. Gandolfo:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-01-19 - CORRESP - HYPERION DEFI, INC.
CORRESP
1
filename1.htm
One Financial Center
Boston, MA 02111
617 542 6000
mintz.com
CONFIDENTIAL TREATMENT REQUESTED
BY EYENOVIA, INC.
FOIA Confidential Treatment Requested Pursuant to 17 C.F.R. §200.83
The entity requesting confidential treatment is:
Eyenovia, Inc.
295 Madison Avenue
Suite 2400
New York, NY 10017
Attention: John Gandolfo, Chief Financial Officer
CERTAIN PORTIONS OF THIS LETTER HAVE BEEN OMITTED FROM THE VERSION
FILED VIA EDGAR. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. INFORMATION THAT WAS OMITTED IN THE EDGAR
VERSION HAS BEEN NOTED IN THIS LETTER WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***].”
January 19, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Frank Wyman
Mary Mast
Re:
Eyenovia, Inc.
Form 10-K for the fiscal year ended December 31, 2020
Filed March 30, 2021
File No. 001-38365
Ladies and Gentlemen:
This letter sets forth the
response of Eyenovia, Inc. (the “Company”) to the comment letter, dated December 22, 2021, of the staff of the Division
of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission with respect to the Company’s
Annual Report on Form 10-K, publicly filed on March 30, 2021 (“Registration Statement”).
Because of the commercially
sensitive nature of information contained herein, this submission is accompanied by the Company’s request for confidential treatment
for selected portions of this letter. The Company has filed a separate letter with the Office of Freedom of Information and Privacy Act
Operations in connection with the confidential treatment request, pursuant to Rule 83 of the Commission’s Rules on Information and
Requests, 17 C.F.R. § 200.83. For the Staff’s reference, we have enclosed a copy of the Company’s letter to the Office
of Freedom of Information and Privacy Act Operations, as well as a copy of this correspondence, marked to show the portions redacted from
the version filed via EDGAR and for which the Company is requesting confidential treatment.
CONFIDENTIAL TREATMENT REQUESTED BY
Eyenovia, Inc.
Boston London Los
Angeles New York San Diego San
Francisco Washington
MINTZ, LEVIN, COHN, FERRIS, GLOVSKY
AND POPEO, P.C.
MINTZ
January 19, 2022
Page 2
CONFIDENTIAL TREATMENT REQUESTED
BY EYENOVIA, INC.
In order to facilitate your
review, we have repeated each comment in its entirety in italicized text in the original numbered sequence and followed by the Company’s
response.
Form 10-K for the fiscal year ended December
31, 2020
Management's Discussion and Analysis
Financial Overview
Revenue and Cost of Revenue, page 72
1. Please explain how you applied the provisions of ASC 606 to both the Artic Vision and Bausch License
Agreements. In this regard, specify the performance obligations of each party, the amount of the transaction price and how it was determined,
and the method in which revenue is being recognized for each performance obligation. Ensure that all disclosures required by ASC 606 related
to these agreements are provided in future filings. Please also separately quantify the potential aggregate milestone payments by development,
regulatory and sales milestones and tell us your consideration of disclosing this information in future filings.
Response: In response to the
Staff’s comment, the Company will revisit ASC 606’s disclosure requirements and, if necessary, will expand its disclosure
related to both the Arctic Vision and Bausch License Agreements in future filings to enable readers to better understand the nature, amount,
timing, and uncertainty of revenue and cash flows from contracts with customers.
Responses to the Staff’s specific comments with respect
to each license agreement are set forth below.
Arctic Vision License Agreement
The Company concluded that the Arctic
Vision License Agreement represents a collaborative agreement pursuant to ASC 808 that involves a joint operating activity for the following
reasons:
· Both parties are active participants in the activity.
o Arctic Vision has a contractual right to use the intellectual property; and
o The Company is directing and carrying out the activities of the joint operating activity.
· Both parties are exposed to significant risks
and rewards.
o The Company can earn up to $37.75 million of milestone payments, plus royalties earned on Arctic Vision
product sales.
o Arctic Vision will generate future sales from a successfully commercialized product.
Furthermore, the Company concluded that
providing a license of intellectual property within specified territories is part of the Company’s ordinary activities and that
the licensing revenues, milestone revenues and royalty revenues are pursuant to a vendor-customer relationship; and therefore concluded
that such revenues are within the scope of ASC 606, and will be recognized as revenues.
CONFIDENTIAL TREATMENT REQUESTED BY
Eyenovia, Inc.
MINTZ
January 19, 2022
Page 3
CONFIDENTIAL TREATMENT REQUESTED
BY EYENOVIA, INC.
The following summarizes the Company’s
ASC 606 analysis with respect to the various revenue streams:
Non-Refundable Upfront Payment of $4.0 Million License
Fee
The Company recognizes revenue on a
gross basis because it acts as a principal in its arrangement with Arctic Vision as it is the entity that promised to provide goods or
services to its customers, controls the specified good or service before it is transferred to the customer, is primarily responsible for
acceptability of the specified good or service, and has discretion in establishing the prices for the specified goods or service.
The Company has two bundled performance
obligations related to the non-refundable up-front payment from Arctic Vision, which includes a license and delivery of the related trial
data and information for each of the two licensed products. The performance obligations (license and trial data access) related to each
product are bundled together because they are not distinct within the context of the contract and do not provide the customer with value
on a stand-alone basis. Arctic Vision will utilize the license and trial data in order to file with and obtain approval from various Asian
regulators. Ultimately, Arctic Vision intends to develop and commercialize the two licensed products in Greater China (mainland China,
Hong Kong, Macau and Taiwan) and South Korea.
· The transaction price of the promised goods or
services are fixed and do not give rise to variable consideration.
· Since there are two bundled performance obligations,
the $4.0 million transaction price is allocated to the single performance obligation for each licensed product. Management determined
that the license and trial data for each product provide roughly equivalent value to Arctic Vision. Accordingly, the Company allocated
50% or $2.0 million of the transaction price to each licensed product.
· The Company will recognize revenue for each licensed
product at a point in time upon completion of its single performance obligation, when the customer is able to benefit from the license,
which includes delivery of the related trial data.
Milestone Payments of Up to $39.75
Million
Under the terms of the License Agreement
(as subsequently amended on September 14, 2021 for the asterisked items listed below) the specified performance obligations (which include
filings of Marketing Authorization Applications or “MAAs”) are as follows:
Milestone Event
Gross Payment
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
Total
$ 39,750,000
CONFIDENTIAL
TREATMENT REQUESTED
BY Eyenovia, Inc.
MINTZ
January 19, 2022
Page 4
CONFIDENTIAL
TREATMENT REQUESTED
BY EYENOVIA, INC.
Milestone revenue represents variable consideration, which
is only recognized as revenue when the related performance obligation is satisfied. In future filings the Company intends to disclose
the aggregate potential milestone revenues related to (a) the filing of MAAs; and (b) the receipt of regulatory approvals.
