Item 9A. Controls and Procedures
ITEM 9A - CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the company’s management, including its chief executive officer and chief financial officer, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act and regulations promulgated thereunder) as of December 31, 2020. Based on such evaluation, those officers have concluded that, as of December 31, 2020, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during the fourth quarter ended December 31, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over our financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) or 15d-15(f) under the Exchange Act as a process designed by, or under the supervision of, the company’s executive and financial officers and effected by the company’s board of
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directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes and includes those policies and procedures that (a) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company; (b) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (c) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management assessed the effectiveness of our internal control over financial reporting, as of December 31, 2020. In making this assessment, our management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework (2013). Based on our assessment, management concluded that, as of December 31, 2020, our internal control over financial reporting was effective based on these criteria.
ITEM 9B - OTHER INFORMATION
None.
PART III
ITEM 10 - DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this item is incorporated herein by reference to the disclosures which will be included in a subsequent amendment to the Form 10-K, which will be filed not later than 120 days after December 31, 2020 pursuant to General Instruction G(3) of Form 10-K.
ITEM 11 - EXECUTIVE COMPENSATION
The information required by this item is incorporated herein by reference to the disclosures which will be included in a subsequent amendment to the Form 10-K, which will be filed not later than 120 days after December 31, 2020 pursuant to General Instruction G(3) of Form 10-K.
ITEM 12 - SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREHOLDER MATTERS
The information required by this item is incorporated herein by reference to the disclosures which will be included in a subsequent amendment to the Form 10-K, which will be filed not later than 120 days after December 31, 2020 pursuant to General Instruction G(3) of Form 10-K.
ITEM 13 - CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this item is incorporated herein by reference to the disclosures which will be included in a subsequent amendment to the Form 10-K, which will be filed not later than 120 days after December 31, 2020 pursuant to General Instruction G(3) of Form 10-K.
ITEM 14 - PRINCIPAL ACCOUNTANT FEES AND SERVICES
PricewaterhouseCoopers LLP served as our principal independent registered public accounting firm for the year ended December 31, 2020. Kesselman & Kesselman (a member firm of PricewaterhouseCoopers International Limited, or PwC), served as our principal independent registered public accounting firm for the year ended December 31, 2019.
The following table provides information regarding fees paid by us to PwC for all services, for the years ended December 31, 2020 and 2019:
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Fiscal year ended December 31,
2020 2019
(in thousands of U.S. dollars)
Audit fees (1)
$ 994 $ 428
Audit-related fees 5 —
Tax fees (2)
15 9
Total Fees $ 1,014 $ 437
______________________________
(1) Includes professional services rendered in connection with the audit of our annual financial statements, the review of our interim financial statements and fees for registration statements.
(2) Includes professional services rendered in connection with assistance in preparation of applications to the Israel Tax Authorities.
Our audit committee’s specific responsibilities in carrying out its oversight of the quality and integrity of the accounting, auditing and reporting practices of the Company include the approval of audit and non-audit services to be provided by the external auditor. The audit committee pre-approves all non-audit services provided to the Company during year.
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PART IV
ITEM 15 - EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) Documents Filed as Part of This Report
1. Financial statements .
See Index to Financial Statements under Item 8 of Part II of this Annual Report, which is incorporated herein by reference.
2. Financial statement schedules .
No schedules are applicable or required, or the information is included in the consolidated financial statements or notes thereto.
3. Exhibits . See Item 15(b) below.
(b) Exhibits
Incorporation by Reference
Exhibit Number Description Of Document Form SEC File No. Exhibit Filing Date Filed Herewith
2.1* Agreement and Plan of Merger, dated as of November 10, 2019, by and among Foamix Pharmaceuticals Ltd., Menlo Therapeutics Inc. and Giants Merger Subsidiary Ltd.
8-K 001-38356 2.1 November 12, 2019
2.2 Amendment No. 1 to the Agreement and Plan of Merger, dated as of December 4, 2019, by and among Foamix Pharmaceuticals Ltd., Menlo Therapeutics Inc. and Giants Merger Subsidiary Ltd.
