Presbia PLC (Form: 10-Q, Received: 08/12/2016 16:56:47)

UNITED STATES

SECURITIES and EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

x	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2016

o	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission file number: 001-36824

Presbia PLC

(Exact name of registrant as specified in its charter)

Ireland	98-1162329
(State or other jurisdiction of incorporation or organization)	(IRS Employer Identification No.)

120/121 Baggot Street Lower, Dublin 2 Ireland (Address of principal executive offices)	(Zip Code)

+353 (1) 659 9446

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	o	Accelerated filer o

Non-accelerated filer	o (Do not check if a smaller reporting company)	Small reporting company x

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

The number of outstanding shares of the Registrant’s ordinary shares as of July 25, 2016 was 13,371,445 shares, $0.001 par value per share.

PRESBIA PLC

TABLE OF CONTENTS

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2016

Item		Page

	PART I. FINANCIAL INFORMATION

Item 1.	Financial Statements

	Consolidated Balance Sheets as of June 30, 2016 (unaudited) and December 31, 2015	2

	Consolidated Statements of Operations for the three and six months ended June 30, 2016 and 2015 (unaudited)	3

	Consolidated Statements of Cash Flows for the six months ended June 30, 2016 and 2015 (unaudited)	4

	Notes to Consolidated Financial Statements (unaudited)	5

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	12

Item 3.	Quantitative and Qualitative Disclosures about Market Risk	17

Item 4.	Controls and Procedures	17

	PART II. OTHER INFORMATION

Item 1.	Legal Proceedings	17

Item 1A.	Risk Factors	17

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	18

Item 3.	Defaults Upon Senior Securities	18

Item 4.	Mine Safety Disclosures	18

Item 5.	Other Information	18

Item 6.	Exhibits	19

	Signatures	20

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” “will,” or “would,” and or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to 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 Quarterly Report on Form 10-Q, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain.

The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:

●

the timing, progress and results of our clinical trials, our regulatory submissions and our research and development programs;

●

our ability to advance our products into, and successfully complete, clinical trials;

●

our ability to obtain pre-market approvals;

●

the commercialization of our products;

●

our anticipated cash needs and our needs for additional financing;

●

the implementation of our business model, strategic plans for our business, products and technology;

●

the scope of protection we are able to establish and maintain for intellectual property rights covering our products and technology;

●

estimates of our expenses, future revenues, capital requirements and our needs for additional financing;

●

the timing or likelihood of regulatory filings and approvals;

●

our financial performance; and

●

developments relating to our competitors and our industry.

You should refer to “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (”SEC”) on March 28, 2016 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. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report on Form 10-Q will prove to be accurate. You 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 complete discussion of all potential risks or uncertainties that may substantially impact our business. Moreover, we operate in a competitive and rapidly changing environment. New factors emerge from time to time and it is not possible to predict the impact of all of these factors on our business, financial condition or results of operations.

Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the 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 new information, future events or otherwise, except as required by law.

You should read this Quarterly Report on Form 10-Q and any documents that we reference in this report completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

PART I. FINANCI AL INFORMATION

ITEM 1.

FINANCIAL STATEMENTS

PRESBIA PLC

CONSOLIDATED BALANCE SHEETS

(in thousands, except share data and par value amount)

	June 30, 2016			December 31, 2015
Assets	(unaudited)
Current assets
Cash	$	14,642		$	21,749
Accounts receivable		33			116
Inventory, net		510			430
Prepaid expenses and other current assets		443			242
Total current assets		15,628			22,537
Property and equipment, net		741			775
Intangible asset		25			32
Other assets		158			63
Total assets	$	16,552		$	23,407
Liabilities and shareholders’ equity
Current liabilities
Accounts payable	$	471		$	736
Due to related parties		51			55
Other current liabilities		682			569
Total current liabilities		1,204			1,360
Deferred rent		13			22
Total liabilities		1,217			1,382
Commitments and contingencies (note 10)
Shareholders' equity
Common Ordinary Shares
$0.001 par value, 350,000,000 shares authorized; 13,371,445 and 13,355,477 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively.		13			13
Deferred Ordinary Shares
€ 1.00 (US$1.35) par value, 39,994 shares authorized, issued and outstanding at June 30, 2016 and December 31, 2015, respectively.		54			54
Additional paid-in capital		78,463			77,505
Accumulated deficit		(63,195	)		(55,547	)
Total shareholders' equity		15,335			22,025
Total liabilities and shareholders’ equity	$	16,552		$	23,407

See accompanying notes to these consolidated financial statements.

PRESBIA PLC

Consolidated Statements of Operations

(in thousands, except per share amounts)

(Unaudited)

	Three-Months Ended June 30,						Six-Months Ended June 30,
	2016			2015			2016			2015
Revenues	$	3		$	42		$	6		$	115
Cost of goods sold		26			14			47			61
Gross profit (loss)		(23	)		28			(41	)		54
Operating expenses:
Research and development		1,244			2,502			2,538			4,278
Sales and marketing		733			834			1,412			1,353
General and administrative		1,881			2,007			3,659			4,326
Total operating expenses		3,858			5,343			7,609			9,957
Operating loss		(3,881	)		(5,315	)		(7,650	)		(9,903	)
Interest income		5			—			9			—
Other income		—			—			1			—
Loss before income tax provision		(3,876	)		(5,315	)		(7,640	)		(9,903	)
Income tax provision		6			4			9			9
Net loss	$	(3,882	)	$	(5,319	)	$	(7,649	)	$	(9,912	)
Net loss per ordinary share-basic and diluted	$	(0.29	)	$	(0.40	)	$	(0.57	)	$	(0.79	)
Weighted average shares outstanding - basic and diluted		13,337,042			13,333,334			13,337,042			12,539,787

See accompanying notes to these consolidated financial statements.

PRESBIA PLC

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

	Six-Months Ended June 30,
	2016			2015
Cash flow from operating activities:
Net loss	$	(7,649	)	$	(9,912	)
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation		88			74
Amortization		8			6
Inventory provisions		47			44
Share-based compensation (including allocation from Presbia Holdings)		959			1,403
Non-cash interest expense on funding from the Presbia Holdings		—			1
Non-cash operating expenses allocated from the Presbia Holdings		—			182
Changes in operating assets and liabilities:
Accounts receivable		82			(7	)
Inventory		(126	)		(67	)
Prepaid expenses and other current assets		(202	)		(347	)
Other assets		(96	)		(2	)
Accounts payable and other current liabilities		(139	)		884
Income taxes payable		(17	)		6
Deferred rent		(8	)		(7	)
Due to related parties		(3	)		47
Net cash used in operating activities		(7,056	)		(7,695	)
Cash flow from investing activities:
Purchases of property and equipment		(52	)		(97	)
Net cash used in investing activities		(52	)		(97	)
Cash flow from financing activities:
Proceeds from issuance of ordinary shares upon initial public offering, net of underwriting costs		—			38,750
Deferred offering costs		—			(2,431	)
Proceeds from sale of equipment		1			-
Funding from the Parent		—			1,141
Net cash provided by financing activities		1			37,460
Net (decrease) increase in cash		(7,107	)		29,668
Cash balance at beginning of period		21,749			138
Cash balance at end of period	$	14,642		$	29,806

Supplemental disclosure of cash flow information:
Cash paid for income taxes	$	—		$	3
Supplemental disclosures of non-cash investing and financing activities:
Purchase of property and equipment included in accounts payable	$	—		$	33
Allocated operating expenses funded by Presbia Holdings	$	—		$	182
Capitalization of amounts due to Presbia Holdings persuant to the 2015 Debt Conversion	$	—		$	1,559

See accompanying notes to these consolidated financial statements.

PRESBIA PLC

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

(1) Basis of Presentation

Principles of Consolidation. The accompanying consolidated financial statements have been derived from the historical cost basis of the assets and liabilities, financial condition and cash flows of Presbia PLC and Presbia Ireland, Limited, both organized in Ireland, Presbia Investments, a direct subsidiary of Presbia PLC organized in the Cayman Islands, and Presbia Ireland, Limited’s subsidiaries, Presbia USA, Inc., and OPL, LLC. Presbia USA, Inc. and OPL, LLC are both entities organized in the United States, and include Presbia USA, Inc.’s subsidiaries, Visitome, Inc. and PresbiBio, LLC, both organized in the United States, and OPL, LLC’s direct and indirect subsidiaries, PIP Holdings, C.V and Presbia Cooperatief U.A., both organized in the Netherlands, and PresbiOptical LLC, organized in the United States (collectively, including Presbia PLC, the “Company”). The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The Company’s fiscal year ends on December 31. The entities presented in the consolidated financial statements have been under common control during the periods presented. All intercompany accounts have been eliminated in consolidation.

Basis of Presentation. The accompanying unaudited consolidated financial statements as of June 30, 2016 and for the three and six months ended June 30, 2016 and 2015, respectively, have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) for interim financial reporting, and with the instructions to Form 10-Q and Article 8 of Regulation S-X, which do not conform in all respects to the requirements of U.S. GAAP for annual financial statements. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements presented in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2015. The accompanying condensed balance sheet as for December 31, 2015 has been derived from the audited financial statements at that date but does not include all the information and footnotes required by GAAP for complete financial statements. The results of operations for the three and six months ended June 30, 2016 are not necessarily indicative of the results to be anticipated for the entire year ending December 31, 2016, or any other period. In the opinion of management, the accompanying consolidated financial statements reflect all adjustments which are necessary for a fair presentation of the results of operations and cash flows for the periods presented. The results of operations for such interim periods are not necessarily indicative of results of operations to be expected for the full year.

References to amounts in the consolidated financial statement sections are in thousands, except per share data, unless otherwise specified.

Reclassification of Prior Year Presentation. Certain prior year amounts have been reclassified for consistency with the current period presentation. These reclassifications had no effect on the reported results of operations and cash flows.