Royalty Payments
Arctic Vision will purchase its supply
of MicroPine and MicroLine from the Company or, for such products not supplied by the Company, will pay the Company a percentage royalty
on net sales of such products in the range of between one percent and nine percent, subject to certain adjustments. The Company will pay
a percentage of such payments, royalties, or net proceeds of such supply to Senju pursuant to the Exclusive License Agreement with Senju,
as amended by the License Amendment dated April 8, 2020, a Letter Agreement dated August 10, 2020 and the License Amendment 2, effective
September 14, 2021.
ASC 606 provides
specific guidance for licenses of intellectual property with consideration that varies entirely based on the customer’s subsequent
sales or usage of the intellectual property. For these licenses, the consideration is not included in the transaction price until it is
no longer variable. Accordingly, the Company recognizes such revenue as sales are generated.
Bausch License Agreement
The Company concluded that the Bausch
License Agreement represents a collaborative agreement pursuant to ASC 808 that involves a joint operating activity for the following
reasons:
· Both parties are active participants in the activity.
o The Company owns the underlying intellectual property; and
o Bausch is directing and carrying out the activities of the joint operating activity.
CONFIDENTIAL
TREATMENT REQUESTED
BY Eyenovia, Inc.
MINTZ
January 19, 2022
Page 5
CONFIDENTIAL TREATMENT REQUESTED
BY EYENOVIA, INC.
· Both parties are exposed to significant risks
and rewards.
o The Company can earn up to $35 million of milestone payments, plus royalties earned on Bausch gross profit.
o Bausch will generate future sales from a successfully commercialized product.
Furthermore, the Company concluded that
providing a license of intellectual property within specified territories is part of the Company’s ordinary activities and that
the licensing revenues, milestone revenues and royalty revenues are pursuant to a vendor-customer relationship; and therefore concluded
that such revenues are within the scope of ASC 606, and will be recognized as revenues.
The following summarizes the Company’s ASC 606 analysis
with respect to the various revenue streams:
Non-Refundable Upfront Payment of $10.0 Million License
Fee
· The Company recognizes revenue on a gross basis
because it acts as a principal in its arrangements with Bausch as it is the entity that promised to provide goods or services to its customers,
controls the specified good or service before it is transferred to the customer, is primarily responsible for acceptability of the specified
good or service, and has discretion in establishing the prices for the specified goods or service.
· Related to its license agreement with Bausch,
the Company’s performance obligations are to provide the licensed technology, deliver the related trial data and transfer the clinical
trial supervisory oversight to Bausch.
· The promises are bundled together since they
are not distinct within the context of the contract and do not provide the customer with value on a stand-alone basis.
· The $10.0 million transaction price of the promised
goods or services is fixed and does not give rise to variable consideration.
· Since there is one bundled performance obligation,
the entire $10.0 million upfront cash license fee is solely attributed to the single performance obligation.
· The Company will recognize revenue at a point
in time upon the completion of its single performance obligation, when the customer is able to benefit from the license, which includes
(i) delivering the trial data; and (ii) transferring supervisory control of the clinical trial.
Milestone Payments of Up to $35.0
Million
Under the terms of the License Agreement,
the specified performance obligations are as follows:
Milestone Event
Milestone Payment
[***]
[***]
[***]
[***]
$ 35,000,000
CONFIDENTIAL
TREATMENT REQUESTED
BY Eyenovia, Inc.
MINTZ
January 19, 2022
Page 6
CONFIDENTIAL TREATMENT
REQUESTED
BY EYENOVIA, INC.
Milestone revenues represent variable
consideration, which is only recognized as revenue when the related performance obligation is satisfied. In future filings, the Company
intends to continue to disclose the aggregate potential milestone revenues, without further breakdown.
Royalty Payments
Under the terms of the License Agreement,
Bausch will pay the Company royalties on a tiered basis ranging up to fifteen percent, based on gross profits from the sales of the Bausch
Licensed Product in the United States and Canada, subject to certain adjustments in the event of generic entry, negative gross profits
or patent expiration, for a period of the later to occur of the tenth anniversary of the first commercial sale of a Bausch Licensed Product
in such country in the Licensed Territory or the expiration of the last valid patent claim for a Bausch Licensed Product in such country
in the Licensed Territory.
ASC 606 provides specific guidance for
licenses of intellectual property with consideration that varies entirely based on the customer’s subsequent sales or usage of the
intellectual property. For these licenses, the consideration is not included in the transaction price until it is no longer variable.
Accordingly, the Company recognizes such revenue as the gross profit is generated.
Research and Development Expenses, page 73
2. Please clarify your accounting policy for cost reimbursements received under these agreements. As it
appears that you are recognizing these reimbursements as an offset to research and development expense, please explain how you concluded
that these payments do not fall under the guidance of ASC 606 and cite the specific authoritative guidance upon which you relied.
Response: In response to the
Staff’s comments, the Company respectfully submits the following explanation:
Arctic Vision is assuming financial
responsibility for twenty-five percent of the development activities of the Licensed Device effective with the execution of the Arctic
Vision License Agreement.
Bausch is assuming full financial responsibility
for the development activities of the licensed product, effective with the execution of the Bausch License Agreement. There is a transition
period whereby Bausch will reimburse the Company for its development costs.
Both license agreements were determined
to represent collaborative arrangements. Pursuant to ASC 808-10-15-5, the Company determined that the licensing, milestone and royalty
transactions were ordinary activities for us, but providing research and development activities in the context of the collaboration were
not ordinary activities. Accordingly, the counterparties represent customers for the licensing, milestone and royalty transactions (each
a distinct unit of account), which should be accounted for under ASC 606. The Company’s accounting policy is to recognize research
and development cost reimbursements from non-customers as contra-research and development expense, because the Company believes that this
treatment best reflects the economics of the cost reimbursement arrangement.
CONFIDENTIAL
TREATMENT REQUESTED
BY Eyenovia, Inc.
MINTZ
January 19, 2022
Page 7
CONFIDENTIAL TREATMENT REQUESTED
BY EYENOVIA, INC.
Note 10--Related Party Transactions, page F-19
3.
2021-12-22 - UPLOAD - HYPERION DEFI, INC.
United States securities and exchange commission logo
December 22, 2021
John Gandolfo
Chief Financial Officer
Eyenovia, Inc.
295 Madison Avenue, Suite 2400
New York, New York 10017
Re:Eyenovia, Inc.
