Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934




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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 20 F

 

 

(Mark One)

☐   REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

 

OR

 

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

 

For the fiscal year ended December 31, 2017

 

OR

 

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

 

OR

 

☐   SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

Date of event requiring this shell company report: Not applicable

For the transition period from           to         

 

Commission file number 001 36622

 

 

PROQR THERAPEUTICS N.V.

(Exact name of Registrant as specified in its charter)

 

 

 

The Netherlands

(Jurisdiction of incorporation or organization)

 

Zernikedreef 9

2333 CK Leiden

The Netherlands

(Address of principal executive offices)

 

Smital Shah, Chief Financial Officer

Tel: +31 88 166 7000

sshah@proqr.com, Zernikedreef 9, 2333 CK Leiden, The Netherlands

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

 

 

Securities registered or to be registered pursuant to Section 12(b) of the Act:

 

Title of each class

    

Name of each exchange on which registered

Ordinary Shares, nominal value € 0.04 per share

 

NASDAQ Stock Market

 

Securities registered or to be registered pursuant to Section 12(g) of the Act:

 

Table of Contents

None

(Title of Class)

 

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:

None

(Title of Class)

 

 

 

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.

Ordinary shares, nominal value € 0.04 per share: 31,921,865

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

☐ Yes   ☒ No

 

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

☐ Yes   ☒ No

 

Note – Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.

 

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   ☐ No

 

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   ☐ No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b 2 of the Exchange Act. (Check one):

 

 

 

 

 

 

 

☐ Large accelerated filer

☒ Accelerated filer

☐ Non-accelerated filer

☒ Emerging growth company

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards†  provided pursuant to section 13(a) of the Exchange Act.

†The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

☐ U.S. GAAP

☒ International Financial Reporting Standards as issued by the International Accounting Standards Board

☐ Other

 

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

☐ Item 17   ☐ Item 18

 

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b 2 of the Exchange Act).

☐ Yes   ☒ No

 

 

 

 

Table of Contents

TABLE OF CONTENTS

 

 

Page

 

 

 

Introduction 

4

 

 

Forward-looking statements 

5

 

 

Part I 

6

 

 

 

Item 1: Identity of Directors, Senior Management and Advisers

6

 

 

 

Item 2: Offer Statistics and Expected Timetable

6

 

 

 

Item 3: Key Information

6

 

 

 

 

A. Selected financial data

6

 

 

 

 

B. Capitalization and indebtedness

7

 

 

 

 

C. Reasons for the offer and use of proceeds

7

 

 

 

 

D. Risk factors

7

 

 

 

Item 4: Information on the Company

43

 

 

 

 

A. History and development of the company

43

 

 

 

 

B. Business overview

43

 

 

 

 

C. Organizational structure

96

 

 

 

 

D. Property, plants and equipment

96

 

 

 

Item 4A: Unresolved staff comments

96

 

 

 

Item 5: Operating and Financial Review and Prospects

96

 

 

 

 

A. Operating results

97

 

 

 

 

B. Liquidity and capital resources

103

 

 

 

 

C. Research and development, patents and licenses, etc.

107

 

 

 

 

D. Trend information

107

 

 

 

 

E. Off-balance sheet arrangements

107

 

 

 

 

F. Tabular disclosure of contractual obligations

108

 

 

 

 

G. Safe harbor

108

 

 

 

Item 6: Directors, Senior Management and Employees

108

 

 

 

 

A. Directors and senior management

108

 

 

 

 

B. Compensation

111

 

 

 

 

C. Board practices

112

 

 

 

 

D. Employees

116

 

 

 

 

E. Share ownership

116

 

 

 

Item 7: Major Shareholders and Related Party Transactions

116

 

 

 

 

A. Major shareholders

116

 

 

 

 

B. Related party transactions

118

 

 

 

 

C. Interests of experts and counsel

119

 

 

 

Item 8: Financial Information

119

 

1

 

Table of Contents

 

 

 

 

 

A. Consolidated Statements and Other Financial Information

119

 

 

 

 

B. Significant Changes

120

 

 

 

Item 9: The Offer and Listing

120

 

 

 

 

A. Offering and listing details

120

 

 

 

 

B. Plan of distribution

120

 

 

 

 

C. Markets

120

 

 

 

 

D. Selling shareholders

120

 

 

 

 

E. Dilution

121

 

 

 

 

F. Expenses of the issue

121

 

 

 

Item 10: Additional Information

121

 

 

 

 

A. Share capital

121

 

 

 

 

B. Memorandum and articles of association

121

 

 

 

 

C. Material contracts

129

 

 

 

 

D. Exchange controls

129

 

 

 

 

E. Taxation

130

 

 

 

 

F. Dividends and paying agents

138

 

 

 

 

G. Statement by experts

138

 

 

 

 

H. Documents on display

138

 

 

 

 

I. Subsidiary information

139

 

 

 

Item 11: Quantitative and Qualitative Disclosures about Market Risk

139

 