Liquidity

The Company has incurred significant operating losses since inception and had relied on funding from Presbia Holdings (the “Parent”) to fund operations prior to its IPO on February 3, 2015. Presbia Holdings was dissolved on November 25, 2015 and ceased to be the Parent of Presbia PLC. At June 30, 2016, the Company has an accumulated deficit of $63.2 million. As the Company continues to incur losses, its transition to profitability will depend on the following: (i) the completion of its U.S. staged pivotal trial, obtaining FDA approval of its microlens and, if approval is received from the FDA, the commercialization of its product within the United States and (ii) the successful commercialization of its product in certain jurisdictions outside the United States in which the Company has market approval, including the European Economic Area. The Company may never achieve profitability, and unless and until it does, it will need to continue to raise additional capital. Management expects that existing cash as of June 30, 2016, coupled with anticipated revenues outside of the United States will be sufficient to meet the Company’s anticipated cash requirements, including funding the initial payment for the acquisition of assets from Neoptics, through the second quarter of 2017 .

(2) Summary of Significant Accounting Policies

During the three months and six months ended June 30, 2016 there have been no changes to the Company’s significant accounting policies as described in the Annual Report on Form 10-K for the fiscal year ended December 31, 2015, except for the adoption of new accounting standards as discussed below.

Foreign Currency

The functional currency of subsidiaries outside the United States of America is the U.S. Dollar. Transactions in foreign currencies during the year are re-measured at rates of exchange on the dates of the transactions. Gains and losses related to re-measurement of items arising through operating activities are accounted for in the statement of operations and comprehensive loss and included in general and administrative expense. Aggregate foreign exchange loss was $7,000 and 16,000 for the three and six month periods ended June 30, 2016, respectively, and aggregate foreign exchange loss was $14,000 and $0 for the three and six month periods ended June 30, 2015, respectively.

Comprehensive Loss

Comprehensive income or loss is defined as a change in equity of a company attributable to all transactions excluding those transactions resulting from investment with owners and distributions to owners. There were no differences between net loss and comprehensive loss in the three and six month periods ended June 30, 2016 and 2015, respectively.

Deferred Offering Costs

During the three and six month periods ended June 30, 2015, the Company incurred approximately $0.2 million and $1.2 million, respectively, in costs related to its IPO which was completed on February 3, 2015. Upon completion of the IPO, the Company netted approximately $2.0 million in offering costs against the gross proceeds in shareholders’ deficit.

Recent Accounting Standards

In March 2016, the Financial Accounting Standards Board issued Accounting Standard Update (ASU) 2016-09 Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. ASU 2016-09 modifies multiple provisions intended to simplify various aspects of accounting for share-based payments including income tax consequences, accounting for forfeitures, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-09 will be effective for the Company beginning in the first quarter of 2017. The adoption of this standard is not expected to have a material impact on the Company's financial position or results of operations.

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). The new standard requires lessees to recognize most leases on their balance sheets as lease liabilities with corresponding right-of-use assets and eliminates certain real estate-specific provisions. ASU 2016-02 will be effective for the Company in the first quarter of 2019. ASU 2016-02 will be adopted on a modified retrospective transition basis for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The Company is currently evaluating the impact of ASU 2016-02 on its consolidated financial statements.

In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. The new standard requires management to assess, at each annual and interim reporting period, an entity's ability to continue as a going concern within one year after the date that the financial statements are issued and to provide related footnote disclosures. ASU 2014-15 will be effective for the Company beginning in the first quarter of 2017. The Company is currently evaluating the impact of ASU 2014-15 on its consolidated financial statements.

In June 2014, the FASB issued ASU 2014-12, Compensation - Stock Compensation (Topic 781): Accounting for Share-Based Payments When the Terms of an Award Provide that a Performance Target Could be Achieved after the Requisite Service Period. The new standard requires that a performance target that affects vesting and that could be achieved after the requisite service period be treated as a performance condition. As such, the performance target should not be reflected in estimating the grant date fair value of the award. Compensation cost should be recognized in the period in which it becomes probable that the performance target will be achieved and should represent the compensation cost attributable to the periods for which the requisite service has already been rendered. The Company adopted ASU 201-12 effective as of January 1, 2016, and the adoption of this standard had no impact on the Company's financial position or results of operations.

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). The new standard is based on the principle that revenue should be recogn ized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 will be effective for the Company in the fi rst quarter of 2018 and allows for full retrospective or a modified retrospective adoption approach. The Company has not yet assessed the potential impact of ASU 2014-09 on its consolidated financial statements.

(3) Loss per Share

Basic net loss per ordinary share is calculated by dividing net loss allocated to ordinary shareholders by the weighted average number of ordinary shares outstanding during the reporting period. Diluted net loss allocated to ordinary shareholders per share is calculated based on the weighted average number of Ordinary Shares and dilutive potential Ordinary Shares outstanding during the period. Dilutive potential ordinary shares consist of the shares issuable upon the exercise of options and upon the vesting of restricted shares under the treasury stock method. In net loss periods, basic and diluted net loss per share are identical since the effect of potential ordinary shares is anti-dilutive and therefore excluded.

Basic and diluted loss per share for the three and six months ended June 30, 2016 and 2015 were calculated as follows:

	Three-Months Ended June 30,						Six-Months Ended June 30,
	2016			2015			2016			2015
Net Loss	$	(3,882	)	$	(5,319	)	$	(7,649	)	$	(9,912	)
Weighted average shares outstanding - basic and diluted		13,337,042			13,333,334			13,337,042			12,539,787
Net loss per ordinary share - basic and diluted	$	(0.29	)	$	(0.40	)	$	(0.57	)	$	(0.79	)

Antidilutive securities, which consist of options and restricted shares that are not included in the diluted net loss per share calculation, consisted of an aggregate of approximately 1,111,968 and 1,040,573 for the three months ended June 30, 2016 and 2015, respectively, and 1,112,087 and 844,024 weighted average shares for the six months ended June 30, 2016 and 2015, respectively.

(4) Share Based Awards

Equity Issued by Parent

Liquidation of Presbia Holdings

As described in the Company’s Annual Report on form 10-K for the fiscal year ended December 31, 2015, in May 2015 pursuant to a plan to liquidate the Parent and distribute all of its assets to its ordinary shareholder by August 2015, the shareholders of the Parent approved a plan in which all options and unvested restricted shares outstanding as of May 13, 2015 were to become fully vested immediately, and, in the case of the options, the expiration date of the options were accelerated to June 15, 2015. By November 2015, the Company’s Parent was dissolved, and, as such, no share-based compensation expense was recognized in the three and six months ended June 30, 2016.

Options

Prior to 2014, the Parent granted options to purchase its ordinary shares to both employees and non-employees of the Company and share-based compensation related to such awards was recognized as expense in the Company’s Consolidated Statements of Operation and Comprehensive Loss for all reported periods including the three and six months ended June 30, 2015. Information regarding awards granted in periods prior to 2014 is available in the Company's Annual Reports on Form 10-K for the fiscal years ended December 31, 2015 and 2014. As of June 30, 2015, there were no options outstanding to purchase the Parent’s ordinary shares, as the expiration of the options were accelerated to June 15, 2015. During the three and six month periods ended June 30, 2015, approximately $21,000 of incremental stock-based compensation expense was recognized due to the acceleration of the expiration dates of the options.

Restricted Shares

No restricted shares were granted by the Parent during the three and six months ended June 30, 2015, and, similarly, as of June 15, 2015, the Parent accelerated vesting of all unvested restricted shares. As of June 30, 2015, there were no unvested restricted shares of the Parent and approximately $104,000 was recognized as incremental stock-based

compensation expense due to the acceleration of the vesting dates in the thr ee and six month periods ended June 30, 2015.

Unrecognized Share-based Compensation

As of June 30, 2015 and 2016, there was no unrecognized stock-based compensation expense related to the awards issued by the Parent .

Equity Issued by Presbia PLC

Presbia Incentive Plan

On January 14, 2015, the Company approved a compensation incentive plan (the “Presbia Incentive Plan”). The Presbia Incentive Plan permits the Company to grant awards of options, restricted shares, share appreciation rights, restricted share units, performance shares, performance share units, dividend equivalent rights in respect of awards and other share-based and cash-based awards, including annual and long-term cash incentive awards. A total of 1,800,000 ordinary shares were authorized for issuance under the Presbia Incentive Plan of which approximately 14,889 were available on June 30, 2016 for future grants and awards. Subsequently, on August 4, 2016, the Company’s shareholders approved an amendment to increase the shares authorized for issuance under the Presbia Incentive Plan by 400,000. The exercise price of each option award shall be determined by the Board of Directors (or a committee thereof) at the date of grant in accordance with the terms of the Presbia Incentive Plan awards, and generally vest 20% annually over a five-year period and expire no later than 10 years from the grant date. The Presbia Incentive Plan terminates on January 14, 2025, unless terminated earlier by the board of directors. Awards under the Presbia Incentive Plan may be granted to employees, directors, consultants and other persons who perform services for the Company or a subsidiary of the Company.

The following table shows share-based compensation expense based upon all equity awards issued by Presbia PLC included in the Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2016 and 2015.