Form 10-K for the fiscal year ended December 31, 2020
Filed March 30, 2021
File No. 001-38365
Dear Mr. Gandolfo:
We have reviewed your filing 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 these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 10-K for the fiscal year ended December 31, 2020
Management's Discussion and Analysis
Financial Overview
Revenue and Cost of Revenue, page 72
1.Please explain how you applied the provisions of ASC 606 to both the Artic Vision and
Bausch License Agreements. In this regard, specify the performance obligations of each
party, the amount of the transaction price and how it was determined, and the method in
which revenue is being recognized for each performance obligation. Ensure that all
disclosures required by ASC 606 related to these agreements are provided in future
filings. Please also separately quantify the potential aggregate milestone payments by
development, regulatory and sales milestones and tell us your consideration of disclosing
this information in future filings.
FirstName LastNameJohn Gandolfo
Comapany NameEyenovia, Inc.
December 22, 2021 Page 2
FirstName LastName
John Gandolfo
Eyenovia, Inc.
December 22, 2021
Page 2
Research and Development Expenses, page 73
2.Please clarify your accounting policy for cost reimbursements received under these
agreements. As it appears that you are recognizing these reimbursements as an offset to
research and development expense, please explain how you concluded that these
payments do not fall under the guidance of ASC 606 and cite the specific authoritative
guidance upon which you relied.
Note 10--Related Party Transactions, page F-19
3.Please confirm you will disclose in future filings, a ten-point percentage range for royalty
payments under the amended Senju license agreement. In addition, you disclose on page
15 of the September 30, 2021 10-Q that you amended the Senju agreement, effective
September 14, 2021, such that you must make payments to Senju based on non-royalty
license revenue and sales revenue, including a one-time upfront payment of $250,000.
Please clarify the amount and nature of each payment you may be required to pay.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
You may contact Frank Wyman at 202-551-3660 or Mary Mast at 202-551-3613 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-12-20 - UPLOAD - HYPERION DEFI, INC.
United States securities and exchange commission logo
December 20, 2021
Tsontcho Ianchulev
Chief Executive Officer
Eyenovia, Inc.
295 Madison Avenue, Suite 2400
New York, New York 10017
Re:Eyenovia, Inc.
Registration Statement on Form S-3
Filed December 14, 2021
File No. 333-261638
Dear Mr. Ianchulev:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Megan Gates, Esq.
2021-12-20 - CORRESP - HYPERION DEFI, INC.
CORRESP
1
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EYENOVIA, INC.
295 Madison Avenue, Suite 2400
New York, New York 10017
December 20, 2021
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Alan Campbell
RE: Eyenovia, Inc.
Registration Statement on Form S-3
Filed December 14, 2021
File No. 333- 261638
Acceleration Request
Dear Mr. Campbell:
With respect to the above-referenced
Registration Statement on Form S-3 (the “Registration Statement”), and pursuant to Rule 461 of Regulation C promulgated under
the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of Eyenovia, Inc. (the “Company”),
that the Securities and Exchange Commission accelerate the effective date of the Registration Statement to December 23, 2021, at 10:00
a.m. Eastern Time, or as soon as practicable thereafter.
The cooperation of the staff
in meeting the timetable described above is very much appreciated.
Please call Megan N. Gates
of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 542-6000, with any comments or questions regarding
the Registration Statement.
Very truly yours,
EYENOVIA, INC.
/s/ John Gandolfo
John Gandolfo
Chief Financial Officer
cc: Tsontcho Ianchulev, Eyenovia, Inc.
John Gandolfo, Eyenovia, Inc.
Megan N. Gates, Esq., Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo, P.C.
2020-05-11 - CORRESP - HYPERION DEFI, INC.
CORRESP
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EYENOVIA, INC.
295 Madison Avenue, Suite 2400
New York, NY 10017
May 11, 2020
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Paul Fischer
Division of Corporation Finance
Office of Healthcare & Insurance
Re:
Acceleration Request
Eyenovia, Inc.
Registration Statement on Form S-3
Filed April 22, 2020, as amended on May 8, 2020
(File No. 333-237790)
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended (the “Act”), Eyenovia, Inc. (the “Registrant”) hereby requests that the U.S. Securities
and Exchange Commission (the “Commission”) take appropriate action to accelerate the effective date of the above-referenced
registration statement (the “Registration Statement”) so as to become effective on Wednesday, May 13, 2020, at 4:15
p.m. Eastern Time, or as soon thereafter as practicable.
The Registrant understands that the Commission
will consider this request for acceleration of the effective date of the Registration Statement as a confirmation of the fact that
the Registrant is aware of its responsibilities under the Act and the Securities Exchange Act of 1934, as amended, as they relate
to the proposed public offering of the securities specified in the Registration Statement.
Once the Registration Statement is effective,
please orally confirm the event with our counsel, Wyrick Robbins Yates & Ponton LLP, by calling S. Halle Vakani at (919) 865-1125.
We also respectfully request that a copy of the written order from the Commission verifying the effective date and time of the
Registration Statement be sent to Ms. Vakani via email at hvakani@wyrick.com.
Sincerely,
EYENOVIA, INC.
By:
/s/ Tsontcho Ianchulev
Tsontcho Ianchulev, Chief Executive Officer
cc:
S. Halle Vakani, Wyrick Robbins Yates & Ponton LLP
2020-05-08 - CORRESP - HYPERION DEFI, INC.
CORRESP
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Wyrick
Robbins Yates & Ponton LLP
ATTORNEYS
AT LAW
4101
Lake Boone Trail, Suite 300, Raleigh, NC 27607
PO
Drawer 17803, Raleigh, NC 27619
P:
919.781.4000 F: 919.781.4865 www.wyrick.com
May 8, 2020
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention: Mr. Paul Fischer
Ms. Celeste Murphy
Division of Corporation Finance
Office of Life Sciences
Re: Eyenovia, Inc.
Draft Registration Statement on Form S-3
Filed April 22, 2020
File No. 333-237790
Ladies and Gentlemen:
We write this letter on behalf of our client Eyenovia, Inc.
(the “Company”) in response to the comments of the staff (the “Staff”) of the U.S. Securities and Exchange
Commission with respect to the above-captioned filing, as set forth in the Staff’s letter dated May 5, 2020. For ease of
review, we have set forth below in italics each of the numbered comments of the Staff’s letter and have followed each comment
with the Company’s response thereto.
Registration Statement on Form S-3 filed on April 22, 2020,
File No. 333-237790
Exhibit 5.1, Opinion of Wyrick Robbins, page II-1
1. Please revise your legality opinion to differentiate
between shares currently outstanding, and those yet to be issued. With respect to the 2,675,293 shares registered for resale currently
outstanding, your opinion should state that the shares "are" and not "will be" legally issued, fully paid,
and non-assessable. Please refer to Staff Legal Bulletin 19, Legality and Tax Opinions, Section II.2.h.
In response to the Staff’s comment, Wyrick Robbins
Yates & Ponton LLP has revised its legality opinion to (a) differentiate between shares currently outstanding, and those
yet to be issued, and (b) with respect to the 2,675,293 shares registered for resale currently outstanding, state that the
shares “are” and not “will be” legally (or validly) issued, fully paid, and non-assessable. The
Company has filed such revised legality opinion with Amendment No. 1 to its Registration Statement on Form S-3 (File No.