 

 

Item 12: Description of Securities other that Equity Securities

140

 

 

 

 

A. Debt securities

140

 

 

 

 

B. Warrants and rights

140

 

 

 

 

C. Other securities

140

 

 

 

 

D. American depositary shares

140

 

 

 

Part II 

 

 

 

 

Item 13: Defaults, Dividend Arrearages and Delinquencies

141

 

 

 

Item 14: Material Modifications to the Rights of Security Holders and Use of Proceeds

141

 

 

 

Item 15: Controls and Procedures

141

 

 

 

 

A. Disclosure controls and procedures

141

 

 

 

 

B. Management’s annual report on internal control over financial reporting

141

 

 

 

 

C. Attestation report of the registered public accounting firm

142

 

 

 

 

D. Changes in internal control over financial reporting

142

 

 

 

Item 16A: Audit Committee Financial Expert

142

 

2

 

Table of Contents

 

Item 16BCode of Ethics

142

 

 

 

Item 16CPrincipal Accountant Fees and Services

142

 

 

 

Item 16DExemptions from the Listing Standards for Audit Committees

142

 

 

 

Item 16EPurchases of Equity Securities by the Issuer and Affiliated Purchasers

142

 

 

 

Item 16FChange in Registrant’s Certifying Accountant

143

 

 

 

Item 16GCorporate Governance

143

 

 

 

Item 16HMine Safety Disclosure

143

 

 

 

Part III 

 

 

 

 

Item 17Financial Statements

143

 

 

 

Item 18Financial Statements

143

 

 

 

Item 19Exhibits

144

 

 

3

 

Table of Contents

Introduction

This document contains information required for the annual report on Form 20 F for the year ended December 31, 2017 of ProQR Therapeutics N.V. (the “2017 Form 20 F”). Unless the context specifically indicates otherwise, references in this 2017 Form 20 F to “ProQR Therapeutics N.V.”, “ProQR Therapeutics”, “ProQR”, “we”, “our”, “ours”, “us”, the “Company” or similar terms refer to ProQR Therapeutics N.V.

IFRS based information

The audited financial statements as at December 31, 2017 and 2016, and for the years ended December 31, 2017,  December 31, 2016 and December 31, 2015, included in the 2017 Form 20 F have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB).

Non-GAAP information

In presenting and discussing our financial position, operating results and cash flows, management uses certain non-GAAP financial measures. These non-GAAP financial measures should not be viewed in isolation as alternatives to the equivalent IFRS measure and should be used in conjunction with the most directly comparable IFRS measure(s).

Exchange rates

All references in this annual report to “U.S. dollars” or “$” are to the legal currency of the United States, and all references to “€” or “euro” are to the currency of the European Economic and Monetary Union. Our business to date has been conducted primarily in the European Union, and we prepare our financial statements in euros.

Fair value information

In presenting our financial position, fair values are used for the measurement of various items in accordance with the applicable accounting standards. These fair values are based on market prices, where available, and are obtained from sources that are deemed to be reliable. Readers are cautioned that these values are subject to changes over time and are only valid at the balance sheet date. When quoted prices or observable market values do not exist, fair values are estimated using valuation models, which we believe are appropriate for their purpose. They require management to make significant assumptions with respect to future developments which are inherently uncertain and may therefore deviate from actual developments. Critical assumptions used are disclosed in the financial statements. In certain cases, independent valuations are obtained to support management’s determination of fair values.

Trademarks

“ProQR” and “Axiomer” are our trademarks. Other trademarks or trade names referred to in this annual report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this annual report may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent permissible under applicable law, their rights thereto.

4

 

Table of Contents

Forward-looking statements

Pursuant to provisions of the United States Private Securities Litigation Reform Act of 1995, ProQR is providing the following cautionary statement.

This document contains certain forward looking statements with respect to the financial condition, results of operations and business of ProQR and certain of the plans and objectives of ProQR with respect to these items. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events, including our clinical development plans or our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements, including in relation to the clinical development of eluforsen (formerly known as QR 010), QR 110, QR 313, QR-421a or any other pipeline program, to be materially different from any future results, performance or achievements, including in relation to the clinical development of eluforsen, QR 110, QR 313, QR-421a or any other pipeline program, expressed or implied by these forward-looking statements. Forward-looking statements can be identified generally as those containing words as “aim,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, although not all forward-looking statements contain these identifying words.

Forward-looking statements appear in a number of places in this Annual Report and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to management. By their nature, forward-looking statements involve risk and uncertainty, because they relate to events that depend on circumstances that will occur in the future. As a result, ProQR’s actual future results may differ materially from the plans, goals and expectations set forth in such forward-looking statements. For a discussion of factors that could cause future results to differ from such forward-looking statements, reference is made to the information in Item 3.D: “Risk Factors”.

Forward-looking statements speak only as of the date they are made, and we do not undertake any obligation to update them in light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events.

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