	Three-Months Ended June 30,				Six-Months Ended June 30,
	2016		2015		2016		2015
Research and development	$	103	$	81	$	163	$	107
General and administrative		414		424		729		1,220
Sales and marketing		26		46		67		76
	$	543	$	551	$	959	$	1,403

Options

The following table sets forth the Company’s option activity for the six months ended June 30, 2016:

	Number of Presbia PLC Shares			Weighted Average Exercise Price Per Share		Aggregate Intrinsic Value
Balance, January 1, 2016		1,084,583			—		—
Granted		—			—		—
Exercised		—			—		—
Forfeited/cancelled/expired		(17,583	)	$	8.49		—
Balance, June 30, 2016		1,067,000		$	9.74		—
Vested and expected to vest, June 30, 2016		1,030,371		$	9.76		—
Exercisable, June 30, 2016		339,484		$	9.85		—

Employee Options

The Company utilizes the Black-Scholes valuation model for estimating the fair value of granted stock options with the following assumptions in addition to the closing price of the Company’s ordinary shares on the date of the grant: (i) the Company estimates the expected term of the option utilizing the simplified method because of its limited history of option exercise activity and its options meet the criteria of a "plain-vanilla" option as defined by the Securities Exchange Commission (ii) due to its limited stock price volatility history, the Company uses a peer group average as permitted under

Accounting Standards Codification (“ASC”) 718 consistent with the expected term of the stock option at the time of the grant and (iii) applies a risk-free interes t rate based on the U.S. Treasury securities yield consistent with the expected term of the option at the time of the grant. The simplified method calculates the expected term as the average of the weighted average vesting period and contractual terms of t he award. The following table presents the grant date assumptions used in the Black-Scholes model for determining the fair value of 0 and 12,500, and 0 and 1,022,500 employee options issued during the three and six months ended June 30, 2016 and 2015, resp ectively:

	Three-Months Ended June 30, 2016		Three-Months Ended June 30, 2015		Six-Months Ended June 30, 2016		Six-Months Ended June 30, 2015
Stock price per share		—	$	8.67		—	$	8.89
Expected term		—	6.5 Yrs.			—	5.5 - 6.5 Yrs.
Volatility		—		84.5%		—	76.8% - 84.5%
Dividends		—		—		—		—
Risk-free rate		—		1.8%		—	1.3% - 1.8%

The weighted-average grant date fair values of employee options granted during the three and six months ended June 30, 2015 was $5.71 and $6.98 respectively, per share. For those options granted to employees, stock-based compensation expense was based upon the fair value of the option as of the grant-date and attributed to future reporting periods on a straight-line basis over the vesting period, or the requisite service period. The forfeiture rate, which reduces the amount of expense that is recorded reflecting the anticipated number of options that ultimately will vest in future periods, is subject to review and may be adjusted based upon experience. During 2015 and for the three months ended March 31, 2016, a 5% annualized forfeiture rate was applied. Based upon review of pre-vesting forfeitures, commencing with the second quarter of 2016, the forfeiture rate was reduced to 3%.

Non-Employee Options

During the three and six months ended June 30, 2016 and 2015, 0 and 54,000, and 0 and 66,500 options, respectively, were granted to non-employee consultants and medical advisors. The following assumptions were used in the Black-Scholes valuation model to determine the option fair values:

	Three-Months Ended June 30, 2016		Three-Months Ended June 30, 2015		Six-Months Ended June 30, 2016		Six-Months Ended June 30, 2015
Stock price per share	$	4.52	$	8.22	$	4.52	$	8.22
Expected term	9.0 Yrs.		9.9 Yrs.		8.7 - 9.4 Yrs.		9.9 Yrs.
Volatility		66.1%		78.8%	66.1%			78.8%
Dividends		—		—		—		—
Risk-free rate		1.5%		2.4%	1.5%		1.9% - 2.4%

In contrast to the determination of the fair value of options granted to employees, which are determined based upon the grant-date assumptions and applying the Black-Scholes model, the fair values for non-employee options and the related stock-based compensation expense are remeasured each financial reporting period based upon the assumptions applicable on the dates in which the financial statements are prepared, which are disclosed in the preceding table. Because the performance criteria of these grants is based solely upon a requisite service period, but are subject to forfeiture if the service conditions are not met, stock-based compensation expense is determined by a straight-line attribution of the remeasured expense (mark-to-market) over the requisite service period subject to a forfeiture rate of 3%. As described in the preceding section, the annualized forfeiture rate was reduced from 5% to 3%.

Restricted Shares

On January 19, 2016, the Company’s board of directors approved a grant of 15,968 restricted ordinary shares of the Company, with a grant date value of $5.01 and a five-year vesting period consisting of 20% on each annual anniversary date commencing one-year following the date of grant, to Dr. Gerald Farrell upon joining the board. No additional restricted share awards were granted during the six-month period ended June 30, 2016. During the three and six month periods ended June 30, 2015, 0 and 9,270 restricted shares, respectively, were each granted to two board members upon joining the board with a grant date fair values of $0 and $8.63, respectively, a five-year vesting period consisting of 20% on each annual anniversary date commencing one-year following the date of grant.

The following table sets forth the Company’s restricted sha re activity for the three and six months ended June 30, 2016 and 2015:

	Unvested Number of Shares			Weighted Average Fair Value per Share
Balance, December 31, 2015		20,289
Granted		15,968		$	5.01
Vested		(1,854	)	$	8.63
Forfeited/cancelled		—
Unvested, June 30, 2016		34,403		$	6.51
Vested and expected to vest, June 30, 2016		32,549		$	6.68
Vested, June 30, 2016		3,708		$	8.63

Restricted Share Units

On April 28, 2016, the Board of Directors approved the award of 682,500 restricted share units (“RSU” or “RSU’s” or “RSU Plan”) to officers and employees in accordance with the guidelines provided by the Presbia Incentive Plan, which includes a provision that that recipient must be employed as a condition of vesting. Generally, under an RSU program, an entity will issue new shares of its common stock, at a future date subject to a plan expiration date, to recipients of RSU’s, if and when, some or all, stated objectives under the plan are met. The Presbia RSU Plan authorizes the issuance of 20% of each recipient’s total RSU award for the first occurrence that the closing price of the Company’s ordinary shares exceed, for a period of 20 consecutive business days, price thresholds of $10.00, $15.00, $20.00, $25.00 and $30.00, respectively. The RSU Plan also provides for a one-year “wait” or service period prior to any vesting permitted under the plan. The RSU Plan has a seven-year expiration period following the date of the grant.

Fair value of the 682,500 RSU’s awarded on April 28, 2016 was determined using a Monte Carlo Simulation (“MCS”) methodology, which considers the separate probabilities that each of the price thresholds or market conditions will be achieved under the RSU Plan guidelines. Each probability is weighted by its respective price threshold, or its intrinsic value, which provides the basis for an aggregate fair value of approximately $2,016,000, or a weighted average fair value of $2.95 per RSU. The Company used the following key inputs in determining the fair value using the MCS model: (i) the volatility of the entity’s common stock and (ii) the closing price of the entity’s stock as of the measurement date of the RSU award. The volatility of the Company’s stock and the closing price as of April 28, 2016 was approximately 83.9% and $3.85, respectively. In accordance with GAAP, the Company recognizes as stock-based compensation expense, using a straight-line attribution method, the aggregate fair value of $2,016,000 over future periods based upon the respective derived service periods and fair values for each of the price thresholds as provided by the MCS model. A 3% forfeiture rate was applied to account for future cancellations and forfeitures. During the three and six months ended June 30, 2016, approximately $110,000 was recorded as stock-based compensation related to the RSU Plan. No such expense was recognized in the same periods in 2015.

As of June 30, 2016, 680,000 RSU’s were outstanding with none vested.

Unrecognized Share-based Compensation

As of June 30, 2016 and 2015, there were $4.0 million and $5.5 million, respectively, of unrecognized compensation expense related to employee and non-employee options of the Company, which collectively is expected to be recognized by the Company over the weighted average vesting period of 3.4 and 4.0 years, respectively. Unrecognized compensation expense for the same periods related to restricted shares was $177,000 and $151,000, respectively, and is expected to be recognized over the weighted average vesting periods of 4.3 and 4.7 years, respectively. As of June 30, 2016, there was approximately $1.7 million of unrecognized compensation expense with respect to the RSU’s granted in April 2016 over a weighted average remaining derived service period of 3.3 years.

(5) Concentration of Credit Risk

The Company had cash of $14.6 million and $29.8 million as of June 30, 2016 and 2015, respectively, which consists of checking account deposits. The Company maintains cash balances at financial institutions located in the United States and secured by the Federal Deposit Insurance Corporation up to $250,000.

In the six month periods ended June 30, 2016 and 2015 there were two and five customers, respectively, that represented 100% of total sales recognized for each period. As of June 30, 2016, the Company was not authorized to manufacture or

sell any of its products or services within the United States and, as a result, all of the Company’ revenues are deriv ed from foreign customers.

With respect to suppliers for the microlens, the Company has a five-year supplier agreement that will expire in January 2017 with a lens manufacturer in Israel from which the Company receives 100% of its lens supply for use in commercial activities outside the United States. The Company also has its own manufacturing facility in Irvine, California that we believe can be scaled to meet excessive lens demand or a possible disruption from our foreign supply source.

(6) Income Taxes

Deferred income tax assets and liabilities are recognized for temporary differences between financial statement and income tax carrying values, using tax rates in effect for the years such differences are expected to reverse. Due to uncertainties surrounding the Company's ability to generate future taxable income and consequently realize such deferred income tax assets, a full valuation allowance has been established. The Company continues to maintain a full valuation allowance against its deferred tax assets as of June 30, 2016.

The impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that is more likely than not to be sustained upon audit by the relevant tax authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. There have been no material changes in the Company's unrecognized tax benefits since December 31, 2015; and, as such, disclosures included in the Company's 2015 Annual Report on Form 10-K continue to be relevant for the period ended June 30, 2016.

(7) Commitments and Contingencies

In May 2012, the Company entered into a five-year non-cancelable lease for office and manufacturing space in Irvine, California that expires in May 2017, a 26-month sublease of office space in the same California location that commenced in June 2014 that will expire in July 2016, a one-year lease (which is now month to month) in Dublin, Ireland that commenced on December 1, 2013, a 30-month lease in Amsterdam, the Netherlands that commenced on January 1, 2016 and a four-year lease for office space in Irvine, California that will commence on August 1, 2016 and will expire in September 2020. Aggregate rent expense for the three months ended June 30, 2016 and 2015 was $85,000 and $51,000, respectively. For the six months ended June 30, 2016 and 2015, aggregate rent expense was $170,000 and $102,000, respectively.

From time to time, the Company may be subject to legal proceedings and claims arising in the ordinary course of business. Management does not believe that the outcome of any of these matters will have a material effect on the Company’s consolidated financial operations .