333-237790) filed on May 8, 2020 (the “Amended Registration Statement”).
U.S. Securities and Exchange Commission
May 8, 2020
Page 2
General
2. We note that Article X of your Third Amended and Restated Certificate of Incorporation provides for the Court of Chancery
of the State of Delaware as the exclusive forum for certain litigation, including any “derivative action.” Please disclose
whether this provision applies to actions arising under the Securities Act or Exchange Act. In that regard, we note that Section
27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by
the Exchange Act or the rules and regulations thereunder, and Section 22 of the Securities Act creates concurrent jurisdiction
for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules
and regulations thereunder. If the provision applies to Securities Act claims, please also revise your prospectus to state that
there is uncertainty as to whether a court would enforce such provision and that investors cannot waive compliance with the federal
securities laws and the rules and regulations thereunder. If this provision does not apply to actions arising under the Securities
Act or Exchange Act, please also ensure that the exclusive forum provision in the governing documents states this clearly, or tell
us how you will inform investors in future filings that the provision does not apply to any actions arising under the Securities
Act or Exchange Act.
The Company acknowledges the Staff’s comment and
respectfully advises the Staff that the Company addresses the exclusive forum provision appearing in its Third Amended and
Restated Certificate of Incorporation in a risk factor in the Company’s Annual Report on Form 10-K, filed with the
Securities and Exchange Commission on March 30, 2020 (the “Form 10-K”), which is incorporated by reference into
the Registration Statement on Form S-3 initially filed on April 22, 2020 and the Amended Registration Statement. The Company intends
to retain this risk factor in its set of comprehensive risk factors in future filings, in order to inform investors that the
provision does not apply to any actions arising under the Securities Act or Exchange Act. The risk factor, appearing on page
59 of the Form 10-K, is copied here for reference:
Our certificate of incorporation provides that the Court
of Chancery of the State of Delaware is, to the fullest extent permitted by law, the sole and exclusive forum for substantially
all disputes between us and our stockholders. These choice of forum provisions could limit the ability of stockholders to obtain
a favorable judicial forum for disputes with us or our directors, officers or employees.
Unless we consent to the selection of an alternative forum,
our certificate of incorporation provides that the Court of Chancery of the State of Delaware, or the Court of Chancery, will be,
to the fullest extent permitted by law, the sole and exclusive forum for any derivative action or proceeding brought on our behalf;
any action asserting a claim of breach of fiduciary duty owed by any of our directors, officers or other employees or agent to
the Company or our stockholders; any action asserting a claim against us arising pursuant to the Delaware General Corporation Law,
or DGCL, or our certificate of incorporation or bylaws; any action to enforce or determine the validity of our certificate of incorporation
or bylaws; or any action asserting a claim against us that is governed by the internal affairs doctrine. Since the choice of forum
provisions are only applicable to “the fullest extent permitted by law,” as provided in our certificate of incorporation,
the provisions do not designate the Court of Chancery as the exclusive forum for any derivative action or other claim for which
the applicable statute creates exclusive jurisdiction in another forum. As such, the choice of forum provisions do not apply to
any actions arising under the Securities Act of 1933, as amended or the Exchange Act.
U.S. Securities and Exchange Commission
May 8, 2020
Page 3
These choice of forum provisions may limit a stockholder’s
ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees,
which may discourage such lawsuits against us and our directors, officers and other employees. Alternatively, if a court were to
find the choice of forum provisions contained in our certificate of incorporation to be inapplicable or unenforceable in an action,
we may incur additional costs associated with resolving such action in other jurisdictions, which could materially adversely affect
our business, financial condition and operating results.
* * * * *
The Company respectfully submits that the foregoing is appropriately
responsive to the Staff’s comments. If the Staff has any further comments, please direct them to the undersigned.
Sincerely,
/s/ S. Halle Vakani
S. Halle Vakani
cc: Tsontcho Ianchulev, Chief Executive Officer, Eyenovia, Inc.
2020-05-05 - UPLOAD - HYPERION DEFI, INC.
United States securities and exchange commission logo
May 5, 2020
Tsontcho Ianchulev
Chief Executive Officer
Eyenovia, Inc.
295 Madison Avenue, Suite 2400
New York, New York 10017
Re:Eyenovia, Inc.
Registration Statement on Form S-3
Filed April 22, 2020
File No. 333-237790
Dear Mr. Ianchulev:
We have limited our review of your registration statement to those issues we have
addressed in our 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.
Registration Statement on Form S-3 filed on April 22, 2020, file no. 333-237790
Exhibit 5.1, Opinion of Wyrick Robbins, page II-1
1.Please revise your legality opinion to differentiate between shares currently outstanding,
and those yet to be issued. With respect to the 2,675,293 shares registered for resale
currently outstanding, your opinion should state that the shares "are" and not "will be"
legally issued, fully paid, and non-assessable. Please refer to Staff Legal Bulletin 19,
Legality and Tax Opinions, Section II.2.h.
General
2.We note that Article X of your Third Amended and Restated Certificate of Incorporation
provides for the Court of Chancery of the State of Delaware as the exclusive forum for
FirstName LastNameTsontcho Ianchulev
Comapany NameEyenovia, Inc.
May 5, 2020 Page 2
FirstName LastName
Tsontcho Ianchulev
Eyenovia, Inc.
May 5, 2020
Page 2
certain litigation, including any “derivative action.” Please disclose whether this provision
applies to actions arising under the Securities Act or Exchange Act. In that regard, we note
that Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits
brought to enforce any duty or liability created by the Exchange Act or the rules and
regulations thereunder, and Section 22 of the Securities Act creates concurrent jurisdiction
for federal and state courts over all suits brought to enforce any duty or liability created by
the Securities Act or the rules and regulations thereunder. If the provision applies to
Securities Act claims, please also revise your prospectus to state that there is uncertainty
as to whether a court would enforce such provision and that investors cannot waive
compliance with the federal securities laws and the rules and regulations thereunder. If
this provision does not apply to actions arising under the Securities Act or Exchange Act,
please also ensure that the exclusive forum provision in the governing documents states
this clearly, or tell us how you will inform investors in future filings that the provision
does not apply to any actions arising under the Securities Act or Exchange Act.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Paul Fischer, Staff Attorney, at 202-551-3415 or Celeste M. Murphy,
Legal Branch Chief, at 202-551-3257 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Lorna Knick, Esq.
2019-02-11 - UPLOAD - HYPERION DEFI, INC.
February 7, 2019
John Gandolfo
Chief Financial Officer
EYENOVIA, INC.
295 Madison Avenue, Suite 2400
New York, New York 10017
Re:EYENOVIA, INC.
Registration Statement on Form S-3
Filed January 25, 2019
File No. 333-229365
Dear Mr. Gandolfo:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Todd Schiffman at 202-551-3491 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-02-08 - CORRESP - HYPERION DEFI, INC.