8-K 001-38356 2.1 December 4, 2019
3.1 Amended and Restated Certificate of Incorporation
X
3.2 Amended and Restated Bylaws
8-K 001-38356 3.2 September 8, 2020
4.1 Description of Securities Registered Under Section 12 of the Securities Exchange Act of 1934
X
4.2 Second Amended and Restated Warrant, by and among Menlo Therapeutics Inc. and Perceptive Credit Holdings II, LP.
10-Q 001-38356 4.1 May 11, 2020
4.3 Second Amended and Restated Warrant, by and among Menlo Therapeutics Inc. and Orbimed Royalty & Credit Opportunities III, LP.
10-Q 001-38356 4.2 May 11, 2020
4.4 Contingent Stock Rights Agreement, dated as of March 9, 2020, by and between Menlo Therapeutics Inc. and American Stock Transfer & Trust Company, LLC.
8-K 001-38356 10.1 March 10, 2020
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10.1† Exclusive License Agreement, dated as of December 20, 2012, by and between the Registrant and Merck Sharp & Dohme Corp.
S-1/A 001-38356 10.1 January 18, 2018
10.2 Sales Agreement, dated February 1, 2019, by and between the Company and Cantor Fitzgerald & Co.
S-3 001-38356 1.2 February 1, 2019
10.3* Amended and Restated Credit Agreement and Guaranty, dated as of March 9, 2020, among Foamix Pharmaceuticals Inc., Menlo Therapeutics Inc., Foamix Pharmaceuticals Ltd., the subsidiary guarantors from time to time party thereto, the lenders from time to time party thereto and Perceptive Credit Holdings II, LP.
10-Q 001-38356 10.3 May 11, 2020
10.4 Amendment No. 1 to Amended and Restated Credit Agreement and Guaranty, dated August 5, 2020, by and among Menlo Therapeutics Inc., Foamix Pharmaceuticals Ltd., Foamix Pharmaceuticals Inc., the lenders party thereto and Perceptive Credit Holdings II, LP as administrative agent.
10-Q 001-38356 10.2 August 6, 2020
10.5* Amended and Restated Security Agreement, dated as of March 9, 2020, among Foamix Pharmaceuticals Inc., Foamix Pharmaceuticals Ltd., Menlo Therapeutics Inc. and Perceptive Credit Holdings II, LP for the benefit of Perceptive Credit Holdings II, LP, OrbiMed Royalty & Credit Opportunities III, LP and the other lenders from time to time party to the Amended and Restated Credit Agreement.
10-Q 001-38356 10.4 May 11, 2020
10.6† Contract Manufacturing and Supply Agreement, dated October 21, 2019, by and between Foamix Pharmaceuticals Ltd. and ASM Aerosol-Service AG (incorporated by reference to Exhibit 10.26 of Foamix Pharmaceuticals Ltd.’s Annual Report on Form 10-K filed on March 12, 2020).
10-K 001-36621 10.26 March 12, 2020
10.7† License Agreement, dated as of April 21, 2020, by and between Foamix Pharmaceuticals Ltd. and Cutia Therapeutics (HK) Limited.
10-Q 001-38356 10.1 August 6, 2020
10.8# 2009 Israeli Share Option Plan.
F-1/A 001-36621 10.1 September 3, 2014
10.9(a)# 2011 Stock Incentive Plan, as amended.
S-1 001-38356 10.4(a) December 28, 2017
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10.9(b)# Amendment to 2011 Stock Incentive Plan.
S-1 001-38356 10.4(b) December 28, 2017
10.9(c)# Form of Stock Option Agreement under 2011 Stock Incentive Plan.
S-1 001-38356 10.4(c) December 28, 2017
10.9(d)# Form of Immediately Exercisable Stock Option Agreement under 2011 Stock Incentive Plan.
S-1 001-38356 10.4(d) December 28, 2017
10.10# 2015 Israeli Share Incentive Plan.
F-3 001-36621 10.2 October 21, 2015
10.11(a)# 2018 Omnibus Incentive Plan.
S-1/A 001-38356 10.5(a) January 12, 2018
10.11(b)# Form of Stock Option Grant Notice and Stock Option Agreement under the 2018 Equity Incentive Plan.
S-1/A 001-38356 10.5(b) January 12, 2018
10.11(c)# Form of Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Agreement under the 2018 Equity Incentive Plan.
X
10.12(a)# 2019 Equity Incentive Plan.
10-Q 001-38356 10.5 May 11, 2020
10.12(b)# Form of Share Option Grant Notice and Option Agreement under the 2019 Equity Incentive Plan for U.S. and Israeli Employees.