(8) Subsequent Event

On August 2, 2016, Presbia Ireland, Limited, a wholly-owned subsidiary of the Company, entered into an asset purchase agreement (the “Agreement”) with Neoptics AG (“Neoptics”) pursuant to which the Company acquired certain assets from Neoptics for an aggregate purchase price of 1.5 million Swiss Francs (approximately $1.5 million based on the exchange rate between the Swiss Franc and US Dollar on August 2, 2016) payable in three equal installments on each of August 2, 2016, December 31, 2017 and December 31, 2018. The assets being acquired include patents, pending patents, specified trademarks, equipment, inventory, technical documents and other related documents. Effective August 2, 2016, the Company shall be responsible for all expenses associated with such assets. Pursuant to the terms of the Agreement, the acquisition closed on August 2, 2016.

On August 4, 2016, the Company’s shareholders approved amendments to the Presbia Incentive Plan to increase the number of ordinary shares available for awards by 400,000 ordinary shares and to approve the material terms of Section 162(m) performance goals.

ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

We refer to the 2015 Debt Conversion and the 2015 Capital Contribution, each described in Note 1 of the Company’s 2015 Annual Report on Form 10-K, collectively, the Reorganization Transactions. Unless we state otherwise, the terms “we,” “us,” “our,” “Presbia” and the “company” refer to Presbia PLC and its consolidated subsidiaries after giving effect to the Reorganization Transactions. Prior to the completion of the Reorganization Transactions, the foregoing terms refer to the entities that became the consolidated subsidiaries of Presbia PLC upon consummation of the Reorganization Transactions.

Our Management’s Discussion and Analysis of Financial Condition and Results of Operations is organized as follows:

●

Overview. This section provides a general description of our Company and background information on certain trends and developments affecting our Company.

●

Critical Accounting Policies and Estimates. This section discusses those accounting policies that are considered important to the evaluation and reporting of our financial condition and results of operations, and whose application requires us to exercise subjective or complex judgments in making estimates and assumptions. In addition, all of our significant accounting policies, including our critical accounting policies, are summarized in Note 2, “Summary of Significant Accounting Policies,” of our notes to consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015. There have been no material changes, except for the adoption of new accounting standards as discussed elsewhere in this report.

●

Overview of Results of Operations. This section provides our analysis and outlook for the significant line items on our consolidated statements of operations and comprehensive loss, as well as other information that we deem meaningful to understand our results of operations on a consolidated basis.

●

Liquidity and Capital Resources. This section provides an analysis of our liquidity and cash flows.

Overview

We are an ophthalmic device company which has developed, and is currently marketing, a proprietary optical lens implant for treating presbyopia. Presbyopia is the age related loss of near field vision. It is the condition that requires many adults to require reading glasses. Our Flexivue microlens is a miniature lens designed to be surgically implanted in the cornea of the patient’s non-dominant eye. Through a process called “neural adaptation”, the patient’s brain rapidly adapts to use the dominant eye for distance, and the microlens assisted non dominant eye for near vision. The procedure is fast, non-invasive, and can be reversed or updated if necessary.

We have commercialized the Flexivue microlens in certain strategic countries where we currently have marketing approval. Our goal is to become a leading provider of corneal inlay presbyopia-correcting treatment worldwide.

Through our European Union CE Mark, we are generally authorized to market the Flexivue microlens throughout the European Economic Area, or EEA (all European Union member states plus Iceland, Liechtenstein and Norway), and Switzerland. We currently market our product in certain strategic EEA countries as well as countries outside of the EEA in which we possess marketing approval.

We are presently seeking marketing approval in the United States. In December 2013, we received approval to commence a staged pivotal clinical trial as part of the U.S. Food and Drug Administration, or FDA, approval process. Beginning in May 2014, we enrolled a total of 75 subjects at six investigational sites in the United States and each subject underwent insertion of our microlens in the non-dominant eye. Based on nine-month data on 52 subjects, in January 2015, we submitted an interim safety report as a supplement to our investigational device exemption, or IDE, to the FDA. In February 2015, we received approval from the FDA to commence second stage enrollment in this trial. During September 2015, we completed the enrollment of the second stage study of 346 subjects at up to five additional investigational sites. This trial is necessary in order to obtain clinical data to provide the primary support for a safety and effectiveness evaluation to support a pre-market approval, or PMA, for marketing clearance in the United States. Data on a minimum of 300 subjects with 24-month data will be submitted as part of the PMA, and all subjects will be followed for three years following implantation. We are targeting submission of our final PMA, containing 24-month data on 300 subjects, to the FDA in the fourth quarter of 2017. We are pursuing a modular PMA submission strategy whereby we intend to submit to the FDA information regarding preclinical testing, engineering, and manufacturing beginning in the second quarter of 2016 to the first quarter of 2017 prior to the submission of our final PMA. We are targeting PMA

approval of our microlens by the fourth quarter of 2018. We are al so targeting submission to the FDA of a final report with 36-month data on these 300 subjects in the fourth quarter of 2018.

These milestones could be delayed by further interactions with the FDA or by a variety of other factors. In addition, no assurance can be given that the FDA will grant us PMA approval or, if granted, that it will be granted in accordance with our anticipated time schedule. Also, the FDA may require us to conduct post-approval studies as a condition of approval.

We own intellectual property related to refractive powered inlays to treat presbyopia. We believe that our intellectual property portfolio, specifically the patents therein, also gives us the ability to expand into broader vision correction solutions if we so decide.

We are an ophthalmic device company with a limited operating history. We are not profitable and have incurred losses in each year since our formation. We have reported recurring net losses and negative cash flow from operating activities since inception and, as of June 30, 2016, we had an accumulated deficit of $63.2 million. We expect to continue to incur significant losses for the foreseeable future.

Critical Accounting Policies and Estimates

The discussion and analysis of our consolidated financial statements and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, costs and expenses and related disclosures. We have based and will base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. In many instances, we could have reasonably used different accounting estimates, and in other instances changes in the accounting estimates are reasonably likely to occur from period to period. Accordingly, actual results could differ significantly from the estimates made by our management. To the extent that there are material differences between these estimates and actual results, our future financial statement presentation, financial condition, results of operations and cash flows will be affected. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

We describe our significant accounting policies in Note 2, “Summary of Significant Accounting Policies,” of our notes to consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2015. We discuss our critical accounting policies and estimates in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” of our Annual Report on Form 10-K for the year ended December 31, 2015. There have been no material changes in our significant accounting policies or critical accounting policies and estimates since the year ended December 31, 2015, except for the adoption of new accounting standards as discussed elsewhere in this report.

Results of Operations

Comparison of the Three and Six Months Ended June 30, 2016 and June 30, 2015 (in thousands).

	Three-Months Ended June 30,						Change
	2016			2015			$000's			%
Revenues	$	3		$	42		$	(39	)		-93	%
Cost of goods sold		26			14			12			86	%
Gross profit (loss)		(23	)		28			(51	)		-182	%
Operating expenses:
Research and development		1,244			2,502			(1,258	)		-50	%
Sales and marketing		733			834			(101	)		-12	%
General and administrative		1,881			2,007			(126	)		-6	%
Total operating expenses		3,858			5,343			(1,485	)		-28	%
Operating loss		(3,881	)		(5,315	)		1,434			-27	%
Interest income		5			—			5			0	%
Other income		—			—			—			0	%
Loss before income tax provision		(3,876	)		(5,315	)		1,439			-27	%
Income tax provision		6			4			2			50	%
Net loss	$	(3,882	)	$	(5,319	)	$	1,437			-27	%

	Six-Months Ended June 30,						Change
	2016			2015			$000's			%
Revenues	$	6		$	115		$	(109	)		-95	%
Cost of goods sold		47			61			(14	)		-23	%
Gross profit (loss)		(41	)		54			(95	)		-176	%
Operating expenses:
Research and development		2,538			4,278			(1,740	)		-41	%
Sales and marketing		1,412			1,353			59			4	%
General and administrative		3,659			4,326			(667	)		-15	%
Total operating expenses		7,609			9,957			(2,348	)		-24	%
Operating loss		(7,650	)		(9,903	)		2,253			-23	%
Interest income		9			—			9			0	%
Other income		1			—			1			0	%
Loss before income tax provision		(7,640	)		(9,903	)		2,263			-23	%
Income tax provision		9			9			-			0	%
Net loss	$	(7,649	)	$	(9,912	)	$	2,263			-23	%

Revenue

Revenue for the three months ended June 30, 2016 was $3,000 as compared to $42,000 for the corresponding period in 2015. The reduction of $39,000 is attributable to $33,000, $5,000 and $1,000 in less revenue in Ireland, Canada and South Korea, respectively. For the six month period ended June 30, 2016, revenue was $109,000 lower that the corresponding period in 2015 due principally to lower revenue in Ireland and South Korea, the later a new market for the microlens. Revenues were immaterial for both periods presented and are expected to continue to be immaterial in the near-term due to the fact that in the near term we are undertaking limited commercialization efforts in only a few selected markets. Unless and until we receive FDA approval to sell and market our microlens within the United States, we are focusing our sales and marketing resources to sell our microlens to refractive laser centers outside the United States.

Cost of Goods Sold

Cost of goods sold was $26,000 for the three months ended June 30, 2016 as compared to $14,000 in the three months ended March 31, 2015, or an increase of $12,000, compared to a $39,000 decline in revenue for the same period. Cost of sales includes inventory adjustments, such as a provision for inventory obsolescence, which can fluctuate from period to period depending upon the mix, the current shelf life of lens inventory in relation to our regulated policy and the size of our finished goods inventory. During the three months ended June 30, 2016 and 2015, we recorded additional provisions for inventory obsolescence of $25,000 and $9,000, respectively. For the six month period ended June 30, 2016 and 2015,

cost of goo ds sold was $47,000 and $61,000, respectively, or a decrease of $14,000 compared to a $109,000 decrease in revenue for the same periods.

Research and Development

Research and development expense declined by $1.3 million, or 50%, for the three months ended June 30, 2016 as compared to the same period in 2015. In February 2015, we received approval from the FDA to commence the second phase of the staged U.S. clinical trials, which resulted in higher expense levels in 2015 that will not be repeated in 2016. The decline in research and development spend is primarily due to (i) a $1.1 million cost decline related to our U.S. clinical trials attributed to 2016 costs incurred for patient compliance activities under both Phases I and II as compared to higher 2015 costs incurred for patient recruiting costs and equipment acquisition costs related to the 2015 ramp-up of Phase II; and (ii) $0.2 million for reduced surgical training costs related to the Phase II study not required in 2016. For the six months ended June 30, 2016, research and development costs decreased by $1.7 million, or 41% as compared to the six month period ended June 30, 2015, primarily attributable to a (i) $1.6 million in cost decline related to our U.S. clinical trials attributed to 2016 costs (described above); and (ii) $0.1 million for reduced surgical training costs related to the Phase II study not required in 2016.