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EYENOVIA, INC.
295 Madison Avenue, Suite 2400
New York, NY 10017
February 8, 2019
VIA EDGAR
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Mr. Todd Schiffman
Division of Corporation Finance
Office of Healthcare & Insurance
Re: Acceleration Request
Eyenovia, Inc.
Registration Statement on Form S-3
(File No. 333-229365)
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended (the “Act”), Eyenovia, Inc. (the “Registrant”) hereby requests that the U.S. Securities
and Exchange Commission (the “Commission”) take appropriate action to accelerate the effective date of the above referenced
registration statement (the “Registration Statement”) to Tuesday, February 12, 2019, at 4:01 p.m. Eastern Time, or
as soon thereafter as practicable.
The Registrant understands that the Commission
will consider this request for acceleration of the effective date of the Registration Statement as a confirmation of the fact that
the Registrant is aware of its responsibilities under the Act and the Securities Exchange Act of 1934, as amended, as they relate
to the proposed public offering of the securities specified in the Registration Statement.
Once the Registration Statement is
effective, please orally confirm the event with our counsel, Wyrick Robbins Yates & Ponton LLP, by calling S. Halle Vakani
at (919) 865-1125. We also respectfully request that a copy of the written order from the Commission verifying the effective
date and time of the Registration Statement be sent to Ms. Vakani via email at hvakani@wyrick.com.
By:
/s/ Tsontcho Ianchulev
Tsontcho Ianchulev, Chief Executive Officer
cc:
S. Halle Vakani, Wyrick Robbins Yates & Ponton LLP
2018-12-14 - CORRESP - HYPERION DEFI, INC.
CORRESP
1
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December 14, 2018
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re: Eyenovia, Inc.
Registration Statement on Form S-1
File No. 333-228761
Ladies and Gentlemen:
In connection with
the above referenced Registration Statement, and pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended
(the “Act”) we, as representative of the proposed underwriters, hereby join in the request of Eyenovia, Inc.
that the effective date of such Registration Statement be accelerated so that it becomes effective at 4:01 p.m., eastern time,
on Tuesday, December 18, 2018 or as soon thereafter as possible.
We hereby authorize
each of Darrick Mix, Esq. and Jonathan Cohen, Esq. of Duane Morris LLP, attorneys for the underwriters, to orally modify or withdraw
this request for acceleration.
National Securities
affirms that it is aware of its obligations under the Act in connection with this offering.
Very truly yours,
National Securities Corporation,
as Representative
By: /s/ Jonathan C. Rich
Jonathan
C. Rich
EVP
& Head of Investment Banking
2018-12-14 - CORRESP - HYPERION DEFI, INC.
CORRESP
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EYENOVIA, INC.
295 Madison Avenue, Suite 2400
New York, NY 10017
December 14, 2018
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Ms. Dorrie Yale
Ms. Irene Paik
Division of Corporation Finance
Office of Healthcare & Insurance
Re:
Acceleration Request
Eyenovia, Inc.
Registration
Statement on Form S-1
(File
No. 333-228761)
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended (the “Act”), Eyenovia, Inc. (the “Registrant”) hereby requests that the U.S. Securities
and Exchange Commission (the “Commission”) take appropriate action to accelerate the effective date of the above-referenced
registration statement (the “Registration Statement”) so as to become effective on Tuesday, December 18, 2018, at 4:01
p.m. Eastern Time, or as soon thereafter as practicable.
The Registrant understands that the Commission
will consider this request for acceleration of the effective date of the Registration Statement as a confirmation of the fact that
the Registrant is aware of its responsibilities under the Act and the Securities Exchange Act of 1934, as amended, as they relate
to the proposed public offering of the securities specified in the Registration Statement.
Once the Registration Statement is effective,
please orally confirm the event with our counsel, Wyrick Robbins Yates & Ponton LLP, by calling S. Halle Vakani at (919) 865-1125.
We also respectfully request that a copy of the written order from the Commission verifying the effective date and time of the
Registration Statement be sent to Ms. Vakani via email at hvakani@wyrick.com.
Sincerely,
EYENOVIA, INC.
By:
/s/ Tsontcho Ianchulev
Tsontcho Ianchulev, Chief Executive Officer
cc:
S. Halle Vakani, Wyrick Robbins Yates & Ponton LLP
2018-12-12 - CORRESP - HYPERION DEFI, INC.
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Wyrick Robbins Yates &
Ponton LLP
ATTORNEYS AT LAW
4101 Lake Boone Trail, Suite
300, Raleigh, NC 27607
PO Drawer 17803, Raleigh, NC
27619
P: 919.781.4000 F: 919.781.4865
www.wyrick.com
December 12, 2018
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention: Ms. Dorrie Yale
Ms. Irene Paik
Division of Corporation Finance
Office of Healthcare & Insurance
Re: Eyenovia, Inc.
Draft Registration Statement on Form S-1
Filed November 21, 2018
File No. 377-02385
Ladies and Gentlemen:
We write this letter on behalf of our client Eyenovia, Inc.
(the “Company”) in response to the comments of the staff (the “Staff”) of the U.S. Securities and Exchange
Commission with respect to the above-captioned filing, as set forth in the Staff’s letter dated December 4, 2018. For ease
of review, we have set forth below in italics each of the numbered comments of the Staff’s letter and have followed each
comment with the Company’s response thereto.
Draft Registration Statement on Form S-1
Cover Page
1. Please revise your prospectus to disclose the number of shares of common stock being offered. For guidance, please refer
to Rule 430A and Compliance and Disclosure Interpretations, Securities Act Rules, Question 227.02.
We acknowledge the Staff’s comment and have updated the
prospectus to disclose the number of shares of common stock being offered.
U.S. Securities and Exchange Commission
December 12, 2018
Page 2
Description of Securities, page 19
2. We note that your certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the
sole and exclusive forum for any derivative action or proceeding brought on your behalf. Please revise this section to include
disclosure regarding this provision. Your disclosure should include a discussion regarding whether your exclusive forum
provision applies to actions arising under the federal securities laws. In this regard, we note that Section 27
of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created
by the Exchange Act or the rules and regulations thereunder.
We acknowledge the Staff’s comment and have updated the
disclosure on page 19 of the prospectus. The exclusive forum provisions contained in our certificate of incorporation only apply
to “to the fullest extent permitted by law,” as provided in Article X. Accordingly, the provisions do not designate
the Court of Chancery as the exclusive forum for any derivative action or other claim for which the applicable statute creates
exclusive jurisdiction in another forum, such as the Exchange Act and the Securities Act. We have updated the disclosure on page
19 of the prospectus to expressly reference this fact.
* * * * *
The Company respectfully submits that the foregoing is appropriately
responsive to the Staff’s comments. If the Staff has any further comments, please direct
them to the undersigned.
