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




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NameRegistration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934
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As at December 31, 

 

    

2017

    

2016

    

2015

    

2014

    

2013

 

 

(€ in thousands)

Statement of financial position data:

 

  

 

  

 

  

 

  

 

  

Cash and cash equivalents

 

48,099

 

59,200

 

94,865

 

112,736

 

4,129

Total assets

 

53,103

 

65,543

 

100,109

 

115,247

 

4,504

Total liabilities

 

13,778

 

12,407

 

10,310

 

5,843

 

4,593

Total shareholders’ equity

 

39,363

 

53,136

 

89,799

 

109,404

 

(89)

 

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Exchange rate information

Our business is primarily conducted in the European Union, and we maintain our books and records in euros. We have presented results of operations in euros. In this annual report, translations from euros to U.S. dollars were made at a rate of $ 1.1993 to € 1.00, the official exchange rate quoted by the European Central Bank at the close of business on December 31, 2017. As at March 9, 2018, the official exchange rate of Euro to U.S. dollars was $ 1.2291 to € 1.00. Such U.S. dollar amounts are not necessarily indicative of the amounts of U.S. dollars that could actually have been purchased upon exchange of euros at the dates indicated.

The following table presents information on the exchange rates between the euro and the U.S. dollar for the periods indicated:

 

 

 

 

 

 

 

 

 

 

    

Period-end

    

Average for period

    

Low

    

High

 

 

(€ per U.S. dollar)

Year ended December 31, 

 

  

 

  

 

  

 

  

2013

 

1.3791

 

1.3281

 

1.2768

 

1.3814

2014

 

1.2141

 

1.3285

 

1.2141

 

1.3953

2015

 

1.0887

 

1.1095

 

1.0552

 

1.2043

2016

 

1.0541

 

1.1069

 

1.0364

 

1.1569

2017

 

1.1993

 

1.1297

 

1.0385

 

1.2060

 

 

 

 

 

 

 

 

 

Month ended

 

  

 

  

 

  

 

  

September 30, 2017

 

1.1806

 

1.1915

 

1.1741

 

1.2060

October 31, 2017

 

1.1638

 

1.1756

 

1.1605

 

1.1856

November 30, 2017

 

1.1849

 

1.1738

 

1.1562

 

1.1952

December 31, 2017

 

1.1993

 

1.1836

 

1.1736

 

1.1993

January 31, 2018

 

1.2457

 

1.2200

 

1.1932

 

1.2457

February 28, 2018

 

1.2214

 

1.2348

 

1.2214

 

1.2493

 

B. Capitalization and indebtedness

Not applicable.

C. Reasons for the offer and use of proceeds

Not applicable.

D. Risk factors

Our business is subject to numerous risks and uncertainties. If any of these risks actually occurs, our business, prospects, operating results and financial condition could suffer materially. These risks include, but are not limited to, the following:

Risks Related to Our Capital Needs and Financial Position

We are a clinical stage biopharmaceutical company with a history of losses. We expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability, which could result in a decline in the market value of our ordinary shares.

We are a clinical stage biopharmaceutical company with a limited operating history, engaged in the discovery and development of RNA-based therapeutics for the treatment of severe genetic disorders. Since our inception in February 2012, we have devoted a significant portion of our resources to the development of our product candidates in cystic fibrosis (CF),  eluforsen,  Leber’s congenital amaurosis (LCA), QR 110, epidermolysis bullosa (EB), QR 313 and Usher syndrome, QR-421a. We have had significant operating losses since our inception. Our net losses for the years 

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ended December 31, 2015,  December 31, 2016 and December 31, 2017 were € 20,832,000, € 39,103,000 and € 43,675,000 respectively. At December 31, 2017, we had an accumulated deficit of € 119,370,000. Substantially all of our losses have resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations. Our technologies and product candidates are in early stages of development, and we are subject to the risks of failure inherent in the development of product candidates based on novel technologies.

To date, the only income we have generated has been from the receipt of research grants. Our ability to generate revenue and become profitable depends upon our ability to obtain marketing approval and successfully commercialize eluforsen, QR 110, QR 313, QR-421a or any other product candidates that we may develop, in-license or acquire in the future.

Even if we are able to successfully achieve regulatory approval for these product candidates, we do not know when any of these product candidates will generate revenue for us, if at all. We have not generated, and do not expect to generate, any product revenue for the foreseeable future, and we expect to continue to incur significant operating losses for the foreseeable future due to the cost of research and development, pre-clinical studies and clinical trials and the regulatory approval process for product candidates. The amount of future losses is uncertain. Our ability to achieve profitability, if ever, will depend on, among other things, us or any future collaborators successfully developing product candidates, obtaining regulatory approvals to market and commercialize product candidates, manufacturing any approved products on commercially reasonable terms, establishing a sales and marketing organization or suitable third party alternatives for any approved product and raising sufficient funds to finance business activities. If we or any future collaborators are unable to develop and commercialize one or more of our product candidates or if sales revenue from any product candidate that receives approval is insufficient, we will not achieve profitability, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