With the patient recruiting and surgical treatment phase of the second phase of the U.S. staged clinical trials completed during 2015, we believe research and development expense associated with the clinical trials will decline in the third and fourth quarters of 2016 relative to the same quarterly expenditure levels in 2015.

Sales and Marketing

Sales and marketing expense decreased by $0.1 million or 12%, for the three months ended June 30, 2016 as compared to the three months ended June 30, 2015. The decrease is primarily a result of lower marketing and advertising costs of $0.1 million. Sales and marketing expenses increased by $59,000, or 4%, for the six months ended June 30, 2016 as compared to the six months ended June 30, 2015. The increase is a result of higher selling expenses of $59,000.

Due to increased commercial activity outside the United States consisting of training of surgeons, additional headcount and related salary and benefit expenses, travel and marketing costs in general, we believe that selling and marketing expense will increase during future quarterly periods relative to the level of expense recorded in the six months ended June 30, 2016.

General and Administrative

General and administrative expense declined by $0.1 million, or 6%, for the three months ended June 30, 2016 as compared to the same period in 2015. General and administrative expenses declined primarily due to (i) reduced professional fees of $0.1 million related to the initial public offering conducted in 2015. For the six month period ended June 30, 2016 as compared to the same period of 2015, general and administrative expenses decreased by $0.7 million, consisting of (i) decreased stock-based compensation costs of $0.5 million primarily due to 90,000 stock option grants that were fully expensed in the first quarter of 2015 as compared to 2016, (ii) lower professional fees of $0.3 million primarily due to costs related to the initial public offering incurred in 2015. These cost reductions were partially offset by (i) higher outside services costs of $0.1 million primarily due to recruiting expenses.

Interest Income

Interest income was $5,000 for the three months ended June 30, 2016, compared to $0 for the three months ended June 30, 2015. Interest income was $9,000 for the six months ended June 30, 2016, compared to $0 for the six months ended June 30, 2015.

Net Loss

Our net loss of $3.9 million for the three months ended June 30, 2016, was $1.4 million less, or 27% less, than the net loss of $5.3 million in the corresponding period in 2015. We expect that losses will continue through 2018, and possibly further, due to anticipated costs related to our U.S. staged pivotal clinical trial and ongoing costs required to develop the market outside of the United States for our microlens.

Liquidity and Capital Resources

On February 3, 2015, we completed the initial public offering of our Ordinary Shares. We sold a total of 4,166,667 Ordinary Shares at a public offering price of $10.00 per share. At June 30, 2016, we had cash of $14.6 million, reflecting a $7.1 million decline from our cash balance at December 31, 2015 of $21.8 million. The decline reflects the use of cash to fund operations during the first half of 2016 of $7.1 million.

Our primary uses of cash are to fund operating expenses, primarily general and administrative expenditures and research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Our future capital requirements are difficult to forecast and will depend on many factors, including:

the progress, timing, costs and completion of clinical trials for our products;

the number and characteristics of products that we market and sell;

the progress, costs and results of our clinical trials;

the outcome, timing and cost of regulatory approvals;

delays that may be caused by changing regulatory requirements;

timing and amount of revenue resulting from sales to customers outside the United States; and

timing and amount of investments in our commercialization efforts outside the U.S.

The following table summarizes our cash flows for the periods indicated (in thousands):

	Six-Months Ended June 30,
	2016			2015
Net cash used in operating activities	$	(7,056	)	$	(7,695	)
Net cash used in investing activities	$	(52	)	$	(97	)
Net cash provided by financing activities	$	1		$	37,460

On February 3, 2015, Presbia PLC completed its initial public offering (“IPO”) of 4,166,667 of its ordinary shares at a price to the public of $10.00 per ordinary share and commenced trading on The NASDAQ Global Market under the symbol LENS. The net proceeds from the IPO consisted of aggregate gross proceeds of approximately $41.7 million less underwriting discounts and commissions of approximately $2.9 million and other issuance costs of approximately $2.0 million resulting in net proceeds of approximately $36.8 million. In addition, the Company received $1.1 million in funding from the Parent in 2015.

At June 30, 2016, we had an accumulated deficit of approximately $63.2 million and we expect to incur additional operating losses through 2018, and possibly further. As we continue to incur losses, our transition to profitability will depend on the successful development, approval and commercialization of our microlens in the United States. We may never achieve profitability, and unless and until we do, we will need to continue to raise additional capital. Based on our current business plan, we believe that our cash and cash equivalents at June 30, 2016, coupled with anticipated revenues outside of the United States will be sufficient to meet our anticipated cash requirements, including funding the initial payment for the acquisition of assets from Neoptics, through the second quarter of 2017. Our current commercialization strategy is targeted to countries where we believe we can both establish the market for our technology and achieve positive cash flow from such geographic market as soon as possible. This commercialization strategy will undergo continual prioritization and in the future we may adjust our commercialization efforts to preserve our existing cash or realize better results than anticipated which could have a positive impact on cash. Our U.S. pivotal clinical trial and planned FDA approval is our highest priority. That priority, coupled with our current commercialization efforts outside the U.S., will likely result in our need to raise additional capital to fund our operations. We may raise additional capital through equity offerings, debt financings, collaborations and/or licensing arrangements. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not available on acceptable terms, we may be required to delay, reduce the scope of, or curtail, our operations. To the extent that we raise additional funds by issuing equity securities, our shareholders will experience dilution, and debt financing, if available, may involve restrictive covenants.

Off-Balance Sheet Arrangements

We have not entered into any off-balance sheet arrangements and do not have any holdings in variable interest entities.

Recent Accounting Pronouncements

Refer to Note 2, “Summary of Significant Accounting Policies,” of our notes to consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for a discussion of new accounting standards.

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Under Securities and Exchange Commission, or SEC, rules and regulations, as a smaller reporting company we are not required to provide the information otherwise required by this item.

ITEM 4.

CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has 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 Securities Exchange Act of 1934, as amended) as of the end of the period covered by this Quarterly Report on Form 10-Q. 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. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective.

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended June 30, 2016 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

ITEM 1.

LEGAL PROCEEDINGS

We are not aware of any pending or threatened legal proceeding against us that could have a material adverse effect on our business, operating results or financial condition. However, the medical device industry is characterized by frequent claims and litigation, including claims regarding patent and other intellectual property rights as well as improper hiring practices. As a result, we may be involved in various legal proceedings from time to time.

ITEM 1A.

RISK FACTORS

Please refer to “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission on March 28, 2016 for a description of certain significant risks and uncertainties to which our business, operations and financial condition are subject. There have been no material changes to the risk factors disclosed in our Annual Report on Form 10-K for the year ended December 31, 2015.

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Use of Proceeds from Initial Public Offering of Ordinary Shares

On January 28, 2015, our registration statement on Form S-1 (File No 333-194713), as amended, was declared effective by the SEC for our initial public offering. Upon the closing of our initial public offering on February 3, 2015, we sold 4,166,667 ordinary shares, $0.001 par value per share, at a public offering price of $10.00 per share, for an aggregate public offering price of $41.7 million.

There has been no material change in the use or planned use of proceeds from our initial public offering from that described in the final prospectus related to the offering, which we filed with the SEC on January 29, 2015.

ITEM 3.

DEFAULTS UPO N SENIOR SECURITIES

None.

ITEM 4.

MINE SAFETY DISCLOSURES

Not Applicable

ITEM 5.

OTHER INFORMATION

None.

ITEM 6.

EXHIBITS

Exhibit Number		Exhibit Description

10.1+**		Asset Purchase Agreement, dated August 2, 2016, by and between Neoptics AG and Presbia Ireland, Limited.

10.2+		Amendment No. 1 to Presbia PLC Incentive Plan.

31.1+		Certification of Principal Executive Officer Required by Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2+		Certification of Principal Financial Officer Required by Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1*		Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS+		XBRL Instance

101.SCH+		XBRL Taxonomy Extension Schema

101.CAL+		XBRL Taxonomy Extension Calculation

101.DEF+		XBRL Taxonomy Extension Definition

101.LAB+		XBRL Taxonomy Extension Label

101.PRE+		XBRL Taxonomy Extension Presentation

+	Indicates filed herewith.

*	Indicates furnished herewith

**	Annexes have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company hereby undertakes to furnish supplemental copies of any of the omitted annexes to the U.S. Securities and Exchange Commission upon request.

SIGNAT URES

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.