Sincerely,
/s/ S. Halle Vakani
S. Halle Vakani
cc: Tsontcho Ianchulev, Chief Executive Officer, Eyenovia,
Inc.
2018-12-04 - UPLOAD - HYPERION DEFI, INC.
December 4, 2018
Tsontcho Ianchulev
Chief Executive Officer
Eyenovia, Inc.
295 Madison Avenue, Suite 2400
New York, NY 10017
Re:Eyenovia, Inc.
Draft Registration Statement on Form S-1
Filed November 21, 2018
File No. 377-02385
Dear Dr. Ianchulev:
We have conducted a limited review of your draft registration statement. 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 any requested information and by publicly
filing your registration statement and non-public draft submission 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
filed registration statement, we may have additional comments.
Draft Registration Statement on Form S-1
Cover Page
1.Please revise your prospectus to disclose the number of shares of common stock being
offered. For guidance, please refer to Rule 430A and Compliance and Disclosure
Interpretations, Securities Act Rules, Question 227.02.
Description of Securities, page 19
2.We note that your certificate of incorporation provides that the Court of Chancery of the
State of Delaware will be the sole and exclusive forum for any derivative action or
proceeding brought on your behalf. Please revise this section to include disclosure
regarding this provision. Your disclosure should include a discussion regarding whether
your exclusive forum provision applies to actions arising under the federal securities
FirstName LastNameTsontcho Ianchulev
Comapany NameEyenovia, Inc.
December 4, 2018 Page 2
FirstName LastName
Tsontcho Ianchulev
Eyenovia, Inc.
December 4, 2018
Page 2
laws. In this regard, we note that Section 27 of the Exchange Act creates exclusive
federal jurisdiction over all suits brought to enforce any duty or liability created by the
Exchange Act or the rules and regulations thereunder.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
We also remind you that your registration statement must be on file no later than 48 hours
prior to the requested effective date and time. Refer to Rules 460 and 461 regarding requests for
acceleration. Please allow adequate time for us to review any amendment prior to the requested
effective date of the registration statement.
Please contact Dorrie Yale at 202-551-8776 or Irene Paik at 202-551-6553 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: S. Halle Vakani
2018-01-22 - CORRESP - HYPERION DEFI, INC.
CORRESP
1
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Eyenovia, Inc.
501 Fifth Avenue, Suite 1404
New York, NY 10017
January 22, 2018
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jeffrey Gabor
Re: Eyenovia, Inc.
Registration Statement on Form
S-1
File No. 333-222162
Dear Mr. Gabor:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended, Eyenovia, Inc. hereby requests acceleration of effectiveness of the above referenced Registration Statement
so that it will become effective at 4:30 pm EDT on Wednesday, January 24, 2018, or as soon as practicable thereafter.
Very truly yours,
/s/ Tsontcho Ianchulev
Tsontcho Ianchulev
Chief Executive Officer
cc: Ellenoff Grossman & Schole LLP
Goodwin Procter LLP
2018-01-22 - CORRESP - HYPERION DEFI, INC.
CORRESP
1
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January 22, 2018
Via EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Jeffrey Gabor
Re: Eyenovia, Inc.
Registration Statement
on Form S-1
File No. 333-222162
Acceleration Request
Requested Date:
Wednesday, January 24, 2018
Requested Time:
4:30 p.m., Eastern Daylight Time
Ladies and gentlemen:
In accordance with
Rule 461 under the Securities Act of 1933, as amended (the “Act”), Ladenburg Thalmann & Co. Inc.
and Roth Capital Partners, LLC hereby join Eyenovia, Inc. in requesting that the Securities and Exchange Commission (the “Commission”)
take appropriate action to cause the Registration Statement on Form S-1 (File No. 333-222162) to become effective on January 24,
2018, at 4:30 p.m., Eastern Daylight Time, or as soon as practicable thereafter.
Additionally, pursuant
to Rule 460 of the Act, we hereby advise you that approximately 507 copies of the Preliminary Prospectus, dated January 10, 2017,
were distributed by us from January 15, 2018 through the date hereof to underwriters, institutions, dealers and others.
We will comply, and
have been informed by the participating underwriters that they will comply, with the requirements of Rule 15c2-8 under the Securities
Exchange Act of 1934, as amended, to the extent applicable.
Very truly yours,
Ladenburg Thalmann & Co. Inc.
By:
/s/ David J. Strupp, Jr.
Name:
David J. Strupp, Jr.
Title:
Managing Director
Roth Capital Partners, LLC
By:
/s/ Aaron
M. Gurewitz
Name:
Aaron M. Gurewitz
Title:
Head of Equity Capital Markets
cc: Michael D. Maline, Goodwin
Procter LLP
Seo Salimi, Goodwin Procter LLP
Benjamin S. Reichel,
Ellenof Grossman & Schole LLP
2018-01-05 - CORRESP - HYPERION DEFI, INC.
CORRESP
1
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* FOIA Confidential Treatment Request*
Confidential Treatment Requested by Eyenovia, Inc.
VIA FEDERAL EXPRESS
December 29, 2017
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Healthcare & Insurance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Jeffrey Gabor
Re: Eyenovia, Inc.
Registration Statement on Form S-1
Filed December 19, 2017
File No. 333-222162
Dear Mr. Gabor:
On behalf of Eyenovia, Inc. (the “Company”), we
are submitting this letter in response to comment No. 5 received from the staff (the “Staff”) of the Securities and
Exchange Commission (the “Commission”) in your correspondence received on December 14, 2017 regarding the Registration
Statement on Form S-1 filed on December 19, 2017 (“Registration Statement”). In this letter, we are responding only
to comment No. 5 in the comment letter. For the Staff’s convenience, we have repeated below the Staff’s comment in
bold, and have followed such comment with the Company’s response.
Confidential Treatment Request
Due to the commercially sensitive nature
of information contained in this letter, the Company hereby requests, pursuant to 17 C.F.R. §200.83, that certain portions
of this letter be maintained in confidence, not be made part of any public record and not be disclosed to any person. In accordance
with 17 C.F.R. §200.83(d)(1), if any person (including any governmental employee who is not an employee of the Commission)
should request access to or an opportunity to inspect this letter, we request that we be immediately notified of any such request,
be furnished with a copy of all written materials pertaining to such request (including, but not limited to, the request itself)
and be given at least ten business days’ advance notice of any intended release so that the Company may, if it deems it to
be necessary or appropriate, pursue any remedies available to it.
Estimated Price Range:
Based upon discussions with the lead underwriters, the Company
expects to include an estimated price range of $[*] to $[*] (the “Estimated Price Range”) per share, after effecting
a 1-for-3.75 reverse stock split (“Reverse Split”), in an amendment to the Registration Statement that would be filed
shortly before the commencement of a road show for the initial public offering (the “IPO”). The Estimated Price Range
to be included in the preliminary prospectus is subject to further change, which may result from various factors, including, but
not limited to, then-current market conditions and subsequent business, market and other developments affecting the Company and
its markets.