Our ability to generate revenue from our product candidates also depends on a number of additional factors, including our ability to:

 

·

 

successfully complete development activities, including the ongoing and planned pre-clinical and clinical studies for our product candidates;




 

·

 

complete and submit New Drug Applications, or NDAs, to the U.S. Food and Drug Administration, or FDA, and Marketing Authorization Applications, or MAAs, to the European Medicines Agency, or EMA, and obtain regulatory approval for indications for which there is a commercial market;




 

·

 

complete and submit applications to, and obtain regulatory approval from, other foreign regulatory authorities;




 

·

 

set a commercially viable price for any products for which we may receive approval;




 

·

 

obtain commercial quantities of our products at acceptable cost levels;




 

·

 

develop a commercial organization capable of sales, marketing and distribution for the products we intend to sell ourselves in the markets in which we have retained commercialization rights;




 

·

 

find suitable partners to help us market, sell and distribute our approved products that we do not intend to sell ourselves in one or more markets;




 

·

 

achieve acceptance among patients, clinicians and advocacy groups for any product we develop; and




 

·

 

obtain coverage and adequate reimbursement for our products from third-parties, including government payors.

In addition, because of the numerous risks and uncertainties associated with product development, including the risk that our product candidates may not advance through development or be shown to be safe and effective for their intended

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uses, the FDA, the EMA or other regulatory agencies may require additional clinical trials or pre-clinical studies or impose post-approval requirements.

We are unable to predict the timing or amount of increased expenses, or when or if we will be able to achieve or maintain profitability. Even if we are able to complete the processes described above, we anticipate incurring significant costs associated with commercializing our product candidates. Moreover, our first commercial sale of eluforsen, if ever, will trigger a milestone payment to Cystic Fibrosis Foundation Therapeutics, Inc., or CFFT, of approximately $ 16 million pursuant to our agreement with CFFT, and we may not have sufficient funds to support this payment obligation. Commercialization of QR-421a will trigger payments of up to $ 37.5 million pursuant to our agreement with Foundation Fighting Blindness, or FFB. See “Item 5. Operating and Financial Review and Prospects—Clinical support agreement” and the notes to the financial statements included elsewhere in this annual report for more details on these transactions.

Even if we are able to generate revenues from the sale of any of our product candidates, we may not become profitable and may need to obtain additional funding to continue operations. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce our operations.

We will require additional capital to fund our operations and if we fail to obtain necessary financing, we will not be able to complete the development and commercialization of our product candidates.

Our operations have consumed substantial amounts of cash since inception. We expect to continue to spend substantial amounts to conduct further research and development and pre-clinical testing and clinical trials of our product candidates, to seek regulatory approvals for our product candidates and to launch and commercialize any product candidates for which we receive regulatory approval, including potentially building our own commercial organization to address the United States, the European Union and certain other markets. As at December 31, 2017, we had € 48,099,000 in cash and cash equivalents. Based on our current operating plan, we believe that the existing cash and cash equivalents will be sufficient to fund our anticipated level of operations into the second half of 2019. However, our future capital requirements and the period for which our existing resources will support our operations may vary significantly from what we expect. Our monthly spending levels will vary based on new and ongoing development and corporate activities. Because the length of time and activities associated with successful development of our product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and commercialization activities. Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:

 

·

 

the initiation, progress, timing, costs and results of pre-clinical studies and clinical trials for our product candidates;




 

·

 

the clinical development plans we establish for these product candidates;




 

·

 

the number and characteristics of product candidates that we develop or may in-license, or programs that we may pursue in our innovation unit;




 

·

 

the terms of any collaboration arrangements we may choose to enter into;




 

·

 

the outcome, timing and cost of meeting regulatory requirements established by the FDA, the EMA and other comparable foreign regulatory authorities;




 

·

 

the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;




 

·

 

the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us or our product candidates;

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·

 

the effect of competing technological and market developments;




 

·

 

the cost and timing of completion of commercial-scale outsourced manufacturing activities; and




 

·

 

the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own.

We cannot be certain that additional funding will be available on acceptable terms, or at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our products or product candidates or one or more of our other research and development initiatives. We also could be required to seek collaborators for one or more of our current or future product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves.

Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

We may seek additional capital through a combination of private and public equity offerings, debt financings, strategic partnerships and alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, existing ownership interests will be diluted and the terms of such financings may include liquidation or other preferences that adversely affect the rights of existing shareholders. Debt financings may be coupled with an equity component, such as warrants to purchase shares, which could also result in dilution of our existing shareholders’ ownership. The incurrence of indebtedness would result in increased fixed payment obligations and could also result in certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business and may result in liens being placed on our assets and intellectual property. If we were to default on such indebtedness, we could lose such assets and intellectual property. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, or grant licenses on terms that are not favorable to us.

We have a limited operating history, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

We were founded in February 2012 and began operations in May 2012. Our operations to date have been limited to organizing and staffing our company, acquiring and developing product and technology rights, and conducting development activities for our product candidates. Consequently, any predictions about our future success, performance or viability may not be as accurate as they could be if we had a longer operating history, more experience with clinical development or approved products on the market.
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