	PRESBIA PLC

Date: August 12, 2016	By:	/s/ Todd Cooper
		Todd Cooper
		President and Chief Executive Officer

Date: August 12, 2016	By:	/s/ Jarett Fenton
		Jarett Fenton
		Chief Financial Officer,
		Vice President, Finance and Secretary

Asset Purchase Agreement

RDA X0342534.docx

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Asset Purchase Agreement

(hereinafter " Agreement ")

between

Neoptics AG

Bösch 80A, 6331 Hünenberg, Switzerland

(hereinafter referred to as " Seller ")

and

Presbia Ireland, Limited

120-121 Lower Baggot Street, Dublin 2, Republic of Ireland

(hereinafter referred to as " Buyer ")

Seller and Purchaser together referred to as the " Parties ", and each of them as a " Party "

regarding

the sale, purchase and transfer of certain assets of Seller

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Table of Contents

Definitions4

Objects of Sale and Purpose6

2.1

Sale and Purchase of Assets6

2.1.1

IP Rights6

2.1.2

Equipment and Inventory6

2.1.3

Trademarks6

2.1.4

Documents and Electronic Data7

2.2

No Further Assets7

2.3

Allocation of Revenues and Expenses7

2.4

Transfer of Risk and Benefit7

Purchase Price7

3.1

General7

3.2

Payment of the Purchase Price7

Closing8

4.1

Closing Date and Place of Closing8

4.2

Conditions Precedent to Closing8

4.2.1

Conditions Precedent8

4.2.2

Satisfaction or Waiver of Conditions Precedent8

4.3

Actions before Closing9

4.4

Closing Actions9

4.4.1

Seller's Closing Obligations9

4.4.2

Buyer's Closing Obligations9

Representations and Warranties10

5.1

Representations and Warranties of Seller10

5.1.1

Organisation10

5.1.2

IP Rights10

5.1.3

Equipment and Inventory11

5.1.4

Trademarks11

5.1.5

Documents and Electronic Data12

5.2

Representations and Warranties of Buyer12

5.3

Representations and Warranties Exclusive12

5.4

Remedy of Buyer13

5.4.1

Notice of Breach13

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5.4.2

Seller's Right to Cure and Seller's Liability 13

5.4.3

Term of Representations and Warranties14

5.4.4

Exclusion and Limitation of Liability for Matters Disclosed14

5.4.5

Limitations of Remedies of Buyer14

5.5

Remedy of Seller14

5.6

Remedies Exclusive14

Covenants of the Parties15

Miscellaneous Provisions15

7.1

Transaction Costs and Taxes15

7.2

Confidentiality15

7.3

Public Announcements16

7.4

Entire Agreement16

7.5

Amendments and Modifications16

7.6

Notices16

7.7

Severability17

7.8

Transfer and Assignment17

7.9

Governing Law18

7.10

Jurisdiction18

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P reamble

Whereas , Seller is a company duly existing under the laws of Switzerland with registered seat and principal place of business at Bösch 80A in Hünenberg (Zug), Switzerland;

Whereas , Seller was dedicated to the development, the production and the commercialisation of ophthalmological precision instruments, devices and medical products as well as to the acquisition, development and the management of intellectual property rights in the field of ophthalmology and recently resolved to sell its assets, in particular intellectual property, equipment, documents etc. as set out under Section 2.1 hereinafter;

Whereas , Buyer is interested in purchasing assets of Seller (" Transaction "), and Buyer and Seller signed a letter of intent to that effect on 1 July 2016;

Now, therefore, the Parties hereto agree, as follows:

1.	Definitions

Terms used in this Agreement in capitalised form shall have the following meaning:

Agreement shall mean this agreement, including i ts Annexes.

Annex shall mean an annex to this Agreement.

Assets

shall mean the entirety of the IP Rights, the Equipment and Inventory, the Trademarks, the Documents etc. as set out under Section 2.1 hereinafter, which shall be sold and transferred to Buyer all upon the terms and subject to the conditions set forth in this Agreement.

Business Day

shall mean any full day on which banks in Zurich, Switzerland, are open for the transaction of normal commercial business.

Buyer

shall have the meaning set forth on the cover page of this Agreement.

Cap shall have the meaning set forth in Section 5.4.5.

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Closing

shall mean the actual consummation of the Transaction contemplated under this Agreement as set forth in Section 4 .

Closing Date

shall mean the date of the Closing of this Transaction as set forth in Section 4.1.

CO	shall mean the Swiss Code of Obligations (OR, Obligationenrecht) .

Conditions Precedent shall have the meaning set forth in Section 4.2.1.

Damage shall have the meaning set forth in Section 5.4.2.

De Minimis Amount shall have the meaning set forth in Sec tion 5.4.5.

Documents

shall mean the Technical Dossier including the design and other relevant documents as listed in Annex 4.

Electronic Data

shall mean all items listed in Annex 5

Equipment and Inventory shall mean all items as listed in Annex 2.

IP Rights

shall mean all patents and pending patents as listed in Annex 1.

Notice of Breach shall have the meaning set forth in Section 5.4.1.

Party shall mean Seller or Buyer, as the context may require.

Parties

shall have the meaning set forth on the cover page of this Agreement.

Purchase Price shall have the meaning set forth in Section 3.

Section shall mean a section of this Agreement.

Seller

shall have the meaning set forth on the cover page of this Agreement.

Seller's Representations

and Warranties shall have the meaning set forth in Section 5.1.

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Signing

shall mean the actual signing of this Agreement by the Parties.

Signing Date

shall mean the date of the Signing of this Agreement as set out in Section 2.4.

Trademarks shall mean all trademarks as listed in Annex 3.

Transaction shall mean all transactions contemplated by this Agreement.

Transfer Agreement

shall have the meaning as set forth in Section 4.4.1 as reflected in Annex 5.

2.	Objects of Sale and Purpose

2.1	Sale and Purchase of Assets

The subject of this Agreement is the sale and purchase of the following Assets as per Closing Date:

2.1.1

IP Rights

Seller sells the IP Rights to Buyer and undertakes to assign and to transfer the IP Rights to Buyer as per Closing Date ( Annex 1 ).

2.1.2

Equipment and Inventory

Seller sells all Equipment and Inventory to Buyer and undertakes to transfer all Equipment and Inventory to Buyer at the time of Closing ( Annex 2 ).

2.1.3

Trademarks

Seller sells all Trademarks to Buyer and undertakes to transfer all Trademarks to Buyer at the time of Closing ( Annex 3 ).

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2.1.4

Documents and Electronic Data

Seller sells to Buyer and undertakes to assign and transfer all Documents as listed in Annex 4 and all electronic data as listed in Annex 5 .

2.2	No Further Assets

Buyer does not acquire any assets from Seller other than those Assets as set out in Section 2.1 of this Agreement.

2.3	Allocation of Revenues and Expenses

Buyer shall as of and including the Signing Date be responsible for all expenses which become due in relation to the Assets.

2.4	Transfer of Risk and Benefit

The benefit and the risk of the Assets (Übergang von Nutzen und Gefahr) shall pass from Seller to Buyer on the Signing Date.

3.	Purchase Price

3.1

General

The purchase price for the Assets (" Purchase Price ") to be paid by Buyer to Seller shall be CHF 1,500,000 (in words: one million and five hundred thousand Swiss Francs).

3.2	Payment of the Purchase Price

The Purchase Price shall be paid by Buyer to Seller in three instalments in immediately available funds to a bank account of Seller as set out in Section 4.4.2.

CHF 500,000 shall be payable on the Signing Date.

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CHF 500,000 shall be payable on the Business Day immediately preceding 31 December 2017.

CHF 500,000 shall be payable on the Business Day immediately preceding 31 December 2018.

Closing

4.1	Closing Date and Place of Closing

The Closing shall take place at the offices of Seller on 2 August 2016.

4.2	Conditions Precedent to Closing

4.2.1

Conditions Precedent

The obligations of each Party to effect the Transaction shall be subject to the satisfaction (or waiver) on the Closing Date of the following conditions precedent (" Conditions Precedent "):

-	no judgement, injunction or order shall have been issued by any competent governmental, regulatory, administrative or judicial authority and no proceedings shall have been instituted which would prohibit the consummation of the Closing;

-	the representations and warranties are true and correct in all material respects.

4.2.2

Satisfaction or Waiver of Conditions Precedent

Each Party shall have the right to waive satisfaction of the conditions set out in Section 4.2.1.

lf any of the Conditions Precedent has not been satisfied or waived prior to or on the Closing Date, this Agreement shall automatically terminate.

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4.3	Actions before Closing

Seller shall give Buyer access for due diligence to all Assets, provided that the first instalment of the Purchase Price is paid on the Signing Date.

4.4	Closing Actions

On the Closing Date, the following actions shall be taken:

4.4.1

Seller's Closing Obligations

At Closing, Seller shall deliver to Buyer the following documents:

-	Annex 1 listing all IP Rights to be transferred according to Section 2.1.1 together with the assignment agreement in the form as set out in Annex 6 , according to which the IP Rights are transferred and assigned unconditionally and without reservation to Buyer, duly signed by Seller.

-	Annex 2 listing all Inventory.

-	Annex 3 listing all Trademarks to be transferred according to Section 2.1.3 together with the assignment agreement in the form as set out in Annex 7 , according to which the Trademarks are transferred and assigned unconditionally and without reservation to Buyer, duly signed by Seller.

-	Annex 4 listing all Documents and all Documents listed in Annex 4 in electronic format.

-	Annex 5 listing all electronic data and all electronic data listed in Annex 5 in electronic format.

In addition, at Closing, or at any time thereafter, Seller shall transfer to Buyer all items listed in Annex 2. If Buyer does not take possession of these items by 15 September 2016, Buyer is deemed to have waived its claim to the items.

4.4.2

Buyer's Closing Obligations

At Closing, Buyer shall deliver to Seller the following documents:

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-	A copy of the resolution of the board of directors approving the Transacti on.

-	A copy of the Swift confirmation issued by the bank of Buyer evidencing that Buyer has paid the first instalment of the Purchase Price according to Section 3.2 of this Agreement on the Signing Date to the following account of Seller:

IBAN:

bank account holder:

bank account number:

bank:

SWIFT/BIC:

clearing number:

reference:

5.	Representations and Warranties

5.1	Representations and Warranties of Seller

Seller hereby represents and warrants to Buyer that the representations and warranties as set forth in this Section 5.1 (" Seller's Representations and Warranties ") are true and accurate in all respects as of the Signing Date and as of the Closing Date.

5.1.1

Organisation

Seller is duly incorporated and validly existing under the laws of Switzerland and has all requisite corporate power and authority to own its assets and to carry out its business.

5.1.2

IP Rights

Seller is entitled and empowered to sell and assign all IP Rights as stated in this Agreement.

All IP Rights are free and clear of any pledge, mortgage, lien, charge, encumbrance or other security interest and any rights of third parties.

No claims have been made or threatened in writing by competitors which are challenging the validity or enforceability of the IP Rights.

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There are no assignments, licences, sublicenses, agreements or commitments outstanding or effectiv e granting any other person any right to use, operate under, license or sublicense or otherwise exploit any of the IP Rights.

No IP Rights are the subject of any outstanding order, judgement, injunction, decree, legal or governmental proceedings over covenant restricting or affecting in any material manner the use of the IP Rights.