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
* FOIA Confidential Treatment Request*
Confidential Treatment Requested by Eyenovia, Inc.
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 not redeemable.
Company Response –
During calendar year 2017, the Company did not issue any shares
of common stock, but issued options and preferred stock as further described below. The Company granted options to purchase an
aggregate of 3,366,534 shares of common stock at an exercise price of $0.52 per share (which, after giving effect to the Reverse
Split, is equal to options for 496,686 shares at an exercise price of $1.95 per share). All of these options were granted on July
7, 2017.
As stated in the Registration Statement, stock options granted
to employees and directors are based upon the fair value of the award and are measured on the grant date. For non-employees, the
fair value of the award is re-measured on vesting dates and interim reporting dates until the service period is completed. The
fair value is then recognized over the period which services are required which generally corresponds to the vesting dates. The
Company’s Board of Directors (the “Board”) intended that all options be granted at an exercise price per share
not less than the fair market value of the common stock on the date of grant. Given the absence of an active trading market for
the Company’s common stock, determining the fair value requires the Board to make complex and subjective judgements.
Stock Option Grants and Common Stock Valuations –
The fair value of our common stock was based upon an analysis
completed by management that considered the cash sale prices of our convertible preferred stock. In addition, with input from management,
the Board considered numerous factors including:
- The Company’s stage of development
- Rights, preferences and privileges of our preferred stock compared
to our common stock
- The Company’s financial condition and operating results
- Status of the Company’s product development efforts and regulatory
approval
- Lack of marketability of our common stock
In March 2017, the Company engaged an independent
third party valuation specialist to determine the fair value of the Company’s common stock at such time. Since the Company’s
capital structure includes preferred equity, this third party valuation was done in accordance with the guideline outlined in the
American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately Held Company
Equity Securities Issued as Compensation.
The independent analysis utilized the Backsolve method since this method is generally considered the most
reliable and recommended by the AICPA guide. In addition, the method utilizes the economics from a direct transaction in the Company’s
securities in determining the fair market value. This method utilizes the Black Scholes option pricing model which allocated a
probability weighted equity value to the
* FOIA Confidential Treatment Request*
Confidential Treatment Requested by Eyenovia, Inc.
Company’s Series A-2 preferred stock. The Series A-2 preferred
stock was utilized since it included a new investor, was considered at arms’ length and closed in the fourth quarter of 2016.
The March 2017 independent appraisal utilized the Option Pricing
Method (“OPM”) as the most reliable method with the following steps being applied:
- Establishment of total enterprise or equity value;
- Analysis of equity rights for each class of security;
- Selection of appropriate model for valuation purposes;
- Determination of key valuation inputs; and
- Computation of the fair value of the subject security.
Under the OPM, it was determined the Company’s common
stock had an allocated per share value of $0.86 per share (which, after giving effect to the Reverse Split, is equal to options
at an exercise price of $3.23 per share). As a private company, the analysis provided for a discount for lack of marketability
of 40% resulting in a fair market value of the Company’s common stock of $0.52 per share ($1.95 per share post reverse stock
split) as of March 2017 based upon the independent appraisal. This price represents the same exercise price of the stock options
granted by the Company in July 2017.
Preferred stock issuances and characteristics –
Below is a list of the preferred stock issuances of the Company
in the last 18 months:
· Series A2 issued on 10/6/16 – 2,985,100 shares at $1.40 per
share (796,027 shares at $5.25 per share post reverse stock split)
· Series B issued on 7/31/17 – 3,446,058 shares at $1.86 per share
(918,949 shares at $6.98 per share post reverse stock split)
The Company’s preferred stock has the following rights
compared to the Company’s common stock:
Liquidation Rights – The holders of preferred shares shall
be entitled to receive, on a pari passu basis, prior to and in preference to any distribution to the holders of common stock, an
amount per share equal to 1 times the original issue price plus any accrued and unpaid dividends;
Dividends – Preferred shareholders are entitled to receive
noncumulative noncompounding dividends when, as and if declared by the Board of Directors prior and in preference to common shareholders;
Participation Rights – After the payment of the liquidation
and dividend rights above, the holders of preferred stock are entitled to receive all remaining assets legally available for distribution
on a pro rata basis with common shareholders;
Voting Rights – Preferred stock vote with common stock
as a single class on an as converted basis on all matters that common stock is entitled to vote on. In addition, preferred stock
are entitled to elect three directors as a single class and vote as a separate class on certain other matters under the Company’s
Second Amended and Restated Certificate of Incorporation.
Based upon the characteristics of the preferred stock noted above, specifically the liquidation preference
and participation rights, the Company believes that the value of the preferred stock is approximately 3 times the value of its
common stock on a per share basis. The Company’s history of preferred stock sales and common stock issuances support this
assertion. In addition, the independent appraisal and valuation
* FOIA Confidential Treatment Request*
Confidential Treatment Requested by Eyenovia, Inc.
report received in March 2017 also validated the Company’s
common stock fair value pricing methodology which was approximately one third of the value of the last preferred stock sales price.
The Company believes that the difference between the historical
fair value of its common stock and the midpoint of the Estimated Price Range is the result of the following factors:
- Stock Market Conditions - The Estimated Price Range takes into consideration
the valuation and performance of companies that the underwriters believe will be comparable to the Company as well as the recent
performance of successful initial public offerings outside of the Company’s line of business.
- Increased Probability of an IPO and Substantially Enhanced Liquidity
and Marketability of the Company’s common stock – The independent appraisal and valuation report received in March
2017 reflected the illiquidity of the Company’s common stock as well as the uncertainty of an IPO. Given the proximity to
the completion of a successful IPO, the Estimated Price Range represents the estimated fair value of freely tradable unrestricted
common stock that will be sold in the public markets without discounts for illiquidity and lack of marketability.
- Conversion of Preferred Stock – As noted above, the holders
of the preferred stock enjoy substantial economic rights and preferences over the holders of common stock including liquidation
preferences in the event of any liquidation, dissolution or winding up of the Company. The Estimated Price Range assumes the conversion
of the Company’s convertible preferred stock upon the completion of its IPO which results in an increased common stock valuation
due to the elimination of the preferred stock’s superior rights and preferences.
- Enhanced Balance Sheet and Financial Resources – The Estimated
Price Range assumes a successful offering which provides the Company with proceeds that (a) substantially strengthen the Company’s
balance sheet as a result of increased cash and access to public company debt and equity markets and (b) increase the probability
that the Company will be successful in its product development initiatives.
- Product Development Milestones – In 2016, the Company developed
procedures for mass production of its products. Since that time, the Company has not experienced any setbacks with respect to manufacturing
of its products.