10-Q 001-38356 10.8 May 11, 2020
10.12(c)# Form of Restricted Share Unit Grant Notice and Restricted Share Unit Award Agreement under the 2019 Equity Incentive Plan for U.S. and Israeli Employees.
10-Q 001-38356 10.9 May 11, 2020
10.13# 2019 Employee Share Purchase Plan.
10-Q 001-38356 10.10 May 11, 2020
10.14# Offer Letter, dated as of March 25, 2020, by and between Menlo Therapeutics Inc. and David Domzalski
10-Q 001-38356 10.13 May 11, 2020
10.15# Offer Letter, dated as of March 20, 2020, by and between Menlo Therapeutics Inc. and Andrew Saik.
10-Q 001-38356 10.14 May 11, 2020
10.16# Termination of Employment Agreement and Release, dated as of March 22, 2020, by and between Foamix Pharmaceuticals Ltd. and Ilan Hadar.
10-Q 001-38356 10.15 May 11, 2020
10.17# Offer Letter, dated as of August 17, 2015 by and between the Company and Steven Basta.
S-1 001-38356 10.7 December 28, 2017
10.18# Amendment No. 1 to Offer Letter, by and between the Company and Steven Basta, effective as of May 3, 2018.
8-K 001-38356 10.1 May 7, 2018
10.19# Offer Letter, dated as of August 15, 2017 by and between the Company and Kristine Ball.
S-1 001-38356 10.9 December 28, 2017
10.20# Amendment No. 1 to Offer Letter, by and between the Company and Kristine Ball, effective as of May 3, 2018.
8-K 001-38356 10.2 May 7, 2018
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10.21 Form of Securities Purchase Agreement, dated January 26, 2021, among VYNE Therapeutics Inc. and the purchasers identified therein.
8-K 001-38356 10.1 January 28, 2021
16.1 Letter from Mayer Hoffman McCann P.C. dated April 2, 2020.
8-K 001-38356 16.1 April 6, 2020
21.1 List of Subsidiaries of VYNE Therapeutics Inc.
X
23.1 Consent of independent registered public accounting firm.
X
23.2 Consent of independent registered public accounting firm.
X
31.1 Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
X
31.2 Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
X
32.1** Certification of the Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
32.2** Certification of the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
101.INS XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. X
101.SCH XBRL Taxonomy Extension Schema Document X
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document X
101.DEF XBRL Taxonomy Extension Definition Document X
101.LAB XBRL Taxonomy Extension Label Document X
101.PRE XBRL Taxonomy Presentation Linkbase Document X
104 Cover Page Interactive Data Filed (embedded within the XBRL document)
* Exhibits and schedules omitted pursuant to Item 601(a)(5) of Regulation S-K.
† Portions of this exhibit have been omitted in accordance with Item 601(b)(10)(iv) of Regulation S-K.
# Indicates management contract or compensatory plan.
** These certifications are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, irrespective of any general incorporation language contained in such filing
ITEM 16 - FORM 10-K SUMMARY
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: March 4, 2021
VYNE Therapeutics Inc.
By: /s/ David Domzalski
David Domzalski
Chief Executive Officer
KNOW ALL MEN AND WOMEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints David Domzalski and Andrew Saik, and each of them, his or her attorney-in-fact and agent, each with the power of substitution, for him or her in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the U.S. Securities and Exchange Commission, hereby ratifying and confirming all that said attorneys-in-fact, or his or her or their substitute or substitutes, may do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Signature Title Date
/s/ David Domzalski Director and Chief Executive Officer ( Principal Executive Officer )
March 4, 2021
David Domzalski
/s/ Andrew Saik Chief Financial Officer ( Principal Financial Officer and Principal Accounting Officer )
March 4, 2021
Andrew Saik
/s/ Sharon Barbari Director March 4, 2021
Sharon Barbari
/s/ Steven Basta Director March 4, 2021
Steven Basta
/s/ Rex Bright Director March 4, 2021
Rex Bright
/s/ Anthony Bruno Director March 4, 2021
Anthony Bruno
/s/ Patrick LePore Director March 4, 2021
Patrick LePore
/s/ Elisabeth Sandoval Director March 4, 2021
Elisabeth Sandoval
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