All applications, registrations, annual fees and other fees in connection the IP Rights that are due before or on the Signing Date have been paid.

5.1.3

Equipment and Inventory

Seller is entitled and empowered to sell and transfer the Inventory as stated in this Agreement to Buyer.

Seller owns good and valid title to the Inventory, free and clear of any pledge, mortgage, lien, charge, encumbrance or other security interest and any rights of third parties.

5.1.4

Trademarks

Seller is entitled and empowered to sell and assign all Trademarks as stated in this Agreement.

All Trademarks are free and clear of any pledge, mortgage, lien, charge, encumbrance or other security interest and any rights of third parties.

No claims have been made or threatened in writing by competitors which are challenging the validity or enforceability of the Trademarks.

There are no assignments, licences, sublicenses, agreements or commitments outstanding or effective granting any other person any right to use, operate under, license or sublicense or otherwise exploit any of the Trademarks.

No Trademarks are the subject of any outstanding order, judgement, injunction, decree, legal or governmental proceedings over covenant restricting or affecting in any material manner the use of the Trademarks.

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All applications, registrations, annual fees and other fees in connection the Trademarks that are due before or on the Signing Dat e have been paid.

5.1.5

Documents and Electronic Data

Seller is entitled and empowered to sell, assign and transfer all Documents and electronic data as stated in this Agreement to Buyer.

Seller owns good and valid title to the Documents and electronic data, free and clear of any pledge, mortgage, lien, charge, encumbrance or other security interest and any rights of third parties. The transfer of the electronic data and Documents does not infringe any rights of third parties.

5.2	Representations and Warranties of Buyer

Buyer hereby represents and warrants to Seller that the representations and warranties as set forth in this Section 5.2 (" Buyer's Representations and Warranties ") are true and accurate in all respects as of the Signing Date and as of the Closing Date.

Buyer is duly incorporated and validly existing under the laws of the Republic of Ireland and has all requisite corporate power and authority to own its assets and to carry out its business.

5.3	Representations and Warranties Exclusive

Each Party acknowledges that, other than as expressly provided in Section 5.1 and Section 5.2, the other Party has not made, and does not make, and that it has not relied and does not rely on, any representation or warranty, express or implied, pertaining to the subject matter of this Agreement.

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5.4	Remedy of Buyer

5.4.1

Notice of Breach

Should Buyer detect any misrepresentation or breach of any of Seller's Representations and Warranties, Buyer shall, within the time period specified in Section 5.4.3, deliver to Seller a notice in writing describing the facts and the claim in reasonable detail (the " Notice of Breach "). If Buyer fails to deliver a Notice of Breach within the period of time specified in Section 5.4.3, the respective claims of Buyer for misrepresentation or breach of any of Seller's Representations and Warranties shall be precluded and forfeited ( verwirkt ).

If Seller has received a Notice of Breach in accordance with paragraph 1 of this Section within the time periods set forth in Section 5.4.3, and any claims in relation to such Notice of Breach have not been settled between the parties within a period of 60 (sixty) Business Days from the date of such Notice of Breach, Buyer shall, within a period of further 3 (three) months, initiate court proceedings in accordance with Section 7.10 in respect of such claim. Should Buyer not bring legal action in accordance with Section 7.10 within such 3 (three) months period, the respective claims of Buyer for misrepresentation or breach of Seller's Representations and Warranties shall be precluded and forfeited ( verwirkt ).

5.4.2

Seller's Right to Cure and Seller's Liability

With respect to a misrepresentation or a breach of Seller's Representations and Warranties notified by Buyer to Seller pursuant to Section 5.4.1, Seller shall have the right, within 60 Business Days after receipt of the Notice of Breach, to put Buyer in the same position in which it would have been if no misrepresentation or breach of such Seller's Representations and Warranties had occurred. lf, and to the extent that, such cure cannot be effected, or is not effected within such period, Seller shall pay to Buyer all damages, loss, costs and expenses ([excluding consequential, indirect and punitive damages, loss of profit or opportunities and management time]; the " Damage ") arising out of such misrepresentation or breach of Seller's Representations and Warranties with the limitations and exclusions as set out in Sections 5.4.3 through 5.4.5.

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5.4.3

Term of Representations and Warranties

Seller's Representations and Warranties shall survive until 6 months after the Closing Date.

5.4.4

Exclusion and Limitation of Liability for Matters Disclosed

All information, facts and circumstances concerning the Assets and the Transaction which have been disclosed in this Agreement including its appendices shall be deemed disclosed to Buyer and shall operate as an exclusion of, or limitation to, Seller's Representations and Warranties and Buyer's respective rights under Section 5.

5.4.5

Limitations of Remedies of Buyer

Seller shall only be liable for any and all claims and Damage of Buyer resulting from a misrepresentation or a breach of Seller's Representations and Warranties if such claim on a stand-alone basis exceeds the amount of CHF 50,000 (" De Minimis Amount "). Seller's liability for all misrepresentations and/or breaches of Seller's Representations and Warranties shall, in the aggregate, not exceed 100% of the cash paid to Seller as part of the Purchase Price at the time the breaches are communicated to Seller.

5.5	Remedy of Seller

The provisions of Section 5.4 shall apply by analogy with respect to any misrepresentation or breach of Buyer's Representations and Warranties.

5.6	Remedies Exclusive

No statutory examination or notification requirements shall apply to this Agreement. The provisions set forth in Section 5.4 shall supersede the provisions of articles 201 and 210 of the CO which shall not be applicable to this Agreement.

Furthermore, The remedies set forth in Section 5.4 and Section 5.5 shall be in lieu of and supersede any remedies provided for or available under applicable laws, and the Parties hereby waive Articles 192 et seq. CO, articles 197 et seq. CO (including article 200 CO and article 97 CO to the extent that it applies to misrepresentations or breaches of warranties). For the avoidance of doubt, this Section 5.6 does not exclude article 199 CO.

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6.	Covenants of the Parties

Seller undertakes to take all measures, sign all documents and effect all declarations necessary to give effect to the Transaction, in particular with regard to the transfer of the IP Rights at no additional costs.

7.	Miscellaneous Provisions

7.1	Transaction Costs and Taxes

Unless otherwise stated herein, each Party shall bear its own costs incurred in relation to this Agreement and the Transaction (including fees of attorneys, experts and advisors).

Unless otherwise stated in this Agreement, any and all taxes and other public charges imposed on one of the Parties in connection with this Agreement and the Transaction are to be borne by the Party on which such tax or public charge is imposed.

Any and all cost incurred in relation to the registration and transfer of IP Rights and Trademarks in connection with this Agreement and the Transaction are to be borne by Buyer.

7.2	Confidentiality

Except to the extent necessary to comply with (i) applicable law or (ii) any legal requirements of any governmental authority from time to time in force and save as permitted by this Agreement, no Party shall divulge or communicate to any person any information regarding this Agreement and/or the Transaction without the other Party's prior written consent.

7.3	Public Announcements

The Parties shall consult with each other before issuing any press release or otherwise making any public statement with respect to this Agreement and the Transaction unless required to do so by law or applicable stock exchange regulations.

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7.4	Entire Agreement

This Agreement constitutes the entire agreement between the Parties with respect to its subject matter, and shall replace all other prior agreements or understandings of the Parties relating thereto.

The Annexes and preamble to this Agreement form an integral part of this Agreement.

7.5	Amendments and Modifications

This Agreement, including this Section 7.5, may not be amended or modified except by a document in writing duly executed by the Parties. The Parties agree that they jointly negotiated and prepared this Agreement and that it shall not be construed against any Party on the grounds that such Party prepared it.

7.6

Notices

Any notice, request, consent or instruction deemed by any Party to be necessary or desirable to be given to the other Party, shall be validly given, made or served, if in writing and sent by registered mail, courier or fax (in the latter case, a copy also to be sent by registered mail) to the following addresses:

Any notice to be given to Seller hereunder shall be addressed as follows:

Neoptics AG

Bösch 80a

6331 Hünenberg

attn.: Simon Vischer

email: vischer@vischer-partner.ch

Any notice to be given to Buyer hereunder shall be addressed as follows:

Presbia PLC

120-121 Lower Baggot Street

Dublin 2

Republic of Ireland

with a copy to:

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PresbiBio, LLC

8845 Irvine Center Drive

Suite 100

Irvine, CA 92618

United States of America

attn.: Jarett Fenton

email: jfenton@presbia.com

Each Party may at any time change its address by giving notice to the other Party in the manner described above.

A notice shall be deemed to have been delivered on the calendar day it has been dispatched.

7.7	Severability

If any provision of this Agreement shall be invalid under applicable laws, the remaining provisions of this Agreement shall continue to be binding. Instead of the invalid provision, a rule shall apply that achieves as closely as possible the initial intention of the Parties in drafting the invalid provision.

7.8	Transfer and Assignment

Neither Party may assign any of its rights contained in this Agreement to any other party without the consent of the other Party. In case of liquidation of Seller, Seller shall be entitled to transfer its claims under this Agreement after expiry of any period to initiate claims for breach of representations and warranties.

7.9	Governing Law

This Agreement shall be governed by and construed in accordance with Swiss law, without regard to the conflict of laws principles and without regards to the Vienna Convention on international sales of goods.

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7.10	Jurisdiction

All disputes arising out of or in connection with this Agreement, including disputes on its conclusion, binding effect, amendment and termination, shall be resolved exclusively by the competent courts of Zug, Switzerland.