- FDA Clinical Trials – In March 2017, the Company received notice
from the FDA which allows the Company to proceed directly to phase III clinical trials on several of its products which, if successful,
could accelerate the commercialization of the Company’s products. In December 2017, the Company had a meeting with the FDA
to confirm phase III clinical trial plans for its myopia program.
Conclusion –
In light of the foregoing, the Company believes that the actions
of the Board to estimate the fair value of its common stock complied with the requirements of Financial Accounting Standards Board’s
Accounting Standards, the AICPA accounting and valuation guide and the Internal Revenue Code of 1986, as amended.
Eyenovia, Inc. respectfully requests that the information contained in the response be treated as
confidential information and that the Commission provide timely notice to Tsontcho Ianchulev,
* FOIA Confidential Treatment Request*
Confidential Treatment Requested by Eyenovia, Inc.
Chief Executive Officer, Eyenovia, Inc., 501 Fifth Avenue,
Suite 1404, New York, New York 10017, before it permits any disclosure of the double-underlined and highlighted information in
this letter.
The Company respectfully requests that the Staff return to the
undersigned this letter pursuant to Rule 418 of the Securities Act of 1933, as amended, once the Staff has completed its review.
For the convenience of the Staff, we have provided a self-addressed stamped envelope for this purpose. We respectfully reserve
the right to request that this letter be returned to us at an earlier date.
In addition, the Company requests confidential treatment under
17 C.F.R. § 200.83 for the contents of this letter and has submitted a separate request for confidential treatment in accordance
therewith to the Commission’s Office of Freedom of Information and Privacy Act Operations.
* * *
If you have any further questions or comments, or if you require
any additional information, please contact the undersigned by telephone at 917-289-1117. Thank you for your assistance.
Very truly yours,
/s/ Tsontcho Ianchulev
Tsontcho Ianchulev, Chief Executive Officer
2018-01-05 - UPLOAD - HYPERION DEFI, INC.
January 3, 2018
Tsontcho Ianchulev
Chief Executive Officer
Eyenovia, Inc.
501 Fifth Avenue, Suite 1404
New York, NY 10017
Re:Eyenovia, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted December 19, 2017
CIK No. 0001682639
Dear Dr. Ianchulev:
We have reviewed your amended 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 S-1 filed December 19, 2017
Results of Operations
Nine Months Ended September 30, 2017 Compared with Nine Months Ended September 30,
2016, page 55
1.We have reviewed your revised disclosures in response to prior comment 3. Please
revise to disclose, if true, that you do not track research and development costs by
project.
Critical Accounting Policies
FirstName LastNameTsontcho Ianchulev
Comapany NameEyenovia, Inc.
June 16, 2017 Page 2
FirstName LastName
Tsontcho Ianchulev
Eyenovia, Inc.
January 3, 2018
Page 2
Stock Based Compensation , page 58
2.We have reviewed your revised disclosures in response to prior comment 4. In your
disclosures, you indicate that you obtained a third-party valuation of your common stock
that was done in accordance with the guidance outlined in the American Institute of
Certified Public Accountants' Accounting and Valuation Guide, Valuation of Privately-
Held-Company Equity Securities Issued as Compensation. Please revise to disclose the
specific method(s) the third party used to determine the fair value of the company's
shares and the nature of the material assumptions involved.
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
otherquestions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Benjamin Reichel
2017-12-19 - CORRESP - HYPERION DEFI, INC.
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Eyenovia, Inc.
501 Fifth Avenue, Suite 1404
New York, NY 10017
VIA EDGAR AND FEDERAL EXPRESS
December 19, 2017
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Healthcare & Insurance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Jeffrey Gabor
Re: Eyenovia, Inc.
Draft Registration Statement on Form S-1
Submitted November 15, 2017
CIK No. 0001682639
Dear Mr. Gabor:
On behalf of Eyenovia, Inc., a Delaware
corporation (the “Company”), we hereby transmit the Company’s response to the comment letter received
from the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”)
on December 14, 2017, regarding the Registration Statement on Form S-1 confidentially submitted to the Commission on November
15, 2017 (the “Draft Registration Statement”). The Company is concurrently filing its Registration
Statement (the “Registration Statement”), which includes changes to the Draft Registration Statement in response
to the Staff’s comments.
For the Staff’s convenience, we have
repeated below the Staff’s comments in bold, and have followed each comment with the Company’s response. In addition
to confidentially submitting this letter via EDGAR, we are sending via Federal Express five (5) copies of each of this letter
and the Registration Statement (marked to show changes from the Draft Registration Statement).
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.”
In response to the Staff’s comment, we have revised the
prospectus summary in the Registration Statement to expand the discussion of the “Risks Associated with our Business”
and relocated the discussion.
2. Your product candidates appear to require a device for
administering. Please clarify 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.
We respectfully advise the Staff that following our
March 2017 meeting with the FDA, the FDA provided written feedback that our clinical programs will not be treated as a
medical device or as a drug/device combination. All of our programs are treated as drug development programs because
only the drug comes into contact with the eye. Consequently, we do not need separate FDA approval for the device or to comply
with FDA regulations for medical devices. In response to the Staff’s comment, we have revised pages 2 and 64 of the
Registration Statement to include the requested disclosure.
Results of Operations
Nine Months Ended September 30, 2017 Compared with Nine
Months Ended September 30, 2016
Research and Development Expenses, page 54
1
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.).
In response to the Staff’s comment, we have revised pages
55 and 56 of the Registration Statement to include the requested disclosure.
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.
In response to the Staff’s comment, we have revised pages
57, 58, F-8, F-10 and F-26 of the Registration Statement to include the requested disclosure.
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.
We acknowledge that the Staff may have additional comments
on our accounting for equity issuances and undertake to supplementally provide the requested analysis under separate cover.
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.
In response to the Staff’s comment, we have revised page
74 of the Registration Statement to include the requested disclosure.
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.
In response to the Staff’s comment, we have revised page
77 of the Registration Statement to include the requested disclosure.
Management, page 89
2
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.
In response to the Staff’s comment, we have revised pages
92 and 94 of the Registration Statement to include the requested disclosure.
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.
We hereby confirm that we have no outstanding obligations and
are not currently eligible to receive any milestone payments under the Senju license agreement.
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.
We will supplementally provide the Staff with copies of all
such written communications, if any, under separate cover. We further advise the Staff that investors will not retain copies of
any such materials.
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.
To the extent not already included, we will provide the Staff
with copies of any graphics, visual, or photographic information that we intend to use in the printed prospectus prior to its use.
We acknowledge that the Staff may have comments regarding this material.
We thank the Staff in advance for its consideration
of the Registration Statement. Should you have any questions regarding the foregoing, please contact Benjamin Reichel, Esq. of
Ellenoff Grossman & Schole LLP at (212) 370-1300.
Sincerely,
/s/
Tsontcho Ianchulev
Tsontcho
Ianchulev
3
2017-12-14 - UPLOAD - HYPERION DEFI, INC.
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