UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): ~~February~~April 13, 2019

PRESBIA PLC

(Exact Name of Registrant as Specified in Charter)

Ireland

(State or Other Jurisdiction

of Incorporation)

001-36824

(Commission

File Number)

98-1162329

(IRS Employer

Identification No.)

Suite 7, Sandyford Office Centre, 17 Corrig Road, Sandyford

Dublin 18 Ireland

(Address of Principal Executive Offices)(Zip Code)

+353 (1) 551 1487

Registrant's Telephone Number

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

Item 58.0201. ~~Departure~~Other ~~of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.~~Events

~~Transition~~On October 5, 2018, Presbia PLC (the “Company,” “we” or “us”) received notification from the U.S. Food and Drug Administration (the “FDA”) that 36-month data on all subjects enrolled in the Company’s staged pivotal clinical trial, including additional safety and efficacy related information, is required before the FDA can complete its review of ~~Finance~~the ~~Leadership~~Company’s pre-market approval application (the “PMA”). As previously disclosed in the Company’s Current Report on Form 8-K filed on October 12, 2018, the Company had to respond by April 3, 2019, otherwise it had to amend the PMA within the 180-day period to request an extension of time to respond. On April 3, 2019, the FDA granted an additional extension of time to respond, as the Company will need additional time to complete the 36-month Clinical Study Report and provide additional safety and efficacy related information requested by the FDA in its October 5, 2018 letter. The extension will provide the Company an additional 180-day period to respond, and the Company anticipates (though no assurance can be given) that the Company will complete the submission of all the requested information before the 180-day extension date of September 30, 2019. No assurance can be given that the FDA will grant the Company PMA approval. Also, the FDA may require the Company to conduct post-approval or new clinical studies as a condition of approval.

~~Effective~~Forward-Looking February 1, 2019 (the “Commencement Date”), in connection with the transition of the finance leadership of Presbia PLC (the “Company”), the Company’s Board of Directors appointed Valeriano Lima as the Company’s Corporate Controller, Head of Financial Planning and Analysis, and Company Secretary. In such capacity, Mr. Lima is now the Company’s “principal financial officer” and “principal accounting officer” for purposes of the rules and regulations of the Securities and Exchange Commission.Statements

~~Prior~~This toCurrent ~~his~~Report ~~appointment~~ on Form 8-K contains forward-looking statements, within the ~~Commencment~~meaning ~~Date~~of asthe Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the ~~Company’s~~words ~~Corporate~~“anticipate,” ~~Controller~~“believe,” ~~Head~~“continue,” of“could,” ~~Financial~~“estimate,” ~~Planning~~“expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” “will,” or “would,” and ~~Analysis~~or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and ~~Company~~unknown ~~Secretary~~risks, ~~Valeriano~~uncertainties ~~Lima~~and other factors that may cause our actual results, ~~age~~levels 37of activity, ~~had~~performance ~~served~~or asachievements ~~Senior~~to ~~Manager~~be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Current Report on Form 8-K, ~~Finance~~we caution you that these statements are based on a combination of facts and ~~Strategy~~factors currently known by us and our expectations of the ~~Company~~future, ~~since~~about ~~February~~which ~~2018~~we cannot be certain. ~~Mr.~~The ~~Lima~~forward-looking ~~served~~statements asin ~~Senior~~this ~~Financial~~Current ~~Analyst~~Report aton ~~Google~~Form 8-K include, ~~Inc~~among other things, statements about the timing, progress and results of our U.S. instaged ~~2015~~pivotal clinical trial and ~~Senior~~our ~~Financial~~regulatory ~~Analyst~~submissions, atour BTability ~~Group~~to advance our microlens and successfully complete our U.S. staged pivotal clinical trial, ~~PLC~~our (ability to obtain pre-market approvals, and the targeted timeframe thereof, and the timing or likelihood of regulatory filings and approvals. You should refer to “~~British~~Part ~~Telecom~~I, Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2017, filed with the Securities and Exchange Commission (”SEC”) on March 30, 2018, as well as our Quarterly Reports on Form 10-Q filed since such time, and our other filings from ~~2008~~time to ~~2012~~time with the Securities and Exchange Commission, for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. MrAs a result of these factors, we cannot assure you that the forward-looking statements in this Current Report on Form 8-K will prove to be accurate. ~~Lima~~You ~~holds~~should understand that it is not possible to predict or identify all such factors. Consequently, you should not consider any such list to be a Bcomplete discussion of all potential risks or uncertainties that may substantially impact our business.S Moreover, we operate in a competitive and rapidly changing environment. ~~degree~~New ~~from~~factors ~~California~~emerge ~~State~~from ~~University,~~time ~~San~~to ~~Bernardino~~time and ait ~~Master~~is not possible to predict the impact of ~~Business~~all ~~Administration~~of (Mthese factors on our business, financial condition or results of operations.B Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material.~~A.)~~ ~~from~~In light of the ~~University~~significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of ~~Notre~~new ~~Dame~~information, future events or otherwise, except as required by law.

There are no family relationships between Valeriano Lima and any director or executive officer of the Company, and he has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation 8-K. Mr. Lima will receive an annual base salary of $160,000. Mr. Lima will be eligible to receive such equity awards as may be determined in the discretion of the Compensation Committee. The Company and its Presbia USA, Inc. subsidiary have entered into indemnification agreements with Mr. Lima, providing for indemnification for matters arising out of Mr. Lima’s services to the Company.

In connection with the finance transition, the Company and Richard T. Fogarty mutually agreed that effective on the Commencement Date, Mr. Fogarty is no longer serving as the Company’s Chief Accounting Officer, Vice President of Finance and Company Secretary, and as of such date has transitioned from employee to consultant status. The Company and Mr. Fogarty have entered into a Consulting Agreement, dated as of the Commencement Date and having a one-year term (subject to earlier termination as provided therein). Pursuant to the Consulting Agreement, Mr. Fogarty will provide certain consulting services as requested by the Company, including accounting and financial support services in connection with the finance transition, at a rate of $150 per hour plus reimbursement of certain expenses. Given Mr. Fogarty’s agreement to assist with the transition, the Company has agreed pursuant to the Consulting Agreement that unvested stock options held by Mr. Fogarty will continue to vest in accordance with their terms during such period that the Consulting Agreement remains in effect. The foregoing description of the Consulting Agreement is a summary and does not purport to be complete, and is qualified in its entirety by reference to the full text of the Consulting Agreement, a copy of which is attached hereto as Exhibit 10.1, and is incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit		Description
10.1		Consulting Agreement, dated as of February 1, 2019, by and between Presbia PLC and Richard T. Fogarty.

SIGNATURES

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 hereunto duly authorized.

				PRESBIA PLC

			By: /s/ Mark Yung
			Name: Mark Yung
			Title: Chief Executive Officer

Dated: ~~February~~April 14, 2019

Filing Compare · Presbia PLC