For Seller

Neoptics AG

__________________________ _____________________________________

Place, Date by: Simon Vischer by: Manuel Salvisberg

For Buyer

Presbia Ireland, Limited

__________________________ _____________________________________

Place, Date by: Todd Cooper

Table of Annexes

Annex 1: IP-Rights

Annex 2: Equipment and Inventory

Annex 3: Trademarks

Annex 4: Documents

Annex 5: Electronic Data

Annex 6: Transfer Agreement for IP Rights

Annex 7: Transfer Agreement for Trademarks

E xhibit 10.2

PRESBIA PLC

AMENDMENT NO. 1 TO

PRESBIA PLC INCENTIVE PLAN

The Presbia PLC Incentive Plan (the “Plan”) is hereby amended by the Board of Directors, subject to approval of shareholders of Presbia

PLC, as follows:

1. Section 3.2 of the Plan is hereby amended to increase the total number of Ordinary Shares available for issuance under the Plan by 400,000 shares and to limit the number of options and share appreciation rights that may be granted to any employee in any fiscal year, such that Section 3.2 of the Plan, as so amended, shall read in its entirety as follows:

3.2 Shares Reserved Under Plan . Subject to adjustment as provided in Section 9.3, the total number of Ordinary Shares which may be issued pursuant to Awards granted under the Plan shall not exceed 2,200,000 shares (all of which may be issued pursuant to the exercise of Incentive Stock Options). Such shares may be authorized but unissued Ordinary Shares or, to the extent permitted by applicable law, authorized and issued Ordinary Shares held in the Company’s treasury or acquired by the Company for the purposes of the Plan. The Committee may direct that any share certificate evidencing shares issued pursuant to the Plan shall bear a legend setting forth such restrictions on transferability as may apply to such shares pursuant to the Plan. If any Award is forfeited or otherwise terminates or is canceled without the delivery of Ordinary Shares or Ordinary Shares are withheld from any Award (other than restricted shares) to satisfy a Grantee’s tax withholding obligations, then the shares covered by such forfeited, terminated or canceled Award or which are equal to the number of shares withheld shall again become available for transfer pursuant to Awards granted or to be granted under this Plan. Any Ordinary Shares delivered by the Company, any Ordinary Shares with respect to which Awards are made by the Company and any Ordinary Shares with respect to which the Company becomes obligated to make Awards, through the assumption of, or in substitution for, outstanding awards previously granted by an acquired entity, shall not be counted against the shares available for Awards under this Plan. Notwithstanding the foregoing, in the case of the cancellation or forfeiture of Restricted Shares or other Awards with respect to which dividends have been paid or accrued, the number of shares with respect to such Restricted Shares or other Awards shall not be available for subsequent grants hereunder unless, in the case of shares with respect to which dividends were accrued by unpaid, such dividends are also canceled or forfeited. Subject to adjustment as provided in Section 9.3, no Employee may be granted Options or share appreciation rights in any one fiscal year of the Company with respect to more than 400,000 Ordinary Shares each.

2. In order to permit grants of performance-based Awards in accordance with Section 162(m) of the Internal Revenue Code of 1986, as amended, Article X is hereby added to the Plan, to read in its entirety as follows:

Article X

10.1 Grant . The Committee, in its discretion, may grant Awards that are intended to be exempt from the deduction limitation under Section 162(m) of the Code by virtue of the exception for “qualified performance-based compensation” under Section 162(m) of the Code (“Section 162(m) Awards”). Section 162(m) Awards must comply with the additional requirements set forth in this Article X, which shall control over any other provision that pertains to such Award.

10.2 Performance Measures .

(a) Each Section 162(m) Award shall be contingent on the attainment of one or more pre-established, objective performance goals based on one or more Performance Measures (“Performance Goals”). Further,

at the discretion of the Committee, a Section 162(m) Award may be su bject to goals and restrictions in addition to the attainment of Performance Goals.

(b) “Performance Measures” are one or more measures of performance based on one or more of the following criteria, or a combination of any of the following criteria, as determined by the Committee: (i) net earnings or net income (before or after taxes); (ii) earnings growth; (iii) earnings per share (including, but not limited to, growth in diluted earnings per share from continuing operations); (iv) net sales (including, but not limited to, net sales growth); (v) gross profits or net operating profit; (vi) return on assets, return on equity, return on capital or return on sales; (vii) cash flow (including, but not limited to, operating cash flow, free cash flow, cash flow return on capital and statutory cash measures); (viii) revenue growth; (ix) earnings before or after taxes, interest, depreciation, and/or amortization; (x) productivity ratios; (xi) Ordinary Share price (including, but not limited to, growth measures), (xii) total stockholder return; (xiii) expense targets; (xiv) gross or operating margins, earnings before or after taxes, interest, depreciation, and/or amortization margins; (xv) operating efficiency; (xvi) customer satisfaction or increase in the number of customers; (xvii) division working capital turnover; (xviii) strategic business or operational criteria consisting of one or more objectives based on meeting specified goals relating to (A) acquisitions or divestitures, (B) business expansion, (C) cost targets, (D) diversity and inclusion, (E) efficiency, (F) management of employment practices and employee benefits, (G) market penetration, (H) product quality and quality audit scores, (I) reductions in errors and omissions, (J) reductions in lost business, (K) supervision of litigation and information technology, or (L) sustainability; (xix) market share; (xx) cost reductions; (xxi) working capital targets; (xxii) sales backlog; (xxiii) net debt and (xxiv) economic value added. The foregoing criteria shall have any reasonable definitions that the Committee may specify, which may include or exclude any or all of the following items, as the Committee may specify: extraordinary, unusual or non-recurring items; asset write-downs; effects of changes in tax laws, accounting principles or other laws or provisions; effects of currency fluctuations; effects of industry volumes, customer mix or customer tooling payments and receipts; effects of financing activities (e.g., effect on earnings per share of issuing convertible debt securities); expenses for reorganizations and restructuring, productivity initiatives or new business initiatives; non-operating items; acquisition and divestiture expenses; effects of litigation or claim judgments or settlements and effects of acquisitions and divestitures (collectively, “Unusual or Non-Recurring Items”). Performance Goals may be (i) used to measure the performance of the Company and/or any of its Subsidiaries as a whole, any business unit thereof, or any combination thereof (ii) absolute or relative (to prior performance of the Company or to the performance of one or more other entities or external indices) and (iii) expressed in terms of a progression within a specified range.

(c) To the extent permitted by Section 162(m) of the Code, unless the Committee provides otherwise at the time of establishing the Performance Goals with respect to a Section 162(m) Award, for each fiscal year of the Company, the Committee shall have the authority to make equitable adjustments to the Performance Measures in recognition of any Unusual or Non-Recurring Item(s) affecting the Company or any Subsidiary.

(d) For each Section 162(m) Award, the Committee shall (i) select the Employee who shall be eligible to receive a Section 162(m) Award, (ii) determine the Performance Goals, (iii) determine the applicable period of service to which the Performance Goals relate (the “Performance Period”), and (iv) determine, in terms of an objective formula or standard, the method for computing the amount of compensation payable to the Employee if the Performance Goal is obtained. The Committee shall make the foregoing determinations prior to the commencement of the Performance Period applicable to an Award (or within the permissible time period established under Section 162(m) of the Code) and while the outcome of the Performance Goals is substantially uncertain.

10.3 Certification of Attainment of Performance Goals; Negative Discretion .

(a) After each Performance Period, but in all cases prior to payment or settlement of a Section 162(m) Award, the Committee shall certify in writing (which may include the written minutes for any meeting of

the Committee) that the Performance Goals and all other material terms applicable to a Section 162(m) Award were in fact satis fied. At the time of such certification, the Committee shall also determine the amount of compensation payable to the Employee as a result of the attainment of such Performance Goals. The Committee shall have no discretion to waive all or part of the Perfo rmance Goals applicable to the receipt of full or partial payment of a Section 162(m) Award, except in the case of a Change of Control or the death or disability of an Employee.

(b) Notwithstanding the foregoing, the Committee may, in its discretion, reduce any Section 162(m) Award based on such factors as may be determined by the Committee, including, without limitation, a determination by the Committee that such a reduction is appropriate in light of pay practices of competitors, or the performance of the Company, a Subsidiary or an Employee relative to the performance of competitors, or performance with respect to the Company’s strategic business goals.

10.4 Individual Participant Limitations . Subject to adjustment as provided in Section 4.2, with respect to Section 162(m) Awards intended to be exempt from the deduction limitation under Code Section 162(m), no Employee may be granted in any one fiscal year of the Company (a) Restricted Shares or restricted share units with respect to more than 400,000 Ordinary Shares each; and (b) performance shares, performance share units or other share-based Awards that are denominated in Ordinary Shares with respect to more than 400,000 Ordinary Shares each. The maximum dollar value payable to any Employee in any one fiscal year of the Company with respect to performance shares, performance share units or other share- or cash-based Awards that may be settled in cash or other property (other than Ordinary Shares) is $1,000,000. If an Award is cancelled, the cancelled Award shall continue to be counted towards the applicable limitations. The limitations in this Section 10.4 shall be interpreted and applied in a manner consistent with Section 162(m) of the Code.

ADOPTED BY BOARD OF DIRECTORS: June 15, 2016

ADOPTED BY SHAREHOLDERS: August 4, 2016

Exhibit 31.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER REQUIRED BY

RULE 13A-14(A) OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Todd Cooper, certify that:

1.	I have reviewed this Quarterly Report on Form 10-Q of Presbia PLC;

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements, and other financial informat ion included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

	(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)			Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
	(c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
	(d)	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 12, 2016	By:	/s/ Todd Cooper
		Todd Cooper
		Chief Executive Officer

Exhibit 31.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER REQUIRED BY

RULE 13A-14(A) OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Jarett Fenton, certify that:

1.	I have reviewed this Quarterly Report on Form 10-Q of Presbia PLC;

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements, and other financial informat ion included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

	(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)			Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
	(c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
	(d)	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 12, 2016	By:	/s/ Jarett Fenton
		Jarett Fenton
		Chief Financial Officer

Exhibit 32.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of Presbia PLC (the “Company”) for the quarterly period ended June 30, 2016 (the “Report”), the undersigned hereby certify in their capacities as Chief Executive Officer and Chief Financial Officer of the Company, respectively, pursuant to 18 U.S.C. section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: August 12, 2016	By:	/s/ Todd Cooper
		Todd Cooper
		Chief Executive Officer
		(Principle Executive Officer)

Date: August 12, 2016	By:	/s/ Jarett Fenton
		Jarett Fenton
		Chief Financial Officer
		(Principle Financial Officer)

A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signatures that appear in typed form within the electronic version of this written statement required by Section 906, has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.